PHA 314 - Title 26, Chapter 4: Article 5

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Article 5

Prescription drugs


Anyone engaged in the practice of pharmacy MUST be ____________.



Prescriptions may be dispensed only pursuant to a _____________________.

valid prescription order


RPh’s have the same _________________________ for Rx’s as the issuing prescriber.

corresponding liability


Valid Rx’s include those written by who?

a physician, dentist, podiatrist, veterinarian, or other licensed person authorized by law to prescribe


Through what forms may rx’s be accepted by a RPh or pharmacy intern/extern?

written, oral, via electronic visual image (fax), or electronic data prescription drug order


A hard copy Rx that has a visual image of the prescriber’s electronic signature that is not faxed to the pharmacy MUST be ____________________________.

printed on security paper


True or False: Rx’s transmitted electronically must be sent to the patient’s pharmacy of choice with no intervening person having access to the prescription.



Electronic Rx’s transmitted by fax or computer must include:

- Complete name and address of prescriber
- DEA registration of prescriber, if Rx is for a controlled substance
- Prescriber’s telephone number
- Patient’s name and address
- Transmission time and date
- Full name of person transmitting Rx
- Practitioner’s signature


Who must exercise professional judgment regarding the accuracy and authenticity of any electronically transmitted, issued, or produced rx?



True or False: Name of the person transmitting the prescription drug order is required for rx’s transmitted by fax or computer in the institutional setting.



Examples of institutional settings

Hospital pharmacies, nursing home pharmacies, clinic pharmacies, or pharmacies owned or operated directly by HMO’s


Hospital pharmacies may use remote order entry for Rx drug orders when what conditions are present?

◦ RPh is not physically present in the hospital, the hospital pharmacy is closed, and a licensed RPh will be present in the hospital within 24 hours
◦ At least 1 RPh is physically present in the hospital
◦ At least 1 RPh is physically present in another hospital within GA which remotely serves… on weekends <4 hospitals under the same ownership and have average daily census of <12 acute patients


What must happen before a hospital can engage in remote entry?

The pharmacy director MUST submit written policies and procedures to the BOP for approval


Information in the patient’s medication record is confidential and can only be released to:

◦ Patient
◦ Patient’s authorized representative
◦ Prescriber
◦ Other licensed practitioners caring for the patient
◦ Another RPh
◦ Board of Pharmacy, or
◦ Any other person duly authorized to receive such information


True or False: Rx’s may not be refilled without authorization from the prescriber.



When refills are dispensed pursuant to authorization contained on the original Rx or when no refills are authorized on the original Rx but refills are subsequently authorized, the refill authorization must be recorded ____________________ and the record of any refill made is maintained _________________________ or some other uniformly maintained record (e.g. computer system).

on the original Rx; on the back of the original Rx


What must a pharmacist who is dispensing a refill pursuant to authorization contained on the original Rx or when no refills are authorized on the original Rx but refills are subsequently authorized document?

must record the refill date, quantity dispensed, and dispensing RPh’s initials


Original rx’s for Schedule III, IV, or V controlled substances which contain no refill information may not be authorized to be refilled more than ___ times or after ___ months from the date of issuance, whichever comes first.

5; 6


How shall any authorization for additional refills of a Schedule III, IV, or V controlled substance in excess of 5 refills or after 6 months from the date of issuance be treated?

as a new Rx


No Rx shall be filled/refilled with ____________________ than the approximate interval of time than the dosage regimen would indicate unless there are extenuating circumstances

greater frequency


When a patient no longer seeks treatment from a practitioner, the patient-practitioner relationship is ______________.



Rx’s are invalid ___ months after the patient-practitioner relationship is terminated.



Patients have 6 months to _______________________ and get a new Rx.

establish a new relationship


To prevent unintended interruptions in drug therapy for topical ophthalmic products...

a RPh may permit refills without refill authorization or obtaining a new Rx at 70% of the predicted days supply


True or False: At the patient’s request, practitioner’s may authorize refills earlier than 70% of the predicted days supply.



Can a RPh dispense up to a 72-hour supply of a prescribed medication in the event the RPh is unable to contact the prescriber to get a refill authorization?



RPh may dispense a 72 hr fill provided that __________________________ may produce undesirable health consequences or physical/mental discomfort.

interruption of therapy


Can an emergency 72-hour fill be for controlled substances?



What must a RPh do after dispensing a 72-hour fill?

Notify the prescriber within 7 days of dispensing


How must a RPh document a 72-hour fill?

Record the dispensing as a separate non-refillable Rx. Rx is filed with all other Rx’s and has all required Rx information including the Rx number from which the Rx was dispensed


When dispensing a 72-hour fill, what does a RPh have to record on the PT's record and on the new rx?

the circumstance(s) which warranted dispensing


Can a RPh employ the 72-hour fill provision regularly for the same patient for the same medication?



All out-patient Rx’s dispensed must be labeled appropriately with the following info:

◦ Pharmacy name and address
◦ Prescriber’s name
◦ Directions for use
◦ Initials or identifying code of dispensing RPh
◦ Prescription number
◦ Patient’s name
◦ Fill/refill date


Written schedule II controlled substance rx's must be on _________ paper and signed in _________ ink by the prescriber.

security; indelible


Security paper requirements do not apply to:

◦ Rx’s transmitted by phone, fax, or other electronic means
◦ Rx’s for hospital inpatients, nursing home residents, mental facility inpatients/residents, or prisoners


A person picking up a CII rx must present a _________________________ and the RPh must document the full name of the person taking possession of the Rx.

government-issued photo ID


RPh’s may substitute a drug with the same generic name in the same strength, quantity, dose and dosage form as the prescribed name brand product so long as it is ______________________________________.

therapeutically and pharmaceutically equivalent


Can RPh's substitute a biological with an interchangeable biological product?



If a prescriber writes for a generic product, the RPh must dispense the _________________ drug in stock which is equivalent.

lowest retail priced


What must a RPh do whenever a substitution is made?

record it on the original Rx


The words “generic for…” or “interchangeable biological product for…” or other similar language must appear on the Rx label or an auxiliary label on a substituted medication, but this does not apply to what settings?

medications dispensed to hospital in-patients or medications in specialty packaging


True or False: Patients may not request the RPh not to substitute a generic product in lieu of the brand name.



A prescriber may instruct the RPh not to substitute a generic product in lieu of a brand name by writing _________________ on the Rx

“Brand Necessary”


Requirements of prescriber writing "Brand Necessary" on a rx

◦ Must be in the prescriber’s handwriting
◦ Cannot be pre-printed or stamped on the Rx

◦ When the Rx is electronic, “Brand Necessary” must be on the Rx in some way


Substitution can only occur with __________________________ if "Brand Necessary" has been conveyed.

the prescriber’s expressed consent


Within 48 hours of dispensing an interchangeable biological, the RPh must do what?

communicate to the prescriber the specific product dispensed (name of the product and manufacturer)


In what situation does a RPh not have to communicate with the prescriber when dispensing a substituted biological?

if it is a refill and the product dispensed is the same that was previously dispensed


When dispensing, who can perform duties or functions that require professional judgment?

only a licensed RPh


Who can provide counseling to patients or with other license healthcare professionals and accept telephone Rxs or provide information relative to a prescription or prescription drugs?

Only a pharmacist, pharmacy intern, or pharmacy extern


Functions requiring professional judgment that may not be performed by a pharmacy technician:

- Acceptance of initial oral prescriptions
- Certification of a filled or finished prescription drug order
- Weighing or measuring active ingredients without a mechanism of verification
- Reconstitution of prefabricated medication without a mechanism of verification
- Verification of the constituents of final IV admixtures for accuracy, efficacy, and patient utilization
- Order entry on patient profiles without verification by a RPh
- Provision of drug information that has not been prepared by or approved by the pharmacist


True or False: When dispensing, RPh must be present and personally supervising all technician activities.



Who is responsible for all activities involving preparation of a drug for delivery?