FPGEE Drug Information 4 — Questions and Answers
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?
- Briggs' Drugs in Pregnancy and Lactation
- AHFS Drug Information
- Lexi-Drugs
- Both A and C (Correct answer)
Correct answer: Both A and C
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?
- Approving new drug applications
- Monitoring medication adherence in patients
- Voluntary reporting of adverse drug events and safety signals (Correct answer)
- Registering clinical trials
Correct answer: Voluntary reporting of adverse drug events and safety signals
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?
- Investigational use
- Legitimate off-label use (Correct answer)
- Unapproved experimental use
- Compassionate use
Correct answer: Legitimate off-label use
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?
- Goodman & Gilman's
- Micromedex Identidex or Lexi-Drugs Pill Identification (Correct answer)
- Clinical Pharmacology
- PubMed
Correct answer: Micromedex Identidex or Lexi-Drugs Pill Identification
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?
- Efficacy measures safety; effectiveness measures benefit
- Efficacy is measured in controlled trials; effectiveness is measured in real-world practice (Correct answer)
- Efficacy applies to brand drugs; effectiveness applies to generics
- Efficacy is a pharmacokinetic term; effectiveness is a pharmacodynamic term
Correct answer: Efficacy is measured in controlled trials; effectiveness is measured in real-world practice
Efficacy refers to how well a drug works under ideal, controlled trial conditions, while effectiveness reflects performance in routine clinical practice.
Question 6: Which organization publishes the Orange Book, which lists FDA-approved drug products with therapeutic equivalence evaluations?
- Centers for Disease Control and Prevention (CDC)
- Food and Drug Administration (FDA) (Correct answer)
- Drug Enforcement Administration (DEA)
- United States Pharmacopeia (USP)
Correct answer: Food and Drug Administration (FDA)
The FDA publishes the Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations), which guides generic drug substitution decisions.
Question 7: A pharmacist needs information about controlled substance scheduling. What is the MOST direct resource?
- USP-NF
- DEA's Controlled Substances Schedule (21 CFR Part 1308) (Correct answer)
- Package insert
- AHFS
Correct answer: DEA's Controlled Substances Schedule (21 CFR Part 1308)
The DEA's Controlled Substances Schedule published in 21 CFR Part 1308 is the authoritative regulatory source for scheduling information.
FPGEE Drug Information 4
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?