FPGEE FPGEE Pharmacy Law and Ethics 2 — Questions and Answers
Question 1: The Durham-Humphrey Amendment of 1951 established which important distinction in pharmacy practice?
- Requirement for child-resistant packaging
- Distinction between prescription-only (Rx) and over-the-counter (OTC) drugs (Correct answer)
- Mandate for drug efficacy testing before approval
- Creation of the controlled substances scheduling system
Correct answer: Distinction between prescription-only (Rx) and over-the-counter (OTC) drugs
The Durham-Humphrey Amendment defined which drugs require a prescription and established the legal framework for Rx-only versus OTC classification.
Question 2: A pharmacy technician calls in a refill authorization for a Schedule II controlled substance from a prescriber's office. Under federal law, this practice is:
- Permitted if the pharmacist verifies the information afterward
- Permitted with DEA authorization
- Prohibited; Schedule II drugs cannot be refilled (Correct answer)
- Permitted in emergency situations only with a 7-day supply
Correct answer: Prohibited; Schedule II drugs cannot be refilled
Federal law prohibits refills of Schedule II controlled substances; a new prescription is required for each dispensing.
Question 3: Under the Combat Methamphetamine Epidemic Act (CMEA), which requirement applies to the sale of pseudoephedrine-containing products?
- Prescription required in all states
- Products must be kept behind the pharmacy counter and purchasers must show ID and sign a logbook (Correct answer)
- Purchasers must be at least 21 years old
- Sale is limited to licensed pharmacies only, with no OTC availability
Correct answer: Products must be kept behind the pharmacy counter and purchasers must show ID and sign a logbook
CMEA requires pseudoephedrine products to be stored behind the counter, with purchasers presenting photo ID, signing a logbook, and subject to daily/monthly purchase limits.
Question 4: The concept of 'standard of care' in pharmacy malpractice refers to:
- The minimum number of prescription checks required per shift
- The level of care a reasonably competent pharmacist would provide under similar circumstances (Correct answer)
- The FDA-approved labeling for drug use
- State board of pharmacy inspection standards
Correct answer: The level of care a reasonably competent pharmacist would provide under similar circumstances
Standard of care is the benchmark of what a reasonably competent pharmacist with similar training would do in comparable circumstances, used to evaluate negligence.
Question 5: The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires pharmacists in Medicaid programs to offer:
- Generic substitution for all brand prescriptions
- Drug utilization review (DUR) and patient counseling (Correct answer)
- Medication therapy management (MTM) for all patients
- Therapeutic interchange without prescriber consent
Correct answer: Drug utilization review (DUR) and patient counseling
OBRA-90 mandated prospective drug utilization review and an offer to counsel Medicaid patients about their medications.
Question 6: Under the Kefauver-Harris Amendment of 1962, drug manufacturers must demonstrate to the FDA that new drugs are:
- Safe only
- Safe and effective (Correct answer)
- Effective and cost-efficient
- Safe, effective, and manufactured under GMP
Correct answer: Safe and effective
The Kefauver-Harris Amendment, passed after the thalidomide tragedy, required manufacturers to prove both safety and efficacy before FDA approval.
FPGEE FPGEE Pharmacy Law and Ethics 2
The Durham-Humphrey Amendment of 1951 established which important distinction in pharmacy practice?