MPharm Master of Pharmacy Master of Pharmacy: Pharmacy Law and Ethics 5 — Questions and Answers
Question 1: Which of the following actions by a pharmacist constitutes 'unprofessional conduct' under most state pharmacy practice acts?
- Refusing to fill a prescription due to a suspected forgery
- Dispensing a generic drug when a brand is prescribed without patient notification (Correct answer)
- Providing drug information to a healthcare provider over the phone
- Counseling a patient about potential drug interactions
Correct answer: Dispensing a generic drug when a brand is prescribed without patient notification
Substituting a generic for a brand-name drug without notifying the patient (where required by state law) can constitute unprofessional conduct and a legal violation.
Question 2: Under the Americans with Disabilities Act (ADA), pharmacy staff must provide reasonable accommodations to patients with disabilities. Which scenario BEST exemplifies this obligation?
- Offering curbside prescription pickup for a patient who uses a wheelchair (Correct answer)
- Charging disabled patients reduced co-pays as a legal accommodation
- Waiving counseling requirements for deaf patients
- Requiring disabled patients to present additional ID for controlled substances
Correct answer: Offering curbside prescription pickup for a patient who uses a wheelchair
Offering curbside pickup for a wheelchair user is a reasonable accommodation that ensures equal access to pharmacy services without undue burden.
Question 3: The Stark Law (Physician Self-Referral Law) most directly prohibits:
- Pharmacists from accepting gifts from pharmaceutical sales representatives
- Physicians from referring Medicare/Medicaid patients to entities in which they have a financial interest (Correct answer)
- Pharmacies from dispensing brand drugs when a generic is available
- Drug manufacturers from providing free samples to physicians above federal limits
Correct answer: Physicians from referring Medicare/Medicaid patients to entities in which they have a financial interest
The Stark Law prohibits physicians from referring Medicare and Medicaid patients to healthcare entities in which the physician or an immediate family member has a financial relationship.
Question 4: A pharmacist is approached by a researcher who wants access to de-identified patient prescription data for a study. Under HIPAA, this data:
- Cannot be shared under any circumstances without each patient signing an authorization form
- May be shared for research without authorization if properly de-identified per HIPAA Safe Harbor standards (Correct answer)
- Requires DEA approval before release for controlled substance data
- Can only be released after state board of pharmacy authorization
Correct answer: May be shared for research without authorization if properly de-identified per HIPAA Safe Harbor standards
De-identified data that meets HIPAA Safe Harbor standards (18 identifiers removed) is no longer PHI and may be shared without patient authorization.
Question 5: Which principle from the Code of Ethics for Pharmacists (APhA) specifically addresses a pharmacist's obligation to act in the patient's best interest even when it conflicts with the pharmacist's own interests?
- Principle of covenantal relationship
- Principle of promoting the right to self-determination
- Principle of serving individual, community, and societal needs
- Principle of placing patient welfare foremost (Correct answer)
Correct answer: Principle of placing patient welfare foremost
The APhA Code's principle of placing patient welfare foremost requires pharmacists to prioritize patient interests above personal gain or benefit.
Question 6: A pharmacist in a state that has enacted the Uniform Controlled Substances Act (UCSA) finds a conflict between state and federal controlled substance law. Which standard applies?
- Federal law always supersedes state law for all controlled substance matters
- State law supersedes federal law if state penalties are harsher
- The stricter of the two laws applies, whether federal or state (Correct answer)
- The pharmacist must petition the DEA for a ruling before dispensing
Correct answer: The stricter of the two laws applies, whether federal or state
When state and federal controlled substance laws conflict, pharmacists must comply with whichever is more stringent to satisfy both legal systems.
Question 7: Which of the following best describes the concept of 'therapeutic privilege' and its ethical limitations in pharmacy practice?
- A pharmacist's right to decline filling any prescription based on professional judgment
- Withholding information from a patient because disclosure might cause harm, which is ethically controversial and rarely justified (Correct answer)
- A prescriber's privilege to prescribe off-label drugs without informing patients
- A pharmacy's right to limit counseling time based on operational needs
Correct answer: Withholding information from a patient because disclosure might cause harm, which is ethically controversial and rarely justified
Therapeutic privilege (withholding information to prevent patient harm) is ethically controversial because it undermines patient autonomy and informed consent.
Which of the following actions by a pharmacist constitutes 'unprofessional conduct' under most state pharmacy practice acts?