Master of Pharmacy: Pharmacy Law and Ethics Flashcards
7 cards from real MPharm Master 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 7 Master of Pharmacy: Pharmacy Law and Ethics flashcards as text
A pharmacist is asked to compound a drug that is commercially available in an FDA-approved form. Under what circumstance is this generally permissible?
Answer: Only if the patient has a documented allergy to an excipient in the commercial product
Compounding a commercially available drug is generally prohibited unless there is a legitimate clinical difference, such as a patient's allergy to an inactive ingredient.
Which of the following best describes the doctrine of 'respondeat superior' as it applies to pharmacy practice?
Answer: An employer's legal liability for negligent acts of employees performed within scope of employment
Respondeat superior holds employers vicariously liable for torts committed by employees acting within the scope of their employment.
What is the maximum number of emergency refills a pharmacist may dispense for a Schedule III controlled substance when unable to reach the prescriber?
Answer: A 72-hour supply
Pharmacists may dispense an emergency supply of Schedule III–V controlled substances limited to a 72-hour supply when unable to contact the prescriber.
Which federal act established the requirement that pharmacists provide medication counseling to Medicaid outpatients?
Answer: The Omnibus Budget Reconciliation Act of 1990 (OBRA-90)
OBRA-90 mandated prospective drug utilization review (DUR) and patient counseling for Medicaid beneficiaries receiving prescriptions.
A pharmacist suspects a colleague is diverting controlled substances. Under professional ethics obligations, what is the MOST appropriate first step?
Answer: Follow the institution's reporting policy, which may include reporting to a supervisor or compliance officer
Professional ethics and most institutional policies require reporting suspected diversion through proper channels to protect patient safety.
The 'learned intermediary' doctrine in pharmacy law primarily refers to:
Answer: The legal principle that drug manufacturers fulfill their duty to warn by informing prescribers, not patients directly
The learned intermediary doctrine holds that manufacturers discharge their duty to warn by adequately informing prescribers, who then counsel patients.
Under the Drug Supply Chain Security Act (DSCSA), pharmacies must be able to trace prescription drug products using which system?
Answer: Electronic interoperable track-and-trace systems linking all supply chain stakeholders
DSCSA requires an electronic, interoperable system to track and trace prescription drug packages through the entire supply chain.