Pharmacy Law and Ethics Flashcards
6 cards from real Pharm.D. Doctor of Pharmacy practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Pharmacy Law and Ethics flashcards as text
Which agency is responsible for regulating the manufacture and distribution of controlled substances in the United States?
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.
Under the Food, Drug, and Cosmetic Act, drugs that require a prescription must bear the legend:
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.
Which ethical principle requires pharmacists to act in the patient's best interest?
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.
A pharmacist discovers a dispensing error after the patient has left. What is the first required action?
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.
Under FDA regulations, which phase of clinical trials primarily evaluates drug safety in a small group of healthy volunteers?
Answer: Phase I
Phase I trials evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in a small group (20–80) of healthy volunteers or patients.
Which law established the requirement for child-resistant packaging for most prescription and OTC drugs in the United States?
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.