Importance of drug safety monitoring MCQs With Answer

Importance of drug safety monitoring MCQs With Answer

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Drug safety monitoring, or pharmacovigilance, is vital for B. Pharm students to understand post-marketing surveillance, adverse drug reaction (ADR) detection, and risk–benefit assessment. Mastery of pharmacovigilance principles—including spontaneous reporting systems, causality assessment tools (Naranjo, WHO‑UMC), signal detection, regulatory reporting requirements, risk management plans, and pharmacoepidemiology—prepares pharmacists to protect patients and comply with regulations. Familiarity with data sources (VigiBase, MedWatch), data mining methods (PRR, ROR), and concepts like seriousness, severity, and expectedness strengthens clinical judgment. These competencies enable safe medication use, minimize medication errors and drug interactions, and support informed decisions during drug development and after market approval. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which of the following best defines pharmacovigilance?

  • The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
  • The study of drug development processes before clinical trials
  • The manufacturing quality control of pharmaceutical products
  • The economic evaluation of drug pricing and reimbursement

Correct Answer: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem

Q2. Which database is maintained by the Uppsala Monitoring Centre for global ADR reports?

  • VigiBase
  • MedWatch
  • FAERS
  • CPMP Database

Correct Answer: VigiBase

Q3. Which causality assessment algorithm produces categories such as “definite,” “probable,” “possible,” and “unlikely”?

  • Naranjo algorithm
  • Cochrane algorithm
  • Kaplan–Meier method
  • Henderson scale

Correct Answer: Naranjo algorithm

Q4. Which of the following is a key characteristic of a serious adverse drug reaction?

  • Requires hospitalization or prolongation of existing hospitalization
  • Causes mild transient headache only
  • Leads to minor local irritation
  • Is predictable and nonharmful

Correct Answer: Requires hospitalization or prolongation of existing hospitalization

Q5. What does the term “signal” mean in pharmacovigilance?

  • Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event
  • A confirmed causal relationship established by randomized trials
  • A marketing strategy to promote safer drugs
  • A routine safety update report

Correct Answer: Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event

Q6. Which method is commonly used in spontaneous reporting data to detect disproportionality signals?

  • Proportional Reporting Ratio (PRR)
  • ANOVA
  • Kaplan–Meier estimator
  • Fisher’s exact test for clinical trials

Correct Answer: Proportional Reporting Ratio (PRR)

Q7. What is the primary purpose of Phase IV clinical studies?

  • Post-marketing surveillance to monitor long-term safety and rare ADRs
  • Initial safety testing in healthy volunteers
  • Dose-ranging efficacy studies in animals
  • Preclinical pharmacokinetic profiling

Correct Answer: Post-marketing surveillance to monitor long-term safety and rare ADRs

Q8. Which agency runs the MedWatch reporting system?

  • U.S. Food and Drug Administration (FDA)
  • European Medicines Agency (EMA)
  • World Health Organization (WHO)
  • Central Drugs Standard Control Organization (CDSCO)

Correct Answer: U.S. Food and Drug Administration (FDA)

Q9. Which of the following is considered an “unexpected” adverse reaction?

  • An ADR whose nature or severity is not consistent with the applicable product information
  • An ADR that is well documented in the package insert
  • A known, mild side effect listed in clinical trial reports
  • A predictable dose-dependent side effect

Correct Answer: An ADR whose nature or severity is not consistent with the applicable product information

Q10. What is the WHO‑UMC causality category that indicates a “probable” relationship?

  • Probable/Likely
  • Certain
  • Unrelated
  • Conditional/Unclassified

Correct Answer: Probable/Likely

Q11. Which term describes unintended errors in prescribing, dispensing, or administering medicines that may cause harm?

  • Medication errors
  • Adverse drug reactions
  • Pharmacokinetic variations
  • Therapeutic duplications

Correct Answer: Medication errors

Q12. Risk Management Plans (RMPs) are used primarily to:

  • Describe measures to identify, characterize, prevent or minimize risks associated with a medicinal product
  • Plan clinical efficacy endpoints for Phase II trials
  • Document manufacturing batch release procedures
  • Provide pricing strategies for market access

Correct Answer: Describe measures to identify, characterize, prevent or minimize risks associated with a medicinal product

Q13. Which of the following is a key limitation of spontaneous reporting systems?

  • Under-reporting of adverse events
  • High cost of reporting compared to trials
  • Inability to detect rare events
  • Requirement for randomized controls

Correct Answer: Under-reporting of adverse events

Q14. What does the Reporting Odds Ratio (ROR) measure in pharmacovigilance datasets?

  • Disproportionality of reporting of a specific drug–event combination compared to all other drugs and events
  • Absolute incidence rate of ADRs in the population
  • Time to onset distribution for an ADR
  • Number needed to harm

Correct Answer: Disproportionality of reporting of a specific drug–event combination compared to all other drugs and events

Q15. Which of these ADR types is dose-dependent and predictable from the drug’s pharmacology?

  • Type A (augmented)
  • Type B (bizarre)
  • Type C (chronic)
  • Type D (delayed)

Correct Answer: Type A (augmented)

Q16. What is VigiFlow?

  • An electronic case reporting and management system used by national pharmacovigilance centres to submit data to VigiBase
  • A statistical method for disproportionality analysis
  • A randomized controlled trial registry
  • A patient adherence monitoring tool

Correct Answer: An electronic case reporting and management system used by national pharmacovigilance centres to submit data to VigiBase

Q17. Which statement about black box warnings is correct?

  • They indicate serious or life-threatening risks that must be highlighted on the product labeling
  • They are only used for over-the-counter products
  • They denote common and minor side effects
  • They are voluntary statements drafted by manufacturers

Correct Answer: They indicate serious or life-threatening risks that must be highlighted on the product labeling

Q18. In causality assessment, rechallenge refers to:

  • Re-administration of a drug to see if the adverse event recurs
  • Reviewing literature for similar case reports
  • Performing an in vitro assay to test toxicity
  • Switching to a different drug in the same class

Correct Answer: Re-administration of a drug to see if the adverse event recurs

Q19. Which is an example of active surveillance in pharmacovigilance?

  • Prospective cohort studies or sentinel systems that actively collect safety data
  • Voluntary spontaneous reports from healthcare professionals
  • Retrospective literature reviews only
  • Advertising soliciting patient experiences

Correct Answer: Prospective cohort studies or sentinel systems that actively collect safety data

Q20. Which parameter differentiates “seriousness” from “severity” in ADR reporting?

  • Seriousness is regulatory (hospitalization, death), while severity describes intensity (mild, moderate, severe)
  • Severity is regulatory, and seriousness is subjective intensity
  • They are interchangeable terms with no difference
  • Severity refers to likelihood of recurrence, seriousness to clinical mechanism

Correct Answer: Seriousness is regulatory (hospitalization, death), while severity describes intensity (mild, moderate, severe)

Q21. Which of the following is NOT typically a source used in pharmacoepidemiology for safety studies?

  • Randomized animal toxicology data
  • Electronic health records
  • Insurance claims databases
  • Spontaneous reporting databases

Correct Answer: Randomized animal toxicology data

Q22. What is the main role of a national pharmacovigilance centre?

  • Collect, evaluate and report adverse reaction data and coordinate national safety activities
  • Approve marketing authorizations for new drugs
  • Manufacture generic medicines for national supply
  • Conduct Phase I clinical trials for all drugs

Correct Answer: Collect, evaluate and report adverse reaction data and coordinate national safety activities

Q23. Which statistical measure indicates a signal when PRR ≥ 2, chi-square ≥ 4, and at least 3 cases?

  • Standard signal detection threshold for many pharmacovigilance analyses
  • Definition of causality in randomized controlled trials
  • Criteria for orphan drug designation
  • Threshold for clinical significance in PK studies

Correct Answer: Standard signal detection threshold for many pharmacovigilance analyses

Q24. Which of the following best describes an idiosyncratic ADR?

  • An unpredictable, not dose-related reaction occurring in a small fraction of patients
  • A common dose-related reaction predictable from pharmacology
  • A medication error resulting from wrong dose administration
  • A reaction due to drug–drug interaction only

Correct Answer: An unpredictable, not dose-related reaction occurring in a small fraction of patients

Q25. What is the primary aim of signal validation?

  • Determine whether a detected signal is likely to represent a true safety concern warranting further evaluation
  • Calculate the market share impact of an ADR
  • Design a clinical trial to prove efficacy of a new drug
  • Replace spontaneous reports with trial data

Correct Answer: Determine whether a detected signal is likely to represent a true safety concern warranting further evaluation

Q26. Which documentation is mandatory for marketing authorization holders to submit periodically regarding safety?

  • Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER)
  • Annual manufacturing volume report only
  • Patent renewal application
  • Clinical trial recruitment statistics

Correct Answer: Periodic Safety Update Report (PSUR) or Periodic Benefit-Risk Evaluation Report (PBRER)

Q27. Which of the following is a common objective of risk minimization measures?

  • Reduce the occurrence or severity of adverse reactions while preserving therapeutic benefit
  • Increase promotional sales of a medicine
  • Eliminate the need for patient monitoring entirely
  • Replace black box warnings with minor label changes

Correct Answer: Reduce the occurrence or severity of adverse reactions while preserving therapeutic benefit

Q28. In vaccine safety monitoring, what does AEFI stand for?

  • Adverse Events Following Immunization
  • Antibody Efficiency For Immunization
  • Adverse Efficacy Findings in Immunology
  • Automated Event Frequency Index

Correct Answer: Adverse Events Following Immunization

Q29. Which factor can confound signal detection in spontaneous reporting systems?

  • Reporting bias such as stimulated reporting after media attention
  • Universal adoption of standardized diagnostic criteria
  • Complete capture of all patient exposures
  • Homogeneous patient populations in all reports

Correct Answer: Reporting bias such as stimulated reporting after media attention

Q30. Which action is appropriate when a validated signal indicates a serious new risk?

  • Initiate regulatory assessment, communicate safety information, and consider risk minimization or label changes
  • Immediately withdraw all products without assessment
  • Ignore the signal unless randomized trials confirm causality
  • Delay any action until multiple meta-analyses are published

Correct Answer: Initiate regulatory assessment, communicate safety information, and consider risk minimization or label changes

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