Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 1 — Questions and Answers
Question 1: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit for pseudoephedrine products per purchaser?
- 6 grams
- 3.6 grams (Correct answer)
- 9 grams
- 1.8 grams
Correct answer: 3.6 grams
The CMEA limits pseudoephedrine sales to 3.6 grams per day and 9 grams per 30-day period per purchaser, requiring a photo ID and logbook entry.
Question 2: Which DEA schedule includes drugs with accepted medical use but the highest potential for abuse among scheduled drugs with a medical use?
- Schedule I
- Schedule II (Correct answer)
- Schedule III
- Schedule IV
Correct answer: Schedule II
Schedule II drugs have accepted medical use but the highest potential for abuse among drugs with accepted uses, with severe psychological or physical dependence potential.
Question 3: Under HIPAA, which of the following is NOT considered protected health information (PHI)?
- Patient's date of birth linked to their diagnosis
- De-identified patient data with all 18 identifiers removed (Correct answer)
- Patient's medication list stored in a pharmacy computer
- Patient's lab results faxed to a specialist
Correct answer: De-identified patient data with all 18 identifiers removed
De-identified health information, from which all 18 HIPAA-specified identifiers have been removed, is NOT considered PHI and is not subject to HIPAA protections.
Question 4: A pharmacist refuses to dispense a valid controlled substance prescription due to personal moral objections. Under most state laws, the pharmacist must:
- Refuse without explanation
- Inform the patient and refer them to another pharmacist or pharmacy who can fill it (Correct answer)
- Report the prescriber to the DEA
- Require a second opinion from another prescriber
Correct answer: Inform the patient and refer them to another pharmacist or pharmacy who can fill it
Most state pharmacy laws require that pharmacists exercising conscientious refusal must inform the patient and ensure they have access to care by transferring or referring to another provider.
Question 5: Which federal law requires pharmacies to offer medication counseling to Medicaid patients?
- HIPAA (1996)
- OBRA-90 (Omnibus Budget Reconciliation Act of 1990) (Correct answer)
- Durham-Humphrey Amendment (1951)
- Kefauver-Harris Amendment (1962)
Correct answer: OBRA-90 (Omnibus Budget Reconciliation Act of 1990)
OBRA-90 mandated that pharmacies offer prospective drug use review (DUR) and counseling to Medicaid outpatients, which many states extended to all patients.
Question 6: What is the maximum number of refills permitted for a Schedule III controlled substance prescription under federal law?
- No refills permitted
- 3 refills within 6 months
- 5 refills within 6 months (Correct answer)
- Unlimited refills for 1 year
Correct answer: 5 refills within 6 months
Under federal DEA regulations, Schedule III and IV controlled substance prescriptions may be refilled up to 5 times within 6 months of the date of issue.
Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 1
Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily sales limit for pseudoephedrine products per purchaser?