FPGEE FPGEE Pharmacy Law and Ethics 2

Question 1

The Durham-Humphrey Amendment of 1951 established which important distinction in pharmacy practice?

Accepted Answer

Distinction between prescription-only (Rx) and over-the-counter (OTC) drugs

Answer

Requirement for child-resistant packaging

Answer

Mandate for drug efficacy testing before approval

Answer

Creation of the controlled substances scheduling system

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:

Accepted Answer

Prohibited; Schedule II drugs cannot be refilled

Answer

Permitted if the pharmacist verifies the information afterward

Answer

Permitted with DEA authorization

Answer

Permitted in emergency situations only with a 7-day supply

Question 3

Under the Combat Methamphetamine Epidemic Act (CMEA), which requirement applies to the sale of pseudoephedrine-containing products?

Accepted Answer

Products must be kept behind the pharmacy counter and purchasers must show ID and sign a logbook

Answer

Prescription required in all states

Answer

Purchasers must be at least 21 years old

Answer

Sale is limited to licensed pharmacies only, with no OTC availability

Question 4

The concept of 'standard of care' in pharmacy malpractice refers to:

Accepted Answer

The level of care a reasonably competent pharmacist would provide under similar circumstances

Answer

The minimum number of prescription checks required per shift

Answer

The FDA-approved labeling for drug use

Answer

State board of pharmacy inspection standards

Question 5

The Omnibus Budget Reconciliation Act of 1990 (OBRA-90) requires pharmacists in Medicaid programs to offer:

Accepted Answer

Drug utilization review (DUR) and patient counseling

Answer

Generic substitution for all brand prescriptions

Answer

Medication therapy management (MTM) for all patients

Answer

Therapeutic interchange without prescriber consent

Question 6

Under the Kefauver-Harris Amendment of 1962, drug manufacturers must demonstrate to the FDA that new drugs are:

Accepted Answer

Safe and effective

Answer

Safe only

Answer

Effective and cost-efficient

Answer

Safe, effective, and manufactured under GMP