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

Pharmacist's Letter of Practice

Answer

State Board of Pharmacy Practice Act

Answer

Joint Commission Medication Standards

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

The prescriber writes 'brand necessary' on the prescription

Answer

The patient agrees and the brand drug is unavailable

Answer

The pharmacist decides the generic is cheaper

Question 3

The FDA MedWatch program is used for:

Accepted Answer

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

Answer

Registering new drug applications

Answer

Tracking controlled substance distribution

Answer

Managing drug shortage communications

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

Methotrexate

Answer

Warfarin

Answer

Amlodipine

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

Durham-Humphrey Amendment (1951)

Answer

Omnibus Budget Reconciliation Act (OBRA-90)

Answer

Controlled Substances Act (1970)

Question 6

Informed consent in pharmacy practice primarily requires that patients receive:

Accepted Answer

Information about the drug's purpose, expected benefits, risks, alternatives, and the right to refuse

Answer

Only the drug name and dose

Answer

A written contract signed before receiving any prescription

Answer

Approval from their insurance company before counseling