NC MPJE Prep

RxPrep: What are the requirements for selling dextromethorphan?

None in NC

When must a pharmacist register for the NCCSRS?

Must individually register for access to the CSRS w/in 30 days after obtaining an initial or renewal of pharmacy license (if controls are dispensed)

What is the purpose of DEA Form 510?

Wholesale Distribution of SLCPs (i.e. Pseudoephedrine)

What notation is required when dispensing a donated drug?

Must remove any HIPAA protected info from donated items before the dispensing to patient and note that the donated drug was dispensed - either on the face of a written Rx or in the electronic record of a prescription · Keep ALL donated items SEPARATE from other inventories

Are $4 or $10 lists by retail pharmacies acceptable?

$4 and $10 generic drug list advertising are OKAY per FDA because they are considered "reminder advertising"

RxPrep: 1) What are the requirements for pharmacist to be designated as a "provider" and what tasks are permitted under this designation? 2) Does a CPA have to be submitted to the BOP? 3) How often does a CPA have to be renewed? 4) What actions can be performed under a CPA? 5) Are there any restrictions on what diseases a pharmacist can manage under a CPA?

(1) -CPPs must have an unrestricted license and an agreement w/ a supervising prescription. In addition, must have at least ONE of the following: 1) Completed a Board of Pharmaceutical Specialties (BPS) Certification or Geriatric certification, or an ASHP accredited residency program and have 2 years of clinical experience 2) Earned a PharmD, have 3 years experience, and have completed a certificate program 3) Earned a BS degree, have 5 years of experience, and have completed TWO certificate programs -CPPs have the ability to prescribe and modify medications as aa mid-level practitioner (2) YES 3) Annually 4) Prescribe, review, evaluate and manage drug therapy 5) NO

RxPrep: FDA and USP say that the BUD for UNIT-DOSE containers is NO LATER than the EARLIEST of ___________

(1) 6 months from the repackaging date or (2) Manufacturer's EXP date

Records that must be kept by ALL pharmacies include:

(1) Patient profile for every person that has filled a prescription: -Patient name, address, phone number, DOB, Gender, drugs previously dispensed, any other info pharmacist deems important (2) Dispensing record for each patient: -Rx number, name and manufacturer of drug dispensed, Quantity dispensed with each fill, name or initials of dispensing pharmacist, date of fill (or refill), number of refills remaining (3) Receipt for all drugs purchased and received by the pharmacy -Transaction info (TI), Transaction history (TH), and a Transaction Statement (TS) to satisfy the requirements of the Drug Supply Chain Scurity Act (4) Compounding log (when applicable) (5) DEA Form 222 copies and other CS records, such as inventory (6) Logbook for the OTC sale of ephedrine or pseudoephedrine products

Reporting requirements for pharmacies that compound: pharmacies that perform ANY type of compounding shall notify BOP (both on initial permit application AND on each annual renewal) --> WHAT to report?

(1) whether they compound (2) good-faith estimate of the percentage of dispensing that involves compounded products (3) Whether the pharmacy engages in NS, S, or both (4) What risk level of S compounding the pharmacy performs as defined by USP 797

Can a pharmacy deliver a filled Rx for a buprenorphine to supply their office stock for general dispensing to patients? What about a single patient's Rx?

-A pharmacy MAY deliver a filled Rx for a buprenorphine implant or injection to the Practitioner's office after receiving a patient specific Rx -The Rx may NOT be issued to supply their office stock for general dispensing to patients § Must be delivered to the address on the Practitioner's DEA certificate of registration to the prescribing Practitioner OR the Practitioner administering the medication

Who is EXEMPT from registering with the DEA?

-Agents or employees of registrants, drug reps, common carriers, ultimate users, law enforcement officers, and prescribers and dispensers in the service of the US government -NOTE: Government practitioners may wish to maintain a DEA number for private practice

Can Basaglar be dispensed for glargine?

-Approved by FDA in 2015 as the first "follow-on" glargine product to treat DM -Considered a FOLLOW-ON biologic, NOT a biosimilar and is NOT in the Purple Book -The ONLY way you can dispense Basaglar is if the prescriber specifically writes for it

What is the goal of the Poison Prevention Packaging Act?

-Goal is to prevent ingestions of common substances found around the house by children (meds, solvents, furniture polish, etc.) -Meds (OTC and Rx) must be stored and dispensed in child-resistant containers (child-proof lids)

What should be done if a loss of controlled substances occurs In-Transit? Who is responsible-the pharmacy or the supplier?

-If all or part of an in-transit shipment fails to reach the pharmacy, the SUPPLIER is responsible until he purchaser "takes custody" (signs} for the shipment -If the pharmacy signs for the shipment and discovers a loss, the PHARMACY must complete the DEA Form 106

Which controls can each type of mid-level practitioners prescribe?

-PAs and NPs: Schedule 2-3 (limited to 30 day supply), schedule 4-5 drugs O fell like this might be for TCS

RxPrep: What requirements must be met before an out-of-state pharmacy can compound drugs for dispensing to pts in this state (e.g. inspections, permits, fees)?

-Submit evidence of registration in the state where the BOP is located, inspection reports (either by the NCBOP or the board in the state of residence) -Annual fee for registration

RxPrep: What intern/technician functions can be done w/o the presence of a pharmacist?

-Techs can process the transaction for prescriptions already checked by the pharmacist, receive and assemble new Rxs -Certified Techs can receive telephone Rxs if a policy has been made by the pharmacy-manager

What if the total number of dosage units distributed to practitioners exceeds 5% of TOAL number of dosage units of controls distributed and dispensed by the pharmacy during a calendar year?

-The pharmacy would then have to register with the DEA as a DISTRIBUTOR

If requesting DEA assistance for help with destroying controlled substances, what are the options?

-Transfer to a registrant authorized to transport or dispose of the drug -Delivery to a DEA agent or office -Destruction in the presence of a DA agent or authorized person o Must fill out a DEA Form 41 to record the destruction of controls (ALL schedule à requires TWO witnesses) § Must record: Drug name, NDC, strength, package quantity, number of full packages, and partial package count of each control to be disposed

C3-C5s can be dispensed pursuant to _____________

-WRITTEN, FAXED, ELECTRONIC, or VERBAL order -Whereas C2s are normally just written or electronic (there are exceptions) -Verbals must be promptly reduced to writing by the pharmacist -Written and faxed Rxs must have prescriber's signature

Q: What are the responsibilities of a Pharmacist-Manager?

-The Pharmacist-Manager must notify the Board within 30 days of employing a pharmacy technician and must provide a training program for each technician covering each of several prescribed topics -All Pharmacist-Managers shall notify the Board of any change in pharmacist personnel within 30 days of such change -Every Pharmacist-Manager shall maintain prescription records for at least three years -Every Pharmacist-Manager or other pharmacist at his discretion, shall review prescription records at least weekly in health departments and be responsible for all dispensing at health department clinics -The Pharmacist-Manager accepts responsibility for the operation of a pharmacy in conformance with all statutes and regulations pertinent to the practice of pharmacy -Permits are issued to the Pharmacist-Manager and must be counter-signed by the PharmacistManager -The permit is only valid as long as the Pharmacist-Manager performs duties as required by law -A Pharmacist-Manager must personally appear at the Board's office to obtain a permit -The Pharmacist-Manager has the responsibility for security of fax transmissions of prescriptions including readable records -In Health Departments Pharmacist-Managers must [.2400]: (a) Develop a system of control and accountability of all drugs dispensed (b) Verify accuracy of records either weekly or daily depending on prescription volume (c) Is personally responsible for compliance with all laws governing the practice of pharmacy and distribution of drugs -The Pharmacist-Manager is responsible for [.2502]: (a) Assuring that all prescription drugs and controlled substances are safe and secure in the pharmacy (b) Being present at least half the time the pharmacy is open or 32 hours per week, whichever is less; a pharmacist employee not meeting this requirement may serve as pharmacist-manager of the permit holder temporarily for a period not to exceed 90 days from the departure date of the previous pharmacist-manager, if the pharmacist employee is present at least 20 hours per week in the pharmacy (c) Completing a controlled substance inventory within 10 days of a change in pharmacist-manager (d) Developing a system of inventory record keeping and control to detect any shortages or discrepancies in controlled substances at the earliest possible time (e) Control of all keys to the pharmacy as well as the ultimate security of the pharmacy (f) Serving as Pharmacist-Manager at only one full service permit at one time (g) Informing the Board and DEA of a pharmacy closing and arrange for the proper transfer of files and pharmaceuticals to another pharmacy (h) Preparing a plan to safeguard prescription records and pharmaceuticals in the event of a natural disaster such as a hurricane (i) Separating from the dispensing stock all pharmaceuticals over 6 months out of date (j) Reporting to the Board any deaths due to drugs dispensed through the pharmacy -Pharmacist-Managers where sterile pharmaceuticals are prepared must be knowledgeable in specialized functions including aseptic techniques and quality assurance (a) Develop all policies, procedures and training manuals as well as quality assurance programs (b) The Pharmacist-Manager is responsible for a system for disposing of infectious wastes Pharmacist-Managers in Hospitals and Other Health Facilities: -The Pharmacist-Manager in a health care facility shall be an employee of the health care facility who is thoroughly familiar with the specialized functions of health care facility pharmacy practice who is responsible for meeting the requirements of law [14.10(a)] -The Pharmacist-Manager shall develop and implement written policies and procedures to be performed and insure that an adequate number of qualified and trained pharmacists are employed at the facility -The Pharmacist-Manager shall establish written procedures for the safe and effective distribution of pharmaceuticals and many other responsibilities including the detection of discrepancies in controlled substances records [.1411(a) and (b)] -The Pharmacist-Manager in a facility without 24 hour day, 7 day a week pharmacy services has several responsibilities for activities which occur in the absence of a pharmacist [.1413(a), (b) and (c)] -The Pharmacist-Manager shall develop policies and procedures for preparation and labeling of parental admixtures [.1414(d)(2)] -The Pharmacist-Manager shall develop an approved drug list for unit dose inventories [.1414(f)] -The Pharmacist-Manager, in connection with appropriate committees, shall develop a list of drugs to be placed in ancillary drug cabinet inventories [.1414(g)] -The Pharmacist-Manager shall develop policies and procedures for automatic dispensing devices such as Pyxis machines [.1414(h)] -The Pharmacist-Manager shall develop policies and procedures for emergency kits [.1414(I)] -The Pharmacist-Manager has extensive responsibilities for medication records in health care facilities [.1414(j)] -The Pharmacist-Manager has responsibility for developing and supervising a system of control and accountability including a formulary for drugs dispensed from the emergency department

According to NC law, LTCF are grouped together with ________ as "________"

-hospitals -HCFs

Prescribing or administering a narcotic to maintain addiction is illegal outside of narcotic Tx facilities (methadone clinics) or "qualifying practitioners" prescribing buprenorphine products 1) What are the exceptions to this law?

1) -A physicians may administer from his/her office supply, but NOT prescribe, narcotic drugs for 3 DAYS while arrangements are being made for referral for Tx, w/ only a ONE DAY supply medication given at a time to alleviate acute withdrawal Sx -Hospitalized patients incidental to treating a condition other than addiction

1) Records of DISPENSING must be made and kept for pharmacies for ________ 2) What info is kept? 3) The pharmacy file copy of every Rx shall include ________________

1) 3 YEARS 2) -Quantity dispensed, if the quantity of the refill is different than the quantity of the orginal -Date of dispensing -Serial number (or equivalent in an institution) -Patient name and address -ID of the pharmacist responsible for filling -Records of refills to date -Records of dispensing in institutional pharmacies may be made and kept as part of the patient's medical record 3) the brand or generic name, if any, or the established name AND the manufacturer of the drug dispensed -In pharmacies who use a MANUAL system of record keeping, the dispensing pharmacist must initial and date EACH filling on the document -Pharmacies may also use an "automated data processing system" to identify the date and dispensing pharmacist

First letter of DEA numbers: 1) If a physician: 2) Mid-level practitioner:

1) A, B, F, or G 2) M

1) When is an IND (investigational new drug) filed for a new drug? 2) When is a NDA (new drug application) or BLA (biologic license application) filed for a new drug?

1) AFTER a drug is proven safe in ANIMAL studies but BEFORE phase 1 trials -IND represents the FDA's permission to BEGIN phase 1 trials 2) AFTER a phase 3 trial --> reviewed within 10 months (6 months for priority drugs)

1) How often do Manufacturers and Distributors have too renew their DEA registrations? 2) How about Dispensers (pharmacists) and practitioners (prescribers)?

1) ANNUALLY 2) every THREE years NOTE: DEA Certificate of Registration must be maintained at the registered location

If a pharmacist's license lapses, what steps can be taken for reinstatement?

1) Apply to the BOP 2) Pay reinstatement and renewal fees 3) Undergo criminal background check 4) if they have not practiced in the last 2 years, may have to take additional CE, take one or more parts of the licensure examination, undergo practical pharmacy experience (as determined by the board) 5) If license lapsed for 5+ years, appear before the BOP

1) Definition of a breach in PHI: 2) Exceptions to a breach in PHI 3) What actions must a pharmacy take in case of a breach? 4) Factors to consider when determining if a breach occurred:

1) Breach is defined as impermissible use or disclosure under privacy rule that compromises the security or privacy of PHI 2) Unintentional acquisition of PHI at a covered entity location or inadvertent disclosure between two individuals at the same covered entity (i.e. two physicians at the same hospital) 3) o Pharmacy must determine if a breach occurred and document and demonstrate why the breach met an exclusion or that there is a low probability that the PHI has been compromised à either way the event must be documented (retained for 6 YEARS) 4) § The nature of the PHI involved § The unauthorized person who used the PHI or to whom the disclosure was made § Whether the PHI was actually acquired or viewed § The extent to which the risk to the PHI has been mitigated § A pharmacy can use these factors to determine if there is a low probability that PHI has been compromised

1) What is the purpose of DEA Form 224? 2) What is the purpose of DEA Form 224a? 3) What is the purpose of DEA Form 224b?

1) Dispenser registration ("Dispenser" includes prescribing, administering, and dispensing --> thus, retail pharmacies, hospitals, physicians, and mid-levels will use this form) 2) Renewal registration for dispensers 3) chain pharmacy renewal

Requirements to become/continue to be an immunizing pharmacist:

1) Hold a current provider level CPR certification 2) Successfully completed a certificate program in vaccine administration 3) Maintain documentation of THREE HOURS of CE (vaccine topics) every TWO YEARs 4) Complete training approved by the Division of Public Health's Immunization Branch for participation in the NC Immunization Registry 5) Notify the NCBOP and the NC Medical Board of Immunizing pharmacist Status

What should the pharmacist do if a prescriber writes "PRN" for the number of refills?

1) If the prescriber writes "PRN" as the amount of refills for an Rx, that Rx shall NOT be refilled MORE THAN ONE YEAR after the issue date, unless otherwise specified -Ex. Prescriber can write PRN x 2 years **NON-control refills can be refilled for more than 1 years (recall no expiration of non-control)

1-3) What donated items can be accepted by a pharmacy? 4) What can NOT be accepted?

1) In the original, unopened, sealed, and tamper-evident packaging -If packaged in SINGLE-unit doses, the single unit dose is unopened 2) Pharmacist has determined the drug, supplies, or medical device is safe for redistribution 3) NOT expired, adulterated, or misbranded 4) o Control o Drug that is subject to a restricted distribution system o Biologicals, UNLESS donated by the manufacturer or a prescription drug wholesaler o Compounded drugs or parenteral admixtures o ANY drug requiring refrigerated storage unless donated y the (a) manufacturer (b) prescription drug wholesaler or (c) pharmacy that has stored the drug according to the manufacturer's labeling and has NOT previously dispensed the drug

RxPrep: What are the state-specific requirements for selling select Schedule 5 cough syrup w/o a prescription?

1) Must be at least 18 yrs old and proof of age is required 2) Name and address of the purchaser must be documented

Responsibilities of Pharmacy Manager (PM) When a pharmacy is closing permanently: 1) Inform _____ and _____ and arrange for deposition of controlled substances 2) Return the pharmacy permit to _____ w/in ___ of the closing date 3) If possible, provide notice to the public w/in ____ day of closing, and keep sign posted until ____ after the closing date 4) If pt do not transfer the Rxs, the PM shall __________ 5) If pharmacy is closing more than ____ consecutive days (but not closing permanently), must provide similar notice to the public as above

1) NC-BOP and DEA 2) NCBOP -10 days 3) 30 days -15 days 4) transfer prescription files to another pharmacy for maintenance of pt therapy and inform public on the notice 5) 14 days

RxPrep: 1) Other than Rxs for Medicaid pts, do Rxs require tamper-resistant security forms? 2) What security elements must be on tamper-res security forms?

1) NO 2) Follows federal requirements -One or more features designed to prevent unauthorized copying of a completed or blank Rx form -One or more features designed to prevent the erasure or modification of info written on the Rx by the prescriber -One or more features designed to prevent the use of counterfeit Rx forms

RxPrep: 1) Does NC have stricter requirements for compounding than federal laws? 2) Any differences in labeling compounded products?

1) NO 2) No, same as federal laws

RxPrep: 1) Does NC require an Rx for syringes and needles? 2) Does NC allow syringe exchange programs?

1) NO 2) Yes

1) If a Practitioner prescribes from multiple offices, do they need more than one DEA registration? 2) When would they need multiple registrations?

1) NO -KEY: only ONE DEA registration is required if they are ONLY PRESCRIBING controls 2) Administering, dispensing, or storing controls in each office WOULD require more than one registration

RxPrep: 1) What is the MAX days supply that can be dispensed for an emergency refill of Schedule 3-5s w/o prescriber authorization? 2) What are the additional requirements when dispensing an emergency refill for Schedule 3-5s?

1) One-time refill for up to 30 day supply (same as non-controls) 2) Dispensing pharmacist must notify prescriber w//in 72 hrs

RxPrep: 1) What is the name of the inspection or assessment form/s used by pharmacists? 2) Who is required to complete the inspection and form? 3) How often does this need to be completed? 4) Does the completed form have to be sent to BOP or kept at pharmacy?

1) Pharmacy Inspection Report 2) The pharmacist manager may fill out the inspection form prior to scheduled inspections to ensure the pharmacy is compliant -The Board inspector will fill out the official version of the form during the inspection 3) -Annual for high-risk compounding facilities -Every 2 years for pharmacies with medium-risk compounding -Every 4 years for pharmacies w/low-risk compounding and for retail pharmacies 4) Final form will be used to create a Corrective Action Plan for any significant deficiencies -The Board inspector will return in 90 days and deficiencies must be corrected -BOTH the pharmacy and Board will retain copies

1) Which formulations of pseudoephedrine do the state laws NOT apply to? 2) Does this change with regards to federal?

1) State law does NOT apply to any pseudoephedrine product that is in the form of a LIQUID, LIQUID CAPSULE, GEL CAPSULE, or PEDIATRIC PRODUCT 2) However, federal law applies to ALL pseudoephedrine products, therefore, the quantity limits still apply to the above products

RxPrep: What additional activities are certified technicians allowed to do (e.g. filling, taking verbal Rxs)?

1) Transfers 2) Receive telephone Rx orders while pharmacist is on break 3) Serve as "validating technician" in the hospital 4) Potential for increase in Pharm/Tech ratio

1) Can Shipping and financial records (invoices and packing slips) for controls be kept at a central location? 2) How about Executed order forms, prescriptions, and inventory records?

1) Yes w/ notification to the DEA -Registrant may begin central recordkeeping 14 days AFTER the DEA receives notification, UNLESS DEA denies permission -Records must be able to be delivered to registered location w/in 2 business days at request of DEA or allow DEA to inspect the central location w/o a warrant 2) NO --> (must be kept at the registered location-i.e. at the pharmacy)

KEY requirements of the Compounding Act: 1) Law makes it clear that compounds may only be dispensed pursuant to ______ 2) Can you compound "for office use only"? 3) If you want to compound WITHOUT an Rx, you must register as _____________

1) an Rx 2) § NO LONGER able to compound "for office use only" --> included BOTH sterile and non-sterile products 3) an outsourcing facility (hospitals generally do not need to register)

Procedure for Disposing of Drugs 1) Non-controlled substances: 2) CONTROLS:

1) returning them to the manufacturer, by incineration at a properly permitted facility, or by any other means approved by BOP -Destruction of meds must be witnessed by a licensed pharmacist and documented -A form is available on the BOP's website that must be filled out (pharmacy name, PM, pharmacist-witness, drugs to be disposed, etc.) -Once approved by the BOP, disposal may take place 2) file a written request on a form provided by the BOP for approval of witnesses and method of disposal o After approved, form will be mailed back to the pharmacy o If destroyed at the pharmacy, shall be jointly witnessed by AT LEAST 2 licensed pharmacists approved by the BOP o Document and sign after the destruction occurs end a copy to the DEA, and retain for 3 YEARS and fill out DEA Form 41

What are the standards for Schedule 6 controls in NC? 1) May be dispensed or distributed ONLY for ___________ 2) Hemp extract (< _____THC and >/= ______ cannabidiol by weight) 3) MAY be used by a person with __________

1) scientific or research purposes 2) 0.9% -5% 3) intractable epilepsy (hemp to be acquired in another jurisdiction)

ANYONE that compounds 1) Manufacturer of bulk compounding substances MUST be registered with ______ and MUST send __________ with EACH bulk drug 2) Ingredients (aside from bulks) used to compound must comply with _______ standards 3)Can NOT compound what?

1) the FDA -a valid certificate of analysis with EACH bulk drug 2) USP/NF 3) a drug product that presents demonstrable difficulties for compounding (as identified by the FDA) -Can NOT compound "essentially a copy of a commercially available drug" -EXCEPTION: making a change for a patient that produces a CLINICAL DIFFERENCE as determined by the prescribing practitioner (i.e. different dose, liquid form, pt allergic to a component of commercially available product) -MUST document reason on Rx

1) WHat has to be accessed BEFORE giving a vaccine? 2) After giving a vaccine, must Notify the patients PCP within _____ after administering ANY vaccine 3) What else is required?

1) · Access the NC Immunization Registry BEFORE giving the vaccine 2) 72 hours -o If they do not have a PCP, give patient info about benefits of having a PCP 3) Log into the NC NC Immunization Registry within 72h (except flu)

The dispenser shall report which of the following information to controlled substances reporting system? I. The date the prescription was written. II. Whether the prescription is new or a refill. III. Method of payment for the prescription. A. I only B. I and II only C. All D. None of the above

1. Answer: (c) All, [North Carolina Pharmacy Practice Act 90-113.73(b)].The Commission shall adopt rules requiring dispensers to report the following information. The Commission may modify these requirements as necessary to carry out the purposes of this Article. The dispenser shall report:(1). The dispenser's DEA number.(2). The name of the patient for whom the controlled substance is being dispensed, and the patient's:a. Full address, including city, state, and zip code,b. Telephone number, andc. Date of birth.(3). The date the prescription was written.(4). The date the prescription was filled.(5). The prescription number.(6). Whether the prescription is new or a refill.(7). Metric quantity of the dispensed drug.(8). Estimated days of supply of dispensed drug, if provided to the dispenser.(9). National Drug Code of dispensed drug.(10). Prescriber's DEA number.(11). Method of payment for the prescription

In North Carolina, a pharmacist should not dispense any non-controlled drug or device if the prescription is presented: A. More than 180 days after the date of issuance. B. More than 90 days after the date of issuance. C. More than 365 days after the date of issuance. D. More than 30 days after the date of issuance.

1. Answer: (c) In North Carolina, a pharmacist should not dispense any non-controlled drug or device if the prescription is presented more than 365 days after the date of issuance, [North Carolina Pharmacy Practice Act 90-85.32(a)]. · Is this right?? I may need to ask them for a refund because I do not think this is correct

A pharmacy quality assurance program may evaluate which of the following? I. The cause of alleged medication errors and incidents. II. Pharmaceutical care outcomes. III. Methods to reduce alleged medication errors and incidents. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 90-85.47].Every person or entity holding a valid pharmacy permit shall establish or participate in a pharmacy quality assurance program to evaluate the following:(1). The quality of the practice of pharmacy.(2). The cause of alleged medication errors and incidents.(3). Pharmaceutical care outcomes.(4). Possible improvements for the practice of pharmacy.(5). Methods to reduce alleged medication errors and incidents.

RxPrep: List of schedules collected in NC's PDMP?

2-5

RxPrep: How long does the pharmacy need to keep paper and electronic documents for schedule drugs (i.e. DEA Forms 222,106, Rxs, invoices)?

3 years

RxPrep: How many years must Rx records be kept?

3 years

RxPrep: How long does a pharmacist have to notify the BOP after a change in NAME, ADDRESS, or EMPLOYER?

30 days

503A or 503B: Outsourcing facilities

503B

Q: What information is required to be on a prescriber's prescription blank?

A. Under North Carolina law, NCGS § 106-134.1(4)(a), a written prescription must "bear the printed or stamped name, address, telephone number, and DEA number of the prescriber in addition to his legal signature." The federal Controlled Substances Act specifies that all prescriptions for controlled substances must bear: (1) the full name and address of the patient; (2) the drug name, strength, dosage form; (3) quantity prescribed; (4) directions for use; (5) the name, address and DEA number of the prescriber; and (6) the prescriber's signature.

Q: If a physician retires, dies, or loses his license, may I fill a prescription written before the physician ceased practicing?

A. Yes. A physician's (or other prescriber's) death, retirement, or loss of license does not void prescriptions written prior to the date the physician ceased practicing. As long as, in your professional judgment, the prescription was written for a legitimate medical purpose and pursuant to a valid physician-patient relationship, you may fill the prescription and any authorized refills.

Q. Are pharmacies required to have a quality assurance plan?

A. Yes. By statute, all pharmacies "shall establish or participate in" a QA program to evaluate: • The quality of the practice of pharmacy• The cause of medication errors and incidents• Pharmaceutical care outcomes• Possible improvements for the practice of pharmacy• Methods to reduce medication errors and incidents

Q. Does North Carolina have a "pharmacy of choice" statute?

A. Yes. N.C.G.S. § 58-51-37 - a part of the North Carolina Insurance Code - provides as follows: § 58-51-37. Pharmacy of choice. (a) This section shall apply to all health benefit plans providing pharmaceutical services benefits, including prescription drugs, to any resident of North Carolina. This section shall also apply to insurance companies and health maintenance organizations that provide or administer coverages and benefits for prescription drugs. This section shall not apply to any entity that ha~ its own facility, employs or contracts with physicians, pharmacists, nurses, and other health care personnel, and that dispenses prescription drugs from its own pharmacy to its employees and to enrollees of its health benefit plan, provided, however, this section shall apply to an entity otherwise excluded that contracts with an outside pharmacy or group of pharmacies to provide prescription drugs and services This section shall not apply to any federal program, clinical trial program, hospital or other health care facility licensed pursuant to Chapter 131E or Chapter 122C of the General Statutes, when dispensing prescription drugs to its patients.(b) As used in this section:(1) "Copayment" means a type of cost sharing whereby insured or covered persons pay a specified predetermined amount per unit of service with their insurer paying the remainder of the charge The copayment is incurred at the time the service is used. The copayment may be a fixed or variable amount.(2) "Contract provider" means a pharmacy granted the right to provide prescription drugs and pharmacy services according to the terms of the insurer.(3) "Health benefit plan" is as that term is defined in G S. 58-50-110(11).(4) "Insurer" means any entity that provides or offers a health benefit plan.(5) "Pharmacy" means a pharmacy registered with the North Carolina Board of Pharmacy.(c) The terms of a health benefit plan shall not:(1) Prohibit or limit a resident of this State, who is eligible for reimbursement for pharmacy services as a participant or beneficiary of a health benefit plan, from selecting a pharmacy of his or her choice when the pharmacy has agreed to participate in the health benefit plan according to the terms offered by the insurer;(2) Deny a pharmacy the opportunity to participate as a contract provider under a health benefit plan if the pharmacy agrees to provide pharmacy services that meet the terms and requirements, including terms of reimbursement, of the insurer under a health benefit plan, provided that if the pharmacy is offered the opportunity to participate, it must participate or no provisions of G.S. 58-51-37 shall apply;(3) Impose upon a beneficiary of pharmacy services under a health benefit plan any copayment, fee, or condition that is not equally imposed upon all beneficiaries in the same benefit category, class, or copayment level under the health benefit plan when receiving services from a contract provider;(4) Impose a monetary advantage or penalty under a health benefit plan that would affect a beneficiary's choice of pharmacy. Monetary advantage or penalty includes higher copayment, a reduction in reimbursement for services, or promotion of one participating pharmacy over another by these methods.(5) Reduce allowable reimbursement for pharmacy services to a beneficiary under a health benefit plan because the beneficiary selects a pharmacy of his or her choice, so long as that pharmacy has enrolled with the health benefit plan under the terms offered to all pharmacies in the plan coverage area; or(6) Require a beneficiary, as a condition of payment or reimbursement, to purchase pharmacy services, including prescription drugs, exclusively through a mail-order pharmacy.(d) A pharmacy, by or through a pharmacist acting on its behalf as its employee, agent, or owner, may not waive, discount, rebate, or distort a copayment of any insurer, policy, or plan, or a beneficiary's coinsurance portion of a prescription drug coverage or reimbursement and if a pharmacy, by or through a pharmacist's acting on its behalf as its employee. agent or owner, provides a pharmacy service to an enrollee of a health benefit plan that meets the terms and requirements of the insurer under a health benefit plan, the pharmacy shall provide its pharmacy services to all enrollees of that health benefit plan on the same terms and requirements of the insurer A violation of this subsection shall he a violation of the Pharmacy Practice Act subjecting the pharmacist as a licensee to disciplinary authority of the North Carolina Board of Pharmacy pursuant to G.S. 90-85.38(e) At least 60 days before the effective date of any health benefit plan providing reimbursement to North Carolina residents for prescription drugs, which restricts pharmacy participation, the entity providing the health benefit plan shall notify, in writing, all pharmacies within the geographical coverage area of the health benefit plan, and offer to the pharmacies the opportunity to participate in the health benefit plan. All pharmacies in the geographical coverage area of the plan shall be eligible to participate under identical reimbursement terms for providing pharmacy services, including prescription drugs The entity providing the health benefit plan shall, through reasonable means, on a timely basis, and on regular intervals in order to effectuate the purposes of this section, inform the beneficiaries of the plan of the names and locations of pharmacies that are participating in the plan as providers of pharmacy services and prescription drugs. Additionally, participating pharmacies shall be entitled to announce their participation to their customers through a means acceptable to the pharmacy and the entity providing the health benefit plans. The pharmacy notification provisions of this section shall not apply when an individual or group is enrolled, but when the plan enters a particular county of the State.(f) If rebates or marketing incentives are allowed to pharmacies or other dispensing entities providing services or benefits under a health benefit plan, these rebates or marketing incentives shall be offered on an equal basis to all pharmacies and other dispensing entities providing services or benefits under a health benefit plan when pharmacy services, including prescription drugs, are purchased in the same volume and under the same terms of payment. Nothing in this section shall prevent a pharmaceutical manufacturer or wholesale distributor of pharmaceutical products from providing special prices. marketing incentives, rebates, or discounts to different purchasers not prohibited by federal and State antitrust laws.(g) Any entity or insurer providing a health benefit plan is subject to G.S 58-2-70. A violation of this section shall subject the entity providing a health benefit plan to the sanctions of revocation, suspension, or refusal to renew license in the discretion of the Commissioner pursuant to G.S. 58-3-100.(h) A violation of this section creates a civil cause of action for damages or injunctive relief in favor of any person or pharmacy aggrieved by the violation.(i) The Commissioner shall not approve any health benefit plan providing pharmaceutical services which does not conform to this section.(j) Any provision in a health benefit plan which is executed, delivered, or renewed, or otherwise contracted for in this State that is contrary to any provision of this section shall, to the extent of the conflict, be void.(k) It shall be a violation of this section for any insurer or any person to provide any health benefit plan providing for pharmaceutical services to residents of this State that does not conform to the provisions of this section.

What would be the maximum quantity of pseudoephedrine allowed for any given single transaction, according to North Carolina Pharmacy Law? A. 1 gram B. 4 grams C. 3.6 grams D. 10 grams

Answer: (c) 3.6 grams, [Methamphetamine Lab Prevention Act of 2005, 90-113.53].North Carolina Pharmacy Law strictly prohibits a single transaction purchase of more than two packages of certain products containing pseudoephedrine (3.6 grams total), and no more than three packages (9 grams total) of certain products containing pseudoephedrine within a 30-day period.This section does not apply to any pseudoephedrine products that are in the form of liquids, liquid capsules, gel capsules, or pediatric products labeled pursuant to federal regulation primarily intended for administration to children under 12 years of age according to label instruction.

Within _______ after obtaining an initial or renewal license that confers the authority to prescribe a controlled substance for the purpose of providing medical care for a patient, the licensee shall demonstrate to the satisfaction of the licensing board that he or she is registered for access to the controlled substances reporting system. A. 72 hours B. 7 days C. 30 days D. 180 days

Answer: (c) 30 days, [North Carolina Pharmacy Practice Act 90-113.74A].Within 30 days after obtaining an initial or renewal license that confers the authority to prescribe a controlled substance for the purpose of providing medical care for a patient, the licensee shall demonstrate to the satisfaction of the licensing board that he or she is registered for access to the controlled substances reporting system.A violation of this section may constitute cause for the licensing board having jurisdiction over the licensee to suspend or revoke the license.

Q: Can I give an emergency refill on a weekend if the patient needs it when there are no refills left on the script?

A: Board Rule .1809 allows a pharmacist to give up to a 30 day supply of any drug except a Schedule II controlled substance under these circumstances. You must contact the prescriber or the prescriber's office within 72 hours to notify them of what you have done.

Q: What are the CE requirements for Clinical Pharmacist Practitioners (CPPs)?

A: CPPs must obtain 35 hours of "continuing education" per year. 21 NCAC 46.3101(d)(1). "Continuing education" is defined by the CPP rules as "courses or materials which have been approved for credit by the American Council on Pharmaceutical Education." 21 NCAC 46.3101(a)(8).The 15 hours (8 hours live) needed for renewal of a pharmacy license count toward this amount, so CPPs need an additional 20 hours of CE (live or correspondence) per year to maintain that credential.

Q: Are pre-filled saline/heparin flush syringes treated as prescription drugs or prescription devices?

A: Consistent with the federal Food and Drug Administration's August 2006 designation of pre-filled syringes of saline/heparin (100 U/ml or 10 U/ml) flush as medical devices, the North Carolina Board of Pharmacy will likewise regulate such flushes as medical devices under the Pharmacy Practice Act.

Q: I have been approached by a business that says it can broker sales of prescription drugs among pharmacies. Is this business model allowed under North Carolina law?

A: No. Board staff and North Carolina Department Agriculture and Consumer Services, Food & Drug Protection staff (the latter are responsible for wholesale prescription drug regulation in North Carolina) have received multiple inquiries regarding contacts from businesses that represent themselves as Internet-based marketplaces for independent pharmacies. The business model described is an on-line point of product exchange, allowing independent pharmacies to buy and sell t over-stocked prescription drug inventory and prescription drugs in short supply among themselves. Typically, such businesses suggest that, under FDA guidelines, a pharmacy may transfer up to 5% of its annual sales to another pharmacy without a wholesale license. Board staff and Food & Drug Protection staff view these models as inconsistent with both federal and state law governing wholesale prescription drug transactions (discussed above in the question "May a pharmacy transfer prescription drugs to another pharmacy?") North Carolina General Statutes are consistent with applicable portions of the federal Food, Drug & Cosmetic Act with respect to limited transfers of prescription drugs between pharmacies for legitimate emergency medical reasons; transfers between retail pharmacies without a wholesale license simply for inventory management reasons are not allowed in North Carolina. CAUTION TO NORTH CAROLINA PHARMACIES CONCERNING "SECONDARY" WHOLESALER SOLICITATIONS FOR SHORTAGE DRUGS. Board of Pharmacy staff and staff of the Food and Drug Safety Division of the North Carolina Department of Agriculture has been made aware that at least one "secondary" wholesaler is soliciting pharmacies to purchase "shortage" drugs from a primary wholesaler and then resell them to the "secondary" wholesaler. There are several important issues that pharmacies should keep in mind:(1) Any sales of this sort are wholesale prescription drug transactions. Any pharmacy engaged in such transactions that is not also a currently licensed prescription drug wholesaler would be in violation of North Carolina law.(2) The "secondary" wholesaler has suggested that a pharmacy may engage in such transactions without being a wholesaler under a "5% rule" allowing sales to relieve shortages; any such suggestion is false. North Carolina law provides a limited mechanism whereby one pharmacy may, in an emergency situation, transfer a small amount of prescription drugs to another pharmacy to help that pharmacy through an emergency. North Carolina law does not provide a mechanism for a pharmacy to sell any amount of a prescription drug to a wholesaler for subsequent distribution to other pharmacies or wholesalers. More information may be found here: http://www.ncbop.org/faqs/Pharmacist/faq_Wholesalers.htm(3) As most pharmacists are aware, Congress recently passed the Drug Quality and Security Act. Title II of that act, governing drug supply chain security, sets forth many federal law requirements for prescription drug wholesalers. Provisions of this statute are being rolled out gradually, but any pharmacy contemplating becoming a prescription drug wholesaler must be aware of these stringent requirements and prepared to meet them. (4) The issue of "gray market" wholesaling of shortage prescription drugs is one that North Carolina authorities have worked closely with federal officials to monitor and address. A Congressional investigation into these practices, and their often significant threat to the public health and safety, was conducted last year. More information may be found here: http://democrats.oversight.house.gov/investigation-of-the-gray-market/

Q: Are pharmacists required to hand sign and date controlled substance prescriptions?

A: North Carolina Law no longer requires pharmacists to hand sign and date controlled substance prescriptions they fill.

Q: Is Emergency Contraception/"Plan B®" available over-the-counter, and are there any restrictions as to what patients may obtain Emergency Contraception/"Plan B®" over-the-counter?

A: Single-dose levonorgestrel emergency contraception (also known as Plan B One-Step) is available over-the-counter without restriction.

Q: I would like to attend a Board meeting. When do Board meetings occur?

A: The Board of Pharmacy meets at 9 am the third Tuesday of each month, except for August and December. If a meeting has to be rescheduled, notice will appear on the Board's website.

Q: Do I need to register my pharmacy as a professional LLC?

A: With regard to pharmacy practice, the law which requires incorporation and registration with the applicable licensing board as a professional corporation does not apply to pharmacies. Someone wishing to incorporate a pharmacy may do so as a regular corporation or an LLC and would not have to be a professional corporation or a PLLC.

Q: Is a prescription with a specific number of refills good for more than one year?

A: Yes, providing the prescription is not for a controlled substance. A prescription is valid beyond one year if a specific number of refills is authorized and they have not been used. A pharmacist can always decline to fill or refill a prescription as noted in Board Rule. 1801: http://www.ncbop.org/ch46-18.htm

Q: Can I fill a prescription written by a foreign physician?

A: Yes, so long as you believe there is a physician/patient relationship and the prescription is not for a controlled substance. Foreign prescribers are almost certainly not registered with DEA, which is a requirement for writing a prescription for a controlled substance.

Q: Does a free or charitable clinic require a Drug Enforcement Agency registration for dispensing, storing, or administering controlled substances?

A: Yes. A DEA number is required by any pharmacy that orders, stores, or dispenses any controlled substances. The statue describing who must register with the DEA can be found here: http://www.usdoj.gov/dea/pubs/csa/822.htm

Q: Can a pharmacist receive contact continuing education credit for serving as a preceptor?

A: Yes. A pharmacist who instructs a student for at least 400 hours can receive five (5) contact hours of continuing education. Internship forms (forms 1 & 2) must be completed and returned to the North Carolina Board of Pharmacy to be sure that credit is obtained for both the preceptor and intern. Pharmacists should be aware that the hours of credit cannot be split among several students; one student must receive at least 400 hours of instruction in order for the pharmacist to receive credit. Only five (5) hours per year can be awarded per pharmacist, regardless of how many students he/she may precept in a given year. Pharmacists may also receive continuing education credit for serving as a preceptor through one of the North Carolina pharmacy school programs. Pharmacists who serve as a preceptor for a minimum of 160 hours may receive 5 hours of continuing education per year.

Q: Has the FDA taken action against pharmacies that compound "bio-identical hormone replacement" products?

A: Yes. See https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm.

28. A prescription for modafinil would be subject to which of the following requirements? (Select all that apply} A. The prescriber may issue a 30 day supply with 3 refills B. May be called in to the pharmacy by the prescriber's secretary C. Must be filled within 1 year of date of Issuance D. No limit on the amount of times the prescription is transferred between CVS and Walgreens

AB

24. A prescription for Tylenol with Codeine suspension written by a PA must include which of the following? (Select all that apply) A.The date of issuance B. The PA's DEA number C. The name of the PA's supervising physician D. The address of the patient

ABCD

30. A medication with an attached REMS (Risk Evaluation and Mitigation Strategy) may require which of the following? (Select all that apply) A. A medication guide is dispensed with each prescription B. The pharmacy is registered or certified to dispense the medication C. The prescriber is registered or certified to prescribe the medication D. The pharmacy obtains an authorization number prior to dispensing the medication E. A patient may need to have routine labs drawn during the course of treatment

ABCDE

(3) If a pharmacist would like to dispose of an expired bottle of hydrocodone, which of the following options does the pharmacist have? (Select all that apply) A. Return the bottle to the wholesaler they obtained the hydrocodone from B. Discard the bottle at a sheriffs office at the next "Drug Take Back Day" C. Transfer the bottle to a reverse distributor D. Fill out and submit a DEA Form 41 to destroy the hydrocodone at the pharmacy

ACD

34.Which of the following situations may a pharmacist dispense an emergency refill to patient for a 90 day supply?(Select all that apply) A. The patient's physician died B. The patient's physician is out of the office until next week C. The patient's physician is traveling out of the country D. The governor declared a state of emergency after a hurricane

ACD

52. A manufacturer's container for an over-the-counter medication must include which of the following on the label? (Select all that apply) A. Name of drug product B. Caution: Federal law prohibits dispensing without prescription C. Expiration date D. "Drug Facts" Panel E. Package insert

ACD

58. Which of the following is a correct statement about emergency kits in a hospital? (Select all that apply) A. Must follow the requirements for 'Auxiliary Medication Inventory' B. May include maintenance medications for a patient's chronic disease state C. Medications included are to meet the immediate therapeutic need of a patient D. A noncertified technician may verify a noncertified technician's stocking of the kit E. A medication order must be given to the pharmacist-manager after drug removal

ACE

Anabolic Steroids Act of 2004:

All anabolic steroids are schedule 3

When is an offer to counsel patients REQUIRED upon dispensing an Rx?

An offer to counsel shall be made on NEW or TRANSFER prescriptions at the time of dispensing or delivered to patient/representative

According to North Carolina State Pharmacy Law, all drugs dispensed by a nurse practitioner or physician assistant MUST be retrospectively reviewed by a pharmacist on a daily basis. A. True B. False

Answer: (b) False, [21 NCAC 46.1706].

The preprinted prescription blanks with the names of scheduled III, IV or V substances are allowed under the North Carolina Pharmacy Law. A. True B. False

Answer: (b) False.The preprinting of or use of preprinted prescription blanks with the name of scheduled substances is prohibited. Prescription blanks that are individually generated (aka: computer generated prescriptions) are permissible.

In which of the following instances is patient counseling NOT required? A. When a patient is picking up the prescription at any retail pharmacy counter. B. When a patient is receiving medications via mail order pharmacy. C. When a patient is being discharged from a hospital. D. When a patient resides in a hospital.

Answer: (d) Patient counseling, as described in this rule, shall not be required for inpatients of hospitals or other institutions where a nurse or other licensed health care professional administers the medication(s), [21 NCAC 46 .2504(e)(4) and 21 NCAC 46.2504 (g) ].In all other instances, patient counseling is required.Records of counseling compliance, including documentation of refusals to receive counseling, shall be maintained on file for three years.

What types of CE does the NCBOP accept?

As per our rule change in 2018, we now only accept: - ACPE accredited CE - NCAP accredited CE (North Carolina Association of Pharmacists) - Preceptor for an instate pharmacy school student

82. Who may dispense methadone to a patient to treat opioid addiction? A. Community Pharmacy B. Narcotic Treatment Facility C. Manufacturer D. A&B

B

(19) Which of the following correctly matches the situation to when the NC BOP must be notified? A. Hired new staff pharmacist: notify NC BOP within 60 days B. Theft of a controlled substance: notify NC BOP within 1 business day C. CPP discontinues working as a CPP: notify NC BOP within 10 days D. Determined an incorrect drug dispensed led to patient's death: notify NC BOP within 30 days

C

(18) Which of the following regulations must be followed by a Clinical Pharmacist Practitioner (CPP)? (Select all that apply) A. A doctor in postgraduate residency training may serve as the Supervising Physician B. A Clinical Pharmacist Practitioner must complete 15 hours of continuing education yearly c. A pharmacist with a Pharm.D. and no advanced training or certificates is eligible to become a CPP D. The CPP must meet with their Supervising Physician monthly for the first 6 months

D

(4) Which of the following statements correctly describes regulations for pharmacy technicians? A. A certified pharmacy technician may counsel a patient on the side effects of a medication B. A pharmacy technician can become a certified pharmacy technician after completing an employer training program C. The technician to pharmacist ratio in NC is 3:1 D. All pharmacy technicians must register with the NC BOP

D

57. Which of the following correctly describes handling 'Hazardous Drugs' according to USP <800>? A. A 'Hazardous Drug' refers to drugs that only cause cancer or developmental abnormalities B. USP <800> only needs to be followed by places that compound sterile or nonsterile 'Hazardous Drugs' C. The pharmacist-manager is the only person who needs to be trained on handling 'Hazardous Drugs' D. 'Hazardous Drugs' can be exempt from some requirements of USP <800> after an Assessment of Risk is performed

D

69. Which of the following is a requirement for continuing education? {Select all that apply) A. An immunizing pharmacist must complete 5 hours of vaccine CE yearly B. A Clinical Pharmacist Practitioner must complete 35 hours of CE every 2 years C. All pharmacists must complete at least 8 hours of live CE D. There is a 60 day grace period to earn CE after the renewal deadline

D

Q: Is it "legal" for a pharmacist to add a DEA number to a controlled substance prescription when the prescriber omits that information?

DEA's own website states that "pharmacists are instructed to adhere to state regulations or policy" concerning changes or additions to controlled substance prescriptions (http://www.deadiversion.usdoj.gov/faq/general.htm#rx-7). Furthermore, Board Rule .2301 (21 NCAC 46.2301) specifically provides that pharmacists may retain and add a DEA number to a controlled substance prescription when the provider inadvertently leaves it off.

DELETE

DELETE

What is the purpose of DEA Form 222?

DISTRIBUTION, PURCHASE or TRANSFER of a C2

How is a Narrow Therapeutic Index Drug defined?

Defined as a drug with ONE or MORE of the following: 1) LESS than TWOFOLD difference in the minimum toxic concentration and minimum effective concentration 2) Exhibits limited or erratic absorption 3) Formulation dependent BA 4) Wide intra-patient PK variability that requires blood level monitoring

Delete

Delete

_______________ may review info in the NCSRS and notify practitioners and their licensing board or the Attorney General if they find unusual prescribing patterns

Department of Health and Services

What is the purpose of DEA Form 41?

Disposal or Destruction of controls

How are OTC drugs approved?

Either through NDA process like Rx drugs OR the simpler, less $$$ "OTC monograph process" -As long as a company follows the OTC monograph process" the can market an OTC product without FDA pre-approval or an NDA

What is meant by "equivalent" with regards to generic substitution?

Equivalent drug product = a drug product which has the same established name, active ingredient, strength, quantity, dosage form, and which is therapeutically equivalent to the drug product identified in the Rx

RxPrep: What is the pharmacist responsible for after a Class 1 recall?

For a Class 1 recall, the pharmacist is responsible for identifying patients who may have received the recalled drug and should notify AND DOCUMENT notification to the patients prescriber (some states require notifying the pt directly) o Federal law requires pharmacies maintain recall records for 2 years

What is the purpose of DEA Form 363?

Methadone for addiction

What is the penalty for pharmacies who do NOT upload info into the CSRS?

Monetary fines

RXPREP: How long after a med error does It have to be reported?

NABP says 3 days To who? NABP says ISMP and or the FDA

Is patient counseling required in a hospital?

NO

RxPrep: Are pharmacists required to provide translation services to non-english speaking pts?

NO

RxPrep: Do preceptors have to register with the BOP?

NO

RxPrep: Does NC have death w/ dignity laws?

NO

RxPrep: Is there a MAX quantity for days supply for schedule 3-5 drugs?

NO -Note there is a MAX of 5 refills

Is an offer to counsel patients REQUIRED upon dispensing an Refill?

NO --> Use professional judgement to determine if any counsel to offer should be made on refills

Quantity limit for C2s

NONE per federal law (unless it is an emergency C2)

Q: Are pharmacy students required to register with the Board as pharmacy technicians?

No

RxPrep: Does NC allow pharmacists to furnish emergency contraception?

No

If practicing in another state for the entire year, but want to maintain licensure in NC, do you have to complete NC's CE requirements to renew?

No- only the CE requirements of the state practicing in, but do have to pay renewal fee

RXPREP: Drugs exempt from the DSCSA (track and trace)

OTC drugs, veterinary drugs, APIs, blood products for transfusion, homeopathic drugs, compounded preparations

Can techs and clerks offer patient counseling to a patient?

Offer to counsel MAY be made by ancillary personnel (i.e techs, clerks) but the pharmacist OR intern must do the actual counseling

Who can disclose or disseminate data about a particular patient to each other?

Persons authorized to dispense or prescribe controls AND authorized to access the CSRS may disclose or disseminate data about a particular patient to each other

Can interns, or technicians make and/or receive transfers?

Pharmacists, interns, or CERTIFIED techs may MAKE or RECEIVE the transfer of NON-CONTROLLED meds

How do hospitals usually dispose of their controls?

Practitioners (most commonly hospitals) may apply for "blanket authorization" for routine disposal of controls (Witnessed by TWO people, record disposal, files PERIODIC report to DEA)

Can a pharmacy have a designated drop off/pick up location?

Prescription drugs can ONLY be dispensed at the address on the pharmacy permit à NOT allowed to have a "drop-off/pick-up" site at an off-site location

What happens to the prescriptions if Death, retirement, or loss of license of a prescriber?

Prescriptions are still valid even if one of the above occurs assuming the Rx was written before the prescriber retired or lost their license

Pure Food and Drug Act of 1906

Prohibited the adulteration and misbranding of foods and drugs in interstate commerce

Combat Methamphetamine Act of 2005 and Meth Prevention Act of 2008:

Pseudoephedrine laws

Drug Listing Act of 1972

Required drugs to have an NDC number

CPP MUST wear a nametag with what on it?

SPELLING OUT "Clinical Pharmacy Practitioner"

RxPrep: What drugs are in a different schedule in NC vs. the federals schedule?

Schedule 3: human chorionic gonadotropin (hCG)

Are HCFP resposnible for following laws for inventory recordkeeping of CONTROLS (i.e. every 2 YEARS and documents) and DEA Forms (i.e. 221,41,106) if controls are stocked and dispensed?

YES

Can Manufacturers market a biosimilar of the brand name product?

YES

Can other medications be written on the same Rx as a C2?

YES

Can the NC CSRS Report in the patient's confidential medical chart?

YES

Are compounds from Traditional Compounding Pharmacies exempt from the FDA new drug approval process, Current Good Manufacturing Practices, and federal labeling requirements?

YES (i.e. they are labeled according to STATE law)

503A compounding: Is "Anticipatory compounding" allowed? Under what conditions?

YES -· can compound in anticipation of receiving prescriptions, in limited quantities based on established history of receiving orders for a preparation à can only dispense AFTER the prescription is received

Can a facility operate as a 503A AND 503B facility?

YES but but there must be COMPLETE physical segregation

Does a patient have the right to WAIVE counseling?

YES but ·a refusal can be considered effective ONLY if the patient understands the offer and did not want the counseling MUST documenting refusals and keep it for THREE YEARs

If a pharmacist has a physical disability, and cannot get a CPR card, can they still administer immunizations?

YES, but but another pharmacist or tech that CAN perform CPR must be present

Is there a grace period for renewal and earning CE?

Yes. The Board allows a 60-day grace period after the December 31st deadline. During that time, you may obtain CE and renew, with no penalty.

I'm a CPP, do I have to renew my CPP license separately from my Pharmacist license?

Yes. There is a tile next to your Pharmacist tile that has a banner to renew. Click on the banner, then click RENEW and it will take you to the CPP renewal application. The renewal fee is $50.

How many hours of Immunization-related CE do I need to maintain my Immunization Certification? Do those hours need to be live?

You need 3 hours every 2 years to maintain your Immunization Certification. No. The hours can be either or live or correspondence.

What happens if I don't renew my license?

Your license status will move to INACTIVE if not renewed by the March 1 deadline and you are no longer allowed to work as a pharmacist in NC.

Drug Addiction Treatment Act (DATA) of 2000

allows office-based opioid addiction treatment (i.e. Suboxone)

The Patient Safety and Quality Improvement Act of 2005 (PSQIA):

creates a voluntary program through which healthcare providers, including pharmacies, share information related to patient safety events with patient safety organizations

Drug Price Competition (DPC) and Patent Term Restoration Act (PTRA) of 1984:

o AKA the Waxman-Hatch amendment o Streamlined the generic drug approval process while giving patent extensions for innovative drugs

Federal Comprehensive Drug Abuse Prevention and Control Act of 1970

o AKA the controlled substances act o Controls have potential for addiction and abuse o Established the 5 schedules o Established a CLOSE SYSTEM for manufacturing, distributing, and dispensing to decrease diversion o The DEA enforces the CSA

Can an automated dispensing device be located inside a LTCF? Can it have controls inside? Any permits or authorization required?

o An ADD CAN be installed in a LTCF by a retail pharmacy registered with a DEA o LTCFs are allowed to have controls in ADDs (reduces waste of meds) o Pharmacy controls system remotely and dispenses drug on a single-dose basis (pursuant to a prescription) § LTCF staff access the ADD o Retail pharmacy that installs ADD must maintain separate DEA registration at LTCF location § Retail pharmacy may keep records for the ADD at their pharmacy o In NC, a pharmacy permit from the NCBOP is REQUIRED § Can apply for a limited-service permit in order to have an ADD at the LCTF

RxPrep: How does ordering C3-5s differ from ordering C2s?

o C3-5: can be obtained from a supplier by using a PURCHASE ORDER or the CSOS § The INVOICE is used to record the delivery date and to confirm the correct items have been received. The receipts must be readily available and contain the following info: · NAME of each drug · Drug FORMULATION · QUANTITY in each container · NUMBER OF PACKAGES ORDERED and delivered o C1-2: § PM must register with DEA using form 224 before ordering § CSOS can be sued to order schedule 1-5 § DEA Form 222 is used to obtain schedules 1-2

Kefauver-Harris Amendment of 1962

o Drugs must ALSO be proven to be EFFECTIVE (in addition to safe) o Transferred Rx drug advertising from FTC to FDA o Established Good Manufacturing Practices o Required informed consent of research participants and reporting of ADRs o FDA given oversight of Rx drug advertising and FTC for OTC advertising

Durham-Humphrey Amendment of 1951

o Established 2 classes of medications (Rx and OTC) o Authorized oral prescriptions and refills of Rx drugs o Introduced label requirements for pharmacies

Comprehensive Addiction and Recovery Act of 2016

o Extends time frame in which C-2s can be partially filled o Allows NP's and PA's to apply for a waiver to prescribe buprenorphine for opioid addiction

Food and Drug Amendments Act (FDAAA) of 2007

o FDA may mandate labeling changes related to safety o Require clinical trial data reporting and registries o Require post-market clinical studies to assess risk (Phase 4 studies) o Biologics Price Competition and Innovation Act (included in the ACA of 2010): allows a pathway for biosimilar approval

RXPREP: NABP "Red Flags" for Diversion

o Frequent requests for early refills o Prescriber and/or patient located unusually far from pharmacy o Patient profile refills multiple prescribers for same meds o Similar or identical prescriptions from same doctor to multiple patients (i.e. Pill Mill) o Rx not within scope of practice o Patients coming to pharmacy in groups o Unusual patient behavior including using slang terms for meds o Paying cash for opioids Patient prescribed drug cocktail (Opioid + BZD + muscle relaxer)

What HIPAA Training of Employees is required?

o HIPAA is flexible with covered entities creating their own training requirements to fit their size and need o Must document that each employee has completed treatment o Covered entities must also develop policies and procedures and ID a privacy officer to oversee the entity's compliance with HIPAA

RXPREP: Drugs that are NOT safe to deliver by pneumatic tube

o Liquid Hazardous drugs (like chemo) or ANY antineoplastics o Combustible products including some gels and sprays o Protein products that can become damaged by agitation (insulin an IGs)

When disposing of controlled substances, what form is completed? DO you need witnesses?

o Must fill out a DEA Form 41 to record the destruction of controls (ALL schedules --> requires TWO witnesses) § Must record: Drug name, NDC, strength, package quantity, number of full packages, and partial package count of each control to be disposed

HIPAA Act of 1996:

o Regulated the privacy and security of health information o Improved efficiency and effectiveness of the HCS o Improved the continuity of health insurance coverage and prohibits discrimination in health coverage

RxPrep: Generic Substitution for a drug to be therapeutically equivalent, the following must be met:

o Same amount of ACTIVE ingredient o Meet the same standards of strength, quality, purity, and identity, o Have IDENTICAL DOSAGE FORM, and ROUTE

What is defined as "Readily available" w/ regards to recordkeeping being available to NCBOP

open for review by the BOP w/in 48 hours of request

RxPrep: Do techs have to be licensed or registered?

registered

Drug Quality and Safety Act of 2013:

regulated pharmacy compounding and tracking of medications throughout the distribution system

CPP provides "drug therapy management" which includes _________________

the implementation of predetermined drug therapy, modification of prescribed drugs, and ordering tests o MAY include controls IF CPP obtains a DEA license o CPP's do NOT diagnose patients, tests are used to monitor and adjust Tx *i.e. A1c test) à physician will diagnose BEFORE referring the patient to a CPP o May prescribe meds according to their protocol/CPA

RxPrep: How many days after a pharmacy closing does the board have to be notified?

within 10 days of closing

Medical Device Amendments of 1976:

§ Established criteria for classifying devices into one of 3 classes

Hospital and Healthcare Facility Pharmacy What labeling is required for compounded drugs?

§ Identifier of person who prepared the compound § Pharmacist who verified he compound § EXP date (or BUD) § Storage requirements § Appropriate packaging/labeling for hazardous materials o When a drug is added to a parenteral admixture, it shall be labeled with a distinctive supplementary label indicating the name and amount of the drug added, EXP date and EXP time (if applicable) § If the admixture is prepared OUTSIDE the HCFP, the PM must develop policies and procedures for preparation and handling

Who can obtain a NCCSRS report?

§ Persons authorized to prescribe or dispense controls § Individual requesting their own records § Special agents or authorities of the state § Sheriff or police chief engaged in a bona fide specific investigation § Licensing boards in an ongoing investigation § Any county medical examiner o A practitioner or pharmacist may allow other persons working under his/her direction and supervision to access the NC CSRS

What is required of a retail pharmacist in terms of Patient profile/Documentation as part of the DUR?

§ Requires pharmacists to make me a "reasonable effort" to obtain, record and maintain a record of significant patient info § Information included in the patient profile: · Name, address, phone number, DOB, Gender · Diseases, Allergies and DDIs, comprehensive list of meds (includes OTC) and relevant devices · Ancillary personnel may collect the above info but a pharmacist must review and is responsible for accuracy · Review and update info before future meds are dispensed

When could a FAXED C2 serve as the original Rx (and thus, a written Rx would not be required)

· (1) Schedule 2 narcotic substance to be COMPOUNDED for the direct administration to a pt by parenteral, IV, IM, SC, or intraspinal infusion · (2) Schedule 2 substance for a resident of a LTCF · (3) Schedule 2 narcotic substance for a pt in HOSPICE (prescriber must note somewhere on the Rx that the pt is in hospice)

When should a pharmacist notify the BOP after a change of name, mailing address, or change of employment?

w/in 30 days of the change (for all licenses, including technicians)

Pseudoephedrine is known as a _____________

"Scheduled Listed Chemical Product" (SLCP)

Q: Can the police get to protected health information in my pharmacy?

(1) A pharmacy may disclose PHI to any law enforcement agency at any time if the pharmacy believes in good faith that such information constitutes evidence of criminal conduct that occurred on the pharmacy's premises. For instance, if an employee of the pharmacy was stealing drugs or if an individual presented a forged prescription, the pharmacy may disclose PHI relevant to such crime. (2) If a law enforcement officer serves a court ordered warrant or court issued subpoena upon the pharmacy, the pharmacy may disclose the PHI sought. (3) Other situations should be reviewed on a case-by-case basis. A pharmacy should attempt to determine whether the law enforcement agency is conducting an oversight activity before releasing PHI under the less stringent oversight requirements. In the event that a law enforcement officer seeks PHI without a court order or warrant, the pharmacy should document the following and use its best judgment in determining whether to release PHI to a law enforcement officer: a. Identity of law enforcement agency seeking disclosure of PHI; b. Name of Officer; c. Description of PHI sought; and d. Description of specific oversight activity in which the law enforcement officer is engaged. Once again, Section 164.512(d)(2) defines a health oversight activity as directly related to (1) the receipt of health care; (2) a claim for public benefits related to health; or (3) qualification for, or receipt of, public benefits or services when a patient's health is integral to the claim for public benefits or services. (4) It is important to note that Section 164.512(d)(2) states that "a health oversight activity does not include an investigation or other activity in which the individual is the subject of the investigation or activity." For instance, if the SBI is investigating a nurse, the SBI agent would not be entitled to obtain a list of that nurse's personal prescriptions that were filled by the Pharmacy.

Classifications of Biosimilars. Where to find the difference?

(1) Biosimilar or Biosimilarity · The product is highly similar to the reference product even if there are MINOR differences in clinically INACTIVE components · There are no clinically meaningful differences between products in terms of SAFETY, PURITY, and POTENCY of the product (2) Interchangeable or interchangeability: · The biological product is biosimilar to the reference product · It can be expected to produce the same clinical result as the reference product in any given patient · For a product administered more than once, the safety and reduced efficacy risks of alternating or switching are not greater than with repeated use of the reference product -NOTE: the FDA Purple Book will provide to determine biosimilar vs interchangeable status o A Pharmacist receiving a prescription for a biological drug prescribed by its brand name MAY dispense ANY INTERCHANGEABLE product (MUST have interchangeable and NOT simply biosimilar status) § DAW and such still applies and prohibits interchangeable substitution

1) What are the requirements on a Rx? 2) What additional info is required if written by a PA/NP/CPP? 3) For controls, the Rx MUST contain _________ ****Corresponding responsibility of pharmacist and prescriber that a control comply with ALL requirements****

(1) Issue Date (Pre or Post Dating NOT allowed) (2/3) Name and Address of Patient (4-8) Drug name, strength, dosage form, quantity, directions for use (9) Number of refills OR stop date (for hospitals)** (10) Route of administration** (11-14) Name, Address, Phone number of prescriber** (15) DEA number of prescriber if applicable** (16) Legal signature of prescriber (for written/faxed Rxs) --> MUST be signed on the issue date **State law allows this information to be stored in a data file IN LIEU OF appearing on the Rx (Note: DEA has taken the position that Rx requirements must appear on the FACE of the Rx) 2) -Prescribing/license/approval number (NOTE: this is DIFFERENT than their DEA number and MUST be written on ALL prescriptions) -NP/PA must also write the supervising physician's name on EACH Rx 3) the date of DISPENSING

No prescription for Schedule V controlled medications shall be filled or refilled more than 6 months after the written date or refilled more than five times. A. True B. False

(b) False, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRev1117.pdf and http://www.ncbop.org/faqs/Pharmacist/faq_SchVControlledSub.htm and CFR 1306.22 (a-b)].Schedule V controlled substances may be refilled as authorized. Schedule V medications are not subject to the 6-month, 5 refill limit.

What happens if an e-scribed prescription transmission fails? WHat should the prescriber do? How about the pharmacist?

**requirements must be followed*** 1) Prescriber may print out a copy of prescription and manually sign it -MUST indicate the Rx was originally transmitted to a specific pharmacy and the transmission failed -This is now considered a WRITTEN Rx and NOT an electronic Rx 2) The Pharmacist must make sure the transmitted Rx was NOT received and dispensed by another pharmacy -If it was received but not dispensed: have other pharmacy VOID -If it was received AND dispensed: paper copy must be VOIDED

Pharmacy Labeling Requirements for DISPENSED Meds:

(1) Name and Address of the Pharmacy -Requires N and A of both if central fill (2) Serial Number of the RX (3) Date of the Rx (4) Name of the prescriber and patient (5) Name and strength of the drug (6) Generic name of the drug even if the generic drug is unavailable to dispense or if the brand is dispensed (7) Directions for Use (8) Appropriate cautionary statements (9) "Filled or Dispensed By" w/ name of dispensing pharmacist --> name must include AT MINIMUM, the first initial and FULL LAST NAME (10) If the drug Is a "tranqualizer or sedative" it should bear the warning "the consumption of alcoholic beverages while on this medication can be harmful to your health" if the prescriber so directs on the medication (11) If dispensed in a container other than the manufacturer's original container, a discard date, which shall be the EARLIER of ONE YEAR from date dispensed OR the manufacturer's expiration date -For tablets, capsules, nonsterile solid and liquid drug products going into the typical prescription vial -Assuming there is no data to the contrary (i.e. reconstituting AMX oral powder) (12) If the Rx IS dispensed in the manufacturer's original container, the label must NOT cover the expiration date and storage statement § Additional requirements for retail pharmacies: o C2-C4: "Caution: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed" o C3-C5: Refills should be labeled with date of initial filling and date of dispensing

What are the 3 components of a DUR?

(1) Screening: Detect drug use problems before it is dispenses (right dose, interactions, allergies, etc.) (2) Counseling: -An offer to counsel shall be made on NEW or TRANSFER prescriptions at the time of dispensing or delivered to patient/representative -Offer to counsel MAY be made by ancillary personnel (i.e techs, clerks) but the pharmacist OR intern must do the actual counseling -If the Rx is delivered (including mail order), the offer may be made orally or by telephone from the pharmacist à provide a toll-free number to the patient -Patients who speak a foreign language may be given PRINTED info instead of counseling IF requested by the patient/rep -Use professional judgement to determine if any counsel to offer should be made on refills -Offer to counsel shall be communicated in a POSITIVE manner to encourage acceptance -Patient has the right to WAIVE counseling · A refusal can be considered effective ONLY if the patient understands the offer and did not want the counseling -Counseling must be done "face to face" unless for inmates, may be through an officer with printed materials -Alternative forms of patient info may be used to supplement patient counseling -Patient counseling to inpatients in a hospital is NOT required -Recordkeeping includes documenting refusals and keeping it for THREE YEARs (3) Patient profile/Documentation -Requires pharmacists to make me a "reasonable effort" to obtain, record and maintain a record of significant patient info -Information included in the patient profile: · Name, address, phone number, DOB, Gender · Diseases, Allergies and DDIs, comprehensive list of meds (includes OTC) and relevant devices · Ancillary personnel may collect the above info but a pharmacist must review and is responsible for accuracy · Review and update info before future meds are dispensed

Q. What information must be reported under the controlled substance reporting act?

(1) The dispenser's DEA number. (2) The name of the patient for whom the controlled substance is being dispensed, and the patient's: a. Full address, including city, state, and zip code, b. Telephone number, and c. Date of birth. (3) The date the prescription was written. (4) The date the prescription was filled. (5) The prescription number. (6) Whether the prescription is new or a refill. (7) Metric quantity of the dispensed drug. (8) Estimated days of supply of dispensed drug, if provided to the dispenser. (9) National Drug Code of dispensed drug. (10) Prescriber's DEA number. ALSO: § Method of payment for the Rx

NCBOP Compounding Section: In advance of dispensing the compounded drug preparation, a pharmacy shall prepare the compounded drug preparation only:

(1) upon the pharmacy's receipt of a valid prescription order for an individual patient; or (2) in anticipation of a prescription order based on an established history of receiving prescription orders for the compounded drug preparation. Any compounded drug preparation prepared in anticipation of a prescription order shall not be dispensed until the pharmacy receives a valid prescription order for an individual patient.

State law allows what information to be stored in a data file IN LIEU OF appearing on the Rx?

(9) Number of refills OR stop date (for hospitals)** (10) Route of administration** (11-14) Name, Address, Phone number of prescriber** (15) DEA number of prescriber if applicable** -Does federal law require this on the face? if so would that take precedence bc it is more strict?

RXPREP: MedGuides are FDA approved and supplied to the dispenser by the manufacturer for _______

(MUST be given with all of the following meds (and more) pretty much anything with "anti" in the name (anti-inflammatory, anticoag, etc.) o NSAIDs o Antidepressants and Antipsychotics o Antiarrhythmics o Anticoagulants o Anticonvulsants § MedGuides required in outpatient setting for INITIAL fill and EVERY REFILL o There are other times (p. 69 but this is the main one)

Each CPP shall earn 35 hours of practice relevant CE each year approved by the Pharmacy Board. A. True B. False

(a) True, [21 NCAC 46 .3101(d),(g)(4)].(d). Continuing Education.(1). Each CPP shall earn 35 hours of practice relevant CE each year approved by the Pharmacy Board.(2). Documentation of these hours shall be kept at the CPP practice site and made available for inspection by agents of the Medical Board or Pharmacy Board.The supervising physician of the CPP shall supervise no more than three pharmacists.

The dispenser shall report the information required under the controlled substances reporting system no later than three business days after the day when the prescription was delivered. A. True B. False

(b) False, [NC Controlled Substances Act and Regulations 90-113.73(a)].

A permit holder shall not require a pharmacist to work longer than ___ continuous hours per workday. A pharmacist working longer than ___continuous hours per workday shall be allowed during that time period to take a _______ meal break and one additional _______ break.

-12 -6 -30 minute -15 minute

Electronic Recordkeeping 1) ANY documentation required by the NCBOP may be electronically created and maintained as long as the system is secure, has daily back-up, and records can be printed within _____ -Unless otherwise prohibited by another law/rule (i.e. federal)

-48h

What is the MAX quantity or days supply that a pt can receive of a Schedule 2 drug?

-A prescriber can issue multiple Rxs for up to a 90 day supply as long as there are written instructions indicating the earliest fill date

Q: Under what circumstances can a pharmacist continue to dispense refills on a prescription written by a deceased prescriber?

-A: If the prescription still has refills remaining at the time of the prescriber's death, the pharmacist may continue to dispense those refills as ordered. The death of the prescriber does not void valid prescriptions or refills ordered prior to the death -If the prescription has no refills remaining, Board Rule .1815 authorizes a pharmacist to provide a one-time emergency refill for up to a 90-day supply when the prescriber is "unable to provide medical services." A prescriber's death qualifies. You can find the rule here: http://www.ncbop.org/ch46-18.htm

Q: Does the NC Board of Pharmacy conduct background checks on licensees and registrants?

-A: Yes. Consistent with its obligation to protect the public health and safety, the Board of Pharmacy has implemented a system to conduct periodic sweeps of the North Carolina court system for public records concerning criminal charges filed, pending, or resolved against Board licensees or registrants. -Board licensees and registrants are, of course, still obligated to report information concerning criminal charges or dispositions each year as part of the license and registration renewal process.

RxPrep: What controlled schedules require identification for dispensing?

-ALL Schedule 3s -Combination narcotic schedule 3 meds (i.e. codeine w/ one or more non-narcotic active ingredients)

CPP is renewed _________ by December 31st --> if not within ______ it is consider lapsed (fee, renewal form and CE required)

-ANNUALLY -60 days

"Strengthen Opioid Misuse Prevention Act of 2017" or the "STOP Act."

-Among other things, the STOP Act requires all pharmacists to register for access to the North Carolina Controlled Substance Reporting System ("CSRS"), with a narrow exemption. -As a condition of renewing a pharmacist license for 2018, a pharmacist must attest either: (a) he/she has registered, or applied, for CSRS access; or (b) he/she is not employed in a pharmacy practice setting where Schedule II, III, or IV controlled substances are dispensed from a North Carolina-based facility or to North Carolina patients. -Prior approval is now required for short-acting opioids for greater than a five-day supply for acute pain and seven-day supply for post-operative acute pain. Prior approval is also required for long-acting opioids for greater than a seven-day supply.

(1) Which of the following must occur if a pharmacist determines a bottle of alprazolam was stolen from the pharmacy? {Select all that apply) A.The NC BOP must be notified within 5 days B. The DEA must be notified within 1 business day C. The pharmacist must fill out a DEA Form 41 D. The pharmacist must fill out a "Drug Disaster & Loss Report''

-B -D

RxPrep: What are the requirements for tech-check-tech (e.g. practice type setting, training, or certification required)?

-Called a "validating technician" -Must be a certified tech -Only allowed in hospitals -Validates the functions of other techs filling floor stocks and dose distribution systems

Food, Drug, and Cosmetic Act of 1938

-Core of today's drug laws -No new drug can be marketed/sol until proven safe and approved by FDA -Label must contain adequate directions for use and warnings about their habit-forming properties

Q: What is the formulation for UNC Hospitals Mucositis Mixture, also known as "Sleepy Butter"?

-Diphenhydramine liquid 2.5 mg/mL -Maalox suspension (or formulary equivalent) -Lidocaine, viscous 2%Admix equal volumes of the three ingredients. UNC usually dispenses 300 mL total volume. Oral Formulation. USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions. The directions for an oral formulation of Mucositis Mixture would be "swish and swallow" or similar. Mucosal Liquid Formulation. USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a BUD that is no longer than 30 days under room temperature storage. The directions for a mucosal liquid formulation of Mucositis Mixture would be "swish and spit" or similar. If a pharmacy compounds one batch of Mucositis Mixture to fulfil all Mucositis Mixture prescriptions - whether the directions are "swish and spit" mucosal formulation or "swish and swallow" oral formulations - the assigned BUD must be the stricter one: no longer than 14 days under refrigerated storage.

Who must register with the DEA? What acitivities warrant registration?

-EVERY person or entity that handles controls MUST be registered with DEA or be exempt from registering -Activities requiring registration: manufacturing, distributing, dispensing, prescribing, reverse distributing, research, narcotic Tx program, importing/exporting, chemical analysis -A SEPARATE registration is required for EACH principal place of business or professional practice where controls are manufactured, distributed, stored, administered, or dispensed (i.e. each community pharmacy needs their own DEA number)

PARTIAL filling of C3-C5s can be done IF:

-Each partial is recorded in the same manner as a refill -Total quantity dispensed must not exceed what was prescribed -NO dispensing occurs after 6 months beyond the issue date for C3s and C4s

What is required when making a generic substitution?

-Equivalent drug product = a drug product which has the same established name, active ingredient, strength, quantity, dosage form, and which is therapeutically equivalent to the drug product identified in the Rx -Generic drug must be manufactured in accordance w/ good manufacturing practices and have a logo or other ID mark -Price to the purchaser must be less than the brand -Selection of generic drug should not impose a greater liability upon the pharmacist or prescriber

Q: Do prescription orders or prescription documents have an expiration date?

-Federal regulations provide that prescriptions for drugs in Schedules III and IV shall not be filled or refilled more than 6 months after the date of issue. -North Carolina law provides that "No Schedule II substance shall be dispensed pursuant to a written prescription more than six months after the date it was prescribed."

Can a patient receive drug quantities in excess of the face amount of a prescription for a NON-control?

-If deemed appropriate, a patient may receive upon request, drug quantities in excess of the face amount of a prescription for a NON-control, UP TO the total amount authorized § NOT allowed for controls or psychotherapeutic drugs w/o authorization from the prescriber

When can a physician DISPENSE meds?

-If dispensing for a fee, must register with BOP as a Dispensing Physician § Does not include drug samples given for free § Must comply with all laws pertaining to pharmacists (labeling, recordkeeping, patient counseling, prospective DUR, etc.) § Physicians must do the dispensing themselves

In NORMAL (non-terminal or LTCF pt) can a pharmacist partially fill a C2? What are the rules surrounding a partial fill?

-If patient or prescriber requests -Total dispensed in all partial fills does NOT exceed the total prescribed -Total amount of the Rx be filled NO LATER than 30 days from the issue date -If AFTER 30 days, must notify prescriber and no further quantity may be supplied w/o a new RX -If the C2 is an EMERGENCY ORAL Rx, the pharmacist only has 72 hours after the Rx is issued to fill the remainder

RxPrep: What are the advertising limitations for pharmacies?

-It is ILLEGAL for a business that is NOT a pharmacy to use the terms "drug", "pharmacy", "prescription drugs", "prescription", "Rx", or "apothecary" in its name, on a sign or in advertising that would imply that the business is licensed or registered to practice pharmacy

How are paper prescriptions filed in a pharmacy?

-May file paper prescriptions in one of two ways: (1) Three separate files · All C2s · C3-C5 · Non-controls (2) TWO files · All C2s · All other drugs dispensed (C3-C5 must have a RED LETTER C not less than one inch high stamped on the face of the Rx, lower right corner) -Red C requirement can be waived IF the pharmacy uses a computer recordkeeping system for Rxs (the system must be able to ID prescriptions by Rx number and retrieve original documents by prescriber name, Patient's name, drug dispensed and date filled)

Healthcare professionals can submit ADRs to ____ or ______

-MedWatch (in combo with FAERS) -Manufacturers who then report to MedWatch at quarterly intervals for first 3 years then annually thereafter --> this is part of the post-marketing surveillance

1) What happens in a hospital when there is absence of a pharmacist? (i.e. If a HCFP is not open 24/7) What is required? 2) Can other personnel still working in the HCFP?

-Medical staff to have access to an "on-call" pharmacist -The PM has TWO options to assure access to drugs and care in absence of a pharmacist: (1) Contract with another HCF, pharmacy/ist (2) Authorize and train a nurse to remove drugs and/or devices from the pharmacy · Occur only if the drug needed is NOT in the auxiliary med inventory · PM maintains a current list of authorized persons and documents the initial orientation, continuing education, and quality control process · Maintain a list of restricted meds that can NOT be taken (only can be removed by an on-call pharmacist) · An "on call pharmacist" MUST be accessible for questions by the authorized nurse · Within 24h,a pharmacist shall verify the order and med removed 2) Supportive personnel may still be working in absence to perform clerical, repackaging, and distributive functions -Drugs may ONLY leave pharmacy if checked by pharmacist (unless removed by an authorized nurse)

RxPrep: What are the requirements for pharmacy staff ID badges?

-Must contain NAME and ROLE (i.e. license, certification, or registration)

RxPrep: What resource can be used to select a suitable substitution (e.g. Orange book, state formulary)?

-NC Product Selection does not refer tot he Orange Book rating published by the FDA -Ultimate decision on equivalency is up to the pharmacist

RxPrep: What are the limits on prescribing controlled on non-controlled drugs for oneself or family members?

-Not allowed except for minor illnesses and emergencies

Q: In what schedule did DEA list carisoprodol products? How do I refill a Soma (carisoprodol) prescription written prior to January 11, 2012?

-On December 12, 2011, DEA published a Final Rule in the Federal Register making carisoprodol a schedule IV controlled substance. -Accordingly, as of January 11, 2012, a pharmacy may only fill or refill a prescription for a drug containing carisoprodol if all of the following requirements are met: the prescription was issued for a legitimate medical purpose by a DEA-registered practitioner acting in the usual course of professional practice (21 C.F.R. § 1306.04); the prescription contains all the information required by 21 C.F.R. § 1306.05; and the number of refills authorized by the prescribing practitioner is five or less

Q: What can Physician Assistants and Nurse Practitioners prescribe?

-PAs: http://reports.oah.state.nc.us/ncac/title%2021%20-%20occupational%20licensing%20boards%20and%20commissions/chapter%2032%20-%20north%20carolina%20medical%20board/subchapter%20s/21%20ncac%2032s%20.0212.pdf -NPs: http://reports.oah.state.nc.us/ncac/title%2021%20-%20occupational%20licensing%20boards%20and%20commissions/chapter%2032%20-%20north%20carolina%20medical%20board/subchapter%20m/21%20ncac%2032m%20.0109.pdf

In Terminal or a LTCF pts can a pharmacist partially fill a C2? What are the rules surrounding a partial fill?

-Partial fills can be done for UP TO 60 days from issue date -Total quantity dispensed must not exceed what was prescribed -Pharmacist AND prescriber had corresponding responsibility in determining fit he pt is terminally ill -Pharmacist must write "Terminally-Ill" or "LTCF Patient" on the Rx · For EACH partial fill, the Pharmacist must record: o Date of partial filling o Quantity dispensed o Quantity remaining o Identification of dispensing Pharmacist

**Prescription orders are NOT public records** Who is allowed access to the contents of the Rx records or may receive a copy?

-Patient, guardian, emancipated minor, prescribing practitioner, practitioner treating the patient, pharmacist providing pharmacy services, anyone the patient allows via written authorization, person authorized by court order, BOP, researchers and surveyors approved by the BOP, HIPAA covered entity, Medical and Dental Boards, and others o Caveat: A pharmacist may disclose any info to any person ONLY when they reasonably determine that the disclosure is necessary to protect the life or health of any person

Can CPPs prescribe ALL controls?

-Per NCBOP website: "CPPs are essentially in the same position as a PA or NP. CPPs that have controls in their protocols CAN obtain a DEA registration: RECALL: PA or NP must personally consult w/ their supervising physician PRIOR to prescribing a Targeted Controlled Substance when all of the following apply: · The facility primarily engages in pain Tx · Use of TCS will or is expected to exceed 30 days · If the TCS is continuously prescribed to the same patient, the PA or NP must consult w/ supervising physician AT LEAST ONCE every 90 days

RxPrep: What drugs (e.g. NTI drugs) are not permitted to be substituted?

-Pharmacists must get documented consent oof the prescriber and the pt before switching manufacturers on refills for the following meds: 1) Carbamazepine 2) Cyclosporine 3) Digoxin 4) Ethosuximide 4) Levothyroxine sodium tabs 5) Lithium 6) Phenytoin 7) Procainamide 8)Tacrolimus 9) Theophylline 10) Warafrin sodium tabs

When e-scribing controls, can a pharmacist make changes to e-prescription?

-Pharmacy application service provider must digitally sign and archive a prescription on receipt -Pharmacist MAY make changes to e-prescription after receipt -If a pharmacist needs to make a notation (as he/she would on a paper prescription), must make the same notation electronically and retain the annotation electronically in the prescription record or linked files

Can a prescriber fax a C2? Is it considered valid?

-Prescriber MAY fax a C2 to the pharmacy for the pharmacist to prepare the order so it is ready ahead of the patient's arrival to the pharmacy -However, the patient MUST present an original, written, signed Rx to the pharmacy BEFORE dispensing -The faxed Rx is NOT considered valid, the written Rx must be the prescription kept for recordkeeping purposes In these 3 instances, a pharmacy may legally receive a faxed Rx for a C2 by a prescriber where the FAXED Rx serves as the ORIGINAL Rx (written Rx NOT needed) · (1) Schedule 2 narcotic substance to be COMPOUNDED for the direct administration to a pt by parenteral, IV, IM, SC, or intraspinal infusion · (2) Schedule 2 substance for a resident of a LTCF · (3) Schedule 2 narcotic substance for a pt in HOPSICE (prescriber must note somewhere on the Rx that the pt is in hospice)

RxPrep: What are counseling requirements for Rx delivered too the pt or sent by mail?

-Pt must be provided w/ a toll-free number to facilitate communication w/ the pharmacist -Printed materials can also be used

RxPrep: What agencies must a CS loss or theft be reported to and w/in what time frame must this be reported?

-Report significant loss or theft to the DEA division office in writing w/in ONE business day -A Drug Disaster and Loss Report should be filed w/ the Board w/in 10 days of the loss/theft

How many CPPs may a supervising physician supervise?

-Responsible for the ongoing supervision and evaluation of the CPP, readily available for consultation with CPP, licensed with NC Medical Board, NOT a resident, and can supervise NO MORE than 3 CPPs -CPP may have multiple supervising physicians (a primary a back up(s))

RxPrep: Can techs accept new Rxs over the phone?

-Yes if they are CERTIFIED and the Pharm-manager has developed a policy allowing it

Q: What is my responsibility as a pharmacist in case of drug loss or theft?

-a DEA registrant shall notify the field division office of DEA in writing, of the theft or significant loss of any controlled substances within ONE BUSINESS DAY of discovery of such loss or theft. Registrants are also required to complete a DEA 106 regarding the loss or theft.

Q: May a pharmacy transfer an "on file" prescription for a controlled substance that the pharmacy never dispensed?

-a pharmacy, "once it has filled an original prescription for a controlled substance in Schedule III-V," to "transfer the original prescription information to another DEA registered pharmacy for the purposes of allowing that second pharmacy to then dispense any remaining valid refills -"an allowance currently does not exist for the forwarding of an unfilled prescription from one DEA registered retail pharmacy so that it may be filled at another DEA registered pharmacy." -it is DEA's "policy" that an electronic prescription for a controlled substance of any schedule may be "forwarded from one DEA registered retail pharmacy to another DEA registered retail pharmacy" even if that prescription had not been filled. All that said, however, DEA has shown no inclination to reconsider or clarify these positions. Where does that leave us? (1) Though "forwarding" of unfilled electronic controlled substance prescriptions is available by "policy," the lack of any guidance from DEA on how a "forwarding" should occur and be documented means that most pharmacies and pharmacists are reluctant to entertain the practice. And who can blame them? (2) For unfilled verbal prescriptions for a Schedule III-V controlled substances, DEA's position means that there is no mechanism for moving them from one pharmacy to another. (3) For unfilled paper prescriptions for a Schedule III-V controlled substances, a pharmacy could return the original to the patient to physically carry to another pharmacy. Board staff understand completely the practical problems of this approach.

RXPREP: CSTDs are "recommended" when _________ hazardous drugs, but REQUIRED when __________

-compounding -administering § Administering HDs o Requires TWO pairs of chemo gloves AND a chemo gown when administering IV HDs If manipulation of capsules/tabs/etc. it should be done INSIDE a plastic bag to contain any dust or particles

Can Prescriptions blanks pre-printed for non-controls? How about controls?

-o Prescriptions blanks for controls may NOT be pre-printed (it IS allowed for non-controls) -(it IS allowed for non-controls)

Is Confidentiality of Alcohol and Drug Abuse Patient Records more or less strict than HIPAA? How so?

-· MORE strict than HIPAA --> this is for patients for Tx of substance abuse · The following procedures ONLY apply to patients in a substance use disorder (SUD) Tx program that is "federally assisted" and meets the definition of a "Part 2 Program" o Some examples of "federally assisted" includes a program that receives federal funds, a prescriber registered to provide buprenorphine, or an opioid Tx program o "Part 2 Program" refers or an individual or entity that "holds itself out" as providing diagnosis, Tx, or referral for Tx of a SUD · Prohibited to disclose or redisclose any info that might identify an individual as having or have has a SUD o Patient consent MUST be received in writing in order to make a disclosure

Transfer of a prescription: 1) What is required of the TRANSFERRING pharmacy? 2) What is required of the RECEIVING pharmacy? 3) Can this info be facilitated by a computer system?

1) -Invalidate the prescription and any remaining refills by writing "VOID" on the face of the invalidated prescription or its equivalent -Record on the back of the prescription: Name, address, and DEA number of the pharmacy to which it was transferred (if a control) PLUS person's name receiving the Rx -Record date of transfer PLUS their own name -For controls originally sent electronically by a prescriber to the pharmacy --> all info (as state above) must be added to the prescription (electronic) record 2) -Write "transfer" on the face of the prescription -Reduce to writing all that is required on a prescription PLUS: § Date and time of transfer § Issue date of original Rx § Original number of refills § Number of refills remaining plus date of last refill § Transferring pharmacy's name, address, DEA number (if control), and prescription number § Name of transferring pharmacist, CT, or intern § Manufacturer or brand of drug dispensed § For controls: · Date of original dispensing · Pharmacy's name, address, DEA number, prescription number from there the Rx was originally filled (if different) · Dates and locations (if different) of previous refills 3) State law permits the above documentation requirements to be facilitated by use of a computer or data system without reference to an original prescription document -The system must be able to identify transferred prescriptions and prevent subsequent prescription refills at that pharmacy

RxPrep: 1) How many members serve on the NCBOP and how long are the terms of service? 2) How many public (non-pharmacists) and pharmacists serve on the NCBOP?

1) -6 members -5 years term, limited to 2 consecutive terms 2) 5 pharmacists; 1 public member

1) What is unique about dispensing a NTI drug? Any exceptions to the normal rules?

1) Prescriptions for NTI drugs must be refilled using the SAME drug MANUFACTURER as previous fill -Includes a new Rx which is a continuation of previously initiated therapy -EXCEPTION: Another manufacturer's product may dispensed, however, must first receive approval from the prescriber AND the patient (documented consent) Examples: BBZ, Cyclosporine, Digoxin, Ethosuximide, levothyroxine, Lithium, Phenytoin, Procainamide, Tacrolimus, Theophylline, Warfarin

1) What records must be kept in the absence of a pharmacist in a HCFP? 2) What type of drugs can be taken by the authorized nurse?

1) -A record of drugs removed (from auxiliary medication inventories or from pharmacy inventory) shall be kept for 3 YEARS -The PM shall AT LEAST QUARTERLY verify accuracy of records 2) o ONLY drugs in UNIT-DOSE packaging shall be removed in amounts sufficient to meet the needs for immediate therapeutic use § Drugs shall be pre-labeled by the pharmacist with drug name, strength, lot number and EXP date o CONTROLs may be stocked and removed from auxiliary inventories; controls may NOT be removed from the pharmacy in the absence of a pharmacist

1) What are the requirements to become a "Validating" Tech (i.e. for Tech-Check-Tech) 2) What are their permissible activities?

1) -Be registered with the NCBOP -Be a CERTIFIED tech -Hold an associate's degree in pharmacy technology 2) -Stocking of patient care unit medication inventories -Stocking of ancillary drug cabinet inventories -Stocking of automated dispensing units -Stocking of emergency kits -Prepackaging of prescription drugs w/in the hospital pharmacy o May validate the filling of floor stock and unit dose distribution systems of already compounded or admixed prescription drugs assuming a pharmacist verified they have ben made correctly

1) When MUST a patient or representative present an ID to pick up a prescription? 2) WHat must be documented by the pharmacy? 3) Types of IDs allowed? 4) How long must records be maintained? **Does NOT apply for employees of healthcare facilities picking up Rxs for the residents** 5) Who can have access to these ID records?

1) -Before dispensing ANY C2s and select C3s (i.e codeine combo products), the person picking up the Rx MUST present a valid ID -Patient CAN designate someone else to pick up their Rx 2) Pharmacy MUST document the person's name, type of ID, and ID number 3) Types of IDs allowed: unexpired, government issued --> DL, special ID card issued by the NC DMV, military ID, passport 4) Must retain with records for THREE YEARS on the premises of the central locations 5) People authorized to receive info from the Controlled Substance Reporting System can also have access to the ID records kept by the pharmacy (pharmacy must provide within 72h)

Immunizing Pharmacist: THREE SEPARATE categories of immunizations a pharmacist may administer (each has its own requirements for type of vaccine, minimum age, and whether a patient needs a prescription from a practitioner beforehand) 1) May administer the following vaccines to patients 18 or older: 2) FLU vaccine to Patients at least _______ of age pursuant to a protocol: 3) An immunizing pharmacist may administer ANY vaccination recommended by the CDC (for other vaccines not listed in 2 or 3 below) but what requirements must be met? 4) What is required on an IP's protocol with a physician?

1) -Both PNA vaccines -Herpes Zoster Vaccine -HepA and HepB -Meningococcal polysaccharide, conjugate, or serogroup B -Td, Tdap, tetanus toxoid vaccines · But NOT if the patient discloses they have an open wound -HPV § Requires a written protocol w/ a supervising physician who is licensed in a and has a practice physically located in NC 2) 10 years -Influenza vaccine to patients AT LEAST 6 years old after obtaining a prescription (prescriber must have done a physical exam first) 3) -Requires a specific prescription order order and written protocol w/ a supervising physician (MD or DO) -Patients must be 18 or older 4) o Prepared, signed, and dated by the Physician and Immunizing Pharmacist o Name of physician and IP o Vaccines that may be administered o Screening questionnaires and safety procedure (on NCBOP website) o Procedures to follow in the event of an emergency or ADR o Reporting requirements by IP to the physician, including content and time frame o Locations where IP may immunize o Must be reviewed with physician and documented ANNUALLY · IP must have drugs listed in their written protocol to Tx ADRs and must have them in custody when giving a vaccine · Physician needs to be accessible to the IP or available to the IP via telecommunication · Physician must receive periodic status reports from IP

1) Can C3-C5s be transferred to another pharmacy? If so, how many times? 2) Can technicians or interns initiate and/or receive the transfer? 3) What if they have never been filled at the original pharmacy, but instead were just on file?

1) -C3-C5: MAY be transferred to another pharmacy on a ONE-TIME basis for refill purposes -Pharmacies who share a real-time, online database (i.e. within their company) may transfer C3-C5s up to the MAX number of refills permitted 2) Transfer must be completed by means of direct communication between two licensed pharmacists for C3-C5 3) For controls that have NOT been filled ("on file"), yet a pharmacy wants to forward them to another pharmacy, the current DEA policy ONLY allows ELECTRONIC prescriptions to be forwarded

RxPrep: 1) Are a mail-order pharmacy's hours and/or toll-free number required to be listed on the prescription container labeling 2) Do mail-order pharmacies have to be open for a defined number of days and hours per week?

1) -Hours are NOT on the Rx label -Toll free numbers ARE 2) Yes-40 hours/wk

Inventory of controls: 1) When should they be done? What is recorded? 2) What if an entity owns multiples locations, can all their inventory records be kept at the same place? 3) When is an EXACT count required? When can it be estimated? 4) How can the records be maintained? 5) What if a drug becomes newly scheduled?

1) -Initial inventory of ALL controls on hand must be done BEFORE a pharmacy begins business -Initial inventory should include the following: date, drug name, strength, dosage form, bottle size, number of commercial containers (i.e. four 100 tablet bottles), count of the substance -Inventory must be taken EVERY TWO YEARS after date of initial inventory § May be performed on ANY date within 2 years of previous inventory § Requires same info to be recorded as initial inventory -If a change in ownership OR change in PM occurs, the NEW PM must complete an inventory of ALL controls within 10 DAYS 2) NO --> Inventory must be kept at EACH registered location 3) -C2: EXACT count of the medication MUST be performed -C3-5: "estimate" is permissible UNLESS the container holds MORE than 1000 tabs/caps in which an EXACT count must be done 4) o Records must be maintained in WRITTEN, TYPED, or PRINTED form 5) o Newly scheduled drugs MUST be inventory on THE DATE THEY BECOME SCHEDULED

Drug Supply Chain Security Act "Track and Trace" Prescription drugs will be ID'd and traced down to package level throughout the entire drug supply chain (from manufacturer to wholesaler to pharmacy) 1) WHat are the 3 T's? 2) Transaction records must be maintained for________

1) · Transaction history · Transaction info · Transaction statements 2) 6 YEARS (post-transaction) · Dispenser should NOT accept drugs if Transaction info not provided

If a CPP stops working, MUST notify the BOP within ______

10 DAYS

If a change in ownership OR change in PM occurs, the NEW PM must complete an inventory of ALL controls within _______

10 DAYS

Office-Based Opioid addiction treatment -Allows "qualify practitioners" to prescribe from their office, any opioid in schedules C3-5 that was approved by the FDA for Tx of opioid addiction 1) What qualifies a practitioner? 2) Which practitioner can become qualified to prescribe buprenorphine products? Is there a way around this? 3) What is unique about their DEA registration? 4) Can they Tx as many pt as they want?

1) -Must apply for a waiver be registered with the DEA, and licensed by their state's Medical Board -Must complete approved training or have certain qualifications 2) -A "qualifying physician" (MD or DO) MUST have certain qualifications or credentials to apply for a waiver -Certain Mid-levels ("Qualifying OTHER Practitioner") are also able to apply for a waiver and prescribe buprenorphine product for opioid addiction § Includes NPs, PAs, clinical nurse specialists, certified registered nurse anethesist, or certified nurse midwife § Must complete 24 HOURS of training or have previous experience in treating opioid addiction Must be supervised by or work in collaboration with a "Qualifying prescription -WAY AROUND THIS: A buprenorphine product may be prescribed off-label for pain by any prescriber (therefore, the Rx would not need the "X" number) 3) Practitioners are given a UNIQUE ID NUMBER after for a waiver is approved § MUST be recorded ON the Rx (begins with an X) in addition to their DEA number 4) NO --> o There ARE limitations on the number of patients they are allowed to treat at a time

1) When can a Practitioner prescribe for a family member? 2) How about controls?

1) -ONLY for MINOR illnesses and EMERGENCIES -Includes themselves, family members, or anyone with whom they have a significant emotional relationship -MUST keep record of such events 2) o Practitioners shall NOT prescribe controls for themselves, their supervising physicians (for NPs/PAs) their own immediate family, anyone living at their residence, or anyone with whom they are having a sexual relationship

RxPrep: 1) How many pharmacies can a pharmacist serve as the pharmacist-manager for at one time? 2) Minimum number of hours a Pharm-manager must be present at the pharmacy?

1) -One -EXCEPTION: Can serve at 2 if one is newly permitted and is not open yet When the new pharmacy begins operation (or 6 months after the permit was issued if still not open) the pharmacist can no longer serve as manager 2) At least 1/2 the hours the pharmacy is open or 32 hours per week, whichever is less

1) What records must be kept when ordering C3-C5s? 2) Records of receipt MUST include what required info?

1) -Pharmacy must keep a receipt (invoice or packaging slip) of drugs received and confirm that the order is accurate -Must be maintained in a readily retrievable manner § If invoice contains Controls AND non-controls, controls must be identified in a readily retrievable manner 2) § Drug Name § DOSAGE FORM § Strength § Number of dosage units or volume in container § Number of containers received § Date of receipt § Name, address, and registration number of supplier

Sale of certain C5s OTC (i.e. Cheratussin AC) 1) What dispensing laws apply? 2) What records are kept? Where are they kept?

1) -Purchaser must be AT LEAST 18 yo and furnishes a suitable ID -Must be for legit medical purpose --> Dispensing done ONLY by a pharmacist (NON- pharmacist may complete the register transaction) -NO MORE than 240 mL (8 oz) OR 48 dosage units of an opium containing product or 120 mL (4 oz) or 24 dosage units of ANAY OTHER controlled substance may be dispensed to the same purchaser w/in a 48h period (at retail) 2) Sale recorded in a bound record book w/ all required info: § Name and address of purchaser § Name and quantity of control purchased § Date § Name or initials of pharmacist

1) How soon after a theft or significant loss of controls, or significant loss must a pharmacy report? How do they report it to? 2) What if the theft or loss is not deemed "significant"? 3) What form should be filled out if significant? 4) What if the "theft" or "loss" is due to miscounts or adjustments due to clerical errors? 5) What if Breakage or spillage occurs causing a loss of controlled meds?

1) -Registrant must notify DEA within ONE business day of discovery of "theft of significant loss" of any control -PM to notify NCBOP w/in TEN days of ANY theft (Controlled OR non-controlled) à MUST fill out "Drug Disaster and Loss Report" on BOP website 2) If it is determined the loss is NOT significant, registrant should place a records of the occurrence in a theft and loss file for future reference (i.e. "insignificant loss binder") -If after initial notification to DEA the investigation finds no such loss occurred, a DEA Form 106 does NOT need to be filled out but should contact DEA to resolve the initial report and explain why a Form 106 was not filled out 3) Registrant MUST complete DEA from 106 available online 4) should NOT be reported on a DEA Form 106, but noted in a separate log kept at the pharmacy 5) does NOT count as a loss of controlled substance and does NOT warrant a form 106 --> instead, it must be disposed of according to DEA requirements if the drug can be recovered

1) Currently approved products for opioid addiction Tx include: 2) Can these be filled by pharmacies?

1) -Subutex (buprenorphine) -Sublocade (buprenorphine ER injection) -Probuphine (buprenorphine implant) -Buprenorphine/naloxone (Suboxone, Cassipa, Bunavil, Zubsolv) 2) YES

Pharmacy Quality Assurance Protection Act 1) All pharmacies "shall establish or participate" in a QA program that evaluates: 2) Are the proceedings of these meetings public record? 3) Is a person in attendance at a QA meeting required to testify in a civil or administrative action? · The BOP is allowed to obtain info about a med error for an investigation or complaint 4) If given notice by the BOP, the pharmacy MUST provide documentation (WITHIN ________) of any alleged med error or incident committed by the pharmacist in the past 12 months, when WHAT occurs?

1) -The quality of the practice of pharmacy -The cause of alleged med errors and incidents -Pharmaceutical care outcomes -Possible improvements for the practice of pharmacy -Methods to reduce alleged med errors and incidents 2) · The proceedings of a pharmacy QA program, the records and materials it produces, and the materials it considers shall be confidential and NOT considered public records (NOT subject to discovery in a civil action or BOP administrative hearing) o However, info, documents, or records otherwise available are NOT immune from discovery or use in a civil action merely because they were presented during proceedings of the QA program 3) NO but the can -o Can NOT be asked about the person's testimony before QA program or any opinions formed as a result of the QA program 4) 10 DAYS o The alleged error leads to a physician visit, ED visit, hospitalization, or death o The BOP initiated a disciplinary proceeding against the pharmacist as a result of an investigation

1. What collection methods of pharmaceutical controlled substances does the DEA authorize? 2. Who may modify their DEA registration in order to become an authorized collector? 3. How does a DEA registrant modify their registration to become an authorized collector? §1301.51(b) 5. How does collection receptacle-based program work? §1317.75 7. Methods of destruction

1) a. Collection receptacles b. Mail-back programs c. Take back events conducted by law enforcement only 2) a. Manufacturers b. Distributors c. Reverse distributors d. Narcotic treatment programs e. Hospital or Clinic with an on-site pharmacy f. Retail pharmacies 3) a. Submit an online request http://www.deadiversion.usdoj.gov/drug_disposal/or send a written request to Registration Unit at DEA (mailing address found in §1321.01)b. The request shall contain: registrant's name, address, registration number as printed on the certificate of registration, signature of registrant and the type of collection (mail-back and / or collection receptacle) that the registrant plans to conduct.c. No fee will be collected for the modification of the registration to become an authorized collector.d. Modification to a registration to become an authorized collector is voluntary. The new rule does not require any registrant to become a collector. 5) b. Schedule II-V controlled substances that are lawfully possessed by an ultimate user or other authorized non-registrant person may be collected in a collection receptacle. Non-controlled substances may be comingled with controlled substances in collection receptacles. c. Collection receptacles shall be placed securely and maintained inside a collector's registered location, inside law enforcement's physical location or at an authorized long term care facility -There are other requirements specific to like the inner lining of receptacles, etc.: http://www.ncbop.org/faqs/pharmacist/faq_DrugTakeBack.htm 7) b. Two (2) employees of the registrant shall personally witness the destruction of the controlled substance until it is rendered non-retrievable. c. Must keep complete and accurate records of destruction (DEA Form 41) with names and signatures of two (2) employees who witnessed the destruction. These records must be kept for 2 years.

NUCLEAR Pharmacy 1) What are the Labeling Requirements (In addition to labeling requirements of normal Rx)? 2) MUST contain a tamper-resistant seal and an "outer" or delivery container with the following info:

1) o Standard radiation symbol o Words "CAUTION-RADIOACTIVE CHEMICALS) o The Radionuclide of the Radiopharmaceutical contained therein AND its chemical form o The amount of radioactivity of the Radiopharmaceuticals contained therein and the date and time of the calibration of that radioactivity o The date and time of the expiration of the Radiopharmaceuticals o If LIQUID --> volume o If SOLID --> number of capsules or weight o If GAS --> number of ampules, vials, or syringes o The name, address, and phone number of the nuclear pharmacy dispensing o Prescription or lot number o Name of the pharmaceutical 2) o Standard radiation symbol o Words "CAUTION-RADIOACTIVE MATERIAL o The Radionuclide and chemical form o Volume if liquid o Requested activity and calibration date and time o Rx number o Labels for radioactive blood components and therapeutic dosages must always contain the patient's name at time of dispensing § If not available (usually in cases for diagnostic dosing), 72-hour exemption is allowed to obtain the name of the patient o Name and address of nuclear pharmacy o Name of the end authorized used, must also be a prescriber o Lot number of the preparation

Pharmacists MUST record refills of control on EITHER an electronic or a manual system 1) IF using a manual, the following info must be recorded on the BACK of the Rx or on another document that is readily retrievable: -Info must be retrievable by Rx number NOTE: same info is recorded in the electronic prescription record for electronic purposes) 2) What if the Pharmacist merely initials and dates the back of the Rx or annotates the electronic Rx record? 3) What is different for C3-C4s?

1) § Name and Dosage form of control substance § Date filled or refilled § Quantity dispensed § Initials of dispensing pharmacist for EACH refill § Total number of refills for that Rx 2) it is deemed the FULL-FACE AMOUNT of the Rx was refilled 3) May only use a manual system OR a computerized system for refill recordkeeping, NOT both (for original written, fax, or oral prescriptions) § Must provide online retrieval of ALL ORIGINAL prescription information and current refill history for C3 or C4 prescriptions (the same info as stated above in the "Manual System" section) · Name and Dosage form of control substance · Date filled or refilled · Quantity dispensed · Initials of dispensing pharmacist for EACH refill · Total number of refills for that Rx § Pharmacists must verify and document that the refill data entered into the system is correct · If a system provides a printout of each day's controlled substance prescription order refill data, the printout must be verified dated, and signed by EACH Pharmacist who refilled the prescriptions listed on the printout within 72 hours (printout maintained in a separate file at the pharmacy) · In lieu of a printout, may maintain bound logbook or separate file (kept at pharmacy) o Pharmacist involved in dispensing control signs a statement verifying the Rxs that the Pharmacist refilled for that day (signed everyday) § All computerized systems must be able to PRINT OUT a refill-by-refill audit trail of any specified controlled substance

Agents of the Prescriber in LTCF -LTCF nurse or employee is allowed to be an agent of the prescriber provided there is a written agreement 1) Agent may only perform certain acts: WHAT? 2) What can they not do?

1) § Prepare a written Rx for the signature of the practitioner § Call in an Rx from C3-C5 to the pharmacy § Transmit a fac prescription from the prescriber (including C2s 2) An agent may NOT call in an emergency oral C2 Rx to the pharmacy

What are the prescriber requirements for E-scribing controls? 1) Digitally E-sign Rxs using 2 of 3 possible factors for authentication --> What are they? 2) Can somebody that works for the prescriber enter in the info for the Rx? 3) What about the signature? How do they sign it to make it valid?

1) · (1) Something only practitioner knows (Password) · (2) Something the practitioner IS (biometrics) · (3) Something the practitioner HAS (token) 2) An agent of the prescriber CAN enter the Rx info but can NOT have access to authentication factors or sign the Rx 3) Prescription must contain all required info, an "electronic signature" is permissible

1) AFTER direct consultation w/ practitioner and documenting on the Rx, what may a Pharmacist add or change for missing or incorrect information on a C2 Rx per NCBOP? 2) What can NOT be modified or added?

1) · Issue date (add, NOT change) · Patient address · Strength · Dosage form · Directions for Use · Quantity (may be modified in conjunction with change in strength ONLY, and do not exceed original total dosage prescribed) 2) · Patient's NAME · Name of controlled substance (EXCEPT for generic substitution) · Prescriber's signature (New Rx must be issued)

1) What is a Privacy Practices Notice?When does it have to be given? 2) How do they know patients got it?

1) · Privacy Practices Notice o Each covered entity, with certain exception, must provide a notice of its privacy practices o Must contain several elements, mainly concerning how the covered entity will use the patient's PHI, safeguards, and grievance process o Must deliver a privacy practices notice to patients NOT later than the FIRST service encounter o Notice must also be posted in a clear and prominent place at the pharmacy o MUST supply notice to anyone on request and make it electronically available on website 2) · Acknowledgement of Notice Receipt o Must make good faith effort to obtain a written acknowledgement by ALL pts that they received the Privacy Practices Notice § Can also extend the acknowledgement electronically or by mail o MUST document reason for any failure to obtain the patients written acknowledgement § Can NOT refuse Tx if patient refuses to sign o Only required ONCE for each pt (even if you update the Privacy Practices Notice) o ONLY may be signed by the patient or their rep

1) What is a Targeted Control Substance? 2) A practitioner is REQUIRED to issue _________ for TCSs 3) Exceptions to this rule: 4) If a pharmacist receives a PAPER (written, fax, oral) prescription for a TCS, are they required to verify that the practitioner falls under one of the exceptions?

1) "Targeted" controls refers to any C2 OPIOID and select schedule 3 opioids (i.e. buprenorphine and codeine combo products) 2) ELECTRONIC Rxs 3) -A practitioner OTHER than a pharmacist dispensing directly to an ultimate user -Prescriptions for inpatient administration (i.e. hospital, nursing home, LTCF, Hospice, dialysis clinic) -Practitioner experiences technological or electrical failure -The prescription will be dispensed by a pharmacy on federal property -Persons licensed to practice veterinary medicine 4) NO

EMERGENCY C2s (Oral): situation a C2 can be CALLED-IN to the pharmacy: 1) Emergency defined as ___________ 2) Quantity limited to __________ 3) Prescription must be __________ by the pharmacist and contain all necessary info for a C2 (except prescriber's signature) 4) Prescriber has __________ to get a WRITTEN, SIGNED Rx to pharmacy 5) ______________ must appear on the face of the Rx AND the ________ 6) Alternatively, the prescriber may send the Rx __________ -Pharmacist MUST notify the local DEA if the prescription is not received 7) Pharmacist must maintain _____ w/ __________

1) (1) immediate administration is necessary (2) no appropriate medical alternative is available (3) is NOT reasonably possible for prescriber to provide an Rx before the drug is dispensed 2) emergency period 3) reduced to writing 4) SEVEN DAYS 5) "Authorization for Emergency Dispensing" -date of the ORAL order 6) ELECTRONICALLY 7) call-in Rx -written Rx (or annotate the record of the electronic Rx with the original authorization and date of the original order)

1) A Pharmacist receiving a prescription for a biological drug prescribed by its brand name MAY dispense ANY ____________ product 2) What else should the pharmacist do if dispensing the substitute?

1) (MUST have interchangeable and NOT simply biosimilar status) § DAW and such still applies and prohibits interchangeable substitution 2) Pharmacist or designee must notify the prescriber "within a reasonable time" if dispensing an interchangeable -Product name and manufacturer -Communication can be made via interoperable electronic medical records system, facsimile, telephone, electronic transmission, or other prevailing means -Notification is NOT required IF a refill prescription is not changed from product dispensed on the prior filling

1) How are escripts filed/stored in a pharmacy? 2) What about in a hospital?

1) -If an Rx is created, signed, transmitted, and received electronically, all records related to that Rx MUST be retained electronically -Must be able to SEPARATE out from all other records in a reasonable time (readily retrievable) and records must be sortable by prescriber name, patient name, drug name, and date dispensed 2) Institutional (Hospital) medical records: Medication or chart orders are NOT considered prescriptions per the DEA, see state law for guidance

1) Can NPs and PAs prescribe ALL controls? 2) What are the rules surrounding TCSs?

1) -MAY prescribe ALL controls and non-controls provided these drugs are included in their CPAs with the supervising physician 2) PA or NP must personally consult w/ their supervising physician PRIOR to prescribing a Targeted Controlled Substance when all of the following apply: · The facility primarily engages in pain Tx · Use of TCS will or is expected to exceed 30 days · If the TCS is continuously prescribed to the same patient, the PA or NP must consult w/ supervising physician AT LEAST ONCE every 90 days

RxPrep: 1) What is the Pharm/Tech ratio? 2) When could this be increased?

1) 1 Pharm: 2 Techs 2) Pharm Manager receives written approval from BOP in advance; each tech is certified

1) Drug Disaster and Loss Reports - NCGS 90-85.25(B) states that "the pharmacist in charge of a pharmacy shall report within ____ to the Board any disaster, accident, theft, or emergency which may affect the strength, purity, labeling of drugs and devices in the pharmacy". 2) Incident Reports - 21 NCAC 46.2502(l) states that "The pharmacist-manager shall report to the Board of Pharmacy information that reasonably suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient or customer. This report shall be filed in writing on a form provided by the Board within _____ of the owner representative or pharmacist-manager's becoming aware of the event. The pharmacist-manager shall retain all documents, labels, vials, supplies, substances and internal investigative reports relating to the event. All such items shall be made available to the Board upon request".

1) 10 days 2) 14 days

Sections of an NDC number: 1) How many digits? 2) What is the first segment of numbers (4-5 digits)? 3) What is the second segment of numbers (3-4 digits)? 4) What is the third segment of numbers (1-2 digits)

1) 10-11 2) labeler code --> manufacturer, repackager, or distributor and is assigned by the FDA 3) Product code --> ID's the strength, dosage, and formulation --> determined by the labeler 4) Package code --> ID's pack size and type --> determined by the labeler

Internet Pharmacies MUST Report to the DEA on a MONTHLY basis the amount of EACH control dispensed IF:

1) 100 or more prescriptions for controls filled 2) 5,000 or more dosage units dispensed of ALL controls combined 3) If amount are less than the above thresholds, a report is still required that indicates a negative response (due on the 15th of each month) · The thresholds include ALL controls filled (EVEN by means other than on the internet like walk-in business)

Continuing Education: ***NOTE THERE WAS A PRACTICE QUESTION THAT INCLUDED MORE INFO THAN THIS THAT DISCUSSED CARRYING HOURS OVER ETC.-this was for diff practice exam, but still need to look into*** 1) ____ hours of Board-approved CE required each year 2) ___ hours must be "live" or "contact" 3) May acquire _____ hours of CE for precepting, for at least _____, a student enrolled in one of the 4 NC pharmacy schools 4) Must keep records for CE for ___ 5) How many CE hours are required for the first renewal if licensed by examination that year? **ALL pharmacists, technicians, and pharmacies must obtain an NABP eProfile number and report the number to the board**

1) 15 2) 5 -Live and in-person OR ability to have 2-way communication like webinars -Remaining hours may be live or "correspondence" (read an article and answer questions) 3) 5 hrs -160 hrs 4) 3 years -Not required to maintain records IF the CE provider maintains an electronic database of all CE credits (i.e. ACPE or NCAP) -Subject to auditing 5) None -Although CE must be completed for 1st renewal if licensed by reciprocity that year

NCBOP Compounding Section: In a pharmacy where compounded drug preparations are prepared, labeled, or dispensed, the pharmacistmanager or the pharmacist-manager's designated pharmacist shall be knowledgeable in the specialized functions of preparing, labeling, and dispensing compounded drug preparations. 1) If the pharmacist-manager chooses to designate another pharmacist for this purpose, the pharmacist-manager shall notify the Board on the pharmacy's permit application and, in writing, within ______ of any change in the designation

1) 15 days -Notwithstanding the pharmacist-manager's designation of another pharmacist as knowledgeable in the specialized functions of preparing, labeling, and dispensing compounded drug preparations, the pharmacistmanager shall be responsible for ensuring the pharmacy's compliance with all statutes, rules, and standards that govern such activities.

1) Maintain EVERY original prescription order for a period of _______ 2) Can an automated data processing system be used? 3) NC Medicaid requires pharmacies to maintain the hard copy prescription for _______ 4) Medicare Part D requires prescriptions to be retained for ______ 5) Can an electronic image of the hard copy be maintained for recordkeeping?

1) 3 YEARS -EXCEPT for prescription orders recorded in a patient's medical record 2) YES -An automated data processing system may be used for the storage and retrieval of refill info for prescriptions 3) 5 YEARS 4) TEN YEARS 5) YES -Do NOT need to keep the HARD copy -Must be able to retrieve w/in 48 hrs of request by BOP -Federal law does NOT permit for controls

Pseudoephedrine 1) Law limits retail/OTC sale to NO MORE than _______ of pseudoephedrine, ephedrine, or phenylpropanolamine base to a single purchaser per day: 2) MAX _________ within a 30-day period 3) MAX ________ within a 30-day period by MAIL-ORDER 4) Must be AT LEAST _____ to buy OTC 5) Products MUST be stored and sold ___________ and shall ONLY be sold in __________ packs · Must post a sign: "NC law strictly prohibits.... Then it gives all the limits..... the ends with the pharmacy maintains records of sales that may be accessible to law enforcement"

1) 3.6 grams 2) 9 grams 3) 7.5 grams 4) 18 yo 5) BEHIND a pharmacy counter -BLISTER

CE Requirements for CPPs

1) 35 hours of PRACTICE-RELEVANT Ce EVERY year approved by BOP -15 normal CE hours are included in this (w/ 5 live) -Essentially only need 20 more CE hours 2) Documentation of these hours shall be kept at the CPP practice site

Wholesaler/Distributor Registration 1) One registrant may "distribute" a control to another registrant without being registered with the DEA as a distributor -KEY: the total number of dosage units distributed does not exceed ______ of the total units of controlled substances distributed and dispensed in one year ***The following activities are NOT considered "distributing" and do NOT count towards the above mentioned 5%: returning controls to a manufacturer or supplier, a registered retail pharmacy restoking an automated dispensing system at a LTCF, a CFP sending a filled Rx to originating pharmacy 2) COME BACK AND WORK ON THIS · ALL wholesale distributors engaged in the wholesale distribution of Rx drugs in NC shall obtain a license and renew ANNUALLY (w/ NC Dept of Agriculture's Food and Drug Protection Division) o Includes OOS wholesalers doing business in NC o Must have suitable securities, storage, facilities o Must visually examine ach outside shipping container upon receipt o Quarantine and physically separate Rx drugs that are outdated, damaged, deteriorated, misbranded, or adulterated o Subject to inspection o Establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of Rx drugs § Retain for 2 YEARS per NC law (although drug supply chain security act require 6 YEARS) o Establish, maintain, and adhere to written procedures for the receipt, security, storage, inventory, and distribution of Rx drugs o Keep a list if responsible persons o Exempt form registering as a Wholesale Distributor in NC § Intracompany Sales § Hospital or other healthcare entity that is a member of a GPO § Charitable organization to a nonprofit affiliate § Hospitals or other healthcare entities that are under common control § Transfer of Rx drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage · Gross dollar value of the transfers can NOT exceed 5% of total Rx drug sales revenue of either the transferor or transferee pharmacy during an 12-consecutive month periods § Dispensing of a Rx drug pursuant to a Rx § Distribution of drug samples § Blood and blood components intended for transfusion

1) 5%

1) C3 and C4 may NOT be filled more than _______ after issue date 2) How about C5s?

1) 6 months -C3s and C4s may be refilled UP TO 6 months after issue date OR 5 times, whichever comes first 2) NOT subject to the same restrictions as C3s and C4s -NO expiration date and NO limit on the amount of refills

1) Q: How do I obtain Board approval for increasing the pharmacist-to-technician ratio at my pharmacy? 2) Q: A student enrolled in a pharmacy technician educational program is present in my pharmacy. Does that student count toward the permissible pharmacist:technician ratio?

1) A: A pharmacist may not supervise more than two pharmacy technicians unless: (1) the pharmacist-manager receives written approval from the Board in advance; and (2) each additional technician is certified. (See G.S. § 90-85.15A.) To request an increase above the 1:2 pharmacist-to-technician ratio, 2) A. Students currently enrolled in community college-based technician training programs typically spend some time at pharmacy practice sites as part of their education. Such students present in a pharmacy solely for educational purposes as part of the technician training curriculum do not count toward the permissible pharmacist:technician ratio. The Board emphasizes, however, that the student must be present in the pharmacy solely for educational purposes. A student who is employed by a pharmacy as a technician does count toward the permissible pharmacist:technician ratio, notwithstanding that the student is also enrolled in a community college-based technician training program.

1) Q: Must a foreign pharmacy school graduate obtain FPGEC certification prior to obtaining experiential hours toward pharmacist licensure in North Carolina? 2) Q: May foreign pharmacy graduates work as pharmacy interns or technicians in North Carolina?

1) A: Effective August 1, 2008, any graduate of a foreign school of pharmacy who wishes to begin acquiring the 1,500 experiential hours required for licensure as a pharmacist in North Carolina must first provide to the Board of Pharmacy proof that he/she has obtained Foreign Pharmacy Graduate Examination Committee Certification ("FPGEC"). 2) A: The Board of Pharmacy frequently receives questions about Board requirements concerning foreign pharmacy graduates who work as pharmacy interns. These inquiries are frequently in connection with applications for H-1B visas. Under North Carolina law, an individual who has received the foreign equivalent of a U.S. Bachelor of Science degree in pharmacy may not work as a pharmacy intern without having obtained the Foreign Pharmacy Graduate Examination Committee Certification ("FPGEC"). A pharmacy intern does not require a license from the Board of Pharmacy, but all interns seeking practical pharmacy experience toward licensure as a pharmacist must register with the Board's internship program on forms provided by the Board. These forms must be filed with the Board of Pharmacy within five (5) days of the beginning of any training period. The practical pharmacy experience forms may be found at this link: http://www.ncbop.org/Forms%20and%20Applications%20-%20Pharmacists/PracticalPhcyExperienceAffidavit.pdf. Any person working as a pharmacy technician must register with the Board within thirty (30) days of beginning employment. The technician registration form may be found at this link: http://www.ncbop.org/technicians_forms.htm. To ultimately obtain a license to practice pharmacy in North Carolina, the foreign graduate would have to pass the FPGEE, the Test of English as a Foreign Language, the Test of Spoken English, the NAPLEX, and the Multi-State Pharmacy Jurisprudence Exam. The Foreign Pharmacy Graduate Examination Committee of the National Association of Boards of Pharmacy ("NABP") administers the FPGEC Certification Program, and foreign graduates should contact the NABP directly for further information. The foreign graduate would also have to complete 1500 Board-approved practical pharmacy experience hours as a Pharmacy Intern as a condition for licensure. As noted above, all interns seeking practical pharmacy experience must register with Board's internship program on forms provided by the Board.

Frequently Asked Questions for Pharmacists on Licensure by Reciprocity 1) Q: Can I reciprocate to North Carolina using a license that I obtained through Reciprocity? 2) Q: Does my "licensure by exam" state license need to be active in order to use it to reciprocate with?

1) A: No. You can only reciprocate with a license you obtained through Exam. 2) A: Yes

1) Q: Must a drug be rated AB in FDA's Orange Book to be used in product selection in North Carolina? 2) Q: Does an AB Rating from FDA change how a prescription for a Narrow Therapeutic Index drug is handled?

1) A: The North Carolina Product Selection Law does not refer to the Orange Book rating published by the Food and Drug Administration. That rating can be useful in determining what is used in product selection, but it is not necessarily determinative. The ultimate decision on equivalency is up to the pharmacist. 2) A: It has come to the Board's attention that one manufacturer has received an AB Rating for their Levothyroxine product. Pharmacists should be aware that the Narrow Therapeutic Index Drug concept is found in the state's Product Selection Law, G.S. 90-85.27 and .28. Levothyroxine qualifies as an NTI drug under this statute which means that pharmacists need to get the documented consent of the prescriber and the patient before switching manufacturers on refills. An AB Rating by the Food and Drug Administration in its Orange Book publication does not change the application of the NTI rule as noted above.

BOP Inspections Conducted by the BOP either in response to a complaint or on a routine schedule 1) Ranges from _________ to every _______ -Inspectors record and discuss violations w/ pharmacist on duty o Copy of inspection is sent to PM -· Checklists for inspections based on pharmacy setting can be found on the BOP website 2) PM must respond with _______________ regarding severe and/or significant deficiencies identified during the inspection within ________ 3) If filing a CPA, when is a pharmacy reinspected?

1) ANNUALLY -4 YEARS 2) a Corrective Action Plan (CAP) -o Within 30 DAYS 3) o The pharmacy will be re-inspected within 90 DAYS and the BOP may open an investigation if needed

Requirements to become a CPP

1) Active and unrestricted NC pharmacy license 2) Submits an application, fee, and other info to BOP 3) Has a signed written CPP agreement 4) Meets ONE of the following qualifications: § (1) Earned a BPS (board certified specialty) certification or Geriatric certification, or has completed an ASHP accredited residency with TWO years clinical experience approved by BOP § (2) Earned a PharmD and has THREE years of clinical experience approved by the boards and has completed one ACPE approved certificate program in the area of practice covered by the CPP agreement § (3) Possesses a BS in Pharmacy and has FIVE years clinical experience approved by BOP and has completed TWO ACPE approved certificate programs with AT LEAST ONE program in the area of practice covered by the CPP agreement

1) Which pharmacies in NC may ACCEPT and DISPENSE donated drugs? 2) What about free clinics? 3) Who are they dispensed to?

1) Any pharmacy or free clinic holding a NC pharmacy permit may ACCEPT and DISPENSE donated drugs à just a normal pharmacy permit or a special one? · A pharmacy or dispensing physician wishing to participate must notify the BOP in writing at time participation begins à ALSO must notify the BOP ANNUALLY on permit or registration renewal 2) Able to apply for a "limited-service permit" --> The PM IS allowed to act as PM of a separate, full-service pharmacy NOTE: · A "dispensing physician" registered with BOP who provides services to the patients of a free clinic that does NOT have a pharmacy permit MAY accept and dispense donated drugs 3) Donated drugs are dispensed to an uninsured or underinsured patient who meets eligibility criteria established by BOP, free clinic, or a pharmacy (patient must reside in NC) -· Drug must be prescribed by a practitioner for use by an eligible NC patient

1. If a provider prescribes Concerta and authorizes generic substitution, what may I substitute? 2) What if the provider prescribes Concerta, authorizes generic substitution, and the patient was previously stabilized on a Mallinkrodt or Kudco product?

1) As noted above, the Actavis marketed generic is the only AB-rated equivalent product to Concerta. 2) A pharmacist may seek a verbal authorization/clarification from the prescriber that a patient already taking, and stabilized on, a Mallinkrodt or Kudco product should continue to receive that product. Clinical discussion and documentation of any such approval is critical, however, for at least two reasons: (a) the product is a Schedule II controlled substance; and (b) FDA's decision to redesignate these products as "BX" rated to Concerta stems from bioavailability concerns. Note further that the FDA's statement (linked above) warns that the Mallinkrodt and Kudco products may be withdrawn from the market if the companies do not or cannot confirm the bioequivalence of their products to Concerta within six (6) months.

RxPrep: 1) W/in what time frame must a pharmacy submit the records of dispensed controls to the state's PDMP? 2) What healthcare professionals have access to PDMP?

1) By close of the next business day 2) All controlled substances dispensers and prescribers

Where are controlled substances records kept within a pharmacy?

1) C2s -ALL C2 records and inventories must be maintained SEPARATELY from ALL other pharmacy records 2) C3-5 -Records and inventories of C3-5 must be maintained SEPARATELY from ALL other pharmacy records (i.e. non-controls) OR readily retrievable from ordinary business records -"Readily retrievable" means the records are marked in a manner which distinguishes them from other items (asterisked, redlined)

What are the rules surrounding dispensing meds from an out of state prescriber? How about foreign prescribers?

1) CAN dispense NON-Controlled meds from OOS Practitioner 2) NC Controlled substances Act states the Practitioner MUST be licensed in NC to dispense CONTROLs from OOS prescribers 3) Same with FOREIGN prescribers (likely NOT registered with DEA)

If choosing to dispose of controls to a REVERSE distributor, manufacturer or wholesaler, what forms or documentation is required?

1) For C2s: REVERSE distributor, manufacturer or wholesaler issues a DEA 222 to the pharmacy 2) For C3-C5: Pharmacy keeps a record of the distribution on an invoice (drug name, dosage form, strength, quantity, and date transferred) 3) The REVERSE distributor, manufacturer or wholesaler submits a DEA Form 41

Responsibilities of Pharmacy Manager (PM) 1) Must be present for AT LEAST _____ the hours the pharmacy is open or ___ hours a week, whichever is LESS 2) A pharmacist may temporarily serve as PM for NOT more than ____ -In this case, must be present AT least ____ hours per week in pharmacy 3) If a change in ownership or change in PM occurs, the new PM must complete an inventory of ALL controlled substances in the pharmacy within ______ (written record, signed, dated, and kept in pharmacy for ______)

1) Half -32 2) 90 days -20 3) 10 days -3 years

1) When could an NP or PA dispense medication? 2) What drugs can they dispense? 3) MUST work with __________ o ALL drugs must be dispensed from a place holding a current pharmacy license o Must personally register with BOP as a dispensing NP or PA o ALL drugs dispensed should be PRE-labeled by the pharmacist with all info required by law EXCEPT name of patient and directions for use § Including auxiliary labels § Drugs are prepackaged in safety closure containers § PA/NP add patient name and directions at time of dispensing

1) Can ONLY dispense under supervision of a licensed pharmacist -EXCEPTION: handing out drug samples or starter packs ONLY (no fees can be charged) -A dispensing physician is not allowed to be the supervisor, NP's and PA's must be under supervision of a pharmacist 2) MAY dispense any drug that they are allowed to prescribe 3) a consulting pharmacist whose duties include: § Ensuring adequate amounts of drugs are available to be dispensed § Ensuring proper storage and packaging of drugs § Available during times of dispensing for consultation by phone, in person, or other means of direct communication § Retrospectively review all drugs dispensed on a weekly basis

Adulterated vs. Misbranded 1) Define Adulterated: 2) Define Misbranded:

1) Consists of any filthy, Putrid, or decomposed substance; prepared, packed, or held under conditions where it may have been contaminated; methods used to manufacture, process, package do NOT conform to CGMP; strength, quality, or purity differs from USP standards unless plainly stated on the label; container may be poisonous or deleterious to product -Meds stored in room with extreme temperatures -Location where med was prepared for dispensing is unsanitary 2) Manufacturer, packer, or distributor name and place of business is not on the label; Manufacturer is not registered with the FDA; Word, statement or other info not prominently placed on the label as required by law; the generic name is not on the label; inactive ingredients (trade secrets) are lacking; adequate warnings lacking; Labeling is false or misleading; if the drug is liable to deterioration and its label does not state such precaution -Dispensing an prescription drug w/o a prescription would be misbranding -Refilling an Rx when there are no valid refills would be misbranding -Dispensing the wrong strength of a drug -Inaccurate info on the label placed on the dispensed vial by pharmacy -Not following regulations from the Poison Prevention Packaging Act -Failure to manufacture OTC products in tamper resistant packaging (may also be adulterated)

1) Who must comply with HIPAA? 2) ·General Principle for Use and Disclosures -A covered entity may NOT use or disclose PHI, EXCEPT EITHER:

1) Covered entities: include health plans and providers (physicians, pharmacists), and personnel that conduct transactions electronically (for finance or admin purposes) o Covered entity may EXEMPT NON-health parts of its operation (i.e. grocery store) 2) § (1) as the Privacy Rule permits/requires § (2) As the patient (or representative) authorizes in writing

1) _______ is used for the DISTRIBUTION, PURCHASE or TRANSFER of a C2 2) Where does the pharmacy get the forms? 3) What do the forms look like? How many copies of the forms are there? 4) How are the filled out?

1) DEA Form 222 2) Forms are obtained when registering w/ DEA 3) Each from contains an original, duplicate, and triplicate copy (Copy 1,2,3) -Forms are serially numbered and issued w/ name, address, and registration number of registrant the authorized activity and schedules the registrant is authorized to handle 4) ALL 3 copies must be executed simultaneously with a pen, typewriter, or indelible pen) -10 numbered lines on each form, only enter 1 item (C-2) per line

1) What happens when a pharmacy that has registered with the DEA discontinues business or professional practice, or surrenders a registration? 2) What if a registrant wishes to transfer its business operations to another pharmacy (must also be registered w/ DEA)? 3) How are controls transferred? What recordkeeping is required?

1) DEA registration of ANY person shall terminate, w/o any further action by the DEA -MUST return DEA certificate of registration, PLUS unused DEA Forms 222 to the DEA upon d/c of business (unless business is transferred) and controls must be properly disposed 2) require DEA approval -proposal must be submitted to DEA AT LEAST 14 DAYS PRIOR to transfer w/ required info: § Name, address, DEA #, and authorized business activity of BOTH pharmacies § Whether business activities will be continued at old location or moved to a new building § Date on which transfer of controls will occur -Transfer may occur UNLESS DEA notifies otherwise 3) COMPLETE inventory of controls must be taken ON DATE OF TRANSFER · C2s must be recorded with DEA Form 222 · C3-C5s record: Drug name, dosage form, strength, quantity, date transferred, names/addresses/DEA numbers of BOTH pharmacies · EACH pharmacy includes a copy in their records (NOT necessary to send to DEA unless DEA requests) § All records w/ reference to control being transferred must be transferred to § KEY: Record accuracy remains with TRANSFEROR, record custody goes to transferee

1/2) Licenses expire on ________ each year and must be renewed _________ (must also pay a fee 3) What is the grace period? Is there a penalty? Can CEs be obtained during the grace period?

1) December 31st 2) Annually 3) 60 days -No penalty -Yes may continue to earn CE for renewal and renew during the grace period w/o penalty

1) What does a community pharmacy have to do to be able to dispense controls? 2) What about hospital pharmacies?

1) EVERY community/retail pharmacy must be registered with DEA AND must obtain a STATE permit from BOP 2) Hospital pharmacies do NOT need to register with the DEA, they are covered under the hospital's DEA

1) What can be used to order C2s instead of filling out a DEA form 222? 2) How long do suppliers have to fill the orders? 3) What do purchasers use to sign the orders? 4) How long are the digital certificates good for?

1) Electronic Controlled Substance Ordering System (CSOS) -Purchaser can order ANY control (C2-5) 2) Orders must also be filled by the supplier within 60 days following the date of order 3) Registrant (or power of attorney) must obtain a digital certificate for EACH DEA registered location -The digital certificate is what the registrant uses to sign the order for controls -A registrant appoints a CSOS coordinator to mange issuance of, revocation of, and changes to digital certificates (registrant CAN be CSOS coordinator) 4) Digital certificates are valid until the DEA registration expires, will then need to be renewed

1) Prescription drug marketing is regulated by _________ 2) OTC drug marketing is regulated by _________

1) FDA 2) Federal Trade Commission FTC

How to check a DEA number

1) FIRST LETTER -If a physician: A, B, F, or G -Mid-level practitioner: M 2) Second letter is usually the first letter of their LAST name 3) Add the 1st, 3rd, and 5th digits 4) Add the 2nd, 4th, and 6th digits and MULTIPLY x 2 5) Add the two totals together and the LAST digit should be equal to the LAST digit of the DEA number

Immunizing Pharmacist 1) What must be given to the patient? 2) WHat records must be kept?

1) IP must give the most current vaccine info to the patient or guardian and give them a chance to read it before giving vaccine and allows patient to ask questions 2) For ALL vaccines given: o Name, address, DOB of patient o Date of administration o SITE of injection and ROUTE o Name, manufacturer, lot number, and EXP date of vaccine o Dose administered o Name and address of the patient's primary healthcare provider o Name or identifiable initial of the IP

Q: May a pharmacist disclose to a treating physician that a patient is a receiving a prescription drug for the treatment of substance abuse?

1) If the pharmacist works for a federally funded substance abuse treatment facility or a federally funded organization with personnel whose primary function is substance abuse assessment and/or treatment, then the Substance Abuse Confidentiality Regulations (which are not part of HIPAA, but are applied as a secondary level of protection for substance abuse treatment patients) prohibit pharmacists from disclosing a patient's substance abuse treatment history to a physician. In this situation, a pharmacist must have the patient's consent to disclose the confidential information. 2) If the pharmacist does not work for a federally funded substance abuse treatment facility or a federally funded organization with personnel whose primary function is substance abuse assessment and/or treatment, then HIPAA permits the disclosure to a treating physician. If a patient's pharmacological history indicates the patient has a record of substance abuse, then a pharmacist may discuss this with a physician when working to prescribe the appropriate medication.

1) Can a covered entity market PHI? 2) Pertinent exceptions to the definition of marketing

1) KEY: ANY communication that meets the definition of marketing is NOT permitted, unless the covered entity obtains an individual's Authorization § Authorization includes a detailed description of disclosures, patient signature, date, and an EXP date (may be revoked by the pt at any time) -o Could mean one covered entity selling PHI to another business for that business's own purposes (i..e a pharmacy selling a list of all their diabetic patient to Pfizer, who would then market a new diabetes med to a patient) 2) § ANY face to face communications with the patient · CAN hand the patient printed info § Communications or describe a health-related product or service offered by the covered entity (the covered entity does NOT receive financial payments for making thr communication § Communications for Tx, contacting individuals with info about treatment alternatives, case management, or rare coordination for the pt (the covered entity does NOT receive a financial incentive to make the communication) · Physician refers to another physicians (i.e. specialist) · Physician shares medical records when consulting another Physician

1) How often does a CPP have to meet with supervising physician? 2) What documentation is required and how long are documents required?

1) MONTHLY for the FIRST 6 MONTHS, then every 6 months 2) Documentation included: -Clinical issues discussed and actions taken -Signed and dated by those attended meeting -Retained by both CPP and Supervising physician for FIVE YEARs

What records must be kept regarding donated drugs? How long must they be kept?

1) Maintain a written or electronic inventory of each donated drug for 3 YEARS -Name, strength, dosage form, number of units, manufacturer's loot number and EXP date -Name, address and phone number of eligible donor providing each type of drug, supply, or medical device · Maintain written or electronic documentation of prescriptions dispensed and comply with all other pharmacy laws and regulations (includes NON-RX medications too)

Manufacturing/Repackaging Registration 1) ___________ means the production, preparation, compounding or processing of a drug, as well as packaging, repackaging, labeling, or relabeling 2) ___________ means a person who repacks, relabels, or manipulates a prescription drug which was in a unit packaged and sealed by a manufacturer 3) Manufacturers and repackagers MUST register with ______________ -· OOS Rx drug manufacturers or repackagers shipping directly to NC are also required to register 4) Subject to inspection, will be given a license (renewed __________) and assigned a registration number · Pharmacies are exempt from registering if engaged in the ordinary course of pharmacy practice (i.e. receives a patient-specific Rx) o HOWEVER< you may need to reconsider if you compound, repackage, or re-label meds outside of the ordinary course of practice (i..e NOT pursuant to an Rx)

1) Manufacturing 2) "Repackager" 3) NC Dept of Agriculture's Food and Drug Protection Division 4) ANNUALLY

Requirements to operate as an internet pharmacy in NC:

1) Must be certified by National Association of BOPs as a Verified Internet Pharmacy Practice Site (VIPPS) 2) Provide NCBOP w/ names of corporate officers and stakeholders -Also provide percentage of annual business conducted via internet 3) If the pharmacy dispenses controls: -Must notify DEA and EACH state BOP that you intend to dispense to within 30 DAYS of starting -Register for a DEA number, then apply fir a modification of registration to operate as an internet pharmacy -Comply with all states' laws -Website must contain: · Display on homepage a declaration of compliance with law along w/ the name of pharmacy · Contain info about the pharmacy (name, address, phone #, email) and about the PIC (name, degree, states of licensure, phone #,) · Include a statement about dispensing controls

What are the requirements for Obtaining a NC Pharmacy license by EXAM?

1) Must complete a form by NCBOP, pay fees, and submit a criminal record report -NCBOP runs PERIODIC background checks for LICENSED pharmacists 2) Must have graduated from an approved school and pass NAPLEX and MPJE (within a TWO-YEAR period from the date of the FIRST passing score) · Maximum of 5 attempts on each exam 3) Must have obtained 1500 hours of practical experience under supervision of a licensed pharmacist during pharmacy school

Hospital and Healthcare Facility Pharmacy 1) ALL hospital HCFPs MUST register with ___________ and acquire a _________ 2) Who is exempt from registering? 3) SEPARATE registration required: -Dispensing of drugs from separate locations owned by a HCF (i.e. satellite pharmacies, outside clinics, health maintenance organizations or physician offices) requires a separate registration if ANY of the following exists: 4) MUST also register with ___________ and renew ___________

1) NCBOP AND acquire a permit 2) HCF that ONLY ADMINISTER drugs are exempt from registering § SHALL secure their pharmaceutical services through a licensed NC pharmacist 3) -The drugs dispensed are obtained from a source outside of the HCF -The PM is controlled and supervised from a source other than the healthcare facility pharmacy -Dispensing drugs to outpatients 4) the NC Drug Control Unit (a division of the NC Dept. of Health and Human Services) if handling controls -ANNUALLY

1) For which controlled substances is photo identification required prior to dispensing? 2) What is an acceptable form of identification? 3) If a patient lacks an unexpired identification that meets the statutory requirement, may someone else obtain the prescription? 4) When a patient who presented identification for initial dispensing returns for a refill, and the pharmacist knows it is the same person seeking the refill, does the pharmacist have to again obtain and record the identification? 5) Does the identification check and record requirement apply to outpatient and/or employee pharmacy services at hospitals? 6) What does the statute require the pharmacy to record? 7) Where and how long do I have to retain the documentation?

1) NCGS § 90-106.1 imposes an identification prior to dispensing all Schedule II controlled substances and "Schedule III controlled substances listed in subdivisions 1 through 8 of G.S. 90-91(d)." Those subdivisions list the "combination" Schedule III controlled substances - i.e., Vicodin and the like. 2) The statute states that only four types of identification are acceptable: a driver's license, a special identification card issued by the North Carolina Department of Motor Vehicles, a military identification, and a passport. This requirement is likely to pose access problems for a number of patient populations 3) Yes. The statute specifies that "[n]othing . . . shall be deemed to require that the person seeking the dispensation and the person to whom the prescription is issued be the same person." If a patient lacking the requisite identification is able to convince a friend or family member to present their identification, that person may receive the prescription on behalf of the patient. The identification of the person receiving the prescription must be documented 4) Board staff believes the answer to this question is "no." There is no apparent purpose served by requiring a second presentation and recording of an identification in this circumstance. Nor does repeat identification check in this circumstance appear to be compelled by the North Carolina Controlled Substance Act's definition of "dispense." 5) Yes. When a hospital (or other "health care facility") pharmacy provides controlled substances to employees who will then going to administer those substances to inpatients, the identification requirement does not apply (see question #12 above). But if a hospital operates an outpatient pharmacy, dispensing is not being provided from that facility to "residents or patients," and the identification check and record provision applies. 6) The pharmacy must "document the name of the person seeking the dispensation, the type of photographic identification presented by the person seeking the dispensation, and the photographic identification number." 7) The documentation must be retained "on the premises or at a central location apart from the premises as part of its business records for a period of three years following the dispensation."

NCBOP Compounding Section: 1) Can compounded drugs offered to other entities to be resold? 2) Can they be supplied to practitioners? 3) Non-sterile compounded drug preparations shall comply with the standards established by United States Pharmacopeia chapter <______> 4) The preparation, labeling, and dispensing of sterile compounded preparations shall comply with standards established by United States Pharmacopeia chapter <_____>

1) NO --> Compounded drug preparations shall not be offered to other entities for resale. 2) YES: A pharmacy may supply compounded drug products to practitioners authorized by law to prescribe drugs for those practitioners to administer to those practitioners' patients. Such compounding for office use shall comply with applicable federal law 3) 795 4) 797

Distribution of Controls from a Dispenser to a Practitioner 1) Can it be dispensed for office use? 2) What should be done if selling C2s to a practitioner? 3) Is there a limit of how much can be dispensed to prescribers?

1) NO --> Practitioner may NOT obtain controls by writing an Rx for "office use" 2) -If selling a C2 to a practitioner, a DEA FORM 222 must be used -Do NOT use a Form 222 for C3-C5 --> instead, use an INVOICE (Drug name, dosage form, strength, quantity, date transferred, names/addresses/DEA number of parties involved) 3) Total number of dosage units distributed to practitioners must NOT exceed 5% of TOAL number of dosage units of controls distributed and dispensed by the pharmacy during each calendar year -The pharmacy would then have to register with the DEA as a DISTRIBUTOR

What are the rules surrounding dispensing meds from a telemedicine visit?

1) NON-controls: Acceptable to fill, assuming the pharmacist determines the Rx is legit 2) Controls; NCBOP says prescribing controls for PAIN via telemedicine is NOT appropriate -DEA notes absence of in-person evaluation as a RED FLAG 3) In general, an in-person evaluation is required for a control

The FDA requires a drug advertisement have what THREE items?

1) Name (brand and generic) 2) AT LEAST ONE FDA-approved indication 3) The most significant RISKS of the drug

Recordkeeping Requirements for Central Fill Pharmacies Per NCBOP Regulations: Both pharmacies maintain complete and accurate records of the Rx, including:

1) Name of the pharmacist AND pharmacy who fills or refills the Rx 2) Name of the pharmacy that received the fill or refill request

RxPrep: 1) What organization operates the impaired pharmacy recovery program? 2) Who can enroll? 3) Can a healthcare professional self-enroll?

1) North Carolina Professional Health Program (NCPHP) in conjunction w/ the BOP 2) Pharmacist and pharmacy personnel 3) YES

1) How can a prescription for a control (C2-5) be be transmitted to a Central Fill Pharmacy? 2) What is required of the Originating pharmacy transmitting the Rx? 3) What is required of the Central Fill Pharmacy?

1) ONE of TWO ways (From the retail pharmacy): -Copy of the Rx is faxed -Prescription info is sent electronically 2) -Record the following on the original paper prescription (for electronic prescriptions-add the following info to the electronic record): · Write the words "CENTRAL FILL" on the face of the Rx · Name, address, and DEA number of the CFP · Retail pharmacist name · Date of the transmittal -Ensure transmission contains all required prescription info -Include in the transmission to the CFP the number of refills already dispensed and the number of refills remaining -Keep a record of receipt of the filled Rx (Date of receipt, method of delivery, pharmacy employee accepting delivery) o Retail pharmacies must keep a record of all the CFPs they utilize and vice versa § Name, address, DEA number § Must verify the other pharmacy's DEA registration 3) -Keep a copy of the faxed prescription or an electronic record of all the info transmitted by the retail pharmacy (plus the name, address, and DEA number of the retail pharmacy) -Keep a record of the date of receipt of the transmitted Rx, name of the pharmacist filling the Rx, date of filling or refilling the Rx -Keep a record of the date the filled Rx was delivered and the method of delivery (back to the retail/originating pharmacy)

Licensure Reinstatement 1) Out of practice for up to 2 years: 2) Out of practice for up to 5 years: 3) Out of practice for more than 5 years:

1) Obtain 10 hours of CE for each yr out of practice, half of which must be contact and take the NC MPJE 2) Obtain 500 hours of internship, 10 hours of CE for each yr out of practice, half of which must be contact and take the NC MPJE 3) Obtain 1500 hrs experience and pass NAPLEX and NC-MPJE (must appear before the board)

What are the requirements for Obtaining a NC Pharmacy license for Foreign Graduates?

1) Pass a FPGEE (equivalency test) FIRST 2) Complete 1500 BOP-approved hours as an INTERN (must register with BOP's internship program) 3) Pass the Test of Spoken English 4) Pass NC-MPJE and NAPLEX

What are the requirements for Obtaining a NC Pharmacy license by Reciprocity? What if the pharmacist took some time off in between?

1) Passed the NAPLEX and NC-MPJE 2) Must have been licensed by a state which deems licensee from this state to be equivalent 3) Pay a fee and complete NABP licensure transfer application, complete a form provided by NCBOP and submit criminal record report 4) If you have not practiced within TWO years, you must: -Obtain additional CE, additional practice experience, complete one or more part of the licensure examination, or any combo of the above (as deemed by the BOP)

When can a prescription be stored/dispensed in a NON-child-resistant container?

1) Patient or prescriber request 2) SL NTG and SL and chewable isosorbide dinitrate should ALWAYS be packaged in NON-child-res packaging 3) Institutionalized patients (i.e. hospitalized) 4) Certain meds that are not feasible to be packaged in child-res packaging (i.e. methylprednisolone dose pack, COCs) 5) Medications stored in pharmacies 6) Manufacturers (including OTC) à needs warning statement and must also be separately available in a C-P container

1) What is required of a pharmacy to be able to participate in Drug Take-Back programs? 2) How do pharmacies dispose of them?

1) Pharmacies MUST apply to MODIFY its DEA registration to accept patient's controls for disposal 2) Pharmacies may utilize a MAIL-BACK program and/or collection receptacle -Meds must be destroyed ON SITE upon receipt of a sealed mail-back package -Meds may be destroyed on-site OR transferred to a REVERSE distributor if utilizing collection receptacles IF using a collection receptacle, Collection receptacles MUST be located inside the registered location § Must be locked, secured to a permanent structure, and visible from the pharmacy counter -Pharmacy employees should NOT physically touch the meds -Subject to additional recordkeeping requirements

1) How are CSOS records manitained? 2) WHat about defective orders? 3) What happens if the supplier cancels thee order? 4) WHat if an electronic order is lost?

1) Purchaser must create a record of the quantity of each item received and the date received and electronically link the receipt of controls w/ the original electronic order 2) DEFECTIVE orders (incomplete, not signed, invalid) will NOT be accepted by the supplier -Can NOT be corrected, new order MUST be entered -Supplier must notify the purchaser and provider a statement as to the reason -Supplier may also refuse to accept any order for any reason and provide a statement that the order is not accepted -Purchaser must electronically link the statement of nonacceptance to the original order 3) Supplier can cancel or void ALL or PART of the order -Must notify the purchaser of voiding -If ENTIRE order is voided, the supplier must make an electronic copy of the order, indicate on the copy "VOID", and return it to the purchaser · Purchaser retains an electronic copy of the voided order -Suppliers indicate partially voided orders by making notations next to each item that nothing was shipped 4) If an unfilled electronic order is lost -Purchaser must send the supplier a signed statement including the tracking number, date of lost order, and the goods were not received -If a purchaser issues a new (second) order, must electronically link to first order and include copy of the above statement -If the supplier receives the first order, the supplier must indicate that it was "not accepted" and return to the purchaser · The purchaser must link the returned order to the record of that order and the statement

1) What must the Pharmacy record after a Pseudoephedrine sale? 2) Where must it be submitted to? 3) Records made available within ________ and kept for _________ 4) Sellers must __________ engage in self-certification and employees must be trained. What training is required? 5) Certificate will be generated by the DEA --> Must renew ________

1) Purchaser's name, address, product sold, quantity, and date/time of sale -MUST obtain a valid, unexpired, government-issued photo ID -Seller MUST collect the purchaser's signature 2) -Must submit required sale info electronically to the to the National Precursor Log Exchange (NPLEx) -If system is done, must record sale and make documentation of the sale not being entered into NPLEx -Do NOT complete sale if NPLEx system generates a stop alert (happens when purchaser exceeded quantity limit) 3) 48 hours -TWO YEARS 4) ANNUALLY -Employees must complete training materials designed by the DEA and NC commission for Mental Health, Developmental disabilities, and substance abuse services 5) ANNUALLY

Local Health Department Clinic 1) Who may dispense prescription drugs and devices at a Local Health Department Clinic other than a pharmacist? Any additional training required? Dispensing only occurs at a clinic to only health department patients -EXCEPTION: Naloxone and Epi-Pen may be dispensed to anyone (patients, school personnel, organizations) 2) Is a permit required? 3) Must secure the services of a _____ that must review dispensing records AT LEAST __________ and be responsible to the BOP for ALL dispensing activity 4) Limited to drugs and devices in a formulary approved by _____________

1) RN but NOT controls -Nurses must have training in labeling and packaging of drugs acceptable to the BOP 2) YES -Clinic shall obtain a pharmacy permit, must be in compliance with NCBOP rules -· Must have written procedures for the storage, packaging, labeling, and delivery of prescription drugs 3) PM -WEEKLY -Must review dispensing records w/in 24 hours if the health department personnel dispenses to more than 30 patients in a 24h period 4) the BOP (TB, STDs, contraceptives, etc.)

Product Recalls 1) Class 1: 2) Class 2: 3) Class 3: NOT likely to cause adverse health consequences

1) Reasonable probability for serious adverse health consequences or death 2) May cause temporary or medically reversible adverse health consequences or probability if serious adverse events is remote 3) NOT likely to cause adverse health consequences

Hospital and Healthcare Facility Pharmacy Measures must be taken to avoid indefinite, open-ended med orders, these can include:

1) Routine monitoring of drug therapy by a pharmacist 2) A healthcare facility-approved, drug-class specific, automatic stop order policy covering those drug orders NOT specifying a number of doses or duration of therapy 3) A healthcare facility-approved automatic cancellation of all medication orders after a predetermined time interval unless rewritten by prescriber

Entities engaged in non-traditional compounding to voluntarily register as "Outsourcing facilities" (AKA 503B) 1) Defined as a facility that compounds ________ drugs 2) Allowed to manufacture and send interstate shipments of larger quantities of compounded drugs without ________ 3) Required to be a licensed pharmacy? 4) Are they subject to Current Good Manufacturing Practices? 5) Can compounded products be offered to other entities for resale? 6) May use a bulk drug substance to compound that: 7) Are they exempt from the new drug approval process and requirements of "Track and Trace"? 8) In NC, are required to register as a _______ and would need to apply for a pharmacy permit if they are directly dispensing prescriptions to patients

1) STERILE -(can also do non-sterile, but not ONLY non-sterile) 2) prescriptions being issued 3) NO -o Not required to be licensed pharmacy but must enter under the direct supervision of a licensed pharmacist 4) YES -Also risk-based inspections, reporting amounts of compounds dispensed, reporting ADRs, labeling requirements, and other standards (under FDA jurisdiction) 5) NO 6) -Appears on a list published by the FDA ("503B Bulks list") -Drug compounded from such bulk drug substance appears on the FDA shortage list -Bulk drug substances used to compound must comply with the standards of the USP/NF if an applicable monograph exists 7) YES 8) wholesaler

1) What is the purpose of a Nursing Home Medication Management Advisory Committee? 2) How often do they meet? 3) Duties of a consultant pharmacist:

1) Similar to QA Programs, but for nursing homes à purpose is to assist nursing homes to identify med errors, evaluate the causes of errors, and take actions to ensure safe prescribing, dispensing, and administration of meds o Confidentiality rules similar to QA Programs 2) · Medication management advisory committee, including a consultant pharmacist, must meet AT LEAST QUARTERLY 3) o Conduct retrospective drug specimen review on every patient receiving a medication § AT LEAST MONTHLY o Provide recommendations to attending physicians or nurse in charge (and document) o Ensure allergies and ADRs are documented in chart o Notify prescribers on orders near expiration o Submit a QUARTERLY report to a committee on any weakness in the nursing home's pharmaceutical care system o Available for consultation via direct communication at all times when drugs are dispensed

When, prior to dispensing a TCS, must a pharmacist review and document the CSRS report for the preceding 12 months?

1) Suspect the patient is using the TCS non-medically (i.e. drug-seeking) 2) Prescriber is located outside the usual geographic area served by the pharmacy 3) Patient resides outside the usually geographic area served 4) Patient demonstrated misuse of a control by: -Over-utilization of control -Requests for early refills -Utilizes multiple prescribers -Appears overly sedated or intoxicated -A request by an unfamiliar patient using a specific name, street name, color, or identifying marks of an opioid drug

Acute Pain Prescriptions for TCSs 1) Acute pain is defined as pain that is reasonably expected to last for _________ 2) Acute pain prescriptions for (non-post-op) TCSs may NOT exceed a ______ supply, initially 3) Prescriptions for TCSs for POST-OPERATIVE ACUTE pain may NOT exceed a ________ supply, initially -Upon subsequent consultation for the same pain, the practitioner may issue a new Rx 4) What if these patients were in a hospital or LTCF? 5) What happens to a pharmacy if the dispence an Rx that breaks this rule?

1) THREE MONTHS or less -Does NOT include chronic pain, or pain as part of cancer, hospice, palliative care or medicine-assisted Tx for substance abuse disorder 2) FIVE DAY 3) SEVEN DAY 4) These limitations do NOT apply for prescriptions for INPATIENT administration (hospital, nursing home, hospice, LTCF) 5) Again, pharmacies are IMMUNE from discipline if they dispense an Rx in violation of this section

1) Describe the Minimum Necessary concept of HIPAA: 2) Exceptions to this rule:

1) The use of ONLY the Minimum Necessary amount necessary to accomplish the intended purpose of the user, disclosure, or request § I.e. "Limited data set" (PHI from which certain specified direct identifiers have been removed) 2) § Disclosure to or request by a provider for treatment § Disclosure to an individual or rep who is the subject of the info o Use or Disclosure made pursuant to an authorization (by pt) o Disclosure required by law

RxPrep: 1) W/in what time frame from the issue date are non-controls permitted to be refilled? 2) Is there a MAX number of refills for non-controls? 3) What is the MAX days supply that can be dispensed for an emergency refill of non-controls w/o prescriber authorization? 4) What are the additional requirements when dispensing an emergency refill for non-controls?

1) There is no rule or specific expiration dates 2) No 3) Up to a one-time, 30 day supply 4) -Has to be an ESSENTIAL medication and interrupting therapy may harm the pt -Dispensing pharmacist must notify the prescriber of the emergency fill w/in 72 hrs

What options are available for disposal of controls?

1) Transfer back to the manufacturer or wholesaler (where they came from) 2) Transfer to a REVERSE distributor 3) Request DEA assistance o If requesting DEA assistance, they provide instruction: § Transfer to a registrant authorized to transport or dispose of the drug § Delivery to a DEA agent or office § Destruction in the presence of a DA agent or authorized person o Must fill out a DEA Form 41 to record the destruction of controls (ALL schedule à requires TWO witnesses) § Must record: Drug name, NDC, strength, package quantity, number of full packages, and partial package count of each control to be disposed

Requirements for pharmacies that compound 1) Maintain a reference library including ___________ 2) ____ shall be knowledgeable in the specialized functions of preparing, labeling, and dispensing compounded drug preparations -MAY designate another pharmacist for this purpose but must notify board w/in __________ 3) Create a recordkeeping system that identifies EVERY compounded preparation prepared, labeled, or dispensed in the LAST ____________

1) USP and references on compatibility, stability, storage, handling, and preparation of compounded drugs (if doing sterile products) 2) PM -MAY designate another pharmacist for this purpose but must notify board w/in 15 DAYS 3) 3 YEARS (may be electronic)

1) When must Covered entities notify affected individuals following discovery of a breach? WHo else is notified? 2) What If MORE than 500 persons affected?

1) WITHOUT unreasonable delay and NO LATER THAN 60 days after discovery by mail or electronically -§ Secretary of DHHS must be notified not later than 60 days after the end of the calendar year in which the breach was discovered 2) pharmacy must notify the media and DHHS without unreasonable delay and NO LATER THAN 60 days after discovery o In NC, a breach of "personal info" requires notification to the affected person and the NC AG's Consumer Protection Division w/o unreasonable delay § If the breach involves more than 1000 persons, all consumer reporting agencies must be notified

1) In general, C2s can only be prescribed pursuant to a ____________ Rx 2) WHen could one be called in?

1) WRITTEN or ELECTRONIC 2) EMERGENCY C2s -Emergency defined as (1) immediate administration is necessary (2) no appropriate medical alternative is available (3) is NOT reasonably possible for prescriber to provide an Rx before the drug is dispensed -Quantity limited to emergency period -Prescription must be reduced to writing by the pharmacist and contain all necessary and contain all necessary info for a C2 (except prescriber's signature) -Prescriber has SEVEN DAYS to get a WRITTEN, SIGNED Rx to pharmacy -"Authorization for Emergency Dispensing" must appear on the face of the Rx AND the date of the ORAL order -Alternatively, the prescriber may send the Rx ELECTRONICALLY -Pharmacist MUST notify the local DEA if the prescription is not received -Pharmacist must maintain call-in Rx w/ written Rx (or annotate the record of the electronic Rx with the original authorization and date of the original order)

Pharmacist MUST adhere to the following regulations for meds to Tx a SUD:

1) Would NOT include meds that could be used for BOTH SUD and non-SUD purposes (even if the Rx if for Tx of SUD) 2) Prescribers should obtain written consent from the patient to allow communication with a pharmacy -For phone-in or faxed prescriptions (possibly electronic too-awaiting final rule MAY NEED TO CHECK THIS) -Allows the pharmacist to discuss validity of the Rx with prescriber 3) When the prescription is directly transmitted by the prescriber, there are also prohibitions on the further redisclosure of patient identifying info by the pharmacist (would require SIGNED patient consent) 4) Patient identifying info may be disclosed to medical personnel to the extent necessary to meet a bona fie medical emergency in which the patient's prior informed consent cannot be obtained -must document disclosure)

1) Can a pharmacist demand to see a pt's or rep's ID before dispensing? 2) Can they refuse to fill based on ID? If so, is documentation required?

1) YES -A pharmacist or personnel MAY demand, inspect and record proof of ID from ANY patient presenting an Rx OR any person acting on behalf of the pt 2) "May exercise discretion and refuse to fill ANY Rx or dispense ANY drug if unsatisfied as to the legitimacy or appropriateness of Rx presented, the validity of a photo ID" -Refusal to fill should be noted on the Rx

RxPrep: 1) Are pt profiles required to be kept in the pharmacy for all pts (e.g. a traveling pt getting a one-time fill)? 2) How long must pt profiles be kept after the last fill?

1) YES 2) 3 years

Central Fill Prescriptions 1) Can they fill NEW prescriptions? Controls? 2) Can it be in another state? 3) Which address goes on the pharmacy label? 4) Which is responsible for counseling the patient counseling?

1) YES --> May fill both new AND refill prescriptions, including controls 2) YES --> CFP CAN be located in another state 3) Pharmacy label must have BOTH pharmacies names and addresses 4) Originating pharmacy is responsible for counseling the patient and maintaining the original prescription

RxPrep: 1) Do interns have to submit fingerprints to register? 2) Do interns have to have a background check?

1) Yes 2) Yes

1) Can a prescription be transferred via computer or data system? 2) Once transferred, the Rx can NOT be refilled more than _________ or ___________ 3) How long must records be kept? Is the original or transferred prescription kept? 4) Can prescriptions from out-of-state practitioners be transferred?

1) Yes for pharmacies accessing the same Rx record) 2) the original amount authorized, OR 1 year, whichever is LESS (exception: C3-4 expire 6 months after issue date) 3) Original AND transferred prescription must be kept for THREE YEARS following LAST dispensing 4) Per state law, it IS permissible to transfer prescriptions issued by prescribers in other states

Pharmacy Renewal FAQs 1) Do Pharmacies have a grace period to renew? 2) Can I update the PM within the renewal?

1) Yes. The Board allows a 60-day grace period to renew after December 31st with no penalty. The grace period for Pharmacies ends March 1st and for the next 30 days, the permit may renew, but with a late penalty. During the month of March, the late renewal fee is $400. 2) No. Please submit the PM change request prior to renewing the permit by using the UPDATE MANAGER tile on the main menu of the permit. Please allow 3-5 business days for the update to be processed. Once the update has been processed, then the permit may be renewed.

1. Will pharmacists be able to administer more vaccines to patients 18 and older pursuant to protocol? 2. Will pharmacists be able to administer flu vaccine by protocol to younger patients? 3) Q: How do the immunizing pharmacist provisions of the Pharmacy Practice Act impact the dispensing of oral typhoid vaccine (marketed as Vivotif)?

1) Yes. This legislation adds Serogroup B meningococcal vaccines, human papillomavirus vaccine, and Hepatitis A vaccine to the list of vaccines that a pharmacist may administer to persons 18 or older pursuant to protocol. 2) Yes. This legislation authorizes pharmacists to administer flu vaccine to patients at least ten (10) years old pursuant to protocol. Pharmacists are authorized to administer flu vaccine to patients at least six (6) years old pursuant to a prescription order. 3) A: Several pharmacists have contacted Board staff with questions about how, if at all, the immunizing pharmacist provisions of the Pharmacy Practice Act impact the dispensing of oral typhoid vaccine (marketed as Vivotif). The short answer is that, for all practical purposes, they do not. Recall that the immunizing pharmacist provisions of the Pharmacy Practice Act speak to whether and under what circumstances a pharmacist may administer a vaccine to a patient. The dispensing of oral typhoid vaccine, which a patient self-administers just as any other oral medication, is not limited those provisions governing vaccine administration. The most frequent question concerning oral typhoid vaccine is along the following lines: "I have a prescription for oral typhoid vaccine for a 16-year-old patient. But the immunizing pharmacist provision limit administration of vaccines other than those allowed by protocol to patients 18 or older. May I nonetheless dispense the oral typhoid vaccine to this patient?" Again, the answer is yes. Limitations on vaccine administration do not prohibit the dispensing of this self-administered oral vaccine to a patient, regardless of age, pursuant to a valid prescription.

Emergency Refills 1) If a patient is out of refills or unable to obtain refill authorization form the prescriber, the pharmacist MAY dispense a ONE-TIME emergency refill for UP TO _______ supply provided: 2) The Rx is NOT _____ 3) Medication is ___________ -In the pharmacist's professional judgement, the interruption of therapy might reasonably produce undesirable health consequences 4) What must a pharmacist do? 5) A pharmacist may issue a ONE TIME ______ SUPPLY of medication If the pharmacist is unable to readily obtain refill authorizations a result of the prescriber's inability to provide medical services (i.e. prescriber dies of goes on vacation, natural disaster) but same rules as above apply

1) a 30 day 2) a C2 3) essential to maintenance of life or continuation of chronic condition therapy 4) -Dispensing pharmacist creates a WRITTEN order containing all the Rx info required and signs the order -Dispensing pharmacist notifies the prescriber or the prescriber's office of the emergency refill within 72 HOURS after dispensing 5) 90 DAY

Medication in HCF Emergency Departments Permissible to dispense meds to registered patients of the emergency department (to take home) 1) If a 24h outpatient pharmacy service is not available, who can dispense an Rx? What are the laws surrounding this? 2) Upon dispensing to a patient, the label should include: 3) Is an Rx and/or counseling required? 4) Perpetual record of all dispensed drugs shall be maintained w/in the pharmacy for _______

1) a physician or RN under a physician's supervision may dispense the Rx (PA/NP too) -Limited to NOT more than a 24h or the smallest commercially available quantity -PM shall develop an ED formulary which may be dispensed from the ED -PM shall develop and supervise a system of control and accountability of all drugs administered in, or dispensed from the ED -Drugs shall be prepackaged in safety closure containers and shall be pre-labeled by the pharmacist (name, strength, lot number, manufacturer, and EXP date) 2) -The name, address and phone number of the HCFP -Dispensing date -Full name of the patient -Generic name or brand name -Direction for use to patient -Name of prescribing physician and dispensing the product -Required precautionary or further accessory cautionary info as may be desirable for proper use and safety to the patient 3) o A prescription still needs to be issued o Physician, nurse, NP, PA still required to counsel patient 4) 3 YEARS § Include: Date dispensed patient name, physician's name, and name, strength, dosage form, Quantity, , and dose of the drug dispensed § PM to verify the accuracy of these records AT LEAST MONTHLY

Automated data processing system (Electronic record keeping system) **Capable of producing documents of all original and refilled prescription info, including records of dispensing and prescription order entry** 1) Secure and back-up ________ 2) Contains a current ____ software program 3) Pharmacist is responsible for completeness and accuracy of data entered in system signs an acknowledgment within _______ of dispensing 4) A ____________ is established in case of inoperability of the automated data processing system (backed up ________)

1) daily 2) DDI 3) 72 HOURS 4) "auxiliary record keeping system" -weekly -IF used, prescription info from the auxiliary record system must be transferred to the automated data system -Calculating for when the data has to be transferred = inoperable period x 3

Practitioner prescribing privileges -MDs and DOs generally have unlimited and independent prescribing authority -Dentists, Podiatrists Optometrists, Veterinarians have independent prescribing authority limited to their scope of practice 1) What about PAs, NPs, CPPs, and Nurse Midwives? 2) What about Chiropractors, Clinical Nurse Specialists, CRNAs, and Certified Professional Midwives? 3) What about Doctors of Homeopathy, and Naturopathic Doctors?

1) have DEPENDENT prescribing authority (CPAs or protocol with a supervising physician) 2) have NO prescribing authority in North Carolina 3) have NO prescribing authority in North Carolina § Note difference between "professional midwife and nurse midwife"

SECURITY requirements for controls: 1) Where must Practitioners store controls? 2) What about Pharmacies and institutional practitioners? **there are Special security requirements for wholesalers and manufacturers (not detailed)** 3) Can you employ a person whose application for DEA registration has been denied/revoked/surrendered or was convicted of a felony relating to a control?

1) in a securely locked, substantially constructed cabinet 2) MAY disperse controls throughout stock of non-controls 3) NO but (may apply for a waiver)

Additional Recordkeeping Requirements for a HCFP 1) Record and ID the responsible pharmacists and techs for__________ -MUST be readily retrievable and kept for _______ 2) PM shall document med errors resulting from the administration of an incorrect med or dose and keep for ________ 3) PM shall retain all documents labels, vial, supplies, substances, and internal investigative reports relating to an event where a prescription drug or device has caused or contribute to death of a pt and keep for______ 4) PM shall maintain records of ordering, receiving, dispensing, or transfer of CONTROLs and Keep for ______ 5) Records available to NCBOP and retrievable within _______

1) medication compounding and dispensing -30 DAYS § Activities include: · Interpretation and appropriateness of new med orders · Profile entry if new med orders · Dispensing of new med orders including stat doses · Daily cart fills · IV admixtures · Compounded meds · Assessing the quality of pharmacy procedures for preparation and release of drugs and devices for replenishment of auxiliary medication inventories and automated dispensing devices in locations outside the pharmacy 2) 3 YEARS 3) 3 YEARS 4) 3 YEARs § Includes: · Invoices or other documents verifying the ordering and receipt of controls · Perpetual inventories of controls transferred to auxiliary med inventories and ADDs o Transfer date; the location transferred to; identity of a drug; strength; dosage form; quantity transferred; transferring pharmacist's name · Records of disposition of a control prepared for a patient but not used, including documentation of the details of the destruction other disposition and identification of the individuals involved · Controls dispensed directly to the patient including: patient name, date dispensed, dispensing pharmacist's name; name; strength; dosage form and quantity dispensed; Records shall also document drugs returned and credited · Perpetual inventory on all controls awaiting destruction or a return to a vendor § An automated system may be used to keep records regarding controls dispensed to patients as long as the original med order info and dispensing history can be immediately retrieved (consistent with federal law requirements) 5) 48 HOURS

METHADONE for opioid addiction (Narcotic Tx facility) 1) Practitioners wishing to prescribe and dispense methadone for opioid addiction must do what? 2) When can a retail pharmacy dispense methadone? 3) When can a hospital pharmacy dispense methadone?

1) must obtain a SEPARATE DEA registration via DEA Form 363 2) When used to treat opioid addiction, methadone is administered by a NARCOTIC TX FACILITY ("Methadone clinic") -Community pharmacies should NOT dispense methadone for this purpose, ONLY when used for PAIN 3) A HOSPITAL pharmacy MAY dispense methadone for opioid addiction as CONTINUATION of therapy for patients Tx at a methadone clinic

Pharmacy Permits: -EVERY pharmacy mist apply for a permit with the BOP -Permits identifies the PM and all pharmacy personnel (pharmacists and techs) 1) Permits are issued pursuant to a JOINT application of ______ and ______ -Permits are NOT valid until assigned by ______ -Permits can be reissued at any tome to a successor PM -Upon application, the NCBOP may issue and renew separate permits for multiple pharmacies operating at one location (i.e. inpt and output pharmacy at a hospital) 2) BEFORE issuing the permit, the _____ must make a personal appearance before the board for the ORIGINAL permit application **A mobile pharmacy also needs to register w/ BOP -Dispenses Rx drugs at no/reduced charge to pts < 200% of the federal poverty level and have no type of insurance -Operated by a nonprofit -Shall provide the board w/ the address of every location from which prescription drugs will be dispensed

1) owner; PM -PM 2) PM

Responsibilities of Pharmacy Manager (PM) 1) Can NOT as a PM at more than one pharmacy, EXCEPT for (2 answers): 2) The PM must notify the board within ___ of any changes in pharmacy personnel 3) Report to the board w/in _____ of becoming aware of a drug dispensed by the pharmacy that has caused or contributed to the death of a patient or customer (retain all documents, vials, labels, etc.)

1) serving at a "limited service pharmacy" (charitable pharmacy or department of health clinic -May serve simultaneously at 2 pharmacies (w/ full-service permits) if one of the pharmacies is newly permitted and has not yet begun providing pharmacy services to patients (once the new pharmacy begins providing pharmacy services or 6 months from the permit issuance date has passed, whichever is first, the PM must step-down and notify the board) 2) 30 days 3) 14 days

1) If dispensing for an animal --> ____________ must be on the Rx and label · Drugs that say caution: federal law restricts this to us by or on the order of a licensed vet" on the manufacture's bottle may be dispensed only by a licensed veterinarian or by a pharmacist from a pharmacy pursuant to a prescription

1) the SPECIES of the patient, patient name, and caretaker info

North Carolina Controlled Substance Reporting System (NCCSRS) -Dispensers are REQUIRED to submit certain info electronically -May receive a waiver if unable to submit electronically and can submit by other means 1) Must report info to the NCCSRS NO LATER than _____________ 2) What info is reported to the system? 3) When is it NOT required?

1) the close of the next business day after the Rx was dispensed --> "encouraged" to be within 24h -If unable to load info due to technological failure, upload ASAP and document the occurrence 2) -Dispenser's DEA number -Name, address, telephone number, and DOB of the pt -Date the Rx was written AND date filled -Rx number -Whether it is a NEW Rx or Refill -Metric Quantity dispensed -Estimated days supply (if provided to dispenser) -NDC Number -Prescriber's DEA and NPI (if provided) numbers -Method of payment for the Rx 3) -Licensed hospital or LTCF that dispenses such substances for the purpose of inpatient admission -Wholesale distributor -Dispensed directly to the ultimate user and the quantity provided does NOT EXCEED a 48 hour supply -SAMPLES of schedule 5 NON-narcotic, NON-anorectic control

NCBOP Compounding Section: 1) In addition to complying with all recordkeeping and labeling requirements specified or referred to by United States Pharmacopeia chapters <795> or <797>, a pharmacy that prepares, labels, or dispenses compounded drug preparations shall create and maintain a record-keeping system that enables the pharmacy immediately upon request to identify every compounded drug preparation prepared, labeled, or dispensed in the past ________ This recordkeeping system may be created and maintained electronically in compliance with 21 NCAC 46 .2508.

1) three years.

Hospital and Healthcare Facility Pharmacy 1) Meds are dispensed ONLY ____________ 2) Oral orders shall be ______________ 3) Medication order shall contain: WHAT? 4) Med orders are listed in a patient's medication profile (manual or automated) which shall contain:

1) upon receipt of a med order 2) recorded IMMEDIATELY and signed within the time frame 3) § Patient's name, location, and other identifying info such as history or med records § Medication name, strength, dosage form, route of and directions for administration § Discernable quantity to be dispensed. I n absence of an indicated quantity or facility policy, be deemed to authorize dispensing of 30 DAYS supply § Date order was written § Prescriber's signature 4) § Patient's name, location, and clinical date required for safe dispensing and administration of medication orders, such as age, height, weight, sex , and allergies § Medication name, strength, dosage form, route of and directions for administration § Start date and Stop date § ID of pharmacist responsible for or verifying tech entry of the order

Expedited Partner Therapy (EPT) Prescription 1) What is this? 2) Per NCBOP, you may label the vial as __________ 3) Is counseling required?

1) · EPT is the clinical practice of treating the sex partners of patients diagnosed with chlamydia or gonorrhea by providing prescriptions or medications to the patient to take his or her partner WITHOUT the healthcare provider first examining the partner -These ARE legal in NC even though there is no previous medical exam 2) "John Doe Partner 1" or some other unique identifier -o Do NOT need to obtain the partner's name, address, etc. 3) · Counseling MAY be bypassed (not encouraged) but written info is dispensed with Rx

1) Where do nuclear pharmacies get their licenses from and which are required? 2) Who can seek a permit? 3) How often must a QNP be there? 4) What records must be kept? · MUST have Radioactive storage and product decay area · Library to have copies of current state and federal regulations governing the safe storage, handling, use, dispensing, transport, and disposal of Radiopharmaceuticals · Shall have a procedures manual for Radiopharmaceuticals QA 5) What are the Labeling Requirements (In addition to labeling requirements of normal Rx)?

1) · Obtain licenses by the Nuclear Regulatory Commission (NRC) and other state regulatory agencies as required (North Carolina Division of Radiation Protection) -· Must obtain a Nuclear Pharmacy Permit from NCBOP 2) Person seeking permit MUST be a "qualified nuclear pharmacist (QNP)" o Board certified by the "Board of Pharmaceutical Specialties OR o Meets minimum standards of training for "authorized user status" from the US Nuclear Regulatory Commission or the appropriate state nuclear regulatory services § Minimum of 200 contact hours of instruction in nuclear pharmacy from an approved college of pharmacy AND § Minimum of 500 hours of clinical nuclear pharmacy training under supervision of a qualified nuclear pharmacist 3) · QNP is the responsible person and must be present at all times o In emergency situations designated qualified licensed professionals may prepare SINGLE doses of radiopharmaceuticals § According to established written policies and procedures § Such emergencies must be documented 4) · Maintain records of acquisition, inventory and disposition of all radiopharmaceuticals 5) o Standard radiation symbol o Words "CAUTION-RADIOACTIVE CHEMICALS) o The Radionuclide of the Radiopharmaceutical contained therein AND its chemical form o The amount of radioactivity of the Radiopharmaceuticals contained therein and the date and time of the calibration of that radioactivity o The date and time of the expiration of the Radiopharmaceuticals o If LIQUID --> volume o If SOLID --> number of capsules or weight o If GAS --> number of ampules, vials, or syringes o The name, address, and phone number of the nuclear pharmacy dispensing o Prescription or lot number o Name of the pharmaceutical

Disasters and Emergencies PIC must report within ________ to the BOP any disaster, accident, theft, or emergency which may affect the strength, purity, or labeling of drugs and devices (C or non-C)

10 DAYS · Insurance companies must still pay pharmacies in cases of "refills too soon"

In North Carolina, after issuing an emergency prescription for an unauthorized refill, the pharmacist must contact the prescriber within: A. 72 hours after such dispensing. B. 7 days after such dispensing. C. 48 hours after such dispensing. D. 15 days after such dispensing.

1. Answer: (a) 72 hours after such dispensing, [21 NCAC 46 .1815 and 21 NCAC 46 .1809].**Please note under section 21 NCAC 46 1809, the NC law authorizes to dispense a one-time emergency supply of up to 30 days of the prescribed medication whereas under section 21 NCAC 46 1815, it authorizes to dispense a one-time emergency supply of up to 90 days of the prescribed medication.**In North Carolina, in the event a pharmacist or device and medical equipment permit holder receives a request for a prescription refill and the pharmacist or permit holder is unable to obtain readily refill authorization from the prescriber because of the prescriber's inability to provide medical services to the patient, the pharmacist or permit holder may dispense a one-time emergency supply of up to 90 days of the prescribed medication, provided that:(1). The prescription is not for a Schedule II controlled substance;(2). The medication is essential to the maintenance of life or to the continuation of therapy in a chronic condition;(3). In the pharmacist's or permit holder's professional judgment, the interruption of therapy might reasonably produce undesirable health consequences;(4). The dispensing pharmacist or permit holder notifies, or makes a good faith attempt to notify, the prescriber or the prescriber's office of the emergency dispensing within 72 hours after such dispensing. · Make sure to differentiate which emergency refill requires prescriber permission and which doesn't (and C2 rules)

A 45-year-old patient comes to the pharmacy and presents a prescription for Ambien written by his podiatrist. A pharmacist shall: A. not fill the prescription. B. fill the prescription. C. ask the patient to get a new prescription from an authorized prescriber. D. fill Ambien only after filling out a DEA 222 order form.

1. Answer: (a) A pharmacist shall not fill the prescription, [NC Controlled Substances Acts and Regulations 90-87, Definition 23].For a controlled substance prescription drug order to be legal, it must be issued for a legitimate medical purpose by an authorized individual practitioner acting in the usual course of his or her professional practice.The responsibility for the proper prescribing of controlled substances is upon the prescribing practitioner, but the pharmacist is responsible for the proper filling of the prescription drug order.A registered physician, dentist, veterinarian, or podiatrist authorized by this state to prescribe controlled substances can issue a prescription for controlled substances only in the usual course of his or her professional practice. Therefore, a pharmacist shall question the prescription for sleeping pill (Ambien) prescribed by a registered podiatrist.

Which of the following statements is/are TRUE about hiring a pharmacy technician? I. A pharmacist-manager may hire a person who has a high school diploma or equivalent or is currently enrolled in a program that awards a high school diploma or equivalent to work as a pharmacy technician. II. A pharmacist-manager must notify the Board within 60 days of the date the pharmacy technician began employment. III. A pharmacist may not supervise more than three pharmacy technicians at any given time. A. I only B. I and II only C. II and III only D. All

1. Answer: (a) I only, [North Carolina Pharmacy Practice Act 90-85.15A(a)-to-(d)].A registration program for pharmacy technicians is established for the purposes of identifying those persons who are employed as pharmacy technicians.A pharmacy technician must register with the Board within 30 days after the date the pharmacy technician completes a training program conducted by the pharmacy technician's pharmacist-manager.The registration must be renewed annually by paying a registration fee.A pharmacist-manager may hire a person who has a high school diploma or equivalent or is currently enrolled in a program that awards a high school diploma or equivalent to work as a pharmacy technician.A pharmacist-manager must notify the Board within 21 days (NOT 60 days) of the date the pharmacy technician began employment. Is this right??A pharmacist-manager may hire a certified pharmacy technician who has registered with the Board. The certified pharmacy technician shall notify the Board within 10 days of beginning employment as a pharmacy technician. Is this right??The pharmacist-manager must provide a training program for a pharmacy technician that includes pharmacy terminology, pharmacy calculations, dispensing systems and labeling requirements, pharmacy laws and regulations, record-keeping and documentation, and the proper handling and storage of medications.The training program must be provided and completed within 180 days of the date the pharmacy technician began employment unless the pharmacy technician is registered with the Board.A pharmacist may not supervise more than two (NOT three) pharmacy technicians unless the pharmacist-manager receives written approval from the Board.The Board may not allow a pharmacist to supervise more than two pharmacy technicians unless the additional pharmacy technicians have passed a nationally recognized pharmacy technician certification board exam, or its equivalent, that has been approved by the Board.The Board must respond to a request from a pharmacist-manager to allow a pharmacist to supervise more than two pharmacy technicians within 60 days of the date it received the request.

Which of the following requires a DEA 222 form for purchase? A. Mescaline B. Pemoline C. Modafinil D. Clonazepam

1. Answer: (a) Mescaline is classified as Schedule I controlled drug. It requires a DEA 222 order form for purchase, [NC Controlled Substances Act and Regulations 90-89 and NC Controlled Substances Act and Regulations 90-105].

In a healthcare facility setting, controlled substances may be stocked and removed from auxiliary medication inventories. A. True B. False

1. Answer: (a) True, [21 NCAC 46 .1413(d)].Auxiliary Medication Drug Inventory: A secure, segregated, supplementary source for drugs to be used solely for the purpose of providing adequate drug availability when the pharmacy is closed or the pharmacist is unavailable.1. Only drugs in unit-of-use packaging shall be removed from the auxiliary medication inventory or from the pharmacy; they shall be used for administration to a specific patient only, in amounts sufficient to meet the needs for immediate therapeutic requirements.2. Controlled substances may be stocked and removed from auxiliary medication inventories; controlled substances may not be removed from the pharmacy in the absence of a pharmacist.3. Drugs shall be pre-labeled by the pharmacist with drug name, strength, lot number and expiration date. A copy of written orders for new medications shall be provided to the pharmacy.

The pharmacist-manager shall separate from the dispensing stock all drug products more than six months out of date. A. True B. False

1. Answer: (a) True, [21 NCAC 46 .2502(k)].The pharmacist-manager shall separate from the dispensing stock all drug products more than six months out of date.

A pharmacy may supply starter doses of medication to doctors' offices for subsequent dispensing to patients. A. True B. False

1. Answer: (a) True, [21 NCAC 46 .2502(o)].The pharmacist-manager shall ensure that all starter doses of medication supplied to doctors' offices from the pharmacy are accompanied by written materials advising the patient that such doses of medication may be supplied by any pharmacy. Starter doses shall be limited to a 24 hour dose supply per patient. **How is this any different from a drug sample?**

Permits issued by the Board expire on December 31 and become invalid 60 days following expiration. A. True B. False

1. Answer: (a) True, [North Carolina Pharmacy Practice Act 21 NCAC 46 .1609 and 46.1610].Permits issued by the Board expire on December 31 and become invalid 60 days following expiration. An individual whose licensing privileges have been forfeited shall immediately surrender to the Board office his or her permit or license, current renewal certificate, and wallet card.In order to have the licensing privileges reinstated, the individual must appear before the Board and submit evidence that it would be in the public interest to reinstate the licensing privileges and that he or she can safely and properly practice pharmacy.

A pharmacy may supply compounded drug products to practitioners authorized by law to prescribe drugs for those practitioners to administer to those practitioners' patients. A. True B. False

1. Answer: (a) True, [North Carolina Pharmacy Practice Act 21 NCAC 46 .2801].(a). A pharmacy may dispense a compounded drug preparation to a patient only pursuant to a prescription that is valid and complies with all requirements of the law, including 21 NCAC 46 .1801. In advance of dispensing the compounded drug preparation, a pharmacy shall prepare the compounded drug preparation only:(1). upon the pharmacy's receipt of a valid prescription order for an individual patient; or(2). in anticipation of a prescription order based on an established history of receiving prescription orders for the compounded drug preparation. Any compounded drug preparation prepared in anticipation of a prescription order shall not be dispensed until the pharmacy receives a valid prescription order for an individual patient.(b). Compounded drug preparations shall not be offered to other entities for resale.(c). A pharmacy may supply compounded drug products to practitioners authorized by law to prescribe drugs for those practitioners to administer to those practitioners' patients. Such compounding for office use shall comply with applicable federal law.

An emergency oral prescription for Schedule II controlled drugs must be mailed to dispensing pharmacy by an authorized prescriber within: A. 48 hours after an oral authorization. B. 7 days after an oral authorization. C. 10 days after an oral authorization. D. 72 hours after an oral authorization.

1. Answer: (b) 7 days, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRev1117.pdf (Page 2) and CFR 1306.11(d)].In case of an emergency situation, a pharmacist may dispense a controlled substance in Schedule II upon receiving the orally or electronically transmitted authorization of a prescribing practitioner, provided that:(a). The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period.(b). The prescription contains all information required by the federal and state law except for the actual signature of the prescribing practitioner, and in the case of an oral prescription, or prescription transmitted electronically by computer modem or other similar electronic device, the prescription is immediately reduced to writing by the dispensing pharmacist; and(c). The dispensing pharmacist makes a good faith effort to determine that the orally or electronically transmitted authorization was issued by an authorized practitioner, which effort may include a callback to the prescribing practitioner or other good faith efforts to ensure the prescribing practitioner's identity.Within seven days after authorizing an emergency oral prescription, the prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the pharmacy which must have written on its face "Authorization for Emergency Dispensing" and should comply with federal and state law.Upon receipt of the written prescription, the dispensing pharmacist shall attach the prescription to the orally or electronically transmitted emergency prescription which had earlier been reduced to writing.

Under a North Carolina State Pharmacy Law, a registered nurse in a local health department clinic may dispense prescription drugs and devices, other than controlled substances. A. True B. False

1. Answer: (a) True, [North Carolina Pharmacy Practice Act 90-85.34A].A registered nurse in a local health department clinic may dispense prescription drugs and devices, other than controlled substances, under the following conditions:(1). The registered nurse has training acceptable to the Board in the labeling and packaging of prescription drugs and devices;(2). Dispensing by the registered nurse shall occur only at a local health department clinic;(3). Only prescription drugs and devices contained in a formulary recommended by the Department of Health and Human Services and approved by the Board shall be dispensed;(4). The local health department clinic shall obtain a pharmacy permit in accordance with G.S.;(5). Written procedures for the storage, packaging, labeling and delivery of prescription drugs and devices shall be approved by the Board; and(6). The pharmacist-manager, or another pharmacist at his direction, shall review dispensing records at least weekly, provide consultation where appropriate, and be responsible to the Board for all dispensing activity at the local health department clinic.(b). This section is applicable only to prescriptions issued on behalf of persons receiving local health department clinic services and issued by an individual authorized by law to prescribe drugs and devices.(c). This section does not affect the practice of nurse practitioners pursuant to G.S. 90-18.2 or of physician assistants pursuant to G.S. 90-18.1.

Pharmacies may ship medications for home use by patients with renal failure to renal dialysis facilities for delivery to patients who receive dialysis treatments in a Medicare certified dialysis facility. A. True B. False

1. Answer: (a) True, [Pharmacy Laws of North Carolina 90-85.21D].Pharmacies may ship medications for home use by patients with renal failure to renal dialysis facilities for delivery to(i). patients who receive dialysis treatments in a Medicare certified dialysis facilityor(ii). patients who self-dialyze at home, provided that all of the following criteria are met:(1). The patient authorizes, in writing, the dialysis facility staff to act as the patient's designated agent for the purpose of receiving mailed medical packages at the dialysis facility.(2). The pharmacy, whether in-state or out-of-state, is licensed as a pharmacy in North Carolina.(3). The medications for home use are dispensed by the licensed pharmacist pursuant to a valid prescription order.(4). The delivered medication packages are held in a secure location in an area not accessible to the public and delivered by the dialysis facility staff, unopened, to the patient.(5). Medication packages are individually labeled with the patient name.(6). The medications exclude controlled substances.

The device and medical equipment committee shall consist of: [Select ALL That Apply]. A. a representative of the medical equipment suppliers B. a representative of the medical oxygen suppliers C. a representative of the rehabilitation technology suppliers. D. four pharmacy board members.

1. Answer: (a,b,c), [NC Rule 21 NCAC 46.1207. Device and Medical Equipment Committee.].(a). The device and medical equipment committee shall consist of the following:(1). a representative of the medical equipment suppliers;(2). a representative of the medical oxygen suppliers;(3). a representative of the rehabilitation technology suppliers; and(4). two Board members.(b). Each of the members of the device and medical equipment committee shall be appointed by the Board. Device and medical equipment permit holders may provide input in these appointments.The representative must practice in the area for which he or she is nominated but need not practice exclusively in that area.In case of death, resignation, or removal from the committee, the Board shall fill the vacancy with a representative who meets the criteria for the position.

A practitioner must electronically prescribe all targeted controlled substances. However, this does not apply to prescriptions for targeted controlled substances issued by a practitioner who: [Select ALL That Apply]. A. dispenses directly to an ultimate user. B. orders a controlled substance to be administered in a hospital. C. orders a controlled substance to be administered in an outpatient dialysis facility. D. who orders a controlled substance to be administered in a hospice facility.

1. Answer: (a,b,c,d), [NC Law 90-106(a1). Prescriptions and labeling.].(a1). Electronic Prescription Required; Exceptions.--Unless otherwise exempted by this subsection, a practitioner shall electronically prescribe all targeted controlled substances. This subsection does not apply to prescriptions for targeted controlled substances issued by any of the following:(1). A practitioner, other than a pharmacist, who dispenses directly to an ultimate user.(2). A practitioner who orders a controlled substance to be administered in a hospital, nursing home, hospice facility, outpatient dialysis facility, or residential care facility.(3). A practitioner who experiences temporary technological or electrical failure or other extenuating circumstance that prevents the prescription from being transmitted electronically. The practitioner, however, shall document the reason for this exception in the patient's medical record.(4). A practitioner who writes a prescription to be dispensed by a pharmacy located on federal property. The practitioner, however, shall document the reason for this exception in the patient's medical record.(5). A person licensed to practice veterinary medicine may continue to prescribe targeted controlled substances from valid written, oral, or facsimile prescriptions that are otherwise consistent with applicable laws.A dispenser (pharmacist) is not required to verify that a practitioner properly falls under one of the exceptions specified in subsection (a1) of this section prior to dispensing a targeted controlled substance. A dispenser may continue to dispense targeted controlled substances from valid written, oral, or facsimile prescriptions that are otherwise consistent with applicable laws.

Which of the following drugs is/are termed as "Restricted Drugs" under the North Carolina State Pharmacy Law? [Select ALL THAT APPLY] A. Ribavirin B. Chloroquine C. Darunavir D. Lopinavir-ritonavir

1. Answer: (a,b,c,d), [NC Rule 21 NCAC 46.1819].(a). The following drugs are "Restricted Drugs" as that term is used in this Rule:(1). Hydroxychloroquine;(2). Chloroquine;(3). Lopinavir-ritonavir;(4). Ribavirin; and(5). Darunavir.(b). A pharmacist shall fill or refill a prescription for a Restricted Drug only if that prescription bears a written diagnosis from the prescriber consistent with the evidence for its use.(c). When a patient has been diagnosed with COVID-19, any prescription of a Restricted Drug for the treatment of COVID-19 shall:(1). Indicate on the prescription order that the patient has been diagnosed with COVID-19;(2). Be limited to no more than a 14-day supply; and(3). Not be refilled, unless a new prescription order is issued in conformance with this Rule, including not being refilled through an emergency prescription refill.(d). A pharmacist shall not fill or refill a prescription for a Restricted Drug for the prevention of, or in anticipation of, the contraction of COVID-19 by someone who has not yet been diagnosed.(e). A prescription for a Restricted Drug may be transmitted orally only if all information required by this Rule is provided to the pharmacy by the prescriber or the prescriber's agent, and that information is recorded in writing by the pharmacy, along with the identity of the prescriber or prescriber's agent transmitting the prescription.(f). This Rule does not affect orders for administration to inpatients of health care facilities.(g). This Rule does not apply to prescriptions for a Restricted Drug for a patient previously established on that particular Restricted Drug on or before March 10, 2020.

An applicant for license must show that he has received _______ of practical experience under the supervision of a licensed pharmacist which has been acquired after the satisfactory completion of two years of college work. A. 1400 hours B. 1500 hours C. 1600 hours D. 2100 hours

1. Answer: (b) 1500 hours, [North Carolina Pharmacy Practice Act 21 NCAC 46 .1503].(a). An applicant for license must show that he has received 1500 hours of practical experience under the supervision of a licensed pharmacist which has been acquired after the satisfactory completion of two years of college work. The Board shall accept hours of experience certified by the school from which the applicant has graduated.(b). All practical pharmacy experience to be acceptable must be acquired under the general conditions approved by the Board as follows:(1). All practical pharmacy experience must be validated through registration in the internship program administered by the Board.(2). Persons working under the supervision of registered pharmacists and expecting to qualify for the registered pharmacist examination must notify the Board within five days of the beginning and the ending of such employment.(3). The Board shall not allow credit for claims of practical experience required under the pharmacy laws, unless such claims can be corroborated by records on file in the Board's office showing the beginning and the ending of the practical experience claimed as supplied by the applicant during this training period.(4). Practical experience shall be credited only when it has been obtained in a location holding a pharmacy permit, or a location approved by the Board for that purpose.

A patient brings a new prescription for Alprazolam with 5 eligible refills. The prescription is written on April 1, 2021. The prescription reads:Alprazolam 1 mg: 1 tablet by mouth at bed time x 30 days. Refills: 5 timesA patient has requested medication to be partially filled. Below is the list of partially filled transactions: 1. 04/04/2021: 20 tablets 2. 05/05/2021: 40 tablets 3. 05/25/2021: 18 tablets 4. 06/09/2021: 23 tablets 5. 06/21/2021: 5 tablets 6. 08/11/2021: 35 tablets 7. 09/05/2021: 11 tablets 8. 10/11/2021: 36 tablets 9. 10/28/2021: 21 tablets 10. 11/05/2021: 6 tablets Based on above information what shall be the dispensed quantities (legally)? A. 180 tablets B. 152 tablets C. 150 tablets D. Cannot be partially filled.

1. Answer: (b) 152 tablets, [http://www.deadiversion.usdoj.gov/faq/general.htm].Partial refills of schedules III and IV controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed, and no dispensing occurs after six months past the date of issue.In above example, the prescription expires on 10/01/2021 (six months from an issue date of 04/01/2021). Therefore, all partial filling before this date should be considered legal.The second thing the pharmacist has to observe that the total quantity dispensed in all partial fillings shall not exceed the total quantity prescribed.The prescription is written for 180 tablets, 1 tablet by mouth qd x 30 days with additional 5 refills. When adding all the partial filling starting from 04/04/2021 to 09/05/2021, the total quantities that the pharmacist can dispense legally come about 152 tablets.

A pharmacist shall verify the accuracy and appropriateness of the medication order and the medication removed from a health care facility pharmacy, which is NOT OPEN 24 hours a day, by an authorized nurse in the absence of the pharmacist within: A. 3 hours. B. 24 hours. C. 48 hours. D. 72 hours.

1. Answer: (b) 24 hours, [21 NCAC 46 .1413(a)]. · When a health care facility pharmacy is not open 24 hours a day, seven days a week, arrangements shall be made in advance by the pharmacist-manager for provision of drugs and pharmaceutical care to the medical staff, other authorized personnel, and patients of the health care facility by use of an "on call" pharmacist accessible to the facility during all absences, and auxiliary medical inventories as described in Rule .1414(d) of this Section.In addition, one or both of the options in Subparagraphs (a)(1) and (2) may be authorized by the pharmacist-manager to assure access to drugs and pharmaceutical care in the absence of a pharmacist:(1). a contractual arrangement with another health care facility, pharmacy, or pharmacist; or(2). a nurse trained and authorized by the pharmacist-manager to remove drugs or devices from the pharmacy in the absence of a pharmacist. Entry into the pharmacy in the absence of a pharmacist shall occur only if the drug needed is not in the auxiliary medication inventory.The pharmacist-manager shall maintain a current list of authorized persons and document the initial orientation, continuing education, and quality control processes on an ongoing basis.The pharmacist-manager shall maintain a list of restricted medications that shall not be taken from the pharmacy and may only be removed after contacting the "on call" pharmacist to verify the appropriateness and accuracy of the medication order and medication removed from the pharmacy at the time of removal.For medications not on the restricted list, an "on call" pharmacist must be accessible for questions by the authorized nurse.Within 24 hours, a pharmacist shall verify the accuracy and appropriateness of the medication order and the medication removed from the pharmacy.

A practitioner shall not prescribe more than a ________ supply of any targeted controlled substance upon the initial consultation and treatment of a patient for acute pain, unless the prescription is for post-operative acute pain relief for use immediately following a surgical procedure. A. 3-day B. 5-day C. 7-day D. 30-day

1. Answer: (b) 5 days, [NC Law 90-106(a3). Prescriptions and labeling.].(1). Acute pain.--Pain, whether resulting from disease, accident, intentional trauma, or other cause, that the practitioner reasonably expects to last for three months or less. The term does not include chronic pain or pain being treated as part of cancer care, hospice care, palliative care, or medication-assisted treatment for a substance use disorder. The term does not include pain being treated as part of cancer care, hospice care, or palliative care provided by a person licensed to practice veterinary medicine.(2). Chronic pain.--Pain that typically lasts for longer than three months or that lasts beyond the time of normal tissue healing.Limitation on Prescriptions Upon Initial Consultation for Acute Pain:--------------------------------------------------------------------------------------------1. A practitioner shall not prescribe more than a five-day supply of any targeted controlled substance upon the initial consultation and treatment of a patient for acute pain, unless the prescription is for post-operative acute pain relief for use immediately following a surgical procedure.2. A practitioner shall not prescribe more than a seven-day supply of any targeted controlled substance for post-operative acute pain relief immediately following a surgical procedure.Upon any subsequent consultation for the same pain, the practitioner may issue any appropriate renewal, refill, or new prescription for a targeted controlled substance.3. This subsection does not apply to prescriptions for controlled substances issued by a practitioner who orders a controlled substance to be wholly administered in a hospital, nursing home, hospice facility, or residential care facility.4. This subsection does not apply to prescriptions for controlled substances issued by a practitioner who orders a controlled substance to be wholly administered in an emergency facility, veterinary hospital, or animal hospital.-------------------------------------------------------------------------------------------------(g). Copies.--When a copy of a prescription for a controlled substance under this Article is given as required by G.S. 90-70, the copy shall be plainly marked: "Copy--for information only." Copies of prescriptions for controlled substances shall not be filled or refilled.(h). Fill Date.--A pharmacist dispensing a controlled substance under this Article shall enter the date of dispensing on the prescription order pursuant to which the controlled substance was dispensed.

Which of the following statements are TRUE about removing drugs from the auxiliary medication inventory during AFTER HOURS to serve a patient's immediate therapeutic need? I. Only drugs in unit-of-use packaging shall be removed from the auxiliary medication inventory. II. Drugs shall be pre-labeled by the pharmacist with drug name, strength, lot number and expiration date. III. Controlled substances may be stocked and removed from the pharmacy. A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II only, [21 NCAC 46.1413(d)].Only drugs in unit-of-use packaging shall be removed from the auxiliary medication inventory or from the pharmacy; they shall be used for administration to a specific patient only, in amounts sufficient to meet the needs for immediate therapeutic requirements.Controlled substances may be stocked and removed from auxiliary medication inventories; controlled substances may not be removed from the pharmacy in the absence of a pharmacist.Drugs shall be pre-labeled by the pharmacist with drug name, strength, lot number and expiration date. A copy of written orders for new medications shall be provided to the pharmacy.

Each "Clinical Pharmacist Practitioner (CPP) shall register annually on or before: A. March 31 B. December 31 C. July 31 D. June 30

1. Answer: (b) December 31, [21 NCAC 46 .3101(c) and 90-85.17].Each CPP shall register annually on or before December 31 by:(A). verifying that the CPP holds a current Pharmacist license;(B). submitting the renewal fee;(C). completing the Pharmacy Board's renewal form; and(D). reporting continuing education credits.(2). If the CPP has not renewed the CPP's annual registration within 60 days of December 31, the approval to practice as a CPP shall lapse.Section 90-85.17: In accordance with Board regulations, each license to practice pharmacy shall expire on December 31 and shall be renewed annually by filing with the Board on or after December 1 an application for license renewal furnished by the Board, accompanied by the required fee.It shall be unlawful to practice pharmacy more than 60 days after the expiration date without renewing the license.All licensees shall give the Board notice of a change of mailing address or a change of place of employment within 30 days after the change.The Board may require licensees to obtain up to 30 hours of continuing education every two years from Board-approved providers as a condition of license renewal, with a minimum of 10 hours required per year.

The pharmacist-manager shall verify the accuracy of the records at least weekly if health department personnel dispense to 30 or more patients in a 24-hour period per dispensing site. A. True B. False

1. Answer: (b) False, [21 NCAC 46 .2401(5)].A registered nurse employed by a local health department may dispense prescription drugs or devices under the following conditions:(1). Drugs or devices may be dispensed only to health department patients;(2). No drugs or devices may by dispensed except at health department clinics;(3). The health department shall secure the services of a pharmacist-manager who shall be responsible for developing and supervising a system of control and accountability of all drugs dispensed from the health department;(4). A suitable and perpetual record of drugs or devices dispensed shall be maintained in the health department.The pharmacist-manager shall verify the accuracy of the records at least weekly, and where health department personnel dispense to 30 or more patients in a 24-hour period per dispensing site, the pharmacist-manager shall verify the accuracy of the records within 24 HOURS (not weekly) after dispensing occurs.

According to North Carolina Pharmacy Law, the maximum quantity of pseudoephedrine solution (60mg/5ml) allowed in a single transaction would be 120ml. A. True B. False

1. Answer: (b) False, [Methamphetamine Lab Prevention Act of 2005, 90-113.52(e)].The pseudoephedrine sale restriction does not apply to any pseudoephedrine product that is in the form of a liquid, liquid capsule, gel capsule, or pediatric product labeled pursuant to federal regulation primarily intended for administration to children under 12 years of age according to label instruction. · Is this saying liquid altogether? Or just because it is not 3.6 g

A prescription order for a Duragesic shall not be dispensed more than 30 days after the date on which the prescription order was issued. A. True B. False

1. Answer: (b) False, [NC Controlled Substances Act and Regulations 90-106(b)].Under North Carolina State Pharmacy Law, no Schedule II substance (e.g. Duragesic) shall be dispensed pursuant to a written or electronic prescription more than six months after the date it was prescribed. · I put True thinking they were talking about a partial fill READ CAREFULLY

A manufacturer's sales representative may distribute a controlled substance as a complimentary sample upon the oral request of a practitioner. A. True B. False

1. Answer: (b) False, [NC Controlled Substances Act and Regulations 90-106(i)].A manufacturer's sales representative may distribute a controlled substance as a complimentary sample only upon the written (NOT ORAL) request of a practitioner.Such request must be made on each distribution and must contain the names and addresses of the supplier and the requester and the name and quantity of the specific controlled substance requested.The manufacturer shall maintain a record of each such request for a period of two years.

According to North Carolina State Pharmacy Law, no person shall purchase or receive by any means whatsoever more than two fluid ounces of Paregoric, U.S.P. within a consecutive 48-hour period, except on prescriptions issued by a duly licensed physician. A. True B. False

1. Answer: (b) False, [NC Controlled Substances Act and Regulations 90-91(e)(1)].According to North Carolina State Pharmacy Law, no person shall purchase or receive by any means whatsoever more than one fluid ounce (NOT TWO) of Paregoric, U.S.P. within a consecutive 24-hour (NOT 48-HOUR) period, except on prescriptions issued by a duly licensed physician.Paregoric, U.S.P. may be dispensed at retail as permitted by federal law or administrative regulation without a prescription only by a registered pharmacist, and no other person, agency or employee may dispense paregoric, U.S.P, even if under the direct supervision of a pharmacist.Paregoric, U.S.P., may only be sold at retail without a prescription to a person at least 18 years of age.A pharmacist must require every retail purchaser of a paregoric, U.S.P, substance to furnish suitable identification, including proof of age when appropriate, in order to purchase paregoric, U S P.The name and address obtained from such identification shall be entered in the record of disposition to consumers.

Which of the following drugs is classified as a Schedule III drug? A. Fioricet B. Fiorinal C. Codeine D. Lorazepam

1. Answer: (b) Fiorinal (Butalbital with Aspirin) is classified as a Schedule III drug, [Section 811(g) (3) (A) of the Controlled Substances Act].Fioricet contains: 325 mg of acetaminophen (APAP), 50 mg of butalbital, and 40 mg of caffeine.Fiorinal contains: 325 mg of aspirin (ASA), 50 mg of butalbital, and 40 mg of caffeine.The only difference between these two is the aspirin in Fiorinal vs acetaminophen in Fioricet. The interesting thing is that Fiorinal is a scheduled class III substance, while Fioricet has a non-scheduled status. It seems really strange because both combinations contain equal amount of the controlled substance butalbital.The exemption requires that one of the active ingredients be a non-narcotic controlled substance and one of the others be a non-scheduled compound. The potential for abuse is decreased if a sufficient amount of a non-controlled substance (e.g., aspirin or acetaminophen) is added.The ratio required for exemption is 70 mg of acetaminophen to 15 mg of butalbital. In contrast, the ratio of aspirin to butalbital is 188 mg to 15 mg.The acetaminophen to butalbital ratio is approximately 97 mg to 15 mg in Fioricet, thus it is exempt from scheduling. In Fiorinal the aspirin to butalbital ratio is approximately 97 mg to 15 mg, which is less than the 188mg:15mg ratio, so it is classified as a Schedule III substance.

The consultant pharmacist for a nursing home shall conduct a drug regimen review for actual and potential drug therapy problems in the nursing home and make remedial or preventive clinical recommendations into the medical record of every patient receiving medication. The consultant pharmacist shall conduct the review at least weekly. A. True B. False

1. Answer: (b) False, [North Carolina Pharmacy Practice Act 131E-128.4].The consultant pharmacist for a nursing home shall conduct a drug regimen review for actual and potential drug therapy problems in the nursing home and make remedial or preventive clinical recommendations into the medical record of every patient receiving medication. The consultant pharmacist shall conduct the review at least monthly.The consultant pharmacist shall report and document any drug irregularities and clinical recommendations promptly to the attending physician or nurse-in-charge and the nursing home administrator. The reports shall include problems identified and recommendations concerning:(1). Drug therapy that may be affected by biological agents, laboratory tests, special dietary requirements, and foods used or administered concomitantly with other medication to the same recipient.(2). Monitoring for potential adverse effects.(3). Allergies.(4). Drug interactions, including interactions between prescription drugs and over-the-counter drugs, drugs and disease, and interactions between drugs and nutrients.(5). Contraindications and precautions.(6). Potential therapeutic duplication.(7). Overextended length of treatment of certain drugs typically prescribed for a short period of time.(8). Beer's listed drugs that are potentially inappropriate for use by elderly persons.(9). Undertreatment or medical conditions that are suboptimally treated or not treated at all that warrant additional drug therapy to ensure quality of care.(10). Other identified problems and recommendations.

Records of invoices or other documents verifying the ordering and receipt of controlled substances shall be archived in a uniform manner and retrieved by the pharmacy within 72 hours of request made by a member or designated employee of the Board. A. True B. False

1. Answer: (b) False, [North Carolina Pharmacy Practice Act 21 NCAC 46 .1414 (J)(4)-to-(6)].(4) The pharmacist-manager shall maintain records of ordering, receiving, dispensing, or transfer of controlled substances. These records shall include the following:(A). Invoices or other documents verifying the ordering and receipt of controlled substances;(B). Perpetual inventories of controlled substances transferred to auxiliary medication inventories and automated dispensing devices. These inventories shall record the transfer date; the location transferred to; the identity of the drug; the strength, dosage form, and quantity transferred; and the transferring pharmacist's name;(C) Records of disposition of a controlled substance prepared for a patient but not used, including documentation of the details of the destruction or other disposition and identification of the individuals involved in that destruction or other disposition;(D) A record of controlled substances dispensed directly to the patient to include the patient's name; date dispensed; dispensing pharmacist's name; name, strength, dosage form, and quantity of the drug dispensed. The records shall also document drugs returned and credited; and(E) A perpetual inventory on all controlled substances awaiting destruction or return to a vendor.(5) Automated systems may be used to collect and store information provided such system allows for the immediate retrieval of original medication order information and dispensing history.(6) All records required by this Section shall be maintained for a period of three years. Such records shall be archived in a uniform manner, retrievable to the pharmacy within 48 hours (Not 72 hours), and open for review, copying, or seizure by a member or designated employee of the Board.

All pharmacist-managers shall notify the Board of any change in pharmacy personnel within 10 days of the change. A. True B. False

1. Answer: (b) False, [Pharmacy Laws of North Carolina 90-85.21(a)].In accordance with Board regulations, each pharmacy in North Carolina shall annually register with the Board on a form provided by the Board. The application shall identify the pharmacist-manager of the pharmacy and all pharmacy personnel employed in the pharmacy.All pharmacist-managers shall notify the Board of any change in pharmacy personnel within 30 days (Not 10 days) of the change.In addition to identifying the pharmacist-manager, a pharmacy may identify a pharmacy permittee's designated agent that the Board shall notify of any investigation of the pharmacy or a pharmacist employed by the pharmacy.The notice shall include the specific reason for the investigation and be given prior to the initiation of any disciplinary proceedings.

A licensed hospital that dispenses Schedule II through V controlled substances for the purpose of inpatient administration must report to The Department of Health and Human Services under the controlled substance dispensing act. A. True B. False

1. Answer: (b) False, [http://www.ncbop.org/faqs/Pharmacist/faq_ControlledSubstances.htm].The controlled substance dispensing act defines a dispenser as "a person who delivers a Schedule II through V controlled substance to an ultimate user in North Carolina, but does not include any of the following: a. A licensed hospital or long term care pharmacy that dispenses such substances for the purpose of inpatient administration. b. A person authorized to administer such a substance pursuant to Chapter 90 of the General Statutes. c. A wholesale distributor of a Schedule II through V controlled substance." DHHS advises that, in determining whether a particular facility is a "dispenser", facility personnel should ask themselves whether the dispensing will occur for administration to a patient population that is resident at, or confined within, the facility.If so, then the facility is not likely to be considered a "dispenser" for reporting purposes. If not, then the facility is likely a "dispenser" for reporting purposes. Some specific examples: -Emergency Departments: Dispensing of controlled substances to emergency department patients, including the dispensing of 24-hour "send home" packs, would not trigger a reporting requirement. -Hospital patients: Dispensing of controlled substances to hospital patients while receiving care at the hospital does not trigger a reporting requirement. This includes outpatient surgery. -Long-Term Care Facility, Assisted Living Facility, Group Homes, Hospice Facility. These facilities are expressly excluded from the definition of a "dispenser" unless the facility has its own pharmacy that dispenses medications for administration outside the facility. -Health Departments, Mental Health Facilities, Free Clinics. Dispensing controlled substances to outpatients of these facilities does trigger a reporting requirement. -Dispensing controlled substances to a hospital patient for administration outside the hospital on an outpatient basis does trigger a reporting requirement.

A prescription written by a licensed practitioner for Ativan for "office stock" should only be filled by a pharmacist-in-charge of a pharmacy. A. True B. False

1. Answer: (b) False, [http://www.ncbop.org/faqs/Pharmacist/faq_SchIIControlledSub.htm].The physician needs to complete a Schedule II Order form (DEA 222; see http://www.deadiversion.usdoj.gov/drugreg/change_requests/order_form.htm) for a drug in Schedule II and send it to the supplier which can be a pharmacy. The supplier keeps one copy and send the other copy to DEA. Note the instructions in the margin of the form.Orders for drugs in Schedule III or IV can occur on an invoice and the supplier (pharmacy) keeps these invoices with other CS records noting that these are outgoing items.These transactions should not occur pursuant to a prescription because prescriptions need to be patient specific.A prescription may not be issued in order for an individual practitioner to obtain a supply of controlled substances for the purpose of general dispensing to his/her patients. Therefore, a prescription written for "office stock" or "medical bag" use is not valid.

Who appoints the members for the North Carolina State Board of Pharmacy? A. Director of Pharmacy Board B. Governor C. Drug inspector of the state D. Healthcare administrator of the state

1. Answer: (b) Governor, [North Carolina Pharmacy Practice Act 90-85.7(a)].The Board of Pharmacy shall consist of six members.Five of the members shall be licensed as pharmacists within this State and shall be elected and commissioned by the Governor.Each pharmacist member of said Board shall be elected for a term of five years and until his successor shall be elected and shall qualify.The sixth member of the Board shall be a person who is not a pharmacist and who represents the interest of the public at large.

Which of the following statement are TRUE about pharmacists administering vaccines, according to North Carolina State Pharmacy Law? I. The pharmacist shall not administer vaccines except influenza vaccine to patients less than 18 years of age. II. The pharmacist or pharmacy intern may administer immunization. III. The Physician and the Immunizing Pharmacist shall review the Written Protocol at least biennially and revise it if necessary. A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II are true, [NC Rule 21 NCAC 46.2507 and North Carolina 90-85.15B].The pharmacist or pharmacy intern who is under the direct, in-person supervision of an Immunizing Pharmacist may administer immunization."Written Protocol" is a document prepared, signed, and dated by the Physician and Immunizing Pharmacist that shall contain the following:(A). the name of the Physician responsible for authorizing the Written Protocol;(B). the name of the Immunizing Pharmacist authorized to administer vaccines;(C). the immunizations or vaccinations that may be administered by the Immunizing Pharmacist;(D). the screening questionnaires and safety procedures that shall at least include the then-current minimum standard screening questionnaire and safety procedures adopted by the Medical Board, the Board of Nursing, and the Board of Pharmacy pursuant to S.L. 2013-246, s. 6, and available at the Board of Pharmacy's office and on its website (www.ncbop.org).(E). the procedures to follow, including any drugs required by the Immunizing Pharmacist for treatment of the patient, in the event of an emergency or adverse event following vaccine administration;(F). the reporting requirements by the Immunizing Pharmacist to the Physician, including content and time frame; and(G). the locations at which the Immunizing Pharmacist may administer immunizations or vaccinations.The Physician and the Immunizing Pharmacist shall review the Written Protocol at least annually (NOT biennially) and revise it if necessary.An Immunizing Pharmacist who, because of physical disability, is unable to obtain a current provider level CPR certification pursuant to G.S. 90-85.3(i1)(1), may administer vaccines in the presence of a pharmacy-intern, a pharmacy technician or pharmacist who holds a current provider level CPR certification.With each dose of vaccine, either the Immunizing Pharmacist or a Pharmacy Intern shall give the most current vaccine information regarding the purpose, risks, benefits, and contraindications of the vaccine to the patient or legal representative.The Immunizing Pharmacist or Pharmacy Intern must ensure that the patient or legal representative has the opportunity to read, or to have read to him or her, the information provided and to have any questions answered prior to administration of the vaccine.

Which of the following information is/are TRUE ABOUT a supply of emergency epinephrine auto-injectors on school property for use in emergency? I. A local board of education shall provide for a supply of emergency epinephrine auto-injectors on school property for use by trained school personnel to provide emergency medical aid to persons suffering from an anaphylactic reaction during the school day. II. The principal shall designate one or more school personnel to receive initial training and annual retraining from a school nurse regarding the storage and emergency use of an epinephrine auto-injector. III. Each school shall store in a secure but unlocked and easily accessible location a minimum of four epinephrine auto-injectors. A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II are true, [North Carolina Pharmacy Practice Act 115C-375.2A].A local board of education shall provide for a supply of emergency epinephrine auto-injectors on school property for use by trained school personnel to provide emergency medical aid to persons suffering from an anaphylactic reaction during the school day and at school-sponsored events on school property.Each school shall store in a secure but unlocked and easily accessible location a minimum of two (not four) epinephrine auto-injectors.For purposes of this section, "school property" does not include transportation to or from school.The principal shall designate one or more school personnel, as part of the medical care program, to receive initial training and annual retraining from a school nurse or qualified representative of the local health department regarding the storage and emergency use of an epinephrine auto-injector.Notwithstanding any other provision of law to the contrary, the school nurse or other designated school personnel who has received training under this subsection shall obtain a non-patient specific prescription for epinephrine auto-injectors from a physician, physician assistant, or nurse practitioner of the local health department serving the area in which the local school administrative unit is located.

Which of the following information about Plan-B One Step is/are TRUE? I. It is intended to prevent pregnancy after known or suspected contraceptive failure or unprotected intercourse. II. With Plan B One-Step, a patient has up to 72 hours to prevent a pregnancy. III. If a patient is 15 or older, Plan B One-Step is available ONLY through a prescription. A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II are true. Plan B One-Step is a backup plan that helps prevent pregnancy after birth control failure. The sooner a patient takes an emergency contraception, the better it works.Plan B One-Step requires just one pill. Other emergency contraception requires two pills, 12 hours apart.With Plan B One-Step, a patient has up to 72 hours (3 days) to prevent a pregnancy. It is not the abortion pill and it is not a substitute for routine birth control.Plan B is available to all Over-The-Counter without the prescription or presenting an id.A patient is required to take a single pill, as soon as possible within 72 hours, after an unprotected intercourse or a contraceptive failure.

A new pharmacy permit is not required in which of the following situations? I. The permit holder is a publicly-traded corporation and continues to hold the permit. II. The permit holder is a corporation which is a wholly-owned subsidiary, and any change in the ownership of the corporation is due to the stock of such corporation being publicly-traded. III. The permit holder is in process of changing the existing location of the pharmacy. A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II only, [21 NCAC 46 .1603 and 1604].A new pharmacy permit is required for a new location, a change to a different or successor business entity, or a change resulting in a different person or entity owning more than 50 % interest in the permit holder.A new permit is required if there is a change in the authority to control or designate a majority of the members or board of directors of a nonprofit corporation holding a pharmacy permit.A new pharmacy permit is NOT REQUIRED in the following situations:1. The permit holder is a publicly-traded corporation and continues to hold the permit.2. The permit holder is a corporation which is a wholly-owned subsidiary, and any change in the ownership of the corporation is due to the stock of such corporation being publicly-traded.

In which of the following instances is a pharmacist NOT required to wear any identification badge? I. For procedures requiring full sterile dress. II. For procedures requiring other protective clothing or covering. III. When it interferes with the therapeutic relationship between the pharmacist and client(s). A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II only, [21 NCAC 46 .2506(a),(b)].A pharmacist is not required to wear a readily visible badge or other form of identification in the following direct patient care situations:(1). For procedures requiring full sterile dress; or(2). For procedures requiring other protective clothing or covering.(b). Identification of a pharmacist may be limited to FIRST NAME only with reference to licensure or other professional designation when the full name identification may:(1). Place the personal safety of the pharmacist in jeopardy; or(2). Interfere with the therapeutic relationship between the pharmacist and client(s).

Which of the following information is/are APPROVED training programs for CPR and use of automated external defibrillator? I. American Heart Association. II. American Red Cross. III. American Pharmacists Association A. I only B. I and II only C. II and III only D. All

1. Answer: (b) I and II, [North Carolina Pharmacy Practice Act 90-21.15]."Automated external defibrillator" means a device, heart monitor, and defibrillator that meets all of the following requirements:a. The device has received approval from the United States Food and Drug Administration.b. The device is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia and is capable of determining, without intervention by an operator, whether defibrillation should be performed.c. Upon determining that defibrillation should be performed, the device automatically charges and requests delivery of, or delivers, an electrical impulse to an individual's heart."Training" means a nationally recognized course or training program in cardiopulmonary resuscitation (CPR) and automated external defibrillator use including the programs approved and provided by the:a. American Heart Association.b. American Red Cross.

Solution and products used in cleaning and disinfecting procedures for medical gas, oxygen and respiratory related equipment shall be found out by referring to which of the following? A. USP B. MSDS C. AHSP D. JACHO

1. Answer: (b) Medical gas, oxygen and respiratory related equipment suppliers shall comply with the following maintenance and cleaning requirements, [21 NCAC 46 .2610]:(1). Maintain documentation demonstrating that a function and safety check of equipment was performed prior to set up;(2). Maintain an established protocol for cleaning and disinfecting equipment which addresses both aerobic and anaerobic pathogens;(3). Maintain a Material Safety Data Sheet (MSDS) on file for solutions and products used in cleaning and disinfecting procedures;(4). Maintain segregated areas on the premises and in delivery vehicles for clean, dirty and contaminated equipment;(5). Clean and disinfect equipment according to manufacturers' specifications; and(6). Instruct the patient on proper cleaning techniques as specified by the manufacturer.

A pharmacist is adding 1000 mg of pure codeine powder to 100 cc of Tylenol with codeine Elixir (120 mg/12 mg/5 cc). The resultant mixture should be classified as: A. Schedule II B. Schedule III C. Schedule IV D. Schedule V

1. Answer: (b) The compounded mixture should be classified as a Schedule III controlled drug. The amount of Codeine present in the final mixture is 1.24 gms (1000 mg plus 240 mg), [NC Controlled Substances Act and Regulations 90-91(d)(2)].It has been stated under CSA that if a mixture contains less than 1.8 gms of Codeine per 100 cc, it should be classified as a Schedule III controlled substance.List of Schedule III controlled drugs:**Newly Added______________________________Amobarbital and noncontrolled active ingredients, Amobarbital suppository dosage form, Anabolic steroids, Barbituric acid derivative, Benzphetamine (Didrex, Inapetyl), Buprenorphine (Buprenex, Temgesic), Butabarbital (Butisol, Butibel), Butalbital (Fiorinal, Butalbital with aspirin), **Calcium, magnesium, potassium and sodium oxybate (Xywav), Codeine and isoquinoline alkaloid (Codeine with papaverine or noscapine), Codeine combination product (Empirin, Fiorinal, Tylenol, ASA or APAP w/codeine), Dronabinol in sesame oil in soft gelatin capsule (Marinol), Ketamine (Ketalar), Lysergic acid, Lysergic acid amide, Methyltestosterone (Android, Oreton, Testred, Virilon), Nalorphine (Nalline), Nandrolone (Deca-Durabolin, Durabolin, Durabolin-50), Norethandrolone(Nilevar, Solevar), Opium combination product (Paregoric), **Perampanel (Fycompa), Pentobarbital and noncontrolled active ingredients, Pentobarbital suppository dosage form, Phendimetrazine (Bontril), Secobarbital and noncontrolled active ingredients, Secobarbital suppository dosage form, **Sodium oxybate (Xyrem), Testosterone (Android-T, Androlan, Depotest, Delatestryl), Thiopental (Pentothal)

How often shall the NADDI forward North Carolina transaction records in NPLEx to the State Bureau of Investigation? A. Daily B. Weekly C. Monthly D. Quarterly

1. Answer: (b) Weekly, [NC 90-113.52A(a), (c)].A retailer shall, before completing a sale of a product containing a pseudoephedrine product, electronically submit the required information to the National Precursor Log Exchange (NPLEx) administered by the National Association of Drug Diversion Investigators (NADDI), provided that the NPLEx system is available to retailers in the State without a charge for accessing the system and the retailer has Internet access.The seller shall not complete the sale if the system generates a stop alert.If a pharmacy selling a product containing a pseudoephedrine product experiences mechanical or electronic failure of the electronic sales tracking system and is unable to comply with the electronic sales tracking requirement, the pharmacy or retail establishment shall record that the sale was made without submission to the NPLEx system in the record of disposition required under G.S. 90-113.52.The NADDI shall forward North Carolina transaction records in NPLEx to the State Bureau of Investigation weekly and provide real-time access to NPLEx information through the NPLEx online portal to law enforcement in the State as authorized by the SBI, provided that the SBI executes a memorandum of understanding with NADDI governing access.

Which of the following best describes Clinical Pharmacist Practitioner (CPP)? A. has finished 1-year residency in the clinical pharmacology. B. is approved to provide drug therapy management. C. has minimum 7-year experience in patient oriented clinical services. D. has passed the NABP approved CPP exam.

1. Answer: (b) is approved to provide drug therapy management, [21 NCAC 46 .3101(a)(3)].A licensed pharmacist who is approved to provide drug therapy management, including controlled substances, under the direction of, or under the supervision of a licensed physician who has provided written instructions for a patient and disease specific drug therapy which may include ordering, changing, substituting therapies or ordering tests.Only a pharmacist approved by the Pharmacy Board and the Medical Board may legally identify himself as a CPP.

A suitable record of drugs or devices removed from ancillary drug cabinets or from pharmacy inventory during after-hours shall be maintained for: A. 1 year. B. 2 years. C. 3 years. D. 4 years.

1. Answer: (c) 3 years, [21 NCAC 46 .1413(b)].Auxiliary Medication Drug Inventory: A secure, segregated, supplementary source for drugs to be used solely for the purpose of providing adequate drug availability when the pharmacy is closed or the pharmacist is unavailable.Ancillary drug cabinet is defined as drugs that are routinely prescribed by the medical staff in a health care facility shall be maintained in quantities limited to not more than five dosage units per drug as a supplementary inventory for use only when the pharmacy is closed.When a health care facility pharmacy is not open 24 hours a day, seven days a week, arrangements shall be made in advance by the pharmacist-manager for provision of drugs and pharmaceutical care to the medical staff, other authorized personnel, and patients of the health care facility after normal working hours by use of an "on call" pharmacist accessible to the facility during all absences, and an ancillary drug cabinet.A suitable record of drugs or devices removed from ancillary drug cabinets or from pharmacy inventory during AFTER HOURS shall be maintained for three years in the health care facility.The pharmacist-manager shall verify the accuracy of the records at least quarterly.

In which of the following instances shall a dispensing of a drug be classified as misbranded? A. A tablet falls on a floor dispensed by a pharmacist. B. A spider is found in an original manufacturer container. C. A returned drug is mixed with the drug containing a different lot number. D. A drug is compounded without properly sanitizing the compounding area.

1. Answer: (c) A returned drug is mixed with the drug containing a different lot number, [Food, Drugs And Cosmetics 53-1-109].The choices a, b and d are considered to be adulterated. A drug shall be classified as misbranded if:(a). Its labeling is false or misleading in any particular way.(b). It is in a package form, unless it bears a label containing:(1). the name and place of business of the manufacturer, packer, or distributor; and(2). an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.(c). Any word, statement, or other information required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.(d). It is a drug and its container is so made, formed, or filled as to be misleading; or(e). It is an imitation of another drug; or(f). It is offered for sale under the name of another drug.(g). It is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.(h). It is a color additive the intended use of which is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive.(i). It was manufactured, prepared, propagated, compounded, or processed in an establishment in any State not duly registered under section 510 of FDCA.

Which of the following requires a tamper-evident packaging? A. Cold EZ lozenges B. Tolnaftate cream C. Prilosec capsules D. Sensodyne fluoride tooth paste

1. Answer: (c) Each manufacturer and packer who packages an OTC drug product (except a dermatological, dentifrice, insulin, or lozenge product) for retail sale shall package the product in a tamper-evident package, if this product is accessible to the public while held for sale.A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.To reduce the likelihood of successful tampering and to increase the likelihood that consumers will discover if a product has been tampered with, the package is required to be distinctive by design or by the use of one or more indicators or barriers to entry that employ an identifying characteristic (e.g., a pattern, name, registered trademark, logo, or picture).A tamper-evident package may involve an immediate-container and closure system or secondary-container or carton system or any combination of systems intended to provide a visual indication of package integrity.The tamper-evident feature shall be designed to and shall remain intact when handled in a reasonable manner during manufacture, distribution, and retail display.

A pharmacist may engage in the administration of which of the following? I. MMR II. Zoster III. Influenza A. I only B. I and II only C. II and III only D. All

1. Answer: (c) II and III only, [21 NCAC 46.2507(a) and 90-85.15B].a. An immunizing pharmacist may administer vaccinations or immunizations only if the vaccinations or immunizations are recommended or required by the Centers for Disease Control and Prevention and administered to persons at least 18 years of age pursuant to a specific prescription order.b. An immunizing pharmacist may administer the vaccinations or immunizations listed in subdivisions (1) through (7) of this subsection to persons at least 18 years of age if the vaccinations or immunizations are administered under written protocols.(1). Pneumococcal polysaccharide or pneumococcal conjugate vaccines.(2). Herpes zoster vaccine.(3). Hepatitis B vaccine.(4). Meningococcal polysaccharide or meningococcal conjugate vaccines.(5). Tetanus-diphtheria, tetanus and diphtheria toxoids and pertussis, tetanus and diphtheria toxoids and acellular pertussis, or tetanus toxoid vaccines. However, a pharmacist shall not administer any of these vaccines if the patient discloses that the patient has an open wound, puncture, or tissue tear.(6). Human Papillomavirus vaccine.(7). Hepatitis A vaccine.(c). An immunizing pharmacist may administer the influenza vaccine to persons at least 10 years of age. He/she may administer an influenza vaccine to persons at least six years of age pursuant to a specific prescription order initiated by a prescriber following a physical examination of the patient by the prescriber.(d). An immunizing pharmacist who administers a vaccine or immunization to any patient pursuant to this section shall do all of the following:(1). Maintain a record of any vaccine or immunization administered to the patient in a patient profile.(2). Within 72 hours after administration of the vaccine or immunization, notify any primary care provider identified by the patient. If the patient does not identify a primary care provider, the immunizing pharmacist shall direct the patient to information describing the benefits to a patient of having a primary care physician, prepared by any of the following:1. North Carolina Medical Board,2. North Carolina Academy of Family Physicians,3. North Carolina Medical Society, or Community Care of North Carolina.(3). Except for influenza vaccines, access the North Carolina Immunization Registry prior to administering the vaccine or immunization and record any vaccine or immunization administered to the patient in the registry within 72 hours after the administration.In the event the registry is not operable, an immunizing pharmacist shall report as soon as reasonably possible.

All of the following are Schedule I controlled drugs EXCEPT: A. Heroin B. LSD C. Methylphenidate D. Marijuana

1. Answer: (c) Methylphenidate(Ritalin) is a Schedule II controlled drug, [NC Controlled Substances Act and Regulations 90-89, and 90-90, 90-94].List of Schedule I controlled drugs:_____________________________Difenoxin(Lyspafen), Dihydromorphine, Heroin (Diacetylmorphine, diamorphine), Lysergic acid diethylamide (LSD, lysergide), Marijuana (Cannabis, marijuana)[**Under NC Law it is classified as a schedule VI controlled substance.**], Mescaline, Peyote

Which of the following is/are classified as Schedule II controlled drug(s)? I. Heroin II. Morphine III. Pentobarbital A. I only B. I and II only C. II and III only D. All

1. Answer: (c) Morphine sulfate and Pentobarbital are classified as Schedule II controlled drugs, [NC Controlled Substances Act and Regulations 90-90]. Heroin is classified as a Schedule I controlled drug, [NC Controlled Substances Act and Regulations 90-89].List of Schedule II controlled drugs:**Newly AddedAlfentanil (Alfenta), Amobarbital (Amytal, Tuinal), Amphetamine (Dexedrine, Biphetamine), Lisdexamfetamine (Vyvanse), Coca Leaves, Cocaine, Codeine, Dextropropoxyphene, bulk (non-dosage forms), Dihydrocodeine (Didrate, Parzone), Diphenoxylate, Diprenorphine, **Dronabinol (Marinol and Syndros), Ecgonine (Cocaine precursor, in Coca leaves), Ethylmorphine (Dionin), Fentanyl (Innovar, Sublimaze, Duragesic), Glutethimide (Doriden, Dorimide), Hydrocodone (dihydrocodeinone), Hydrocodone and isoquinoline alkaloid,,, Hydrocodone combination product (Tussionex, Tussend, Lortab, Vicodin, Hycodan, Anexsia), Hydromorphone (Dilaudid, dihydromorphinone), Levo-alphacetylmethadol (LAAM, long acting methadone, levomethadyl acetate), Meperidine (Demerol, Mepergan, pethidine), Methadone (Dolophine, Methadose, Amidone), Methamphetamine (Desoxyn, D-desoxyephedrine, ICE, Crank, Speed), Methylphenidate (Ritalin), Morphine (MS Contin, Roxanol, Duramorph, RMS, MSIR), **Nabilone (Cesamet), Opium poppy, Opium tincture, Opium, granulated/powdered/raw**Oliceridine - Olinvyk (new schedule II drug), Oxycodone (OxyContin, Percocet, Tylox, Roxicodone, Roxicet), Oxymorphone (Numorphan), Pentobarbital (Nembutal), Poppy Straw Concentrate, Remifentanil (Ultiva), Secobarbital (Seconal, Tuinal), Sufentanil (Sufenta), Tapentadol (Nucynta)

A patient comes to a pharmacy with a prescription for Oxycontin. After processing the claim, the pharmacist finds out that he does not have enough quantity to dispense the full supply. Under this circumstance, the pharmacist may: A. Tell the patient to pick up partial quantities within 60 days. B. Call another pharmacy and borrow a bottle of Oxycontin. C. Reverse the claim and return the prescription back to the patient. D. Call the physician and change the quantity.

1. Answer: (c) Reverse the claim and return the prescription back to the patient, [http://www.ncbop.org/faqs/Pharmacist/faq_SchIIControlledSub.htm].Oxycontin is a schedule II controlled substance. When dealing with schedule II controlled substances, it is better to reverse the claim and return the prescription to the patient.The other option would be to supply partial quantities of the written prescription. The remaining portion of the prescription may be filled within 30 days of the first partial filling; however, if the remaining portion is not or cannot be filled within the 30 days period, the pharmacist shall so notify the prescribing individual practitioner.For each partial filling, the dispensing pharmacist shall record on the back of the prescription (or on another appropriate record, uniformly maintained, and readily retrievable) the:(1). date of the partial filling;(2). quantity dispensed;(3). remaining quantity authorized to be dispensed; and(4). identification of the dispensing pharmacist.No further quantity may be supplied beyond 30 days without a new prescription.Under the Comprehensive Addiction and Recovery Act of 2016 ("CARA"), a pharmacy may provide a partial fill of a Schedule II controlled substance prescription if:(1). state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort);(2). the prescription is written and filled in compliance with federal and state law;(3). the partial fill is requested by the patient or the prescriber; and(4). the total quantity dispensed in all partial fills does not exceed the total quantity prescribed.(5). In general, under CARA, the total amount of a Schedule II controlled substance prescription may be filled no later than 30 days from the date of the prescription.

The dispensing of drugs from physician's offices owned by the health care facility shall require separate registration if: I. The drugs dispensed at the location are ordinarily and customarily obtained from a source outside of the health care facility. II. The pharmacist-manager is controlled and supervised from a source other than the health care facility pharmacy. III. The routine activity at the location is dispensing drugs to outpatients. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .1401(c)]. · The dispensing of drugs from separate locations owned by a health care facility, such as satellite pharmacies, outside clinics, health maintenance organizations, or physician's offices owned by the health care facility shall require separate registration if any one of the following criteria exists:(1). The drugs dispensed at the location are ordinarily and customarily obtained from a source outside of the health care facility;(2). The pharmacist-manager is controlled and supervised from a source other than the health care facility pharmacy; or(3). The routine activity at the location is dispensing drugs to outpatients.Any pharmacy that provides compounding or dispensing services to one or more health care facilities for individual patient administration bearing any labeled name other than that under which it is registered shall require a separate registration.Health care facilities which do not have a pharmacy permit shall secure their pharmaceutical services through a pharmacist holding a current license from the Board.

Drugs which are prepackaged within a health care facility pharmacy for subsequent dispensing or administration shall be labeled to include: I. the generic or trade name, strength, and quantity of drug II. identification of the manufacturer, and lot number. III. cautionary notations, if applicable. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .1416(a)].(a). Drugs which are prepackaged within a health care facility pharmacy for subsequent dispensing or administration shall be labeled to include:(1). the generic or trade name, strength, and quantity of drug;(2). identification of the manufacturer, and lot or control number;(3). the expiration date of the drug being repackaged; and(4). cautionary notations, if applicable.(b). A batch number assigned by the pharmacy may be placed on the label in lieu of the manufacturer's name and lot number, provided that the pharmacy maintains a readily retrievable record which identifies, by batch number, the manufacturer, manufacturer's expiration date, and lot number of the drug.(c). The pharmacy shall have and use facilities, personnel, operational practices, packaging material, and control procedures to assure that the purity, integrity, safety, and effectiveness of the drugs are not affected by such repackaging.All repackaging must be performed by or under the supervision of a pharmacist.

Who may stock or restock medications in Automated Medication Systems? I. Pharmacist II. Pharmacy Technician III. Nurse practitioner A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .3404(b)(2)].(a). Responsibility for accurate stocking and restocking of an automated medication system lies with the pharmacist-manager and with any pharmacist tasked with supervising such functions.(b). The stocking or restocking of an automated medication system, where performed by someone other than a pharmacist, shall follow one of the following procedures to ensure correct drug selection:(1). A pharmacist shall conduct and document a daily audit of drugs placed or to be placed into an automated medication system by a pharmacy technician, which audit may include random sampling.(2). A bar code verification, electronic verification, or similar verification process shall be utilized to assure correct selection of drugs placed or to be placed into an automated medication system.The utilization of a bar code, electronic, or similar verification process shall require an initial quality assurance validation, followed by a quarterly quality assurance review by a pharmacist.When a bar code verification, electronic verification, or similar verification process is utilized as specified in this section, stocking and restocking functions may be performed by a pharmacy technician, pharmacy-intern** or by a registered nurse trained and authorized by the pharmacist-manager.(d). Medication Reuse. Medication that has been removed from the automated medication system shall not be replaced into the system unless:(1). a pharmacist has examined the medication, the packaging, and the labeling and determined that reuse of the medication is appropriate; or(2). specific medications, such as multi-dose vials, have been exempted by the Multidisciplinary Committee.**NC Administrative Code 21 NCAC 46 .1317(29): A pharmacy intern working under a pharmacist preceptor or supervising pharmacist may, while under supervision, perform all acts constituting the practice of pharmacy.

A Validating Technician shall be a pharmacy technician who: I. holds an associate's degree in pharmacy technology conferred by either an institution within the North Carolina Community College System or System. II. assists pharmacists with the preparation, dispensing and distribution of prescription medications that will be administered by a licensed health care provider to an inpatient in a Hospital. III. is a certified technician. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .1418(a),(e)].Pharmacists may permit a Validating Technician to validate the stocking and prepackaging functions of other registered pharmacy technicians in a hospital to facilitate pharmacists' delivery of clinical services.The pharmacist-manager shall develop written policies and procedures that:(1). permit a Validating Technician to validate only the following functions of other registered pharmacy technicians in filling floor stock and unit dose distribution systems for inpatients in a Hospital:(A). stocking of patient care unit medication inventories;(B). stocking of ancillary drug cabinet inventories;(C). stocking of automated dispensing or drug supply devices;(D). stocking of emergency kits; and(E). prepackaging of prescription drugs within the Hospital pharmacy;For the purposes of this Rule, a Validating Technician shall be a pharmacy technician who:(1). is registered with the Board and trained as specified in G.S. 90-85.15A;(2). is a certified technician;(3). holds either:(A). an associate's degree in pharmacy technology conferred by either an institution within the North Carolina Community College System or System;(B). an associate's degree in pharmacy technology conferred by an institution accredited by one of the regional accrediting agencies recognized by the United States Department of Education; or(C). an associate's degree in pharmacy technology conferred by a program accredited by the American Society of Health System Pharmacists; and(4). assists pharmacists with the preparation, dispensing and distribution of prescription medications that will be administered by a licensed health care provider to an inpatient in a Hospital under this Rule.

The pharmacist-manager shall be responsible for obtaining and maintaining a reference library in the pharmacy. The library shall include current references, either hard copy or electronically accessible, covering: I. State and federal statutes and rules relating to the practice of pharmacy and the legal distribution of drugs II. Drug interactions, adverse effects, therapeutic use, dosing and toxicology III. Patient-oriented reference materials for counseling in proper drug usage A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .1601(a)(4)].The pharmacist-manager shall be responsible for obtaining and maintaining a reference library in the pharmacy. The library shall include current references, either hard copy or electronically accessible, covering:(A). State and federal statutes and rules relating to the practice of pharmacy and the legal distribution of drugs;(B). Drug interactions, adverse effects, therapeutic use, dosing and toxicology;(C). Patient-oriented reference materials for counseling in proper drug usage as specified in 21 NCAC 46 .2504;(D). Equivalent drug products as defined in G.S. 90-85.27; and(E). Any reference materials otherwise required by state or federal law, including any otherwise required in these Rules.

All prescription drug orders transmitted by FAX or by electronic transmission shall: I. be transmitted directly to a pharmacist or certified technician in a pharmacy of the patient's choice. II. identify the transmitter's phone number for verbal confirmation. III. be transmitted by an authorized practitioner or his designated agent and contain either a written signature or an electronic signature unique to the practitioner. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .1813(b)].All prescription drug orders transmitted by FAX or by electronic transmission shall:(1). be transmitted directly to a pharmacist or certified technician in a pharmacy of the patient's choice with no intervening person altering the content of the prescription drug order;(2). identify the transmitter's phone number for verbal confirmation, the time and date of transmission, and the identity of the pharmacy intended to receive the transmission;(3). be transmitted by an authorized practitioner or his designated agent and contain either a written signature or an electronic signature unique to the practitioner;(4). be deemed the original prescription drug order, provided it meets all requirements of federal and state laws and regulations; and(5). if a refill order, contain all information required for original prescription orders except for the prescriber's signature.

A drug dispensing using the automated dispensing device shall be labeled with: I. Name and address of the healthcare facility pharmacy II. Unique identification number of the prescription III. Name of the prescribing physician A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .1814(b)(1)].(b). A pharmacist is required to supervise only the following activities pursuant to automated dispensing device:(1). The packaging and labeling of drugs to be placed in the dispensing devices. Such packaging and labeling shall conform to all requirements pertaining to containers and label contents;(2). The placing of previously packaged and labeled drug units into the dispensing device; and(3). The restocking of automated dispensing devices.(c). Only persons authorized by the pharmacist-manager may remove drugs from the dispensing devices and only in the quantity of doses needed to satisfy immediate patient needs. Should a violation of the foregoing occur, the pharmacist manager shall conduct an investigation and report any violations to the entity having jurisdiction over these issues.(d). Bar code scanning of drug packaging and storage units may be utilized as a quality control mechanism if this technology is available in the automated dispensing system.(e). An automated dispensing or drug supply device that is used solely as an Auxiliary Medication Inventory as defined in 21 NCAC 46 .1414(d) shall be governed by the requirements of that Rule.

Which of the following should be part of a patient's counseling? I. The name and description of the drug. II. Techniques for self-monitoring of therapy. III. Action to be taken in the event of a missed dose. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .2504(a)].To optimize drug therapy, a pharmacist shall counsel the patient or patient's agent regarding:1. the name and description of the drug or device.2. dosage form, dosage, route of administration, and duration of drug therapy.3. special direction and precautions for preparation, administration, and use by the patient.4. common severe side or adverse effects or interactions and therapeutic contraindications that may occur with the therapy.5. techniques for self-monitoring of drug therapy.6. proper storage of medication.7. refill information.8. action to be taken in the event of a missed dose.

Which of the following is/are TRUE about counseling? I. An offer to counsel shall be made on new or transfer prescriptions at the time the prescription is dispensed or delivered to the patient or representative. II. Only the pharmacist or pharmacy-intern may personally conduct counseling if the offer for counseling is accepted. III. Ancillary personnel may make the offer to counsel. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .2504(b)].1. An offer to counsel shall be made on new or transfer prescriptions at the time the prescription is dispensed or delivered to the patient or representative.2. Ancillary personnel may make the offer to counsel, but the pharmacist or pharmacy-intern must personally conduct counseling if the offer is accepted.3. The offer shall be made orally and in person when delivery occurs at the pharmacy.4. When delivery occurs outside of the pharmacy, whether by mail, vehicular delivery or other means, the offer shall be made either orally and in person, or by telephone from the pharmacist to the patient.5. If delivery occurs outside of the pharmacy, the pharmacist shall provide the patient with access to a telephone service that is toll-free for long-distance calls.6. Counseling may be conducted by the provision of printed information in a foreign language if requested by the patient or representative.7. Professional judgment shall be exercised in determining whether or not to offer counseling for prescription refills. An offer to counsel shall be communicated in a positive manner to encourage acceptance.NC Administrative Code 21 NCAC 46 .1317(29): A pharmacy intern working under a pharmacist preceptor or supervising pharmacist may, while under supervision, perform ALLacts constituting the practice of pharmacy.

A pharmacist who administers any vaccine shall maintain which of the following information in readily retrievable format? I. The name, address and date of birth of the patient. II. Route of administration of the vaccine. III. The administration site of injection. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .2507(g)].A pharmacist who administers any vaccine shall maintain the following information, readily retrievable in the pharmacy records, regarding each administration:(A). The name, address and date of birth of the patient;(B). The date of the administration;(C). The administration site of injection (e.g. right arm, left leg, right upper arm);(D). Route of administration of the vaccine;(E). The name, manufacturer, lot number and expiration date of the vaccine;(F). Dose administered;(G). The name and address of the patient's primary health care provider, as identified by the patient; and(H). The name or identifiable initials of the administering pharmacist.

What qualifications are required to be a licensed nuclear pharmacist, according to North Carolina State Pharmacy Law? I. Certification as a nuclear pharmacist by the "Board of Pharmaceutical Specialties." II. Has received a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from an approved college of pharmacy. III. Has a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .2702(6)].A pharmacist currently licensed by the Board must meet the following standards:(a). Certification as a nuclear pharmacist by the "Board of Pharmaceutical Specialties"; or(b). Meets minimum standards of training for "authorized user status" of radioactive material in accordance with the licensure guide of the United States Nuclear Regulatory Commission or the appropriate state nuclear regulatory agencies as follows:(i). Has received a minimum of 200 contact hours of instruction in nuclear pharmacy and the safe handling and use of radioactive materials from an approved college of pharmacy, including instruction in the following areas: radiation physics and instrumentation; radiation protection; mathematics of radioactivity; radiation biology; and radiopharmaceutical chemistry; and(ii). Has a minimum of 500 hours of clinical nuclear pharmacy training under the supervision of a qualified nuclear pharmacist.

Which of the following is/are TRUE about destroying or disposing outdated, adulterated or unwanted drugs CONTROLLED substances by a permit holder? I. A permit holder may file a written request on a form provided by the Board for authority and instructions to dispose of such substance. II. All destructions of controlled substances shall be documented and the document shall be retained by the permit holder for a period of at least three years. III. If destruction takes place at the permit holder's premises such destruction shall be jointly witnessed by at least two licensed pharmacists approved by the Board. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .3001(c)].Any permit holder in possession of any controlled substance and desiring or required to dispose of such substance may file a written request on a form provided by the Board for authority and instructions to dispose of such substance.If destruction takes place at the permit holder's premises such destruction shall be jointly witnessed by at least two licensed pharmacists approved by the Board. All destructions of controlled substances shall be documented and the document shall be retained by the permit holder for a period of at least three years.Copies of the document shall be sent to the Drug Enforcement Administration.

While using Automated Medication System, a pharmacist shall perform prospective drug use review and approve each medication order prior to administration of a medication EXCEPT when: I. a drug is classified as a High risk override medication by the Multidisciplinary Committee. II. a drug is classified as a Low risk override medication by the Multidisciplinary Committee. III. a drug is classified as a Physician controlled medication. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46 .3402(2),(3) and 21 NCAC 46 .3401(6),(7),(8)].(2). A pharmacist shall perform prospective drug use review and approve each medication order prior to administration of a medication except a high risk override medication, a low risk override medication or a physician controlled medication.(3). A pharmacist shall perform retrospective drug use review for an override medication.Definitions:(6). A drug that may be removed from an automated medication system prior to pharmacist review because the Multidisciplinary Committee has determined that the clinical status of the patient would be compromised by delay.(7). A drug determined by the Multidisciplinary Committee to have a low risk of drug allergy, drug interaction, dosing error, or adverse patient outcome, which may be removed from an automated medication system independent of a pharmacist's review of the medication order or clinical status of the patient.(8). "Physician controlled medication" is a drug ordered, prepared and administered by a physician or under the physician's direct supervision.

Which of the following are duties of a pharmacist-manager? I. Participation in those aspects of pharmaceutical care that affect drug distribution and control. II. Maintaining records and reports as are required to ensure patient health, safety and welfare. III. The development of policies and procedures for the compounding, admixture, labeling and dispensing of parenteral medications in the health care facility. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [21 NCAC 46.1411].The pharmacist-manager shall establish written procedures for the safe and effective distribution of pharmaceutical products.The pharmacist-manager shall be responsible for the safe and effective distribution, control, and accountability for drugs, including intravenous and irrigation solutions.The pharmacist-manager shall, at a minimum, be responsible for:(1). The development of policies and procedures for the compounding, admixture, labeling and dispensing of parenteral medications in the health care facility, including relevant education and training of all pharmacy and nursing personnel involved in the preparation of parenteral medications;(2). The establishment of specifications or use of compendia specifications for procurement of all pharmaceuticals, including drugs, chemicals, and biologicals used in direct patient care, subject to approval of the appropriate committee of the health care facility;(3). Participation in development and maintenance of a drug formulary when required by the health care facility;(4). Participation in those aspects of pharmaceutical care that affect drug distribution and control;(5). Preparing, packaging, compounding and labeling all drugs;(6). Assuring that drugs are dispensed only by a pharmacist or other persons allowed by law to dispense; supportive pharmacy personnel are properly directed and supervised;(7). The development and implementation of policies and procedures to ensure that discontinued drugs; outdated drugs; drugs recalled; containers with worn, illegible, or missing labels; or products that are otherwise unusable are returned to the pharmacy for proper disposition in a timely manner.

According to North Carolina State Pharmacy Law, which of the following statements are TRUE regarding the sale of Pseudoephedrine? I. A pseudoephedrine product in the form of a tablet, caplet, or gel cap shall not be offered for retail sale loose in bottles but shall be sold only in blister packages. II. Any pseudoephedrine product in the form of a tablet or caplet containing pseudoephedrine as the sole active ingredient or in combination with other active ingredients shall be stored and sold behind a pharmacy counter. III. A pseudoephedrine product may be sold at retail without a prescription only to a person at least 18 years of age. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [Methamphetamine Lab Prevention Act of 2005, 90-113.52].A pseudoephedrine product in the form of a tablet, caplet, or gel cap shall not be offered for retail sale loose in bottles but shall be sold only in blister packages.Any pseudoephedrine product in the form of a tablet or caplet containing pseudoephedrine as the sole active ingredient or in combination with other active ingredients shall be stored and sold behind a pharmacy counter.A pseudoephedrine product may be sold at retail without a prescription only to a person at least 18 years of age.The retailer shall require every retail purchaser of a pseudoephedrine product to furnish a valid, unexpired, government-issued photo identification and to provide, in print or orally, a current valid personal residential address.If the retailer has reasonable grounds to believe that the prospective purchaser is under 18 years of age, the retailer shall require the prospective purchaser to furnish photo identification showing the date of birth of the person

Which of the following is/are classified as Schedule IV controlled drug(s)? I. Oxazepam II. Zaleplon III. Butorphanol A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [NC Controlled Substances Act and Regulations 90-92].List of Schedule IV controlled drugs:**Newly Added______________________________**Alfaxalone (Alfaxan), Alprazolam (Xanax), Barbital (Barbitone), **Brexanolone (Zulresso), Butorphanol (Stadol, Stadol NS, Torbugesic, Torbutrol), Carisoprodol (Soma), Chloral hydrate (Noctec), Chlordiazepoxide (Librium, Libritabs, Limbitrol, SK-Lygen), Clonazepam (Klonopin, Clonopin), Clorazepate(Tranxene), Dexfenfluramine (Redux), Diazepam (Valium, Valrelease), Dichloralphenazone (Midrin), Difenoxin 1 mg/ Atropine 25 mcg (Motofen), Estazolam (ProSom, Domnamid, Eurodin, Nuctalon), Ethchlorvynol (Placidyl), Fenfluramine (Pondimin, Ponderal), Flurazepam (Dalmane), **Fospropofol (Lusedra), **Lemborexant (Dayvigo), **Lorcaserin (Belviq), Lorazepam (Ativan), Mazindol, Meprobamate (Miltown, Equanil, Deprol, Equagesic, Meprospan), Midazolam (Versed), Modafinil (Provigil), Oxazepam (Serax, Serenid-D), Pemoline (Cylert), Pentazocine (Talwin, Talwin NX, Talacen, Talwin Compound), Phenobarbital (Luminal, Donnatal, Bellergal-S), Phentermine (Ionamin, Fastin, Adipex-P, Obe-Nix, Zantryl), **Phentermine + Topiramate (Qsymia), Prazepam (Centrax), Propofol (Diprivan), Propoxyphene dosage forms with other ingredients, Quazepam (Doral, Dormalin), **Remimazolam (Byfavo), **Sibutramine (Meridia), **Solriamfetol (Sunosi), **Suvorexant (Belsomra), Temazepam (Restoril), Tramadol (Ultram), Triazolam (Halcion), Zaleplon (Sonata), Zolpidem (Ambien), Zopiclone (Imovane), Eszopiclone (Lunesta)

Which of the following information is/are TRUE under the North Carolina State Pharmacy Law? I. Upon notification of medication errors resulting from the administration of an incorrect medication or dose, the pharmacist-manager shall document the medication error. II. Documentation shall include chronological information and include documentation on health care facility forms. III. Documents shall be archived in a readily retrievable manner, open for inspection, for a period of three years. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 21 NCAC 46 .1414(j)(1)].(2). Upon notification of medication errors resulting from the administration of an incorrect medication or dose, the pharmacist-manager shall document the medication error.Documentation shall include chronological information and include documentation on health care facility forms. These documents shall be archived in a readily retrievable manner, open for inspection, for a period of three years.(3). Upon notification of information that reasonably suggests that there is a probability a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient, the pharmacist-manager shall retain all documents, labels, vial, supplies, substances, and internal investigative reports relating to the event.All such items shall be maintained by the health care facility, accessible to the pharmacist-manager, and open to the Board of Pharmacy.

Every health benefit plan that provides coverage for prescription drugs or devices and that issues a prescription drug card, shall issue to its insureds a uniform prescription drug identification card. The uniform prescription drug identification card shall contain: I. The American National Standards Institute assigned Issuer Identification Number II. The health benefit plan's card issuer identifier III. The processor control number A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 58-3-177].Every health benefit plan that provides coverage for prescription drugs or devices and that issues a prescription drug card, shall issue to its insureds a uniform prescription drug identification card. The uniform prescription drug identification card shall contain:(a). Every health benefit plan that provides coverage for prescription drugs or devices and that issues a prescription drug card, shall issue to its insureds a uniform prescription drug identification card. The uniform prescription drug identification card shall contain the information listed in subdivisions (1) through (7) of this subsection in the following order beginning at the top left margin of the card:(1). The health benefit plan's name and/or logo.(2). The American National Standards Institute assigned Issuer Identification Number.(3). The processor control number.(4). The insured's group number.(5). The health benefit plan's card issuer identifier.(6). The insured's identification number.(7). The insured's name.(b). In addition to the information required under subsection (a), the uniform prescription drug card shall contain, in one of the lower-most elements on the back side of the card, the following information:(1). The health benefit plan's claims submission name and address.(2). The health benefit plan's help desk telephone number and name. 2.

In which of the following instances is a dispenser not required to report controlled substances data to the controlled substances reporting system? I. A controlled substance is directly administered to the ultimate user in an emergency department. II. A controlled substance is provided directly to the ultimate user and the quantity provided does not exceed a 48-hour supply. III. A Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for the purpose of assessing a therapeutic response when prescribed according to indications approved by the United States Food and Drug Administration. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 90-113.73(c),(d)].(c). A dispenser shall not be required to report instances in which a controlled substance is provided directly to the ultimate user and the quantity provided does not exceed a 48-hour supply.A dispenser shall not be required to report instances in which a controlled substance is directly administered to the ultimate user in an emergency department.(d). A dispenser shall not be required to report instances in which a Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for the purpose of assessing a therapeutic response when prescribed according to indications approved by the United States Food and Drug Administration.

The Department shall release data in the controlled substances reporting system to the: I. Persons authorized to prescribe or dispense controlled substances for the purpose of providing medical or pharmaceutical care for their patients. II. Special agents of the North Carolina State Bureau of Investigation who are assigned to the Diversion and Environmental Crimes Unit. III. An individual who requests the individual's own controlled substances reporting system information. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 90-113.74(c)].The Department shall release data in the controlled substances reporting system to the following persons only:(1). Persons authorized to prescribe or dispense controlled substances for the purpose of providing medical or pharmaceutical care for their patients.(2). An individual who requests the individual's own controlled substances reporting system information.(3). Special agents of the North Carolina State Bureau of Investigation who are assigned to the Diversion and Environmental Crimes Unit and whose primary duties involve the investigation of diversion and illegal use of prescription medication.SBI agents assigned to the Diversion and Environmental Crimes Unit may then provide this information to other SBI agents who are engaged in a bona fide specific investigation related to enforcement of laws governing licit drugs.(4). Primary monitoring authorities for other states pursuant to a specific ongoing investigation involving a designated person, if information concerns the dispensing of a Schedule II through V controlled substance to an ultimate user who resides in the other state or the dispensing of a Schedule II through V controlled substance prescribed by a licensed health care practitioner whose principal place of business is located in the other state.(5). To a sheriff or designated deputy sheriff or a police chief or a designated police investigator who is assigned to investigate the diversion and illegal use of prescription medication or pharmaceutical products.(6). The Division of Medical Assistance for purposes of administering the State Medical Assistance Plan.(7). Licensing boards with jurisdiction over health care disciplines pursuant to an ongoing investigation by the licensing board of a specific individual licensed by the board.(8). Any county medical examiner appointed by the Chief Medical Examiner pursuant to G.S. 130A-382 and the Chief Medical Examiner, for the purpose of investigating the death of an individual.

Which of the following information is/are TRUE ABOUT clinical pharmacist practitioners? I. The clinical pharmacist practitioner shall have current approval from the Boards. II. Clinical pharmacist practitioners are authorized to order laboratory tests pursuant to a drug therapy management agreement. III. The North Carolina Medical Board has assigned an identification number to the clinical pharmacist practitioner which is shown on written prescriptions written by the clinical pharmacist practitioner. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 90-18.4].(a). Any pharmacist who is approved to perform medical acts, tasks, and functions may use the title "clinical pharmacist practitioner".(b). Clinical pharmacist practitioners are authorized to implement predetermined drug therapy, which includes diagnosis and product selection by the patient's physician, modify prescribed drug dosages, dosage forms, and dosage schedules, and to order laboratory tests pursuant to a drug therapy management agreement that is physician, pharmacist, patient, and disease specific under the following conditions:(1). The clinical pharmacist practitioner shall have current approval from both Boards (Pharmacy and Medicine).(2). The North Carolina Medical Board has assigned an identification number to the clinical pharmacist practitioner which is shown on written prescriptions written by the clinical pharmacist practitioner.(3). The drug therapy management agreement prohibits the substitution of a chemically dissimilar drug product by the pharmacist for the product prescribed by the physician without the explicit consent of the physician and includes a policy for periodic review by the physician of the drugs modified pursuant to the agreement or changed with the consent of the physician.

A Schedule V substance may be sold at retail without a prescription by a registered pharmacist or by a pharmacist intern under the direct supervision of a pharmacist. A. True B. False

1. False, [North Carolina Pharmacy Practice Act 90-93(b)]. · According to North Carolina Pharmacy Law, a Schedule V substance may be sold at retail without a prescription only by a registered pharmacist and no other person, agent or employee may sell a Schedule V substance even if under the direct supervision of a pharmacist.

Under a North Carolina State Pharmacy Law, the custody of or access to the prescription orders may be provided to: I. An adult patient for whom the prescription was issued or a person who is legally appointed guardian of that person. II. Anyone who presents a written authorization for the release of pharmacy information signed by the patient or his legal representative. III. Spouse of a deceased patient for whom the prescription order was issued. A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All, [North Carolina Pharmacy Practice Act 90-85.36].The written prescription orders on file in a pharmacy or other place where prescriptions are dispensed are not public records and any person having custody of or access to the prescription orders may divulge the contents or provide a copy only to the following persons:(1). An adult patient for whom the prescription was issued or a person who is legally appointed guardian of that person;(2). An emancipated minor patient for whom the prescription order was issued or a person who is the legally appointed guardian of that patient;(3). An unemancipated minor patient for whom the prescription order was issued when the minor's consent is sufficient to authorize treatment of the condition for which the prescription was issued;(4). A parent or person in loco parentis of an unemancipated minor patient for whom the prescription order was issued when the minor's consent is not sufficient to authorize treatment for the condition for which the prescription is issued;(5). The licensed practitioner who issued the prescription;(6). The licensed practitioner who is treating the patient for whom the prescription was issued;(7). A pharmacist who is providing pharmacy services to the patient for whom the prescription was issued;(8). Anyone who presents a written authorization for the release of pharmacy information signed by the patient or his legal representative;(9). Any person authorized by subpoena, court order or statute;(10). Any firm, association, partnership, business trust, corporation or company charged by law or by contract with the responsibility of providing for or paying for medical care for the patient for whom the prescription order was issued;(11). A member or designated employee of the Board;(12). The executor, administrator or spouse of a deceased patient for whom the prescription order was issued;(13). Researchers and surveyors who have approval from the Board. The Board shall issue this approval when it determines that there are adequate safeguards to protect the confidentiality of the information contained in the prescription orders and that the researchers or surveyors will not publicly disclose any information that identifies any person; or(14). The person owning the pharmacy or his authorized agent.(15). A pharmacist may disclose any information to any person only when he reasonably determines that the disclosure is necessary to protect the life or health of any person.

A permit-holder dispensing sterile pharmaceuticals shall have in its reference library which of the following reference materials? I. Handbook on Injectable Drugs II. King's Guide to Parenteral Admixtures III. American Hospital Formulary Service A. I only B. I and II only C. II and III only D. All

1. Answer: (d) All.A permit-holder dispensing sterile pharmaceuticals shall have in its reference library the following reference materials:1. Handbook on Injectable Drugs (ASHP);2. King's Guide to Parenteral Admixtures;3. American Hospital Formulary Service; and4. Procedure for Handling Cytotoxic Drugs (ASHP).

In which of the following instances is a health care provider considered to be violated The HIPAA Privacy Rules? I. An emergency room doctor may discuss a patient's treatment in front of the patient's friend if the patient asks that her friend come into the treatment room. II. A doctor's office may discuss a patient's bill with the patient's adult daughter who is with the patient at the patient's medical appointment and has questions about the charges. III. A doctor may give information about a patient's mobility limitations to the patient's sister who is driving the patient home from the hospital. A. I only B. I and II only C. III only D. None of the above

1. Answer: (d) None of the above, [http://www.hhs.gov/ocr/privacy/hipaa/understanding/coveredentities/provider_ffg.pdf].If the patient is present and has the capacity to make health care decisions, a health care provider may discuss the patient's health information with a family member, friend, or other person if the patient agrees or, when given the opportunity, does not object.A health care provider also may share information with these persons if, using professional judgment, he or she decides that the patient does not object. In either case, the health care provider may share or discuss only the information that the person involved needs to know about the patient's care or payment for care.Here are few examples:1. An emergency room doctor may discuss a patient's treatment in front of the patient's friend if the patient asks that her friend come into the treatment room.2. A doctor's office may discuss a patient's bill with the patient's adult daughter who is with the patient at the patient's medical appointment and has questions about the charges.3. A doctor may discuss the drugs a patient needs to take with the patient's health aide who has accompanied the patient to a medical appointment.4. A doctor may give information about a patient's mobility limitations to the patient's sister who is driving the patient home from the hospital.5. A nurse may discuss a patient's health status with the patient's brother if she informs the patient she is going to do so and the patient does not object. But a nurse may not discuss a patient's condition with the patient's brother after the patient has stated she does not want her family to know about her condition.

According to North Carolina State Pharmacy Law, upon the Board providing written notice to the pharmacy permittee's designated agent against the pharmacist, the pharmacy permittee's designated agent shall compile and provide documentation within 30 days of the receipt of the notice of any alleged medication error or incident committed by the pharmacist in the 12 months preceding the receipt of the notice. A. True B. False

1. Answer: B-False, [North Carolina Pharmacy Practice Act 90-85.47(e)].Upon the Board providing written notice to the pharmacy permittee's designated agent against the pharmacist, including the specific reason for the Board investigation, the pharmacy permittee's designated agent shall compile and provide documentation within 10 days (NOT 30 days) of the receipt of the notice of any alleged medication error or incident committed by the pharmacist in the 12 months preceding the receipt of the notice, that the pharmacy permittee has knowledge of, when:(1). The alleged medication error or incident resulted in any of the following:a. A visit to a physician or an emergency room that is attributed to the alleged medication incident or error.b. Hospitalization requiring an overnight stay or longer.c. A fatality.

41. Which of the following classes of medications requires a Patient Package Insert? A. Estrogens B. Opioids C. Teratogens D. Carcinogens

A

503A or 503B: Traditional Pharmacy Compounding: in community pharmacies

503A -Can be sterile or nonsterile

Wholesale distributors of SLCPs (bulk quantities) will have to obtain a registration as a chemical distributor (DEA Form ______)

510 -Must submit a report electronically to the State Bureau of Investigation that accounts for all transactions involving pseudoephedrine products with persons or firms located within NC for the preceding month

(16) Which of the following INCORRECTLY matches the controlled substance with the quantity limitation? A. Dextroamphetamine and Amphetamine- 30 day supply B. Lorazepam- Maximum of 5 refills C. Pregabalin- No limit on the number of refills D. Hydrocodone for acute pain- 5 day supply initially

A

39. Which of the following substitutions may a pharmacist make without contacting the prescriber for approval? (Select all that apply) A. A pharmacist may dispense warfarin if the prescription is written for Coumadin (first time filling the drug) B. A pharmacist may dispense a biosimilar if the brand name biologic is prescribed (the biosimilar does not have interchangeable status) C. A pharmacist may dispense tizanidine tablets if Zanaflex capsules are prescribed D. A pharmacist may dispense levothyroxine if the prescriber issues a prescription for Synthroid and signs on the DAW line

A

What is a Central Fill Pharmacy? ***· Corresponding responsibility doctrine applies to pharmacists at BOTH pharmacies***

A retail (originating) pharmacy sends a new prescription or a refill request to another pharmacy (central fill pharmacy) to process. After the Rx is prepared, the central fill pharmacy delivers the filled Rx back to the originating pharmacy who then dispenses it to the patient o The CFP only processes the Rx, they do NOT receive Rxs directly from the patient or deliver them to the patient o The two pharmacies have a contractual arrangement or common owner à MUST share a common, electronic file o These are NOT considered "transferred" prescriptions

Can a retail pharmacy double as a central fill pharmacy? Does it require a separate DEA registration?

A retail pharmacy may double as a central fill pharmacy WITHOUT keeping a separate DEA registration, inventories or records

Q: May a properly trained pharmacy student administer vaccinations?

A. An appropriately trained pharmacy student may administer vaccines so long as, and only if, that student is doing so under the direct supervision of a certified pharmacist vaccinator.

Q. What does the FDA advise on codeine-containing products and tramadol products in the treatment of children?

A. FDA REQUIRES STRENGTHENED WARNINGS ON LABELING FOR CODEINE-CONTAINING PRODUCTS AND TRAMADOL PRODUCTS In fall 2017, the U.S. Food and Drug Administration required manufacturers of codeine-containing and tramadol containing products to strengthen warnings on those products' labeling. Specifically, FDA has advised that children younger than 12 should not take codeine-containing products to treat pain or cough, and children younger than 12 should not take tramadol products to treat pain. FDA also warns that children younger than 18 should not take tramadol products to treat pain after surgery to remove the tonsils (tonsillectomy) or adenoids (adenoidectomy). Finally, FDA warns that youths ages 12 through 18 who are obese, have obstructive sleep apnea (blocked airflow during sleep), or have a weakened respiratory system should not take codeine-containing products or tramadol products.

Q. Must a veterinary prescription contain a DEA number for non-controlled drugs or an NPI number?

A. No. A veterinarian (or, for that matter, any other health care provider) who writes a prescription for a drug that is not a controlled substance does not need a DEA number to do so. Nor does North Carolina law require a DEA number to appear on a prescription for a non-controlled substance. Historically, there had been some confusion on this latter point under North Carolina law, but that confusion was laid to rest in 2008, as detailed in the FAQs at http://www.ncbop.org/faqs/Pharmacist/faq_DEANoOnNoncontrolledRX.htm. Moreover, veterinarians are not eligible to obtain an NPI number. In 2013, the Centers for Medicare and Medicaid Services clarified that veterinarians do not meet the regulatory definition of "health care provider" for purposes of obtaining an NPI. More information can be found at https://nabp.pharmacy/veterinarians-not-eligible-for-npis-cms-clarifies The Board appreciates, as always, pharmacists' efforts to ensure that prescriptions comply with all applicable laws and rules. But demanding a DEA number for a non-controlled substance prescription and/or an NPI number from a veterinarian who is not eligible to obtain one is not required by law. And doing so can pose a barrier to timely, effective treatment of veterinary patients.

Q. Does the federal Drug Quality and Security Act prohibit a pharmacy from compounding veterinary drugs for "office use"?

A. No. The federal Drug Quality and Security Act speaks to compounding of human drug products. The FDA's most current statement of regulatory policy governing veterinary compounding may be found here: https://www.fda.gov/AnimalVeterinary/ResourcesforYou/ucm268128.htm#Compounding_of_Animal_Drugs.

Q. Must my facility report controlled substance dispensing under the act?

A. The act defines a dispenser as "a person who delivers a Schedule II through V controlled substance to an ultimate user in North Carolina, but does not include any of the following: a. A licensed hospital or long term care pharmacy that dispenses such substances for the purpose of inpatient administration. b. A person authorized to administer such a substance pursuant to Chapter 90 of the General Statutes. c. A wholesale distributor of a Schedule II through V controlled substance." DHHS advises that, in determining whether a particular facility is a "dispenser", facility personnel should ask themselves whether the dispensing will occur for administration to a patient population that is resident at, or confined within, the facility. If so, then the facility is not likely to be considered a "dispenser" for reporting purposes. If not, then the facility is likely a "dispenser" for reporting purposes. Some specific examples: Emergency Departments. Dispensing of controlled substances to emergency department patients, including the dispensing of 24-hour "send home" packs, would not trigger a reporting requirement. Hospital patients. Dispensing of controlled substances to hospital patients while receiving care at the hospital does not trigger a reporting requirement. This includes outpatient surgery. Dispensing controlled substances to a hospital patient for administration outside the hospital on an outpatient basis does trigger a reporting requirement. Long-Term Care Facility, Assisted Living Facility, Group Homes, Hospice Facility. These facilities are expressly excluded from the definition of a "dispenser" unless the facility has its own pharmacy that dispenses medications for administration outside the facility. Health Departments, Mental Health Facilities, Free Clinics. Dispensing controlled substances to outpatients of these facilities does trigger a reporting requirement. Prisons or Jails. Dispensing to inmates confined to the facility does not trigger a reporting requirement.

Q. What information is required to be on the prescription label?

A. The following information must be on every prescription label: 1. Name and address of the dispensing pharmacy. 2. Serial number of the prescription. 3. Date of the prescription. 4. Name of the prescriber. 5. Name of the patient. 6. Name and strength of the drug. 7. The generic name of the drug, even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized. 8. Directions for use. 9. Appropriate cautionary statements. 10. "Filled by" or "dispensed by" with the name of the dispensing pharmacist. The name must include, at a minimum, the first initial and full last name of the dispensing pharmacist. 11. If the dispensed drug is a "tranquilizer or sedative," it should bear the warning "The consumption of alcoholic beverages while on this medication can be harmful to your health" if the prescriber so directs on the prescription. 12. If the prescription is dispensed in a container other than the manufacturer's original container, a discard date, which shall be the earlier of one year from the date dispensed or the manufacturer's expiration date, whichever is earlier. 13. If the prescription is dispensed in the manufacturer's original container, the label must not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container.

Q. I have received a prescription generated by a telemedicine encounter. May I dispense it? Q. I thought the Board's rules prohibited pharmacists from dispensing a prescription generated by a telemedicine encounter? Q. May I dispense a prescription for a controlled substance generated by a telemedicine encounter?

A. Yes, upon appropriate exercise of professional judgment. The pharmacist must exercise professional judgment in evaluating the prescription to determine if it is appropriate for the patient. The pharmacist shall not fill or refill a prescription "if, in the exercise of professional judgment, there is or reasonably may be a question regarding the order's accuracy validity, authenticity, or safety for the patient." A. At one time, Board rule .1801 provided that a pharmacist could not fill or refill a prescription if the pharmacist knew or reasonably should have known that a prescription was issued in the absence of a prior prescriber-patient relationship or a physical examination. That rule reflected the Medical Board's then-current position on telemedicine-based prescribing. In late 2014, however, the Medical Board amended its position on telemedicine, which is found here: http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/telemedicine That position notes that telemedicine-based encounters may be appropriate for evaluating patients "if the licensee employs technology sufficient to accurately diagnose and treat the patient in conformity with the applicable standard of care." In response to the revised Medical Board position, the Board of Pharmacy amended Rule .1801 (effective August 1, 2015) to state that a prescription order is valid if "issued by a health care provider for a legitimate medical purpose, in the context of a patient-prescriber relationship, and in the course of legitimate professional practice as recognized by the [Medical Board]." A. The Medical Board's statement states: "It is the position of the Board that prescribing controlled substances for the treatment of pain by means of telemedicine is not consistent with the standard of care." http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/telemedicine Furthermore, the federal Controlled Substances Act and regulations state that a pharmacist may only dispense a prescription for a controlled substance issued for legitimate medical purpose in the usual course of professional practice. Finally, the Ryan Haight Online Pharmacy Consumer Protection Act, a federal statute passed in 2008, specifies at least one in person medical evaluation must precede issuing a controlled substance prescription for any indication (pain or otherwise). 21 USC 829(e). The statute does provide that telemedicine may qualify as medical evaluation, but only if the patient "is being treated by, and physically located in, a hospital or clinic" or "while the patient is being treated by, and in the presence of, a practitioner." 21 U.S.C. 802(54); 21 CFT 1300.04(i) In general, then, an in-person evaluation is required for a controlled substance prescription for any indication to be valid. And the DEA notes that the absence of an in-person evaluation remains a "'red flag' indicating that diversion is occurring." 75 Fed Reg at 15,599 (Apr. 6, 2009)

Q: What changes can be made to Schedule II Prescriptions?

A: After consulting with the prescribing practitioner (you must speak directly to the practitioner, not his/her agent), the pharmacist may modify or add the following: 1) date of issue - may be added but not changed; 2) patient's address; 3) drug strength; 4) drug dosage form; 5) drug quantity - may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed; and 6) directions for use. A pharmacist may never change the name of the drug (except to generic when appropriate), name of the patient, or the signature of the practitioner.

Q: What is North Carolina's law on dispensing naloxone under a standing order?

A: As pharmacists are aware, North Carolina law permits the dispensing of naloxone pursuant to standing orders. The North Carolina Department of Health and Human Services has put together an FAQ document that walks pharmacists through utilization of the statewide standing order, signed by the North Carolina State Health Director. Board staff encourages pharmacists to review the document found here. -Pharmacies dispensing naloxone under the statewide standing order are encouraged to notify the NC Division of Public Health by completing this form on NaloxoneSaves.org. While this is not required, information is used to develop a publicly available map of all pharmacy locations providing naloxone access to individuals in NC. Who is eligible for naloxone through the statewide standing order? Persons who voluntarily request naloxone and are at risk of experiencing an opioidrelated overdose. Specific risk factors are outlined in the statewide standing order. • Persons who voluntarily request naloxone and are the family member or friend of a person at risk of experiencing an opioidrelated overdose. • Persons who voluntarily request naloxone and are in a position to assist a person at risk of experiencing an opioid-related overdose (i.e. law enforcement). Can I initiate a conversation with a patient about naloxone even though the standing order says that the patient must "voluntarily request" naloxone? Yes. If the pharmacist identifies a patient whom they believe to be at risk of overdose, the pharmacist may initiate a conversation with the patient to determine if they would like to receive naloxone. If the patient indicates desire to obtain naloxone, they would be considered to have "voluntarily requested" naloxone under the standing order. Am I required to notify the patient's prescriber that I dispensed naloxone? NO How do I process a prescription for naloxone under the standing order? Can I bill insurance? Yes. Treat the standing order as you would any other prescription. Record keeping, documentation, and labeling requirements remain the same as other prescriptions, but you will select the State Health Director (listed on the standing order) as the prescriber for the prescription. NC Medicaid, many Medicare Part D plans, and some private insurances cover naloxone - copays vary on plan and formulation dispensed. Note, you may bill the insurance of the person purchasing naloxone, even if they may not be the end-user What type of patient education is required under the standing order? Patients receiving naloxone under the statewide standing order of the State Health Director should receive education regarding: • Risk factors of overdose • Signs and symptoms of overdose • How to respond to an overdose • Administration of naloxone Can I be held liable for dispensing naloxone? No. Under G.S. 90-12.7, pharmacists who dispense naloxone under the statewide standing order are immune from any civil or criminal liability. Does the statewide standing order expire? No. The statewide standing order will be renewed or updated if there is a change in the State Health Director or if any relevant information regarding naloxone becomes available.

Q: If a prescription is authorized for several refills, may I dispense more than one refill at a time such as when the patient will be traveling overseas for several months?

A: Board Rule 21NCAC 46.1802 allows for such dispensing under some circumstances. The notable exception is if the prescription is for a controlled substance or psychotherapeutic drug, which does require authorization from the prescriber. This provision is intended to apply to patients who may be suicidal. 21 NCAC 46 .1802 PRESCRIPTION REFILLS (a) Authorization for prescription refills is presumed to be within the prescribed dosage or normal therapeutic use. Refilling prescriptions more frequently than the prescribed dosage would require, or refilling prescriptions in significant excess of normal therapeutic use, may be considered as negligence under G.S. 90-85.38(a)(9). (b) If deemed appropriate in the pharmacist's professional judgment, a patient may receive upon request drug quantities in excess of the face amount of a prescription for a non-controlled substance, up to the total amount authorized. The pharmacist shall not dispense in excess of the face amount of a prescription for a controlled substance or psychotherapeutic drug without authorization from the prescriber.

Q: Can prescriptions be transmitted by fax in North Carolina?

A: Board rule .1813 deals with faxing prescriptions and does allow that practice. A review of that section is useful for any specific questions. This rule is limited by federal rules which provide that, generally, prescriptions for Schedule II drugs cannot be faxed. -Exceptions to this can be found in the July, 1997 issue of the Board's Newsletter on page 2 which does allow the transmission by fax of prescriptions for Hospice patients, pharmacies serving long term care facilities and those filling or compounding Schedule II narcotic drugs for home infusion.

Q: What is the Board's position on pharmacies performing "rapid diagnostic" and other "CLIA-waived" tests?

A: Board staff have received numerous questions about pharmacies' ability to perform "rapid diagnostic" and other "CLIA-waived" tests. Some point-of-care tests for things like streptococcus infection, blood glucose levels, and cholesterol levels are approved by the FDA as so-called "CLIA-waived" tests. CLIA refers to the Clinical Laboratory Improvement Amendments Act, a federal statute that, as the name suggests, governs clinical laboratories. When FDA approves an in vitro diagnostic device, it may designate the device as approved "for home use or that, as determined by the Secretary, are simple laboratory examinations and procedures that have an insignificant risk of an erroneous result, including those that . . . employ methodologies that are so simple and accurate as to render the likelihood of erroneous results by the user negligible, or . . . the Secretary has determined pose no unreasonable risk of harm to the patient if performed incorrectly." 42 USC § 263a(d)(3). If so deemed by the FDA, these tests may be performed in a laboratory that has applied for a waiver of CLIA requirements. Id. § 263(a)(d)(2). CLIA-waived tests don't require, as a condition of FDA approval, any sort of "prescription" or medical order. Unlike some states, North Carolina law does not impose a separate layer of regulations on top of CLIA. If a facility - including a pharmacy - meets the criteria to perform CLIA-waived tests, and obtains from the federal Centers for Medicare and Medicaid Services a CLIA waiver, then that facility may perform any CLIA-waived tests. More information about the CLIA waiver process may be found here: https://www2.ncdhhs.gov/DHSR/ahc/clia/cliafaq.html Staff is of the opinion that there is nothing in the law that would prevent a pharmacy that applies for, and obtains, a CLIA waiver from performing CLIA-waived tests. Of course, a pharmacy performing a CLIA-waived test cannot allow its pharmacists to use the results of a CLIA-waived test to prescribe drug therapy independently, or to do anything with the test results besides provide them to the patient and/or communicate them to the patient's provider of choice. (The exception would be a CPP whose agreement with the supervising physician authorizes the CPP to act on test results.)

Q: What are the degrees of seriousness for recalls and seizures?

A: Class I - A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious, adverse health consequences or death. Class II - A situation in which the use of, or exposure to a violative product may cause temporary or medically reversible, adverse health consequences or where the probability of serious adverse health consequences is remote. Class III - A situation in which the use of, or exposure to a violative product is not likely to cause adverse health consequences.

Q: Is it permissible to compound domperidone?

A: Domperidone compounding is permissible only as part of an investigational new drug application (IND). Domperidone is not a drug approved for human use in the United States. Accordingly, any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and North Carolina law.

Q: The Board office regularly receives questions on the formula for Duke's Magic Mouthwash. What is the formula?

A: Duke's Magic Mouthwash Formula: 1. Nystatin Suspension, 100,000 u/ml, 30 mL. or Nysatin Powder 3 Million Units 2. Hydrocortisone 60 mg. 3. Diphenhydramine HCL Syrupq.s. ad. 240 ml.

1) Q: What certifications are recognized by the NC Board of Pharmacy for technicians? 2) Q: How does a new pharmacy technician register with the Board? 3) Q: Who is responsible for registering Pharmacy Technicians?

A: Effective February 12, 2020, certified pharmacy technician applicants may establish eligibility with NHA's ExCPT certification. Applicants may also continue to establish eligibility with PTCB certification. When completing the on-line technician registration application, applicants will be asked to specify which certification they hold. Further instructions are found within the application itself. 2) A: New technicians must register online here. Technicians must register with the Board within 30 days of beginning employment in the pharmacy. 3) A: Each pharmacist-manager is responsible for technicians at the permit location.

Q: Can pharmaceutical manufacturers donate prescription drug samples to free or charitable clinics?

A: FDA published the following text in the March 14, 2006 edition of the Federal Register on this topic: FDA is announcing the availability of a guidance for industry entitled "Prescription Drug Marketing Act - Donation of Prescription Drug Samples to Free Clinics." The guidance provides information for free clinics that receive donated prescription drug samples from licensed practitioners or other charitable institutions. The guidance discusses concerns that have been expressed by certain individuals regarding regulatory requirements for drug sample donations. The guidance announces that FDA, after reviewing an independent study report analyzing the potential effects of the regulations on free clinics, has decided to propose revisions to those regulations. In the interim, FDA intends to exercise its enforcement discretion and does not intend to object if a free clinic fails to comply with certain regulatory requirements for drug sample donations.

76. Which of the following is required for the renewal of permits and registrations in a pharmacy? (Select all that apply) A. Pharmacies must notify the NC BOP whether they compound on the renewal application B. Pharmacies must renew annually with the DEA to sell pseudoephedrine products C. A community pharmacy fills out Form 224a to renew their DEA registration D. Pharmacies must cease dispensing prescriptions if permits are not renewed by March 1 n

ABC -Why D is not correct: § Subject to MAX reinstatement and renewal fees § After March 31, the pharmacy will be closed and must re-apply for a NEW permit

Q: May a pharmacy that services a nursing home install an automated dispensing device (e.g., Pyxis) to dispense controlled substances at the nursing home?

A: In May 2005, the DEA promulgated a rule that allows, where state law permits, a retail pharmacy to install an automated dispensing system at a long term care facility. These systems allow dispensing of single dosage controlled-substance units, and can mitigate the problem of excess controlled-substance stocks and disposal. Under Board rules, an automated dispensing device may only be installed at a facility holding a pharmacy permit. It is the consensus of the Board that limited service permits may be obtained for the installation of automated dispensing systems in long term care facilities. The DEA rule, found at 21 C.F.R. § 1301.17(c) and § 1301.27, provides that, upon receiving authorization from appropriate state authorities, a pharmacy may apply for an additional DEA registration to operate the automated dispensing system at a long term care facility. Pharmacists who serve long term care facilities are encouraged to investigate the use of automated dispensing systems. The potential public health and safety benefits are significant.

Q: For how long may I provide partial fills of a Schedule II controlled substance prescription?

A: In general, under CARA, the total amount of a Schedule II controlled substance prescription may be filled no later than 30 days from the date the prescription was written. -DEA rules have long allowed a Schedule II controlled substance prescription for a patient in a Long Term Care Facility, or a patient with a documented terminal illness diagnosis, to be dispensed by partial fills for up to 60 days from the date of the prescription. There is nothing in CARA's language that indicates an intent to change this long-standing rule. -If a pharmacist receives a verbal Schedule II controlled substance prescription pursuant to an emergency, the pharmacist may provide a partial fill, but must provide the remainder of the prescription amount within 72 hours. After 72 hours, no further dispensing on the emergency prescription is allowed. All other requirements regarding the need to receive a hard copy (or valid electronic) prescription within seven days remain.

Q: Under what circumstances may a physician prescribe Methadone, Suboxone®, or Subutex®?

A: Methadone may be used for the treatment of pain, and any pharmacy may dispense methadone for such an indication. This would include using methadone as part of a formal pain management program in which a patient is switched from other licit drugs to methadone to control or gradually reduce dosage. -Methadone may only be used to maintain narcotic addiction or to detoxify a patient when the prescriber is registered by Drug Enforcement Administration (DEA) as a narcotic treatment facility (NTF). In such cases, the drug may only be administered by the NTF. -The Drug Addiction Treatment Act of 2000 expanded the clinical context of medication assisted opioid treatment by allowing qualified physicians to dispense or prescribe specifically approved schedule III, IV, and V medications in settings other than an NTP. At the present time, Suboxone® (buprenorphine/naloxone) and Subutex® (buprenorphine) are the only two CIII, IV, or V medications that have been approved by Food and Drug Administration for opioid addiction. To prescribe this medication for maintenance therapy, a qualified physician must receive training and a registration number. Pharmacists receiving a prescription for Suboxone® or another approved narcotic to treat opioid addiction should verify that the prescriber has been granted a waiver. The following can be used to verify that the prescriber is approved to prescribe Suboxone® or Subutex® for opioid addiction: 1) Check the prescriber's Drug Enforcement Administration (DEA) number; physicians granted a waiver under DATA 2000 are issued a special DEA number that always begins with "X"; as of July 2005, physicians are required to include this special DEA number on all prescriptions for Suboxone® or Subutex®; 2) Check the Substance Abuse and Mental Health Services Administration (SAMHSA) physician locator at: http://www.samhsa.gov/; 3) Call SAMHSA at 1-866/287-2728 (physicians can elect not to be listed on the Web site); or 4) Call the prescriber and ask to have the DEA registration certificate faxed to you.

Q: What are the training requirements for pharmacy technicians?

A: N.C.G.S. § 90-85.15A(b) provides that it is the responsibility of the pharmacist manager to provide training for all technicians. The training is not limited to, but must contain training in at least the following areas: -Pharmacy terminology -Pharmacy Calculations -Dispensing systems and labeling requirements -Pharmacy laws and regulations -Record keeping and documentation -Proper handling and storage of medications This training must be completed within 180 days of the technician's beginning work at the free or charitable clinic.

Q: Are pharmacists required to report influenza vaccine administration to the North Carolina Immunization Registry?

A: No. NCGS 90-85.15B(d)(3) (part of the pharmacist vaccine administration statute passed in 2013) previously stated that "except for influenza vaccines administered under G.S. 90-85.15B(b)(6)", an immunizing pharmacists must "access the North Carolina Immunization Registry prior to administering the vaccine . . . and record any vaccine . . . administered to the patient in the registry within 72 hours after the administration." The clear intent of the statute, therefore, was that influenza vaccine administrations not be reported to the Registry. Confusion rose because the referenced paragraph - G.S. 90-85.15B(b)(6) - does not exist. Rather, influenza vaccine administration is discussed in G.S. 90-85.15B(c). The mismatched cross-reference has now been corrected by the General Assembly, and the statute is now clear that influenza vaccines administered under G.S. 90-85.15B(c) do not have to be reported to the Registry.

Q: May a pharmacy legally sell CBD "supplements"?

A: No. On December 20, 2018, FDA Commissioner Scott Gottlieb issued a statement explaining that while the Farm Bill of 2018 removed hemp from the federal Controlled Substances Act, "Congress explicitly preserved the [FDA's] authority to regulate products containing cannabis or cannabis-derived compounds under the FD&C Act." Hence, the FDA "treat[s] products containing cannabis or cannabis-derived compounds as [it does] any other FDA-regulated products." Importantly, FDA reminded the regulated community that it is "unlawful under the FD&C Act . . . to market CBD or THC products as, or in, dietary supplements, regardless or whether the substances are hemp derived. This is because both CBD and THC are active ingredients in FDA-approved drugs and were the subject of substantial clinical investigations before they were marketed as . . . dietary supplements." The full text of Commissioner Gottlieb's statement may be found here: http://www.ncbop.org/pdf/FDACannabisStatement122018.pdf.

Q: Is there a six month/five refill limit on Schedule V controlled substances?

A: No. Prescriptions for Schedule V drugs can be refilled as authorized.

Q: Must a prescription label state the drug's generic name?

A: Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is in the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone". Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke's Mouthwash" or "Compounded Cafergot".

Q: Does the phrase "Do you have any questions?" when directed at the patient satisfy the Board's requirement for offering to counsel patients under the patient counseling rule?

A: No. The Board rule requires that an offer be made in a positive way to encourage acceptance. The phrase "Do you have any questions?" is really a question, not an offer. Also, by merely asking if the patient has any questions does not go to the essence of the matter. Most customers do not know what questions to ask. Going through the patient counseling procedure, including prospective drug use review, also results in catching many errors before they reach the citizen. The members of the Board of Pharmacy have suggested the following potential alternatives to the phrase "Do you have any questions?" "Our pharmacist will talk to you about this if you'd like.""Counseling is available from our pharmacist on this prescription.""Our pharmacist is available to talk to you about your prescription.""Our pharmacist would like to talk to you about your medicines." Please note that if a purported "offer" to counsel does not adequately inform the patient of exactly what it is the patient has a right to, then a pharmacist will not likely have a meritorious argument that the patient "waived" any counseling right by signing a log book.

Q: May a pharmacy transfer prescription drugs to another pharmacy?

A: North Carolina Wholesale Prescription Drug Distributors Laws provide (N.C.G.S. 106-145.2(10)(e)): "The sale, purchase, or trade of a prescription drug or an offer to sell, purchase or trade a prescription drug for emergency medical reasons. Emergency medical reasons include transfers of prescription drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage when the gross dollar value of the transfer does not exceed 5% of the total prescription drug sales revenue of either the transferor or transferee pharmacy during a 12 consecutive month period." -Transfers between pharmacies that fall outside these guidelines would require a North Carolina wholesaler license. Note that the simple sale of excess stock to another pharmacy would be a wholesale activity. Pharmacists should also be aware that federal pedigree requirements could bear on transfers. And transfer of controlled substances between pharmacies requires compliance with all pertinent provisions of the federal Controlled Substances Act and associated regulations.

Q: How does North Carolina law regulate the sale of pseudoephedrine containing products?

A: North Carolina law requires all sellers of pseudoephedrine containing products to participate in a real-time electronic program for the purpose of tracking illegal pseudoephedrine purchases -- the National Precursor Log Exchange (NPLEx). -To avoid double record keeping, the North Carolina Mental Health Commission has deemed reporting into the NPLEX system as a "form approved by the commission," thus eliminating the requirement for keeping two logs and obtaining two signatures. By reporting in to the NPLEX system, NPLEX is essentially keeping your log for you and electronically storing it. Law enforcement may retrieve the information from NPLEX. If the system is down or you are for some reason unable to use it you are then required to keep the log and obtain the signature are previously required. -A pharmacy must still post a sign visible in 10 point bold face print near the place where the electronic signature is obtained that says the following: "North Carolina law strictly prohibits the purchase of more than 3.6 grams total of certain products containing pseudoephedrine per day, and more than 9 grams total of certain products containing pseudoephedrine within a 30-day period. This store will maintain a record of all sales of these products which may be accessible to law enforcement officers."

Q: My pharmacy engages in compounding. How should this be reported to the Board and what information should be provided?

A: Pharmacies that hold a permit from the North Carolina Board of Pharmacy and that engage in any type of compounding are required to notify the Board. Such pharmacies must report (both on an initial permit application and as part of each annual renewal): (1) whether they compound; (2) a good-faith estimate of the percentage of the pharmacy's dispensing that involves compounded products; (3) whether the pharmacy engages in non-sterile compounding; (4) whether the pharmacy engages in sterile compounding; and (5) what risk level of sterile compounding, as defined by USP <797>, the pharmacy performs. Accurate reporting of this information is crucial for at least two reasons: First, failure to provide accurate information in connection with seeking or renewing a permit is grounds to revoke or void a pharmacy permit. N.C.G.S. § 90-85.38. Second, the Board's risk-based inspection intervals are driven by the scope and type of service provided at a pharmacy, particularly compounding services.

Q: Should I compound Itraconazole?

A: Pharmacists should note the following important information regarding compounding of itraconazole products from the bulk chemical: Itraconazole bulk powder (brand name - Sporonox) is NOT bioavailable in mammalian species. All of the commercially available Itraconazole products (capsules, oral solution and injectable) are complexed onto a cyclodextran molecule to increase solubility and systemic bioavailability. Unless compounding pharmacists are also utilizing this cyclodextran technology, the Itraconazole products from bulk chemical are not being absorbed and are therapeutically worthless. Dr. Mark Papich, our clinical pharmacologist, has studied the bioavailability of Itraconazole (both FDA-approved and compounded from bulk) in animal patients, and the bulk chemical is simply not bioavailable. We have had MULTIPLE therapeutic failures (and some resulting deaths in dogs suffering from blastomycosis) in the veterinary community from Itraconazole capsules and suspension compounded from the bulk chemical. We had another therapeutic failure today that resulted from the compounding pharmacist offering to compound Itraconazole suspension because the commercially available products are "too expensive". As most of the systemic fungal infections that animals suffer from are life-threatening, we must do everything we can to educate compounding pharmacists to stop compounding with Itraconazole bulk chemical.

Q: Can pharmacists accept prescription drugs donated by a nursing home?

A: Pursuant to Board policy issued in June 2003, permit holders may dispose of unwanted prescription drugs that are not controlled substances by transferring products in unit dose or bingo cards, not to be resold, to other permit holders which are "free" or charitable clinics in a voluntary written agreement which allows for record keeping and other expenses.Pharmacists accepting such donations must remain aware that they are responsible for ensuring that such drugs are not adulterated or misbranded.

(11) Which of the following prescriptions is inappropriate or illegitimate? (Select all that apply) A. A physician writing a prescription for eszopiclone for himself B. An oxycodone prescription written to maintain an addiction C. A dentist writing a prescription for a 90 day-supply of methylphenidate D. A nurse practitioner issuing a prescription for metformin to treat their spouse's diabetes

ABCD

Q: Must a prescription label state the drug's generic name?

A: Rule .1818 provides that prescription labels shall contain the generic name of the drug even if the brand name is in the container. The purpose of this rule is to make it possible for hospital personnel to easily identify products from the labels on prescription containers that may arrive with the patient in the emergency department. For example, a prescription for Cordarone could be labeled as "Cordarone (Amiodarone)" if the brand name was dispensed. If the generic was dispensed the label would only need to contain the word "Amiodarone". -Compounded products should contain a list of active ingredients. Exceptions could be made for standard items such as "Duke's Mouthwash" or "Compounded Cafergot".

Q: May employers or other groups set up "drop-off/pick-up" locations that are not in a pharmacy? (For example, one inquiry the Board received was from an employer who wanted to set up a station at the work site to which a pharmacy would deliver all prescriptions for employees who would then pick up the prescriptions there.)

A: Such "drop-off/pick-up" sites do not comply with the North Carolina Pharmacy Practice Act. Under that statute, a pharmacy is "any place where prescription drugs are dispensed or compounded" and any such place must be permitted by the Board of Pharmacy. Final dispensing to patients at a non-permitted site as contemplated in these inquiries would not comply with North Carolina law.

Q: I would like to present an issue to the Board of Pharmacy. How can I do that?

A: The Board encourages members of the public, the pharmacy profession, or other interested parties to bring issues of concern or for consideration to the Board's attention. Anyone wishing to appear on a Board agenda should contact the Board's executive director by electronic mail ([email protected]), fax (919-246-1056), or U.S. mail (6015 Farrington Road, Suite 201, Chapel Hill, NC 27517) with a written request. The request should specify the topic to be presented, include any materials that the requestor wishes the Board to review, specifically state the action (if any) requested of the Board, and be received at the Board office no later than two weeks prior to the meeting at which the requestor wishes to speak. The Executive Director will communicate whether the request has been added to an agenda and, if so, on what date and time. Reasonable efforts will be made to accommodate the requestor's preferred meeting date, but requestors are strongly encouraged to identify one or two alternate meeting dates.

Q: Does North Carolina have a "Conscience Clause" for dispensing emergency contraceptives?

A: The Board has adopted a policy on pharmacists' refusal to dispense prescriptions in certain circumstances: -A pharmacist should function by serving the individual, community and societal needs while respecting the autonomy and dignity of each patient. The best practice by a pharmacist is to promote the good for every patient in a caring, compassionate and confidential manner. Pharmacists should discuss and resolve any questions about emergency contraception prior to employment. Compassionate care and conscientious objection are not mutually exclusive. -A pharmacist has the right to avoid being complicit in behavior that is inconsistent with his or her morals or ethics. It is unacceptable, however, for pharmacists to impose their moral or ethical beliefs on the patients they serve. Pharmacists who object to providing a medication for a patient on this basis alone, therefore, should take proactive measures so as not to obstruct a patient's right to obtain such medication. -The Board notes that although pharmacists have a right to avoid moral or ethical conflict, they do not have a right to obstruct otherwise legitimate prescription dispensing or delivery solely on the basis of conscientious objection. -Board of Pharmacy staff interprets this policy to mean that if a pharmacist refuses to fill a prescription for emergency contraception then that pharmacist has an obligation to get the patient and the prescription to a pharmacist who will dispense that prescription in a timely manner.

Q: Is it ok to use tap water to reconstitute antibiotic granules ?

A: The Board has from time to time received inquiries about what type of water should be used to reconstitute antibiotic formulations. The Board believes that the best practice is to use purified or distilled water. Many areas in North Carolina are still served by well water, which could contain various pollutants or contaminants. Accordingly, reconstitution with purified or distilled water should minimize any possible risk to patients receiving antibiotic therapy.

Q: What is the Board's policy on Internet-based pharmacy operations and what should pharmacists do if solicited?

A: The Board is aware that some Internet-based operations are actively soliciting pharmacists - particularly independent pharmacists - to act as a dispensing clearinghouse for Internet-based prescriptions. Internet-based prescriptions generated without a physical examination or a prior prescriber-patient relationship - e.g., Internet consultations, with or without "medical records"; telephone consultations after placing Internet order - are not valid, and filling them violates state law. Filling such prescriptions for controlled substances also violates federal law. Below are cease and desist letters issued by the Board to illegal Internet operations that the Board has discovered to be soliciting North Carolina pharmacies. Any pharmacist who is contacted by any of the below, or any other suspicious operation, is strongly encouraged to contact the Board. Top Rx Partners - Moss Point, MS MyPharma1.net - Liverpool, NY PBM Network, LLC - Miami, FL Precedent Management Systems, LLC - Orlando, FL Trading Data Inc. - Miami, FL Easy Consults - Buffalo Grove, IL Secure Telemedicines, LLC - Tampa, FL

Q: Can pharmacists accept donations of prescription drugs from individuals?

A: The Board of Pharmacy is presently considering a rulemaking effort to codify standards for possible prescription drug donations from individuals. However, no current rule or statute allows such donations. And pharmacists need to be aware that it is frequently impossible to determine whether drugs offered for donation are adulterated. Consistent with advice given to other permittees, the Board strongly recommends that such donations not be accepted unless and until the Board implements a governing rule.

Q: Can I fill Schedule II prescriptions bearing a "do not fill until" date?

A: Yes, within limits established by DEA: (1) An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a Schedule II controlled substance provided the following conditions are met: (ii) The individual practitioner provides written instructions on each prescription (other than the first prescription, if the prescribing practitioner intends for that prescription to be filled immediately) indicating the earliest date on which a pharmacy may fill each prescription;

Q: What federal law product tracing requirements apply to pharmacies?

A: The Drug Supply Chain Security Act (DSCSA) requires dispensers, which primarily include pharmacies, to comply with new requirements related to product tracing beginning July 1, 2015. Today FDA issued the DSCSA Implementation: Product Tracing Requirements for Dispensers-Compliance Policy Guidance. This document announces that FDA does not intend to take enforcement action against dispensers who, prior to November 1, 2015: 1. accept ownership of certain human, finished prescription drugs without receiving the transaction information, transaction history, and a transaction statement (product tracing information) prior to or at the time of a transaction, as required by section 582(d)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act); or 2. do not capture and maintain the product tracing information, as required by section 582(d)(1)(A)(iii) of the FD&C Act. Under the DSCSA, a dispenser cannot accept ownership of certain human, finished prescription drugs unless the previous trading partner provides specific information (product tracing information) about those drugs. Additionally, dispensers must provide, capture and maintain the product tracing information associated with such drugs for all qualifying transactions they engage in. However, FDA recognizes that some dispensers may need more time beyond the July 1st deadline to work with trading partners, to ensure they can properly receive, capture and maintain the product-tracing information required by law. FDA posted a supporting webinar, "DSCSA Updates and Readiness Check: DSCSA Requirements for Dispensers and other Trading Partners," and plans to host a series of stakeholder calls in the coming weeks. Please check http://www.fda.gov/Drugs/DrugSafety/DrugIntegrityandSupplyChainSecurity/DrugSupplyChainSecurityAct/default.htm to find the latest activities on the DSCSA.

Q: What biological products has the FDA determined to be interchangeable biosimilars?

A: The FDA maintains the "Purple Book," which lists biological products, including any biosimilar and interchangeable biological products licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product (an already-licensed FDA biological product). Biosimilar and interchangeable biological products licensed under section 351(k) of the PHS Act will be listed under the reference product to which biosimilarity or interchangeability was demonstrated. The Purple Book may be accessed here: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm411418.htm

Q: How should a pharmacy dispose of drugs, both non-controlled medications & controlled substances?

A: The NCBOP Drug Disposal Form can be found by logging into the facility portal. The Drug Disposal Form Tab is located at the bottom of the facility page. -1. Complete the form making sure a current e-mail address is listed. The form can be saved to be completed later; a confirmation number will be provided to access the form again. Once the form is submitted, you will not be able to access the form to make changes. Community/retail pharmacies are to use this form for controlled or non-controlled medications; however, when listing controlled substances, a separate form(s) must be used. DO NOT COMBINE controlled and non-controlled medications. -Hospitals, clinics and nursing homes (see #3) may use this form for non-controlled medications only. Duplicate/multiple forms are permitted. These forms shall be retained by the pharmacy for a period of three (3) years. 2. Once the form is submitted and reviewed by staff, an e-mail will be sent to notify the permit that approval for drug disposal has been given. The e-mail should be retained in the pharmacy for (3) years. 3. Contact the NC Department of Health & Human Services, Drug Control Unit at (919) 733-1765 for disposal or destruction of controlled substance medications in: - Hospitals- Nursing homes that are skilled facilities with a ten (10) bed limit. Note: this does not include assisted living facilities. - Clinics include: EMS, Veterinary clinics, Methadone clinics, outpatient surgery clinics, weight loss clinics and physician practices with more than one (1) practitioner using common stock of controlled substance medications.

Q: Are there any exemptions to Controlled Substance Reporting System requirements regarding distribution of controlled substance samples?

A: The North Carolina Controlled Substance Reporting System statute provides an express exemption for Schedule V non-narcotic, non-anorectic controlled substance samples: "A dispenser shall not be required to report instances in which a Schedule V non-narcotic, non-anorectic Schedule V controlled substance is provided directly to the ultimate user for the purpose of assessing a therapeutic response when prescribed according to indications approved by the United States Food and Drug Administration." -NOTE: Pharmacies are, of course, prohibited by federal law from dispensing prescription drug samples of any sort. This reporting exemption, then, only applies in practical terms to physicians or other health care providers who are permitted by federal law to provide samples to patients.

Q: Does either the state or federal pseudoephedrine statute apply to hospital pharmacies?

A: The North Carolina statute imposes limitations on the "retail sale" of pseudoephedrine products and upon "retailers." The Act defines a retailer as "an entity that is the general owner of an establishment where pseudoephedrine products are available for sale." Likewise, the federal statute regulates the sale of pseudoephedrine products "at retail," which is defined as "a sale or purchase for personal use." Since it is unlikely that a hospital would be considered a "retailer" because hospitals are not normally engaged in the practice of retail sales of medication, the statutes should rarely, if ever, apply to hospital pharmacies.

Q: Are volunteer pharmacy technicians required to register with the Board?

A: Yes. Amendments to Board Rule .3301, which speaks to pharmacy technician registration, went into effect on July 1, 2015. Among other things, amended Rule .3301 clarifies that pharmacy technicians who provide services solely at a free clinic (as defined at G.S. 90-85.44) are required to register as technicians, but are exempt from the registration fee. Accordingly, technicians practicing solely at free clinics should complete the online registration application (directions below.) The registration fee will be waived upon verification of the free clinic site.

Q: I have begun seeing DEA numbers that begin with the letter "F." Are these numbers valid?

A: Yes. Due to the large Type A (Practitioner) registration population, the initial alpha letter "B" has been exhausted. DEA will begin using the new alpha letter "F" as the initial character for all new registration for Type A (Practitioner) registrations.

Q: May I keep track of pseudoephedrine sales in my C-V controlled substances log?

A: The North Carolina statute requires that retailers record "the name and address of every purchaser," "each pseudoephedrine product purchased, including the number of grams the product contains," and the "date of the transaction." This recording is to be "on a form approved by the Commission." The form "shall be constructed so that it allows for entry of information in electronic format, including electronic signature" and "so as to minimize the disclosure of personal information to unauthorized persons." Each page of the form must contain a 10-point boldface warning prescribed by the statute. To the Board's knowledge, the N.C. Department of Health & Human Services has not approved any particular form. The Board suggests contacting H&HS for clarification: Drug Control Unit, NC Department of Health & Human ServicesPhone: (919) 733-1765 The federal statute requirements for a log book are similar, though the federal statute specifies that the "date and time" of the transaction must be recorded. The federal statute also requires a page-top warning, though, unlike the state statute, this warning must state that purchasers "entering false statements or misrepresentations in the logbook may [be] subject to criminal penalties under section 1001 of title 18, United State Code, which notice specifies the maximum fine and term of imprisonment under such section." The federal statute provides that the Attorney General shall develop criteria for written or electronic logbooks. No such criteria have been promulgated.

Q: How much pseudoephedrine can I sell a customer?

A: The North Carolina statute was amended in 2006, and limits a single over-the-counter transaction to no more than two packages containing a combined total of less than 3.6 grams of pseudoephedrine. No person may purchase more than three packages containing a total of more than 9 grams of pseudoephedrine within 30 days. With the amendment, the North Carolina statute conforms with the federal statute, which likewise limits the daily OTC purchase amount to no more than 3.6 grams of pseudoephedrine base, regardless of the number of transactions. The federal statute also limits the 30-day total to nine grams of pseudoephedrine.

Q: What is the proper procedure for providing heparin, saline, sterile water for irrigation and hydration fluids to home health agencies?

A: The agency may store sterile normal saline for irrigation and sterile water for irrigation at the clinical offices. A physician's order for one of the above for a specific patient serves as a prescription. If sterile normal saline for irrigation or sterile water for irrigation are ordered, it is not necessary for a pharmacist to dispense them. However, if the solution is left in a patient's home, it must be labeled according to pharmacy regulations.

Q: What is the appropriate Beyond Use Date (BUD) for Magic Mouthwash?

A: The appropriate USP <795> BUD for Magic Mouthwash depends on whether it is compounded and dispensed as an oral formulation or as a mucosal formulation. Oral Formulation. USP <795> requires that water-containing oral formulations be assigned a BUD that is no longer than 14 days under refrigerated storage conditions. The directions for an oral formulation of Magic Mouthwash would be "swish and swallow" or similar. Mucosal Liquid Formulation. USP <795> requires that water-containing topical, dermal, and mucosal liquid and semisolid formulations be assigned a BUD that is no longer than 30 days under room temperature storage. The directions for a mucosal liquid formulation of Magic Mouthwash would be "swish and spit" or similar. If a pharmacy compounds one batch of Magic Mouthwash to fulfil all Magic Mouthwash prescriptions - whether the directions are "swish and spit" mucosal formulation or "swish and swallow" oral formulations - the assigned BUD must be the stricter one: no longer than 14 days under refrigerated storage. USP <795> does allow for longer BUD for Magic Mouthwash if the pharmacy has independent stability testing information.

Q: How must controlled substances maintained in a practitioner's office (as opposed to a pharmacy) for dispensing or administration be stored?

A: The federal Controlled Substances Act and regulations provide that all controlled substances maintained in a practitioner's office (as opposed to a pharmacy) for dispensing or administration should be stored in a locked cabinet or other secure storage container with limited access by the office staff.

Q: Do I need a pharmacy permit to distribute prescription drug samples?

A: The federal Prescription Drug Marketing Act ("PDMA") prohibits a pharmacy from receiving or dispensing sample medications. A free or charitable clinic, however, may provide samples of prescription drugs to patients so long as the samples are obtained in conformance with the PDMA and are provided to the patient under the direct supervision of the physician charged by the PDMA with responsibility for appropriate receipt and disbursement of prescription drug samples. -A pharmacy permit is not required if prescription drug samples are the only prescription drugs being provided to patients. The key question is whether the prescription drugs provided to patients are truly "samples." For instance, full course of therapy or month-long prepackaged medications received from manufactures or other organizations are almost certainly not samples, and a pharmacy permit would be required for dispensing. It is the responsibility of the pharmacist manager to ensure that any prescription drugs provided to patients - even if received prepackaged - meet all federal and state labeling requirements.

Q: What is the procedure in North Carolina for physicians when ordering Schedule II, III, and IV controlled substances for office use?

A: The physician needs to complete a Schedule II Order form (DEA 222; see http://www.deadiversion.usdoj.gov/drugreg/change_requests/order_form.htm) for a drug in Schedule II and send it to the supplier which can be a pharmacy. The supplier keeps one copy and send the other copy to DEA. Note the instructions in the margin of the form. Orders for drugs in Schedule III or IV can occur on an invoice and the supplier (pharmacy) keeps these invoices with other CS records noting that these are outgoing items.

Q: Does the FDA require pharmacists to provide patients with a toll-free number to report adverse drug effects?

A: Yes. Effective January 1, 2008, pharmacists are required to distribute with all prescriptions information alerting patients that they may call a toll-free telephone number to report adverse drug effects to the FDA. The final rule provides a number of ways by which this requirement can be accomplished

(12) In order to be considered a valid prescription, which of the following must be true? (Select all that apply) A. The medication must be in the prescriber's scope of practice B. The prescriber must be registered (or exempt from registering) with the DEA to prescribe controlled substances C. There must be an appropriate patient-prescriber relationship D. The prescription must contain all required elements according to federal and state law

ABCD

Q: What is a Clinical Pharmacist Practitioner and how can I qualify for that designation?

A: Through the efforts of the North Carolina Association of Pharmacists a change of statute occurred in both the Medical Practice Act and the Pharmacy Practice Act. This provides for designating certain pharmacists as Clinical Pharmacist Practitioners who collaborate with a supervising physician to provide optimum health care and use the extensive knowledge of pharmaceuticals by pharmacists. -There are three ways in which a person can be qualified as a Clinical Pharmacist Practitioner. A person could hold a Board of Pharmaceutical Specialty Certification or complete an ASHP Residency and have two years of clinical experience. Another route is for individuals who have a Doctor of Pharmacy Degree with three years of clinical experience plus a certificate program. Pharmacists with B.S. degrees need five years of clinical experience and two certificate programs as defined in 21 NCAC 46.3101(2)(b). -A collaborative practice agreement is necessary with a physician as noted in .3101(6). An initial non-refundable fee of $100 is payable to the NC Board of Pharmacy (by credit card only) with a $50 renewal fee. A total of 35 hours of continuing education is necessary to renew as a Clinical Pharmacist Practitioner (see FAQ above). -Clinical Pharmacist Practitioners are in essentially the same position as a physician assistant or nurse practitioner. Medical acts which can be performed include prescribing and Clinical Pharmacist Practitioners who have controlled substances in their protocol can obtain a DEA registration.

Q: What are the CE requirements for Pharmacists?

A: To renew every year, all Pharmacists are required to have, at minimum, a total of fifteen (15) hours and five (5) of those hours are required LIVE. The remainder of the hours may be Live or Correspondence.

Q: Is adding flavoring to a conventionally manufactured product considered compounding?

A: USP considers adding flavoring to a conventionally manufactured product to fall within the scope of compounding, because there are known instances when flavoring components have destabilized a product. If a pharmacy adds flavoring to a manufactured product it must take into account the manufacturer's Beyond Use Date (BUD) and the effect on stability caused by adding flavoring. If a flavoring component is added to a manufactured product that does not contain a preservative (e.g.: reconstitution of amoxicillin oral suspension) the BUD is 14 days refrigerated or shorter if indicated in the manufacturer's labeling. If a flavoring component is added to a manufactured product that contains a preservative (e.g. pyridostigmine oral solution), then the BUD is 35 days in controlled room temperature or refrigerated or shorter if indicated in the manufacturer's labeling. The addition of flavoring including the flavor manufacturer or product, lot number, and expiration date must be documented in the patient record notes for the prescription.

Q: What grounds are listed in the Board rule on refusing to fill or refill a prescription?

A: Under Rule .1801(a), pharmacists may refuse to fill or refill prescriptions if they believe it would be harmful to the patient, or if there's a question as to its validity or they believe it is not in the patient's best interest.

Q: May a technician, certified technician, or pharmacy student transfer or receive transfers of prescriptions for controlled substances?

A: Under federal law, an original prescription for a C-III, C-IV, or C-V substance may be transferred for refill on a one-time basis. If pharmacies electronically share a "real-time, on-line database," then those sharing pharmacies "may transfer up to the maximum refills permitted by law and the prescriber's authorization." -Federal law, however, requires that any transfer of a C-III, C-IV, or C-V prescription be "communicated directly between two licensed pharmacists Thus, under federal law, neither technicians, nor certified technicians, nor pharmacy students may transfer or receive transfers of prescriptions for controlled substances.

Q: What should pharmacists do in cases where Medication Guides are not being provided by the manufacturer as required by the Federal Food, Drug, and Cosmetic (FD&C) Act?

A: Under the Federal Food, Drug, and Cosmetic (FD&C) Act, Food and Drug Administration (FDA) requires that Medication Guides be dispensed with products the agency deems a serious and significant public health concern. Medication Guides provide consumers with information about the risks and benefits of these drugs and are necessary for patients to use these products safely and effectively. -In addition to reporting to FDA, the agency advises pharmacies to contact the manufacturers directly to discuss problems associated with the availability of Medication Guides.

Q: What pseudoephedrine products are subject to the statute?

A: Under the North Carolina statute, "[a]ny pseudoephedrine product in the form of a tablet or caplet containing pseudoephedrine as the sole active ingredient or in combination with other active ingredients shall be stored and sold behind a pharmacy counter." Pseudoephedrine products "in the form of a liquid, liquid capsule, gel capsule or pediatric product" are not subject to regulation under the North Carolina statute. North Carolina amended its statute to make clear that "such products shall be subject to the requirements of the Combat Methamphetamine Act of 2005." --> link to this document is on the FAQ website see http://www.ncbop.org/PDF/DEA_Guidance_Combat_Meth.pdf

Q: May a prescribing practitioner prescribe other medications on a prescription that already includes a Schedule II medication?

A: Yes, a practitioner may prescribe other medications on the same prescription blank along with Schedule II medications.

Frequently Asked Questions for Pharmacists on DEA Form 222 - Power of Attorney Q: Can there be multiple Powers of Attorney at one location?

A: Yes, as long as the requirements of 21 CFR 1305.07 are met. That rule recognizes powers of attorney and specifies the form. The power of attorney must be signed by the person who signed the most recent application for registration or re-registration and by the person receiving the authority. The rule allows multiple powers of attorney.

Q: Can prescriptions be transferred more than once in North Carolina?

A: Yes, provided that refill authorizations still exist and there are restrictions on controlled substances. Prescriptions for non-controlled drugs can be transferred from one store to another indefinitely providing that refill authorizations do exist. Federal rules (1306.25(a)) permit multiple transfers of controlled substances, provided that authorization exists, only for those pharmacies that share a real time on-line electronic database. Other pharmacies are limited to one transfer only under federal rules.

53. A manufacturer's container for a prescription drug must include which of the following on the label? (Select all that apply) A. Address of manufacturer B. Quantity C. Lot number D. Directions for patient use

ABC

Q: Can a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen?

A: Yes. If a pharmacist receives a prescription for a combination product containing a schedule II drug and acetaminophen that appears to have a missing, incorrect, or unavailable acetaminophen dosage, the pharmacist may add or change the amount of acetaminophen written on the prescription after speaking directly with the prescriber and documenting the clarification on the prescription. Examples: (a) A prescriber writes for "Vicodin 5/325." As pharmacists know, Vicodin is now formulated as hydrocodone 5mg /acetaminophen 300 mg. The pharmacist may call the prescriber to clarify which product was intended - e.g., Vicodin 5/300 or another hydrocodone 5 mg/acetaminophen product containing 325 mg of acetaminophen per dosage unit (see (b) below). The pharmacist must document on the prescription the changes made after consultation with the prescriber. (b) A prescriber writes for "Vicodin 5/325," but the prescriber intended to write for Norco (hydrocodone 5 mg /acetaminophen 325 mg). The pharmacist may change the brand name to match the correct combination product intended. The pharmacist must document the clarification after consultation with the prescriber.

Q: I received a prescription for an epinephrine auto-injector for a [camp, college, park, restaurant, etc.]. May I dispense that prescription even though it is not written for a specific patient?

A: Yes. N.C.G.S. 90-21.15A (found here: https://www4.ncleg.net/enactedlegislation/statutes/html/bysection/chapter_90/gs_90-21.15a.html) allows a prescriber to prescribe an epinephrine auto-injector to an "authorized entity" (defined as "any entity or organization . . . at which allergens capable of causing anaphylaxis may be present, including, but not limited to, recreation camps, colleges, universities, day care facilities, youth sports leagues, amusement parks, restaurants, places of employment, and sports arenas"). Pharmacists may dispense such prescriptions "issued in the name of an authorized entity."

Q: Do I need a pharmacy permit to operate a free or charitable clinic?

A: Yes. North Carolina law defines a pharmacy as "any place where prescription drugs are dispensed or compounded." N.C.G.S. § 90-85.3(q). There is no exception to the permitting requirement for clinics that operate on a free or charitable basis. -The Board often permits free or charitable clinics under a "limited service permit." The principal advantage to obtaining a limited service permit is that the pharmacist-manager of a limited service permit is not prohibited from acting as pharmacist manager of a separate, full-service permit. This avoids the need for having to hire a pharmacist solely to operate the free or charitable clinic. There can be other reasons for issuing a limited service permit.

Q: Does the Board enforce patient counseling requirements?

A: Yes. Shoppers have visited many communities already and will visit more in the future. In the event that a pharmacy is observed not offering to counsel patients, one or two follow-up shopping visits occur by Board inspectors. If it is confirmed that offers to counsel are not made and counseling does not occur on a regular basis then the matter will be brought to a pre-hearing conference for a proposed disciplinary action. If the Board member finds that offers to counsel are not being made and patient counseling is not occurring on repeated prescription fillings, then a normal penalty would be a three day active suspension of the pharmacist's license to practice and a one day suspension of the permit to operate the pharmacy where the event occurred. In this way members believe that the public can be better served by promoting compliance with the rule.

Q: Can EMS crews acquire controlled substances to store and administer?

A: Yes. The PPAEMA, signed into federal law on November 17, 2017, substantially clarified the means by which EMS crews can obtain, store, and administer controlled substances.

Q: May I dispense partial fills of a Schedule II controlled substance prescription?

A: Yes. Under the Comprehensive Addiction and Recovery Act of 2016 ("CARA"), a pharmacy may provide a partial fill of a Schedule II controlled substance prescription if: (1) state law does not prohibit partial fills of Schedule II prescriptions (North Carolina law does not prohibit partial fills of this sort); (2) the prescription is written and filled in compliance with federal and state law; (3) the partial fill is requested by the patient or the prescriber; and (4) the total quantity dispensed in all partial fills does not exceed the total quantity prescribed.

37. Which of the following statements correctly describes the requirements of prospective drug use review? (Select all that apply) A. Pharmacists must screen for drug interactions B. Pharmacists must maintain a patient profile C. Pharmacists must counsel patients on every prescription D. Pharmacists must include only prescription medications in the patient's profile

AB

44. Which of the following situations is/are permissible for "Outsourcing Facilities" to perform? (Select all that apply) A. Dispensing a compound based on a patient specific prescription (if they have a pharmacy permit) B. Selling a compound for a physician to administer in his office C. Regularly compound a medication that is the same as a commercially available product D. Compounding a medication that the FDA removed from the market

AB

77. Which of the following describes a correct statement for community/retail pharmacies in NC? (Select all that apply) A. All pharmacies must maintain a reference library B. The hours a pharmacist is on duty must be displayed C. All pharmacist's licenses must be conspicuously posted D. A pharmacy must be closed immediately if a pharmacist is on break

AB

(15) Which of the following statements must be correct in order for a Telemedicine prescription to be legitimate? (Select all that apply) A. There must be an appropriate patient-prescriber relationship B. The medication must be for a legitimate medical purpose C. The Telemedicine technology must be able to complete an adequate assessment of the patient D. Telemedicine encounters are appropriate to prescribe controlled substances for pain

ABC

29. Which of the following must a pharmacist determine when verifying a prescription? (Select all that apply) A. There is an appropriate patient-prescriber relationship B. The medication is for a legitimate medical purpose C. The medication was prescribed in the usual course of professional practice D. If the medication interacts with another medication the patient is taking

ABCD

63. If a health care facility pharmacy is not open 24 hours a day, 7 days a week, how might a nurse be able to retrieve a medication for an emergency? (Select all that apply) A. Remove the medication from an emergency kit B. Remove the medication from an Auxiliary Medication Inventory C. Remove the medication from the pharmacy herself D. Contact the on-call pharmacist to return to the pharmacy

ABCD

70. Which of the following disciplinary actions may the NC BOP do to a licensee? {Select all that apply) A. Issue a letter of reprimand B. Issue an active suspension C. Restrict the amount of hours worked D. Pay a monetary fine E. Suspend a license before a hearing occurs

ABCE

55.Which of the following people may be granted access to a patient's pharmacy record? (Select all that apply) A. An emancipated minor requesting their own record B. A parent requesting their 14 year old son's record C. A spouse requesting their spouse's record D. A prescribing practitioner requesting their patient's record

ABD

66. Which of the following correctly describes a requirement of quality assurance programs? (Select all that apply) A. All pharmacies must establish a Quality Assurance program B. A person's testimony at a QA program is confidential and not public record C. All information presented at a QA meeting is immune from discovery in a civil lawsuit D. The NC BOP may request information about dispensing errors made by a pharmacist

ABD

67. Which of the following statements correctly describes the peer review process? (Select all that apply) A. All confidential information in a peer review program is not subject to discovery in a civil case B. The peer review program may send information to the NC BOP about a pharmacist in treatment C. Pharmacists participating in a peer review program cannot have their licenses reinstated D. The peer review program will advocate or oppose the pharmacy personnel's return to practice

ABD

42. Which of the following is permissible for a 503A pharmacy to compound? (Select all that apply) A. Compounds the pharmacy anticipates dispensing based on trends (but has not yet received a prescription) B. An exact copy of an FDA-approved drug product on a regular basis C. A sterile medication for a specific patient as prescribed by a physician D. A medication withdrawn from the market due to being not effective

AC

72. Which of the following statements correctly describes a requirement for a pharmacy located outside of NC? (Select all that apply) A. An out-of-state remote medication order processing pharmacy must register for a pharmacy permit B. Pharmacists at a mail-order pharmacy in Virginia must be licensed by the NC BOP C. The NC BOP may inspect out-of-state pharmacies who have a NC pharmacy permit D. Out-of-state mail-order pharmacies must follow the pharmacy laws and regulations of NC

AC **They don't have to follow NC laws??**

(5) Which of the following describes a requirement for pharmacies in regards to the acquisition and distribution of pharmaceutical products? (Select all that apply) A. Pharmacies must be able to identify illegitimate products B. Transaction records must be kept for 3 years c. Manufacturers or wholesalers must include product tracing information for each drug package D. Product tracing information and transaction information may be stored electronically

ACD

21. Which of the following is needed in order for a pharmacist to maintain their status as an Immunizing Pharmacist? (Select all that apply) A. Renewing their CPR certification before it expires B. Passing a vaccine certification course every 5 years C. Complying with OSHA requirements at the pharmacy D. Completion of 3 hours of CE on vaccine topics every 2 years

ACD

31. Which of the following examples might lead the pharmacist to consider a patient is misusing a prescription drug?(Select all that apply) A. Request for early refill B. Patient requests the prescription is billed to insurance C. Multiple prescribers appear in the patient's profile D.Appears overly sedated or intoxicated

ACD

56. Which of these requirements would a community pharmacy who does not compound Hazardous Drugs have to follow in order to be compliant with USP <800>? (Select all that apply) A. Maintain a list of their Hazardous Drugs B. Antineoplastic drugs must be kept in a negative-pressure room C. Must establish a 'Hazard Communication Program' D. Decontaminate counting tray after counting Hazardous Drugs E. Hazardous Drugs may be placed in an automated packaging machine

ACD

51. What is the status of syringe sales in North Carolina? (Select all that apply) A. Available to patients for purchase over-the-counter B. Patients must have a prescription from a practitioner C. Pharmacist must determine the medical use of the syringes D. Patients may participate in syringe exchange programs in the state

AD

22. A pharmacist administering immunizations must adhere to which of the following requirements? (Select all that apply) A. Adverse events of vaccine administration are reported to the patient's primary care provider B. Uploads all vaccines administered into the North Carolina Immunization Registry C. Notifies the patient's primary care physician of all vaccines administered except for influenza vaccines D. Administers vaccines pursuant to a written protocol with a physician

AD -B is wrong because flu vaccines do not have to be reported

48. Which of the following statements describes a requirement for patient counseling? (Select all that apply) A. A pharmacy intern may counsel the patient B. All patients must receive counseling on new prescriptions C. Pharmacies must document patients who received counseling D. An offer to counsel shall be made for transferred prescriptions

AD -I am assuming B is wrong because it can be waived -I think you only have to document if they waive the right to counsel

Hospital and Healthcare Facility Pharmacy HCF that credential practitioners for prescribing privileges within the facility must provide the pharmacy with credentialing info ________________

ANNUALLY or IMMEDIATELY if privileges are revoked

How are generic drugs approved?

Abbreviated NDA (ANDA) or 505(b)(2) application -Abbreviated because to does NOT require the pre-clinical and clinical studies the NDA requires -For ANDA, generic drug company must provide study data to establish that the generic drug has the SAME (1) Active ingredient (2) ROUTE (3) Dosage Form (4) Strength as branded drug --> must bee "bioequivalent" (hav the same rate and extent of bioavailability at the site of action in the body) -505(b)(2) application allows manufacturer to submit PREVIOUSLY PUBLISHED reports of safety and effectiveness and unlike a generic approved by an ANDA, the drug can be marketed in different strengths or formulations than the previously approved product

The registration of a pharmacy technician shall be renewed annually and shall expire on: A. December 31 B. March 31 C. September 30 D. June 30

Answer: (a) December 31, [21 NCAC 46 .3301(a)].Following initial registration with the Board, registration of a pharmacy technician shall be renewed annually and shall expire on December 31. It shall be unlawful to work as a pharmacy technician more than 60 days after expiration of the registration without renewing the registration. A registration expired more than 60 days shall be reinstated.

After dispensing an oral emergency Schedule II drug, the pharmacist shall contact which of the following upon not receiving a written prescription from the prescriber within 7 days? I. The DEA Office II. The North Carolina State Pharmacy Board III. The patient A. I only B. I and II only C. I and III only D. All

Answer: (a) I only, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRev1117.pdf (Page 2) and CFR 1306.11(d)(4)].The pharmacist must notify the nearest office of the Administration (DEA) if the prescribing individual practitioner fails to deliver a written prescription to him; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense without a written prescription of a prescribing individual practitioner.

Which of the following is/are NOT TRUE about dispensing Schedule V OTC controlled drugs? I. The purchaser should be at least 21 years of age. II. Dispensing should be done by a registered pharmacist. III. A record of dispensing must be entered in a Schedule V bound book. A. I only B. I and II only C. II and III only D. All

Answer: (a) I is not true, [North Carolina Controlled Substances Act and Regulations 90-93 (b) to (d) and 21CFR1306.26 (a)-to-(e)].The dispensing of Schedule V OTC controlled substances should be done only by registered pharmacist and no other person, agent or employee may sell a Schedule V substance even if under the direct supervision of a pharmacist.The purchaser should be at least 18 years of age. A record of dispensing must be entered in a Schedule V bound book.1. No more than 240 cc or 48 dosage units of any controlled substance that contains opium, and no more than 120 cc or 24 dosage units of any other controlled substance, may be dispensed at retail to the same purchaser in any given 48-hour period. The pharmacist must maintain a bound record book with following information:2. The name and address of purchaser3. The name and quantity of controlled substance4. The date of the purchase5. The initial of the dispensing pharmacist

Which of the following drugs are NOT AUTHORIZED to be dispensed by registered nurses in local health department clinics? I. Nifedipine II. Isoniazid III. Rid shampoo A. I only B. I and II only C. II and III only D. All

Answer: (a) I only, [21 NCAC 46 .2403].Prescription drugs and devices included in the following general categories may be dispensed by registered nurses in local health department clinics when prescribed for the indicated conditions:(1). Anti-tuberculosis drugs, as defined by the latest edition of Drug Facts and Comparisons, as published by Facts and Comparison Div., J.B. Lippincott Co., or as recommended by the Tuberculosis Control Branch of the North Carolina Division of Health Services, when used for the treatment and control of tuberculosis;(2). Anti-infective agents used in the control of sexually-transmitted diseases as recommended by the United States Centers for Disease Control;(3). Natural or synthetic hormones and contraceptive devices when used for the prevention of pregnancy;(4). Topical preparations for the treatment of lice, scabies, impetigo, diaper rash, vaginitis, and related skin conditions; and(5). Vitamin and mineral supplements.(6). Opioid antagonists prescribed pursuant to G.S. 90-106.2; and(7). Epinephrine auto-injectors prescribed pursuant to G.S. 115C-375.2A

When does durable medical equipment (DME) permit expire? A. March 1 B. November 30 C. January 1 D. April 30

Answer: (a) March 1, [North Carolina Pharmacy Board NewsLetter April 2018].Pharmacy or durable medical equipment (DME) permit expires on March 1. From March 1 through March 31, pharmacy and DME permits can be renewed with a late penalty.

Mr. Shroff is a registered pharmacist. He is working for an institutional pharmacy. He receives a fax for compounding Morphine Sulfate with TPN. Mr. Shroff will: A. Fill the prescription. B. Not fill the prescription and ask for the original prescription. C. Hold the prescription for a physician's authorization.

Answer: (a) Mr. Shroff will fill the prescription, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRev1117.pdf and CFR 1306.11 (e) to (g)].Prescriptions for Schedule II narcotic substances to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the prescribing practitioner or his agent to a pharmacy by facsimile.The prescription transmitted via facsimile will be accepted as the original prescription for purposes of this section.

A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented. A. True B. False

Answer: (a) True, [21 NCAC 46 .2504(g)].A pharmacist shall not be required to counsel a patient or care giver when the patient or care giver refuses such consultation and such refusal is documented. Records, including documentation of refusals to receive counseling, shall be maintained for three years.

A prescription for a CII may be transmitted by the practitioner or his authorized agent via facsimile provided that the original written prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance. A. True B. False

Answer: (a) True, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRevFeb2013.pdf and CFR 1306.11(a)].A prescription for a CII may be transmitted by the practitioner or his authorized agent via facsimile provided that the original written prescription is presented to the pharmacist for review prior to the actual dispensing of the controlled substance.

The death of the prescriber does not void valid prescriptions or refills ordered prior to the death. A. True B. False

Answer: (a) True, [http://www.ncbop.org/faqs/Pharmacist/faq_DeceasedPrescribers.htm].If the prescription still has refills remaining at the time of the prescriber's death, the pharmacist may continue to dispense those refills as ordered. The death of the prescriber does not void valid prescriptions or refills ordered prior to the death.If the prescription has no refills remaining, Board Rule .1815 authorizes a pharmacist to provide a one-time emergency refill for up to a 90-day supply when the prescriber is "unable to provide medical services." A prescriber's death qualifies.

In North Carolina, a permit holder or registrant requesting a change from the prescription drug originally prescribed to a different prescription drug shall disclose to the prescriber at the time of the request any business relationship between the permit holder or registrant and the manufacturer of the requested prescription drug. A. True B. False

Answer: (a) True, [21 NCAC 46 .1812].A permit holder or registrant requesting a change from the prescription drug originally prescribed to a different prescription drug shall disclose to the prescriber at the time of the request any business relationship between the permit holder or registrant and the manufacturer of the requested prescription drug.

The prescribing practitioner may authorize his agent to transmit by FAX or by electronic transmission a prescription drug order to a pharmacist or certified technician in a pharmacy provided that the identity of the transmitting agent is included in the order. A. True B. False

Answer: (a) True, [21 NCAC 46 .1813(c)].The prescribing practitioner may authorize his agent to transmit by FAX or by electronic transmission a prescription drug order to a pharmacist or certified technician in a pharmacy provided that the identity of the transmitting agent is included in the order.

Prior to release the drug from an automated dispensing device for access by the nurse in health care facility pharmacy, the pharmacist must perform the Prospective DUR for a patient. A. True B. False

Answer: (a) True, [21 NCAC 46 .1814].(a). Automated dispensing or drug supply devices may be used in health care facility pharmacies and where a pharmacy permit exists for a patient profile dispensing system, provided the utilization of the devices is under the supervision of a pharmacist. The pharmacist-manager shall develop and implement procedures to assure safe and effective use of medications and shall assure that:(1). only authorized personnel, as indicated by written policies and procedures, may obtain access to the drug inventories;(2). a system of accountability exists for all drugs contained therein and the purity, potency, and integrity of the drugs is preserved;(3). requirements for controlled substances security are met; and(4). prior to the drug being released for access by the nurse, the pharmacist enters the medication order into a computerized pharmacy profile that is interfaced to the automated dispensing unit, so that drug allergy screening, therapeutic duplication, and appropriate dose verification is done prior to the drug being administered.

In order to be a pharmacist-manager of premises, the pharmacist must be present for at least one-half the hours the pharmacy is open or 32 hours a week, whichever is less. A. True B. False

Answer: (a) True, [21 NCAC 46 .2502(b)].The pharmacist-manager employed or otherwise engaged to supply pharmaceutical services may have a flexible schedule of attendance but shall be present for at least one-half the hours the pharmacy is open or 32 hours a week, whichever is less.A pharmacist employee not meeting this requirement may serve as pharmacist-manager of the permit holder temporarily for a period not to exceed 90 days from the departure date of the previous pharmacist-manager, if the pharmacist employee is present at least 20 hours per week in the pharmacy.

For a community pharmacy setting, a person shall not serve as pharmacist-manager at more than one pharmacy at any one time. A. True B. False

Answer: (a) True, [21 NCAC 46 .2502(g)].

According to North Carolina State Pharmacy Law, the nurse practitioner may dispense all drugs that the nurse practitioner is authorized by law to prescribe. A. True B. False

Answer: (a) True, [21 NCAC 46.1703].According to North Carolina State Pharmacy Law, the nurse practitioner may dispense any and all drugs that the nurse practitioner is authorized by law to prescribe.Similarly, the physician assistant may dispense any and all drugs that the physician assistant is authorized by law to prescribe. All drugs dispensed by a nurse practitioner or physician assistant must be dispensed from a place holding a current pharmacy permit from the Board as required by the law.The consulting pharmacist shall be available for consultation in person, by telephone, or other means of direct communication at all times when drugs are dispensed.All drugs dispensed by the nurse practitioner or physician assistant shall be prepackaged in safety closure containers and shall be appropriately prelabeled (including necessary auxiliary labels) by the pharmacist with all information required by law except the name of the patient and the directions for use.The name of the patient and directions for use of the drugs shall be placed on the label by the nurse practitioner or physician assistant at the time it is delivered to the patient or his agent

All starter doses of medication supplied to doctors' offices from the pharmacy shall be limited to a 24-hour dose supply per patient. A. True B. False

Answer: (a) True, [21 NCAC 46.2502(o)].The pharmacist-manager shall ensure that all starter doses of medication supplied to doctors' offices from the pharmacy are accompanied by written materials advising the patient that such doses of medication may be supplied by any pharmacy. Starter doses shall be limited to a 24-hour dose supply per patient.

Supportive personnel approved by the pharmacist-manager may be present in the health care facility pharmacy at other than regular service hours to perform clerical, repackaging and distributive functions without the direct supervision of pharmacist. A. True B. False

Answer: (a) True, [North Carolina Pharmacy Practice Act 21 NCAC 46 .1413(c)].Supportive personnel approved by the pharmacist-manager may be present in the health care facility pharmacy at other than regular service hours to perform clerical, repackaging and distributive functions according to written policies and procedures if the drugs so handled are not permitted to leave the health care facility pharmacy until all work performed has been checked and certified as being correct by the pharmacist.

A pharmacy utilizing an automated medication system may distribute patient-specific drugs within the health care facility without verifying each individual drug selected or packaged by the system, if the initial medication order has been reviewed and approved by a pharmacist. A. True B. False

Answer: (a) True, [North Carolina Pharmacy Practice Act 21 NCAC 46 .3402(f)].A pharmacy utilizing an automated medication system may distribute patient-specific drugs within the health care facility without verifying each individual drug selected or packaged by the system, if:(1). The initial medication order has been reviewed and approved by a pharmacist; and(2). The drug is distributed for subsequent administration by a health care professional permitted by North Carolina law to administer drugs.

A person who receives an opioid antagonist that was prescribed for his/her own use may administer an opioid antagonist to another person if the person has a good faith belief that the other person is experiencing a drug-related overdose. A. True B. False

Answer: (a) True, [Pharmacy Laws of North Carolina 90-12.7].(b)(1). A practitioner acting in good faith and exercising reasonable care may directly or by standing order prescribe an opioid antagonist to(i). a person at risk of experiencing an opiate-related overdose or(ii). a family member, friend, or other person in a position to assist a person at risk of experiencing an opiate-related overdose.A pharmacist may dispense an opioid antagonist to a person described in subdivision (b)(1) of this section pursuant to a prescription issued pursuant to subsection (b) of this section.A person who receives an opioid antagonist that was prescribed for his/her own use may administer an opioid antagonist to another person if the person has a good faith belief that the other person is experiencing a drug-related overdose and the person exercises reasonable care in administering the drug to the other person.

The pharmacist in charge of a pharmacy shall report within 10 days to the Board any disaster, accident, theft, or emergency which may affect the strength, purity, or labeling of drugs and devices in the pharmacy. A. True B. False

Answer: (a) True, [Pharmacy Laws of North Carolina 90-85.25].The pharmacist in charge of a pharmacy shall report within 10 days to the Board any disaster, accident, theft, or emergency which may affect the strength, purity, or labeling of drugs and devices in the pharmacy.

A pharmacist may charge an eligible patient a handling fee to receive a donated drug, supplies, or medical device, which shall not exceed the amount specified by the Board. A. True B. False

Answer: (a) True, [Pharmacy Laws of North Carolina 90-85.44(d)].A pharmacist may accept and dispense drugs, supplies, and medical devices donated to the Program to eligible patients if all of the following requirements are met:(1). The drug, supplies, or medical device is in the original, unopened, sealed, and tamper-evident packaging or, if packaged in single-unit doses, the single-unit dose packaging is unopened.(2). The pharmacist has determined that the drug, supplies, or medical device is safe for redistribution.(3). The drug bears an expiration date that is later than six months after the date that the drug was donated.(4). The drug, supplies, or medical device is not adulterated or misbranded, as determined by a pharmacist.(5). The drug, supplies, or medical device is prescribed by a practitioner for use by an eligible patient and is dispensed by a pharmacist.(d). Fee. - A participating pharmacist or free clinic shall not resell a drug, supplies, or a medical device donated to the Program. A pharmacist or free clinic may charge an eligible patient a handling fee to receive a donated drug, supplies, or medical device, which shall not exceed the amount specified in rules adopted by the Board.

e compounding of Cisplatin shall be performed under: A. Vertical laminar flow. B. Horizontal laminar flow.

Answer: (a) Vertical laminar flow.(1). All anti-neoplastic drugs shall be compounded in a vertical flow, Class II, biological safety cabinet, or similar preparation area.(2). Protective apparel shall be worn by personnel compounding anti-neoplastic drugs.(3). Prepared doses of anti-neoplastic drugs must be dispensed, labeled with precautions inside and outside, and shipped in a manner to minimize the risk of accidental rupture of the primary container.

A pharmacist receives a new prescription for Celexa 20 mg, manufactured by Forest Laboratories, Inc. Which of the following shall be required on the dispensing label? A. Celexa 20 mg (Forest Labs) B. Celexa (Citalopram) 20 mg C. Citalopram 20 mg D. Citalopram 20 mg (Forest Labs)

Answer: (b) Celexa (Citalopram) 20 mg, [21 NCAC 46 .1818].Prescription labels shall list at a minimum the generic name of the drug, even if the generic drug is unavailable to dispense or even if the substitution of a generic drug is not authorized.**Please also see Question No 7 from Section 1.

Can a pharmacist change or add the correct amount of acetaminophen to a prescription for a combination product containing a schedule II drug and acetaminophen? A. Yes B. No

Answer: (a) Yes, [http://www.ncbop.org/faqs/Pharmacist/faq_CombinationProducts.html].Yes. If a pharmacist receives a prescription for a combination product containing a schedule II drug and acetaminophen that appears to have a missing, incorrect, or unavailable acetaminophen dosage, the pharmacist may add or change the amount of acetaminophen written on the prescription after speaking directly with the prescriber and documenting the clarification on the prescription.Examples:(a). A prescriber writes for "Vicodin 5/325." As pharmacists know, Vicodin is now formulated as hydrocodone 5mg /acetaminophen 300 mg. The pharmacist may call the prescriber to clarify which product was intended - e.g., Vicodin 5/300 or another hydrocodone 5 mg/acetaminophen product containing 325 mg of acetaminophen per dosage unit (see (b) below). The pharmacist must document on the prescription the changes made after consultation with the prescriber.(b). A prescriber writes for "Vicodin 5/325," but the prescriber intended to write for Norco (hydrocodone 5 mg /acetaminophen 325 mg). The pharmacist may change the brand name to match the correct combination product intended. The pharmacist must document the clarification after consultation with the prescriber.

May a prescribing practitioner prescribe Codeine and Erythromycin on the same prescription blank? A. Yes B. No

Answer: (a) Yes, [http://www.ncbop.org/faqs/Pharmacist/faq_ControlledSubstances.htm].Yes, a practitioner may prescribe other medications on the same prescription blank along with Schedule II medications.

If a patient lacks an unexpired identification that meets the statutory requirement, may someone else obtain the prescription? A. Yes B. No

Answer: (a) Yes, [http://www.ncbop.org/faqs/PhotoIDFAQ.pdf, Question 5].The statute specifies that "[n]othing . . . shall be deemed to require that the person seeking the dispensation and the person to whom the prescription is issued be the same person." If a patient lacking the requisite identification is able to convince a friend or family member to present their identification, that person may receive the prescription on behalf of the patient. The identification of the person receiving the prescription must be documented.

An Emergency department of health care facilities having 24 hour outpatient pharmacy service shall consist of drugs of the nature and type to meet the immediate needs of emergency department patients, and quantities in each container shall be limited to not more than:' A. a 24 hour supply. B. a 48 hour supply. C. a 72 hour supply. D. a week supply.

Answer: (a) a 24-hour supply, [21 NCAC 46 .1415(b)(3)].1. In those health care facilities having 24-hour outpatient pharmacy service, all drugs dispensed to outpatients including emergency department patients must be dispensed by a pharmacist.2. When drugs are not otherwise available from a pharmacist, drugs may be dispensed for use outside the emergency department by the physician, registered nurse under physician supervision, or a person authorized to prescribe and dispense drugs subject to the following:(1). Drugs shall be dispensed only to a registered patient of the emergency department;(2). The pharmacist-manager shall develop and supervise a system of control and accountability of all drugs administered in, or dispensed from the emergency department;(3). The pharmacist-manager, in conjunction with the committee responsible for policy in the emergency department, shall develop an emergency department formulary which may be dispensed from the emergency department for patients receiving care in that department.This formulary shall consist of drugs of the nature and type to meet the immediate needs of emergency department patients, and quantities in each container shall be limited to not more than a 24 hour supply or the smallest commercially-available quantity.

A health care provider may prescribe epinephrine auto-injectors in the name of an authorized entity for use, and pharmacists and health care providers may dispense epinephrine auto-injectors pursuant to a prescription issued in the name of an authorized entity. A prescription issued pursuant to this section shall be valid for no more than __________. A. 1 year B. 2 years C. 3 years D. 4 years

Answer: (b) 2 years, [North Carolina Pharmacy Practice Act 90-21.15A(b)].A health care provider may prescribe epinephrine auto-injectors in the name of an authorized entity for use, and pharmacists and health care providers may dispense epinephrine auto-injectors pursuant to a prescription issued in the name of an authorized entity. A prescription issued pursuant to this section shall be valid for no more than 2 years.

All licenses and registrations issued to individuals that are not renewed by December 1 of the succeeding year, lapse and are subject to the maximum reinstatement and renewal fees in order to be reinstated. A. True B. False

Answer: (b) False [21 NCAC 46 .1612].(a). All licenses and registrations issued to individuals that are not renewed by March 1 of the succeeding year, lapse and are subject to the maximum reinstatement and renewal fees in order to be reinstated.(b). All permits and registrations issued to locations that are reinstated after March 1 and prior to April 1 of the succeeding year are subject to the maximum reinstatement and renewal fees.(c). After March 31, permits and registrations issued to locations shall submit new applications and are subject to the maximum original registration fees. This Rule also applies to licenses, registrations, and permits reinstated following voluntary surrender or disciplinary action by the Board.(d). All applicants shall submit to the Board a signed release form, completed Fingerprint Record Card, and such other form(s) required to perform a criminal history check at the time of application.(e). The Board shall require applicants for reinstatement of a lapsed license who have not practiced pharmacy within two years prior to application for reinstatement to obtain continuing education, practical pharmacy experience, successfully complete one or more parts of the Board's licensure examination, or a combination of the foregoing, as the Board deems necessary to ensure that the applicant can safely and properly practice pharmacy.

A pharmacy dispensing and delivering devices and medical equipment must hold a device and medical equipment permit. A. True B. False

Answer: (b) False, [21 NCAC 46 .2601(b),(c)]. -Basically, if you have a current pharmacy permit you do not need either a device or medical equipment permit

The supervising physician of the CPP shall supervise no more than one pharmacist at any given time. A. True B. False

Answer: (b) False, [21 NCAC 46 .3101(g)].The supervising physician of the CPP shall:(1). be fully licensed, engaged in clinical practice and in good standing with the Medical Board;(2). not be serving in a postgraduate medical training program;(3). supervise no more than THREE (not one) pharmacists.

In those health care facilities having 24-hour outpatient pharmacy services, all drugs dispensed to outpatients, including emergency department patients during AFTER HOURS, must be dispensed by a registered nurse or any authorized person appointed by the healthcare facility. A. True B. False

Answer: (b) False, [21 NCAC 46.1415(a)].In those health care facilities having 24-hour outpatient pharmacy services, a pharmacist must dispense all drugs dispensed to outpatients, including emergency department patients.

A pharmacist shall notify the field division office of DEA in writing, of the theft or significant loss of any controlled substances within 72 hours of discovery of such loss or theft. A. True B. False

Answer: (b) False, [http://www.ncbop.org/faqs/Pharmacist/faq_ControlledSubstances.htm and 21CFR-1301.76].A DEA registrant shall notify the field division office of DEA in writing, of the theft or significant loss of any controlled substances within ONE BUSINESS DAY of discovery of such loss or theft.Registrants are also required to complete a DEA 106 regarding the loss or theft. When determining whether a loss if significant, a registrant should consider the factors listed in 1301.76 (b).A Drug Disaster and Loss Report should also be completed and filed with the NC Board of Pharmacy office within 10 days of the drug loss/theft.

Whenever a change of ownership or change of pharmacist-manager occurs, the successor pharmacist-manager shall complete an inventory of all controlled substances in the pharmacy within 30 days. A written record of such inventory, signed and dated by the successor pharmacist-manager, shall be maintained in the pharmacy with other controlled substances records for a period of three years. A. True B. False

Answer: (b) False, [21 NCAC 46.2502(c) and CFR 1304.11(3)]. · Whenever a change of ownership or change of pharmacist-manager occurs, the successor pharmacist-manager shall complete an inventory of all controlled substances in the pharmacy within TEN (10) days. · A written record of such inventory, signed and dated by the successor pharmacist-manager, shall be maintained in the pharmacy with other controlled substances records for a period of three years.

A retailer shall maintain a record of disposition of pseudoephedrine products to the consumer for a period of six months from the date of each transaction. A. True B. False

Answer: (b) False, [Methamphetamine Lab Prevention Act of 2005, 90-113.52(d)].A retailer shall maintain a record of disposition of pseudoephedrine products to the consumer for a period of TWO YEARS (NOT six months) from the date of each transaction.A record shall be readily available within 48 hours of the time of the transaction for inspection by an authorized official of a federal, State, or local law enforcement agency.The retailer may destroy the information after two years from the date of the transactions.

The North Carolina Medical Board's rules governing physician assistants (PAs) and nurse practitioners (NPs) state that prescriptions issued by these practitioners must contain the name of the practitioner's supervising physician (PAs and NPs) and the phone number of the supervising physician (PA only). A prescription shall be considered illegal if it is devoid of supervising practitioner's name, and pharmacist should NOT fill it. A. True B. False

Answer: (b) False, [North Carolina Pharmacy April 2020 News Letter]. -See number 51

An identification card is required prior to dispensing a Schedule II or covered Schedule III controlled substance to a hospice patient receiving hospice care at his/her home. A. True B. False

Answer: (b) False, [http://www.ncbop.org/faqs/PhotoIDFAQ.pdf, Question 12].The statute states that delivery of such prescription drugs to "employees" of a "health care facility" for "the benefit of residents or patients or such health care facilities" does not trigger the identification check requirement.The relevant statute defines "hospice" as "any coordinated program of home care with provision for inpatient care for terminally ill patients and their families. . . ."Accordingly, Board staff concludes that the identification check requirement does not apply to home-based hospice patients when delivery of the covered medication is made to an "employee" of the hospice care provider.However, when a non-employee caretaker of a home hospice patient (such as a family member) picks up a prescription for a covered drug. In this case, the statute does require checking the identification of the person picking up the prescription. The "health care facility" exception (which, as noted, includes hospice) is limited to delivery to "employees" of the health care facility.

Which of the following is/are TRUE about using the Centralized Processing system for prescription orders? I. The prescription container clearly shows the name and address of the pharmacy refilling the prescription. II. The prescription container clearly shows the name and address of the pharmacy which receives the refilled prescription for dispensing to the patient. III. The supplying pharmacy is responsible for recordkeeping and patient counseling. A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II are true, [21 NCAC 46 .1816].(a). A pharmacy permitted by the Board may process a request for the filling or refilling of a prescription order received by a pharmacy within this State, provided:(1). The pharmacy that is to fill or refill the prescription either has a contract with the pharmacy which received the prescription or has the same owner as the other pharmacy.(2). The prescription container:(A). is clearly labeled with all information required by Federal and State laws and regulations; and(B). clearly shows the name and address of the pharmacy refilling the prescription and the name and address of the pharmacy which receives the refilled prescription for dispensing to the patient.(3). The patient is provided with written information, either on the prescription label or with the prescription container, that describes which pharmacy to contact if the patient has any questions about the prescription or medication.(4). Both pharmacies maintain complete and accurate records of the prescription, including:(A). the name of the pharmacist who fill or refills the prescription;(B). the name of the pharmacy filling or refilling the prescription; and(C). the name of the pharmacy that received the fill or refill request.(5). The pharmacy that fills or refills the prescription and the pharmacy that receives the prescription for dispensing to the patient share a common electronic file.(6). The originating pharmacy (Not the supplying pharmacy) is responsible for compliance with the requirements of Federal and State laws and regulations regarding recordkeeping and patient counseling.(b). Nothing in this Rule shall be construed as barring a pharmacy from also filling new prescriptions presented by a patient or a patient's agent or transmitted to it by a prescriber.

Which of the following is/are TRUE about destroying or disposing outdated, adulterated or unwanted drugs OTHER THAN controlled substances by a permit holder? I. Such drugs may dispose or destroy by returning them to the manufacturer. II. Such drugs may dispose or destroy by incineration at a properly permitted facility. III. Destructions taking place at the permit holder's premises shall be witnessed by two licensed pharmacists and documented. A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II are true, [21 NCAC 46 .3001(b)].(a). All registrants shall develop and implement policies and procedures to insure that all outdated, improperly labeled, adulterated, damaged or unwanted drugs or drug containers with worn, illegible or missing labels are destroyed or disposed of so as to render them unusable.(b). Any permit holder in possession of outdated, adulterated or unwanted drugs other than controlled substances may dispose or destroy such drugs by returning them to the manufacturer, by incineration at a properly permitted facility, or by any other means approved by the Board which will assure protection against unauthorized possession or use.Destructions under this Paragraph taking place at the permit holder's premises shall be witnessed by a licensed pharmacist and documented.(c). Any permit holder in possession of any controlled substance and desiring or required to dispose of such substance may file a written request on a form provided by the Board for authority and instructions to dispose of such substance.If destruction under this Paragraph takes place at the permit holder's premises such destruction shall be jointly witnessed by at least two licensed pharmacists approved by the Board.All destructions of controlled substances shall be documented and the document shall be retained by the permit holder for a period of at least three years. Copies of the document shall be sent to the Drug Enforcement Administration.

To become a licensed pharmacist in North Carolina, an applicant shall pass which of the following examination(s)? I. a national examination II. a jurisprudence examination III. a practical examination which includes an error and omission section A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only, [21 NCAC 46 .1505].(a). The applicant shall pass the following examinations:(1). the North American Pharmacist Licensure Examination ("NAPLEX"); and(2). the North Carolina version of the Multistate Pharmacy Jurisprudence Examination ("MPJE").(b). In order to pass either the NAPLEX or the MPJE, the applicant shall achieve the passing score set by the National Association of Boards of Pharmacy (or any organization designated by the National Association of Boards of Pharmacy to administer the NAPLEX or the MPJE).(c). An applicant who achieves a passing score on one examination must achieve a passing score on the remaining examination within a two calendar year period starting from the date of the first passing score. Failure to achieve passing scores on both examinations in this two calendar year period shall result in the applicant's application for licensure being denied. The applicant may, subject to the testing attempt limitations of Paragraph (d) of this Rule, reapply for licensure and restart the examination process.(d). The applicant shall be afforded a total of five attempts to achieve a passing score on each examination. Failure to achieve a passing score on each examination within five attempts shall result in the applicant being ineligible for licensure.

Which of the following statements is/are TRUE regarding continuing education programs? I. As a condition of license renewal, a pharmacist shall accumulate 15 hours of continuing education annually. II. All records of hours and certificates of credit shall be preserved for at least three years. III. A pharmacist who accumulates more than the required 15 hours of continuing education in a single year may carry forward up to five surplus hours to be applied to the following year's continuing education requirements. A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only, [21 NCAC 46 .2201].VERSION EFFECTIVE ON JANUARY 1, 2018(a). As a condition of license renewal, a pharmacist shall accumulate 15 hours of continuing education annually.(b). Five of these continuing education hours shall be obtained through contact programs. Contact programs are those in which there is an opportunity for live two-way communication between the presenter and attendee. An on-line continuing education course may satisfy this contact-hour requirement provided that the continuing education course includes live two-way communication between the presenter and attendee.(c). A pharmacist shall preserve all continuing education records for three years. If a continuing education provider approved in Paragraph (e) of this Rule maintains an electronic database of all pharmacists granted continuing education credits accredited by the provider, then the storage of that information in the provider's database shall be deemed to satisfy the pharmacist's recordkeeping requirement.(d). Upon license renewal, the pharmacist shall report continuing education hours through the Board's online license renewal portal. The Board may require a pharmacist to submit records, reports of accredited hours and certificates of credit on a random basis pursuant to a continuing education audit.(e). All continuing education shall be obtained through continuing education courses accredited by the Accreditation Council for Pharmacy Education or the North Carolina Association of Pharmacists.Pharmacists may also acquire five hours continuing education credit for precepting, for at least 160 hours, a student enrolled in the University of North Carolina Eshelman School of Pharmacy, the Campbell University College of Pharmacy and Health Sciences, the Wingate University School of Pharmacy, or the High Point University Fred Wilson School of Pharmacy as part of these schools' academic program.

Pharmacists who want to administer vaccines shall: I. Hold a current provider level cardiopulmonary resuscitation (CPR) certification issued by the American Heart Association or the American Red Cross or equivalent. II. Successfully complete a certificate program in the administration of vaccines accredited by the Centers for Disease Control, the ACPE or a similar health authority or professional body approved by the Board. III. Fulfill six hours of continuing education every two years which are designed to maintain competency in the disease states, drugs and administration of vaccines. A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only, [NC Chapter 90 Section 90-85.3.(i1) Definition].Pharmacists who want to administer vaccines shall:(1). Holds a current provider level cardiopulmonary resuscitation certification issued by the American Heart Association or the American Red Cross, or an equivalent certification.(2). Has successfully completed a certificate program in vaccine administration accredited by the Centers for Disease Control and Prevention, the Accreditation Council for Pharmacy Education, or a similar health authority or professional body approved by the Board.(3). Maintains documentation of three hours of continuing education every two years, designed to maintain competency in the disease states, drugs, and vaccine administration.(4). Has successfully completed training approved by the Division of Public Health's Immunization Branch for participation in the North Carolina Immunization Registry.(5). Has notified the North Carolina Board of Pharmacy and the North Carolina Medical Board of immunizing pharmacist status.

A valid photo identification is required prior to dispensing: I. Morphine sulfate II. Vicodin III. Alprazolam A. I only B. I and II only C. II and III only D. All

Answer: (b) I and II only, [North Carolina General Assembly NCGS 90-106.1 and http://www.ncbop.org/faqs/PhotoIDFAQ.pdf].NCGS 90-106.1 imposes an identification prior to dispensing all Schedule II controlled substances and "Schedule III controlled substances listed in subdivisions 1 through 8 of G.S. 90-91(d)." Those subdivisions list the "combination" Schedule III controlled substances.

What changes may a pharmacist make to a prescription written for a controlled substance in schedule II after verbally consulting with a practitioner? I. The dosage form of the drug II. The strength of the prescribed drug III. The name of the controlled substance A. I only B. I and II only C. II and III only D. All.

Answer: (b) I and II only, [http://www.ncbop.org/faqs/Pharmacist/faq_ChangestoSchIICS.htm].After consulting with the prescribing practitioner (you must speak directly to the practitioner, not his/her agent), the pharmacist may modify or add the following:1. date of issue - may be added but not changed;2. patient's address;3. drug strength;4. drug dosage form;5. drug quantity - may be modified in conjunction with change in strength only, not to exceed the original total dosage prescribed; and6. directions for use.A pharmacist may never change the name of the drug (except to generic when appropriate), name of the patient, or the signature of the practitioner.

JD comes to a pharmacy and requests a transfer of a prescription for Alprazolam from another pharmacy. His patient profile shows that three eligible refills have been left on the prescription. If both pharmacies, transferring and receiving, share the same database electronically, how many times may the original prescription be transferred between pharmacies? A. One-time only B. Maximum three times C. As many times as needed until prescription expires D. Cannot be transferred

Answer: (b) Maximum three times, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRev1117.pdf and CFR 1306.25(a)].The one-time transfer of the original prescription information for a controlled substance listed in Schedules III, IV, or V, if any authorized refills remain, for the purpose of dispensing is permissible between pharmacies within six (6) months from the date the prescription was issued.However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization.If the prescription order is assigned a new prescription number at the receiving pharmacy, the prescription may be transferred on a one-time basis only. ***Why is it not C****

A patient brings a new prescription for Zoloft. The prescription reads: Zoloft 25 mg, take 1 tablet by mouth every day for 30 days x 5 refills. The patient requests to fill the whole prescription, for 180 tablets, in a single filling. Which of the following would be the most appropriate action by the pharmacist under North Carolina Pharmacy Law? A. Fill the requested amount. B. Obtain the authorization from the prescribing physician. C. Fill only 30-day supply. D. Tell the patient that law does not permit to fill the whole supply.

Answer: (b) Obtain the authorization from prescribing physician, [21 NCAC 46 .1802(b)].If deemed appropriate in the pharmacist's professional judgment, a patient may receive upon request drug quantities in excess of the face amount of a prescription for a non-controlled substance, up to the total amount authorized.The pharmacist shall NOT dispense in excess of the face amount of a prescription for a controlled substance or psychotherapeutic drug (e.g. Zoloft) without authorization from the prescriber.

All of the following are an acceptable form of valid photo identification cards EXCEPT: A. a valid passport B. identifications issued by the Mexican Consulate C. a military identification D. a driver's license

Answer: (b) identifications issued by the Mexican Consulate, [http://www.ncbop.org/faqs/PhotoIDFAQ.pdf, Question 3].The North Carolina statute states that only four types of identification are acceptable:a. a driver's license,b. a special identification card issued by the North Carolina Department of Motor Vehicles,c. a military identification, andd. a passport.Identifications issued by the Mexican Consulate are not a "driver's license," "passport," or "military identification" and thus do not satisfy the statutory requirement.The pharmacist personally may not be required to review the identification card.The statute places responsibility for reviewing and documenting proper identification on "the pharmacy." Accordingly, other pharmacy staff (e.g., technicians or cashiers) may review and document the identification.Both the pharmacy permit and pharmacist manager are, of course, responsible for ensuring that the statute's requirements are being met.

An impaired pharmacist recovery program in North Carolina is established under: A. J. Quincy Recovery Fund B. L. Stanley Haywood Recovery Fund C. M. Talat Recovery Fund D. G. Elizabeth Recovery Fund

Answer: (b),

Hard-copy printouts of the day's controlled substance prescription orders and refills shall be verified, dated, and signed by the pharmacist who filled these orders. This document must be maintained in the pharmacy for: A. 2 years from the dispensing date. B. a year from the dispensing date. C. 3 years from the dispensing date. D. 5 years from the dispensing date.

Answer: (c) 3 years from the dispensing date, [http://www.ncbop.org/about/Student%20Projects/CSpocketcardRev1117.pdf and CFR 1306.22(3)].Hard-copy printouts of the day's controlled substance prescription orders and refills shall be verified, dated, and signed by the pharmacist who filled these orders. This document must be maintained in the pharmacy for 3 years from the dispensing date.

Which of the following statements is/are NOT TRUE about Automated Data Processing Systems? I. The system shall have the capability of producing sight-readable documents of all original and refilled prescription information. II. When the inoperative automated data processing system is restored to operation, the information regarding prescriptions filled, refilled or transferred during the inoperative period shall be entered into the automated data processing system within the time equal to the number of inoperative days times three. III. The printout with daily prescription information must be provided to the pharmacy within 24 hours of date of dispensing. A. I only B. I and II only C. III only D. All

Answer: (c) III only, [21 NCAC 46 .2304].An automated data processing system may be employed as a record-keeping system if the following conditions are met:(1). The system shall have the capability of producing sight-readable documents of all original and refilled prescription information. The term "sight-readable" means that a regulatory agent shall be able to examine the record and read the information.In the case of administrative proceedings before the Board, records must be provided in a readable paper printout form.(2). The individual pharmacist responsible for completeness and accuracy of the entries to the system must provide documentation of the fact that prescription information entered into the computer is correct.(3). Documentation in Paragraph (2) of this rule must be provided in the pharmacy within 72 hours (Not 24 hours) of date of dispensing.(4). An auxiliary record-keeping system shall be established for the documentation of refills if the automated data processing system is inoperative for any reason.When the automated data processing system is restored to operation, the information regarding prescriptions filled, refilled or transferred during the inoperative period shall be entered into the automated data processing system within the time equal to the number of inoperative days times three; for example, if the system were inoperative for five days then all interim data shall be entered within 15 days of the last inoperative day.The auxiliary record-keeping system shall be backed up at least weekly.

A pharmacist has substituted generic Metoprolol (Mfg: Mylan) for the prescribed brand name Lopressor (Mfg: Pfizer). Which of the following shall be placed on dispensing label? A. Metoprolol, (Mylan) B. Metoprolol, Lopressor (Mylan) C. Metoprolol D. Lopressor (Pfizer), Metoprolol

Answer: (c) Metoprolol, [Pharmacy Laws of North Carolina 90-85.29 and 90-85.30].The prescription label of every drug product dispensed shall contain the brand name of any drug product dispensed, or in the absence of a brand name, the established name. The prescription drug label of every drug product dispensed shall:(1). Contain the discard date when dispensed in a container other than the manufacturer's original container. The discard date shall be the earlier of one year from the date dispensed or the manufacturer's expiration date, whichever is earlier, and(2). Not obscure the expiration date and storage statement when the product is dispensed in the manufacturer's original container.The pharmacy file copy of every prescription shall include the brand or trade name, if any, or the established name and the manufacturer of the drug product dispensed.**Please also see Question No 26 from Section 2.

Remote medication order processing services (RMOP) consists of all of the following EXCEPT: A. receiving, interpreting, or clarifying medication orders B. performing drug regimen review C. remote dispensing of drugs at remote site D. entering data and transferring medication order information

Answer: (c) Remote dispensing of drugs at remote site, [21 NCAC 46 .1417 and http://www.ashp.org/DocLibrary/BestPractices/AutoITGdlRMOP.aspx].A health care facility pharmacy may outsource medication order processing services to a remote medication order processing pharmacy provided the pharmacies have the same owner or the pharmacy has entered into a written contract or agreement with a remote medication order processing pharmacy that outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations.The pharmacy providing the remote processing of medication orders must notify the Board of Pharmacy prior to providing such services.Usually, a health care facility pharmacy that is not continuously open contracts with a larger hospital or a service to provide RMOP when its pharmacy is closed.The model, known as Contracted Services Model, is typically applied when a health care facility pharmacy without 24-hour pharmacy services has sufficient automated dispensing cabinet capacity that RMOP allows nursing staff to keep functioning without having a pharmacist present, although some institutions have developed models for remote verification by pharmacists of dispensing performed by pharmacy technicians at the client site."Remote medication order processing services" consists of the following:(A). receiving, interpreting, or clarifying medication orders;(B). entering data and transferring medication order information;(C). performing drug regimen review;(D). interpreting clinical data;(E). performing therapeutic interventions; and(F). providing drug information concerning medication orders or drugs.

According to North Carolina State Pharmacy Law, the prescription record should be kept on file for: A. Two years from the date of dispensing. B. Five years from the date of dispensing. C. Three years from the date of dispensing. D. A year from the date of dispensing.

Answer: (c) Three years from the date of dispensing, [North Carolina Pharmacy Practice Act 90-85.26(a) and 21 NCAC 46 .2302].Every pharmacist-manager of a pharmacy shall maintain for at least three years the original of every prescription order and refill compounded or dispensed at the pharmacy except for prescription orders recorded in a patient's medical record.An automated data processing system may be used for the storage and retrieval of refill information for prescriptions pursuant to the regulations of the Board.A pharmacist-manager may comply with this section by capturing and maintaining an electronic image of a prescription order or refill. An electronic image of a prescription order or refill shall constitute the original prescription order, and a hard copy of the prescription order or refill is not required to be maintained.If a pharmacist-manager elects to maintain prescription orders by capturing electronic images of prescription orders or refills, the pharmacy's computer system must be capable of maintaining, printing, and providing in an electronic or paper format, upon a request by the Board, all of the information required pursuant to this Chapter within 48 hours of such a request.

(8) A pharmacy may sell controlled substances to a practitioner in which of the following situations? (Select all that apply) A. The practitioner writes a prescription "For Office Use Only" B. The practitioner is registered with the DEA for the schedule of controlled substance requested C. The practitioner uses a DEA 222 Form for medications in Schedules 11-V D. The pharmacy must be registered with the DEA as a distributor

B

The pharmacist-manager shall report to the Board of Pharmacy information that reasonably suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient or customer. This report shall be filed in writing on a form provided by the Board within ______ of the owner representative or pharmacist-manager's becoming aware of the event. A. 3 days B. 5 days C. 7 days D. 14 days

Answer: (d) 14 days, [North Carolina Pharmacy Practice Act 21 NCAC 46 .2502(l)].The pharmacist-manager shall report to the Board of Pharmacy information that reasonably suggests that there is a probability that a prescription drug or device dispensed from a location holding a permit has caused or contributed to the death of a patient or customer. This report shall be filed in writing on a form provided by the Board within 14 days of the owner representative or pharmacist-manager's becoming aware of the event.The pharmacist-manager shall retain all documents, labels, vials, supplies, substances and internal investigative reports relating to the event. All such items shall be made available to the Board upon request. The Board shall not disclose the identity of a pharmacist-manager who makes a report.

The transfer of prescription drugs from one pharmacy to another pharmacy can be communicated between: I. two pharmacists II. a pharmacist and a certified pharmacy technician III. a pharmacist and a registered pharmacy intern A. I only B. I and II only C. II and III only D. All

Answer: (d) All **, [21 NCAC 46 .1806(a)].Under North Carolina State Pharmacy Law, the transfer of original prescription information for the purpose of refill dispensing is permissible between pharmacies subject to the following requirements:(1). the transfer is communicated directly from either a pharmacist or certified technician to either a pharmacist or certified technician;(2). the transferring pharmacist or certified technician invalidates the prescription and any remaining refills at the transferring pharmacy by marking the word "void" on the face of the prescription or its equivalent;(3). the transferring pharmacist or certified technician records the name and address of the pharmacy to which it was transferred and the name of the pharmacist or certified technician receiving the prescription information on the reverse of the invalidated prescription;(4). the transferring pharmacist or certified technician records the date of the transfer and the name of the pharmacist or certified technician transferring the information.The transferred prescription, as well as the original, must be maintained for a period of three years from the date of last refill.NC Administrative Code 21 NCAC 46 .1317(29): Any person who is registered with the Board under the internship program of the Board to acquire pharmacy experience or enrolled in approved academic internship programs. A pharmacy intern working under a pharmacist preceptor or supervising pharmacist may, while under supervision, perform all acts constituting the practice of pharmacy.**Conflict Information: Please note under Controlled Substance Rules and Regulations Pocket card on North Carolina Website, the following rule is stated regarding the transfer of original prescription information for the purpose of refill dispensing between pharmacies:Transfer of CIII-V Prescriptions between pharmacies:The transfer of CIII-V prescriptions is permissible for refilling only once. However, pharmacies electronically sharing a real-time, on-line database may transfer the maximum allowable refills as permitted by law. CFR 1306.25(a):(a). The transfer of such prescriptions must be communicated directly between two licensed pharmacists. **

26.Which of the following correctly matches a controlled substance with the time limit for when a prescription for the given controlled substance must be filled by? A. Tramadol: 1 year B. Carisprodol: 6 months C. Pregabalin: 6 months D. Morphine: 90 days

B

The auxiliary medication inventories may include which of the following? I. patient care unit medication inventories II. ancillary drug cabinet inventories III. emergency kits A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [21 NCAC 46 .1414(d)(1)].The pharmacist-manager of the health care facility pharmacy shall, in consultation with medical staff, develop a list of drugs and devices that may be stocked in auxiliary medication inventories (which may include patient care unit medication inventories, ancillary drug cabinet inventories, and emergency kits) located at the health care facility.This list shall include those drugs and devices that may be required to meet the immediate therapeutic needs of patients, but that are not reasonably available from the health care facility pharmacy in sufficient time to prevent prolonged discomfort or risk of harm to the health care facility's patients.An auxiliary medication inventory shall contain drugs and devices only in amounts sufficient to meet immediate therapeutic needs of patients.

Which of the following statements are TRUE about dispensing prescription orders by using a centralized processing system? I. The pharmacy that is to fill or refill the prescription either has a contract with the pharmacy that received the prescription or has the same owner as the other pharmacy. II. The pharmacy that fills or refills the prescription and the pharmacy that receives the prescription for dispensing to the patient share a common electronic file. III. The patient is provided with written information, either on the prescription label or with the prescription container, which describes which pharmacy to contact if the patient has any questions about the prescription or medication. A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [21 NCAC 46 .1816].A pharmacy permitted by the Board may process a request for the filling or refilling of a prescription order received by a pharmacy within this State via a centralized processing system, provided:(1). The pharmacy that is to fill or refill the prescription either has a contract with the pharmacy that received the prescription or has the same owner as the other pharmacy.(2). The prescription container:(A). is clearly labeled with all information required by Federal and State laws and regulations; and(B). clearly shows the name and address of the pharmacy refilling the prescription and the name and address of the pharmacy that receives the refilled prescription for dispensing to the patient.(3). The patient is provided with written information, either on the prescription label or with the prescription container, which describes which pharmacy to contact if the patient has any questions about the prescription or medication.(4). Both pharmacies maintain complete and accurate records of the prescription, including:(A). the name of the pharmacist who fills or refills the prescription;(B). the name of the pharmacy filling or refilling the prescription; and(C). the name of the pharmacy that received the fill or refill request.(5). The pharmacy that fills or refills the prescription and the pharmacy that receives the prescription for dispensing to the patient share a common electronic file.The originating pharmacy is responsible for compliance with the requirements of Federal and State laws and regulations regarding record-keeping and patient counseling.

The requirements for application for CPP approval include that the pharmacist: I. Has an unrestricted and current license to practice as a pharmacist in North Carolina. II. Has earned Certification from the Board of Pharmaceutical Specialties. III. Submits the required application, a written endorsement from the Pharmacy Board and the fee to the Medical Board. A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [21 NCAC 46 .3101(b)].The requirements for application for CPP (Clinical Pharmacist Practitioner) approval include that the pharmacist:(A). Has an unrestricted and current license to practice as a pharmacist in North Carolina;(B). Meets one of the following qualifications:(i). Has earned Certification from the Board of Pharmaceutical Specialties, is a Certified Geriatric Pharmacist or has completed an American Society of Health System Pharmacists (ASHP) accredited residency program, which includes two years of clinical experience approved by the Boards;Or(ii). Has successfully completed the course of study and holds the academic degree of Doctor of Pharmacy and has three years of clinical experience approved by the Boards and has completed a North Carolina Center for Pharmaceutical Care (NCCPC) or American Council on Pharmaceutical Education (ACPE) approved certificate program in the area of practice covered by the CPP agreement;Or(iii). Has successfully completed the course of study and holds the academic degree of Bachelor of Science in Pharmacy and has five years of clinical experience approved by the Boards and has completed two NCCPC or ACPE approved certificate programs with at least one program in the area of practice covered by the CPP agreement;(C). Submits the required application, a written endorsement from the Pharmacy Board and the fee to the Medical Board;(D). Submits any information deemed necessary by the Medical Board in order to evaluate the application; and(E). Has a signed supervising physician agreement.If for any reason a CPP discontinues working in the approved physician arrangement, both Boards shall be notified in writing within 10 days and the CPP's approval shall automatically terminate or be placed on an inactive status until such time as a new application is approved in accordance with this Subchapter.

Which of the following must be done by the pharmacist-manager before closing or ceasing pharmacy's operation at a specific place?I. The pharmacist-manager shall inform the Board of Pharmacy and the United States Drug Enforcement Administration in advance of the closing of the pharmacy.II. The pharmacist-manager shall arrange for the proper disposition of the pharmaceuticals and return the pharmacy permit to the Board's offices within 10 days of the closing date.III. Notice of the closing shall be given to the public by posted notice at the pharmacy at least 30 days prior to the closing date and 15 days after the closing date. A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [21 NCAC 46.2502(h)].When a pharmacy is to be closed permanently, the pharmacist-manager shall inform the Board and the United States Drug Enforcement Administration of the closing, arrange for the proper disposition of the pharmaceuticals and return the pharmacy permit to the Board's offices within 10 days of the closing date.Notice of the closing shall be given to the public by posted notice at the pharmacy at least 30 days prior to the closing date and 15 days after the closing date.Such notice shall notify the public that prescription files may be transferred to a pharmacy of the patient's or customer's choice during the 30 day period prior to the closing date.During the 30 day period prior to the closing date, the pharmacist-manager, and the pharmacy's owner (if the owner is other than the pharmacist-manager), shall transfer prescription files to another pharmacy chosen by the patient or customer, upon request.Absent specific instructions from the patient or customer, the pharmacist-manager, and the pharmacy's owner (if the owner is other than the pharmacist-manager), shall transfer prescription files to another pharmacy for maintenance of patient therapy and shall inform the public of such transfer by posted notice at the pharmacy for 15 days after the closing date, if possible.

Immediately prior to dispensing a Schedule II controlled substance, each pharmacy holding a valid permit shall require the person seeking the dispensation to present one of the following valid, unexpired forms of government-issued photographic identification. These may include: I. a driver's license II. a military identification card III. a passport A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [NC Controlled Substances Act 90-106.1].(a). Immediately prior to dispensing a Schedule II controlled substance, or any of the Schedule III controlled substances listed in subdivisions 1. through 8. of G.S. 90-91(d), each pharmacy holding a valid permit pursuant to G.S. 90-85.21 shall require the person seeking the dispensation to present one of the following valid, unexpired forms of government-issued photographic identification:(i). a driver's license,(ii). a special identification card issued under G.S. 20-37.7,(iii). a military identification card, or(iv). a passport.Upon presentation of the required photographic identification, the pharmacy shall document the name of the person seeking the dispensation, the type of photographic identification presented by the person seeking the dispensation, and the photographic identification number.The pharmacy shall retain this identifying information on the premises or at a central location apart from the premises as part of its business records for a period of three years following dispensation.(b). The pharmacy shall make the identifying information available to any person authorized under G.S. 90-113.74 to receive prescription information data in the controlled substances reporting system within 72 hours after a request for the identifying information.A pharmacy that submits the identifying information required under this section to the controlled substances reporting system established and maintained pursuant to G.S. 90-113.73 is deemed in compliance with this subsection.

Which of the following substance's preparations shall be classified as a Schedule II controlled substance? I. Opium poppy II. Coca leaves III. Poppy straw A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [NC Controlled Substances Act and Regulations 90-90].The preparations prepared from opium poppy, coca leaves and poppy straw should all be classified as Schedule II controlled substances.

The Board shall not issue any original or annual renewal pharmacy permit to any Internet pharmacy until the Board is satisfied that: I. The Internet pharmacy is certified by the National Association of Boards of Pharmacy as a VIPPS. II. The Internet pharmacy has certified the percentage of its annual business conducted via the Internet on a form provided by the Board, when it applies for permit or renewal. III. The Internet pharmacy has provided the Board with the names, addresses, social security numbers, phone numbers, facsimile numbers, email addresses, and titles of all principal corporate officers of the Internet pharmacy. A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [North Carolina Pharmacy Practice Act 21 NCAC 46 .1601(d)].The Board shall not issue any original or annual renewal pharmacy permit to any Internet pharmacy until the Board is satisfied that:(1) The Internet pharmacy is certified by the National Association of Boards of Pharmacy as a Verified Internet Pharmacy Practice Site (VIPPS);(2) The Internet pharmacy has certified the percentage of its annual business conducted via the Internet on a form provided by the Board, when it applies for permit or renewal; and(3) The Internet pharmacy has provided the Board with the names, addresses, social security numbers, phone numbers, facsimile numbers, email addresses, and titles of all principal corporate officers of the Internet pharmacy;the names, addresses, social security numbers, phone numbers, facsimile numbers, email addresses, and titles of all principal officers of any company, partnership, association, or other business entity holding any ownership interest in the Internet pharmacy;the names, addresses, social security numbers, phone numbers, facsimile numbers, email addresses, and titles of any individual holding any ownership interest in the Internet pharmacy.

1Which of the following information is/are TRUE ABOUT pseudoephedrine sales under the North Carolina State Pharmacy Law? I. The name and address of every purchaser shall be entered in a record of disposition of pseudoephedrine products to the consumer on a form approved by the Commission. II. The retailer shall require that every purchaser sign the form attesting to the validity of the information. III. The form approved by the Commission shall be constructed so that it allows for entry of information in electronic format, including electronic signature. A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [North Carolina Pharmacy Practice Act 90-113.52 (c)].A pseudoephedrine product may be sold at retail without a prescription only to a person at least 18 years of age.The retailer shall require every retail purchaser of a pseudoephedrine product to furnish a valid, unexpired, government-issued photo identification and to provide, in print or orally, a current valid personal residential address.If the retailer has reasonable grounds to believe that the prospective purchaser is under 18 years of age, the retailer shall require the prospective purchaser to furnish photo identification showing the date of birth of the person.The name and address of every purchaser shall be entered in a record of disposition of pseudoephedrine products to the consumer on a form approved by the Commission.The record of disposition shall also identify each pseudoephedrine product purchased, including the number of grams the product contains and the purchase date of the transaction.The retailer shall require that every purchaser sign the form attesting to the validity of the information.The form approved by the Commission shall be constructed so that it allows for entry of information in electronic format, including electronic signature. The form shall also be constructed and maintained so as to minimize disclosure of personal information to unauthorized persons.

The drug substance used for compounding purposes must be: I. USP grade. II. NF grade. III. FCC grade. A. I only B. I and II only C. II and III only D. All

Answer: (d) All.The drug substances used for compounding shall be USP or NF grade, or if unavailable, AR, CP, ACS or FCC grade substances may be used. If none of the foregoing grades are available, then the pharmacist must establish the purity and safety of the ingredient prior to its use.

35. Which of the following statements describes a requirement for verifying a patient's photo identification when dispensing a controlled substance prescription? A. The pharmacist must personally review the photo identification B. The pharmacy must maintain documentation of the person's name, type of ID, and ID number C. Photo identification must be verified for all controlled substance prescriptions dispensed D. The patient who was prescribed the medication must pick up the filled prescription

B

1According to North Carolina State Pharmacy Law, which of the following mid-level practitioners may prescribe and/or dispense a Schedule II controlled substances in the course of their professional practices? I. Physician's assistant II. Nurse practitioner III. Optometrists A. I only B. I and II only C. II and III only D. All

Answer: (d) All, [http://www.deadiversion.usdoj.gov/drugreg/practioners/mlp_by_state.pdf]. Pursuant to Title 21, Code of Federal Regulations, Section 1300.01(b28), the term mid-level practitioner means an individual practitioner, other than a physician, dentist, veterinarian, or podiatrist, who is licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he/she practices, to dispense a controlled substance in the course of professional practice. -Examples of mid-level practitioners include, but are not limited to, health care providers such as nurse practitioners, nurse midwives, nurse anesthetists, clinical nurse specialists and physician assistants who are authorized to dispense controlled substances by the state in which they practice.1. AMB (Ambulance Service)2. AS (Animal Shelters)3. DOM (Doctors of Oriental Medicine)4. ET (Euthanasia Technicians)5. HMD (Homeopathic Physician)6. MP (Medical Psychologists)7. ND (Naturopathic Physician)8. NP (Nurse Practitioners)9. NH (Nursing Homes)10. OD (Optometrists)11. PA (Physician Assistants)12. RPH (Registered Pharmacists) -For the State of North Carolina, only following mid-level practitioners can either prescribe or administer or both, schedule controlled substances.1. AS (Animal Shelters): -Can administer or procure Schedule II to III controlled substances.2. NP (Nurse Practitioner): Can prescribe, dispense and procure Schedule II to V controlled substances. Also, 30-day supply restriction when prescribing schedule II and III narcotic controlled substances.3. PA (Physician assistants): Can prescribe, dispense and procure Schedule II to V controlled substances. Also, 30-day supply restriction when prescribing schedule II and III narcotic controlled substances.4. AMB (Ambulance Service): Can administer, dispense or procure Schedule II to V controlled substances (Line 2 requires physician's name)5. NH (Nursing Homes): Can administer, dispense or procure Schedule II to V controlled substances.6. OD (Optometrists): Can prescribe, administer and dispense Schedule II to V controlled substances.7. RPH (Registered Pharmacists): Can prescribe Schedule II to V controlled substances.

Phenergan with Codeine syrup is classified as: A. Schedule II B. Schedule III C. Schedule IV D. Schedule V

Answer: (d) Phenergan with Codeine syrup is classified as a Schedule V controlled drug, [NC Controlled Substances Act and Regulations 90-93].List of Schedule V controlled drugs:**Newly AddedCodeine preparations - Not more than 200 mg per 100 ml or 100 gm (Robitussin AC, Phenergan with Codeine)., Difenoxin preparations - Not more than 0.5 mg Difenoxin + 25mcg Atropine sulfate (Motofen)., Dihydrocodeine preparations - Not more than 100 mg per 100 ml or 100 gm., Diphenoxylate preparations- Not more than 2.5 mg Diphenoxylate + 25mcg Atropine sulfate (Lomotil, Logen)., Ethylmorphine preparations - Not more than 100 mg per 100 ml or 100 gm., Opium preparations - Not more than 100 mg per 100 ml or 100 gm (Parepectolin, Kapectolin PG, Kaolin Pectin P.G.)., Lyrica - Pregabalin, Vimpat - Lacosamide, Potiga - Ezogabine, **Briviact - Brivaracetam, **Xcopri - Cenobamate, **Reyvow - Lasmiditan, **Pyrovalerone

45. Which of the following statements describes a requirement a pharmacist must follow in a Drug Repository Program? A. The pharmacist may accept a medication that is a controlled substance B. If a donated drug is dispensed, it must be documented on the written prescription or electronic record C. The Pharmacist Manager cannot serve as a pharmacist-manager for a free clinic and a retail pharmacy D. Only hospitals or drug manufacturers can donate a prescription drug

B

(14) Which of the following describes a correct statement for practitioners prescribing buprenorohine for opioid addiction? (Select all that apply) A. Any practitioner registered with the DEA may prescribe buprenorphine for opioid addiction B. A pharmacy may fill a prescription issued for buprenorphine for opioid addiction C. A practitioner must issue buprenorphine prescriptions electronically D. Prescriptions for buprenorphine are limited to a 5-day supply initially

B

(17) Which of the following activities is outside the scope of practice for a Clinical Pharmacist Practitioner? A. Issuing a prescription based on the parameters in the written protocol B. Diagnosing a patient with diabetes after ordering labs C. Adjusting a patient's dose to lower their blood pressure D. Ordering labs to monitor for side effects of a medication

B

(7) Which of the following correctly describes recordkeeping requirements for ordering controlled substances? A.A pharmacy would order buprenorphine using a DEA 222 form B. The purchaser must record the number of containers received on Copy 3 of the DEA 222 form C. Executed DEA 222 forms must be kept by the pharmacy for a period of 2 years D. A DEA 222 form can be filled out and signed by any pharmacist working at the pharmacy

B

47. Which of the following describes a correct requirement for the NC Controlled Substances Reporting System? A. A pharmacy must upload information into the database within 72 hours of dispensing a prescription for lorazepam B. A pharmacist may authorize a pharmacy technician to generate a report C. A pharmacist must review a patient's report prior to dispensing a prescription for pregabalin D. Controlled substances administered in a hospital must be reported to the system

B

61. Which of the following statements describes a requirement for health care facility pharmacies? A. An outpatient pharmacy can operate under the inpatient pharmacy's pharmacy permit B. Medication orders listed in a patient profile must have a stop date C. Must keep the records of persons involved in the dispensation of new medication orders for 3 years D. Health care facility pharmacy refers to only hospital pharmacies

B

68. A Pharmacist-Manager is required to notify the NC BOP within 14 days if which of the following occurs? A. An out-of-state pharmacy's license was suspended by their home state B. The pharmacy dispenses a medication that led to the death of a patient C. If a change in pharmacy personnel occurs D. The pharmacy discovered a bottle of tramadol was stolen

B

23. A patient comes to the pharmacy counter on a Friday night and does not have any valid refills remaining on any of his prescriptions. The doctor's office is closed until Monday morning. Which of the following medications and day supply would be permissible for you to provide an emergency refill for? (Select all that apply) A. Hydrocodone for pain: 5 day supply B. Alprazolam for anxiety: 5 day supply C. Atorvastatin for high cholesterol: 60 day supply D. Sildenafil for erectile dysfunction: 3 day supply

B **Can NOT refill C2 without talking to prescriber**

40. Which of the following requirements must be followed by pharmacists when dispensing a medication? (Select all that apply) A. The phone number of the pharmacy must be listed on the label B. Oral medications must be in child-resistant packaging unless the patient requests otherwise C. The pharmacist's first initial and full last name must appear on the label D. A maximum discard date of 6 months must be written on the label

BC

43. A pharmacy who only compounds medications upon the receipt of a prescription from a prescriber must do which of the following? (Select all that apply) A. Register with the FDA as an "Outsourcing Facility" B. Comply with USP chapters 797 and 795 C. Maintain a recordkeeping system to identify compounded preparations D. Compound medications according to Current Good Manufacturing Practices E. Sell compounded preparations to prescribers "For Office Use Only''

BC

(13) Which of the following prescriptions should a pharmacist refuse to fill? (Select all that apply) A. A prescription written one week before a prescriber retired B. A prescription written for methadone for chronic opioid addiction treatment C. A prescription written by a prescriber whose license is suspended by the NC Medical Board D. A prescription written by a veterinarian for a human patient

BCD

(9) Which of the following statements describe regulations for wholesalers or distributors in NC? (Select all that apply) A. Standards for facilities and security systems are the same for wholesalers as pharmacies B. An "Outsourcing Facility" must register as a wholesaler C. Inventories and records of all transactions of prescription drugs distributed must be maintained D. A wholesaler may donate a refrigerated medication to a Drug Repository Program

BCD

60. A hospital pharmacy with Automated Dispensing Devices (i.e. Pyxis machines) must follow which of these requirements? (Select all that apply) A. Unused medications removed from an Automated Dispensing Device may not be restocked B. An Automated Dispensing Device can function as an emergency kit C. Must keep records of controlled substances stocked in an Automated Dispensing Device for 3 years D. A hospital pharmacy may elect to use "Tech check Tech" to stock the Automated Dispensing Devices

BCD

74.Which of the following describes a correct statement in regards to inspections performed by the NC BOP? (Select all that apply) A. Inspections only occur after the NC BOP receives a complaint B. A Corrective Action Plan may be required for severe deficiencies C. A copy of the inspection will be made available to the Pharmacist-Manager D. The NC BOP may inspect compliance with controlled substances laws

BCD

Q: What is the proper way to document receipt of schedule II controlled substance orders when using DEA's Controlled Substance Ordering System (CSOS)?

Board investigators have found the CSOS orders were properly placed in accordance with 21 Code of Federal Regulations (CFR) 1305.21 and 1305.22(a). However, upon receipt of the controlled substances, a copy of the E-222 form was printed and receipt of the order manually noted on paper. This paper receipt process violates 21 CFR 1305.22(g), although Board investigators have found these violations to be unintentional and are treating them as an educational issue, not a disciplinary one. Under that federal rule, when a purchaser receives a shipment, the purchaser must create a record of the quantity of each item received and the date received, and that record must be electronically linked to the original order and archived. Board staff strongly recommend that pharmacies ordering Schedule II controlled substances using CSOS, but unsure how to electronically link the receipt with the original order, contact the schedule II controlled substance supplier for assistance.

(2) Which of the following correctly describes inventory requirements for pharmacies in NC? A. The pharmacist-manager must perform an inventory of all controlled substances if a new staff pharmacist is hired B. An inventory of controlled substances must be taken every year C. The pharmacy must implement a system to identify discrepancies of controlled substances D. It is permissible to estimate the number of tablets in a bottle of oxycodone when taking an inventory

C

(6) Which of the following correctly describes a requirement for the distribution of drug samples? A. A pharmacy is permitted to hand out drug samples to patients without a prescription B. A physician must register with the NC BOP to hand out drug samples for free c. A nurse practitioner must follow record keeping requirements when handing out a drug sample D. A physician must make a report to the NC CSRS for samples handed out of pregabalin

C

32. A patient requests their prescription to be transferred from a community pharmacy near their home to a chain pharmacy near their place of employment. Which of the following describes a requirement for transferring a prescription? (Select all that apply) A. A noncertified technician may transfer the patient's simvastatin B. The patient's atenolol may only be transferred once C. Records for the transfer of the prescription must be kept for 3 years D. A patient's clonazepam may be transferred within 1 year of initial filling

C

36. Which of the following is legal In NC? A. Death with dignity/physician-assisted suicide B. Medical marijuana for chronic pain C. lnvestigational drugs outside of clinical trials ("Right to Try") D. Prescribing controlled substances for family members

C

38. Which of the following correctly describes a requirement for dispensing medications? A. A generic drug may be dispensed if the prescriber writes "DAW" on the prescription for a brand drug B. A pharmacist may dispense a different manufacturer of warfarin for each refill c. The generic name must be included on the prescription label, even if the brand drug is dispensed D. A generic oral solution may be substituted for a brand name tablet

C

50. Which of the following describes a requirement for selling pseudoephedrine? A. There is no age limit for patients to purchase pseudoephedrine over-the-counter B. Pharmacies must keep a paper logbook to record the transactions C. Quantity limits do not apply for pseudoephedrine dispensed from a prescription D. Pseudoephedrine may be sold at a gas station

C

62. Which of the following statements describes a requirement for health care facility pharmacies? (Select all that apply) A. A hospital pharmacy wishing to repackage medications for use at their institution must register as a 'Repackager' with the State of North Carolina B. A hospital pharmacy needs to register as an "Outsourcing Facility" if they compound sterile products C. A hospital must have some sort of access to a pharmacist 24 hours a day, 7 days a week D. Pharmacist-Managers in hospital pharmacies only need to document medication errors leading to a patient's death E. A Validating Technician may verify a patient-specific order in a hospital pharmacy

C

65. In order to reciprocate a pharmacist license to NC from another state, which of the following must the applicant do? A. Retake and pass the NAPLEX B. Complete 15 hours of CE per each year the pharmacist has been licensed C. Pass the NC MPJE D. Complete 1500 more hours of practical experience

C

71. Which of the following correctly describes pharmacy permits In NC? A. The owner of the pharmacy must serve as the Pharmacist-Manager on the permit B. Pharmacy permits are renewed every 2 years C. An out-of-state pharmacy shipping medications to NC residents must register for a permit in NC D. A Local Health Department Clinic is not required to apply for a pharmacy permit if prescriptions are dispensed

C

73.Which of the following is an example of an internet pharmacy? A. A pharmacy who creates a website that allows a patient to email a pharmacist B. A website created by a community pharmacy that allows a patient to make a refill request for a prescription previously filled at that pharmacy C. A website that facilitates the dispensing of a new prescription D. A website that advertises a prescription drug

C

75. Which of the following refers to the requirements for renewal of a license or registration? A. Pharmacy technicians renew their registration on their birthday B. Pharmacists cannot practice pharmacy if their license is not renewed by December 31st C.Pharmacists licensed by examination do not need to complete continuing education for their first renewal D.Pharmacists who are licensed, residing, and practicing in another state must complete NC's CE requirements to renew their NC license

C

78. A compound dispensed "For office use only" by a pharmacy not registered as an "Outsourcing Facility'' would be: A. Adulterated B. Misbranded C. Both D. Neither

C

79. A specified drug product has an NDC of 00129-4437-10. The "00129" represents: A. The generic name of the drug B. The strength of the drug C. The manufacturer of the drug D. The quantity of the drug in the bottle

C

83. Within what timeframe must an Immunizing Pharmacist notify a physician of a vaccine administered to their patient? A. 24 hours B. 48 hours C. 72 hours D. 7 days

C

49. Which of the following describes a requirement for selling C-V medications without a prescription? (Select all that apply) A.All liquid Schedule V medications can be sold over-the-counter B. No quantity limits apply when selling C-V medications without a prescription C. All transactions must be recorded in a logbook D. Pharmacist determines it is for a legitimate medical purpose

CD

59. Which of the following statements correctly describes the use of remote order verification? (Select all that apply) A. A pharmacist may remotely verify a prescription in another community pharmacy B. A pharmacist may remotely verify an IV prepared by a pharmacy technician in a hospital C. A pharmacist may remotely verify medication orders if other pharmacists are present in the hospital pharmacy D. A pharmacist providing remote order verification who is located in another state must be registered with the NC BOP

CD

64. A health care facility pharmacy repackaging medications may utilize a 'batch number' which is a substitute for which of the following piece(s) of information on the label of the repackaged drug? (Select all that apply) A. Drug name B. Drug strength C. Manufacturer D. Lot number E. Expiration date

CD

(10) A prescription written for atorvastatin must contain which of the following? (Select all that apply) A. Telephone number of the patient B. The DEA number of the prescriber C. The prescribing/license number of CPP D. The address of the prescriber E. Quantity of medication

CDE

How do OFF-LABEL indications become real indications?

Company submits a sNDA or BLA (supplemental)

Does counseling have to be done face-to-face in retail?

Counseling must be done "face to face" unless for inmates, may be through an officer with printed materials

20. A 40 year-old patient must obtain a prescription from a prescriber in order for a pharmacist to administer which of the following vaccines? A. Influenza B. Pneumococcal polysaccharide C. Tdap D. Haemophilus influenzae type b

D

25. After a patient drops off a written prescription for oxycodone, your pharmacy technician realizes the prescriber did not write the quantity on the prescription. Which of the following describes a possible course of action? A. The pharmacist asks the patient how much the prescriber wanted to issue B. The pharmacy technician contacts the prescriber and adds the quantity to the prescription C. The prescription must be returned to the prescriber to write the quantity D.The prescriber may electronically send a new prescription to the pharmacy

D

RxPrep: What exams or certifications are required for all technicians?

EITHER 1) Hold a PTCB certification OR 2) Hold a high school diploma or equivalent, be employed by a pharmacy, and complete a training program approved by the supervising pharmacists/manager

27. A college-aged patient is upset at having to go to his doctor's office every month to receive a written prescription for his Adderall since his insurance company will only cover a 30 day supply. Which of the following options could a prescriber do to prevent the student from coming to his office every month? (Select all that apply) A. Fax a new prescription into the pharmacy every month B. Write one prescription for a 90 day supply and have the patient request a partial fill every 30 days C. Call a new prescription into the pharmacy every month D. Write three prescriptions at the next appointment, each for a 30 day supply with instructions on when to fill

D

33. Which of the following correctly describes the partial dispensing of a controlled substance? A. A healthy patient may partially fill the total amount of a C-11 medication within 60 days of prescription issuance B. A patient in a long term care facility must partially fill the total amount of a C-IV medication within 60 days of prescription issuance C. A terminally ill patient must partially fill the total amount of a C-11 medication within 60 days of the initial prescription dispensing D. A prescription for a C-111 medication can be partially filled up to six months after the date of issuance

D

46. A Central Fill pharmacy is subject to which of the following regulations? A. Controlled Substance prescriptions filled at a Central Fill pharmacy may only be filled once B. A Central Fill pharmacy must register as a distributor to ship filled prescriptions to the originating pharmacy C. The label on the dispensed vial must contain both pharmacies names and phone numbers D. The originating pharmacy may fax a C-11 prescription to the Central Fill pharmacy to fill

D

54. Which of the following correctly describes a requirement for pharmacy recordkeeping? A.Paper prescriptions of C-ll's may be stored with C-I11, C-IV, and C-V prescriptions B. A pharmacy has 72 hours to give the NC BOP access to a prescription on file C. A pharmacist must sign an acknowledgement within 48 hours of prescription information entered in an Automated Data Processing System D. A pharmacy may maintain an electronic image of non-controlled substance prescriptions and discard the paper prescription

D

80. Which of the following is a Schedule IV controlled substance? A. Buprenorphine B. Human chorionic gonadotropin C. Lisdexamfetamine D. Phentermine

D

81. Which of the following is a 'Targeted Controlled Substance'? A. Zaleplon B. Diazepam C. Dextroamphetamine and Amphetamine D. Fentanyl

D

Can electronic precriptions be transferred?

Electronic controlled prescriptions MAY be transferred electronically (receiving pharmacist must document their name in addition to the requirements below) § TRANSFERRING pharmacy must: o Invalidate the prescription and any remaining refills by writing "VOID" on the face of the invalidated prescription or its equivalent o Record on the back of the prescription: Name, address, and DEA number of the pharmacy to which it was transferred (if a control) PLUS person's name receiving the Rx o Record date of transfer PLUS their own name o For controls originally sent electronically by a prescriber to the pharmacy à all info (as state above) must be added to the prescription (electronic) record § RECEIVING pharmacy must: o Write "transfer" on the face of the prescription o Reduce to writing all that is required on a prescription PLUS: § Date and time of transfer § Issue date of original Rx § Original number of refills § Number of refills remaining plus date of last refill § Transferring pharmacy's name, address, DEA number (if control), and prescription number § Name of transferring pharmacist, CT, or intern § Manufacturer or brand of drug dispensed § For controls: · Date of original dispensing · Pharmacy's name, address, DEA number, prescription number from there the Rx was originally filled (if different) · Dates and locations (if different) of previous refills

Q: What is required when submitting a DEA registration?

Following the submission of your DEA application, the following information should be sent via email to DEA Registration Program Specialists [email protected] and [email protected], to continue with the approval process: 1) Owner(s): Full Name, DOB, and a copy of all owner(s) NC Driver's License 2) P.I.C. (Pharmacist in Charge)/Pharmacist(s): Full Name, NC State Pharmacist License#, and copy of NC Driver's License for PIC and all pharmacists for this location. 3) Pharmacy Technician(s): Full Name, DOB, NC State Pharmacy Tech License#, and a copy of NC Driver's License for all Pharmacy Technicians 4) Address: Include Suite # if applicable (indicate if located in shopping plaza; provide name of shopping plaza) 5) Indicate if pharmacy is located within a clinic/medical practice; provide name of clinic/practice 6) Telephone & Fax 7)Opening Date

Hospital and Healthcare Facility Pharmacy includes _______________

Includes a hospital, LTCF, mental health facility, drug abuse Tx center, penal institution, HOSPICE à pharmacy that serves one of these

Do Pseudoephedrine laws apply to OTC, Rx, or both?

Law applies to retail/OTC sale of pseudoephedrine only, NOT orders pursuant to a prescription

RxPrep: Are remaining refills required to be listed on the Rx bottle label?

NO

RxPrep: Can marajuana be legally obtained from a state-approved dispensary?

NO

Can a pharmacy or free clinic resell the donated drugs?

NO but may charge the patient a small handling fee

How many times can a NON-control can be transferred? Can they be transferred by fax or electronically?

NO limit on the amount of times a NON-control can be transferred o MAY be transferred by FAX or electronic transmission

Do practitioners (e.g. interns, residents, staff physicians, mid-level practitioners) working in a hospital require their own DEA numbers?

NO: they can use the hospital's providing the following are met: -Dispensing, administering, or prescribing is done in the usual course of his/her professional practice -Authorized to do so in this state -Hospital or institution has verified that the practitioner is authorized to do so w/in the state -Institution has assigned a specific internal code number to the practitioner as a suffix to the institution's DEA number (i.e. AP0123456-10) and the list of internal codes is kept by the institution

RxPrep: What are the limitations on medication delivery (couriers, pharmacy employees, or by kiosk)?

NONE

Are preprinted prescription blanks allowed?

NOT FOR CONTROLS Escripts for controls: (READ ONLY) The preprinting of or use of preprinted prescription blanks with the name of scheduled substances is prohibited. Prescription blanks that are individually generated (aka: computer generated prescriptions) are permissible. 45.G NCAC .0307

RXPREP: Chart orders are EXEMPT from the standard prescription requirements (discussed in pharmacy practice chapter) Instead must contain:

Patient name, issue date, Drug name, strength and dosage form, directions for use, prescribers signature or signature of the patient's licensed healthcare designee along with the prescriber's name

What is meant by Tech-Check-Tech?

Permits a Validating Tech to verify other registered pharmacy techs in filling floor stocks and unit dose distribution systems for inpatient ins a hospital (AKA Tech-Check-Tech)

How often must pharmacies back up e-scribing records?

Pharmacy must back-up records DAILY, keep an internal audit trail

RxPrep: What are the requirements for generic substitution (e.g. must notify the pt, etc.)?

Substituted medication must cost less than the original branded product

RxPrep: Federal law mandates that OUTPATIENT MEDICAID prescriptions must be written on _______________ in order to be eligible for state Medicaid reimbursement

TAMPER-RESISTANT SECURITY FORMS o Does NOT apply to electronic, oral or faxed prescriptions o Must contain at least THREE tamper-resistant features and the CMS-required security features must contain at least ONE from EACH category § (1) Prevents duplication: (e.g. the word VOID appears when PHOTOCOPIED or FAXED, thermochromic ink changes to a visible color when heated from a copy machine or fax) § (2) Prevents the erasure or modification of written info: e.g. with quantity checkboxes, refill indicators, or with chemically reactive paper that changes color when an eraser is applied) § Prevents the use of counterfeit forms: (e.g. pre-printed serial numbers, watermarks, or microprint signature line)

Q. Must the supervising physician's name and phone number be included on prescriptions written by a nurse practitioner or physician assistant?

The answer is no. The Medical Board's requirements are imposed on a PA or NP for purposes of the Medical Board's supervision of those practitioners. The absence of a supervising physician's name and telephone number does not render a PA- or NP-issued prescription "invalid," "illegal," or otherwise ineligible for dispensing under the North Carolina Food Drug and Cosmetic Act or the North Carolina Pharmacy Practice Act. These statutes set forth requirements for a valid prescription under North Carolina law - and neither requires supervising physician information to be included on PA- or NP-issued prescriptions.

What are the requirements to be an immunizing pharmacist?

The immunizing pharmacist must have a current provider-level CPR certification prior to administering vaccines, must begin obtaining required biennial immunization-specific CE, and must obtain training to participate in North Carolina Immunization Registry as required by the immunizing pharmacist statute.

When is generic substitution NOT permitted?

The pharmacist may NOT dispense a generic drug if the prescriber signs on the DISPENSE AS WRITTEN line by one of the following methods: 1) Prescription form contains two signature lines and signs of the DaW line 2) Handwrite DaW or words or abbreviations of the same meaning on an Rx 3) For ORAL prescriptions: VERBALLY states DaW

What is the purpose of DEA Form 106?

Theft or loss

Expiration date for a non-controlled prescription?

There is NO specific provision in NC for an expiration of NON-Controls -Need to check for federal laws

RxPrep: What is the MAX pharmacist/intern supervision ratio?

There is NOT one

Are Remote Medication Order Processing Services allowed in NC?

YES --> BUT -ALL pharmacists must be licensed by the NCBOP -An OOS remote medication order processing pharmacy must be registered with the BOP as an OOS pharmacy -The pharmacy providing the remote services MUST notify the BOP prior to providing remote order services and apply for a permit -The remote site is located in the US and electronically linked to a HCF in NC o Provide "Remote medication order processing services" such as: § Receiving, interpreting, or clarifying medication orders § Entering data and transferring medication order info § Performing drug regimen review

Can a pharmacist refuse to fill an Rx if he/she deems it not in the best interest of patient or if the validity of the Rx is in question?

Yes --> Excise of Professional Judgement

RxPrep: Does NC require the submission of pseudophedrine sales to NPLEx?

Yes BEFORE completion of the sale

Can patients who speak a foreign language be given printed info instead of counseling?

Yes IF requested by the patient/rep

**Starting FAQs*** May an automated dispensing device be used as an "emergency kit"?

Yes. 21 NCAC 46 .1814 allows automated dispensing devices to be placed in facilities that hold a pharmacy permit. The placement of an automated dispensing device in a building owned by a health care facility, but without its own pharmacy permit, would only be allowed if the device were used solely as an "Auxiliary Medication Inventory." Automated dispensing devices used in this manner are governed by by 21 NCAC 46 .1414(d). -21 NCAC 46 .1414(d) defines an "auxiliary medication inventory" as an "emergency kit", "ancillary drug cabinet," or "patient care unit medication inventor[y]." -In consultation with medical staff at the facility, a list of drugs and devices must be developed that will be stocked in an auxiliary medication inventory. Such drugs and devices may only be ones required to meet the immediate therapeutic needs of patients, and that are not available from the facility's pharmacy in a sufficient time to prevent prolonged discomfort or risk of harm to patients. The pharmacist-manager and pharmacy must develop and implement policies and procedures to ensure that only those individuals authorized to administer medications under North Carolina law can access the auxiliary medication inventory. Amounts of medications and devices contained in these inventories must be limited to an amount sufficient to meet the immediate therapeutic needs of patients. -Further, if controlled substance are contained in the device, it must also comply with 10A NCAC 26E .0408, which allows skilled nursing facilities, intermediate care facilities, and combination facilities licensed by the Department of Health and Human Services to have a controlled substance emergency kit. -A controlled substance emergency kit, whether an automated dispensing device or another implementation, can contain no more than seven (7) controlled (II-V) drug entities, as determined by the medical staff and as approved by the pharmaceutical service committee. Controlled substances for emergency use shall be obtained through purchase orders from the licensed pharmacist who regularly provides medications to the facility. If CIIs are purchased, DEA order forms must be used. The controlled substances must be provided in unit-dose form. "A facility shall not be permitted to possess more than 5 doses of each controlled substance entity for each 50 licensed beds or fraction thereof."

Once approved as a CPP, BOP issues ________________

a number that will be printed on EVERY Rx written by the CPP (controlled AND non-controlled)

RXPREP: Any drug produced by a manufacturer that does not comply with CGMP is considered _________ by law and should not be purchased by pharmacies or dispensed to patients

adulterated

Q: Can I dispense a single-ingredient oral colchicine product other than Colcrys?

all single-ingredient oral colchicine products other than Colcrys have been ordered off the market, and any still circulating are unapproved drug products.

FDA Safety and Innovation Act of 2012:

contains provisions directed at reducing drug counterfeiting, blocking the import of adulterated products, detecting and reducing drug shortages

What should happen if in the case of a loss or theft of pseudoephedrine?

must be reported to local DEA office within 15 DAYS (DEA Form NOT required)

RXPREP: FEDERAL LAW for prescription label

o Patient's name o Prescriber's name o Name and address of the dispenser o Directions for use o Rx number o Date of fill o Cautionary statements o Some states require extra info including: Date of initial fill, name of dispensing pharmacist, business hours, pharmacy phone number, EXP date of drug, Drug name and strength, address of patient, name of manufacturer and distributor, lot or control number, physical description of the drug, refills remaining SEE WHAT NC has as extra

Can Emergency Kits be placed in a LTCF who is responsible for it? Limits to what it can contain?

o A pharmacy MAY place an emergency kit controls in a NON-DEA registered LTCF o The pharmacy responsible for the emergency kit and MUST registered with the DEA § Considered an extension of the pharmacy and is covered under the pharmacy's DEA registration o Emergency kits follow the same regulations as "Auxiliary Medication Inventories" (see Healthcare Facility Pharmacy Section) § A valid Tx is still necessary § An ADD may also be used as an emergency kit o Can contain NO MORE THAN 7 controls (C2-C5) § No more than FIVE doses of each control for every 50 beds or fraction thereof § The five doses may b of the same or differening concentration § Controls for emergency use shall be provided in SINGLE UNIT-DOSE form § Securely locked and sotreed with acces limited to authorized personnel § The pharmacist supplier of the control for emergency use shall have primary responsibility forhte proper control and acoountaibility of asuch drugs in the facility

Prescription Drug Marketing Act (PDMA) of 1987

o Bans sale, trade, or purchase of Rx drug samples o Established sales restrictions and recordkeeping requirements for Rx drug samples o Prohibits hospitals and other healthcare entities from reselling their Rx drugs to other businesses o Requires state licensing of wholesalers o Bans re-importation of Rx drugs except by the manufacturer

Requirements for bulk substances used in 503A compounding

o Complies with standards of an applicable USP or NF monograph, if a monograph exists o If such a monograph does NOT exist, drug substances must be components of an FDA approved product o FDA is also developing a list of acceptable bulk substances which do NOT fall into either of the above categories ("503A Bulks List")

Substance Use-Disorder Prevention that Promotes Opioid Recovery and Tx for Patients Communities Act

o Controlled substance prescriptions for Medicare Advantage and Part D will be required to be transmitted electronically beginning January 1, 2021 o Allows additional mid-level practitioners to prescribe buprenorphine for opioid addiction

Dietary Supplement Health & Education Act (DSHEA) of 1994

o Created a new category of food called "dietary supplements" o Permits manufacturers to make claims that would have otherwise been illegal under FDCA o Forced FDA to regulate dietary supplements more as foods than as drugs

RxPrep Control Label Requirements:

o Date of initial fill o Date of current fill (if it is a refill) o Pharmacy name and address o Rx number o Name of patient AND prescriber o Directions for use o Cautionary statements o Warning required for C2-4: § "CAUTION: Federal law prohibits the transfer of this drug to any person other than for whom it is prescriber" § Federal law does NOT require this for C5s CHECK NC o Label requirements for central fill pharmacies: § Must include retail pharmacy's name and address on the label and a unique identifier (such as central fill pharmacy's DEA number) to indicate it was a central fill o EXEMPTIONS: § These do not apply to institutionalized patients for these pts · MAX of 7 days of C2s · MAX 34 day supply or 100 doses (whatever is less) for C3-5

How do CE requirements for the FIRST renewal cycle change depending on whether you were license by EXAM or by RECIPROCITY?

o Do NOT need to complete CE for FIRST renewal if licensed by EXAMINATION that year § Different for reciprocity --> you DO have to complete CE UNLESS: "For the entire year preceding license renewal, the pharmacist resided in another state, did not practice pharmacy in North Carolina, and satisfied the state of residence's continuing education requirements for pharmacist licensure"

Permitted Uses and Disclosures for HIPAA

o Pharmacies may use and disclose PHI for the purposes of Tx, payment, and healthcare operations § Treatment: Filling Rxs, counseling, contacting prescribers § Payment: Billing insurance § Operations: QA, audits, business management · Incidental Uses and Disclosures o HIPAA does NOT require that EVERY risk of an incidental or disclosure of PHI be eliminated § Patients in the pharmacy may overhear a conversation at the register o Pharmacies must implement "reasonable safeguards" (i.e. stand behind this line)

RXPREP: For COCs, PPIs are required, but differ based on setting

o Retail/outpatient: PPIs must be given to the patient with EVERY INITIAL fill AND REFILL o Institutional: PPI given before the FIRST dose and every 30 days thereafter o If PPI is not provided, it is considered MISBRANDING

RXPREP: USP says a Med-Pak label (multiple drugs in pack to improve adherence) must have everything normally required on a label PLUS

o Serial number for the pack, name, strength, quantity, and physical description of EACH med, required storage info, date of preparation and BUD

Food and Drug Administration Modernization Act (FDAMA) of 1997

o Streamlined regulatory procedures to expedite the availability of safe and effective drugs and devices o Expands FDA authority over OTC drugs o Establishes a data bank of information on clinical trials

RxPrep Although BUDs will differ, USP states for MULTI-DOSE containers (the Rx bottle the pt receives) BUD is NO LATER than What?

o The manufacturer's EXP date or ONE YEAR from date of dispensing, whichever is earlier

Can LTCF order and maintain controls?

o Unlike hospitals, LTCFs are rarely DEA registrants -If not registered with the DEA, LTCF's may NOT order and maintain stock of controls to be dispensed under the order of a practitioner as occurs in hospitals o Patients at these facilities are usually seen by their personal physicians who prescribe necessary meds § These prescriptions are usually filled by retail pharmacies and delivered to LTCFs (LTCF holds patients meds in a custodial manner for administration to the patient) o One key difference on the federal level between LTCF and hospitals in writing "chart/medication orders" for controls is NOT acceptable In the LTCF setting according to the DEA (assuming they are not registered with the DEA) § Practitioners must issue preparations for controls as they would if they saw a patient in their office § Chart/medication orders for non-controls substances are acceptable in LTCFs according to state law (assuming they are dispensed by a registered HCFP)

Central Fill Pharmacy If a private currier is contracted, who is responsible for reporting the in-transit loss to the DEA for controls?

the CFPs responsible for reporting the in-transit loss to the DEA for controls

RxPrep: Within how many days after changing a PIC does the BOP have to be notified?

w/in 30 days

What are laws surrounding Out of State Pharmacies?

§ BEFORE original registration, a pharmacist that is a representative of the owner MUST make an appearance before the BOP § ANY pharmacy that ships, mails, or deliver in ANY manner a dispensed legend drug into NC MUST obtain a pharmacy permit from the BOP and must provide proof of a current license in their home state § MUST employ a pharmacist who is responsible for dispensing, shipping, mailing, or delivering dispensed legend drugs § Subject to NCBOP jurisdiction and will comply with regulation of the state where it is located § Must maintain records of Rx drugs dispensed to NC residents § Pharmacists do NOT have to be licensed in NC, only in the state where the dispensing is occurring § Develop policies for any delays to a patient's medication or how to get meds to a patient for an acute illness § Must disclose an ANNUAL report of ALL corporate officers, owners, pharmacists, and supportive personal à update w/in 30 days of a major change § Have the same requirements for reporting w/in 14 days to BOP of an Rx or device they dispensed caused death of a pt § Notify the NCBOP w/in 5 days of any disciplinary action on the pharmacy à if permit is revoked or suspended by home state, it is AUTOMATICALLY revoked/suspended in NC

Which of the following statements are TRUE about a pharmacist selecting an equivalent drug product to the originally prescribed drug? I. The pharmacist shall not select an equivalent drug product unless its price to the purchaser is less than the price of the prescribed drug product. II. The pharmacist shall not select an equivalent drug product if the prescriber instructs "DAW" on a prescription. III.A prescription for narrow therapeutic index shall not be switched to an equivalent product without consulting the physician. A. I only B. I and II only C. II and III only D. All

· Answer: (d) All, [North Carolina Pharmacy Practice Act 90-85.28(b1),(c)]The pharmacist shall not select an equivalent drug or interchangeable biological product if the prescriber instructs otherwise by one of the following methods:(1). A prescription form shall be preprinted or stamped with two signature lines at the bottom of the form which read: Product Selection Permitted OR Dispense as Written. On this form, the prescriber shall communicate instructions to the pharmacist by signing the appropriate line.(2). In the event the preprinted or stamped prescription form specified in subdivision (1) of subsection (b) of this section is not readily available, the prescriber may handwrite "Dispense as Written" or words or abbreviations of the same meaning on a prescription form.(3). When ordering a prescription orally, the prescriber shall specify either that the prescribed drug product be dispensed as written or that product selection is permitted. The pharmacist shall note the instructions on the file copy of the prescription and retain the prescription form for the period prescribed by law.A prescription for a narrow therapeutic index drug shall be refilled using only the same drug product by the same manufacturer that the pharmacist last dispensed under the prescription, unless the prescriber is notified by the pharmacist prior to the dispensing of another manufacturer's product, and the prescriber and the patient give documented consent to the dispensing of the other manufacturer's product.For purposes of this subsection, the term "refilled" shall include a new prescription written at the expiration of a prescription which continues the patient's therapy on a narrow therapeutic index drug.When ordering a prescription orally, the prescriber shall specify either that the prescribed drug product be dispensed as written or that product selection is permitted.The pharmacist shall not select an equivalent drug or interchangeable biological product unless its price to the purchaser is less than the price of the prescribed drug product.

What are the laws on Conscientious Objection for Emergency Contraception in NC?

· BOP notes that although pharmacists have the right to avoid moral or ethical conflict, they do NOT have a right to obstruct otherwise legitimate Rx dispensing or delivery solely on the basis of conscientious objection · BOP staff interprets this policy to mean that if a pharmacist refuses to fill a Rx for emergency contraception then that pharmacist has an OBLIGATION to get the patient and the prescription to a pharmacist who WILL dispense it in a timely manner

What should a pharmacy do if they find a substance that violates the Drug Supply Chain Security Act "Track and Trace"?

· Dispensers must have systems in place to identify and quarantine suspect/illegitimate products and notify FDA/trading partners if one is found (within 24h) o Documentation of investigation or product disposition to be kept for 6 YEARS

What are the rules surrounding issuing multiple C2 prescriptions on the same day? What is the MAX days supply?

· Legitimate medical purpose to do this · Each Rx must be on a separate blank · Total quantity prescribed does NOT exceed a 90-day supply · Writes EARLIEST date each Rx may be dispensed (i.e., "Do not fill until") · Multiple prescriptions do not create an undue risk of diversion or abuse

What is the MAX allowable quantity of 503A compounded products distributed out of state?

· May NOT distribute compounded products out of state in quantities that exceed 5% of the total prescription orders dispensed or distributed by such pharmacy -o Enforced once the FDA finalizes an MOU which will be available for states to sign

What did the Drug Supply Chain Security Act "Track and Trace" do?

· Placing unique product identifiers on individual drug packages (Rx drugs only) and providing product and transaction info at each sale info, in paper or electronic format with lot level info, in paper or electronic · Ultimate goal is to prevent counterfeit substances from entering USA à notify FDA if found · Dispensers are also required to send tracing info to subsequent owner (i.e. when transferring a med from one pharmacy to another) o Several exceptions apply: not required when the tracing info is for a specific patient's Rx, product returns, or intracompany distributions