PA LAW - Chapter 4

List functions ONLY a pharmacist can do:

(also known as “pharmacy scope of practice”)

• “final review”- review every rx or drug order prior to being dispensed

  • name of the drug, strength, dosage, quantity, refills, other required info

• supervise interns, techs, and trainees working with the pharmacist

• ensure label requirements are met

• COUNSELING OF PTS.

List delegable tasks that a pharmacy TECHNICIAN can do?

(note: pharmacist has to feel comfortable delegating these tasks)

• carrying pills/containers

• count pills—> put in container

• type/print labels

• maintain records related to pharmacy

• ASSIST pharmacist in

  • preparing/reconstituting parenteral products and other meds

  • compounding of sterile/nonsterile drug products

• enter rx, drug order, or patient info in a patient profile

  • PPA was amended in 2020 to allow this

  • does NOT have to be under direct supervision if certain circumstances apply

What must be in writing before a technician can do anything in the pharmacy?

• who makes this?

• who signs this?

• renewed?

• kept on file for…

WRITTEN PROTOCOL!!!

• made by pharmacy manager

• manager + trainee date and sign protocol

• renew protocol q2 years

• kept on file for 2 years, available to inspector

List non-delegable tasks that a pharmacy TECHNICIAN can’t do?

• BASICALLY—> ANYTHING THAT INVOLVES INDEPENDENT PROFESSIONAL JUDGEMENT (DUR, interactions, etc.)

• accept/transcribe oral orders or telephone rx

• enter/be in pharmacy if a pharmacist is not on duty (excep: 30 min break)

• perform any duty, until trained and in a written protocol

What are tasks that pharmacy INTERNs can do?

• independent professional judgement?

• pharmacy only functions?

• examples?

• CAN do things that require professional judgement… but cannot do pharmacist ONLY functions

• work only under direct supervision of pharmacist

• examples:

  • verifying ingredients

  • compounding ingredients

  • implies—> interns can do pharmacist jobs under supervision

    • ex: receiving verbal rx

    • exceptions: final verification and counseling

• only permitted in pharmacy when pharmacist on duty (excep: 30 min break)

For NON-CONTROLLED substances, what is the time limit for filling and refilling?

• refills: prescription for non-CS can be refilled for 1 YEAR from the DATE of the rx if refills were authorized

• if the prescription was never filled in general: also expires in 1 year

What are the time limits for filling and refilling non-CS for PRN medications?

• same as other non-CS meds—> 1 YEAR from DATE of the rx

CII may not be filled more than ______ from the DATE of the prescription.

6m

Does a pharmacist HAVE to fill every CII medication if it’s within the time limits before expiration???

no—> use professional judgement

• can be filled up to 6m from date of rx, but doesn’t HAVE TO

True or False: CII prescriptions are allowed refills under PA law, but not federal law.

FALSE—> NO REFILLS ON CII

CIII-CV medications may not be filled more than how many times in what time period from DATE of the rx?

CIII, CIV, CV may not be filled more than 5 times in a 6 month period from DATE of the rx

PRACTICE:
A patient has a prescription for a non-CS PRN (as-needed) medication with 5 refills. The date of the rx was 4/15/2025. They picked up one refill for their medication on 5/16/2025. They pick up a second refill on 8/1/2025. On 7/30/2026, they call your pharmacy and are requesting a refill.

Is this allowed to be filled? Why or why not?

NOT ALLOWED TO BE FILLED—> non-CS rx, including PRN refills can only be refilled from the DATE of the rx up to 1 year

What is considered an “early fill”?

Prior to when insurance would cover or when more than 15% of earlier-dispensed med would remain when taken with directions/quantity prescribed

What is an EMERGENCY RX REFILL?

• what conditions must be met?

  • requirements?

• prescriber must be notified in…?

(BURNS SAID EXAM QUESTION ON THIS TOPIC PAY ATTENTION!!!!!!)

• refill of a prescription which is essential to the continuation of

  therapy in a chronic condition. (when refill not authorized)

• REQUIREMENTS:

  • NOT A CONTROLLED SUBSTANCE!!!!!!!!!!!!!!!!!!!!!!

  • essential to life—> in chronic cond.

  • pharmacist uses judgement—> interruption of therapy would lead to health consequences

• PRESCRIBER MUST BE NOTIFIED within 72 HOURS

EMERGENCY RX REFILLS are limited to what quantity?

• 72 hour supply of ALREADY PRESCRIBED medication

  • some exceptions if can’t do 72 hour supply—> insulin, inhalers, etc.

If the pharmacist decides to dispense an emergency refill they must do what documentation wise?

enter on the back of the original rx or other retrievable record the date and quantity of the refills, signs the refill

PRACTICE:

Which of the following is true regarding emergency rx refills?

a. pharmacist can allow a onetime emergency rx refill of a CS

b. pharmacist must notify prescriber within 48 hours

c. pharmacist can refill up to a 30 day supply in emergency refills

d. pharmacist can only allow emergency rx for already prescribed medications

d

What are the label requirements for community/outpatient labels?

(Burns- “the big one”)

• Name, address, phone #, DEA number of pharmacy

• Name of pt.

• Name of prescriber

• Full directions for use

• Serial # of the rx

• Date the rx was originally filled and date of filling

• Trade/brand name of drug, strength, dosage form, quantity dispensed

Answer the following about label requirements for community/outpatient labels:

• when is manufacturer/distributors name or abbreviation needed?

• when is manufacturer’s expiration date needed?

• what is an additional requirement for CS?

• if generic name—> need manufacturer/distributors name or abbr

• Manufacturer’s expiration date of medication when the medication has full potency for less than 1 yr

• if CII-CV—> needs caution statement

  • note federal—> only CII-CIV

What are the label requirements for institution labels (med orders)?

(idk how important)

• Unit dose packaging

• Patient name

• Drug name

• Drug strength

• Dosing instructions

• Lot number

What are the label requirements for parental, enteral, and total nutrition product?

(idk how important)

• Patient name

• Product ingredients:

• Name of each ing.

• Quantity of each ing.

• Diluent

• Expiration date

• Pharmacist initials

What are the label requirements for prepackaged products?

(idk how important)

• Name of drug (if generic than manufacturer)

• Strength of drug

• Expiration date

• Pharmacy must keep a log of all this

PA Act 47 of 2022 allows healthcare practitioners to participate in ________.

EPT—> Expedited Partner Therapy Medications

What is EPT? How does it apply to pharmacists?

• What is it?—> Practice of treating sex partners of pts. diagnosed with certain STDs by providing rx or meds to the pt. to take to their partner without being examined by healthcare practitioner

• If healthcare can’t get name of partner? Prescription includes the words “EPT”

• Allows pharmacists to dispense without name—> but pharmacist must add directions, side effects, or C/I on label

Files kept at a pharmacy must show:

• names addresses of who?

• dates of what?

• label requirements?

• for CS?

• name, address of pt. (1 exception)

• name, address of prescriber

• name, quantity of drug prescribed

• name/initials of dispensing pharmacist

• date rx was issued

  • NOTE: PBOP only requires issuance dates for rx that are CS or PRN refills, but issuance date still may be required for insurance, payment purposes, or to determine the 1 year fill rule with rx

• date rx was compounded/dispensed

• directions for use

• cautions communicated

• for CS—> DEA # of prescriber

Files kept at a pharmacy must show:

• if a rx has refills each refill must show what?

• date of refill

• name/initials of dispensing pharmacist

• quantity dispensed

Prescriptions are kept on file for ________ from the date of the MOST RECENT FILLING!!!!!!!!!

2 years

How does federal law differ from PA state law in terms of CS initial electronic transfers?

What is PA law on initial CS electronic transfers?

• PA DOES NOT ALLOW INITIAL CII ELECTRONIC TRANSFERS

• but for CIII-CV and Non-CS—> 1 time transfer is allowed

What are the transfer conditions for prescriptions in general?

• what does the transferring pharmacist do?

• what does the receiving pharmacist do?

• what about a common database?

• rx must be lawfully refillable

• Transferring pharmacist cancels original rx in their records and indicates where rx was transferred

  • Name of pharmacy, date of transfer, name/initials of pharmacist

• Receiving pharmacy notes rx was transferred and

  • Records:

    • Date of issuance of og rx

    • Date of fg filing of rx

    • Original # of refills authorized

    • Complete refill record

    • Number of refills remaining

• COMMON DATABASE—> Pharmacist may transfer rx to another pharmacist employed by same corporation without having to meet italicized stuff above if both have access to same rx transfer system

Since PA adopted OBRA 90, patient profiles are required.

What are the requirements for these?

• general requirements

• what if they refuse?

• kept on file for…

• Pharmacist, tech, or intern must begin patient profile when pharmacist fills a rx for a NEW pt.

• requirements:

  • name, address, phone #, gender, age/DOB, pt. history

• not REQUIRED IF THEY REFUSE!!!! (single request is reasonable)

  • document this

• profiles kept on file for at least 2 years after last entry

Since PA adopted OBRA 90, prospective drug reviews (PDRs) are required.

• when must pharmacists do PDRs?

• what must the pharmacist attempt to do?

• Pharmacist MUST do before filing, delivering, or sending a new rx or drug order

• pharmacist is to ATTEMPT to identify potential drug therapy problems and ATTEMPT to resolve the problem

  • (ex: therapeutic duplications, d/i, allergies, incorrect dose, etc.)

When are PDRs NOT REQUIRED?

• Physician dispenses drug to pt. in ER

• Pharmacist dispenses radiopharmaceutical or drug—> to physician—> to administer to pt.

• Medical practitioner dispenses a drug

• Pharmacist delivers naloxone to employee of PA prison, jail, drug tx facility under a rx for an individual who is pending release or discharge from said place

Who can offer to counsel vs. who can actually counsel?

• offer: pharmacist, tech, interns

• CAN ACTUALLY COUNSEL—> only PHARMACIST

True or False: PA has mandatory patient counseling.

false—> only requires offer to counsel for NEW PRESCRIPTIONS

Is counseling required in institutions?

not required

Is counseling required when it’s refused? Even if it’s a new prescription?

not required—> must document refusal

For the sale of hypodermic needles:

• sale only allowed to be made by who?

• rx required?

• age and quantity limits?

• where must they be kept?

• sale ONLY to be made by pharmacist or by one delegated under direct supervision (tech, intern)

• NO RX REQUIRED

• NO AGE OR QUANTITY LIMITS

• must be kept in rx area (aka pharmacy)

PPA puts poisons into schedule A or B.

If a pharmacy wants to sell poisons, what are the labeling requirements?

• poison label to package or bottle

  • name of poison

  • must write “poison” on the label

  • the place of business of the seller

  • printed in red ink

Poisons cannot be sold, delivered, or provided to anyone <___ years old.

16

Can poisons be sold by the pharmacy or must you have an rx? recordkeeping requirements?

• can be rx or sold at pharmacy

• if sold at pharmacy—> must have entry book for schedule A

What is the name of the pharmacy that receives the patient’s, or prescribers request to fill/refill a prescription?

originating pharmacy

Central fill pharmacies can also be originating or delivering pharmacies.

What is the ONE EXCEPTION TO WHEN CENTRAL FILL PHARMACIES cannot be a delivering pharmacy?

Central fill pharmacies NOT allowed to be delivering pharmacy for CONTROLLED SUBSTANCES

Can a central processing center dispense drugs?

no

Which of the following is responsible for making the offer to counsel?

a. originating pharmacy

b. delivery pharmacy

c. central fill pharmacy

b.

What are the additional standards for electronic prescriptions?

• must have additional info on rx (idk how imp): valid e-sig, prescribers phone #, date of transmission, name of pharmacy

• hard copy/image of rx stored for at least 2 years from date of most recent filling

• cannot give equipment to prescriber’s office

Computer system standards for pharmacies include:

• provide immediate retrieval of pt. info for all prescriptions filled within the last _______ months

• provide retrieval of pt. info within ___ working das for all prescriptions dispensed in the last ____ months from last activity date

• system must be able to transfer all pt. info to hard copy within __ working days.

• provide immediate retrieval of pt. info for all prescriptions filled within the last 12 months

• provide retrieval of pt. info within 3 working days for all prescriptions dispensed in the last 24 months from last activity date

• system must be able to transfer all pt. info to hard copy within 3 working days.

What is an Automated Medication System used to do?

Who’s in charge of AMS in LTCF?

How often are AMS inspected?

• AMS used to store, package, dispense, or distribute rx

• in LTCF—> pharmacist/pharmacy manager responsible for supervision of the AMS

• inspect meds monthly

Does PPA allow the acceptance back and redistribution of drug after it has left the pharmacy premises? exceptions?

• PPA—> SAYS NOT PERMITTED

• some exceptions:

  • Med is in original, sealed container with name, lot number, and expiration date on original intact manufacturer’s label

• DOES NOT APPLY TO CONTROLLED SUBSTANCES—> NEVER ALLOWED!!!!!!!!!!!!

What does the PBOP say about return to pharmacy stock and redistribution of UNDELIVERED medications?

PBOP allows this (remember these are meds that haven’t left the pharmacy)

What are some considerations regarding returning undelivered medications back into stock?

• can the pharmacist refuse to do this?

• never to be mixed with what?

• can it be kept in the container it was repackaged in?

• when should it be used?

• what to do if lacking original lot number and expiration date?

• pharmacist can choose whether or not to return back to stock

• NEVER mix stock bottles of different lot numbers of expiration dates

• if can’t be returned to stock bottle—> kept in container it was repackaged in

• should be used asap

• if lacking original lot/expiration date—> only be dispensed up to 6 MONTHS FROM DATE drugs were prepared

Can a pharmacist decline to fill/refill a prescription?

Yes!!! MAY decline!!!!

Can prescription blanks be provided to doctor’s offices?

NO

Advertising for pharmacies is allowed within limits:

• must be _________

• CANNOT promote __________

• must be for ________________ quantity

• must be licensed

• cannot promote CS

• must be for commercially reasonable quantity

  • aka can’t say 20% off prices without showing what the retail price is

Faxing in PA is the same as federal + you can’t do what?

provide faxing equipment to offices

What are drug therapy protocols?

What setting are they made in? (instit., community, etc.)

• written agreement or protocol with licensed physician authorizing the pharmacist for management of drug therapy in an institution

• THIS IS FOR INSTITUTIONAL SETTINGS

What is collaborative drug therapy management?

What setting are they made in? (instit., community, etc.)

• written collaborative agreement or with licensed physician authorizing pharmacist for management of drug therapy in a practice setting OTHER than institution

• IN ANY SETTING OTHER THAN INSTITUTIONS

For drug therapy protocols and collaborative practice agreements the physician must be notified within ____ hours following an intervention.

72

Collaborative practice agreements MUST include terms where pharmacists are permitted to do what?

• Adjust drug regimen, strength, frequency of admin, ROA

• Administer drugs

• Order lab tests

• Order/perform other diagnostic tests

PA pharmacies can obtain a CLIA certificate to do what?

What specific tests are allowed?

• CLIA certificate to perform CLIA-waived tests (point of care testing)

• Allows pharmacy to order/perform tests for:

  • Covid

  • influenza

  • RSV

  • streptococcal infections

What is a generic equivalent?

Drug product that is FDA approved as safe and effective and has been determined to be therapeutically equivalent as listed in FDA Orange book

• Note: FDA APPROVED + THERAPEUTICALLY EQUIVALENT

The FDA says WHAT drug products should not be considered generically equivalent? Does this mean you can’t substitute them?

drug products with Narrow therapeutic index (NTI)

• this means pharmacist cannot AUTOMATICALLY substitute them

• still can substitute, but first talk with prescriber!!!!!

What are the 2 definitions of an interchangeable biological product?

• Biological product licensed by the FDA and determined to meet safety standards for interchangeability pursuant to the Public Health Service Act

• Or

• Biological product approved by the FDCA and determined by FDA to be therapeutically equivalent to a prescribed biological product

You can SUBSTITUTE if listed as generic equivalent or interchangeable in what “books” or formularies?

• PA department of health formulary (lowkey outdated and not really used)

• FDA orange book

• FDA purple book

You MUST substitute generically equivalent drug unless requested by who?

pt. or prescriber

For biologics does the law say you MUST substitute?

no!!! you MAY substitute

What are the requirements for when a prescriber wants a BRAND only drug?

• what’s at the bottom of the rx?

• line?

• what statement is on the rx?

• what point font?

• bottom of rx blank must have printed words “substitution permissible” and must contain ONE signature line ABOVE THIS for prescriber’s signature

• under prescriber line—> must have the printed statement:

  • “In order for a brand name product to be dispensed, the prescriber must handwrite “brand necessary” or “brand medically necessary” in the space below

• all info should be in 8-point uppercase print

Pharmacies must have a sign that is printed in bold face letters not less than 1 inch in height on a white background that says what?

In general, a pharmacist cannot automatically substitute a generic for brand name in what 3 situations?

1. drug is an NTI drug

2. non-A rated

3. physician writes brand necessary