Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 2

Question 1

Which agency is responsible for regulating the manufacture and distribution of controlled substances in the United States?

Accepted Answer

DEA (Drug Enforcement Administration)

Answer

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:

Accepted Answer

'Caution: Federal law restricts this drug to sale by or on the order of a licensed practitioner'

Answer

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?

Accepted Answer

Beneficence

Answer

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?

Accepted Answer

Immediately contact the patient and prescriber, and document the error

Answer

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?

Accepted Answer

Phase I

Answer

Phase I trials evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics in a small group (20–80) of healthy volunteers or patients.

Pharm.D. Doctor of Pharmacy Practice Test

Pharm.D. Doctor of Pharmacy Practice Test

Pharm.D. Doctor of Pharmacy Pharmacy Law and Ethics 2