FPGEE Pharmacy Law and Ethics Flashcards

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

Answer: The right of conscience (conscientious objection)

Conscientious objection allows healthcare providers to refuse participation in legal procedures that conflict with deeply held moral or religious beliefs, though policies vary by state.

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

Answer: Adverse drug events and product problems for marketed drugs and devices

MedWatch is the FDA's voluntary reporting system for serious adverse events, product quality problems, and medication errors for marketed drugs, biologics, and devices.

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

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

Off-label use refers to prescribing an FDA-approved drug for indications, patient populations, doses, or routes not specifically approved by the FDA.

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

Answer: Isotretinoin

Isotretinoin requires the iPLEDGE REMS program with mandatory pregnancy testing, contraception requirements, and restricted prescribing/dispensing due to severe teratogenic risk.

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

Answer: Avoiding actions that cause harm to the patient

Non-maleficence ('do no harm') obligates pharmacists to avoid actions, errors, or omissions that could harm the patient.

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

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

The 505(b)(2) pathway allows NDAs that rely on existing published data or prior FDA findings of safety/efficacy, reducing the clinical data burden for new formulations or new uses.