FPGEE Drug Information 4

Question 1

A pharmacist receives a question about a drug's use in pregnancy. Which resource provides FDA pregnancy category and PLLR (Pregnancy and Lactation Labeling Rule) information?

Accepted Answer

Both A and C

Answer

Both Briggs' Drugs in Pregnancy and Lactation and Lexi-Drugs provide detailed pregnancy risk information including PLLR data; Briggs is most specialized for this purpose.

Question 2

The FDA's MedWatch program is used primarily for which purpose?

Accepted Answer

Voluntary reporting of adverse drug events and safety signals

Answer

MedWatch is the FDA Safety Information and Adverse Event Reporting Program, allowing voluntary reporting of serious adverse events by healthcare professionals and consumers.

Question 3

Which term describes an off-label drug use that is supported by strong evidence in tertiary compendia and widely accepted in clinical practice?

Accepted Answer

Legitimate off-label use

Answer

Legitimate off-label use refers to use outside the FDA-approved labeling that is supported by evidence in recognized compendia and accepted medical practice.

Question 4

A pharmacist is asked to verify the identity of an unmarked tablet. Which resource is MOST appropriate?

Accepted Answer

Micromedex Identidex or Lexi-Drugs Pill Identification

Answer

Micromedex Identidex and Lexi-Drugs pill identification databases allow pharmacists to identify tablets by imprint, shape, and color.

Question 5

What is the main difference between efficacy and effectiveness of a drug?

Accepted Answer

Efficacy is measured in controlled trials; effectiveness is measured in real-world practice

Answer

Efficacy refers to how well a drug works under ideal, controlled trial conditions, while effectiveness reflects performance in routine clinical practice.

FPGEE Exam Practice Test

FPGEE Exam Practice Test

FPGEE Drug Information 4