Pharmacovigilance overview MCQs With Answer

Pharmacovigilance overview MCQs With Answer

This collection of MCQs is designed for M.Pharm students specializing in Clinical Pharmacy Practice to build a deep, exam-ready understanding of pharmacovigilance. The questions span fundamental definitions, regulatory frameworks, signal detection methods, reporting systems, causality assessment, risk management and pharmacoepidemiology, emphasizing practical and regulatory concepts encountered in post-marketing safety. Each item includes plausible alternatives and the correct answer to support focused revision and self-assessment. Use these questions to test conceptual clarity, prepare for viva/board exams, and reinforce best practices for drug safety monitoring and decision-making in clinical and regulatory settings.

Q1. What is the WHO definition of pharmacovigilance?

• The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug‑related problem
• The clinical testing of new drugs before market authorization
• The marketing and distribution of medicines to healthcare providers
• A system to ensure correct dosing of medicines in hospitals

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

Q2. What is the primary objective of pharmacovigilance?

• To maximize sales of new medicinal products
• Early detection, assessment, understanding and prevention of adverse drug reactions and other drug‑related problems
• To replace clinical trials with spontaneous reports
• To certify manufacturing quality of pharmaceuticals

Correct Answer: Early detection, assessment, understanding and prevention of adverse drug reactions and other drug‑related problems

Q3. What does ICSR stand for in pharmacovigilance?

• International Clinical Study Report
• Individual Case Safety Report
• Indexed Causality Signal Report
• Investigational Clinical Safety Record

Correct Answer: Individual Case Safety Report

Q4. Which of the following best defines a ‘serious’ adverse event?

• An event defined solely by its high intensity
• Any adverse event resulting in death, life‑threatening situation, hospitalization, persistent or significant disability/incapacity, congenital anomaly, or other medically important condition
• An event that is expected and listed in the product leaflet
• A minor, self‑limiting event that does not require treatment

Correct Answer: Any adverse event resulting in death, life‑threatening situation, hospitalization, persistent or significant disability/incapacity, congenital anomaly, or other medically important condition

Q5. How is ‘severity’ of an adverse drug reaction different from ‘seriousness’?

• Severity relates to the outcome criteria, seriousness relates to intensity
• Severity denotes the intensity of an adverse event while seriousness denotes the event’s regulatory outcome or consequence (e.g., hospitalization, death)
• They are interchangeable terms with no practical difference
• Severity is used only in preclinical studies and seriousness only in clinical trials

Correct Answer: Severity denotes the intensity of an adverse event while seriousness denotes the event’s regulatory outcome or consequence (e.g., hospitalization, death)

Q6. Which causality assessment methods are commonly used in clinical pharmacovigilance?

• WHO‑UMC algorithm and Naranjo scale
• Kaplan‑Meier estimator and Cox regression
• Adverse Event Probability Index and DSMB score
• Good Manufacturing Practice (GMP) checklist and ISO rating

Correct Answer: WHO‑UMC algorithm and Naranjo scale

Q7. The Proportional Reporting Ratio (PRR) is an example of which type of signal detection method?

• Disproportionality analysis
• Time‑series analysis
• Survival analysis
• Bayesian hierarchical modeling only

Correct Answer: Disproportionality analysis

Q8. What does the ‘black triangle’ symbol beside a medicine indicate?

• The medicine is banned in most countries
• It denotes a product under routine monitoring with no special requirements
• Medicine is under additional monitoring to encourage reporting of adverse reactions
• It marks a generic product substitutable at pharmacy level

Correct Answer: Medicine is under additional monitoring to encourage reporting of adverse reactions

Q9. What does PBRER stand for in post‑marketing safety reporting?

• Periodic Benefit‑Risk Evaluation Report
• Preclinical Benefit Review and Evaluation Record
• Periodic Biological Risk Evaluation Record
• Post‑Approval Batch Release Evaluation Report

Correct Answer: Periodic Benefit‑Risk Evaluation Report

Q10. What is the single biggest limitation of spontaneous adverse event reporting systems?

• Overreporting of trivial events
• Inability to collect patient demographics
• Underreporting and reporting bias
• Excessive standardization of reports

Correct Answer: Underreporting and reporting bias

Q11. MedDRA is an essential tool in pharmacovigilance. What does MedDRA stand for?

• Medical Dictionary for Regulatory Activities
• Medication Data Recording Application
• Medical Device Regulatory Agreement
• Medicine Development and Research Atlas

Correct Answer: Medical Dictionary for Regulatory Activities

Q12. Which ICH guideline specifically addresses post‑approval safety data management and expedited reporting?

• ICH E6
• ICH Q10
• ICH E2D
• ICH M4

Correct Answer: ICH E2D

Q13. Which of the following is an example of active pharmacovigilance?

• Spontaneous reporting from clinicians
• Cohort event monitoring with scheduled follow‑up of patients
• Voluntary consumer ADR reports through a hotline
• Passive collection of reports from marketing authorization holders

Correct Answer: Cohort event monitoring with scheduled follow‑up of patients

Q14. Which data source is most suitable for estimating incidence rates of adverse drug reactions?

• Spontaneous adverse event reports alone
• Population‑based electronic health records and cohort studies
• Clinical trial case report forms only
• Product leaflets and promotional materials

Correct Answer: Population‑based electronic health records and cohort studies

Q15. What are the core components of a Risk Management Plan (RMP)?

• Manufacturing batch release data only
• Safety specification, pharmacovigilance plan and risk minimization measures
• Marketing strategy, pricing and distribution plan
• Clinical study protocols and informed consent forms only

Correct Answer: Safety specification, pharmacovigilance plan and risk minimization measures

Q16. A voluntary unsolicited report of an adverse event by a healthcare professional or patient is termed:

• Clinical trial adverse event
• Spontaneous report
• Audit report
• Manufacturing deviation report

Correct Answer: Spontaneous report

Q17. In VigiBase signal detection, the ‘IC’ metric refers to which concept?

• Incidence Coefficient
• Information Component
• Individual Causality score
• International Cumulative risk

Correct Answer: Information Component

Q18. Which structured framework is commonly used for benefit‑risk assessment of medicinal products?

• GMP Framework
• BRAT (Benefit‑Risk Action Team) framework
• CONSORT checklist
• ICH Q8 pharmaceutical development model

Correct Answer: BRAT (Benefit‑Risk Action Team) framework

Q19. In the MedDRA hierarchy, what is the highest level category grouping adverse event terms?

• Lowest Level Term (LLT)
• Preferred Term (PT)
• System Organ Class (SOC)
• High Level Term (HLT)

Correct Answer: System Organ Class (SOC)

Q20. Which organization operates the global pharmacovigilance database VigiBase and coordinates the WHO international drug monitoring programme?

• European Medicines Agency (EMA)
• Uppsala Monitoring Centre (UMC)
• Food and Drug Administration (FDA)
• International Council for Harmonisation (ICH)

Correct Answer: Uppsala Monitoring Centre (UMC)

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