Pharmacy Pharmacy Law 2 — Questions and Answers
Question 1: Under the Combat Methamphetamine Epidemic Act (CMEA), purchasers of pseudoephedrine-containing products must:
- Obtain a prescription
- Show ID and sign a logbook, with daily and monthly purchase limits (Correct answer)
- Provide a pharmacist consultation before purchase
- Have a prior authorization from their insurance
Correct answer: Show ID and sign a logbook, with daily and monthly purchase limits
CMEA requires buyers to present valid ID, sign a logbook, and comply with limits: 3.6 g/day and 9 g/30-day rolling period without a prescription.
Question 2: Which federal law established the FDA and requires drugs to be proven safe before marketing?
- Harrison Narcotic Tax Act (1914)
- Durham-Humphrey Amendment (1951)
- Food, Drug, and Cosmetic Act (1938) (Correct answer)
- Kefauver-Harris Amendment (1962)
Correct answer: Food, Drug, and Cosmetic Act (1938)
The Federal Food, Drug, and Cosmetic Act of 1938, passed after the sulfanilamide disaster, required proof of safety before a drug could be marketed.
Question 3: How long must a pharmacy retain controlled substance records (DEA Form 222, invoices) according to federal law?
- 1 year
- 2 years (Correct answer)
- 3 years
- 5 years
Correct answer: 2 years
Federal DEA regulations require controlled substance records to be maintained for a minimum of 2 years, though some states require longer.
Question 4: OBRA '90 requires pharmacists to perform which service for Medicaid patients?
- Free medication delivery
- Drug utilization review (DUR) and patient counseling offer (Correct answer)
- Generic substitution for all prescriptions
- Annual medication therapy management
Correct answer: Drug utilization review (DUR) and patient counseling offer
OBRA '90 mandates prospective Drug Utilization Review and requires pharmacists to offer counseling to Medicaid outpatients on their medications.
Question 5: A DEA Form 106 must be completed when a pharmacy:
- Orders Schedule II controlled substances
- Dispenses a controlled substance prescription
- Discovers a theft or significant loss of controlled substances (Correct answer)
- Disposes of expired non-controlled medications
Correct answer: Discovers a theft or significant loss of controlled substances
DEA Form 106 (Report of Theft or Significant Loss of Controlled Substances) is required within one business day of discovering a theft or significant loss.
Question 6: The Health Insurance Portability and Accountability Act (HIPAA) primarily protects:
- Pharmacists from malpractice suits
- Patients' protected health information (PHI) (Correct answer)
- Insurance companies from fraudulent claims
- Pharmacy benefit managers' pricing data
Correct answer: Patients' protected health information (PHI)
HIPAA's Privacy Rule protects patients' individually identifiable health information (PHI) from unauthorized disclosure by covered entities including pharmacies.
Pharmacy Pharmacy Law 2
Under the Combat Methamphetamine Epidemic Act (CMEA), purchasers of pseudoephedrine-containing products must: