Pharmacovigilance: aims, types and reporting systems MCQs With Answer

This short quiz collection on “Pharmacovigilance: aims, types and reporting systems” is designed for M.Pharm students preparing for advanced exams and professional practice. It focuses on core principles—objectives of pharmacovigilance, classification of adverse drug reactions, causality assessment, signal detection methods, surveillance types (passive and active), important reporting systems and databases, regulatory timelines and essential documentation such as ICSRs, PSUR/PBRER and RMPs. Each question is crafted to test both conceptual understanding and applied knowledge required in pharmacovigilance operations, safety monitoring and regulatory submissions. Use these MCQs to identify learning gaps and reinforce critical topics needed for quality use of medicines and patient safety.

Q1. What is the primary aim of pharmacovigilance?

• To discover new pharmacological actions of drugs
• To monitor, detect and prevent adverse effects and other drug-related problems
• To promote sales of pharmaceutical products
• To replace clinical trials in determining drug efficacy

Correct Answer: To monitor, detect and prevent adverse effects and other drug-related problems

Q2. Which of the following best defines a “signal” in pharmacovigilance?

• A documented adverse reaction with proven causality
• Any new or changing information that suggests a new causal association or new aspect of a known association between a drug and an adverse event
• A summary of drug efficacy from clinical trials
• A marketing claim approved by regulatory authorities

Correct Answer: Any new or changing information that suggests a new causal association or new aspect of a known association between a drug and an adverse event

Q3. Which database is maintained by the Uppsala Monitoring Centre as the WHO global pharmacovigilance database?

• MedDRA
• VigiBase
• EudraVigilance
• FAERS

Correct Answer: VigiBase

Q4. Which of the following surveillance methods is an example of active pharmacovigilance?

• Spontaneous (voluntary) reporting by healthcare professionals
• Cohort event monitoring where a defined patient cohort is followed prospectively for adverse events
• Retrospective literature review only
• Advertising-driven adverse event collection

Correct Answer: Cohort event monitoring where a defined patient cohort is followed prospectively for adverse events

Q5. Which term describes an adverse drug reaction that is life-threatening, requires hospitalization, or results in disability?

• Minor
• Serious
• Expected
• Non-causal

Correct Answer: Serious

Q6. Which one of the following is a commonly used disproportionality measure for signal detection in spontaneous reporting databases?

• Relative risk reduction (RRR)
• Proportional Reporting Ratio (PRR)
• Number needed to treat (NNT)
• Incidence rate ratio from a randomized trial

Correct Answer: Proportional Reporting Ratio (PRR)

Q7. Which organization developed the widely used causality categories “Certain”, “Probable/Likely”, “Possible”, “Unlikely”, “Conditional/Unclassified” and “Unassessable/Unclassifiable”?

• FDA
• WHO–UMC (Uppsala Monitoring Centre)
• EMA
• CIOMS

Correct Answer: WHO–UMC (Uppsala Monitoring Centre)

Q8. Which document defines the required format and core data elements for an Individual Case Safety Report (ICSR)?

• ICH E2B guidelines
• Good Manufacturing Practice (GMP)
• ICH Q9
• ICH E6 (GCP)

Correct Answer: ICH E2B guidelines

Q9. Which of the following is TRUE about spontaneous reporting systems?

• They provide accurate incidence rates for adverse events
• They are passive systems relying on voluntary reports and useful for signal detection
• They always include a control group for causality assessment
• They replace the need for active surveillance entirely

Correct Answer: They are passive systems relying on voluntary reports and useful for signal detection

Q10. MedDRA is primarily used in pharmacovigilance for which purpose?

• Manufacturing quality control
• Standardized coding of medical terms (adverse events, diagnoses)
• Calculating pharmacokinetic parameters
• Drug pricing and reimbursement

Correct Answer: Standardized coding of medical terms (adverse events, diagnoses)

Q11. In clinical trial safety reporting, what is a SUSAR?

• A study subject who withdraws consent
• A Suspected Unexpected Serious Adverse Reaction
• A standardized safety assessment report
• A supplementary usage and safety annual review

Correct Answer: A Suspected Unexpected Serious Adverse Reaction

Q12. For a fatal or life‑threatening SUSAR occurring in a clinical trial, what is the typical initial reporting timeline to regulatory authorities?

• Within 24 hours
• Within 7 calendar days for initial report, with 8 additional days for follow-up
• Within 90 days
• Only in the annual safety report

Correct Answer: Within 7 calendar days for initial report, with 8 additional days for follow-up

Q13. Which of the following best distinguishes “expected” from “unexpected” adverse reactions in pharmacovigilance?

• Expected reactions are always non-serious; unexpected are always serious
• Expected adverse reactions are listed in the product labeling; unexpected are not listed or differ in nature or severity
• Expected reactions are fabricated; unexpected are genuine
• Expected reactions occur only in preclinical studies

Correct Answer: Expected adverse reactions are listed in the product labeling; unexpected are not listed or differ in nature or severity

Q14. Which of the following reporting systems is the European Union pharmacovigilance database?

• VigiBase
• EudraVigilance
• FAERS
• MedWatch

Correct Answer: EudraVigilance

Q15. Which method uses Bayesian shrinkage to detect signals and is implemented by the UMC as the Information Component (IC)?

• Chi-square test only
• Bayesian Confidence Propagation Neural Network (BCPNN) / Information Component
• Kaplan–Meier estimator
• Cox proportional hazards model

Correct Answer: Bayesian Confidence Propagation Neural Network (BCPNN) / Information Component

Q16. Which element is NOT typically part of an ICSR?

• Patient identifiable information (when permitted) and demographics
• Detailed description of adverse event and outcome
• Batch/lot number of implicated product
• Marketing strategy and sales figures

Correct Answer: Marketing strategy and sales figures

Q17. What is the main purpose of a Risk Management Plan (RMP)?

• To plan clinical trial recruitment strategies
• To describe known and potential safety concerns and measures to minimize and assess risks during the product lifecycle
• To list marketing targets for a new drug
• To replace periodic safety update reports

Correct Answer: To describe known and potential safety concerns and measures to minimize and assess risks during the product lifecycle

Q18. Which report compiles cumulative safety data for a medicinal product at defined intervals and is often referred to as PSUR or PBRER?

• Investigator Brochure
• Periodic Safety Update Report / Periodic Benefit‑Risk Evaluation Report
• Manufacturing batch release certificate
• Clinical trial protocol

Correct Answer: Periodic Safety Update Report / Periodic Benefit‑Risk Evaluation Report

Q19. Which of the following is a limitation of spontaneous reporting systems?

• They provide robust causal proof of drug–event relationships
• They are subject to under-reporting and reporting bias
• They always provide incidence rates for adverse events
• They are primarily used for manufacturing quality assurance

Correct Answer: They are subject to under-reporting and reporting bias

Q20. Which international working group produced standardized case report forms and guidance for vaccine pharmacovigilance and general drug safety reporting (CIOMS forms)?

• International Conference on Harmonisation (ICH)
• Council for International Organizations of Medical Sciences (CIOMS)
• World Trade Organization (WTO)
• Organization for Economic Cooperation and Development (OECD)

Correct Answer: Council for International Organizations of Medical Sciences (CIOMS)

Download