NC MPJE
Product tampering
Federal Anti-tampering act requires manufacturers to package OTC drugs in tamper-evident packaging
Health Insurance Portability and Accountability Act (HIPAA) of 1996
Regulated the privacy and security of health information; prohibits discrimination in health coverage
Automated Dispensing or Drug Supply Devices
"A mechanical system that performs functions relating to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls, and maintains all transaction information" (i.e. Pyxis!) P-M should develop policies/procedures, QA program, multidisciplinary program Only accessed by authorized personnel Medication order needs to be prospectively verified by the pharmacist before the nurse removes the drug (EXCEPTIONS: override medications, physician controlled medications) - pharmacist can retrospectively review order May be stocked by a non-pharmacist but must be supervised either by a) Pharmacist conducts/documents daily audit of drugs placed or to be placed in ADD (may include random sampling) b) Using bar code, electronic verification, or similar technology (still requires an initial and quarterly QA review by a pharmacist that is documented/recorded) c) Tech check tech (hospital pharmacies only) *Transaction records must be kept for 3 years for any ADD *Medication reuse is permissible assuming drug's purity, labeling remains *Must be located in a facility with a pharmacy permit
Drug Samples
"A unit of drug not intended for sale and intended to promote the sale of the drug product" -Pharmacies are prohibited from receiving or dispensing drug samples -Prescribers do NOT need to apply for a pharmacy permit if they are merely "handing out" drug sample ***However, they must still follow all applicable laws for dispensing prescription drugs (i.e. packaging, labeling, and record keeping requirements, child-resistant containers, counseling, DUR, etc.) -A manufacture may distribute a complimentary sample of a CS to a practitioner ONLY AFTER the physician makes a written request ***This request should include names & addresses of manufacturer and practitioner; name & quantity of CS requested; AND the manufacture must then keep this request for 2 years
Prescriptions refills for non-CS
"PRN" allows for 1 year's worth of refills "PRN x 5 years" would allow for 5 years worth If non-CS, refills are good longer than 1 year if the patient has not used them A patient may receive drug quantities in excess of the face amount of the Rx for NON-CS, up to the total amount authorized (EXCEPT CS or psychotherapeutic drugs without authorization from prescriber)
Responsibilities of Pharmacist-Manager
"Person who accepts responsibility for operations of a pharmacy" Must be present for at least half of the hours of operation OR 32 hours a week, whichever is less A pharmacist may serve temporarily as Pharmacist-Manager for not more than 90 days who must be present for at least 20 hours a week in the pharmacy If there is a change in ownership or change in pharmacist-manager, the new pharmacist-manager must conduct an inventory of all controlled substances within 10 days (signed, dated, kept for 3 y) Notify the BOP of any change in pharmacy personnel within 30 days Develop and implement a system of inventory record-keeping and control that will identify discrepancies of CS asap Prepare a plan for natural disaster Separate from the dispensing stock any products that are >6 mo out of date Maintain documentation of alleged medication errors leading to physician/ED visit, hospitalization, fatality Report to the Board within 14 days of becoming aware of a drug dispensed by the pharmacy that has caused or contributed to the death of patient or customer
Pseudoephedrine, ephedrine, or phenylpropanolamine
"Scheduled listed chemical product" Law only applies to OTC sale (not Rx orders) Law limits OTS sale to no more than 3.6 gm to a single purchase per day (max 9 g within 30 days; max 7.5 gm per 30 day by mail order) ***Note that the NC law does not apply to products in form of liquid, gel capsule, or pediatric product BUT Federal law still does, so they are ALL still LIMITED but by federal law *Must be at least 18 y to buy OTC *Pharmacies must post a sign notifying purchases of these regulations *Products must be stored and sold behind the pharmacy counter *Pseudoephedrine products must be packaged as blister-packs
Pharmacy Technician Duties
"may perform technical functions to assist the pharmacist in PREPARING and DISPENSING Rx medications" Prohibited activities: patient counseling, dispensing **Technicians must be certified in order to receive called-in prescriptions or call for refill authorization
Exceptions to the definition of marketing
(all related to tx of pt): face to face communication to individual about their tx, case mgmt, care coordination, direct/ recommend alternatives for tx, refer to alternative physician, talk about health related services offered by pharmacy or health plan, refill reminders, communication about recently lapsed prescriptions, adherence communications
Orphan Drug Act of 1983
* Provides tax & licensing incentives for manufactures to develop and market drugs for rare diseases
Reporting breach of PHI
**Covered entities must notify affected individuals following discovery of breach without delay and no later than 60 days after the discovery either by mail or electronically *Also notify DHHS secretary no later than 60 days after the end of the calendar year in which it was discovered * If more than 500 individuals are affected, notify the media and DHHS without delay and no later than 60 days *In NC, a breach of PHI requires notification to the affected person and the NC Attney Gyn Consumer Protection Division without delay (if the breach involves >1000 persons, all consumer reporting agencies must be notified)
Requirements for Wholesale Distributors
-Suitable security, storage, facilities -Must visually examine each outside shipping container upon receipt -Quarantine and physically separate Rx drugs that are outdates/damages, misbranded, adulterated -Subject to inspection -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 (for 6 years per DSCSA) Establish, maintain, and adhere to written procedures for the receipt, security, storage, inventory, and distribution of Rx drugs -Keep a list of responsible persons
Fax and electronic Rx's
-Transmitter's phone # should be identified, time and date of transmission, pharmacy received, transmitted by an authorized practitioner or their designated agent (agent's name must be on order) IF a refill order, prescribers signature is not needed
Confidentiality of Alcohol and Drug Abuse Patient Records
**The health records of patients receiving treatment for substance abuse are subject to STRICT privacy rules (more strict than HIPAA) The following privacy standards only apply to patients in a substance use disorder treatment program that is "federally assisted" and meets definition of "part 2 program": a) Prohibited to disclose or redisclose any information that might identify an individual as having a SUD (unless patient has consented) b) Pharmacists must adhere to the following regulations for Rx for medications used to treat SUD: -Prescribers should obtain written consent from patient to allow communication with pharmacy -Prohibitions on redisclosure of patient information by pharmacist if Rx is directly transmitted -If Rx is delivered by patient, the above rules do not apply -Patient identifying information may be disclosed to medical personnel to the extent necessary to meet a bona fide medical emergency (must document disclosure)
Automated dispensing devices in LTCF
*An ADD can be installed in a LTCF by a retail pharmacy registered with the DEA (this ADD can contain both CS and non-CS) The pharmacy controls the system remotely and dispenses drug on a single-dose basis (pursuant to Rx) and the LTCF access the ADD ***The retail pharmacy that installs the ADD must have a separate DEA registration at LTCF and can keep the records for this at the pharmacy Per NC law, the LTCF must have a pharmacy permit from BOP in order to have an ADD at LTCF (but can be "limited-service permit")
Transfer of Business
*If transferring business operations to another pharmacy (that is also registered with DEA), then submit proposal at least 14 days prior to transfer (name, address, DEA #, and authorized activity of both; old location vs. new location, date on which transfer of CS will occur) *To transfer CS, complete inventory must be taken ON date of transfer; CII must be recorded on DEA Form 222; CIII-CV can be recorded; both pharmacies keep copy -Any records regarding CS must also be transferred **Record accuracy remains with transferor, record custody goes to transferee
Administrative Hearings General Information
-All administrative hearings shall be conducted by the Board, a panel consisting of a majority of members of the Board or an administrative law judge (when a majority of the Board is unable or elects not to hear a contested case, then an administrative law judge presides at the hearing) -A person may petition the Board to intervene in an administrative hearing (person not involved in the hearing may want to provide statements for or against the person involved in the hearing) -A Board member may disqualify themselves from hearing the case or any party involved in the case to disqualify a Board member (the rest of Board will then decide whether or not to disqualify -A person may request for subpoenas for the attendance and testimony of witnesses or for the production of documents -Any party may be a witness and may present witnesses on the party's behalf at the hearing (all testimony at the hearing is under oath and recorded) -Final decision: the Board will issue its decision within 60 days after its next regularly scheduled meeting following the close of the hearing; If an administrative law judge conducts the hearing, they come up with a "proposal for decision" within 45 days of the hearing & the Board then has 60 days to make a final decision -If the party wishes to appeal the decision, a petition must be filed within 30 days of the decision (appealed for judicial review at a superior court, then appellate court)
Embargo
If an authorized representative of the Board has cause to believe that an drug or device presents a danger to public health, they may attach a notice with a warning to not move or dispose of the time, seize the item, and/or petition for removal and/or destruction of the product
BOP Administrative Process
-Any party that the Board is taking action on has the right to an administrative hearing -Prior to this administrative hearing, an informal meeting may occur with the intent of resolving the dispute (and skipping the administrative hearing) with the party and a member of the Board (this meeting may result in in dismissing the dispute, resolving the dispute by consent, or moving forward with the administrative haring, or simply the issues brought up) -If the dispute is dismissed or resolved, it must still be approved by the full Board (although the member that went to informal meeting cannot vote OR participate in the administrative hearing if one occurs) -A party can also request to have an administrative hearing with with the Board if they believe their individual rights, duties, or privileges have been affected by Board's actions (but has not received notice of a right to an administrative hearing) and must be submitted to the Board's office WITHIN 60 days of receipt of notice of the action taken by the Board which is challenged; The Board can either grant or deny this request (either a denial letter w/ rationale will be sent within 60 days of the submission OR if granted, they will send a notice of a hearing at least 15 days prior to the date of the hearing)
Requirements of a prescription
-Date of issuance (NO pre/post-dating) -Name & address of patient (may be stored in data file by pharmacy in lieu of appearing on Rx) -Drug name, strength, dosage form, quantity prescribed, directions for use -Number of refills (outpatient) or stop date (for institutions) -Route of administration (can be stored) -Name, address, telephone number of prescriber (may be stored) -Legal signature of prescriber (written/fax); must be signed on day of isssuance -DEA # of prescriber if applicable (can be stored) -Name of prescriber -Date of dispensing (*for CS) *Prescribers in armed services, Public Health Service, or Buraeu of Prisons must state their branch of service or agency, their service ID number (in place of DEA registration #), printed name, and signature on Rx *If Rx is written by a PA/NP/CPP, prescribing/license/approval # should be on Rx (different from DEA #) *NP/PA must also write supervising physician's name on the Rx *If you copy a CS Rx - write "copy- for information only" on it *Other medications may be written on the same Rx as CII medications *Prescription blanks for CS may not be pre-printed -Only a pharmacist of bona fide employee of pharmacy can accept Rx from a patient
Other regulations for any type of compounding:
-Manufacture of bulk substances must be registered with FDA and must send a valid certificate of analysis with each bulk substance -Ingredients (other than bulk) must comply with USP/NF standards -Cannot use drugs withdrawn from market due to being found to be "unsafe" or "not effective" -Cannot compound a drug product that has been deemed as difficult for compounding by FDA -Cannot compound "essentially a copy of a commercially available drug product" regularly or in inordinate amounts *Exception: making a change for an individual patient has made a clinical difference between the two products as determined by prescriber (document reason on Rx)
Medication Orders
-Medication dispensed only with order (EXCEPTIONS!) -Oral orders should be recorded immediately and signed within time frame established -Medical staff should agree on abbreviations used in orders -Medication orders shall contain: patient's name, location, other identifying information, medical name, strength, dosage form, route of and administration instructions, discernible quantity to be dispensed (if not indicated, then default is 30-day supply), date, prescriber's signature/verification *Measures must be taken to avoid indefinite, open-ended medication orders: routine monitoring of a patient's drug therapy by pharmacist; a healthcare facility approved automatic stop order policy, automatic cancellation or orders after a predetermined time interval
In order to operate as an Internet Pharmacy in NC the following regulations must be followed:
-Must be certified by the NABP as Verified Internet Pharmacy Practice Site (VIPPS) -Provide NC BOP with names of corporate officers and stakeholders + provide % of annual business conducted over internet + internet-related pharmacy activities are communicated on the pharmacy permit application -Additionally, if the Internet Pharmacy dispenses CS: notify DEA and each state BOP within 30 days of starting; register for DEA # (modified); website should contain a declaration of compliance with law, contain information about the pharmacy and PIC, list of states pharmacy is licensed in, statement about dispensing CS; report on monthly basis to the DEA the amount of each CS dispensed if 100 or more CS Rx's are filled; or 5,000 or more dosage units dispensed on all CS combined (this includes ALL CS, including if not internet) *if amounts are less than these thresholds, a report is still required that indicates a negative response & is due on the 15th of each month
Ordering of CIII-CV drugs
-Must keep receipt/invoice of drugs received and confirm accuracy of order in a way that is retrievable (and identifiable from non-CS if they are on the same invoice)
Nuclear Pharmacy
-Obtain licenses issued by Nuclear Regulatory Commission (NRC) and other state regulatory agencies as required (NC Division of Radiation Protection) -Obtain a Nuclear Pharmacy Permit from NC BOP Person seeking the permit shall be a "qualified nuclear pharmacist" (board certified by BPS OR meet minimum standards of training for "authorized user status" from the US Nuclear Regulatory Commission or the appropriate state nuclear regulatory agencies) ****this entails min. of 200 contact hours of instruction in nuclear pharmacy from an approved college of pharmacy AND min. of 500 hours of clinical nuclear pharmacy training under supervision of qualified nuclear pharmacist
USP 800 Compounding Requirements
-Separate rooms for sterile and non-sterile compounding is recommended -Sterile and non-sterile HDs must be compounded within a C-PEC (ventilated device) located in a C-SEC Non-sterile HD: Class I Biological Safety Cabinet (BSC) or Containment Ventilated Enclosure (CVE); A Class II BSC or compounding aseptic containment isolator (CACI) may also be used Sterile HD: ISO Class 5 or better air quality, such as Class II or III BSC or CACI; CSEC may either by an ISO Class 7 buffer room with an ISO Class 7 ante-room (preferred) or an unclassified containment segregated compounding area (C-SCA)
Physical Requirements
-Sufficient floor space -Storage space to provide sanitation (moisture control, security, etc.) -Controlled substances shall be stored in compliance with Fed and State laws -All areas occupied by pharmacy, including drug supplies, must remain secured at all times
National Drug Code Number (NDC)
11-digits 3 segments Labeler code 00000- identifies manufacturer or distributor Product code 000- identifies strength, dosage form, and formulation of drug Package code 00 - identifies package sized and type
Continuing Education Requirements
15 hours of Board-approved CE annually 5 hours must be live (in-person or Webinar) Pharmacists may acquire 5 hours of CE for precepting a NC pharmacy student for at least 160 hours Must keep CE records for 3 years (unless using electronic data base ii.e. ACPE or NCAP, subject to auditing) All pharmacists, pharmacies, technicians must obtain NABP # and report number to the Board **Do NOT need to complete CE for 1st renewal if licensed by Examination that year (do need to if licensed by Reciprocity)
Four elements of REMS
4 elements a REMS program may require: medication guide or patient package insert; communication plan (education sent to providers); elements to assure safe use (ETASU - lab monitoring, prescriber requirements, etc.); implementation system (manufacture must somehow monitor compliance to these elements)
NC Board of Pharmacy - Structure
6 members (no more than 2 consecutive 5 year terms) 5 licensed pharmacists + 1 public representative that is NOT a healthcare professional and is appointed by the governor Presidential/VP term is 1 year BOP meets at least twice a year Quorum=4 board members Must keep record of proceedings and registry of all licensed persons and issued permits Annual report is written for the Governor and presiding officer of each house of the General Assembly Executive Director - pharmacist that serves as secretary and treasurer, performs administrative functions, may conduct investigations, file a complaint, and prosecute the offender in a Board hearing BOP has INJUNCTIVE authority (this means it can prevent a person from practicing or a pharmacy from operating) The BOP has capacity to waive enforcement of specific rules under certain circumstances
Corresponding responsibility for CS Rx's
A CS Rx must have a "legitimate medical purpose" which does NOT cloned maintaining addiction Must also be in the usual course of professional practice (meaning a medical/physical exam was performed AND it is in scope of practice) *Pharmacist also has corresponding responsibility
Marketing
A communication about a product or service that encourages people to to purchase or use the product/service *A covered entity must obtain patient authorization for any use or disclosure of PHI for marketing purposes KEY: any communication that meets the definition of marketing is not permitted, unless the covered entity obtains an individual's authorization (must be detailed description of disclosures and include patient, signature date, and expiration date)
General Principle for Use and Disclosures
A covered entity may not use or disclose PHI except either: 1) as the Privacy Rule permits or requires 2) As the individual (or their representative) authorizes in writing
Distributions of CS from a Dispenser to a Practitioner
A dispenser may distribute (sell) CS to a practitioner for purpose of general dispensing by practitioner to patients Recipient must be registered with the DEA to dispense to dispense CS *A practitioner may NOT obtain CS by writing a Rx "For Office Use" *Pharmacy must use DEA-222 form if selling CII to practitioner *Pharmacy must use an invoice for CIII-CV Total # of dosage units distributed to practitioners must NOT exceed >5% to total number of dosage units of CS distributed and dispensed by the pharmacy during each calendar year (OR ELSE they would have to register as a "distributor")
Instances where reporting of Rx information is NOT required by the dispenser
A licensed hospital or LTC dispensing for inpatient administration A wholesale distributor Dispensed directly to ultimate user and quantity does not exceed that of a 48-h supply Samples of CV non-narcotic, non-anorectic CS
Exercise of professional judgement
A pharmacist can refuse to fill an Rx if it is against professional judgment A pharmacist SHALL not fill an order if there is question in its accuracy, validity, authenticity, or safety
2:1 Ratio
A pharmacist may NOT supervise more than two pharmacy technicians at a time in a pharmacy -They can petition to increase the ratio -Any additional technicians must be CERTIFIED
Biosimilar Substitution
A pharmacist receiving an Rx for a biological product prescribed by its brand name may dispense any INTERCHANGEABLE biological product (However, if DAW, brand name must still be dispensed) *The pharmacist must notify the prescriber "within a reasonable time" if dispensing an interchangeable biological product (include product name and manufacturer) Note that notification is not required if a refill prescription is not changes from the product dispensed on the prior filling of the Rx
Proof of identification
A pharmacy can demand proof of identification when filling a prescription and can refuse to fill an Rx (i.e. concern of fraud, illegitimate, etc.) but refusal to fill should be noted on the prescription
LTCF emergency kits
A pharmacy may place an emergency kit with CS in a non-DEA registered LTCF Pharmacy is responsible for the kit and must be registered with the DEA ***Emergency kits follow the same regulations as Auxiliary medication inventories (i.e. an Rx is still necessary) Note: An ADD can be used as an emergency kit ***Can contain NO MORE than 7 CS drugs (CII-CV) & no more than 5 doses of each controlled substance for each 50 licensed beds (can be same or diff concentrations/strengths) -CS for emergency use shall be in a single-dose form -Securely locked and secured, limited to authorized personnel **The pharmacist-supplier of the the kit shall have primary responsibility for the proper control and accountability
Records of Theft or Loss
A pharmacy that discovers the theft or significant loss of controlled substances must notify the DEA within ONE day of discovery Pharmacist-manager must notify NC BOP within TEN days of any theft (controlled or non-controlled) and must fill out "drug disaster and loss report" Registrant must complete DEA Form 106 (available online) and if the loss ends up not being real, need to contact DEA and let them know why you are not filling out 106 Miscounts or errors should be logged but do not need to be reported If a transit shipment failed to reach pharmacy, supplier is responsible; If pharmacy signs for a shipment but then discovers a loss, the pharmacy must complete a DEA Form 106 Loss or theft of pseudoephedrine must be reported to local DEA office within 15 days (DEA form not required) Breakage or spillage is not a "loss"
Internet pharmacies
A pharmacy that maintains an Internet web site for the purpose of selling or distributing Rx drugs ***It is illegal to dispense any CS by means of internet unless online pharmacy holds a DEA registration ***Internet-based Rx's generated without a physical exam or a prior prescriber-patient relationship are NOT VALID (for CS and non-CS) The DEA considers a valid Rx to be one that has been issued by a practitioner who has conducted at least one in-person medical evaluation on the patient and is for a legitimate medical purpose
Naloxone
A practitioner acting in good faith and exercising reasonable care may directly or by standing order prescribe an naloxone to: a person at risk, caregiver of person at risk, govt or non-govt org than then distributes it The NC Health Director has issued a statewide standing order which a pharmacist can use to dispense naloxone to anyone listed above The person who was dispensed naloxone to receive training in administering it Practitioner, dispenser, organizations and person administering naloxone are immune from civil or criminal liability
Responsibilities of the nuclear pharmacist
A qualified nuclear pharmacist is the responsible person for a nuclear pharmacy and must be present at all times *In emergency situations, a designated qualified professional may prepare single doses of radio-pharmaceuticals (according to written policies & such emergencies must be documented) Maintain records of acquisition, inventory, and disposition of all radiopharmaceuticals Radiopharmaceuticals must be dispensed pursuant to an Rx 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 quality assurance
Local Health Department Clinics
A registered nurse may dispense Rx drugs and devices in this setting (NOT CS) The nurse must have training in labeling and packaging Dispensing only occurs for patients of health department *Exception: epinephrine and naloxone may be dispensed to anyone! Clinic should have a pharmacy permit and have written procedures for storage, package, labeling, and delivery of Rx drugs & clinic must also secure pharmacist-manager The pharmacist-manager should review dispensing records AT LEAST WEEKLY and must review within 24 hours if the health dept dispenses to more than 30 patients within a 24 hour period Dispensing is limited to drugs and devices in a formulary approved by the BOP (TB, STDs, contraceptives, etc.)
Central Filling of Prescriptions
A retail (originating) pharmacy sends a new or refill Rx (including CS) to another pharmacy (Central Fill pharmacy) to process, which then delivers the filled Rx back to originating pharmacy who then dispenses it to patient *the two pharmacies must have a contractual agreement or a common owner and must share a common, electronic file (I.e. these are not "transferred" Rx's!) -Central fill pharmacy can be in another state -Corresponding responsibility doctrine applies to pharmacists at both pharmacies -Pharmacy label should have both pharmacies information -Patient should be provided with contact information in case of questions -Originating pharmacy maintains original Rx and counsels
Auxiliary Medication Inventories
A secured, segregated source for drugs when pharmacy is closed or pharmacist unavailable; only has amounts sufficient to meet immediate therapeutic needs of patients; listing of drugs contained inside P-M & medical staff put together of list of drugs/devices that may be stored in aux med inventories Drugs still need to be labeled with name, strength, lot #, manufacture, and expiration Records of withdrawal should be kept (date, who removed, for whom it was removed, what was removed) and P-M should monitor for compliance with policies
CIVs
BZDs Chlordiazepoxide Barbital Phenobarbital Fospropofol Methohexital Meprobamate Methohexital Butorphanol Carisopradol Tramadol Tramadol/APAP Eluxadoline Modafinil Phentermine Lorcaserin Suvorexant Zaleplon Zolpidem Eszopiclone
Requirements to become Clinical Pharmacist Practitioner (CPP)
Active and unrestricted NC pharmacist license Submit application, fee, and any other information to the Pharmacy Board; signed written CPP agreement; Meet one of the following qualifications: BPS cert or ASHP accredited residency program with 2 years clinical experience approved by Boards OR PharmD and 3 years of clinical experience and completion of ACPE approved certificate program in area of practice OR possess a BSPharm and 5 years of experience and competition of 2 ACPE certificate programs with at least one program in the area of practice
Acute pain prescriptions for targeted CS
Acute=expected to last 3 mo or less Acute pain Rx cannot exceed 5-day supply **initially** unless it is for post-operative pain, which can be for a max of 7-day supply (doesn't apply to inpatient and pharmacists will not be disciplined if they dispense an Rx in violation of this rule)
Who is exempt from DEA registration?
Agents or employees of registrants, drug reps, common carriers, ultimate users, prescribers or dispensers in the service of the US government, and law enforcement officers Practitioners who are employees of a hospital or other institution may administer, dispense, and prescribe CS without personally registering with DEA provided ALL requirements are met: usual course of practice, authorized by the state to do so, hospital has verified the practitioner is able to do so, institution has a specific internal code # to the practitioner as a suffix to the institution's DEA #
Anabolic Steroids Act of 2004
All anabolic steroids are Schedule III
What are the USP<797> certification requirements for Sterile compounding facilities?
All certification testing and documentation must be compliance with USP Chapter <797> in accordance with Rule 21 NCAC 46.2801. The Pharmacy Manager and/or Designated Compounding Pharmacist should review certification and environmental sampling reports to ensure that appropriate tests are performed and are in compliance with USP Chapter <797> and that the results are compliant with the action levels set forth in USP Chapter <797>. The link below provides guidance on Certification tests and documentation that is required for a sterile compounding facility and sterile compounding equipment. It also provides guidance on environmental sampling and documentation requirements that meet USP Chapter <797> and Rule 21 NCAC 46.2801:
Labeling
All drugs dispensed must be levels and identified up to the point of administration Labeling requirements for healthcare facilities in NC are same as prior discussed for Rx drugs *When a drug is added to a parenteral admixture, it shall be labeled with a distinctive supplementary label indicating name and amount of drug added, expiration date, expiration time if applicable For compounds: identified of person who prepared compound, pharmacist who verified, expiration date, storage requirements, appropriate packaging/ labeling for hazardous materials
Who must comply with HIPAA?
All health care providers (prescribers, pharmacies, pharmacists), health plans, personnel that conduct transactions electronically, and health care clearing houses (billing services) that use, store, maintain or transmit health info *Covered entity may exempt non-health care parts of its operation (i.e. pharmacy within a grocery store)
Prescription Drug Marketing Act of 1987
Bans sale, trade, or purchase of prescription drug samples; Established sales restrictions and record keeping requirements for Rx drug samples; Prohibits hospitals and other health care entities from reselling their Rx drugs to other entities; Requires state licensing of wholesalers; Bans re-importation of Rx drugs except by manufacturer
Pharmacy Quality Assurance Protection Act
All pharmacies must participate in QA program that evaluates: -Quality of practice, cause of medication errors and incidents, patient care outcomes, possible improvements, and methods to decrease errors and incidents. -Proceedings of a pharmacy QA program, records, and materials are confidential (not subject to discovery in a civil action) however information about QA that would otherwise be available can still be used in civil action -A person in attendance at a QA meeting is not required to testify in a civil or administrative action however they may testify (cannot be asked about testimony before QA program); there are rare instances where information from a QA meeting may be disclosed -The BOP is allowed to obtain information about a medication error for an investigation or complaint -If asked by BOP, pharmacy must provide documentation within 10 days of any error or incident committed in preceding 12 months IF the error led to physician visit, ED visit, hospitalization, or death OR if the BOP initiates a disciplinary proceeding against the pharmacist as a result of the investigation
Multiple CII Rx's on same day
Allowed but must be legitimate purpose, each Rx is separate, total quantity cannot except a 90-day supply, must have "Do Not Fill Until" date
Drug Supplies and Medical Device Repository Program
Allows an eligible donor to donate unused drugs, supplies, or devices to free clinic OR pharmacy Donor=patient, patient's family member, manufacture, wholesaler, pharmacy, free clinic, hospital, nursing home, hospice care program Any pharmacy or free clinic holding a NC pharmacy permit can accept and dispense donated drugs A pharmacy or dispensing physician wishing to participate must notify the Board in writing at time participation begins (and notify Board annually on permit or registration renewal); Free clinics must also register for a pharmacy permit or "limited pharmacy service permit" A dispensing physician registered with the Board who provides services to patients of a free clinic that does not have a pharmacy permit can still accept and dispense donated drugs *All donated items should be stored separate from other inventory *Manufacture, pharmacy/free clinic, pharmacist, practitioner, and donor are all immune from civil liability
Drug Addiction Treatment Act of 2000
Allows office-based opioid addiction treatment (i.e. Suboxone)
Office-based opioid addiction treatment
Allows qualifying practitioners to prescribe from their office, and opioid in CIII-CV that has been approved by FDA for opioid addiction -Must apply for a waiver, be registered with DEA, and licensed by state Medical Board, complete approved training or have certain qualifications, register with the NC dept of health & human services; -Practitioners are given a "unique identification #" after waiver is approved (begins with X) -This # must be on Rx (along with DEA #) -A qualifying physician (MD or DO) or NP/PA (in collaboration with physician) may not treat more than 30 patients in the first year, can then petition to treat up to 100 patients (physicians can also petition to treat 275 after that year but they are required to practice in a qualified setting or hold board certification) *If a buprenorphine product is prescribed off-label for pain, it does not need X# *Prescribing or administering narcotics to maintain addiction is illegal outside of methadone clinics but exceptions include: a physician may administer from his/her office supply (but NOT prescribe) narcotic drugs for 3 days while arranging for referral (only 1 day supply of medication given at a time); hospitalized patients incidental to treating a condition other than addiction
Conscientious Objection for Emergency Contraception
Although a pharmacist has a right to avoid moral or ethical conflate, they do NOT have the right to obstruct an otherwise legitimate Rx dispensing or delivery solely based on a conscientious objection (i.e. Board interprets this as you can object but you are obligated to find them another option i.e. send to another pharmacist/pharmacy)
Emergency CII Rx
An emergency CII Rx can be called in but quantity limited to emergency period and Rx has to be reduced to writing and & prescriber has 7 days to get a written, signed Rx to pharmacy (can be mailed or electronic as well) and should state "Authorization for Emergency Dispensing" and pharmacist should keep both Rx's and notify DEA if no Rx is received
Renewal of DEA registration
Annual for manufacturers and distributors Every 3 y for for dispensers (pharmacies) and practitioners *must maintain certificate of registration at the registered location
NCPHP Confidentiality
Any confidential patient information and other non-public information acquired, created, or used in good faith by a peer review program shall remain confidential and shall not be subject to discovery or subpoena Participation with NCPHP is kept confidential and that information is not relayed to anyone without released authorization (including Board) HOWEVER there are instances in which this anonymity is broken (i.e. for patient safety, if you are unable to remain abstinent, refusing treatment, etc.)
Electronic Recordkeeping
Any documentation required by the NC BOP may be electronically created and maintained as long as the system is secure, has daily back-up, and records can be printed within 48 hours *Unless otherwise prohibited by another law/rule (i.e. Federal)
Health Care Facility
Any organization whose primary purpose is to provide a physical environment for patients to obtain health care services (hospital, LTCF, mental health facility, drug abuse treatment center, penal institution, hospice) *Healthcare facility pharmacy: pharmacy permitted by BOP that provides services to a Health Care Facility (must be registered with BOP) *Health care facilities that ONLY administer drugs are exempt from registering as a pharmacy but must secure pharmaceutical services though a licensed NC pharmacist
Out of State Pharmacies
Any pharmacy operating outside of NC which ships, mails, or delivers in any manner a dispensed legend drug into NC must obtain a pharmacy permit from the BOP (although that particular pharmacist does not have to be licensed in NC) Subject to NC BOP jurisdiction Shall comply with regulations of of the state in which the pharmacy is located Shall maintain records of Rx drugs dispensed to NC residents
May registered nurses (RNs) dispense antivirals from health departments?
Board Rule .2403 provides that properly trained RNs may dispense certain types of prescription drugs from health departments. Antivirals are not among the types listed. Board staff, however, has no objection to properly trained RNs dispensing antivirals as needed to treat H1N1 flu. Such dispensing is clearly a benefit to the public health and safety and well within the spirit of Rule .2403.
Electronic-prescribing of CS
Application systems must be approved by DEA or third-party audit Prescriber requirements: 2 of 3 of the following for authentication (password, biometrics, token) and should still contain all required information Pharmacy requirements: application must digitally sign and archive an Rx on receipt and back up records daily; can still make changes to e-prescription the way you can with hard copy *If prescription transmission fails, prescriber can print out copy but indicate that it was transmitted electronically and failed AND the pharmacist must make sure it was not received (have other pharmacy void) AND/OR dispensed by another pharmacy (you void)
Medication Guides (MedGuides)
Applies to certain drug and biologic products that FDA determines "pose a serious and significant public health concern" List of drugs requiring a MedGuide is available on the FDA website Medguides required if: could help prevent serious AE, serious risks patient should be aware of, patient adherence to directions is critical The manufacturer provides MedGuides to pharmacies Responsibility of pharmacy to dispense those MedGuides to the patient: -Community pharmacies: every time the medication is dispensed, anytime the patient requests a MedGuide, and anytime the material in the MedGuide changes -Hospital pharmacies: only if the patient requests a MedGuide or if the medication is in a REMS program (see below) and the REMS program requires providing a MedGuide
Written CPP agreement
Approved and signed by all supervising physicians and the CPP, retain copy in each practice site Be specific in regards to people, patient, diseases/diagnoses, drug therapy, modifications, dosage forms, osage schedules, tests *Prohibits substitution of a chemically dissimilar drug product by CPP without first obtaining written consent form physician *Should include a plan and schedule for meetings to discuss the operation of the CPP agreement and quality improvement measures (monthly for first 6 months, then every 6 months thereafter + documentation that includes signed and dates by those in attendance, clinical issues discussed and actions taken, retained by both CPP and supervising physician for 5 years *Include a pre-determined plan for emergency services and physician consultation *Require that the patient be notified of the collaboration *Terminated when the patient care is transferred to another physician
Epinephrine Rx's for Child-Serving Entities
Are allowed per BOP (can be for a school sample, day care facility, etc.)
If a provider prescribes Concerta and authorizes generic substitution, what may I substitute?
As noted above, the Actavis marketed generic is the only AB-rated equivalent product to Concerta
DEA Form 222 Power of Attorney
Assigned by person that most recently signed application for DEA registration or renewal (2 witnesses required) PoA works for 222 forms or CSOS *PoA does not have to be located at location & can be multiple people *PoA forms must be kept with executed 222 forms *PoA can be revoked by person who granted it
Syringe sale in NC
Available OTC without an Rx Syringe exchange programs are legal in NC NC statute on drug paraphernalia prohibits the distribution or sale of syringe if its known that they will be used for illicit drug purposes (with the decision to sell syringes left up to the pharmacist)
BOP Disciplinary Authority
BOP may issue following disciplinary actions: A letter of reprimand Suspension (active suspension for a specified amount of time vs. stayed which is probation for a specified amount of time in which pharmacist cannot violate any laws but can continue practicing, usually after active suspension is over vs. summary or immediate suspension of license BEFORE hearing) Revoke: license withdrawn from Board (MAY be able to apply for licensure or petition for reinstatement but Board can prohibit this) Restrict: some form of restriction (i.e. cannot be manager, cannot precept, etc.) Refuse to grant or renew a license of pharmacy permit Require remedial education *NO clause about "good moral character" or "unprofessional activities"
Disasters and Emergencies
BOP may waive pharmacy laws in order to permit the provision of drugs, devices, and professional services to the public -PIC shall report within 10 days to the BOP any disaster, accident, theft, or emergency which may affect the strength, purity, labeling of drugs and devices (controlled or non-controlled) -Insurances companies must still pay pharmacies in cases of "refill too soon"
Requirements for Pharmacist Licensure
By examination (graduated from approved SOP, pass NAPLEX and MPJE within 2 years of applying, 1500 hours of practice experience which can be from school APPE/IPPEs, criminal record) *Max 5 attempts on NAPLEX/MPJE By reciprocity (must be licensed in another state + pass NC MPJE, complete licensure transfer application through NABP, submit criminal record report) *If you have not practiced pharmacy within 2 years of application, there is an additional CE requirement, additional practical experience, complete one or more parts of NAPLEX, or any combination of these as determined by the Board Foreign graduates must pass FPGEE and complete 1500 Board-approved practical hours as a Pharmacy Intern, test of english, test of spoken english, pass NAPLEX, MPJE
Targeted controlled substances
CII opioid or CIII opioid (buprenorphine and codeine combination products) *Starting Jan 1, 2020, electronic Rx required *Exceptions: practitioner (not RPh) dispensing directly to patient, Rx for inpatient administration, including nursing home, LTCF, hospice, technological failure, Rx will be dispensed from a pharmacy on a federal property, vets *However, if a pharmacist received a paper Rx for targeted CD, they are NOT required to verify that the provider falls under one of these exceptions
Transfer of CS Rx's
CIII-CV Rx's may be transferred one time only Pharmacies who share a real-time, online data base (i.e. within their company) can transfer CIII-CV up to max # of refills Transfers for CIII-CV MUST be completed by two licensed pharmacists Electronic CS Rx's may be transferred electronically For CS Rx's on hold (not yet been filled), only electronic prescriptions can be "forwarded" to another pharmacy *all requirements for transferring Rx's can be fulfilled using computer system without reference to original Rx however system must be able to identify transferred Rx's and present subsequent Rx refills at that pharmacy
How can Rx drugs be tracked?
Can be traced to package level throughout the entire drug supply chain (manufacturer to wholesaler to pharmacy) using 3 Ts Transaction history Transaction information Transaction statements *Transaction records must be maintained for 6 years after transaction *Dispensers are required to send tracing information to a subsequent owner (such as transferring a medication from one pharmacy to another to replenish their inventory) but there are several exceptions (i.e. if it is for a specific patient's Rx, returns, or intracompany distributions)
CIII, CIV, and CV Rx's
Can be written, faxed, oral, electronic CIII & CIV=6 month expiration CIII & CIV may be refilled up to 6 mo after date of issuance or 5 times, whichever is first Can do partials for CIII & CIV *There are no refill restrictions for CV's!
Electronic CS ordering (CSOS)
Can order any CS (CII-CV) Registrant or PoA must obtain a digital certificate for each DEA registered location Registrant must either appoint a CSOS coordinator to manage issuance, revocation, and changes to digital certificate or serve as CSOS coordinator themselves Digital certificate is valid until DEA registration expires (& then must be renewed) *Same requirements as DEA 222 forms
NP/PA prescribing rights
Can prescribe CS's as long as in their collaborative practice agreement (must still be registered with DEA)
Procedure of drug disposal - non-CS
Can return to manufacturer, incinerate at a facility, or another means approved by Board -destruction of medications but be witnessed by a licensed pharmacist and documented -A form available in Board website that must be filled out (pharmacy, pharmacist-manager, pharmacist witness, drugs to be disposed, etc. ) and once approved by the Board, the disposal can take place
Sale of Certain CV's OTC
Certain C-V are not Rx drugs (Cheratussin AC) and may be sold OTD provided: dispensing is done by a pharmacist (someone else can be on register); for legitimate medical purpose; 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 any other CS may be dispensed to the same purchase within a 28 hour period); purchase must be 18 y; purchase must have identification *Sale should be recorded in record book (name & address of purchaser, name and quantity of CS, date, identification of pharmacist)
DEA Form 224b
Chain pharmacy renewal
Product recalls
Class 1 - reasonable probability for serious harm or death Class 2 - may temporarily cause adverse health consequences or remote probability of serious consequences Class 3 - not likely to cause harm
Medical Devices
Class I - manufacturers only need to provide general controls during products of device (i.e. GMP, registration of facilities, prevention of adulteration/misbranding) Class II - requires "specific controls" to be met (performance standards, post-market surveillance) i.e. blood pressure cuffs, syringes Class III - typically require premarket APPROVAL: because the devices are either life sustaining, important in preventing impairment of human health, or a potential unreasonable risk of illness or injury i.e. pacemakers, heart valves, etc.
Key requirements of the Compounding Act
Compounds may only be dispensed pursuant to an Rx for a patient (sterile and non-sterile) -No longer able to compound "for office use only" If you want to compound without Rx --> must be an outsourcing facility Hospitals do not need to register A facility may operate as both a 503A and 503B BUT there must be complete physical segregation
Duties of consultant pharmacist for Nursing Home Advisory Committee
Conduct a retrospective drug regimen review on every patient receiving a medication at least MONTHLY; provide recommendations to physician/nurse and document; ensure all allergies and AE are documented; notify prescribers on orders that are about to expire or fall off; submit a QUARTERLY report to the committee to the committee on any weaknesses in the nursing homes workflow; available for consultation via direct communication at all times hone drugs are dispensed
BOP Inspections
Conducted by the BOP either in response to complaint or routine schedule (ranges annually to every 4 years) Inspectors record and discuss violations with pharmacist on duty & copy is sent to P-M Checklists for inspection can be found on BOP website PM must respond with a corrective action plan regarding severe and/or significant deficiencies identified WITHIN 30 days of inspection *Pharmacy will be re-inspected within 90 days and the BOP may open an investigation if needed
Basaglar
Considered a "Follow-on" biologic (NOT biosimilar and NOT generic substitution) *Therefore, the only way Basaglar can be dispensed is if an Rx is specifically written for Basaglar
Are pre-filled saline/heparin flush syringes treated as prescription drugs or prescription devices?
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.
Adulteration
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 current GMP; strength, quality, or purity differs from compendia standards unless plaining stated on label; container may be poisonous or deleterious to produce i.e. medications improperly stored
Reusing containers
Container may not be re-used unless: container is made of glass or threaded plastic and given a new closure top Otherwise, use new vial and top at every dispensation
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
Substance Use-Disorder Prevention that Promoted Opioid Recovery and Treatment for Patients and Communities Act
Controlled substance prescriptions for Medicare Advantage and Part D will be required to be transmitted electronically beginning Jan 1 2021
A pharmacist may NOT accept the following donated items:
Controlled substances Drug subject to restricted distribution systems (i.e. REMS) Biologicals unless coming from manufacturer or wholesaler Compounded drugs or parenteral admixtures Any drug requiring refrigeration for storage UNLESS donated by the manufacture, wholesaler, or pharmacy that has always stored it accordingly and not previously dispensed the drug to a patient
Food, Drug, and Cosmetic Act of 1938
Core of today's drug laws. No new drug can be marketed/sold until proven safe and approved by FDA. Labels must contain adequate directions for use and warnings about their habit-forming properties.
Policies and Procedures HIPAA
Covered entities must develop policies and procedures and identify a privacy officer to oversee the entity's compliance with HIPAA
Dietary Supplement Health and Education Act of 1994
Created a new category of food called "dietary supplements"; Permits manufacturers to make claims that would have otherwise been illegal under FDCA and forced FDA to regulate dietary supplements more like food than drugs
Patient Safety and Quality Improvement Act of 2005
Creates a voluntary program through which health care providers, including pharmacies, share information related to patient safety events with patient safety organizations
Ordering CII's
DEA form 222 (for distribution, purchase, or transfer of CII) Forms are obtained when registering with DEA Triplicate copy Forms are serially numbered with name, address, and registration number of registrant, activity and schedules of registrant All 3 copies must be executed at same time 10 numbered lines on each form (only 1 item per line) Number of last line noted at bottom of form Required information: name and address of supplier, name of substance, dosage form, number of units or volume in container, number of containers ordered, NDC#, signed and dated by authorized ***Purchaser keeps Copy 3, sends Copy 1 and 2 to supplier, supplier keeps Copy 1, and Copy 2 goes to DEA***
Narrow Therapeutic Index Drugs
Defined as a drug with one of the following: less than two-fold difference in the minimum toxic concentration and minimum effective concentration, exhibit limited or erratic absorption, formulation-dependent bioavailability, and wide intrapatient PK variability that requires blood-level monitoring (i.e. carbamazepine, CSA, dig, ethosuximide, levothyroxine, lithium, phenytoin, procainamide, tacrolimus, theophylline, warfarin *Rx's for NTIs must be refilled with the same manufacturer as in the past UNLESS approval is obtained from the prescriber AND patient (documented consent)
Entities engaged in non-traditional compounding to voluntarily register as "Outsourcing Facilities" (aka 503B)
Defined as a facility that compounds sterile drugs (can also do non-sterile but cannot only do non-sterile) -Allowed to manufacture and send interstate shipments of larger quantities of compounded drugs without prescriptions being used -Not required to be a licensed pharmacy but must be under the direct supervision of a licensed pharmacist -Subject to current GMP, risk-based inspections, reporting amount of compounds dispensed, reporting AE, labeling requirements, and other standards (under FDA jurisdiction) Compounded preparations shall not be offered to other entities for resale May use a bulk drug substance to compound that: Appear on a a list published by FDA called 503B Bulks list; the drug compounded from such bulk drug substance appears on the FDA drug shortage list; Bulk drug substances used must comply with standards with USP/NF if there is a monograph Compounding from "Outsourcing facilities" are exempt from new drug approval process and requirements of "track and trace" In NC, Outsourcing Facilities are required to register as a Wholesaler and would need to apply for a pharmacy permit if they are directly dispensing prescriptions to patients
Breach of PHI
Defined as an impermissible use or disclosure *Pharmacy must determine how it occurred, document, demonstrate why it met exclusion or that there is low probably the PHI has been compromised *Either way, the event must be documented & kept for 6 YEARS ***Exceptions: unintentional acquisition of PHI & PHI is not further disclosed after the incident; an unauthorized person to whom breach was made could not reasonably have retained the information
USP 800
Describes practice and quality standards for the receipt, storage, compounding, dispensing, administration, and disposal of sterile AND non-sterile HAZARDOUS DRUGS identified as such by NIOSH. *Requirement for pharmacies to develop policies/procedures, enforceable by the FDA, BOP, TJC (beginning December 1 2019) *entities must maintain a list of HDs they handle and review their list at least every 12 months or when a new agent or dosage form is used *Each entity must have a "designated person" that ensures compliance with laws and competency of personnel; monitors the facility and maintains reports of sampling/testing; and reports any hazardous situations to management team All personnel handling HD should have initial training and re-assessment every 12 months
Additional USP 800 Requirements
Designated areas must be available for receipt, unpacking, storage, and compounding of HDs (display warning signs); authorized personnel only, away from break rooms/etc Certain drugs (i.e. pills or final dosage forms that do not need manipulation) would not have to follow ALL USP <800> requirements *The pharmacist must have alternate containment strategies and review every 12 mo (i.e. counting or repackaging HDs on a dedicated equipment and decontaminating after every use) Antineoplastic HDs and all HD ingredients used for compounding must be unpacked in an area that is neutral/normal or negative pressure Antineoplastics requiring manipulation and and any HD ingredient used for compounding must be stored separately from non-HDs (externally ventilated, negative-pressure room with at least 12 changes per hour; HDs requiring refrigeration are required to be stored in their own designated refrigerator) Recommended to perform environmental wipe sampling for HD surface residue regularly PPE is required when unpacking, compounding, cleaning, or administering HDs Use needle-less and closed-systems whenever possible
DEA Form 224
Dispenser registration (including both pharmacies and practitioners and institutions)
DEA Form 41
Disposal/destruction of CS
Repackaging in a Hospital or Health Care Facility
Do not need to register as "repackager" Labeling on repacked pharmaceutical shall include: name, strength, quantity, id of manufacture and lot # (can use a "batch # in place of this as long as it can be traced back to manufacture lot #, expiration), expiration date, and any cautionary notations Still requires pharmacist supervision
Is it permissible to compound domperidone?
Domperidone compounding is permissible only as part of an investigational new drug application (IND). Any domperidone product dispensed in the United States outside of an IND is unapproved, adulterated and misbranded under both federal and NC law.
Dispensing donated drugs
Donated drugs are dispensed to an uninsured or underinsured patient who meets the eligibility criteria established by BOP, free clinic, or pharmacy (patient must reside in NC) Pharmacist and free clinic cannot resell the donated item but may charge patient handling fee Must remove any HIPAA protected information from donated items Must note that a donated Rx drug was dispensed either on Rx or in electronic record
340B drugs
Drug manufacturers provide special pricing to designated entities that serve uninsured or underserved populations. Pharmacies may only dispensed 340B drugs to participants of the 340B program.
Prescription Drug User Fee Act of 1992
Drug manufacturers required to pay fees when submitting a new drug application
Records of receipt for CIII-CV
Drug name, dosage form, strength, # of units/volume in container, # of containers, date of receipt, name, address, and reg # of supplier *Invoices and packing slips may be kept in central location WITH notification to DEA (must wait 14 days after notification to do so) + records must be able to be delivered to central location within 2 business days or allow DEA to inspect without warrant
Kefauver-Harris Amendment of 1962
Drugs must also be proven effective (in addition to safe); Transferred prescription drug advertising from FTC to FDA; Established good manufacturing practices; Required informed consent of research participants and reporting of ADRs
Repackaging
Drugs must be repackaged in accordance with US <795> and <797> and should only be dispensed after receiving an Rx or order Nonaqueous formulations: 6 months or exp date of product Water-containing oral formulations: 14 days or exp date of product Water-containing topical/dermal and mucosal liquid and semisolid formulations: 30 days or the exp date of the drug product being repackaged, whichever is shorter BUD for state-licensed pharmacies repackaging sterile products must also assign a BUD: IF drug product specifies a "in use" time, then use that or exp date on product; If no "in use" time, assign BUD according to USP <797> or exp date on drug product
The Board office regularly receives questions on the formula for Duke's Magic Mouthwash. What is the formula?
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 Syrup q.s. ad. 240 ml.
CPP CE
Each CPP shall earn 35 hours of practice-relevant CE each year approved by the Board *15 normal CE hours are included in this (with 5 live), really 20 additional hours (live or correspondence)
Privacy Practices Notice
Each covered entity, with certain exceptions, must provide a notice of its privacy practices (i.e. how the covered entity will protect and use PHI); must deliver this notice to patients no later than the first service encounter *Notice must also be posted at the pharmacy & be electronically available
Must a foreign pharmacy school graduate obtain FPGEC certification prior to obtaining experiential hours toward pharmacist licensure in North Carolina?
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").
Automated Data Processing Systems
Electronic record-keeping system Capable of producing documents of all original and refilled prescription information, including records of dispensing and prescription order information Secure, backed up daily Contains a drug interaction software program Pharmacist who is responsible for completeness and accuracy of data entered in system signs an acknowledgement within 72 hours of dispensing *An "auxiliary record keeping system" is established in the case of inoperability of the automated data processing system (backed up weekly); if used, Rx information from aux record system must be transferred to the automated data processing system **When does data have to be transferred? Inoperable period x 3
Additional USP 800 Requirements for Entities
Entities are required to establish a "Hazard Communication Program" (develop standards of practice; labeling, transporting, storing, disposal; safety data sheets must be on file for each HD and readily accessible; appropriate training for personnel; personnel understands risk (confirm in writing) Entities are encouraged to establish a "medical surveillance" program (identify individuals who handle HDs and monitor their health status for AE) Do NOT place HDs in automated counting or packaging machines; do NOT use pneumatic tubes to transport liquid HDs or any antineoplastic HDs All areas where HDs are handled and all re-usable equipment must must be deactivated, decontaminated, cleaned, and disinfected Spill kits must be available anywhere HDs are routinely handled
Clinical pharmacist practitioner prescribing rights
Essentially same as PA/NP; Medical acts which can be performed include prescribing and CPP's who have CS in their protocol can obtain a DEA registration
Omnibus Budget Reconciliation Act (OBRA) of 1990
Established 3 esssential components: Prospective DUR Counseling by Pharmacist Patient profiles
Over the Counter Labeling Requirements
Established name of drug product, pharmacological category, name/address of manufacturer/packer/distributor, net quantity, expiration date, tamper-evident labeling, "Drug Facts" panel w/ active ingredient, purpose, use, warning, directions, other information, inactive ingredients, questions?
Durham-Humphrey Amendment of 1951
Established two classes of medications (RX and OTC); Authorized oral prescriptions and refills of prescription drugs; Introduced label requirements for pharmacies
Prospective drug review
Evaluating appropriateness of prescribed drug before the Rx is dispensed: 1) Screening (dose, DDIs, allergies) 2) Counseling (offer to counsel on any new Rx or transfer; use judgment if offer to counsel needs to be made for refills; only pharmacist and intern can do the actual counseling; if mail-order, offer can be made by telephone or provide a toll-free # to patients, can give printed information for foreign patients; patient has right to waive counseling and refusals should be documented & kept for 3 years; counseling should be face to face (except inmates; patient counseling of inpatients of a hospital is not required) 3) Patient profile/documentation: Requires pharmacists to make a "Reasonable effort" to maintain a record of significant patient information Information included in patient profile: name, address, telephone #, DOB, gender, disease states, allergies/drug runs, comprehensive list of medication, etc.); pharmacist should review this formation although ancillary personnel can collect it
Mandatory Reporting Requirement in NC
Everyone has a duty to report in cases whether there is suspected abuse/neglect of a child, disabled adult, or elderly adult by a parent, guardian, custodian, or caretaker
Preservation of 222 Forms
Executed DEA 222 forms must be kept separately from all other records and KEPT for 3 years (including unaccepted or defective forms)
What CS records can NOT be kept at central location?
Executed order forms, prescriptions, and inventory records CII records must be maintained separately from ALL other records Records of CIII-CV must be maintained separately from all other records (i.e. non-controls) OR readily retrievable from ordinary business records of the pharmacy (meaning they must be marked in a distinguishing way)
Comprehensive Addiction and Recovery Act of 2016
Extends time frame in which C-II's can be partially filled; Allows NP's and PA's to apply for a waiver to prescribe buprenorphine for opioid addiction
Food & Drug Administration Amendments Act of 2007
FDA may mandate labeling changes related to safety; Require clinical trial data reporting and registries; Require post-market clinical studies to assess risk (Phase 4 studies)
Patient package insert
FDA requires a pharmacy to dispense a manufacturer-provided patient package insert to the patient for certain medications (estrogen containing drugs) *This law applies to inpatient pharmacy & retail pharmacy (inpatient give prior to first administration and every 30 days; retail give with each time dispensed)
Procedure of drug disposal - CS
File a written request on a form provided by the Board for approval of witnesses and method of disposal (form is mailed back to pharmacy) *Two approved pharmacist witnesses required for destruction *Document and sign after destruction occurs, send a copy to the DEA, and retain for 3 years + MUST also fill out DEA Form 41
Process of intervention, rehab, post-treatment
Following an investigation, if impairment is confirmed, an intervention shall be conducted to assist the personnel in acknowledging the responsibility for the impairment Treatment contract will be designed, and monitoring requirements will be mandated (i.e. drug tests) Peer review program submits a QUARTERLY report to the Board on the status of all pharmacists/technicians who have been previously reported by the Board and a MONTHLY report on all pharmacists/technicians reported by the Board in ACTIVE treatment "Pharmacists and pharmacy personnel can self-refer to NCPHP and remain anonymous to the Board" BUT the NCPHP must establish that the patient is safe to practice OR that they have withdrawn themselves from practice while in treatment Pharmacists can get license re-instated if it was suspended on a case by case basis and the NCPHP will make a recommendation to the Board in regards to this; Pharmacists may have to do some or all of the following: complete application, pay fee, CE, continue compliance with treatment program, etc.
New Pharmacy Permit Required
For a new location, a change to a different successor business entity, or a change resulting in a different person/entity owning more than 50% interest in permit holder *If less than 50% ownership change occurs, a new permit is not required but BOP must be notified There is 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 (i.e. change in president of a nonprofit hospital) *New pharmacy permit requires an application (either "re-registration" for change in address or percentage of ownership or "transfer of ownership") + fee *A new pharmacy permit is NOT required if the permit-hold is a publicly-traded corporation and continues to hold permit and if permit holder is a corporation that is a wholly-owned subsidiary and any changes in the ownership is due to the stock being publicly traded
3 categories of immunizations
For patients 18 years and older: Pneumococcal polysaccharide or conjugate; Herpes zoster; Hepatitis B; Meningococcal polysaccharide or conjugate; Tdap etc *Requires a written protocol with a supervising physician who is licensed in and has a practice physically located in NC 14 years and older: influenza vaccine (pursuant to a protocol) Any other vaccine recommended by CDC (not listed before), requires a specific Rx order and a written protocol with a supervising physician (patient must still be 18 y)
May registered nurses (RNs) "compound" Tamiflu suspension if needed?
For pediatric patients who cannot swallow capsules, TAMIFLU® Oral Suspension is preferred. If the oral suspension is not available, TAMIFLU® capsules may be opened and mixed with sweetened liquids such as regular or sugar-free chocolate syrup. Accordingly, there is no apparent need to "compound" Tamiflu suspension from the capsules. Dispensing professionals should simply instruct parents or other patients to open the capsule and mix the contents as described. Dispensing professionals can also provide this service for parents or other patients who need it.
Permitted Uses and Disclosures
For the purposes of treatment (filling Rx's, counseling, contacting prescribers), payment (billing insurance companies), healthcare operations (quality assessment, audits, business management)
What is a "valid prescription"?
Lawful order for a drug, device, or medical equipment issued by a health care provider for a) a legitimate medical purpose b) in the context of a patient-prescriber relationship c) in the course of legitimate professional practice
What are the guidelines on single-dose versus multi-dose vials?
From the Department of Health & Human Services: As the normal saline (NS) 0.9% bags for injection shortage continues, please take a minute to review the One & Only Campaign. The One & Only Campaign is a reminder of the importance for using single dose and multi-dose vials appropriately and the consequences for failing to do so.
Poison Prevention Packaging Act
Goal: prevent ingestions of common substances by children Pharmacists must dispense oral Rx drug sin child-resistant containers Exceptions: Patient requests that the pharmacy dispense their medications in a non-safety containers (or physician can request for a certain Rx only) Sublingual NTG and SL IDN should NOT be a safety cap Certain medications that are not feasible to be packaged in a child-resistant container (i.e. Medrol dose pack, oral contraceptives) Medications stores in pharamcies OTC medications may or may not be
CIIIs
HCG (*unique to NC) Amobarbital, pentobarbital, secobarbital is suppository form or in combination with non-controlled ingredient Butabarbital Butalbital products Buprenorphine Buprenorphine + naloxone Ketamine Codeine and APAP Anabolic steroids Perampanel Dronabinol capsules Sodium oxybate
Incidental Use and Disclosure
HIPAA does not require that every risk of an incidental use or disclose of PHI be eliminated (i.e. patients in the pharmacy may overhear) BUT pharmacies must implement reasonable safeguards (i.e. stand behind this line)
Training of employees for HIPAA
HIPAA is flexible with covered entities creating their own training requirements to fit their standards/needs but must document that each employee has completed training
Requirements to become an immunizing pharmacist
Hold CPR certification Complete certificate program in vaccine administration Maintain documentation of 3 hours of CE (vaccine topics) every 2 years Complete training approved by the Division of Public Health Immunization Branch for participation in the NC Immunization Registry Notify the NCBOP and NC Medical Board of immunizing pharmacist status
Long-term care facilities
Hybrid between hospitals and nursing homes who may or may not be serviced by a pharmacy; laws and regulations are mix between hospital and community pharmacy *Unlike hospitals, LTCFs are generally not DEA registrants (do not main stock of CS) and patients at these facilities are usually seen by personal physicians who prescribe medications, which are then usually filled at retail pharmacies and delivered to the LTCF for patient's use (LTCF holds medications for administration to patient) According to NC law, LTCFs are health care facilities *One key difference on the federal level between LTCFs and hospitals is writing "chart/medication orders" for CS is NOT acceptable in the LTCF setting according to DEA (unless registered w/ DEA) **Practitioners must issue Rx for CS as they would if they saw pt in office **Chart/med orders for NON-CS are acceptable in LTCFs according to state law (assuming they are dispensed by a registered pharmacy in LTCF)
Partial Filling of CII Rx
If a patient or prescriber requests; The total quantity dispensed in partial fills does not exceed quantity prescribed; total amount has to be filled within 30 days from date of Rx *If CII Rx is an emergency oral Rx then pharmacist has 72 hours from issuance of Rx to fill remainder
Out of State Pharmacies should have the following policies in place and do the following
If a patient's medication is not available or if delivery will be delayed beyond normal time Received of an Rx for an acute illness Patient's medication is not received within normal time and the patient is out of the medication Disclose a report of corporate officers, owners, pharmacists, and all supportive personnel (including license numbers if applicable) on an annual basis & updated within 30 days of a major change Submit evidence of a valid and current pharmacy license in the state is is located Prior to original registration, a pharmacist representing owner must appear before BOP Must report to the Board if there is information that a prescription drug or device dispensed from the pharmacy may have contributed to the death of any patient WITHIN 14 days of becoming aware Notify Board WITHIN 5 days of receipt of of any order or decision by a Board imposing any disciplinary action on pharmacy ***IF their permit is revoked or suspended in that state, it is automatically revoked or suspended in NC***
Absence of Pharmacist in Hospital
If pharmacy is not open 24/7, arrangements need to be made to have an "on call pharmacist" Two options (can use one or both) to ensure access to drugs: 1) contract with another health care facility, pharmacy, or pharmacist (i.e. remote order entry) 2) Authorize and train a nurse to remove medications from pharmacy ---> only if med is no in aux med inventory; must be adequately trained, medications can be restricted for removal (or only removed after calling on call pharmacist), an on call pharmacist must be accessible to the nurse, and within 24 hours, a pharmacist shall verify the order A record of drugs removed (including those from aux med inventory) shall be kept for 3 years P-M shall verify these records at least quarterly Supportive personnel can be working in pharmacy but drug can only leave the pharmacy after it has been checked Only drugs in unit dose packaging shall be removed and in amounts sufficient to meet needs to IMMEDIATE therapeutic requirements ***CS may be stocked and removed from aux med inventories BUT MAY NOT BE removed from pharmacy in absence of a pharmacist
Lost & Stole DEA Forms 222
If unfilled 222 form gets "lost," purchaser must execute another form with a statement that other form was lost (included serial # and date of lost form) and sent with new Copies 1 & 2; Then keep Copy 3 of both forms and statement *If forms are lost or stolen from purchaser, they must notify the DEA
Radiopharmaceuticals labeling requirements
In addition to the labeling requirements of Rxs: Standard radiation symbol "Caution: Radioactive Materials" Radionuclide within Chemical form of the RP contained Amount of radioactivity of the RP contained & date/time of calibration of that radioactivity Date and time of expiration of RP contained If the RP is a liquid, volume; if gas, # of ampules, vials, syringes; if solid, the # of capsules or weight Name, address, and telephone # of pharmacy dispensing Rx or lot # Name of the pharmaceutical *Must also contain a tamper-resistant seal and an "outer" container with the following: Standard radiation symbol "Caution: Radioactive Materials" Radionuclide within Chemical form Volume if liquid Requested activity and calibration date/time Rx # Labels for radiolabeled blood components and therapeutic dosages must always contain the patient's name at the time of dispensing (if not available, 72 hour exemption is allowed to obtain) Name, address of nuclear pharmacy Lot # of preparation Name of the end authorized user (who must also be a prescriber!)
A pharmacist may accept a donated item, given:
In original, sealed packaging Pharmacist has determined it is safe for redistribution Drug bears an expiration date that is later than 6 mo after the date drug was donated Not adulterated or misbranded
Biologics Price Competition and Innovation Act
Included in Affordable Care Act of 2010 Allows a pathway for biosimilar approval
Part 2 program
Individual or entity that "holds itself out" as providing diagnosis, treatment , or referral of treatment for a SUD
When the pharmacy is closing permanently, a pharmacist-manager must:
Inform NC BOP and DEA and arrange for disposition of CS Return pharmacy permit to BOP within 10 days of closing date If possible, provide notice to the public within 30 days of closing and keep sign posted until 15 days after closing If patients do not transfer their Rx's, then the P-M shall transfer Rx filed to another pharmacy for maintenance of patient therapy and inform public on the notice *If pharmacy is closing for more than 14 consecutive days (but not permanently closing), must provide a similar notice as above
The following are exempt from registering as a Wholesale Distributor in NC
Intracompany Sales Hospital or other health care entity that is a member of a group purchasing organization 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 $ value of transfers cannot exceed 5% of the total Rx drug sales of either party during any 12-consecutive month period); dispensing of a Rx drug pursuant to a Rx; distribution of drug samples; blood and blood components intended for transfusion
Transferring pharmacy must:
Invalidate Rx and write "void" on face Record on back: name, address, and DEA # of pharmacy (for CS only) to which it was transferred, plus name of person receiving Rx; record date of transfer and name; For CS Rx's sent electronically, all information required must be added to prescription record
Traditional Pharmacy Compounding (503A)
Is by a licensed pharmacist, in a licensed pharmacy, for a specific patient, based on a Rx Sterile or non-sterile compound Includes compounding performed by a licensed physician authorized by state law to prescribe drugs It is permissible to compound in anticipation of an Rx, in limited quantities, based on established history of receiving Rx orders (can dispense one Rx is received) Must comply with <797> for sterile compounding and <795> for non-sterile compounding May use bulk drugs to compound that: comply with standards of a USP or NF monograph; if no monograph exists, drug substances utilized must be FDA-approved; FDA is to develop a list of acceptable bulk drug substances with do not fall into either of those categories (503A Bulks List) May not distribute compounded products out of state in quantities that exceed 5% of the total Rx orders dispensed by the pharmacy Compounds from Traditional Pharmacy Compounding Pharmacies are exempt from FDA new drug approval process, current GMP, and federal labeling requirements (i.e. they are labeled according to state law)
Should I compound Itraconazole?
Itraconazole bulk powder (brand name - Sporonox) is NOT bioavailable in mammalian species. Do NOT compound with Itraconazole bulk chemical for pets.
Agents of the prescriber in LTCF
LTCF nurse or employee is allowed to be an agent of prescriber assuming there is a written agreement *Agent may only: prepare a written Rx for prescriber to sign, call in a CIII-CV to pharmacy, transmit a fax Rx from prescriber (including CIIs)
Combat Methamphetamine Epidemic Act of 2005 / Methamphetamine Prevention Act of 2008
Regulates Pseudoephedrine, ephedrine, and phenylpropanolamine
License Renewal
License expires on December 31 every year and must be renewed annually (must also pay a fee) 60-day grace period after Dec 31 All licensees must give Board notice of name change, address, or change of employment within 30 days after change If you are residing, licensed, and practicing in another state but keeping NC license active, then you do NOT have to complete CE requirements for renewal (do have to pay renewal fee) but you must satisfy CE requirements of that state There is an extension period for certain members of the Armed Forces (may apply for an extension to pay renewal or licensure free and waiver for CE requirements) but must still notify BOP prior to the expiration of license
Minimum Necessary
Limits disclosure to the minimum necessary to accomplish the intended purpose of the use or request *Exceptions: disclose to a request by another health care provider; to the patient; patient authorizes; any disclose required by law
Requirements for pharmacies that compound
Maintain a reference library including USP and references on compatibility, storage, stability, handling, and preparation of compounded drugs (if sterile compounding) Pharmacist-manager should be knowledgeable about disposing compounded preparations (*may designate another pharmacist for this, notify Board within 15 days) Create and maintain a record-keeping system to identify every compounded drug preparation prepared, labeled, or dispensed in the past 3 years (may be electronic)
Required records for donated drugs
Maintain a written or electronic inventory of each donated drug for 3 years (name, strength, dosage form, number of units, manufacturer lot #, and expiate date & name, address, phone # of the eligible donor providing each drug, supply, or medical device) Maintain records of Rx's dispensed and comply with all other laws/regulations (including OTC) A pharmacy or dispensing physician who discontinues participation must notify Board within 30 days (include detail of disposition of donated drugs)
Prescription Recordkeeping
Maintain every original prescription order for a period of 3 years except those recorded in a patient's chart (NC Medicaid requires 5 years, Medicare Part D requires 10 years) If kept in automated system, must be "readily retrievable" within 48 h of request Records of dispensing must be kept for 3 years Pharmacy file copy of every Rx shall include brand or generic name and manufacturer of product dispensed
Misbranding
Manufacture, packer, or distributor name and place of business is not on the label; manufacture is not registered with the FDA ;word, statement, or other information not prominently placed on the label as required by law; the established name is not on the label (generic name); inactive ingredients (trade secret exceptions) are lacking; adequate warnings are lacking; labeling is false or misleading; If the drug is liable to deterioration and the labeling does not state such precaution; -Dispensing an Rx drug without an Rx -Refilling an Rx without valid refills -Dispensing the wrong strength of the drug -Inaccurate information on the label placed on the dispensed vial by the pharmacy -Not following regulations from the Poison Prevention Packaging Act -Failure to manufacture OTC products in tamper resistant packing (may also be adulterated)
Manufacture Prescription Drug Labeling
Manufacturer Bottle: Name & address of manufacturer, packer or distributor; Established name of the drug (generic +/- brand); Ingredient information; Strength; Quantity; Symbol: Rx only or legend (Caution Federal Law prohibits dispensing without Rx); Route, lot, storage requirement, container to dispense the drug in; expiration date; controlled drug symbol (i.e. CII; if medication is CS) *If the container is too small for all of the above information, it still must have: dosage, route of administration, inactive ingredients, container to dispense the drug in, "Rx only" Unit-dose labeling from a manufacturer: Name; strength; Expiration date; Lot #; Name or place of manufacturer, packer, or distributor; Any statements required by compendia; number of dosage units; CS symbol or "warning: may be habit forming" if applicable
Biosimilar definitions
Manufacturers are now able to market a bio similar of the brand name biological product after receiving FDA approval 1) Biosimilar: biological product is highly similar to the reference product even if there are minor differences in clinically inactive components; and there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product 2) Interchangeable: The biological product is bio similar to the reference product; it can be expected to product 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 products are not greater than with repeated use of the reference product *Can use FDA purple book for guidance on biosimilar vs. interchangeable
Activities that require DEA registration
Manufacturing, distributing, dispensing, prescribing, reverse distributing, research, narcotic treatment program, importing/exporting, chemical analysis *need registration for each location Prescribers of CS: physicians, dentists, vets, NP, PA, pharmacists (CPP), nurse midwives, podiatrists *only one registration is required for a provider as long as they are only PRESCRIBING from multiple offices
Manufacturing & Repackaging
Manufacturing: means production, preparation, compounding/processing of a drug, as well as packaging, repackaging, labeling or re-labeling Repackaging: means a person who repacks, relabels, or manipulates a Rx drug which was packaged and sealed by a manufacturer Pharmacies do not have to register aid engaged in ordinary activity of pharmacy practice but if compounding, repackaging, or relevant-labeling not pursuant to a patient-specific Rx --> need to register Manufacturers and repackagers must register with the NC Dept of Agriculture's Food and Drug Protection Division (also out-of-state manufacturers/ repackagers shipping directly to NC) Subject to inspection, will be given a license (renewed annually), and assigned a registration #
What is the FDA's position on the compounding of hydroxyprogesterone caproate injection?
Many pharmacists are aware that the FDA approved Makena, a hydroxyprogesterone caproate injection, to be marketed by KV Pharmaceuticals. FDA has issued the following statement with respect to compounding of hydroxyprogesterone caproate injection: It can be done as long as there are no safety issues (fact check this?)
Discontinuance of Business
Modifications (change in name/address), terminations, or transferring of DEA registration require DEA approval *The DEA registration of any person shall terminate automatically if that person dies, ceases legal existence, discontinues business or professional practice, or surrenders a registration *Must return DEA certificate of registration, plus unused DEA 222 forms to the DEA upon discontinuance of business (CS must be disposed of properly)
Who can prescribe CS
Must be authorized by state & registered with DEA; ophthalmologists but not optometrists; psychiatrists but not psychologists CS Rx's can be communicated by an employee of the prescribers; An Rx that is prepared must still be signed by prescriber; Mid-levels and CPP would have CPA or protocol w/ physician
Immunizations recordkeeping
Must maintain a record of any vaccine administered to a patient; anemia, address, and DOB of patient; date of administration; the administrate site; route of administration; name, manufacturer, lot #, and expiration date of vaccination, dose administered, name and address of the patient's primary health care provider, as identified by the patient, name or identifiable initials of immunizing pharmacist Notify PCP within 72 hours of immunization Record any vaccine administered to the patient to NC IR within 72 hours (NOT necessary for influenza vaccines) Report AE to prescriber or PCP The immunizing pharmacist must maintain polices and procures for disposal of equipment and comply with OSHA requirements
Acknowledgement of Notice Receipt
Must make a good faith effort to obtain a written acknowledgment by all patients that they received the Practice Practices Notice (can also be electronically or by mail) Document reason for failure to obtain acknowledgement Only required once for each patient (even if notice is updateD) Can only be signed by patient or representative
Recording refills of CII and CIV
Must use either computerized OR manual system for record-keeping; All computerized systems must be able to print out refill by refill audit trail of any specified CS; if system provides a printout of each day's CS Rx refill data, the print out must be verified within 72 hours OR may maintain a logbook
NC CSRS: Information reported
NC CSRS keeps information for 6 years Information reported: Dispenser's DEA #; Name, address, telephone #, and DOC of the patient; date Rx was written; date Rx was filled; Rx #; Rx new or refill; Metric quantity of dispensed rug; estimated days supply of dispensed drug if provided; NDC of drug dispensed; prescriber's DEA #; prescriber's NPI # if received, method of payment for the Rx
Can you serve as pharmacist-manager at multiple pharmacies simultaneously?
NO Exceptions: Serving at a "limited service pharmacy" (charitable pharmacy or dept of health clinic) If one of the two pharmacies is newly permitted and has not yet begun providing pharmacy services to patients (once it is providing services or 6 months from the permit issuance date, whichever is SOONER, then the manager must step-down and notify the BOP
Pharmacy label requirements
Name/address of pharmacy; serial # of Rx; date of Rx; patient name; name/strength of drug; generic name of drug (even if it is not available or if you have dispensed brand); directions for use; appropriate cautionary statements; filled by or dispensed by X pharmacist with at least first initial and full last name *If the drug is a "tranquilizer or sedative" it should bear the warning "consumption of alcohol while on this can be harmful" if the prescriber states it on Rx *If the Rx is dispensed in a container other than the manufacturer's original container, the label must not obscure the storage/expiration *If the Rx is dispensed in another container, a discard date (1 year or manufacture expiration, whichever is earlier) *Additional requirements for retail/community pharmacies: CII-CIV requires "Caution: Federal law prohibits the transfer of the drug to any person outside of whom it was prescribed" *For CIII-CV: Refills should be labeled with the date of original filling and date of dispensing
DEA Form 363
New Application Registration - Narcotic Treatment Program (Methadone for addiction)
Is there a certain date Rx's for non-CS substances need to filled by after prescribed?
No
NC only - "Schedule VI"
No currently accepted medical use Low potential for abuse/dependence Need for further and continuing study Examples: marijuana and THC May be distributed or dispensed only for scientific or research purposes Hemp extract (<0.9% THC and at least 5% cannabidiol by weight) may be used by a person with intractable epilepsy (hemp would be acquired from another jurisdiction) Pilot program underway in NC to allow cultivation and sale of industrial hemp (less than or equal to 0.3% THC)
Are pharmacists required to report influenza vaccine administration to the North Carolina Immunization Registry?
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.
Does the federal Drug Quality and Security Act prohibit a pharmacy from compounding veterinary drugs for "office use"?
No. The federal Drug Quality and Security Act speaks to compounding of human drug products.
Can I dispense a prescription written by an out-of-state prescriber?
Non-CS - yes CS - NC CSA states that a practitioner must be licensed in NC to administer or prescribe CS *However, the NC BOP does not enforce this rule and does not prosecute a pharmacist for filling an out-of-state CS Rx
Telemedicine Rx's
Non-CS are acceptable to fill assuming pharmacist determines that the Rx is legitimate CS: NC Medical Board does not consider prescribing CS for pain via telemedicine is appropriate and generally, in-person valuation is required for any CS
Hospital medication records for CS
Not considered prescriptions per DEA
Opioid Rx Prior Approval for Medicaid
On Aug. 27, 2017, NC Medicaid began requiring prior approval (PA) for opioid prescribed analgesic doses that exceed 120 mg of morphine equivalents per day; are greater than a 14-day supply of any opioid; or are non-preferred opioid products on the NC Medicaid Preferred Drug List (PDL). Effective Jan. 2, 2018, the clinical coverage criteria for opioid analgesics was updated to comply with the quantity limits mandated by the Strengthen Opioid Misuse Prevention (STOP) Act, S.L. 2017-74. 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. Beneficiaries with diagnosis of pain secondary to cancer will continue to be exempt from prior approval requirements.
CPP Application/Process
Once approved, the BOP issues a # that should be printed on every prescription written by CPP (CS and non-CS) If a CPP discontinues working, must notify BOP within 10 days CPP is renewed annually by Dec 31st Considered lapsed if not renewed within 60 days (fee, renewal form, and CE required) CPP shall wear a name tag with "Clinical Pharmacist Practitioner"
Transferring prescriptions
Once transferred, an Rx cannot be refilled more times that what it was written for (or 1 year, whichever is less) Original and transferred Rx's must be kept for 3 years following dispensing Per state law, it is permissible to transfer prescriptions issued by prescribers in other states
Emergency Rx Refills
One-time emergency refill of up to a 30 day supply is allowed give: -The Rx is not a CII -The medication is essential to the maintenance of life or to the continuation of therapy in a chronic condition -In the pharmacist's professional judgment, the interruption of therapy might product undesirable health consequences -The dispensing pharmacist creates a written order containing all Rx information and signs and then MUST notify physician within 72 hours of dispensing -A pharmacist may issue a 90-day supply of medication if the physician is unable to readily obtain refill authorization as a result of the prescribers inability to provide medical services to the patient (same rules as above apply)
Practitioners prescribing for family members
Only appropriate for: minor illnesses and emergencies; must keep record of such events Practitioners shall not prescribe CS for themselves, their supervising physicians (NP/PAs), immediate family, anyone living in their residence, or anyone with whom they are having a sexual relationship
Filing CS paper Rx's
Option 1: 3 separate files (CIIs + CIII-CV + non-controls) Option 2: All CIIs + all others BUT CIII-CV must have a red letter not less than 1 inch high stamped on the face of the prescription in the lower right corner) *Red C requirement is waived if computerized record-keeping (must be able to sort by prescriber name, patient name, drug name, and drug dispensed, and data filled)
DEA Form 222
Ordering CII's
License Reinstatement
Out of practice up to two years: 10 hours of CE for each year out of practice, half of which must be contact + take NC MPJE Out of practice up to five years: obtain 500 hours of internship, obtain 10 hours of CE for each year our of practice, half of which must be contact + take NC MPJE Out of practice more than five years: obtain 1500 hours of experience and pass NAPLEX and NC MPJE + must appear before Board
Drugs dispensed by NP or PA
PA/NP can only DISPENSE under supervision of a licensed *pharmacist* *exception: samples or starter packs only -may dispense any drug that are allowed to prescribe -must work with a consulting pharmacist who dates include ensuring adequate amounts of drugs, storage, packaging, available at times of dispensing by some means of direct communication; WEEKLY retrospective review of drugs *All drugs must be dispensed from a place holding a current pharmacy permit and PA/NP must register with the NC BOP *all drugs dispensed should be pre-labeled and prepackaged in safety containers by a pharmacist with all information required by law except name of patient and directions --> PA/NP will then add patient name and directions at time of dispensing
Partial filling of CII Rx's for LTCF or terminally ill patients
Partial fill for up to 60 days from date of Rx Pharmacist must write "terminally ill" or "LTCF patient" on Rx For each partial fill, record: date, quantity dispensed, quantity remaining, pharmacist identification)
Patient Treatment with Investigational Drugs; "Right to Try"
Patients qualify if there are no currently approved agents that are likely to prolong life and they cannot enroll in a clinical trial *Can obtain medication through FDA's "expanded access program" OR directly from manufacturer (if from manufacturer, it must have at least completed Phase I trial) *Patient wishing to use investigational drug must signed an informed consent prepared by physician
Central filling of CS
Per DEA, CII-CV: Prescription can be transmitted to Central fill either by faxing a copy OR electronically -Originating pharmacy must record the following on the original Rx or add to electronic record: "CENTRAL FILL" on face of Rx; name/address/DEA # of central fill pharmacy; retail pharmacist name; date of transmittal; also include in transmittal # of refills already dispensed and refills remaining; retail pharmacy should also keep record of receipt of the filled Rx (date of receipt, method of delivery, pharmacy employee accepting delivery) -Central fill pharmacy must: keep a copy of the faxed Rx or an electronic record of all information + name, address, and DEA # of retail pharmacy; keep record of the date of receipt of transmitted Rx, name of pharmacist filling, date of filling/re-filling; keep record of date filled Rx was delivered and method of delivery *A retail pharmacy may double as a central fill pharmacy without keeping a separate DEA registration, inventories, or records *Retail pharmacies must keep records of all central pharmacies they utilize and vice versa! (name, address, verified DEA#) *Both pharmacies must maintain complete and accurate records of the Rx's (name of pharmacist, original pharmacy, receiving pharmacy)
Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act)
Regulates manufacture and distribution of controlled substances
Medication in Healthcare facility ED
Permissible to dispense medications to registered patients of the ED (to take home) If a 24 hour outpatient pharmacy service is not available, a physician or RN/PA/NP under physician supervision can dispense the Rx ***Must be limited to 24-h supply or smallest commercially available quantity, P-M shall develop an ED formulary for these drugs, P-M shall develop and supervise a system for all drugs administered in and dispensed from ED, drugs shall be pre-packaged in safety containers by a pharmacist Upon dispensing to patient, label should include: name, address, phone # of pharmacy, dispensing date, full name of patient, name of drug, directions, name of physician prescribing/ dispensing product, required cautionary information An Rx still needs to be used and physician, nurse, NP, or PA required to counsel patient Perpetual record of all dispensed drugs shall be maintained with pharmacy records for 3 years & P-M must verify the accuracy of these records at least MONTHLY
Generic substitution
Permissible to substitute an "equivalent drug product" when a drug is prescribed by brand name; generic drug should be manufactured using GMP; price to purchase must be less than brand drug; selection of generic drug does not impose greater liability on pharmacist/prescriber *Pharmacist may NOT dispense a generic drug if the prescriber instructs otherwise by signing on DAW line; handwrites "dispense as written"; verbally states dispense as written; can also make note on electronic Rx
Supervision of unit dose medication systems
Permits a validating technician to validate filling fo floor stock and unit dose distribution systems (tech check tech) but validating tech must be registered with BOP, be certified, and hold an associates degree in pharmacy technology Permissible activities: -Stocking of patient care unit med inventories, ancillary drug cabinets, ADD, emergency kits, and prepackaging of Rx drugs with the hospital pharmacy P-M shall develop policies for ongoing evaluation for this sort of program and records must kept on validating tech
Pharmacy Permit Renewal
Permits expire on December 31st every year and must be renewed annually Considered lapsed if not renewed by *March 1st* (subject to maximum re-instatement and renewal fees) After March 31st, the pharmacy will be closed and must re-apply for a new permit (start process from beginning)
Dispensing CS RX's
Pharmacies must be registered with DEA (& permit from BOP) expect hospital pharmacies CII Rx: 6 mo expiration date, no refills, BUT there is no quantity limit per federal law
Medwatch number
Pharmacies must provide MedWatch number to patients on all dispensed prescriptions (1-800-FDA-1088)
My pharmacy engages in compounding. How should this be reported to the Board and what information should be provided?
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.
Pharmacy compounding reporting requirements
Pharmacies who compound at all shall notify Board initially on permit application and on each annual renewal: -Whether they compound; Good-faith estimate of percentage of pharmacy's dispensing that involves compounded products; Whether they do sterile or non-sterile or both; what risk level of sterile-compounding is done at the pharmacy
Foreign prescribers
Pharmacist may fill an Rx written by foreign prescriber as long as they believe there is an appropriate patient/prescriber relationship *The medication must not be for a CS
Requirements for Pharmacists for CSRS
Pharmacists must individually register for access to the CSRS within 30 days after obtaining an initial or renewal pharmacist license *not required if employed in a pharmacy that does not dispense CS *If you have reason to believe the Rx if fraudulent or duplicative, withhold dispensing until verifying that the Rx is appropriate
Pharmacist identification badges
Pharmacists must wear visible badge with name and license (unless name is posted elsewhere i.e. office or sterile garb)
Transfer of non-CS
Pharmacists, interns, or certified technicians can make or receive a transfer There is no limit on the amount of times a non-CS can be transferred Can be transferred by fax or electronic
Correcting errors and omissions on CII Rx's
Pharmacy can add or change information after consulting directly with practitioner and documenting on Rx; You can add date, add or change address, drug strength, drug dosage form, directions, drug quantity (in conjunction w/ change in strength only i.e. not to exceed original total dosage prescribed) *CANNOT change patient's name, name of CS (except generic substitution), or prescriber's signature
Drug Take Back
Pharmacy has to apply to modify its DEA registration to accept patients CS for disposal Pharmacies can utilize a mail back program or collection receptacles
DEA Form 224a
Renewal application for registration
Healthcare pharmacy personnel
Pharmacy must be directed by a legally qualified pharmacist (P-M) There should be policies and procedures to specify duties of each personnel *Additional responsibilities for Pharmacist-managers in health care facility pharmacies: -Employee of health care facility -Establish written procedures for safe and effective distribution of pharmaceutic products (reviewed annually, copy kept in pharmacy) -Responsible for safe and effective distribution of, control over, and accountability for drugs (preparing, packaging, compounding, dispensing, etc.) but can delegate responsibilities to other staff -Development of policies/procedures for compounding, admixture, labeling, and dispensing of parenteral medications (involves educating pharmacy and nursing staff) -Establishment of specifications to obtain pharmaceuticals -Participation in development and maintenance of a drug formulary -Participation in those aspects of pharmaceutical care that affect drug distribution and control -Assuring that drugs are dispensed only by a pharmacist; supportive pharmacy personnel are directed and supervised -Adulterated/misbranded drugs returned to pharmacy -Maintaining records and reports required by law to ensure safety -Developing and implementing policies that address safeguarding and handling of all drugs and devices -Policies on drug samples and patient's personal medications -When discrepancies in CS are identified: must be reviewed, and a report of this action, including steps taken to prevent recurrence, where possible, shall be provided to P-M within 24 hours of occurrence (maintain this report and report to NC BOP and DEA if needed)
Selling pseudoephedrine
Pharmacy must records purchaser's name, address, product sold, quantity, and date/time of sale + must obtain a valid, unexpired, govt issued ID *Patient required to sign *Patients must be notified that entering false information may be subject to criminal penalties *Must submit required sale information electronically to the National Precursor Log Exchange (NPLEx) and ifs system is down, must record sale and document sale not being entered into NPLEx Do not complete the sale if NPLEx system generates a stop alert due to quantity limits Records must be available within 48 hours and kept for 2 years Sellers must annually engage in self-certification (generated by DEA, renewed annually) and employees must be trained (designed by DEA and NC Com for MH, DD, and SA) Wholesale distributors of SLCPs (bulk quantities) will have to obtain a registration as a chemical distributor (DEA Form 510) & submit a report 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
Pharmacy Permits
Pharmacy permit application identifies pharmacist-manager and all pharmacy personnel Permits are issued pursuant to joint application of the owner and pharmacist-manager (must be signed by P-M) The Board can issue and renew separate permits for multiple pharmacies operating one location (i.e. inpatient & outpatient) The P-M for the applicant pharmacy permit must appear before the Board issues a permit
Drug dispensed by a Physician
Physicians who wish to dispense must register with the BOP as a "dispensing physician" Exceptions: free drug samples -Comply to all rules of pertaining to pharmacists -Physicians must do the dispensing themselves
Additional Requirements for Pharmacies
Post in a location that the public can see with specific hours that pharmacist is on duty Display every pharmacist-manager's license and every current renewal (the licenses and renewal of all other pharmacists must be readily available) Reference library (electronic or paper): state and federal pharmacy statutes/rules; drug interactions, AEs, therapeutic use, dosing, toxicology; patient-oriented reference materials for counseling; equivalent drug products (Orange book); any reference materials otherwise required by state/federal law For mail-order pharmacies, during the pharmacy's regular hours of operation but not less than six days per week, for a min of 40 h per week, a toll-free telephone service is provided (must be disclosed on label of Rx meds) Pharmacies in grocery stores or other mechanizes need to be physically separated from other business and all pharmacy transactions must be completed in the pharmacy!
Security Requirements for CS
Practitioners must store CS in a securely locked cabinet Pharmacies and institutional practitioners may dispense CS with non-CS *There are special security requirements for manufacturers and wholesalers *May not employee any person whose application for DEA registration has been denied, revoked, or surrendered, OR convicted of a felony relating to a CS (may apply for a waiver)
Methadone for opioid addiction (narcotic treatment facility)
Practitioners wishing to prescribe and dispense methadone for addiction must obtain a separate DEA registration via DEA form 363 When used for addiction, methadone is administered at a Narcotic Treatment Facility (NTF) *Pharmacies should NOT dispense methadone for addiction (okay to dispense for pain) *40 mg methadone tablets now restricted to NTF voluntarily by manufactures
Written Protocol for Immunizations
Prepared, signed, and dated by physician and immunizing pharmacist; name of pharmacist; immunizations that may be administered; screening questionaries and safety procedures, procedures to follow in event of emergency or ADE after immunization; reporting requirements by immunizing pharmacist to physician, including content and time frame; locations where pharmacist may immunize; must be reviewed annually with the Physician Immunizing pharmacists have pharmacists must have drugs written in protocol to create AE and must have in their custody when administering vaccines The physician needs be to accessible (or through telecommunication) Physician must receive periodic status reports from the immunizing pharmacist If a pharmacist has a physical disability (unable to become CPR certified), he/she may still immunizations (although another pharmacist or technician who is CPR-certified must be present) The immunizing pharmacist must give the current VIS to the patient prior to immunization
Practitioner prescribing privileges
Prescribing privileges vary depending on type of profession MD/DO: have (generally) unlimited and independent prescribing authority DDS/Podiatry MD, Optometrists, and Vets have independent prescribing authority BUT limited to their scope of practice PAs, NPs, CPPs, Nurse midwife, midwife, and advanced registered NP's have DEPENDENT prescribing authority (collaborative practice agreements or protocol) Doctors of chiropractic medicine, clinical nurse specialist, certified registered nurse anesthetist, doctor of hemeopathy, emergency medical technician paramedic, and naturopathic doctor have NO prescribing authority in NC
"Behind the counter" Drugs
Regular insulin (Humulin R, Novolin R) and insulin NPH (Humulin N, Novolin N) are OTC (all other are Rx only) Plan B (levonorgestrel 0.75) - OTC for women 17 y and older Rx only for women younger than 17 yo Plan B one-step (levonorgestrel) 1.5 mg Available as OTC in women of all ages, no ID needed
Access to NC CSRS
Prescription information is CONFIDENTIAL DHHS may review information in NC CSRS and notify practitioners and their licensing board or the Attorney General if they find unusual prescribing patterns *Penalties for anyone who intentionally or knowingly releases, obtains, or attempt to access CSRS Who can access a CSRS report: -Persons authroazied to prescribe OR dispense CS -An individual can request their own record -Special agents of the State -Authorities for other states -Sheriff or police chief engaged in a bona fide specific investigation -Licensing boards in an ongoing investigation -Any county medical examiner May retain the NC CSRS report in the patient's confidential medical chart; a practitioner or pharmacist may allow someone working under his/her direct supervision to access the NC CSRS; persons authorized to dispense or prescribe CS and access to NC CSRS may disclose or disseminate data to each other
Availability of Pharmacy Records
Prescriptions are NOT public records However, certain people are allowed to access Rx records or obtain a copy (patient, guardian, emancipated minor, prescribing practitioner, practitioner treating the patient, pharmacist, anyone the patient allows via a written authorization, person authorized by court order, BOP, researchers and surveyors approved by BOP, HIPAA covered entity, Medical and Dental Boards, others) ***A pharmacist may disclose any information to any person ONLY when he/she reasonably determines that the disclosure is necessary to protect the life or health of any person
Death, retirement, or loss of license of prescriber
Prescriptions are still valid even after a prescriber dies, loses their license, or retires
What can technicians do during pharmacist breaks?
Prescriptions may be inputted or received by technicians and assembly can occur; certified technicians can receive telephone Rx's ; Rx's that are already prepared can be picked up *However, a log is required for any of these patients picking up Rx's in case Rph needs to review counseling issues
Photo ID requirements for CS
Prior to dispensing CII's and certain CIII's (codeine combination products), the person picking up the Rx must present a valid ID (document name, type of ID, and ID #) *Types of ID: driver's license, ID card issued by NC DMV, military identification, passport *Must retain with records for 3 years on the premises or at a central location *People authorized to receive information from the CSRS can also have access to the ID records (pharmacy must provide within 72 hours)
Requirements for pharmacists prior to dispensing a targeted CS
Prior to dispensing a targeted CS, must review and document the CSRS report for the preceding 12-months in the following situations: -Suspect the patient is using the targeted CS non-medical -Prescriber is located outside the usual geographic area served by pharmacy -Patient resides outside the usual geographic area served by the pharmacy -Patient pays with cash despite have prescription insurance on file at the pharmacy -Patient demonstrates potential misuse of CS (over-utilization, early refills, multiple prescribers, appearing sedated/intoxicated, etc.)
Federally assisted
Program that receives federal funds Prescriber registered to prescribe buprenorphine Opioid Treatment Program
Pure Food and Drug Act of 1906
Prohibited the adulteration and misbranding of foods and drugs in interstate commerce
Health Insurance Portability and Accountability Act (HIPAA)
Protection of all individually identifiable health information held or transmitted by a covered entity or its business associate ("Protected health information") *Includes paper, electronic, oral form relating to individual's past, present, and future conditions; has the potential to identify the individual (name, address, phone #, etc.)
Pharmacy Audit Rights
Protects pharmacies from unfair audits performed by insurance companies, third-party pairs, managed care companies, etc. *Pharmacy must be given 14 d notice of audit *Any audit that involves clinical judgment requires pharmacist involvement *Clerical or record-keeping errors should not be deemed fraudulent *Pharmacy is allowed at least 30 days following receipt of audit report to produce documentation to address any discrepancies *Audit is limited to 24 months from date claim was submitted *Cannot perform audit during first 5 days of month *Preliminary audit report to be sent to pharmacy within 120 days *Accounting practice of extrapolation not to be used in calculating recoupments *There should be an appeals process established
Nursing Home Medication Management Advisory Committee
QA program for nursing home Committee includes a consultant pharmacist and must meet at least quarterly; develop and implement measures to to minimize risk of errors (includes training staff) Similar confidentially rules
Risk Evaluation and Mitigation Strategy (REMS)
REMS are required risk management plans to ensure that the benefits of certain prescription drugs outweigh the risks *healthcare professionals and distributors may need to follow specific safety procedures prior to prescribing, shipping, or dispensing the drug *Pharmacies may have to be certified with manufacturer, verify prescriber is certified by manufacturer, obtain an authorization number from a call center, obtain a Rx authorization form from the patient/prescriber (i.e. isotretinon, clozapine, TIRF)
Remote Medication Order Processing
Receiving interpreting or clarifying med orders, data entry and transferring of medication order, performing Drug utilization review, interpreting clinical data, performing therapeutic interventions and providing drug information concerning medication orders or drugs from remote pharmacy. Remote site is in US and electronically linked to healthcare facility in NC (either share common owner or contractual agreement) Pharmacies must come up with a plan together for how to handle the resolution of problems detected and communicating to prescribers All must maintain a policies/procedures manual Pharmacy providing remoter services must notify BOP prior to provision of services and apply for a permit An out-of-state remote medication order processing pharmacy must be registered with the BOP as an out-of-state pharmacy All pharmacists must be licensed by NCBOP
Drug Quality and Security Act of 2013
Regulated pharmacy compounding and tracking of medications throughout the distribution system
Mobile Pharmacy
Required to be registered w/ BOP Dispenses prescription drugs at no/reduced charge to patients less than 200% of the federal poverty level and have no type of insurance Operated by a non-profit organization Shall provide the Board with the address of every location from which Rx drugs will be dispensed
Pharmacy Technician Registration/Certification
Required to register with the BOP within 30 days of employment Must pay a fee and renew annually by December 31 (if not renewed within 60 days it is considered lapsed) Certified pharmacy technician: 1) passed nationally recognized pharmacy technician certification board exam or its equivalent and 2) obtains and maintains certification Non-certified technicians must have a high school diploma or equivalent or working towards it and must complete a required training program provided by P-M within 180 days of starting employment *Pharmacy technicians working in free clinics are still required to register, renew, and complete training program (fee is waived)
Drug Supply Chain Security Act ("track and trace")
Requirements for tracing prescription drug products through pharmaceutical supply distribution chain. Goal: prevention of counterfeit substances in US market Dispenses must have systems in place to identify illegitimate products and notify FDA if one is found WITHIN 24 hours *Documentation of investigation or product disposition is to be kept for 6y Trading partners: manufactures, repackagers, wholesale distributors, and dispensers/pharmacies Dispensers must determine if trading partners are legitimate (i.e. licensed w/ FDA)
Supervising physician for CPP
Responsible for supervision of CPP Available for consultation Licensed with NC Medical Board Must not be in a post-grad training program (i.e. cannot be a resident) One physician may not supervise more than 3 pharmacists A CPP may have multiple supervising physicians (i.e. a primary and one or more back-ups)
Filing CS electronic Rx's
Retain electronically but must be able to separate from all other records in a reasonable time and must be sortable by prescriber name, patient name, drug name, and date dispensed
Must a prescription label state the drug's generic name?
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".
Dispensing Rx's
Rx drugs may only be dispensed at address on pharmacy permit (i.e. no pick up or drop off location)
Recordkeeping for Healthcare Facility Pharmacies
Same requirements for record keeping of CS and prescription orders but some additional requirements: -Record and identify responsible pharmacists/techs for medication compounding and dispensing & records kept for 30 DAYS -Documentation of medication errors, including those that resulted in death to patient --> keep for 3 years -Records of ordering, receiving, disposing, or transfer of CS --> keep for 3 years *an automated system may be used to keep records regarding CS dispensed to patients as long as original medication order and dispensing history can be immediately retrieved (consistent w/ fed law requirements) All records must be available to COP, retrievable within 48 hours
Registration and Permits
Separate registration required: Dispensing of drugs from separate location owned by a healthcare facility (.e. satellite pharmacies, outside clinics, health maintenance organizations, physician's offices) r all require a separate registration if ANY of the following is true: -Drugs dispensed are obtained from a source outside of the healthcare facility -P-M is controlled and supervised from a source other the healthcare facility pharmacy -Dispensing drugs to outpatients
Inventory of CS
Should be done prior to opening Inventory should include: drug name, strength, dosage form, bottle size, # of containers, count of substance CII- exact count CIII-CV - estimate is permissible unless container holds more than 1000 tabs/caps *Inventory must be taken every 2 years after initial date (may be performed any date within 2 years *Can be either at beginning OR end of business day *Records must be maintained as hard copies *Newly scheduled drugs must be inventoried on the date they become scheduled
Animal Rx's
Species of patient, patient name, caretaker information should be on prescription and label *Drugs that say "Caution: Federal law restricts this drug to use by or on oder of a licensed veterinarian" on the manufacture bottle may be dispensed only by a vet OR by a pharmacist pursuant to an Rx written by a vet
Impaired Pharmacy Personnel
State allow allows the BOP to enter into an agreement with a peer review program (NC Physicians Health Program or NCPHP) for impaired pharmacists & technicians (mental illness, chemical dependency, physical illness, or aging problems), the purpose of which is to identify, review, and evaluate the ability of these personnel and provide methods of treatment/rehabilitation Peer review activities to be covered by this agreement includes investigation, review/evaluation, reports, complaints, litigation, etc. and the peer review program can receive relevant information from the Board and other sources, as well as conduct any investigation, make reports of this investigation to the Board, etc. They can receive information regarding suspected impairment of personnel from someone else or self-referral or the Board, after which they will initiate an investigation (including interviews) and the peer review program must report immediately to the Board upon investigation detailed information on the pharmacy personnel IF they are endangering the public or themselves, if they refuse to cooperate with the program, refuse to submit to treatment, or remain impaired/show incompetence, or other reasonable grounds for disciplinary action Pharmacy personnel must be granted due process in any action taken pursuant to peer reviewer agreement
North Carolina Controlled Substance Reporting System
State-operated database where dispensed upload information (about CS dispensed (CII-CV) Dispensers are required to submit information electronically (can get a waiver if they cannot do it electronically) - there are fines for pharmacies if information no uploaded Must report to CSRS no later than the close of the next business day after the Rx was dispensed ("encouraged" to do it within 24 hours) and if unable to do it because of technical difficulties, do it as soon as possible and document occurrence
Drug Price Competition and Patent Term Restoration Act of 1984 (Waxman-Hatch)
Streamlined general drug approval process while giving patent extensions for innovative drugs
Food and Drug Administration Modernization Act of 1997
Streamlined regulatory procedures to expedite the availability of safe and effective drugs and devices; Expands FDA authority over OTC drugs; Establishes a data bank of information on clinical trials
Execution of 222
Supplier can sub package sizes (total quantity must be same), records number of containers and date of shipment The purchaser upon recipient f order must record # of containers received and date received on Copy 3 *Partial orders filled by supplier must be completed within 60 days of the date of DEA Form 222 *Errors on 222 void entire form *Supplier can refuse to accept an order for any reason (send a statement and Copy 1 and 2 back to purchaser) and can also cancel part or all of the order
CIIs
Tapentadol Amobarbital Pentobarbital Diphenoxylate (without atropine) Dronabinol oral solution (Syndros) Nabilone Topical cocaine Levorphanol Belladonna + opium suppository Codeine 15 mg, 30 mg, 60 mg, codeine solution 30 mg/5 mL Morphine+naltrexone Opium tincture Phenylcyclidine (PCP) Poppy straw
Is it ok to use tap water to reconstitute antibiotic granules ?
The Board believes that the best practice is to use purified or distilled water. Many areas in NC 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.
I would like to present an issue to the Board of Pharmacy. How can I do that?
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.
May foreign pharmacy graduates work as pharmacy interns or technicians in North Carolina?
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.
I would like to attend a Board meeting. When do Board meetings occur?
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.
Are there any exemptions to Controlled Substance Reporting System requirements regarding distribution of controlled substance samples?
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." Pharmacies are, of course, prohibited by federal law from dispensing prescription drug samples of any sort.
STOP Act
The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention ("STOP") Act. The STOP Act is an effort to combat the opioid abuse and misuse epidemic. The STOP Act makes changes to the laws governing controlled substance prescribing, controlled substance dispensing, and the North Carolina Controlled Substance Reporting System ("CSRS"). Please refer to this FAQ Guidance for more information.
What is the NC Medical Board's position on the use of opiates to treat pain?
The North Carolina Medical Board's policy on the use of opiates to treat pain. The revised guidelines may be found here: http://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/Policy_for_the_use_of_opiates_for_the_treatment_of_pain. Pharmacists are encouraged to familiarize themselves with the guidelines.
What is the proper procedure for providing heparin, saline, sterile water for irrigation and hydration fluids to home health agencies?
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. Ideally, the labeling should be done by a pharmacist. It is not necessary for the clinical offices to obtain any type of permit issued by the Board of Pharmacy. Sterile water and sterile normal saline may be administered by the nurse with a physician's order as long as the unlabeled container is not left in the patient's home.
What is the appropriate Beyond Use Date (BUD) for Magic Mouthwash?
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.
Expedited Partner Therapy (EPT)
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 to his/her partner without the health care provider first examining the partner ***Considered legal in NC -Can label the vial with some identifier but you not need their actual name or address -Board recommends encouraging the patient have the partner call the pharmacy but otherwise counseling can be bypassed (provide written information)
ow must controlled substances maintained in a practitioner's office (as opposed to a pharmacy) for dispensing or administration be stored?
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.
Faxing CII Rx
The prescriber may fax a CII Rx to the pharmacy for the pharmacist to prepare prior to patient's arrival but original Rx required prior to dispensing *A pharmacy may legally receive a faxed CII Rx as the original Rx in the following 3 situations: 1) CII narcotic substance to be compounded for the direct administration to a patient 2) CII substance for a long-term care resident 3) CII narcotic substance for a patient in hospice
Drug leaflets
These are not regulated by the FDA, left up to individual pharmacies to provide for all medications dispensed (i.e. drug leaflets that are attached to the Rx bag)
Medical Device Amendment of 1976
This calls for classification, safety and efficacy of medical devices.
DEA Form 106
To report theft or loss of CS
Disposal of CS
Transfer back to where obtained (manufacture or wholesaler) OR reverse distributor OR request assistance from DEA (deliver to DEA office, use registrant authorized to dispose of substance, and destroy in presence of DEA agent) -Must fill out DEA Form 41 to record destruction of CS (name of drug, NDC, strength, form, package quantity, number of full and partial packages) -All CS destruction requires 2 witnesses -If CS are sent back to reverse distributor, manufacturer, or wholesaler: For CII, they will issue a DEA form 222 to the pharmacy (can be electronic); For CIII-CV, pharmacy keeps a record of the distribution on an invoice; the reverse distributor, manufacturer, or wholesaler submits a DEA Form 41 *If hospital, can apply for blanket authorization fo routine disposal of CS (witness by 2 people, record disposal, file periodic reports to DEA)
What are the compounding record and master formulation record requirements for sterile compounded products?
USP Chapter <797> requires that a compounding record be created and maintained. USP Chapter <797> does not define the specific elements to be included in the compounding record. North Carolina Board of Pharmacy rules have always required a compounding record and did so well before implementation and enforcement of USP standards for compounding. The following link is a Guidance Document for compounding record and master formulation record requirements:
DEA Form 510
Wholesale distribution of SLCP (scheduled listed chemical products) i.e. pseudoephedrine
Wholesaler/Distributor Registration
Wholesaler distributor= distribution of a Rx drug to person who is not a consumer or patient *One registrant may "distribute" a CS to another registrant without being registered with the DEA as a distributor Key: the total # of dosage units distributed does not exceed 5% of the total units of CS distributed and dispensed in one year ***The following activities are not considered "distributing" and do not count towards 5%: returning CS to manufacture or supplier, a registered retail pharmacy restocking an automated dispensing system at a LTCF, a central fill pharmacy sending filled Rx's to originating pharmacy *Wholesale distributors engaged in distribution of Rx drugs in NC shall obtain a license and renew annually with NC Dept of Ag Food & Drug Protection Div (including wholesale distributors that are out-of-state but doing business in NC)
Receiving pharmacy must:
Write "transfer" on face of Rx Required information: Date and time of transfer; date of issuance of original Rx; original # of refills authorized; # of refills remaining plus date of last refill; transferring pharmacies' name, address, DEA (CS only), and Rx #, name of transferring pharmacist/technician/intern, manufacturer or brand of product For CS: date of original dispensing, pharmacy's name, address, DEA #, Rx #, where Rx was originally filled, dates & locations of previous refills (if different)
Tamper Resistant Prescription Pads
Written outpatient Medicaid prescriptions must be tamper resistant Prescription must be designed to prevent unauthorized copying, erasure or modification, and use of counterfeit prescription forms
I am taking a Spanish language course in order to better communicate with my Spanish-speaking customers. Would this count as CE
Yes
Does the NC Board of Pharmacy conduct background checks on licensees and registrants?
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.
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?
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.
Can EMS crews acquire controlled substances to store and administer?
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.
A or NP must personally consult with their supervising physician prior to prescribing a Targeted CS when all of the following apply:
a) the facility primarily engages in the treatment of pain b) use of the targeted CS will or is expected to exceed 30 days c) if the targeted CS is continuously prescribed to the same patient, the PA/NP must consult with their supervising physician at least once every 90 days
Compounding definition
preparation of medication by combining, mixing or altering ingredients for a patient based on a prescription or medication order from health care provider need to use accurate weights and measurements for compounding and research part of pharmaceutical care to have ability and responsibility to compound (accurate weight, measure volume, etc.)
Pharmacist Work Conditions
• A permit holder shall not require a pharmacist to work longer than 12 continuous hours per work day • A pharmacist working longer than six continuous hours per work day shall be allowed to take a 30 minute meal break and one additional 15 minute break "Pharmacists shall not dispense at a rate per hour that would pose a danger to the public health or safety" ***The pharmacy must be closed if the pharmacist is not present for a period of 90 minutes or more***
Pharmacy students/interns
• Not considered pharmacy technicians • Not required to register with the BOP "A pharmacy intern working under a pharmacist preceptor or supervising pharmacist may, while under supervision, perform all acts constituting the practice of pharmacy." EXCEPT anything prohibited by law (i.e transferring CS Rx's)
