Pharmacy Law and Ethics Flashcards
6 cards from real Pharm.D. Doctor of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Pharmacy Law and Ethics flashcards as text
Which document governs the ethical responsibilities of pharmacists as defined by the American Pharmacists Association?
Answer: Code of Ethics for Pharmacists (APhA)
The APhA Code of Ethics for Pharmacists outlines the ethical obligations of pharmacists to patients, society, and the profession across eight principles.
When a patient requests a generic substitution at the pharmacy, the pharmacist may substitute if:
Answer: The generic is AB-rated as therapeutically equivalent and state law permits substitution
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.
The FDA MedWatch program is used for:
Answer: Voluntary and mandatory reporting of serious adverse drug reactions and product problems
FDA MedWatch is a safety information and adverse event reporting program that accepts voluntary reports from healthcare professionals and mandatory reports from manufacturers.
Under Risk Evaluation and Mitigation Strategies (REMS), which drug requires enrollment in a registry due to severe teratogenicity?
Answer: Isotretinoin (iPLEDGE REMS)
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.
Which act requires pharmaceutical manufacturers to report drug shortages to the FDA?
Answer: Food and Drug Administration Safety and Innovation Act (FDASIA, 2012)
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.
Informed consent in pharmacy practice primarily requires that patients receive:
Answer: Information about the drug's purpose, expected benefits, risks, alternatives, and the right to refuse
Informed consent requires that patients be told the purpose, expected benefits, potential risks, and alternatives of a treatment, and that they have the right to refuse — enabling autonomous decision-making.