Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 3

Question 1

Which document governs the ethical responsibilities of pharmacists as defined by the American Pharmacists Association?

Accepted Answer

Code of Ethics for Pharmacists (APhA)

Answer

The APhA Code of Ethics for Pharmacists outlines the ethical obligations of pharmacists to patients, society, and the profession across eight principles.

Question 2

When a patient requests a generic substitution at the pharmacy, the pharmacist may substitute if:

Accepted Answer

The generic is AB-rated as therapeutically equivalent and state law permits substitution

Answer

Generic substitution is permitted when the generic drug has an AB therapeutic equivalence rating (FDA Orange Book) and applicable state pharmacy law allows or mandates substitution.

Question 3

The FDA MedWatch program is used for:

Accepted Answer

Voluntary and mandatory reporting of serious adverse drug reactions and product problems

Answer

FDA MedWatch is a safety information and adverse event reporting program that accepts voluntary reports from healthcare professionals and mandatory reports from manufacturers.

Question 4

Under Risk Evaluation and Mitigation Strategies (REMS), which drug requires enrollment in a registry due to severe teratogenicity?

Accepted Answer

Isotretinoin (iPLEDGE REMS)

Answer

Isotretinoin requires enrollment in the iPLEDGE REMS program because of its severe teratogenic risk, requiring two negative pregnancy tests and reliable contraception use before dispensing.

Question 5

Which act requires pharmaceutical manufacturers to report drug shortages to the FDA?

Accepted Answer

Food and Drug Administration Safety and Innovation Act (FDASIA, 2012)

Answer

FDASIA (2012) requires manufacturers of certain drugs (especially sole-source and critical drugs) to notify the FDA at least 6 months in advance of anticipated drug shortages.

Pharm.D. Doctor of Pharmacy Practice Test

Pharm.D. Doctor of Pharmacy Practice Test

Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 3