MPharm Master of Pharmacy Master of Pharmacy: Pharmacy Law and Ethics 3 — Questions and Answers
Question 1: A pharmacist is asked to compound a drug that is commercially available in an FDA-approved form. Under what circumstance is this generally permissible?
- Never — compounding a commercially available drug is always prohibited
- Only if the patient has a documented allergy to an excipient in the commercial product (Correct answer)
- Anytime the pharmacist judges compounding would benefit the patient
- Only when the prescriber holds a DEA license
Correct 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.
Question 2: Which of the following best describes the doctrine of 'respondeat superior' as it applies to pharmacy practice?
- A pharmacist's duty to report adverse drug events to the FDA
- An employer's legal liability for negligent acts of employees performed within scope of employment (Correct answer)
- The pharmacist's obligation to follow a prescriber's instructions without question
- A patient's right to sue a manufacturer for a defective drug product
Correct 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.
Question 3: What is the maximum number of emergency refills a pharmacist may dispense for a Schedule III controlled substance when unable to reach the prescriber?
- A 72-hour supply (Correct answer)
- A 30-day supply
- No emergency refill is permitted for any controlled substance
- A 7-day supply
Correct 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.
Question 4: Which federal act established the requirement that pharmacists provide medication counseling to Medicaid outpatients?
- The Durham-Humphrey Amendment
- The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) (Correct answer)
- The Drug Quality and Security Act (DQSA)
- The Kefauver-Harris Amendment
Correct 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.
Question 5: A pharmacist suspects a colleague is diverting controlled substances. Under professional ethics obligations, what is the MOST appropriate first step?
- Ignore it to avoid workplace conflict
- Immediately report directly to the DEA without any internal notification
- Follow the institution's reporting policy, which may include reporting to a supervisor or compliance officer (Correct answer)
- Confront the colleague privately and give them a chance to stop
Correct 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.
Question 6: The 'learned intermediary' doctrine in pharmacy law primarily refers to:
- A pharmacist's duty to check for drug interactions before dispensing
- The legal principle that drug manufacturers fulfill their duty to warn by informing prescribers, not patients directly (Correct answer)
- A state board's authority to discipline pharmacists for substandard care
- The requirement for pharmacists to verify prescriber DEA credentials
Correct 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.
Question 7: Under the Drug Supply Chain Security Act (DSCSA), pharmacies must be able to trace prescription drug products using which system?
- A paper lot-number log maintained for 3 years
- Electronic interoperable track-and-trace systems linking all supply chain stakeholders (Correct answer)
- Quarterly DEA inventory submissions
- State board of pharmacy manual inspection reports
Correct 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.
MPharm Master of Pharmacy Master of Pharmacy: Pharmacy Law and Ethics 3
A pharmacist is asked to compound a drug that is commercially available in an FDA-approved form.
Under what circumstance is this generally permissible?