FPGEE FPGEE Pharmacy Law and Ethics 3

Question 1

A pharmacist who refuses to dispense a legally valid prescription for a morning-after pill based on personal religious beliefs is exercising:

Accepted Answer

The right of conscience (conscientious objection)

Answer

Therapeutic substitution rights

Answer

HIPAA privacy protections

Answer

Patient non-abandonment protocol

Question 2

The FDA MedWatch program is designed to allow healthcare professionals to voluntarily report:

Accepted Answer

Adverse drug events and product problems for marketed drugs and devices

Answer

Counterfeit drug sightings to the DEA

Answer

Drug shortages to the FDA drug shortage database

Answer

Controlled substance diversion to local law enforcement

Question 3

Which of the following best describes an 'off-label' use of a medication?

Accepted Answer

Use of a drug for an indication, population, or route not approved in its FDA labeling

Answer

Use of a drug whose patent has expired

Answer

Prescribing a drug without a valid DEA license

Answer

Use of a drug beyond its expiration date

Question 4

Under the Risk Evaluation and Mitigation Strategy (REMS) program, which drug requires enrollment in a restricted distribution program (iPLEDGE) due to teratogenicity?

Accepted Answer

Isotretinoin

Answer

Methotrexate

Answer

Thalidomide

Answer

Clozapine

Question 5

The ethical principle of 'non-maleficence' in pharmacy practice means:

Accepted Answer

Avoiding actions that cause harm to the patient

Answer

Providing maximum benefit to the patient

Answer

Respecting the patient's right to make their own decisions

Answer

Ensuring fair distribution of healthcare resources

Question 6

A drug product receives FDA approval via the 505(b)(2) pathway. This means:

Accepted Answer

It relies at least in part on published literature or data from a previously approved drug

Answer

It is a generic drug demonstrating bioequivalence to a reference product

Answer

It is a new biological entity approved via the biosimilar pathway

Answer

It requires no clinical trials because it is an OTC switch