Oregon MPJE

What are the requirements for a valid prescription?

• Patient name

• Owner + animal species for animal

• Practitioner full name (controlled substances: practitioner address + DEA number)

• Name, strength, dosage form, quantity prescribed, quantity dispensed

• Directions for use

• Date of filling

• Number of refills

• If transmitted orally, name or initials of receiving pharmacist and name of person transmitting

• Specification of substitution permitted or no substitution permitted

Federal Food, Drug, and Cosmetic Act

• Extends consumer protection from adulterated and misbranded foods and drugs to include cosmetics

• Granted the FDA authority to approve or deny drugs based on safety data supplied by the manufacturers

  • Could not be marketed until proven safe for use and labeling requirements were met

  • Established New Drug Application Process

• Required labels that contain:

  • “Adequate directions for use” written so that a layperson could understand and use safely

  • Warnings about the habit-forming properties of certain drugs

Durham-Humphrey Amendment

OTC vs Rx

Kefauver Harris Amendment

Thalidomide - causing fetal harm. Requirement to assess safety and efficacy of drugs before they could enter the market.

PPPA

Poison Prevention Packaging Act - requires child-resistant packaging

HITECH

Health Information Technology for Economic and Clinical Health Act - electronic health record implementation

Adulterated

Anything that affects quality, purity, or strength of the drug. Includes if drugs are not stored/packaged correctly.

Misbranded

False or misleading branding/labeling

FDA Recalls (Class I, Class II, Class III, Market withdrawal, Medical device safety alert)

Class I: reasonable probability that use of product will cause serious adverse health consequences or death

Class II: use of product may cause temporary or medically reversible adverse health consequences or where probability of serious adverse consequences is remote

Class III: use of product is not likely to cause adverse health consequences

Market withdrawal: minor violation with no legal penalty (e.g., product removed due to tampering without manufacturing or distribution problems)

Medical device safety alert: medical device may present unreasonable risk of substantial harm. In some cases, these situations are also considered recalls

Red Book

Drug Pricing

Orange Book

Therapeutic equivalencies

Yellow Book

International Travel Vaccines

Green Book

Animal drug products

Purple Book

Biologics

Pink Book

Vaccine-preventable diseases

USP 795

Nonsterile compounding

USP 797

Sterile compounding

USP 800

Hazardous drug handling

What type of substitutions are allowed by a pharmacist?

• A drug product with same generic name in same strength, quantity, dose and dosage form as the prescribed drug which is, in the pharmacist’s professional opinion, therapeutically equivalent

• When the prescriber is not reasonably available for consultation and the prescribed drug does not utilize a unique delivery system technology, an oral tablet, capsule or liquid form of the prescribed drug so as long as the form dispensed or administered has the same strength, dose, and dose schedule and is therapeutically equivalent to the drug prescribed

• A pharmacist may substitute a drug product under this section only when there will be a savings in or no increase in cost to the purchaser

• If the practitioner prescribes a drug by its generic name, the pharmacist shall dispense or administer the lowest retail cost, effective brand which is in stock

• A pharmacist may not substitute a biosimilar product for the prescribed biological product unless determined by FDA to be interchangeable, the prescriber has not designated that substitution is prohibited, the patient is informed prior to dispensing, the pharmacist provides notification to prescriber within 3 business days of dispensing and retains records for 3 years

Can refills be combined?

Yes, unless the prescription is for a controlled substance or psychotherapeutic drug and the prescriber is notified

Can pharmacist authorize emergency refills?

Yes, for only a 72-hour supply for non-controlled substances and practitioner should be notified

What happens if a prescription that is on auto-refill is returned to stock (or delivery is refused)?

Prescription must be removed from auto-refill program

What prescriptions are okay to be faxed to the pharmacy?

Legend and CIII-Vs - if for controlled must have a manual signature from the provider (no stamp or digital signature)

What information must be provided for a phone Rx?

• Date oral prescription received

• Patient name (or owner + species)

• Full name of practitioner (address + DEA if controlled)

• Name, strength, dosage form, quantity

• Directions for use

• Total refills authorized

• Signature or initials of receiving pharmacist/intern and identify of person transmitting Rx

Who can phone in prescriptions?

Practitioner or someone designated by the practitioner

Can interns receive new prescriptions via phone/voicemail? Refills?

Yes, interns can receive new prescriptions and refills orally and reduce them to writing or on the electronic system

Can technicians receive new prescriptions? Refills?

Technicians cannot receive new prescriptions, but can accept refill authorizations provided nothing about the prescription has changed

What information is required to be on a prescription label?

• Name, address, telephone number of pharmacy

• Date

• Identifying number

• Name of patient

• Name of drug, strength, quantity dispensed

• When generic name used, label must also contain identifier of manufacturer or distributor

• Directions for use

• Name of practitioner

• Required precautionary information regarding controlled substances

• Expiration date

• Such other and further cautionary information as required for patient safety

Where should drugs that are outdated/damaged/deteriorated/misbranded/adulterated be kept?

Quarantined and physically separated from other drugs until they are destroyed or returned to their supplier

Under what circumstances can a pharmacy accept returned drugs/devices?

• Never for controlled substances

• If drug/device is accepted for destruction or disposal AND

• Was dispensed in error, were defective, adulterated, misbranded, dispensed beyond their expiration date, were unable to be delivered to patient, or are subject to recall OR

• After consultation, pharmacist determines that harm could result if not accepted for return

When can drugs or devices previously dispensed be returned and redispensed?

All of the following must be met:

• Drug is in an unopened, tamper-evident unit

• Drug/device have remained in control of person trained and knowledgeable in storage/administration in long term care facility or supervised living group

• Drug/device has not been adulterated or misbranded and has been stored according to manufacturer recommendations

What can a charitable pharmacy accept?

Prescription drug in original sealed, tamper-evident packaging that displays lot number and expiration date and sealed single dose unit packages

What can a charitable pharmacy not accept?

• Any controlled substance

• Non-prescription drugs

• A drug in a container that does not contain a PIL (product identification label) - exception: blister back

• FDA REMs drug

• Drug donated from another state

What are potential features of a tamper-resistant prescription?

• The word “void” when photocopies are attempted

• Background ink which reveals attempted alterations

• Heat sensitive ink that changes colors

• Penetrating ink to prevent chemical alterations

• Watermark that cannot be photocopied

• Coin reactive ink that reveals word when rubbed with coin

• Sequential numbering

How do you validate a DEA number?

2 letters followed by 7 numbers.

First letter: A, B, F is a full practitioner & M is a mid-level practitioner

Second letter: first letter of prescriber’s last name

Math:

1. 1st, 3rd, 5th number are added together

2. 2nd, 4th, 6th number are added together and multiplied by 2

3. Add products from step 1 and 2 together

4. The 7th number of DEA should equal last digit of number obtained in step 3

DEA form for ordering controlled substances

222

DEA form for theft or loss of controlled substances

106

DEA form for expiration of controlled substances

41

Who is allowed to prescribe CIIs?

• Physician (MD, DO)

• Dentist (DDS, DMD)

• Podiatrist (DPM)

• Veterinarian (DVM, VMD)

• Psychiatrist (MD, DO)

• Physician Assistant (PA) - with exceptions

• Nurse Practitioner (NP, APRN)

• Registered Nurse (CNS, CRNA)

• Optometrist (OD) - hydrocodone only

Who can prescribe CIII-CVs?

• Physician

• Dentist

• Optometrist

• Podiatrist

• Veterinarian

• Psychiatrist

• Physician assistant

• Nurse Practitioner

• Registered Nurse

What is on the pharmacist formulary compendium? (What can pharmacists prescribe?)

• Diabetic blood sugar testing supplies

• Injection supplies

• Nebulizers and associated supplies

• Inhalation spacers

• Peak flow meters

• INR testing supplies

• Enteral nutrition supplies

• Ostomy products and supplies

• Non-invasive blood pressure monitors

• CGMs and associated supplies

What is on the pharmacist protocol compendium (what can pharmacists prescribe?)

• Continuation of therapy (noncontrolled only) including emergency refills of insulin and early refills of opioid use disorder medications

  • For non-insulin and non-opioid use disorder meds:

    • May not exceed original duration of therapy

    • May not exceed 60-day supply

    • No more than 1 replacement in rolling 12-mo period per med

    • No more than 2 extensions in rolling 12-mo period per med

  • Insulin: 30-day supply or smallest available package size (whichever is less)

  • No more than 3 emergency refills of insulin and related devices in a calendar year

  • To avoid interruption of treatment

  • For opioid use disorder, no more than 1 refill in 12 mo period per med for expired rx

• Cough/cold symptoms management: benzonatate (not to exceed a 7-day supply), SABAs (not to exceed 1 inhaler with or without spacer or 1 box of nebulizer in 12-mo period), intranasal corticosteroids

• Covid-19 self antigen test

• SARS-CoV-2 antiviral

• Emergency contraception (not abortifacients)

• Male and female condoms

• Tobacco cessation (NRT) and non-NRT after 2 hours of tobacco cessation CE

• Travel meds (after min of 4 hour certificate for travel medicine and 1 hour CE on travel meds every 24 months)

• HIV PEP after completing comprehensive training program

• HIV PrEP after completing comprehensive training program (may prescribe up to 30-day supply of PrEP if pt gets HIV negative result)

• Contraception (after completing training program approved by BOP, refer to PCP or women’s health doctor after

• STI PEP

• Short-acting opioid antagonists

• Vaccines

If a pharmacist prescribes within the Formulary or Protocol Compendia, when do they need to notify the PCP? How long should records be kept?

Within 5 business days

10 years with onsite storage of at least 1 year and off-site retrievable within 3 business days

How much experience does a pharmacist need to be a board member in Oregon?

At least 5 years of experience in the practice of pharmacy

How much experience does a pharmacy technician need to be a board member in Oregon?

At least 3 years

Pharmacists must maintain all records associated with prescribing and other related activities for a minimum of _____ years?

7 years

Who may administer vaccines?

Pharmacists, technicians, interns if appropriately trained and qualified and permitted by the pharmacist.

What is the proper temperature for storage for refrigerated drugs? For frozen products?

Refrigerator: 2-8 degrees Celsius (35 to 46 degrees Fahrenheit)

Freezer: -25 to -10 degrees Celsius (-13 to 14 degrees Farenheit)

How often shall the temperature of the refrigerator be documented?

Measured continuously and documented either manually twice daily (include min, max, current temps) OR with automated system capable of creating producible history of temp readings

For a patient med pak, what beyond-use date should be assigned?

A beyond use date no later than 60 days from the date of preparation

What moisture permeation class is required for packaging a med pak? (in the absence of more stringent packaging requirements)

Class B

When does a pharmacist have to provide notification to the patient’s PCP after prescribing a Compendia drug or device?

Within 5 business days