MPharm Master of Pharmacy Master of Pharmacy: Pharmacy Law and Ethics 2 — Questions and Answers
Question 1: Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily purchase limit for pseudoephedrine products per customer?
- 3.6 grams (Correct answer)
- 9 grams
- 7.5 grams
- 12 grams
Correct answer: 3.6 grams
CMEA limits pseudoephedrine purchases to 3.6 grams per day and 9 grams per 30-day period.
Question 2: A pharmacist receives a prescription for a Schedule II controlled substance written 45 days ago. What is the correct action?
- Dispense it since Schedule II prescriptions have no expiration
- Refuse to fill it as Schedule II prescriptions must be filled within 30 days (Correct answer)
- Fill it since federal law allows 60 days for Schedule II prescriptions
- Contact the DEA for special authorization before dispensing
Correct answer: Refuse to fill it as Schedule II prescriptions must be filled within 30 days
Schedule II prescriptions must be filled within 30 days of the date written under federal DEA regulations.
Question 3: Which ethical principle is MOST directly violated when a pharmacist discloses a patient's HIV status to a third party without consent?
- Beneficence
- Nonmaleficence
- Autonomy (Correct answer)
- Justice
Correct answer: Autonomy
Disclosing confidential health information without consent violates autonomy by overriding the patient's right to control their own information.
Question 4: What is the primary purpose of the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)?
- To list all FDA-approved controlled substances by schedule
- To identify drug products with therapeutic equivalence ratings for generic substitution (Correct answer)
- To provide maximum daily dose recommendations for pharmacists
- To catalog all recalled drug products in the US
Correct answer: To identify drug products with therapeutic equivalence ratings for generic substitution
The Orange Book assigns therapeutic equivalence codes (e.g., AB) to guide safe generic drug substitution.
Question 5: A DEA Form 222 is required for ordering which category of controlled substances?
- Schedule III and IV only
- Schedule II only
- Schedules I and II (Correct answer)
- All schedules I through V
Correct answer: Schedules I and II
DEA Form 222 (or CSOS electronic equivalent) is required to order Schedule I and II controlled substances.
Question 6: Under HIPAA, which of the following is considered a permitted disclosure of Protected Health Information (PHI) without patient authorization?
- Sharing PHI with a patient's employer upon request
- Disclosing PHI to a marketing company for drug promotions
- Reporting communicable diseases to public health authorities (Correct answer)
- Providing PHI to a patient's attorney for a civil lawsuit
Correct answer: Reporting communicable diseases to public health authorities
Public health reporting is a permitted HIPAA disclosure that does not require patient authorization.
Question 7: The Poison Prevention Packaging Act (PPPA) requires child-resistant packaging for most prescription drugs. Which patient population can request non-child-resistant packaging?
- Patients under age 18
- Elderly patients over 65 only
- Any patient or their physician upon request (Correct answer)
- Only patients with documented disabilities
Correct answer: Any patient or their physician upon request
Under the PPPA, any patient or their prescriber may request a waiver for non-child-resistant containers.
MPharm Master of Pharmacy Master of Pharmacy: Pharmacy Law and Ethics 2
Under the Combat Methamphetamine Epidemic Act (CMEA), what is the daily purchase limit for pseudoephedrine products per customer?