Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 2 — Questions and Answers
Question 1: Which agency is responsible for regulating the manufacture and distribution of controlled substances in the United States?
- FDA
- DEA (Drug Enforcement Administration) (Correct answer)
- FTC
- CMS
Correct answer: DEA (Drug Enforcement Administration)
The Drug Enforcement Administration (DEA) under the Department of Justice is responsible for regulating and enforcing the Controlled Substances Act (CSA) in the United States.
Question 2: Under the Food, Drug, and Cosmetic Act, drugs that require a prescription must bear the legend:
- 'For Investigational Use Only'
- 'Caution: Federal law restricts this drug to sale by or on the order of a licensed practitioner' (Correct answer)
- 'Approved by FDA for OTC sale'
- 'Schedule II Controlled Substance'
Correct answer: 'Caution: Federal law restricts this drug to sale by or on the order of a licensed practitioner'
Prescription drugs must bear the Rx legend: 'Caution: Federal law restricts this drug to sale by or on the order of a licensed practitioner,' as required by the Durham-Humphrey Amendment.
Question 3: Which ethical principle requires pharmacists to act in the patient's best interest?
- Autonomy
- Beneficence (Correct answer)
- Justice
- Non-maleficence
Correct answer: Beneficence
Beneficence is the ethical principle that requires healthcare providers to act in the best interest of patients and take positive steps to promote their health and wellbeing.
Question 4: A pharmacist discovers a dispensing error after the patient has left. What is the first required action?
- Wait to see if the patient reports adverse effects
- Immediately contact the patient and prescriber, and document the error (Correct answer)
- Discard the original prescription to avoid liability
- File a DEA report
Correct answer: Immediately contact the patient and prescriber, and document the error
Upon discovering a dispensing error, the pharmacist must immediately notify the patient and prescriber to minimize patient harm, then document the error per institutional and state requirements.
Question 5: Under FDA regulations, which phase of clinical trials primarily evaluates drug safety in a small group of healthy volunteers?
- Phase I (Correct answer)
- Phase II
- Phase III
- Phase IV
Correct answer: Phase I
Phase I trials evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in a small group (20–80) of healthy volunteers or patients.
Question 6: Which law established the requirement for child-resistant packaging for most prescription and OTC drugs in the United States?
- Drug Quality and Security Act (2013)
- Poison Prevention Packaging Act (PPPA, 1970) (Correct answer)
- Hatch-Waxman Act (1984)
- Orphan Drug Act (1983)
Correct answer: Poison Prevention Packaging Act (PPPA, 1970)
The Poison Prevention Packaging Act of 1970 requires child-resistant packaging for most prescription drugs and designated OTC products to prevent accidental pediatric poisoning.
Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 2
Which agency is responsible for regulating the manufacture and distribution of controlled substances in the United States?