Washington MPJE + Federal

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What are Hospital Pharmacy Requirements

040 - Must have director of pharmacy Appropriately qualified by education, training, and experience Each decentralized unit of a hospital pharmacy must have a pharmacist supervisor 050 - Must have 24 hour pharmacy services Policy for after-hours nurse access 060 - Plan for emergency outpatient meds 080 - Distribution of drugs 090 - Administration of drugs 100 - Investigational drugs 110 - Additional responsibilities Authenticated - authorized in writing in the record by means of signature containing at least first initial, last name, and title Drug administration - an act in which a single dose is given to a patient -Removing dose from previously dispensed container -Reviewing the order -Properly recording time and dose given Protocol - written set of guidelines -Workflow that you will follow -HOWEVER A CDTA: authorizes the pharmacist to change therapy, whereas the protocol just explains the process. Self-administration of drugs" - patient administers his or her own meds from properly labeled containers (not same as PCA) -Patient's responsibility to take, however institution must document if they were taken or not... this is done through a policy

Extended Care Facilities (ECFs) - Skilled Nursing Facilities (SNFs)

060 - Pharmaceutical services -Must have consultant pharmacist -Pharmaceutical services committee -Labeling -D/C'd drugs, returns, CSA accounting -Labeling: unit dose, MUD, traditional prescription systems 030 - Emergency kits 040 - Supplemental dose kits 070 - "Pass meds"

Required elements of "Drug Facts" Panel

1) Active Ingredient (including quantity per dose) 2) Purpose (pharmacologic category/intended use) 3) Uses (indications) 4) Warnings 5) Directions (for specific age groups/populations) 6) Other information (Electrolyte labeling, inactive ingredients) 7) Contact information ("Questions" + phone #)

Requirements for an OTC drug label

1) Principal Display Panel 2) Statement of Identity - drug name + pharmacological category/intended action (*should be on principal display panel*) 3) Net quantity of contents (weight, measure or numerical count) 4) Name AND address of manufacturer/packager/distributor 5) Adequate directions for self-use 6) "Drug Facts" Panel

What are the Required Internship Hours

1,500 hours prior to licensing Earned after completing the first term in a pharmacy program 1,200 hours credit given for clinical experiences during the PharmD program Commission will document hours in excess of 1,500 for reporting to other states with larger requirements Commission will document 1,680 hours from WSU clerkships to other states (plus any additional intern hours)

How many members serve on the Board of Pharmacy? How many are public members?

10 pharmacists, licensed in WA for at least 5 years, geographically representative, and representing various areas of practice 4 public members, not affiliated with any aspect of pharmacy, citizens of US and resident of WA 1 pharmacy technician 4-year terms May serve 2 terms Members appointed by governor Executive officer hired by Commission Executive officer reports to Undersecretary of DOH for Health Systems Quality Assurance Staff are employees of Department of Health, Health Professions Quality Assurance Division Commission currently has own investigators within HPQA pool Licenses paid to HPQA Office

What is required to gain a Pharmacist's License

18 years of age Good moral and professional character; not impaired by use of alcohol, drugs or controlled substances or by mental or physical disability Bachelors or Doctor of Pharmacy from accredited school or college. Met internship requirements Passed examinations (NAPLEX, MPJE) Completion of 7 hours of HIV/AIDS education License may be renewed subject to completion of continuing professional education requirements and timely payment of fees Original license -- $145 Annual renewal fee -- $190 Renewals occur on the pharmacist's birthday Initial licenses issued within 90 days of the birthday do not expire until the following year Late renewal penalty -- $100 Note; between the time the license expires and the renewal fee and late penalty fee are received by the Commission, the pharmacist is not eligible to practice pharmacy. Renewal fees may be paid up to 90 days prior to the expiration of the license

Ambulatory vs Institutional Record Elements - WA

Ambulatory: Patient name/address; prescription rx#/date/refills/RPh ID; Drug name/strength/form/Sig/qty; Prescriber name/address/DEA(if needed); Patient allergies/idiosyncrasies/chronic conditions; authorization for non-CRC; Patient age/DOB/gender/telephone/RPh comments [per OBRA-90] Institutional: Patient name/ID/location/status; prescription start/stop dates; drug name/dose/route/form/qty/Sig; Prescriber name/address/DEA(if needed); Patient allergies/idiosyncrasies/chronic conditions; order status/labeling alerts

Are there any special requirements to be pharmacist-in-charge?

An active license in the state, must be specially trained (aseptic technique, quality assurance) Home Infusion: PHARMACIST IN CHARGE MUST HAVE BEEN TRAINED in specialized functions related to parenteral products, including aseptic technique and quality assurance. (The Commission's proposed rules will require all pharmacists or technicians involved in sterile compounding to obtain a "sterile compounding endorsement," to their licenses.)

We have a duty to report unprofessional conduct

2006 Legislature revised RCW 18.130.070: DOH to require "every license holder to report ... any conviction, determination, or finding that another license holder has committed an act which constitutes unprofessional conduct, or to report information ... which indicates that the other license holder may not be able to practice ... with reasonable skill and safety to consumers as a result of a mental or physical condition. Additional requirements were established in 2008

Mid-Level practitioner registration

224

Practitioner registration

224

Teaching institution registration

224

Analytical laboratory registration

225

Distributor registration

225

Exporter registration

225

Importer registration

225

Manufacturer registration

225

Researcher registration

225

OTC Labels

7-point system: Name of Product Name and address of manufacturer, packager, distributor Net contents Active ingredients and quantity of certain other ingredients Name of any habit forming drug Cautions and warnings Adequate directions for use

How long is emergency contraceptive approved for? How long can pharmacists recommend it for?

72 hrs 120 hrs

Low Sodium =

<= 140 mg per day

Very Low Sodium =

<= 35 mg per day

Sodium Free =

<=5 mg per day

Sodium Threshold

>140 mg per day (based on maximum daily dose)

Calcium Threshold

>3.2 g per day (based on maximum daily dose)

Magnesium Threshold

>600 mg per day (based on maximum daily dose)

Potassium Threshold

>975 mg per day (based on maximum daily dose)

Loss or theft must be reported of controlled substances

A "loss" is any reduction in inventory of a controlled substance that is not due to a lawful transfer, administration, or dispensing of the drug. -Controlled substances dispensed by error to the wrong person -Controlled substances dispensed in error instead of another drug -Controlled substances dispensed pursuant to fraudulent prescriptions -Theft, burglary, damage Any "significant loss" must be reported immediately to DEA by phone, fax, or brief written message -Loss in-transit the responsibility of the supplier -Pharmacies must report shortages from shipments they have signed for Must follow up with Form 106, with copy to Pharmacy Commission Not significant losses should be tracked in a file kept at the pharmacy for future reference and evaluation

May a person be pharmacist-in-charge for more than one pharmacy?

A PHARMACIST MAY BE RPM FOR MORE THAN ONE LOCATION. The Commission has indicated that one pharmacist may accept appointment as the RPM for more than one pharmacy location.

Is it possible for pharmacies under a common ownership to share a single patient/prescription database? If so, what are the rules for prescription transfers?

A Washington licensed dispensing pharmacy may outsource prescription filling to another pharmacy under the same ownership, or based on a written contract or agreement outlining responsibilities and accountability of each pharmacy. Unless there is common ownership, the CENTRAL FILL PHARMACY SHALL DELIVER PRESCRIPTIONS TO THE DISPENSING PHARMACY FOR DELIVERY TO PATIENTS. According to DEA rules, controlled substances may be transferred on a "one‐time" basis, unless the transferring pharmacies share a common electronic database. Pharmacies with a common electronic database may track refills for non‐controlled substances at any outlet in this common database, without going through the prescription transfer process. Many chains (e.g., Rite‐Aid and Walgreens) have these databases.

DEA Renewal for Pharmacist Registration

A pharmacy registration must be renewed every three years utilizing DEA Form 224a, Renewal Application for DEA Registration. The cost of the application fee is indicated on the application form.

Do pharmacist licenses have to be on display? The original or official copy? Is a photocopy ok? Can you obscure your address on the copy displayed to the public?

A photocopy of the license is permitted There is no specific rule regarding obscuring the address, however, the Board is not allowed to reveal the address and phone number of a licensee to the public, (RCW 42.56.230), so it seems reasonable that the licensee can obscure the address.

Sales of syringes/needles in WA

A retailer may sell syringes and needles if he or she is satisfied that "the device will be used for the legal use intended." (RCW 70.115.050) Lawful for any person over 18 to possess sterile hypodermic syringes and needles for the purpose of reducing blood borne diseases. (RCW 69.50.412(5)) Nothing in the Drug Paraphernalia Act "prohibits legal distribution of injection syringe equipment through public health and community based HIV prevention programs, and pharmacies." (RCW 69.50.412(3)) Retailers not REQUIRED to sell syringes or needles to any person. (RCW 70.115.060)

Remote Dispensing and Automated Drug Distribution Devices WAC 246-872 - 12/13/06

ADDD - automated equipment for remote storage and distribution of medication for use in patient care Each facility must obtain approval from Commission of Pharmacy Each facility must designate a pharmacist responsible for oversight of the use of ADDD in the facility If controlled substances are to be dispensed, must obtain DEA registration for the device -Will have a separate DEA number than the pharmacy that is providing the machine

Itinerant Vendor

According to Conn. Gen. Stat. § 21-27, 'itinerant vendor' means any person, whether principal or agent, who engages in a temporary or transient business in this state, either in one locality or in traveling from place to place, selling goods, wares and merchandise and who, for the purpose of carrying on such business, hires, leases or occupies any building or structure for the exhibition and sale of such goods, wares and merchandise.

How do you become a pharmacy Preceptor

Actively practicing in a Class "A" pharmacy. Been in active practice for at least 12 months prior to becoming a preceptor Completion of a Commission-approved preceptor training program every 5 years Get 2 credits of CE May supervise more than one intern during a given time period; however, "two interns may not dispense concurrently under the direct supervision of the same preceptor" Could potentially counsel because not dispensing.

Compounding Facilities (WAC 246-878-040)

Adequate space and facilities, with non-sterile compounding areas separate from sterile compounding areas Bulk containers properly stored, with refrigeration if needed Adequate water and cleaning supplies and equipment Facilities kept clean and sanitary

Notice of Privacy Practices(NOPP)

Advises patients that you will use their PHI for TPHCO -Spells out what that means in your operation Advises patients of their rights Advises patients that you need written permission to release PHI for other purposes Identifies Privacy Officer and how to contact Describes business associate relationships Describes state laws and regulations Describes how you will notify of changes (by posting them in the pharmacy) Give to patient at first initial visit Requires patient to acknowledge receipt of the notice -May use a signature log to record -Should place indication in computer record that notice was provided Title of notice is specified in regulation: -"This Notice Describes How Medical Information About You May Be Used And Disclosed And How You Can Get Access To This Information" Must post a notice in the pharmacy indicating the availability of this information Must provide NOPP to any person who requests Must track changes to NOPP

When must a pharmacy provide a copy of its Notice of Privacy Practices to a patient or other person requesting one?

Advises patients that you will use their PHI for TPHCO Spells out what that means in your operation Advises patients of their rights Advises patients that you need written permission to release PHI for other purposes Identifies Privacy Officer and how to contact Describes business associate relationships Describes state laws and regulations Describes how you will notify of changes (by posting them in the pharmacy) Requires patient to acknowledge receipt of the notice May use a signature log to record Should place indication in computer record that notice was provided Title of notice is specified in regulation: "This Notice Describes How Medical Information About You May Be Used And Disclosed And How You Can Get Access To This Information" Must post a notice in the pharmacy indicating the availability of this information Must provide NOPP to any person who requests Must track changes to NOPP

Prescription Monitoring Program Requirements for Pharmacists

All controlled substances prescriptions dispensed by a pharmacy or a practitioner must be entered into the Washington Prescription Monitoring Program -This does not apply to inpatient prescriptions or drugs dispensed in correctional facilities, except for controlled substances dispensed to inmates at time of release Pharmacists must obtain valid photographic ID from the person obtaining the prescription at the time of delivery -The pharmacy must assign its own unique identification number to the patient - this is not the photo ID number -Nothing in the rule requires recording of the photo ID number Pharmacists may access the information in the PMP for their own patients -Must pre-register with the Department to be granted electronic access -Must immediately notify the Department if access authentication is lost or stolen -May, without pre-registering, submit a written request to the Department for information on a given patient Patients may access their own information in accordance with procedures specified in WAC 246-470-040

Prescription Monitoring Program

All controlled substances prescriptions dispensed by an outpatient pharmacy or a practitioner must be entered into the Washington Prescription Monitoring Program -Report every 7 days -Correctional facilities only report at inmate time of release -Veterinarians upload on quarterly basis Pharmacists must obtain valid photographic ID from the person obtaining the prescription at the time of delivery -The pharmacy must assign its own unique identification number to the patient - this is not the photo ID number -Nothing in the rule requires recording of the photo ID number Pharmacists may access the information in the PMP for their own patients -Must pre-register with the Department to be granted electronic access -Must immediately notify the Department if access authentication is lost or stolen -May, without pre-registering, submit a written request to the Department for information on a given patient Patients may access their own information in accordance with procedures

How long are prescriptions for legend drugs valid from the date issued?

All legend drugs expire after 1 year in WA

Is there a maximum number of refills allowed for legend drugs? What is it?

All legend drugs expire after 1 year in WA Refill PRN = 1 year Refills must be consistent with directions If Rx expired, a refill should be treated as a new Rx and given new number The full quantity of a prescription refill may be dispensed up to the last day before the Rx expires Non-CSA drugs: an emergency supply for up to 72-hours may be given (see WAC 246-869-100(f)) Refills must be consistent with directions for use and patients monitored for overuse of drugs Prescribers cannot delegate refill authorization to a nurse or staff NQAC has ruled out "refill protocols" for RNs

Office-based narcotic maintenance programs

Allows office-based narcotic maintenance using buprenorphine Prescribers must obtain a waiver -Are issued an additional DEA number with "X" as the first letter to use for these prescriptions Pharmacists may fill buprenorphine Rxs issued by physicians Due to peculiarities in federal privacy laws, pharmacists should only fill written prescriptions brought directly to them by the patient. Only Subutex® 2 or 8 mg SL tablets, or Suboxone® 2 or 8 mg SL tablets may be used to fill these Rxs -Note: generic versions became available in 2010 and may be dispensed on DATA prescriptions Subutex or Suboxone may be prescribed off-label for treatment of pain, usually dosed 3-4 times a day. These drugs are Schedule III, and no waiver is required to prescribe these drugs for treatment of pain.

FDA clarifies meaning of "contraindication"

"A drug should be contraindicated only in those clinical situations for which the risk from use clearly outweighs any possible therapeutic benefit."

Pharmacists must take action when problems are discovered

"A pharmacist has a duty to take corrective measures when confronted with a prescription containing an obvious or known error, such as obviously lethal dosage, inadequacies in the instructions, known contraindications, or incompatible prescriptions."

"Red flags" for CSA

"Doctor Shopping" - multiple prescribers for multiple controlled drugs Prescription forgery - does the rx appear altered? Selling prescription drugs - does the drug have high street value Patient requesting specific medications and/or refusal of generic equivalents Patient reports multiple episodes of "lost" or "stolen" prescriptions and/or drugs Patient reports or is known to taking prescription drugs from others Unusual quantity

Corresponding Responsibility of Pharmacist for CSA

"Knew or should have known" Medical vs non-medical uses Civic duty to prevent/report crime vs professional duty to treat Right to protect self from being forced to act illegally or from being put at risk of acting illegally Right to protect self from damage claims

ECF: Labeling - Traditional System

"Traditional" - individual prescription bottles labeled for patients -Same as outpatient meds except: -Sig not required on label -CSA (controlled substance) schedule must be on label -CRCs (Controlled safety caps) not required Applies to Bingo Cards Non-prescription drugs -Date of receipt by facility -Patient's name -Manufacturer or pharmacy label -Doesn't apply to selected bulk drugs used by the facility Label changes to any label must be made by pharmacist -Labeling change has to happen from pharmacist

Review WA laws for Pharmacists furnishing emergency contraceptions

***

Which OTC drugs are exempt from "If pregnant or breastfeeding...." warning

- If drug is intended to benefit the fetus or nursing infant - If labeled exclusively for pediatric use

Adequate directions for self use include:

- dosing - preparation - frequency - duration - time - route

What is included in the "other information" section of a "Drug Facts" panel?

- electrolyte information ( Na, Ca, Mg, K) - inactive ingredients - other info required by monograph, regulations or labeling

Unique OTC drug warnings to remember

- sore throat - allergic reaction and asthma alert - flammability - Reye's syndrome - Choking - Dosage for Sodium Phos - STD - "Keep out of reach of children" + accidental ingestion/overdose

New rules - mandatory reporting (WAC 246-16-200 et seq.)

Must report to PQAC or other disciplinary body when you have actual information about ANOTHER licensee that he or she -Has been convicted of or found to have committed unprofessional conduct -Being terminated by a hospital or having privileges restricted due to unprofessional conduct requires reporting -Under current rule, termination by a non-hospital employer is not a "determination or finding" Is unable to practice safely due to mental or physical impairment (e.g., substance or alcohol abuse) -This notice may be to WRAPP unless a patient has been harmed Good idea to discuss any such knowledge with your supervisor or the other individual's supervisor You must SELF-REPORT if you: Have been convicted or found by a hospital employer to have committed unprofessional conduct Have information that you are unable to practice safely due to mental or physical impairment. -May self-report to WRAPP unless a patient has been harmed Have been disqualified from participating in Medicare or Medicaid as a provider Contact an attorney before self-reporting

Methamphetamine Precursors OTC Sales Restrictions

Must store EPP "behind counter" Limits set for the maximum amount that can be purchased OTC Requires seller to maintain a log of sales showing name of purchaser, name of drug, and quantity sold, plus other specific elements Log book must be maintained for 2 yrs Allows for "electronic" logbook WA: Age=18, Daily=3.6g, Month=9g, Max Pack Size=3.6g Federal: Age=N/A, Daily=3.6g, Month=9g (7.5g mail), Exempt Size=60mg/pack/sale, Max Pack Size=3.6g, Packaging=Blister pack, max 2 units/blister

Are there any gender or age restrictions for buying Plan B?

NO (Even though package may say for women 17+ on generics)

Which electrolytes have to be labeled with a warning if they exceed a certain threshold in an OTC product? What is the warning?

Na K Mg Ca Ask a doctor before use if you have kidney stones/kidney disease or a Na/K/Mg/Ca restricted diet Must also list amount of electrolyte *per dose*

USP Labeling Standards for compounded products

Name of preparation Internal identification number Beyond-use date Initials of compounder Storage requirements Other items required by state law

Patient Drug Use Histories

Name, address, phone number, age or DOB, gender Significant disease states Known allergies or prior drug reactions List of drugs and devices previously used by patient Pharmacist comments relevant to individual's therapy

Treatment Programs for Opioid Addiction - NTPs

Narcotic Treatment Programs Use methadone to maintain narcotic addicts in a controlled state free of withdrawal symptoms. Drugs must be administered to patients at the NTP site - no prescriptions allowed. Special rules for hospitals and temporary treatment of a narcotic addict experiencing withdrawal Pharmacists should question methadone prescriptions prescribed for obvious maintenance doses (e.g., 1 daily). After January 1, 2008, methadone dispersible 40 mg tablets (Methadone Disket®) no longer available to community pharmacies.

Legend Drugs Not Requiring CRCs

Nitroglycerine SL SL, chewable isosorbide < 10 mg NaF < 110 mg/pkg Cholestyramine and colestipol powder Oral corticosteroids in doses < 105 mg of prednisone equiv. Mebendazole < 600 mg/pkg K+ supplements < 50 mEq/dose EES granules < 8 g/pkg, tabs < 16 g Aerosols for inhalation Pancrelipase OCs in memory aid containers; MPG; other hormones Sucrase solutions

Patient Counseling Required - WAC 246-869-220

No "offer to counsel" -- must counsel Shall "directly counsel" patient -If delivered, must offer in writing to provide direct counseling and information about the drug, including how to contact the pharmacist Focus is on counseling patient Judgment used to determine amount of counseling: -Reasonable and necessary under the circumstances -Promote safe and effective administration of drug -Facilitate an appropriate therapeutic outcome for the patient All prescriptions except where medication is to be administered by a licensed health professional authorized to administer drugs Recent Commission "policy" is to counsel on all new prescriptions, and on refills when necessary

Is OBRA counseling required for Medicaid only or all patients?

No "offer to counsel" -- must counsel Shall "directly counsel" patient If delivered, must offer in writing to provide direct counseling and information about the drug, including how to contact the pharmacist

Is a separate patient counseling area required?

No separate counseling area required per se, though patient confidentiality must be considered

Is there any provision for dispensing an emergency refill supply of legend drugs when there are no refills left and the prescriber cannot be contacted? What is allowed/required?

Non-CSA drugs: an emergency supply for up to 72-hours may be given (see WAC 246-869-100(f)) Emergency refills—If the prescriber is not available and in the professional judgment of the pharmacist an emergency need for the medication has been demonstrated, the pharmacist may dispense enough medication to last until a prescriber can be contacted - but not to exceed 72 hours' supply. The prescriber shall be promptly notified of the emergency refill.

WA Restrictions on stimulants

Non-narcotic C-II stimulants include: -Amphetamine salts and combinations -Dextroamphetamine salts and combos -Phenmetrazine (Preludin®) -Methylphenidate (Ritalin®) Statutory and regulatory indications for these drugs -Narcolepsy -Hyperkinesis -Epilepsy -Differential psychiatric diagnosis of depression -Depression refractory to other modalities -Multiple sclerosis

Rules for OTC Schedule V drugs

Not allowed in WA state

Do prescriptions "die" with the prescriber?

Not in WA (State v Clausing) If a problem emerges with an Rx, and prescriber is dead or no longer licensed, then will need new Rx from the prescriber who resolves the issue Best practice is to encourage patient to find new prescriber

Exemptions and Waivers of CRC use

Not required for institutionalized patients Prescriber may specify non-CRC on individual prescriptions; no blanket waiver Patient or agent may request non-CRCs on all prescriptions; blanket waiver -Pharmacist may not designate him or herself as patient's agent Under federal law, waiver may be oral or written WA: must be written

Are there any required notices that must be displayed to the public?

Notice to Public regarding generic drugs: Every pharmacy shall post a sign in a location at the prescription counter that is readily visible to patrons stating, "Under Washington law, a less expensive interchangeable biological product or equivalent drug may in some cases be substituted for the drug prescribed by your doctor. Such substitution, however, may only be made with the consent of your doctor. Please consult your pharmacist or physician for more information."

Behind the Counter drugs are technically considered...

OTC

Do pharmacy hours have to be posted? Where?

Operating hours displayed at entrance; if in larger store, at entrance to larger store and near the pharmacy

How does a pharmacist determine whether a particular generic drug is suitable as a substitute for a brand name drug?

Orange book May do "Therapeutic Substitution" based on prior authorization from prescriber Protocol, formulary Per-prescription basis Blanket prior authorization can be verbal, but are required to have documentation of authorization in the pharmacy Substitution using prescriptive authority protocol is not really product selection, but prescribing RCW 69.41.100

DEA form 222

Ordering Schedule I and II drugs

Under what circumstances may a pharmacist fill prescriptions written in another state?

Out of state prescriptions are acceptable. WA allows the following prescribers who are licensed in any state or US territory, or in British Columbia, to issue prescriptions for legend drugs that are valid in WA. (Note: Canadian prescribers cannot issue prescriptions for controlled substances unless they are also licensed in the US and registered with the DEA.) Physicians (MD, DO) Podiatrists (PodD, DPM) Dentists (DDS, DMD) Veterinarians (DVM) Nurse Practitioners (ARNP) Physician Assistants (PA-C) When licensed in any state, territory, or British Columbia (legend drugs only from BC)

What providers are out of state prescriptions allowed?

Structured Professional Labeling and Prescribing Information

Package insert New rules applicable to drugs approved after 2006 or within 5 years prior, and any time the labeling is changed for an existing drug Major change is requirement of a section called "Highlights of Prescribing Information" referring to numbered paragraphs of the main document

Washington State Rules

Patient Medication Record Systems - WAC 246-875-020 -All OBRA requirements except age and telephone number Drug Use Review - WAC 246-875-040 -New and refill prescriptions must be screened Patient Counseling Required - WAC 246-869-220

What needs to be on the label of a completed controlled substance prescription?

Patient name Patient address Date written Drug, Quantity, Directions Physician Address Physician DEA Number Physician Signature or Name Other information required by state WA Commission has indicated that a pharmacist may add any missing information after consultation with prescriber, may add DEA number without consultation if it is already known with certainty.

Which of the following must be on the label of an outpatient prescription: Pt. address, Quantity, Expiration Date, Lot number, Name of drug, RPh initials, Technician initials, Pharmacy telephone number? Other items?

Patient name, prescriber, dose, directions, expiration date Complete directions for use ("UD" not valid) Call for verification as provider, or pharmacist will dispense per package insert Expiration date Quantity dispensed Name and strength of drug Initials of pharmacist (can be in computer system) "Warning: State or federal law prohibits transfer of this medication to any person other than the person for whom it is prescribed."

Do patients have the option of demanding the brand name when substitution is permitted? How about patients whose prescriptions are paid for by public funds?

Patients have the option to receive brand name medications; patients whose prescriptions are paid for by public funds are excluded

Patient access to records

Patients may see records and may request changes in -record to correct errors -Pharmacy must provide copies of records in a timely manner upon request May charge reasonable fee for copying (see RCW 70.02.080, WAC 246-08-200 for maximums in WA changes June 1, 2015) Pharmacy does not have to agree to change record, but must respond in a timely manner to requests If record is not changed, patient may insert a statement in the record Time limits for access to records WA: ASAP, with 15 day limit for initial response, 21 day maximum HIPAA: 30 days for response, 30 day extension Time limits for amendment of records WA: 10 days for response; 21 days maximum HIPAA: 60 days for response, 30 day extension

Nuclear Pharmacies

Permit issued only to nuclear pharmacist Nuclear pharmacist must -Meet radiation control agency (RCA) standards -Meet training or experience requirements of WAC 246-903-030 Must submit equipment list to Commission and RCA prior to licensure of pharmacy

What are special requirements, if any, to be a nuclear pharmacist?

Permit issued only to nuclear pharmacist Nuclear pharmacist must Meet radiation control agency (RCA) standards Meet training or experience requirements of WAC 246-903-030 Must submit equipment list to Commission and RCA prior to licensure of pharmacy Nuclear pharmacists must complete either six months of on‐the‐job training under the supervision of a qualified nuclear pharmacist, or must have completed a nuclear pharmacy training program in an accredited college of pharmacy. (WAC 246‐903‐030(3))

Training for handling of hazardous drugs

Personnel must be trained according to job function (Receipt, storage, compounding, etc.) Training must occur before employee may handle hazardous drugs independently Competency of training must be demonstrated and reassessed at lease once every 12 months or when new HDs are added, SOP change, or new equipment is added Training and competency must be documented Training must include: -Overview of HDs and their risks, SOPs, use of PPE, use of equipment and devices, response to exposure, spill management, and proper disposal

Internet Pharmacies and controlled substances

Pharmacies dispensing controlled substances via Internet must also be separately registered under Ryan Haight Online Pharmacy Consumer Protection Act of 2008 -Prescriptions must be based on a physical examination of patient at least once every 2 years

May any prescribers purchase legend drugs for use in their practice?

Pharmacies may transfer legend drugs to other pharmacies or prescribers without registering as wholesalers "to meet an urgent need" May not exceed 5% of total sales during any previous 12 months Commission has recently suggested that "routine" sales to physicians violate this rule Repackaging may make the transferred drug misbranded, and should not be done

Can refills of legend drugs be transferred from one pharmacy to another? Can they be transferred back?

Pharmacies with a common electronic database track refills for legend drugs at any outlet in this common database DEA Rule: "The transfer of original prescription information for a controlled substance listed in Schedules III, IV or V for the purpose of refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization." Most pharmacies - one time basis means that the pharmacy must transfer all available refills to the other pharmacy. Shared database - may transfer any number from one refill up to all the available refills to the other location.

What are the requirements for remote processing of prescriptions?

Pharmacist at one site reviews and approves drug for another site Commission Guidelines allow for pharmacies that are not owned by a common entity to enter into agreements for remote processing of orders.

Define Pharmacy Assistants

Pharmacist defined in this section but not intern Ancillary personnel Technicians Assistants Training programs for pharmacy technicians Duties of technicians and assistants Limitations (yes/no questions only) Disciplinary actions Pharmacy Application to use Ancillary Personnel Pharmacy or pharmacist responsible

Pharmacy compounding: Pharmacists and ancillary personnel (WAC 246-878-030)

Pharmacist responsible for inspection of drugs, equipment, and for assuring accuracy of product Must keep up to date with continuing education related to compounding Clean clothing and protective apparel Exclude persons from compounding area with lesions or other illness that could affect quality of product

What are the requirements for CE for Pharmacists

Pharmacists are required to complete fifteen (15) hours (1.5 CEUs) of professional CPE as a prerequisite for annual license renewal. No carry over of credit is allowed May be ACPE-accredited CE May use form on Commission website to request approval of individual non-ACPE programs Local associations may obtain approval for their programs without going through ACPE Non-ACPE programs are generally not approved in other states Will need to register with NABP CPE Monitor to obtain an NABP e-Profile ID number to track ACPE-approved CE You will obtain an e-Profile ID as part of signing up for NAPLEX and MPJE Commission has reiterated policy to not require CE for the first renewal following graduation from pharmacy school

May pharmacists administer drugs? By which route(s)?

Pharmacists may administer drugs ordered for a patient by an authorized prescriber, by any route, by virtue of their license to practice. Certification is not required to administer a prescribed drug Certification part of prescriptive authority protocol to be able to order a vaccine or other drug Certification may be needed for payment Injectable drugs administered to pregnant women and children < 3 yrs of age No more than 0.5 mcg of mercury per 0.5 mL dose Flu vaccines: no more than 1 mcg of mercury per 0.5 mL dose Use single-use vials that are preservative free whenever possible

What are the requirements for immunizations administered by pharmacists?

Pharmacists may administer drugs ordered for a patient by an authorized prescriber, by any route, by virtue of their license to practice. Certification programs for immunizations are part of the process by which pharmacists in Washington may easily gain documented competence and adhere to the terms of a prescriptive authority protocol developed by WSPA and endorsed by the Commission in order to prescribe vaccines. However, a pharmacist may develop a prescriptive authority protocol to prescribe and inject drugs without certification, as long as an authorized prescriber agrees to the protocol. Clearly, pharmacists should not undertake procedures unless they are adequately skilled in them.

OBRA-87: Requirements for LTC facilities

Pharmacists must be involved in care of patient Development of a comprehensive care plan for each resident Resident's therapy must be free of unnecessary drugs -Duplicative therapy -Excessive duration -Inadequate monitoring -Inadequate indications for use -Use of drugs in presence of ADRs Comprehensive reviews of psychotropic drugs and plan to reduce use in each patient (everytime try to remove med) Drug Regimen Review by pharmacist q 30 days

Is Sexual contact with patients permitted?

Pharmacists prohibited from engaging or attempting to engage in sexual misconduct with a current patient or "key party" inside or outside the health care setting (WAC 246-16) May not offer sexual favors May not used health care information to attempt to "meet the provider's sexual needs." Prohibits attempting to engage in sexual conduct during a 2-year period after the provider-patient relationship ends

Applying to establish a new pharmacy is made to whom? What forms are used and what items must be sent?

Pharmacy Commission One application form for all pharmacies Differential hours - supplemental application Ancillary personnel - supplemental application Must be submitted 30 days prior to a Commission meeting DEA - use form 224, online application process

Central filling & fulfillment

Pharmacy Commission Guidelines - on web site: -"Requirements for Central Filling of Prescriptions by Washington Pharmacies and Central Prescription Filling Service Providers" Similar to rules for RMOP Must comply with DEA rules -2010 DEA pharmacist manual (NEED TO KNOW) Both pharmacies involved must share electronic records Dispensing pharmacy must maintain records of all prescriptions filled by it and the central fill pharmacy Must inform patient prior to outsourcing that the prescription may be outsourced Label must have name and address of both the dispensing pharmacy and the central fill pharmacy, except where there is common ownership of both pharmacies See other requirements in text and DEA Manual

Must every pharmacy have a pharmacist-in-charge?

Pharmacy Owner Responsibilities Place a pharmacist in charge Pay an annual license fee File a statement of ownership and location If these people change needs to be an adendum or submit a new statement Maintain records of prescriptions and dispensing for a minimum of 2 years (business requirement for maintaining, pharmacist responsibility of accuracy) Maintain CSA records for a minimum of 2 years Ensuring the quality of drug products (safe and pure products, that it is in working order, security, hot and cold running water, etc)

Can the store be open but the pharmacy department closed? Under what requirements?

Pharmacy security Drop off box or mail slot for Rx's Distinct telephone number Recording of phone calls if answered in main store when RPh not present Oral Rx's may be recorded if hours are announced by answering machine Operating hours displayed at entrance; if in larger store, at entrance to larger store and near the pharmacy Advertising must list operating hours

Within scope of practice for dispensing controlled substances

Physician - entire human body Naturopath - entire human body Dentist - head and neck Podiatrist - ankles and feet Nurse practitioner - specialty area Physician assistant - same as supervising physician Optometrist - eyes Ophthalmologist - same as physician Psychiatrist - same as physician Psychologist - not generally allowed to prescribe Veterinarian - entire animal body Pharmacist - humans or animals, within scope of authorizing practitioner

Practitioners with Prescriptive Authority in WA

Physicians MD Osteopath (DO) Podiatrist Dentists Veterinarians Mid-level practitioners -Nurse Practitioner -Physician's Assistant -Naturopath* -Optometrist (OD)* -Pharmacist* -Midwife* * - out of state prescriptions not valid in WA

RX's authorized in all states

Physicians (MD, DO) -All drugs, all schedules, any use in humans Podiatrists (DPM, PodD) -All drugs, all schedules, any use for treatment of conditions of feet and ankles Dentists (DDS, DMD) -All drugs, all schedules, any use for treatment of conditions of head and neck Veterinarians (DVM) -All drugs, all schedules, any use for treatment of diseases in non-human animals

Out of state prescriptions may be filled in WA from

Physicians (MD, DO) Podiatrists (PodD, DPM) Dentists (DDS, DMD) Veterinarians (DVM) Nurse Practitioners (ARNP) Physician Assistants (PA-C) When licensed in any state, territory, or British Columbia (legend drugs only from BC)

Which of the following can prescribe legend drugs: O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician's Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Clinical Psychologist, Physical Therapist, Respiratory Therapist, Pharmacist?

Physicians (MD, DO, Podiatrist) Dentists Veterinarians Mid-level practitioners (NP, PA, Naturopath, OD, PharmD, Midwife)

What are Pharmacy owner responsibilities for a new pharmacy?

Place a pharmacist in charge Pay an annual license fee File a statement of ownership and location If these people change needs to be an adendum or submit a new statement Maintain records of prescriptions and dispensing for a minimum of 2 years (business requirement for maintaining, pharmacist responsibility of accuracy) Maintain CSA records for a minimum of 2 years Ensuring the quality of drug products (safe and pure products, that it is in working order, security, hot and cold running water, etc)

Facility responsibilities for ADDD

Policies and procedures must address -Equipment type, components, and locations -Medication and information access -Track who is loading, inventorying, cleaning, etc.. -Medication management QA and PI program must be developed and maintained

Pharmacist responsibilities for ADDD use

Policies and procedures must be in place Conduct quarterly audits Approve the inventory for the ADDD Checking and stocking must be done by pharmacist, technician or intern Ensure security of medications Develop and implement ongoing training Participate in ongoing facility ADDD system QA and Performance Improvement program

Parenteral Products, Non-Hospitalized Patients -- WAC 246-871

Policy and procedure Class 100 environment (ISO 5) Pharmacist in charge -Must have training in aseptic technique & QA (quality assurance) Clinical services -Monitoring -Training -Administration Quality assurance -QA program reviewed annually -Errors, ADRs, Pt. Satisfaction, Sterility

Legibility of Prescriptions in WA

Prescriptions must be legible in WA Legible means "Capable of being read and understood by the pharmacist filling the prescription or the nurse or other practitioner implementing the medication order." (RCW 69.41.010(11)) "A prescription must be hand printed, typewritten, or electronically generated." SHB 2292 (2006 c 8)

Under what conditions, if any, is therapeutic substitution allowed?

Prior authorization, therapeutic interchange program, collaborative practice agreements

Examples of Treatment regarding TPHCO

Processing prescriptions and dispensing drugs Maintaining and reviewing patient profile Consulting with prescribers relative to the patient's care Providing emergency information necessary for the patient's care Consulting with patient or caregiver regarding the patient's medications Transferring refill information to other pharmacies

Schedule III and IV Rules

Products exchanged between registrants by use of invoice with address and DEA # of each May be telephoned or FAXed May refill up to 5 times within 6 months; Rx expires after 6 months May transfer refills one time to another pharmacy if state law permits Computer records must be kept on-line for 24 months after last possible refill (2.5 years) If use computer records, pharmacist must sign log sheet or bound book at end of each day Label must bear transfer warning Technically, both date of first filling and of refilling must be on label

Schedule V Rules - Legend Drugs

Products exchanged between registrants by use of invoice with address and DEA # of each May be telephoned or FAXed No refill limit or expiration date for Rx under federal law -WA - 6 months from date prescribed and no more than 5 refills -Treat the same way in WA as C-IV or C-V Rxs

Prospective DUR

Prospective - before the fact Screen prescriptions against history prior to dispensing -Therapeutic duplication -Drug-disease contraindications -Drug-drug interactions (including OTCs) -Incorrect dosage or duration of treatment -Drug allergies -Clinical abuse or misuse May be manual and/or computer-assisted May be "on-line"

What use of the profile is required? Review prior to dispensing new Rx's? Review prior to refills?

Prospective - before the fact Screen prescriptions against history prior to dispensing Therapeutic duplication Drug-disease contraindications Drug-drug interactions (including OTCs) Incorrect dosage or duration of treatment Drug allergies Clinical abuse or misuse May be manual and/or computer-assisted May be "on-line" Washington Law Requires examination of the medication record for each dispensing

May a pharmacy transmit a patient's prescription claim information electronically to a third party payor without the patient having provided written consent to the payor or the pharmacy?

Protected health information (PHI) is that which relates to health condition (past, present, future) and identifies the patient (45 CFR § 164.501) May be used for treatment, payment, and health care operations (TPHCO) Consent not required to use information for TPHCO Notice of Privacy Practices must be provided Must obtain permission to use information for marketing, research, etc. May share data that is "de-identified" Stricter state laws must be followed Business associates must assure compliance with rules Consent from minors is subject to state law

Privacy Rule (45 CFR Parts 160, 164)

Examples of Health Care Operations regarding TPHCO

Quality assurance within operation Quality assurance activities with external organizations Contacting providers or patients with information on treatment alternatives and related functions that do not include treatment Medical review, legal services, auditing, and fraud and abuse detection Employee training and development Complying with regulatory agencies and complying with HIPAA Inventory control and planning

Can a pharmacist legally repackage another pharmacy's prescription? Under what circumstances?

REPACKAGING IS MISBRANDING. However, the long‐accepted practice of pharmacists repackaging or relabeling drugs that are loaned, borrowed, or sold to other practitioners is unacceptable under the FDCA or most state laws unless the repackaged product has all of the required labeling. Incomplete relabeling renders the product misbranded.

When must the Board of Pharmacy be notified of any of the following? Change of pharmacist-incharge, change of pharmacy address, closing or sale of a pharmacy, change of pharmacy telephone number, change of an individual pharmacist's address, change of an intern's address, change of a technician's address, change of a person's name?

RPh/Intern's name/address ("promptly"), closing a pharmacy (15d prior)

Is there any requirement for a daily printout of prescriptions that were entered into the computer? Who must sign the printout?

RPhs must sign a daily log sheet/book indicating the correctness of the computer records

What are some pharmacy tasks that cannot be delegated

Receipt of a verbal Rx Consultation with the pt Consultation with Dr. Extemporaneous compounding of the Rx Interpretation of data in the patient record Ultimate responsibility for verification of the Rx Providing patient information as required by WAC 246-869-120 Signing of documents or registry books Professional communications with other health care professionals Decision not to dispense a drug

Pharmacy Commission Complaint Process

Receipt of complaint (written preferred by PQAC) Case Management Team (CMT) reviews complaint -CMT consists of 3 PQAC Members -CMT may decide to investigate or to close case Investigator conducts investigation -Investigator's report provided to Reviewing Commission Member -Reviewing Commission Member may recommend: -Closure -Notice of Correction Statement of Charges and Proposed Settlement Opportunity for Settlement Hearing by Commission -Clear and convincing evidence required Decision by Commission -Fines -Suspension -Revocation for a specific period -Probation -Limitations on practice -Additional education, training, etc. -Stay of discipline during probation Petition for reconsideration, or appeal to Superior Court, with further appeal to Appellate Division, or possibly to Supreme Court

DEA form 41

Record of controlled substances destroyed

What information must be recorded by the transferring pharmacy?

Record that the prescription has been transferred in the medication record system. Record in the medication record system the name and address of the pharmacy to which it has been transferrer and the name of the pharmacist (or intern) that received the information. (first and last name)

Must information regarding the transfer of legend drugs be recorded on the hard copy of the original prescription, or can it merely be recorded in the computer?

Recorded in the computer (legend drugs only, CSA drugs must have original copy with "VOID" written) THE RECEIVING PHARMACIST treats the prescription as an oral prescription, and must perform the following steps: Reduce the prescription to writing on a prescription blank, including patient name, address, prescriber's name and address, and other information required to be on the prescription. Write the word "TRANSFER" on the face of the prescription.

Telephoned, and FAXed Rx

Reduce oral Rx to writing FAX treated like telephoned Rx -Must show date, time, phone #, and location of FAX machine on FAX -Not printed on thermal paper Verify unclear or suspicious orders with prescriber

What information must be placed on the original copy of the transferred prescription by the receiving pharmacy?

Reduce the prescription to writing on a prescription blank, including patient name, address, prescriber's name and address, and other information required to be on the prescription. Write the word "TRANSFER" on the face of the prescription. Also record the following: The date the prescription was originally written (cannot be refilled for a year after that.) When processing a transferred prescription, it is important to override the current date in the computer, and record the original date written Number of refills remaining Date of last refill The name and address of the transferring pharmacy, and the serial number of the original prescription at that pharmacy The name of the transferring (transferor) pharmacist. As noted above, this should normally be the full legal name of the individual. For controlled substances, the receiving pharmacist must also record the following: o Number of original refills allowed on the prescription o Dates (and locations) of all previous refills o Number of valid refills remaining o DEA number of transferring pharmacy o Name, address, serial number and DEA number of pharmacy at which prescription was originally filled (if different from transferring pharmacy).

Shopkeepers and Itinerant Vendors

Registered to sell OTC drugs at retail Shopkeepers (e.g., grocery store without pharmacy or convenience store) register via Master License application system Itinerant vendors register directly with PQAC Only sell OTCs in original manufacturer's packaging May be limited in sales of OTC EPP products if found to have sold EPP in a "suspicious transaction" -Must maintain EPP log

DEA form 363

Registration for Narcotic Treatment Programs

DEA Form 225

Registration for: - Manufacturers - Distributors - Researchers - Analytical laboratories - Importers - Exporters

DEA form 224

Registration for: - Retail pharmacies - Hospitals/clinics - Practitioners - Teaching Institution - Mid-Level Practitioners

Integrity of drug supply chain

Registration of wholesalers Pedigrees -Statements of the origin and all subsequent transfers of the drugs -Not required for "authorized distributors of record" Develop standards and validate technologies (ex. RFID chips) Drug Quality & Security Act of 2013 -Fully electronic Trace and Trace system with 3 types of documentation -Transaction history -for each prior transfer starting with manufacturer -Transaction information - details concerning the product at sale -Transaction statement - statement that the transferor of the product is authorized and has received transaction information from the previous former owner

Weighing Factors

Related to the misconduct -Eg, Gravity, patient vulnerability, degree of responsibility Related to license holder -Eg, Experience, past record, past character, personal problems having a nexus to misconduct Related to disciplinary process -Eg, admission of key facts, full disclosure, bad faith obstruction of process, remorse General factors -Eg, intent, moral fitness, potential for rehabilitation, competence, illegal conduct, selfish motives

DEA form 106

Reporting theft or significant loss of controlled substances

In an NDC require on the OTC labeling?

Requested but *not required*

Periodic physical inventories of controlled substances

Required elements -Inventory date -Time of inventory (opening or closing) -Drug name, strength, form -Number of units/volume -Total quantity Recommended -Name, address, DEA number of registrant -Signature of person taking or responsible for inventory C-II: actual physical count C-III thru V: -Estimated count for most sizes -Actual count if container had > 1000 doses and has been opened

Nursing Home CSA Rules

Requirements depend on UD or non-UD CSA schedule must be on label of CSAs dispensed to nursing home patients Non-unit dose systems -C-II stored separately under lock -C-III stored separately from other drugs but may be stored with C-II -Bound log book for all C-II or C-III drugs -Physical counts q 24 h for C-II and weekly for C-III (see text) Unit dose - may follow above rules or develop alternative system with equivalent record keeping -C-III unit dose may be stored with other UD drugs -Discontinued unit dose drugs other than C-II may be returned to pharmacy

Practitioner responsibilities for e-prescribing

Retain sole possession of any hard token Must not allow any other person to use token or enter knowledge factor to sign Rxs Notify specified individuals if token is lost or stolen or knowledge factor compromise Monitor issued prescriptions to be sure they were valid and notify specified individuals of any Rxs discovered to be issued without his/her e-signature or to have differed from his/her intentions If notified that an e-Rx was not received by the intended pharmacy, insure that any replacement Rx indicates the facts of prior transmission Assure that a third-party auditor or certification organization has certified his or her application Cease using a non-conforming application to sign e-Rxs Assure all Rxs are for legitimate medical purpose within the due course of professional practice Determine that the pharmacy application has been certified to import, store and display -Information required for Rxs in 21 CFR § 1306.05(a) -Indication of signing as required in the rule -The number of refills -The prescriber's digital signature after verification Not process e-Rxs if the system is not compliant Limit access to specifically identified employees E-Rxs must be stored electronically, with any required notations Fulfill pharmacists' corresponding responsibilities under the CSA

What are some Actions against a pharmacist license

Revoked Suspended Probation CE requirements Fines and court costs Being the PIC (pharmacist is charge) vs. staff pharmacist vs. non-pharmacist business owner

Inspections under the 503B for compounding pharmacies

Risk based inspections Risks would include -Compliance history -History of recalls and types of recalls at the facility -Inherent risk of the compounded drugs -Inspection history and frequency -Whether the drug compounded is on a drug shortage list (506E) If a re-inspection is required within 12 months, the facility is charged a fee

Offer to Counsel

Rules set by states: most require pharmacist to offer each patient a chance to discuss their drug therapy, generally must document refusal to be counseled Significant items -Name and description of medication -Dosage form, dose, route, duration of therapy -Special directions for preparation, administration, or use by patient -Common severe side effects, adverse effects, interactions, or contraindications that the patient can detect and deal with -Self-monitoring techniques -Storage and refill information -What to do if a dose is missed

Schedule V Rules - OTCs

Rules that would have allowed for OTC schedule V sales have been repealed effective 7/16/15.

Prescription Drug Samples

Samples may be distributed only to prescribers, or to hospitals at request of prescribers -Free clinics may possess and distribute No fee or charge may be imposed for distributing samples Retail pharmacies may not possess samples

Are there any special requirements for mail order pharmacies?

Sell or ship drugs to patients in WA Must register with WA Pharmacy Commission Registered & regulated by home state Must put 800-number on label for patients to receive consultation Must maintain patient profiles Must provide patient information May be disciplined or fined by WA if home state doesn't investigate a complaint within 45 days.

What are considered Non-Resident Pharmacies (Pharmacies not located in Washington State)? What are their requirements?

"When using this product..." is for_______

Side effects and substances to avoid

What minimum sets of references, products, or equipment are required in all community pharmacies?

Specific reference books are not required. The rule only requires that up‐to‐date references must be available as needed for pharmacists to furnish patients and practitioners with information concerning drugs. The pharmacy must have in place one up‐to‐date copy of Washington statutes and rules governing the practice of pharmacy, the sale and dispensing of drugs, poisons, controlled substances and medicines. Electronic or on‐ line versions are acceptable. (WAC 246‐869‐180(2)) Must have one bottle of Syrup of Ipecac in stock at all times However, this product is no longer available in the US, so this is unenforceable Telephone number of nearest poison control center National Poison Center Number 1-800-222-1222 Connects to Washington Poison Center in Seattle when dialed from anywhere in WA

This should be on the Principal Display Panel of an OTC drug

Statement of Identity = drug name + pharmacologic category/intended action

Sterile Products for compounding pharmacies

Sterile compounding must conform with WAC 246-871 As noted above, must comply with USP <795> or <797>

Storage of Hazardous Drugs

Stored in a manner that prevents breakage and spillage if the container falls Do not store HDs on the floor Use secure shelves with front lips Antineoplastic drugs that require manipulation other than counting or repacking must be stored separately than non-HDs Refrigerated antineoplastic HDs must have their own fridge with negative pressure

What are required to become an Intern

Student enrolled in accredited college of pharmacy Making timely progress towards graduation Engages in practice of pharmacy under supervision of a licensed pharmacist preceptor Notifies Commission prior to starting at site Preceptor oversight May be supervised by non-preceptor RPh in the temporary absence of preceptor Submits final report within 30 days after finishing at site, and at least 30 days prior to taking licensure exam Timely pays the $30 annual fee for an intern permit

Define Automated drug dispensing devices (ADDD)

Technicians may fill or check drugs in automated drug dispensing devices Must meet special training requirements Note: Nursing board has indicated that it believes filling and checking drugs in ADDDs is within scope of RN practice.

Can techs fill IVs? Can techs fill or check drug dispensing machines?

Technicians with special training may prepare IV admixtures "Licensed pharmacist" must check each parenteral drug prepared by technician Technicians may fill or check drugs in automated drug dispensing devices Must meet special training requirements Note: Nursing board has indicated that it believes filling and checking drugs in ADDDs is within scope of RN practice.

WA Death with Dignity Act

Terminally ill (within 6 mos) competent adult Washington residents may request a prescription they may take to end their lives in a dignified manner Must be certified by 2 physicians as terminally ill and competent -Must request a psychiatric evaluation if any question of mental incapacity

What is required on the label of a radiopharmaceutical agent?

The IMMEDIATE OUTER CONTAINER shall be labeled with: The standard radiation symbol The words, "Caution‐Radioactive Material" The name of the radiopharmaceutical The amount of radioactive material contained, in millicuries or microcuries If a liquid, the voume in mL The requested calibration time for the amount of radioactivity contained Expiration data, if applicable Specific concentration of radioactivity The IMMEDIATE CONTAINER shall be labeled with The standard radiation symbol The words, "Caution‐Radioactive Material" The name of the nuclear pharmacy The prescription number The name of the radiopharmaceutical The date The amount of radioactive material contained in millicuries or microcuries

Unprofessional Conduct

The Pharmacy Commission may discipline you for unprofessional conduct, which may include: Conviction of a relevant crime Misrepresentation or concealment of a material fact in obtaining a license False, fraudulent, or misleading advertising Incompetence, negligence, or malpractice which -Results in injury to a patient -Creates an unreasonable risk that a patient may be harmed Suspension, revocation, or restriction of a license in another state Possession, use, prescription for use, or distribution of controlled substances in any way other than for a legitimate medical use, diversion ..., violation of any drug law, or prescribing controlled substances for oneself. Violation of any ... statute ... or rule defining or establishing standards of patient care or professional conduct or practice (OBRA-90?) Failure to cooperate with the disciplinary authority -Not furnishing in writing a full and complete explanation covering the matter contained in the complaint filed with the disciplinary authority -Does this include admitting guilt or responsibility? Failure to comply with an order of the Commission Aiding or abetting an unlicensed person to practice Violations of rules established by any health agency Practice beyond the scope of practice Misrepresentation or fraud in the conduct of a business or profession Failure to adequately supervise auxiliary staff Engaging in a profession while suffering from a contagious or infectious disease Promotion for personal gain of any unnecessary drug, device, treatment, procedure, or service Conviction of any gross misdemeanor or felony relating to the practice of a person's profession Procuring, or aiding in ... a criminal abortion Offering ... to cure or treat ... by a secret method Willful betrayal of a practitioner-patient privilege Violation of RCW 19.68 (anti-kickback statute) Willful interference with a Commission investigation Current misuse of alcohol, controlled substances, or legend drugs Acceptance of more than a nominal gratuity from a representative of a manufacturer or vendor of medical or health-related products or services intended for patients, where a recognized conflict of interest is presented Destroying an unfilled lawful prescription Refusing to return unfilled lawful prescriptions to patient or agent Violating a patient's privacy Discrimination against patients or their agents in a manner prohibited by state or federal law Intimidation or harassment of a patient WAC 246-869-095 (revisions effective 6/1/07)

What about prescriptions that are delivered or mailed to the patient?

The pharmacist shall directly counsel the patient or patient's agent on the use of drugs of devices, based on the pharmacist's review of the patient's profile. This is for prescriptions delivered outside of the pharmacy.

Pharmacists' responsibilities in chronic non-cancer opioid treatment

The prescribing rules do not apply directly to pharmacists, nor do they modify other responsibilities The Pharmacy Commission has encouraged pharmacists to -Learn the requirements for the five covered professional boards -Consider that "prescriptions written for 120 mg MED or greater should give pause, and probably more often than not, trigger a call to the prescriber." -Multiple calls to a prescriber for a patient who is stable on non-escalating doses above 120 mg MED should not be necessary, unless there are other indicators that should be called to the prescriber's attention If prescriptions are from "episodic care providers" the requirements for the ICD-9 code or diagnosis, and the requirement for obtaining photo ID, must be present - otherwise DEA could consider the prescription invalid Prescribers who designate a single pharmacy in a patient agreement should notify the pharmacy. If the pharmacy knows it is the designated dispenser, it should notify the prescriber if it becomes aware that the patient is obtaining prescriptions from other prescribers or at other pharmacies Pharmacists with collaborative practice agreements who are initiating or modifying therapy for chronic non-cancer pain should follow the same standards as the authorizing prescriber, and may wish to amend their CPAs to reflect adherence to these standards

What is the maximum ratio of technicians to pharmacists? Of interns to pharmacists?

The statute established a ratio of 1 pharmacist to 1 technician in retail pharmacies, and a 1:3 pharmacist‐to‐technician ration in institutional pharmacies. However, it also gives the Commission the right to establish other ratios for pharmacies that have filed a utilization plan. (RCW 18.64A.040) In practice, the ratios established in regulation are the ratios that actually apply. The statute also gives the Commission authority to authorize pilot projects designed to investigate different ratios or use of technicians. Washington regulations specify that "The pharmacist preceptor may supervise more than one intern during a given time period; however, two interns may not dispense concurrently under the direct supervision of the same preceptor

What is the ratio of pharmacists to technicians? Does it differ by setting?

Compounding Environmental Controls

There must be a designated area for hazardous drugs that is away from breakrooms, patients, visitors, and personnel not handling the drugs. Certain areas require negative pressure Uninterrupted power sources (maintain negative pressure even in a power outage) Upon receipt of HD, unpack them in negative pressure areas Waste disposal container to discard contaminated PPE and trash that is within the workspace and separate from other waste

USP <800> (Hazardous drugs)

This describes the practice standards for handling hazardous drugs The aim of USP 800 is to promote patient safety, worker safety, and environmental protection Handling hazardous drugs include: -Receipt, storage, compounding, dispensing, administration, disposal, etc. This applies to ALL healthcare professionals and ALL entities (pharmacies, hospitals, veterinary offices) who handle HD The National Institute for Occupational Safety and Health (NIOSH) has a list of hazardous drugs used in healthcare which can be found at http://www.cdc.gov/niosh/docs/2014-138/ This list should be reviewed at least once every 12 months 3 types of hazardous drugs -Antineoplastic drugs -Drugs that carry a reproductive risk to males or females -Non-antineoplastic drugs that meet one or more of the NIOSH criteria for a hazardous drug (teratogenic, carcinogenic, Genotoxic, etc.)

FDA section 503B (outsourcing facilities)

This law applies to outsourced compounding facilities who choose to be registered and inspected by the FDA. This does not apply to compounding health system pharmacies. An outsourcing facility is defined as -A facility who compounds sterile drugs -Is registered with the FDA -Complies with the requirements established in this bill -They DO NOT have to be a pharmacy or fill patient specific prescriptions Annually register with the FDA Send a list of compounded drugs that are made to the FDA every 6 months which includes -The active ingredient/s -Source -Strength per unit -NDC -Adverse event reports Annual establishment fee

Is counseling required on new prescriptions, refills, or both?

This rule applies to all prescriptions except where a medication is to be administered by a licensed health professional authorized to administer medications.

What information is required on the profile?

This system will consist of certain patient and prescription information, and shall provide the pharmacist within the pharmacy means to retrieve all new prescription and refill prescription information relevant to patients of the pharmacy

How rapidly must a pharmacy respond to a patient's request to amend the information in his or her medication record?

Time limits for access to records WA: ASAP, with 15 day limit for initial response, 21 day maximum HIPAA: 30 days for response, 30 day extension Time limits for amendment of records WA: 10 days for response, 11 day extension; 21 days maximum HIPAA: 60 days for response, 30 day extension

Release without permission of patient allowed by RCW 70.02.050

To a person who is reasonably believed to be providing health care to the patient; To a provider who is the successor in interest to the provider providing maintaining the information

Valid CSA Prescriptions

To be dispensed to an ultimate user (patient) -Washington law allows naloxone prescriptions to be filled for a caregiver or friend of opiate user to be administered in case of accidental overdose For a legitimate medical purpose By an authorized prescriber In the due course of professional practice Legitimate Medical Purpose Bona fide prescriber-patient relationship Issued to treat a medical condition Not for "office use" Not fraudulent or forged Not issued solely to maintain an addiction, except -Methadone Maintenance Programs -Office-based Buprenorphine maintenance programs WA - prescriptions issued by a prescriber for his or her own use (considered unprofessional conduct) WA - may not dispense one's own prescription for controlled substances DEA has held that use must be within uses specified in package labeling Not for other statutorily specified exclusions -Anabolic steroids for weight training -Specified CNS stimulants for weight control

Patient Informed Consent

Treatment -CDTA -Immunizations Investigational drug therapy

Product Selection in WA

Two-line prescription blank, out of state ok to substitute unless "DAW" etc. is on Rx -Commission rule (WAC 246-899-050) clarifies further. If prescriber does not clearly indicate instructions, may substitute only if pharmacist -Has personal knowledge of rules in the other state; -Has obtained authorization from the prescriber; or Obtains current information on the rules in the other state Indicate on oral prescriptions if DAW or Substitution Permitted Shall substitute unless patient requests otherwise Must use therapeutically equivalent product of identical base or salt given in same regimen May use any reliable information source to determine bioequivalence

What are Pharmacy Assistant Duties

Typing (typewriter, not a computer), filing, refiling, bookkeeping, pricing, stocking, delivery, nonprofessional phone inquiries (i.e. what time do you open?), documentation of third party reimbursements (in the form of a check can do some accounting) May not enter data into the computer system Cannot enter new medication order into system Cannot retrieve drug product to fill a prescription Cannot stock remote dispensing devices Able to put back drug product to shelf

Preferred emergency contraception when >72 hrs

Ulipristal (Ella) but Rx only...

Can partial fills be done for C-II Medications?

Unable to supply (out of stock) ... must fill remainder within 72 hrs and notify prescriber if remainder not supplied -DEA interprets "unable to supply" to allow for partial filling while awaiting confirmation of the validity of a prescription. (Personal communication, Vickie Seeger, DEA, 4/4/05) -DEA now allows a partial fill due to patient inability to pay, and may receive rest within 72 hours. (Letter to Prof. D. Brushwood in 2001) Terminally ill ... partial filling for up to 60 days Nursing home ... partial filling for up to 60 days

When do you need a Responsible Pharmacist Manager? Who do you notify when you assign one?

Unlawful to operate a pharmacy without placing a pharmacist in charge (RCW 18.64.020) Each non-licensed proprietor must appoint a responsible pharmacist manager (RPM) Must notify Commission when appointed Must notify Commission when appointment is terminated Each RPM must notify Commission when appointed or appointment terminated "Every portion of the establishment coming under the jurisdiction of the pharmacy laws shall be under the full and complete control [of the RPM]." (WAC 246-869-070) Example: Commission held an RPM responsible for inappropriate labeling on OTCs in the front section of a larger pharmacy RPM retains responsibility for ancillary personnel. Policies and procedures in place

Must generic savings be passed on to patients? If so, what proportion, and how determined?

Unless the brand name drug is requested by the patient or the patient's representative, the pharmacist shall substitute an equivalent drug product which he or she has in stock if its wholesale price to the pharmacist is less than the wholesale price of the prescribed drug product, and at least sixty percent of the savings shall be passed on to the purchaser 60% of savings to the patient Brand Acquisition Cost - Generic Acquisition Cost = SAVINGS

Authorized Prescribers to dispense controlled substances

Up to state who can prescribe Must register with DEA and state Registration covers specific schedules for which registrant is authorized Must have registration for each location -If prescriber has 2nd office in same state, but does not store controlled substances there, does not need additional DEA number

Personal Protective Equipment (PPE)

Used typically for compounding but may also be used for treating a patient or cleaning up a spill Required PPE -Gowns, 2 pairs of chemotherapy gloves -Head, hair, and shoe covers -Eye/face protection when there is a risk of spill or splash -Respiratory mask when attending spills larger than can be contained with a spill kit, cleaning and decontaminating underneath the work surface, or there is a known airborne exposure to powder or vapor Any PPE worn while handling hazardous drugs is considered contaminated and needs to be disposed of in a separate clearly marked disposal container before leaving the area

What is the maximum amount of pseudoephedrine that can be sold OTC to an individual in a given day?

WA: Age=18, Daily=3.6g, Month=9g, Max Pack Size=3.6g Federal: Age=N/A, Daily=3.6g, Month=9g (7.5g mail), Exempt Size=60mg/pack/sale, Max Pack Size=3.6g, Packaging=Blister pack, max 2 units/blister

The pharmacist must contact the prescriber if needed following DUR

WAC 246-875-040 requires the pharmacist to contact the prescriber "if needed" May often resolve problems in other ways Consulting with patient to gain more information Tylenol w/ Codeine 30 mg, "1 q4-6h prn infection" Exercising judgment and informing prescriber Amoxicillin 250 mg caps, 1 t.i.d., for a 3-year old

What documentation is required of the pharmacist when product interchange is performed?

WITH PRIOR AUTHORIZATION (Washington requires documentation to be available in the pharmacy records - WAC 246‐899‐030(3).) If a pharmacy has received permission from a prescriber, or group of prescribers, to perform therapeutic substitution for a given class of drugs, and has a record of that permission, then they may undertake that substitution for all of the prescribers' patients unless instructed otherwise on an individual basis. There is no requirement under Washington law that the prior authorization be in writing, although it must be documented in the pharmacy records. A "prior authorization log," recording the dates and times when individual prescribers granted prior authorization, would be one approach to meeting the required documentation. In general, however, written approval will be preferred for many reasons.

Documentation of Counseling Not Required in WA

Washington does not require documentation of counseling Washington does not require documentation when counseling is refused -It is highly recommended that the pharmacist document refusal to be counseled to protect the pharmacist/pharmacy in case of lawsuit but the law does not require documentation

Does the offer to counsel need to be documented? Does the refusal of the offer need to be documented? How?

Washington does not require documentation of counseling Washington does not require documentation when counseling is refused It is highly recommended that the pharmacist document refusal to be counseled to protect the pharmacist/pharmacy in case of lawsuit

What are some Adequate equipment items that a pharmacy needs

Washington is less prescriptive than most states Must have equipment needed for the types of prescriptions filled Must have other references needed for pharmacists to furnish information to patients and practitioners concerning drugs Must have access to current copy of Washington laws and regulations relating to pharmacy; electronic version is permitted and on-line access satisfies this requirement

Can the prescribed brand name be placed on the label when a generic is dispensed? If so, what wording is required?

Washington requires a two prescription blank. Substitution permitted is left line, and brand only is right line. "generic for ..."

Use of Medication Record to Review Drug Therapy for Problems

Washington requires pharmacists to -Examine the patients medication record upon receipt of a prescription or drug order to determine the possibility of -A clinically significant drug interaction; -A clinically significant drug reaction; -A clinically significant therapeutic duplication; or -Improper utilization of the drug Does not distinguish between new and refill orders Washington Law Requires examination of the medication record for each dispensing This involves "interpretation of the data in a patient medication record system," which cannot be delegated by pharmacist This is part of "verification" in WAC 246-901-010(10) Requires evaluation of the patient's "utilization of the drug" Applies to the "prescription or drug order" which covers inpatient and ambulatory settings

NPLEX - electronic tracking

Washington sellers are required to use an electronic tracking system for Methamphetamine Precursors OTC Sales, which will replace the transaction log At time of sale, seller will enter -Customer's ID (e.g., DL) -Product sold (drop-down menu) If the customer has purchased the drug elsewhere too recently, system will notify seller not to sell the product -Seller may enter "safety override" if threatened by purchaser -This will send an alert to law enforcement System provides a website for customer to learn why sale was denied

Minimum Necessary Data Set regarding TPHCO

When disclosing information to another covered entity, must disclose only such information as is necessary for the transaction involved The requesting party must specify the requested data elements -A payer, for example, might limit the information requested to the prescription number, NDC, and patient's date of birth; if the pharmacy provides more than this it is in violation

Rx's Must be on Tamper-Resistant Pads

Written Rxs for Medicaid patients must be on tamper-resistant pads Does not apply to Rx's that are -FAXed -Oral -e-Prescribed If you receive a non-conforming Rx, -Validate with prescriber before dispensing -In emergency, may dispense and validate within 72 hours -Record time of dispensing and validation When receiving a transferred Rx, must ask transferring pharmacist if the original was written on a tamper-resistant pad (Medicaid) All written Rxs handed to ALL patients that are issued in WA must be on state-approved tamper-resistant paper, with a state seal in the lower right hand corner of the Rx

Hospital Use of CSAs

Written orders rather than Rx's Outpatient pharmacies treated like community pharmacies Schedule II requirements in WA -Perpetual inventory of C-IIs in pharmacy -Record of drugs distributed to other units -Records of administration or disposal of C-IIs, usually done in the MAR -Wastage must be witnessed -Policies maintained on destruction (see text) -Monitoring to assure chart records are correct -Use of multiple dose vials of CSA drugs is discouraged -Physical counts of C-II or C-III drugs stored as floor stock required at each shift change

What are policies for Drugs brought into hospital by patients/familes

Written policy must be in place. Such drugs may be administered only if properly ordered. Prior to use a pharmacist must examine them and assure they meet quality standards If not use, remain sealed and are returned to patient or family. By policy, hospital may choose to not return certain drugs if it would be dangerous to the patient Non returned drugs must be destroyed.

Is the "Drug Facts" Panel on OTCs FDA approved?

Yes

Does the Affordable Care Act cover emergency contraception?

Yes but only with a prescription

Define Deliver or delivery

actual transfer from one person to another of a drug or device

Define Distribute

delivery of drug or device other than by administering or dispensing

Define Administer

direct application of a drug or device by injection, inhalation, ingestion or any other means, to body of patient or research subject

Under what circumstances may a pharmacist refuse to fill a lawful prescription?

exceptions to the "timely manner rule": Rx's with an obvious or known error, national or state emergencies or guidelines affecting availability of supplies, lack of specialized equipment/expertise, failure of patient to pay the pharmacy's usual and customary or contracted charge As a matter of Washington state law, no individual may be compelled to participate in an abortion. One does not have to be a "conscientious objector" to opt out of such participation in Washington. Oregon and Washington Death with Dignity laws specify that participating in providing aid‐in‐dying is limited to willing health care providers, and prohibit discrimination against persons who participate in or refuse to participate in aid‐in‐dying. "No individual shall be required to perform or assist in the performance of any part of a health service program or research activity funded ... under a program administered by the Secretary of Health and Human Services if his performance or assistance in performance of such part of such program or activity would be contrary to his religious beliefs or moral convictions." (42 U.S.C. § 300a‐7(d)) A pharmacist or technician who intends to refuse to participate in otherwise lawful activities has two important moral obligations, authenticity and publicity

Labeling on prescription drugs is written for...

healthcare providers

What must be on the label of a multiple-dose container dispensed for a patient in a hospital? In a nursing home?

hospital: drug name, conc., exp. date, storage, auxiliary labels LTC: pharmacy name/address, Rx#, pt name, drug name, conc., CSA schedule, quantity, date prepared/disp., RPh initials

What is required on the label of a parenteral solution dispensed for a patient in a hospital?

hospital: pt name, location, drug name, conc., exp. date, exp. time, RPh initials, preparer initials

Define Dispense

interpretation of order, and selection, measuring, compounding, labeling or packaging necessary to prepare for delivery

Electrolyte thresholds are based on

maximum daily dose

If any required OTC labeling information is missing, the drug is considered

misbranded

How long must the pharmacy maintain the following records: original prescriptions, refill records, drug purchase records, patient profiles? Are any of these different for CSAs? If any of these can be maintained on computer, how long do they need to be maintained "on-line?"

original Rx (2yrs), drug samples (3yrs), CSAs (2yrs), computer-CSAs (2yrs after last possible refill = 2½yrs), Medicaid (6yrs), drug purchase records (3yrs)

Labeling on OTC drugs is written for...

patients

What are the requirements for storage and accountability for controlled substances in a hospital?

perpetual inventory of C-II drugs, physical counts at each shift change, CSA records kept for 2yrs, significant losses reported to DEA

Define Practitioner

person duly authorized by law to prescribe drugs or devices

Define Pharmacist

person duly licensed by Commission to engage in the practice of pharmacy

What is required on the label of a parenteral solution dispensed to a patient for home infusion therapy?

pharmacy name/address/phone#, Rx#, 24-hr phone, pt name, prescriber, drug name, conc., directions, infusion rate, date prepared/disp., exp. date, exp. time, storage, RPh initials, auxiliary labels, transfer caution label

Define Labeling

preparing and affixing a label to any drug or device container

"Stop and ask a doctor if..." is for_______

signs of toxicity

Define Compounding

the act of combining two or more ingredients in the preparation of a prescription

Define Administer

the direct application of a drug or device, whether by injection, inhalation, ingestion, or any other means to the body of a patient or research subject.

Information Required on Label of Dispensed Legend Drug (Federal Law)

the name and address of the dispenser the serial number date of the prescription or of its filling the name of the prescriber if stated in the prescription, the name of the patient the directions for use and cautionary statements, if any, contained in such prescription The "side effects statement" -"Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088."

Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in the actual number of dispensings being greater than the number of refills indicated on the prescription? Partial filling of Schedule III & IV

Answer: Yes. Partial fills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed and no dispensing occurs after six months past the date of issue

Hospital or Institutional DEA Numbers

Any employee of hospital may use hospital DEA number with permission in the course of his or her duties if otherwise authorized to prescribe Unregistered VA employees, likewise Use hospital DEA # plus internal code; must add stamped, printed, or typed name as well as signature May be filled at community pharmacies

USP GuidelinesGeneral chapter <795> (Non-sterile compounding)

Applies to non-sterile preparations Expiration dating recommendations -Non-aqueous liquids and solids -6 months or 25% of mfr label if made from manufactured product -Not greater than 6 months if USP or NF ingredient is source -Aqueous: 14 days, stored in cold place -All other: 30 days or intended duration of therapy Sources -USP or NF -Manufactured product w/ lot #, exp date

USP GuidelinesGeneral chapter <797> (sterile compounding)

Applies to sterile products and responsibilities of pharmacy personnel in their preparation Identifies standards for: -Low-risk, medium-risk, and high-risk sterile compounding -Verification of accuracy and sterilization -Training and evaluation in personnel aseptic skills -Environmental quality and control -Verification of automated devices for compounding parenteral nutrition therapy -Finished product release checks and tests -Storage and beyond-use dating -Quality control post-dispensing and distribution -Packaging, handling, storage and transport -Patient or caregiver training -Patient monitoring and adverse events reporting Requires a quality assurance program

OTCs requiring child-resistant containers

Aspirin Acetaminophen NSAIDs Iron preparations > 250 mg elemental iron/pkg Diphenhydramine > 66 mg/pkg Fluoride > 50 mg/pkg Lidocaine, Dibucaine Loperamide Minoxidil Methacrylic acid Methyl salicylate Ethylene glycol Methyl alcohol Hydrocarbons and solvents NaOH, KOH, H2SO4 Permanent Wave Neutralizers Drugs switched to OTC status after 2001 -Omeprazole -Cetirizine -Fexofenadine OTC controlled substances

What OTC drugs require a special additional pregnancy warning?

Aspirin-containing products

REMS Requirements May Include any or all of the following:

Assessments at 18 months, 3 yrs, and 7 yrs post marketing MedGuide or PPI development (patient info. Leaflet) Communication plan to health professionals (i.e. Tikosyn) Plans -Limit prescribing to physicians with special training -Limit dispensing to certified providers -Limit administration to certain settings (1st dose inpt. Etc..) -Limit distribution to patients with documentation of safe-use conditions, such as lab tests -Monitoring for each patient using the drug -Enrollment of each patient in a registry Ex. iPLEDGE, CARE (Clozaril)

What are Technician Duties

Assist in performing manipulative, nondiscretionary functions associated with the practice of pharmacy Under supervision of a licensed pharmacist

Can an intern transfer refills?

Because interns are allowed to practice pharmacy, they may perform any act that their supervising pharmacist allows within the scope of practice of a pharmacist (other than supervising technicians or checking IV admixtures prepared by technicians). One such act is the transfer of refill information to another pharmacy concerning controlled substances prescriptions. Interns may do this in Washington. Interns in Washington may also sell Schedule V controlled substances and sign the record book, and Washington interns may take oral prescriptions over the phone.

What are Assisted Living Services: Med-packs

Bingo cards and dosage cassettes, prepared under immediate supervision of a pharmacist Original bulk Rx container stays in pharmacy Up to 31 day supply Patient or agent must request non-CRC Labeled with same information for each drug as for outpatient Rx WA Medicaid pays for compliance packaging for qualifying patients (WAC 246-869-255)

Emergency telephoned or FAXed Rx - Schedule II

Bona fide emergency Sufficient quantity to last until written Rx can be provided Written confirming Rx must be postmarked or received at pharmacy within 7 days ... if not received must notify BOP and/or DEA "Authorization for Emergency Supply" at top of telephoned (or FAXed) and written Rx Quantity on written confirmation must match telephoned Rx Staple written confirmation to telephoned Rx

Who can prescribe from British Columbia? Controlled or legend?

British Columbia physicians, NPs, and PAs, can prescribe legend drugs, but not controlled substances unless have a US-issued DEA No.

What are the requirements for storage and accountability for controlled substances in a longterm care facility?

C-II's locked and stored separately, C-III's separate from legend but may be with C-II's, bound log book for C-II and C-III, physical counts by 2 individuals licensed to admin drugs q24h (C-II's) and qwk (C-III's)

How long are prescriptions for each of the following valid: C-2s, C-3s, C-4s, C-5s?

C2: No expiration date on Rx under federal law; 6 months in WA C3-5: May refill up to 5 times within 6 months; Rx expires after 6 months

Is there a maximum number of refills allowed for C-5s? What is it? Are the number of refills for C-3s and C-4s the same as federal or less?

C5: No refill limit or expiration date for Rx under federal law; WA - 6 months from date prescribed and no more than 5 refills C3-4: May refill up to 5 times within 6 months; Rx expires after 6 months; federal and state the same

Under what circumstances are FAXed CSA prescriptions allowed?

CII: injectable to be compounded by RPh for patient use, Rx for LTC or hospice patient, Rx signed by the prescriber, non-emergent situation (RPh may rely on the fax to prepare the order for delivery to the patient until hard copy is presented), emergent situation (Auth for Emergency Supply), order is faxed to a hospital for a patient being admitted or discharged from the hospital

Schedule II FAXes

Can fill a C-2 from FAX if compare to original written Rx prior to dispensing Emergency supply Long-term care facilities, may use as original DEA says prescriber should have a written agent agreement with RN in nursing home if RN is to act as "agent of the prescriber" to transmit orders by fax Home infusion practices - injectables only, may use as original Hospice patients, may use as original. May be for a hospice patient who is being treated by the hospice at home

What is the status of carisoprodol? Tramadol?

Carisoprodol (Soma) (Schedule IV) Tramadol (Schedule IV)

What are the Inspection & Grades of a pharmacy?

Class A: 90-100 Conditional: 80-89 60 days to improve to Class A Unsatisfactory: <80 14 days to improve to Class A 5 pts + taken off for violation of ancillary personnel rules automatic Unsatisfactory grade Self-inspection procedures

What are Hospital: Verbal Orders

Commission Rule: Verbal orders shall be issued in emergency or unusual circumstances, and countersigned within 48 hours. "Interpretive Guideline:" Allows for "passive authorization" of certain verbal orders. These order can be authenticated by review and monitoring undertaken by other health professionals, such as nurses or pharmacists. Orders not subject to the passive authorization policy must be countersigned by the prescriber. Exclusion from the policy must be spelled out in the policy (e.g., chemotherapy) A quality assurance program must be in place to monitor and improve the passive authorization program.

Closing of a Pharmacy

Commission must be notified prior to closing of a pharmacy, regardless of setting (at least 15 days prior): -Intended date of closing -Names and address of persons who shall have custody of pharmacy's records -Names and addresses of persons who will acquire any of the legend drugs or CSAs (if known) Within 15 days after closing, must supply to Commission -The pharmacy license -Written confirmation of -Proper transfer or destruction of legend drugs, including names and addresses of transferees -Proper transfer of any CSAs and names and addresses of transferees -Return of DEA registration and unused forms to DEA -Destruction of pharmacy labels and prescription blanks -Removal of all signs and symbols indicating the presence of pharmacy The Commission has adopted a policy encouraging pharmacies to notify patients 15 days in advance of the closing as a matter of insuring patient access: -Direct mail or newspaper ad, and posting a sign near the pharmacy -Intended date of closing -Name and address of pharmacy to which prescriptions will be transferred -Instructions on how patients can arrange for transfer of their prescriptions to a pharmacy of their choice, and the last day a transfer may be initiated

Information Required on Label of Legend Drug (WA)

Complete directions for use ("UD" not valid) Call for verification as provider, or pharmacist will dispense per package insert Expiration date Quantity dispensed Name and strength of drug Initials of pharmacist (can be in computer system) "Warning: State or federal law prohibits transfer of this medication to any person other than the person for whom it is prescribed."

Is "UD" allowed in WA?

Complete directions for use - "UD" not allowed in WA BC pills - "As directed on dialpak" Written schedules - "As instructed on written schedule from Dr." -Keep copy with original Rx -Estimate days' supply carefully Coumadin - "Take 1 daily or as directed by physician."

"Ask a doctor before use if you have... " is for ________

Conditions

Can legend drug prescriptions be transferred electronically (ie, by computer)? Under what circumstances and requirements?

Consistent with state and federal laws and rules over-the-counter, legend drug and controlled substance prescriptions may be transmitted electronically.

Poison Prevention Packaging Act

Consumer Products Safety Commission to set standards for child-resistant packaging Requires child-resistant containers (CRCs) on certain "household substances" Requires CRCs on all prescription drugs, except for certain listed products Requires CRCs on specifically listed OTC products

"Do not use..." is for ______

Contraindications

National Provider Identifier - required by HIPAA

Covered providers (45 CFR 162.402-414) -Individuals, e.g., physicians, nurses, dentists, pharmacists, physical therapists -Organizations, e.g., hospitals, laboratories, ambulance companies, HMOs, pharmacies Must obtain NPI within 30 days of licensure (or update your information) Implemented on-line, National Plan & Provider Enumeration System (NPPES): http://nppes.cms.hhs.gov/ Make changes to license status, address, etc., within 30 days, on-line.

Electronic prescribing and signatures

Currently DEA does not recognized electronic signatures as valid for CSA prescriptions unless prescriber and pharmacy are using a system that is qualified under the e-prescribing rule -Systems are now becoming available for CS e-prescribing -ScriptPro® pharmacy systems are accredited and indicate on e-Rx if the prescriber's system has also been accredited -CII to CV can be e-prescribed Computer printed e-Rxs that are faxed are valid only if signed before faxing, according to DEA

Required Records for all Pharmacies

DEA Registration Certificate Official Order Forms (222) Power of Attorney to sign order forms Initial inventory Biennial inventory records Reports of theft or loss (106) Inventory of drugs submitted to DEA for disposal (41) Records of transfers between pharmacies Inventory transaction records Must be maintained for 2 years

CSA Transfers (21 CFR § 1306.25) for controlled substances (III-V)

DEA Rule: "The transfer of original prescription information for a controlled substance listed in Schedules III, IV or V for the purpose of refill dispensing is permissible between pharmacies on a one time basis only. However, pharmacies electronically sharing a real-time, on-line database may transfer up to the maximum refills permitted by law and the prescriber's authorization." -Most pharmacies - one time basis means that the pharmacy must transfer all available refills to the other pharmacy. -Shared database - may transfer any number from one refill up to all the available refills to the other location.

Clinic registration

DEA form 224

Hospital registration

DEA form 224

Retail pharmacy registration

DEA form 224

What can be changed by RPh on C-II Rx?

DEA now says to follow state rules. Washington allows the following edits: -Add or change patient's address after verification -After consultation with prescriber, may change or add -Dosage form -Drug strength -Drug quantity -Directions for use -Issue date -Brand-generic changes -Add DEA number if known - no need to contact prescriber

What are some Things Pharmacies cannot do

Destroying a lawful unfilled prescription Both person destroying and business Refusing to return lawful unfilled prescriptions Violations of the patient's privacy Ex. Computer system breach Discrimination against patients or agents in a manner prohibited by law Intimidating or harassing a patient or patient's agent

Examples of Payment regarding TPHCO

Determining eligibility or coverage Preauthorization, utilization review Billing 3rd party payers, justification of charges Collecting payment from the patient, or collecting past-due charge accounts Providing certain information to consumer reporting agencies Transmitting credit card charges Refunding charges

Pharmacy Compounding: Washington revisions to Pharmacy Practice Act [RCW 18.64.011 (16)]

Distribution of a compounded product by a pharmacy for "resale" is "manufacturing," not compounding. -May be distributed for resale subject to approval by pharmacy commission (during shortage, etc.) "Manufacturing" does NOT include: (is ok to do) Office Use - Compounded by a pharmacy on order of licensed practitioner for use in practitioner's professional practice for administration to patients; Limited repackaging - Repackaging of commercially available medication in "small, reasonable quantities" for office use by a practitioner; Centralized compounding - Distribution of a compounded product to other appropriately licensed entities under the ownership or control of the facility in which the compounding takes place; or Delivery - Delivery of finished and appropriately compounded products dispensed pursuant to a prescription to "alternative delivery locations, other than the patient's residence, when requested by the patient, or the prescriber to administer to the patient, or to another licensed pharmacy to dispense to the patient. USP chapters <795> and <797> incorporated into statute when compounding products pursuant to a prescription

Prescribing narcotics for chronic non-cancer pain

Do not apply to palliative, hospice, or other end of life care, nor to management of acute pain secondary to injury or surgery Require prescriber to obtain, evaluate and document the patient's health history prior to beginning treatment: -Past history - current and past pain tx, comorbidities, any substance abuse -Ongoing history - review of information in PMP or ED-based information exchange; any relevant history from a pharmacist provided to practitioner (WAC 246-919-853) -Initial evaluation to include risk screening tools Requirements for prescribing narcotics to chronic non-cancer pain patients include -Well-defined treatment plan -Obtaining of informed consent to treatment -Written agreements for treatment recommended (WAC 246-919-856) -All chronic non-cancer patients should receive prescriptions from one practitioner and one pharmacy whenever possible -When the patient is at high risk for medication abuse, or has a history of substance abuse, or has psychiatric comorbidities, a written agreement shall be used -Periodic reviews must be conducted every 6 months, unless -Patient has stable chronic non-cancer pain involving non-escalating daily doses of 40 mg MED or less, in which case annual reviews must be conducted (WAC 246-919-857) Long-acting opioids, including methadone, should only be prescribed by a practitioner who has completed at least one CME of 4 contact hours on the safe use of long-acting opioids Episodic care practitioners - eg, ED physicians, urgent care practitioners -Prescriptions written for opioids by an episodic care provider "shall include indications for use or the International Classification of Disease (ICD) code and shall be written to require photo identification of the person picking up the prescription in order to fill." (WAC 246-919-859(3)) Mandatory consultation is required when a patient reaches or exceeds 120 mg MED Prescribers are exempted if they are pain management specialists, or have completed 12 Category I CME hours on chronic pain management with at least 2 hours devoted to long-acting opioids, within the prior 2 years

Military Practitioners

Do not need to register with DEA May indicate branch of service plus their service ID number May obtain a DEA number MLPs in military must be specifically licensed in the state in which they are stationed to obtain DEA number To prescribe "off base," need a separate DEA registration

Public Health Service or Bureau of Prisons Employees

Do not need to register with DEA Use Social Security number as DEA number

WAC 246-878: Good Compounding Practices

Documentation that patient and physician agree to use of a compounded product to replace a commercially available product Use of USP or NF products as first choice; otherwise pharmacist allowed to use judgment in selecting bulk sources Limit quantities compounded to need based on a history of receiving orders or to meet existing refills May sell compounded drug to a prescriber for administration to a patient (not for resale to patient) May promote compounding services, but not a specific product

"Ask a doctor or pharmacist before use if you have..." is for _______

Drug-drug and drug-food interactions

New Drugs

Drugs may not be introduced into commerce unless -Proven safe and effective for intended use -Adequate labeling -Meet current Good Manufacturing Practices -Produced by a registered manufacturer

Appropriate Disposal

Each entity must develop their own SOPs which address -Prevention of accidental exposure or spills -Personnel training -Response to exposure or spill -Use of a spill kit -SOPs and disposal must comply with federal, state, and local regulations

Can a patient refuse to give certain information for the profile? If so, must the refusal be documented, and how?

Elements under required by OBRA-90 may be withheld (age/DOB, gender, phone); no documentation needed, though RPh cannot be held responsible for errors d/t the withheld patient info

Minors Ability to Consent to Treatment in WA

Emancipated minors - 16 or over may petition court to become emancipated Minors married to a non-minor 14 or over - May consent to treatment for STDs Any age - May consent to contraceptives or pregnancy termination services 13 or over - May consent to inpatient or outpatient mental health treatment 13 or over - May consent to outpatient chemical dependency treatment

Outsourcing facilities for pharmacy compounding

Entities engaged in large volume compounding, particularly of sterile products, voluntarily register with FDA -Subject to cGMPs -Exempt from NDA or adequate labeling requirements -Subject to FDA inspection -Subject to registration and inspection fees Must be under supervision of a licensed pharmacist

Sterile and Non-Sterile Compounding Controls

Entities who compound sterile and non-sterile hazardous drugs must meet the following: Have a physically separate space (different room from other preparation rooms) Be externally vented through a high efficiency particulate air (HEPA) filter Have appropriate air exchange Have negative pressure Must have a sink for hand washing Must have eye wash station and/or other emergency equipment that meets federal, state, and local regulations If the same room is used for sterile and non-sterile compounding they must be separated by at least 1 meter ISO 5 or better air quality (for sterile compounding)

Washington Recovery Assistance Program for Pharmacy (WRAPP)

Established in 1983 by WSPA and WSSHP Supported by WSPA, UW, WSU, BOP Goals: -Protect the health and safety of the public -Provide a health resource and rehabilitation support for the impaired pharmacist No fee for WRAPP services Costs of assessment and treatment borne by participant (includes costs of drug screens) Details of a self-referral to WRAPP are kept confidential and no notification is made to Commission as long as participant is compliant with monitored treatment program. Program may require participant to voluntarily discontinue active practice during early phase of treatment (800) 446-7220 After a concerned individual has intervened, an involuntary referral to WRAPP will also be kept confidential and not reported to Commission as long as participant is compliant with monitored treatment program If a drug theft is linked to the discovery of an individual's impairment, the Commission may be notified Commission may refer licensee to WRAPP as an alternative to discipline Contract developed with licensee If contract completed, no disciplinary action is taken, and participation in program is kept confidential In case of discipline, WRAPP may be asked to monitor compliance

Federal Controlled Substances Act (CSA)

Establishes a "closed system" of inventory and accounting for distribution of controlled substances 5 Schedules (I, II, III, IV, V) - based on likelihood of abuse Listed chemicals (precursors to controlled substances)

Are patient profiles required for all patients?

Establishment of a patient medication record system is intended to insure that the information it contains will be reviewed by the pharmacist in a manner consistent with sound professional practice when each prescription is filled.

What is expected to be looked for during profile review?

Examine the patients medication record upon receipt of a prescription or drug order to determine the possibility of A clinically significant drug interaction; A clinically significant drug reaction; A clinically significant therapeutic duplication; or Improper utilization of the drug

Can legend drug prescriptions be FAXed? Under what circumstances and requirements?

FAX treated like telephoned Rx Must show date, time, phone #, and location of FAX machine on FAX Not printed on thermal paper

When should RX's not be on tamper-resistant pads

FAXed Oral e-Prescribed

Medication Guides

FDA-developed patient labeling If required for a product or class, must dispense each time prescription is filled -Patient may request and must be supplied -Physician may authorize not dispensing MedGuide, but pharmacist not required to withhold it Where a MedGuide is required, it replaces the corresponding PIL NSAIDs the largest class requiring MedGuides Being required for most new drugs

Adulterated drugs

Fails to conform to compendial standards for purity, quality, strength, and appropriate assays Failed to be stored under USP standards

CSA Prescription Containers Must Bear the "Transfer Warning"

Federal: "Caution: Federal law prohibits transfer of this medication to any person other than the person for whom it was prescribed." -All CSA Rx Containers WA: "Caution: State or Federal law prohibits transfer of this medication to any person other than the person for whom it was prescribed." -All Rx Containers

Pharmacy compounding requirements

For an identified individual patient Based on the unsolicited receipt of a valid prescription By a licensed pharmacist or a physician Limited quantities may be compounded prior to receiving a prescription Based on a history of the pharmacist receiving valid orders Within an established relationship between the pharmacist, physician, and patient

How must the offer to counsel be made?

Can printed materials satisfy the counseling requirement? Under what circumstances?

For prescriptions delivered outside of the pharmacy, the pharmacist shall offer in writing, to provide direct counseling and information about the drug, including information on how to contact the pharmacist. The pharmacist shall directly counsel the patient or patient's agent on the use of drugs of devices, based on the pharmacist's review of the patient's profile. This is for prescriptions delivered outside of the pharmacy.

Pharmacy Compounding Accreditation Board (PCAB)

Formed in 2006 by ACA, APhA, NABP, NCPA, NASPA, NHIA, USP Certification is voluntary, but may be required by insurance companies for sterile compounding Evaluates compounding pharmacies compliance with 35 standards Certifies qualifying pharmacies -Non-sterile, basic -Non-sterile, complex -Sterile, low/medium -Sterile, high Labeling guidelines are extensive, see text

Drug product selection

Generic substitution -Same chemical entity -Same dosage form -Bioequivalent -Same AUC -Same Peak Therapeutic substitution -Same class -Equivalent therapeutic effect

Administration and Devices Used with Hazardous Drugs

Hazardous drugs must be administered using protective medical technique and with protective devices Needleless and closed systems Protective techniques -Spiking and priming IV tubing with non-HD solution -Crushing tablets inside of a plastic bag -Locking devices

State-registered Domestic Partners have same rights as spouses

Health care visitation rights Ability to grant informed consent for a non-competent partner Authority for health care providers to disclose information to the partner under same conditions where disclosure to a spouse would be allowed Domestic partners residing in a LTC facility may share the same room Insurance policies that cover spouses must cover domestic partners

CSA Schedules

I - High potential for abuse and/or no medical use II - Highest potential for abuse -Narcotic (eg, meperidine, codeine, morphine, oxycodone, hydrocodone) -Non-narcotic stimulants (eg, methylphenidate, amphetamine, phenmetrazine, methamphetamine, cocaine) -Non-narcotic depressants (eg, barbiturates, methaqualone) III - Narcotic combinations and others -Up to 90 mg codeine per dose plus other active ingredients -Anabolic steroids (eg, methyltestosterone) -Benzphetamine and phendimetrazine -Barbiturate suppositories -Marinol IV - Primarily non-narcotics -Benzodiazepines (eg, Valium, Halcion) -Barbiturate combos (eg, Fiorinal) -Meprobamate -Phenobarbital -Chloral hydrate -Phentermine, mazindol, diethylpropion -Zolpidem, zaleplon, modafinil, sibutramine, butorphanol -Carisoprodol -Tramadol V - "Exempt narcotics" -Diphenoxylate with atropine -Generally no more than 10 mg codeine per 5 mL (Tylenol w/ Codeine 12 mg/5mL) -Lyrica® (pregabalin)

To what extent are collaborative practice agreements allowed?

IDs of authorizing prescriber and pharmacist(s) who are covered Time period up to 2 years Type of prescriptive authority Types of diseases, drugs, categories, and type of authority (e.g., initiating or modifying) General statement of procedures to be followed Activities required of pharmacist Documentation of decisions made Plan for communication or feedback to authorizing prescriber Note: Copy of CPA must be filed with Commission, but Commisson does not "approve" the protocol (MUST BE FILED, and CAN BE REJECTED, but commission does not have authority to APPROVE... That is up to prescriber and pharmacist)

Can a non-custodial parent act on behalf of a minor to authorize disclosure of information in the patient medication record?

If a minor is receiving mental health, STD, contraceptive, substance abuse, or mental health meds, presume they have control over record - get written permission to disclose to parents In other cases, parent or guardian must approve disclosures and may see records. If parents are divorced, you may disclose to either parent who asserts that he or she is authorized to give consent.

Disclosure to parents or guardians

How can a prescriber indicate that substitution is or is not permitted?

If a written prescription is involved, the prescription must be legible and the form shall have two signature lines at opposite ends on the bottom of the form. Under the line at the right side shall be clearly printed the words "DISPENSE AS WRITTEN." Under the line at the left side shall be clearly printed the words "SUBSTITUTION PERMITTED."

What must be done if the computer system goes down?

If an automated data processing system is used to maintain a patient's medication record, an auxiliary recordkeeping procedure must be available for use when the automated data system is temporarily inoperative due to scheduled or unscheduled system interruption. The auxiliary recordkeeping procedure shall provide for the maintenance of all patient recordkeeping information as required by this chapter. Upon restoration of operation of the automated system the information placed in the auxiliary recordkeeping procedure shall be entered in each patient's records within two working days, after which the auxiliary records may be destroyed. This section does not require that a permanent dual recordkeeping system be maintained.

Faxing according to the DEA (controlled substances)

If can be telephoned, can be FAXed Make sure FAX paper will be readable for 2 years or reduce to writing Pharmacist is responsible for verifying that FAX is not fraudulent -Should show originating number on FAX -FAX machines are programmable -Call back prescriber at known phone to verify DEA is claiming that faxed Rxs must be signed before faxing (e.g., printed out e-Rx) with a "wet signature" DEA is claiming that faxed requests for refills by pharmacy cannot be used as the prescription and faxed back - prescriber must generate new Rx, sign it, and fax that to the pharmacy

Deidentified Information

If the following identifiers are removed, the remaining data is by definition "deidentified" and not subject to privacy rules: Remove -Name -Address -ZIP -City -DOB -Admission date -Discharge date -Age -Telephone number -Fax number -Electronic mail address -Social security numbers -Medical record numbers -Vehicle identification numbers -Pictures

Misbranded drugs

Incomplete labeling Misleading labeling

Federal Pharmacists work in which locations

Indian Health Service, PHS, armed forces, VA Must be licensed in at least one state or territory Do not need to be licensed in the state where stationed Cannot practice part-time outside of the installation unless licensed in that state

ECF: Labeling - Unit Doses

Individual storage unit for each patient, clearly labeled with resident name Individual package must have -Name of drug -Strength -Lot number -Expiration date -CSA Schedule

What must be on the label of a unit-dose or singledose package of a legend drug dispensed for a patient in a hospital or nursing home?

Individual storage unit for each patient, clearly labeled with resident name Individual package must have Name of drug Strength Lot number Expiration date CSA Schedule

What is considered the Practice of Pharmacy

Interpreting prescription orders Compounding, dispensing, labeling, administering and distributing of drugs and devices Monitoring of drug therapy and use Initiating or modifying drug therapy in accordance with written protocols approved for his or her practice by a practitioner authorized to prescribe Participating in DUR and drug product selection Proper and safe storage, distribution, record keeping Providing of information on legend drugs ... therapeutic values, hazards, and uses

DEA Numbers

Issued to registered practitioners, institutions, pharmacies, etc. Format: AA1234567 2 letters plus 6-digit number plus "check digit" 1st letter: usually "A," "B," or "F" for physicians, dentists, etc., and "M" for MLPs 2nd letter: usually first letter of registrant's last name (may be former last name or a number)

Can transfers of refill information be faxed between pharmacies?

Just as an agent of the prescriber can communicate information about a prescription, there is no rule that prohibits the technician completing the fax transmission of refill information to another pharmacy, provided that a pharmacist has reviewed the information on the fax before the technician sends it. The fax should bear the name of the transferring pharmacist, and also the identity of the technician who is communicating that information on behalf of the approving pharmacist. (Note: in Spring 2014, PQAC staff indicated they did not believe that transferring information by fax met the "pharmacist‐to‐pharmacist" test.)

Which electrolytes require kidney *disease* warning?

K, Mg

Which electrolytes require kidney *stone* warning?

K, Mg, Ca (all but Na)

Emergency Contraceptive Pills and Rx vs. OTC

Levonorgestrel (Rx and OTC) Ulipristal = Ella (Rx Only)

Who can prescribe controlled substances in Washington?

MD or DO - all schedules DMD, DDS - all schedules DVM - all schedules PodD, DPM - all schedules ARNPs - all schedules to extent authorized by their state to prescribe CSAs PA-C, Osteopathic PA - all schedules approved by supervising physician Any of the above in any state in the US -British Columbia physicians, NPs, and PAs, can prescribe legend drugs, but not controlled substances unless have a US-issued DEA No. -"State" includes US territories (e.g., Guam, Puerto Rico) ARNPs -Schedule II-V, in accordance with specialty area -May dispense up to a 72 hour supply of CSAs to own patients PAs - All schedules approved by supervising MD Optometrists - limited list, may include III, IV, V -No more than a 7-day supply of CSAs -No more than 30 dosage units of III or IV -Single doses of benzodiazepines for pre-procedure use Naturopaths - C-III and C-IV testosterone and codeine products Pharmacists - any schedule within scope of authorizing prescriber

Which of the following can prescribe CSA drugs (and which classes): O.D., Nurse Practitioner, Clinical Nurse Specialist, Physician's Assistant, Midwife, Nurse Midwife, Chiropractor, Naturopath, Clinical Psychologist, Physical Therapist, Pharmacist?

MD or DO - all schedules DMD, DDS - all schedules DVM - all schedules PodD, DPM - all schedules ARNPs - all schedules to extent authorized by their state to prescribe CSAs PA-C, Osteopathic PA - all schedules approved by supervising physician Any of the above in any state in the US British Columbia physicians, NPs, and PAs, can prescribe legend drugs, but not controlled substances unless have a US-issued DEA No. "State" includes US territories (e.g., Guam, Puerto Rico) Mid-level practitioners in WA ARNPs: Schedule II-V, in accordance with specialty area May dispense up to a 72 hour supply of CSAs to own patients PAs - All schedules approved by supervising MD Optometrists - limited list, may include III, IV, V No more than a 7-day supply of CSAs No more than 30 dosage units of III or IV Single doses of benzodiazepines for pre-procedure use Naturopaths - C-III and C-IV testosterone and codeine products Pharmacists - any schedule within scope of authorizing prescriber

What are Hospital: Drug distribution and control

MUSTS Control of all drugs throughout hospital -Ultimately the responsibility of director of pharmacy Monthly inspections of all areas where drugs are stored or used Monitoring of drug therapy Provision of drug information -Patients (counseling) -Monthly inservices -Providers calling pharmacy SHOULDS Obtaining and recording drug use histories (med rec upon admit) Preparation of all sterile products Distribution and control of all radiopharmaceuticals Administration of drugs Prescribing Director maintains policies, with annual updates -i.e. receiving inventory, inspections, nurse access to pharmacy while closed Labeling (see textbook) (4.1 and 4.2 page 123) Pharmacist must see copy of order before drugs dispensed, except according to policies developed to handle emergencies Controlled substance accountability -Policies in place for inventory and control Handling of recalls, ADRs, and error reporting

Are patients allowed to perform Self-administration of Medicines (SAM)

May be done under a policy and approved protocols in a program of self-care or rehabilitation. Policy must be developed by Director of Pharmacy, and be approved by the administration, and medical and nursing staffs

Are tech-check-tech programs allowed? Under what circumstances?

May check unit doses of another technician or intern in institutional settings No more than 48 hour supply may be included in the checked cassettes Person authorized to administer meds must check the drug before administration Note: the rule does not say that interns can check unit dose drugs prepared by technicians TECH‐CHECK‐TECH PROGRAMS. Technicians may check other technicians or interns who have filled unit‐dose medication cassettes in institutional settings. This is often called a "tech‐check‐tech" program. (Note that the language of the rule does not specify that interns may check the work of technicians.) No more than a 48‐hour supply may be placed in a cassette that is part of a tech‐ check‐tech procedure. Another "licensed health professional" must again check the medication prior to administration to a patient. (WAC 246‐ 901‐035(2))

Therapeutic Substitution in WA

May do "Therapeutic Substitution" based on prior authorization from prescriber -Protocol, formulary -Per-prescription basis Blanket prior authorization can be verbal, but are required to have documentation of authorization in the pharmacy Substitution using prescriptive authority protocol is not really product selection, but prescribing RCW 69.41.100

Drug supply chain: Pharmacies' responsibility for transactions

May not accept a product unless supplied with a transaction history, transaction information, and a transaction statement Must maintain transaction histories, information and statements for 6 years If a pharmacy transfers a product to another owner, must provide transaction history, information and statement, unless -Returns of a saleable product to wholesaler or manufacturer -Returns of a non-saleable product to a manufacturer, wholesaler, or returns processor -Dispensing to a patient -Sales to other pharmacies or to physicians Must have systems in place to quarantine, investigate and dispose of suspect products

What cannot be changed by RPh on C-II Rx?

May not change patient's name (other than spelling) or the controlled substance prescribed (other than brand/generic

Pharmacy compounding prohibited products

May not compound products that are listed by FDA as having been removed from market due to lack of safety or efficacy May not compound "regularly or in an inordinate amount" products that are essentially copies of commercially available drug products. May not compound products that are listed by FDA as having demonstrable difficulties in compounding [list to be developed].

Physical and occupational therapists

May not prescribe May order and use certain legend drugs -Topical antiinflammatories -Topical anesthetics -Silver sulfadiazine (PT only) May administer prescribed drugs appropriate to physical or occupational therapy

Patient Request for Accounting of Disclosures

May request an accounting of disclosures of PHI made in the 6 years prior to the request Do NOT have to account for disclosures -Made directly to the patient -Made to carry out TPHCO -Made pursuant to an authorization granted by the patient -Made to persons involved in the patient's care If the provider maintains a qualifying Electronic Health Record (EHR) as described in the HITECH Act, then must make accounting in e-format of all disclosures for prior 3 years -Effective date of this requirement depends on date of adoption of EHR (see text) No charge for 1st accounting within any 12 month period; reasonable cost-based fee may be charged for additional requests within 12 months

Patient Request for Confidential Communication of PHI

May request that contacting the patient be restricted to particular address, telephone, or electronic address Will acknowledge that this may restrict communication to family or caregivers -Note: WA regulation already restricts communication with family who are not obvious agents or caregivers

Consent Requirements in WA

Minors Emancipated minors are treated as adults Minors married to a person who is not a minor are treated as adults Patients with STDs or HIV must consent Abuse or neglect of a child or vulnerable adult must be reported

The Mature Minor Doctrine

Minors "capable of understanding or appreciating the consequences of the medical procedure" may consent to non-emergency medical procedures based on the health care provider's evaluation of the child's: Age, maturity, experience, general conduct as an adult, intelligence, training, economic independence, freedom from the control of parents

Marriage Equality Act

Modified Domestic Partnership Statute -Eliminates same-sex domestic partnerships when neither partner is 62 or older after June 30, 2014 -Converts same-sex domestic partnerships to marriages on June 30, 2014 Defines "marriage" as "a civil contract between two persons who have each attained the age of eighteen years, and who are otherwise capable." Guarantees same-sex married couples equal treatment under Washington law

Multiple Prescriptions Written on Same Date

Multiple Rxs for single substance and patient, written and signed on same day are allowed when -No more than 90-day supply is authorized -Each Rx after the first includes instructions indicating the earliest date on which the pharmacy may fill the prescription -The prescriber concludes that this does not create an undue risk of diversion or abuse Pharmacists may not fill the Rx prior to the date indicated in the instructions This does not create a 90-day limit on amount of controlled substance that can be on a single prescription Only valid where state law allows: i.e., ok in WA, not ok in ID

Prescriptions under Death with Dignity Act (DWDA)

Must be for a drug the patient can ingest by himself or herself -No injectable drugs may be prescribed Physician may dispense drug(s) directly to patient, or, with patient's permission Physician contacts a willing pharmacist and explains nature of prescription -Must deliver Rx directly to pharmacist or by FAX Pharmacist must deliver Rx directly to physician, patient, or an agent specified in the Rx No pharmacist or physician may be compelled to participate in aid-in-dying No pharmacist or physician may be disciplined or otherwise adversely treated for participating in aid-in-dying -Institutions and clinics may prohibit employees from participating on their premises -Not clear if this exception applies to pharmacies

Wholesalers

Must be licensed by Commission Pharmacies do not need to register as wholesalers in order to engage in "the sale ... or trade of a drug for emergency medical reasons." -Transfers to another pharmacy or practitioner must not exceed 5% of total prescription sales in a 12-month period. Wholesaler sales of EPP are restricted: -March thru October - 5% of prior month's total sales -November thru February - 10% of prior month's total sales

Practitioner's e-Signature for e-prescribing

Must be verified by 2 of the following 3 forms of authentication -A biometric - something the practitioner is, e.g, iris scan or fingerprint -A knowledge factor - something only the practitioner knows, e.g., password or response to a challenge question -A device separate from the computer - something the practitioner has, i.e., a hard token Rx's will be transmitted to the pharmacy as either -Digitally signed -Accompanied by a digital certificate that they were digitally signed

Pharmacy compounding components and methods

Must comply with USP or NF monographs, if they exist, and the USP Chapter on Pharmacy Compounding. If no monographs exist, are made from components of approved drugs, or Are components that appear on a bulk ingredients list developed by FDA Must be manufactured in an FDA registered facility

Do pharmacies need Physical standards: adequate stock

Must have appropriate supplies to meet needs of patients No outdated drugs in stock Free from adulteration, contamination, or deterioration Properly labeled Stored in accordance with USP standards

Requirements for Containers

Must meet USP standards for tightness, light resistance May not be reused Because 1 in 5 children can open, by design, never refer to these containers as "child-proof"

Electronic prescribing

Must meet standards for security and integrity Must be approved by Commission - approved systems listed on web site Staff must sign and adhere to security and integrity policy and procedures Must allow for communicating preferences for substitution Pharmacist responsible to for accuracy, validity, and authenticity of the order Faxes no longer considered a form of electronic prescribing, but considered an image of a written prescription

What are the requirements for use of computers to process prescriptions?

How can changes in the NOPP be communicated to patients?

Must post a notice in the pharmacy indicating the availability of this information Must provide NOPP to any person who requests Must track changes to NOPP

Washington MPJE + Federal

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