MCQ Quiz: Drug Safety Literature for Decision-Making

Ensuring drug safety is a continuous process that extends far beyond a medication’s initial FDA approval. Pharmacists must be skilled at locating, critically appraising, and applying drug safety literature to make informed clinical decisions that protect their patients. This skill is a core component of Evidence-Based Practice, as taught in the PHA5244 course, and is essential for fulfilling the medication safety roles explored throughout the PharmD curriculum. This quiz will test your knowledge on the types of drug safety literature, key resources, and the principles of using this information for patient care decisions.

1. The primary purpose of post-marketing surveillance is to:

• a. Determine the effective dose of a new drug.
• b. Detect rare or long-term adverse drug effects not identified in pre-market clinical trials.
• c. Establish the mechanism of action of a drug.
• d. Get a new drug approved by the FDA.

Answer: b. Detect rare or long-term adverse drug effects not identified in pre-market clinical trials.

2. A physician reports a potential new side effect they observed in a single patient to the FDA. This is an example of a(n):

• a. Randomized controlled trial
• b. Case report
• c. Cohort study
• d. Meta-analysis

Answer: b. Case report

3. The FDA’s voluntary reporting system for adverse events and medication errors is known as:

• a. The Orange Book
• b. The Red Book
• c. MedWatch
• d. ClinicalTrials.gov

Answer: c. MedWatch

4. A major limitation of a spontaneous reporting system like MedWatch is:

• a. Underreporting of events.
• b. The inability to calculate a true incidence rate (no denominator).
• c. The potential for inaccurate or incomplete reports.
• d. All of the above.

Answer: d. All of the above.

5. Which type of observational study is most efficient for studying the potential link between a drug and a very rare adverse event?

• a. Prospective cohort study
• b. Case-control study
• c. Cross-sectional study
• d. All are equally efficient.

Answer: b. Case-control study

6. The “Principles of Evidence-Based Practice” course provides the foundation for appraising all types of literature.

• a. True
• b. False

Answer: a. True

7. A study that identifies a group of patients taking a new drug and a group not taking the drug and follows them forward in time to compare the incidence of liver injury is a:

• a. Case-control study
• b. Cohort study
• c. Case series
• d. Cross-sectional study

Answer: b. Cohort study

8. When a pharmacist critically appraises a drug safety study, the first step is to assess its:

• a. Conclusion
• b. Funding source
• c. Internal validity
• d. Author credentials

Answer: c. Internal validity

9. A “signal” in pharmacovigilance is:

• a. A confirmed causal link between a drug and an adverse event.
• b. Reported information on a possible causal relationship between an adverse event and a drug, which needs further investigation.
• c. A final regulatory decision from the FDA.
• d. A radio transmission.

Answer: b. Reported information on a possible causal relationship between an adverse event and a drug, which needs further investigation.

10. A Risk Evaluation and Mitigation Strategy (REMS) is required by the FDA when:

• a. A drug is proven to be completely safe.
• b. The benefits of a drug are thought to outweigh its risks, but special procedures are needed to ensure safe use.
• c. A drug has a generic version available.
• d. A drug is inexpensive.

Answer: b. The benefits of a drug are thought to outweigh its risks, but special procedures are needed to ensure safe use.

11. The appraisal of cohort studies, a common design for safety literature, is a “Transcending Concept” in the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

12. Why are randomized controlled trials (RCTs) often inadequate for detecting rare adverse drug events?

• a. They are not blinded.
• b. They often have sample sizes that are too small and follow-up durations that are too short.
• c. They do not have a control group.
• d. They are observational studies.

Answer: b. They often have sample sizes that are too small and follow-up durations that are too short.

13. A pharmacist is asked if Drug X causes a specific side effect. The best answer is often framed in terms of:

• a. A definitive “yes” or “no.”
• b. The pharmacist’s personal opinion.
• c. A risk/benefit assessment based on the strength of the available evidence.
• d. What the patient wants to hear.

Answer: c. A risk/benefit assessment based on the strength of the available evidence.

14. A key role of a pharmacist in promoting drug safety is:

• a. To report observed adverse drug events.
• b. To educate patients on potential side effects.
• c. To critically evaluate safety literature.
• d. All of the above.

Answer: d. All of the above.

15. Evaluating relevant primary literature to answer drug information questions is a key objective for student pharmacists.

• a. True
• b. False

Answer: a. True

16. Which of the following would be found in the “Warnings and Precautions” section of a package insert?

• a. The drug’s mechanism of action.
• b. Clinically significant adverse reactions that have a serious risk.
• c. The cost of the drug.
• d. The chemical structure of the drug.

Answer: b. Clinically significant adverse reactions that have a serious risk.

17. The “Medication Safety” module is part of the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

18. A well-conducted cohort study finds a Relative Risk of 3.0 for a side effect. This means the drug:

• a. Is three times safer than the alternative.
• b. Triples the risk of the side effect compared to the alternative.
• c. Causes the side effect in 3% of patients.
• d. Has a p-value of 3.0.

Answer: b. Triples the risk of the side effect compared to the alternative.

19. A major challenge of using observational studies to assess drug safety is:

• a. The high internal validity.
• b. The potential for confounding by indication.
• c. The small sample sizes.
• d. The short duration of follow-up.

Answer: b. The potential for confounding by indication.

20. An active learning session on EBP is part of which course?

• a. PHA5244 Principles of Evidence-Based Practice
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5787C Patient Care 5

Answer: a. PHA5244 Principles of Evidence-Based Practice

21. Where is the best place for a pharmacist to look for the most up-to-date safety information or warnings issued by the FDA?

• a. A textbook published 5 years ago.
• b. The FDA’s MedWatch website or official drug safety communications.
• c. A newspaper article.
• d. A television commercial.

Answer: b. The FDA’s MedWatch website or official drug safety communications.

22. A “case series” is a type of descriptive study that:

• a. Can prove a drug causes a side effect.
• b. Can generate a hypothesis about a potential drug-ADR link by describing a group of patients with a similar exposure and outcome.
• c. Is a type of randomized controlled trial.
• d. Involves a control group.

Answer: b. Can generate a hypothesis about a potential drug-ADR link by describing a group of patients with a similar exposure and outcome.

23. “Bias and Confounding” are key concepts for critiquing safety literature.

• a. True
• b. False

Answer: a. True

24. An active learning session on medication safety is part of which course?

• a. PHA5787C Patient Care 5
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5787C Patient Care 5

25. A pharmacist counseling a patient on a new medication with a REMS program is fulfilling a key role in:

• a. Marketing
• b. Drug safety and risk mitigation
• c. Inventory management
• d. Drug discovery

Answer: b. Drug safety and risk mitigation

26. A meta-analysis of safety data from multiple studies can:

• a. Increase the statistical power to detect a rare adverse event.
• b. Introduce bias if the included studies are of poor quality.
• c. Provide a more precise estimate of the risk.
• d. All of the above.

Answer: d. All of the above.

27. When communicating risk to a patient, it is often more helpful to use:

• a. Relative risk numbers (e.g., “doubles the risk”).
• b. Absolute risk numbers (e.g., “increases the risk from 1 in 10,000 to 2 in 10,000 people”).
• c. The p-value.
• d. Complex statistical terms.

Answer: b. Absolute risk numbers (e.g., “increases the risk from 1 in 10,000 to 2 in 10,000 people”).

28. An active learning session on appraising cohort studies is part of which course module?

• a. Module 5: Urological Disorders
• b. Module 1: Diabetes Mellitus
• c. Module 4: Medication Safety
• d. Module 8: Men’s Health

Answer: a. Module 5: Urological Disorders

29. The highest level of evidence for a drug safety question would come from:

• a. A single case report.
• b. A meta-analysis of well-conducted observational studies or RCTs.
• c. Expert opinion.
• d. A study in rats.

Answer: b. A meta-analysis of well-conducted observational studies or RCTs.

30. The “Pharmacoepidemiology Study Designs” module is part of the EBP course.

• a. True
• b. False

Answer: a. True

31. Which of the following is NOT a limitation of pre-market clinical trials for assessing drug safety?

• a. Limited duration
• b. Limited patient diversity
• c. Use of a placebo control
• d. Small sample size relative to the general population

Answer: c. Use of a placebo control

32. The pharmacist’s role in the medication use system makes them uniquely positioned to:

• a. Identify potential adverse drug events in their patients.
• b. Report ADRs to MedWatch.
• c. Educate patients about medication risks.
• d. All of the above.

Answer: d. All of the above.

33. The information in a drug’s package insert represents:

• a. All known information about the drug.
• b. The information known at the time of the drug’s approval, plus updates from post-marketing surveillance.
• c. A marketing document.
• d. A guide for patients only.

Answer: b. The information known at the time of the drug’s approval, plus updates from post-marketing surveillance.

34. The term “pharmacovigilance” is synonymous with:

• a. Pre-clinical research
• b. Phase 2 clinical trials
• c. Post-marketing drug safety surveillance
• d. Medication adherence monitoring

Answer: c. Post-marketing drug safety surveillance

35. A “Dear Healthcare Professional” letter is a communication tool used by manufacturers or the FDA to:

• a. Market a new drug.
• b. Announce a price increase.
• c. Disseminate important new safety information about a drug.
• d. Recruit for clinical trials.

Answer: c. Disseminate important new safety information about a drug.

36. A key part of the “Assess” step in the Pharmacists’ Patient Care Process is evaluating medication for:

• a. Indication
• b. Efficacy
• c. Safety
• d. All of the above

Answer: d. All of the above

37. When a pharmacist reads a case report linking a drug to a side effect, they should immediately:

• a. Tell all patients to stop taking the drug.
• b. Recognize that a case report can suggest a possible link but cannot prove causation.
• c. Ignore the report as it is not an RCT.
• d. Call the manufacturer and demand they recall the drug.

Answer: b. Recognize that a case report can suggest a possible link but cannot prove causation.

38. “Introduction to Medication Errors” is a module in the Professional Practice Skills Lab II.

• a. True
• b. False

Answer: a. True

39. A key skill for a pharmacist in drug safety is:

• a. The ability to differentiate a true adverse drug reaction from a symptom of the patient’s underlying disease.
• b. Memorizing every side effect in a package insert.
• c. Only focusing on common side effects.
• d. Ignoring patient-reported side effects.

Answer: a. The ability to differentiate a true adverse drug reaction from a symptom of the patient’s underlying disease.

40. An active learning session covering medication safety is part of which course?

• a. PHA5787C Patient Care 5
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5787C Patient Care 5

41. The use of large EHR databases to monitor for safety signals is an example of:

• a. A prospective cohort study
• b. Active surveillance
• c. A randomized controlled trial
• d. A case report

Answer: b. Active surveillance

42. Which of the following is a limitation of a case-control study for assessing drug safety?

• a. It is very expensive.
• b. It takes a long time to complete.
• c. It is susceptible to recall bias.
• d. It is not good for studying rare outcomes.

Answer: c. It is susceptible to recall bias.

43. A pharmacist’s professional responsibility includes staying up-to-date on new drug safety information.

• a. True
• b. False

Answer: a. True

44. The decision to recommend a drug for a patient involves weighing the evidence of its efficacy against the evidence of its:

• a. Cost
• b. Potential for harm (safety)
• c. Availability
• d. Color

Answer: b. Potential for harm (safety)

45. A black box warning for a drug indicates that:

• a. The drug is contraindicated in all patients.
• b. The drug has a risk of serious or life-threatening adverse effects.
• c. The drug is not effective.
• d. The drug is a controlled substance.

Answer: b. The drug has a risk of serious or life-threatening adverse effects.

46. When a pharmacist provides a medication guide to a patient, they are participating in what type of FDA program?

• a. MedWatch
• b. A REMS program
• c. The Orange Book program
• d. The Bad Ad program

Answer: b. A REMS program

47. The “Medication Safety” module is part of the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

48. An active learning session on medication safety is part of which course module?

• a. Module 4: Medication Safety
• b. Module 1: Diabetes Mellitus
• c. Module 3: Women’s Health
• d. Module 8: Men’s Health

Answer: a. Module 4: Medication Safety

49. The overall goal of using drug safety literature is to:

• a. Prevent the use of all new drugs.
• b. Make informed, evidence-based clinical decisions to minimize patient harm.
• c. Find reasons to question every prescription.
• d. Only use drugs that have been on the market for over 20 years.

Answer: b. Make informed, evidence-based clinical decisions to minimize patient harm.

50. The ultimate reason to learn about drug safety literature is to:

• a. Fulfill a professional and ethical obligation to protect patients from medication-related harm.
• b. Pass the NAPLEX.
• c. Be able to publish a case report.
• d. Sound knowledgeable on rounds.

Answer: a. Fulfill a professional and ethical obligation to protect patients from medication-related harm.