Pharmacovigilance history and global programmes MCQs With Answer

Introduction:

Pharmacovigilance history and global programmes MCQs With Answer

This set of MCQs is designed to help M.Pharm students consolidate knowledge of pharmacovigilance history, landmark events and the major global programmes and tools used in drug safety. Questions cover the origins of modern PV (for example the thalidomide tragedy), the establishment and roles of WHO and national pharmacovigilance systems, international bodies such as the Uppsala Monitoring Centre, ICH and CIOMS, and key databases and methodologies like VigiBase, EudraVigilance, MedDRA and signal detection methods. Use these questions to test factual recall and to deepen understanding of how global PV infrastructure evolved and how it functions today in post-marketing safety surveillance.

Q1. Which drug’s withdrawal after causing severe birth defects in the early 1960s prompted the modern pharmacovigilance movement?

• Thalidomide
• Aspirin
• Penicillin
• Streptomycin

Correct Answer: Thalidomide

Q2. In which year was the WHO Programme for International Drug Monitoring established to coordinate global adverse reaction reporting?

• 1968
• 1978
• 1961
• 1990

Correct Answer: 1968

Q3. What is the primary role of the Uppsala Monitoring Centre (UMC) in pharmacovigilance?

• Managing the global adverse reaction database (VigiBase) and supporting signal detection
• Granting marketing authorizations in the EU
• Manufacturing essential medicines for low-income countries
• Conducting Phase I clinical trials

Correct Answer: Managing the global adverse reaction database (VigiBase) and supporting signal detection

Q4. VigiBase is best described as which of the following?

• The WHO global database of individual case safety reports (ICSRs) maintained by UMC
• The FDA’s adverse event reporting system
• The EMA’s clinical trial registry
• A CIOMS guideline document

Correct Answer: The WHO global database of individual case safety reports (ICSRs) maintained by UMC

Q5. The “Yellow Card Scheme”, one of the earliest national spontaneous reporting systems, was introduced by which country?

• United Kingdom
• United States
• Sweden
• India

Correct Answer: United Kingdom

Q6. What is the main purpose of the International Council for Harmonisation (ICH) in relation to pharmacovigilance?

• Harmonizing technical requirements and guidelines for drug registration and safety across major regulatory regions
• Running spontaneous reporting systems globally
• Manufacturing pharmacovigilance software
• Funding post-marketing clinical trials

Correct Answer: Harmonizing technical requirements and guidelines for drug registration and safety across major regulatory regions

Q7. CIOMS (Council for International Organizations of Medical Sciences) is best known in pharmacovigilance for providing guidance on which area?

• Standardized approaches to case causality assessment, safety reporting and benefit–risk evaluation
• Drug pricing and reimbursement policies
• Good Manufacturing Practice (GMP) inspections
• Marketing strategies for pharmaceuticals

Correct Answer: Standardized approaches to case causality assessment, safety reporting and benefit–risk evaluation

Q8. What does MedDRA stand for and why is it important in pharmacovigilance?

• Medical Dictionary for Regulatory Activities; it standardizes medical terminology for coding adverse events
• Medical Device Regulatory Audit; it inspects device safety
• Medication Data Registry Archive; it stores prescription data
• Multinational Drug Registration Association; it harmonizes approvals

Correct Answer: Medical Dictionary for Regulatory Activities; it standardizes medical terminology for coding adverse events

Q9. EudraVigilance, operated by the European Medicines Agency (EMA), primarily serves which function?

• Collecting and analysing suspected adverse reaction reports across the EU to support signal detection and regulatory actions
• Issuing marketing authorizations for new drugs in Europe
• Running clinical trials for orphan drugs
• Manufacturing vaccines on behalf of EU member states

Correct Answer: Collecting and analysing suspected adverse reaction reports across the EU to support signal detection and regulatory actions

Q10. Which statement correctly describes the FDA MedWatch program?

• A voluntary adverse event reporting system for health professionals and consumers to report problems with drugs and medical devices
• An EU-based pharmacovigilance database
• A mandatory worldwide clinical trial registry
• A program that manufactures investigational drugs for clinical trials

Correct Answer: A voluntary adverse event reporting system for health professionals and consumers to report problems with drugs and medical devices

Q11. According to WHO, an Adverse Drug Reaction (ADR) is best defined as which statement?

• A response to a medicine which is noxious and unintended and which occurs at normal doses used in humans for prophylaxis, diagnosis or therapy
• An expected pharmacologic effect caused by overdose only
• A medication error that occurs exclusively during administration
• An adverse event occurring only in clinical trials

Correct Answer: A response to a medicine which is noxious and unintended and which occurs at normal doses used in humans for prophylaxis, diagnosis or therapy

Q12. What does the acronym ICSR mean in pharmacovigilance?

• Individual Case Safety Report
• International Clinical Study Record
• Immediate Causality Safety Review
• Integrated Case Study Report

Correct Answer: Individual Case Safety Report

Q13. Which of the following is a commonly used disproportionality measure for signal detection in spontaneous report databases?

• Proportional Reporting Ratio (PRR)
• Number Needed to Treat (NNT)
• Absolute Risk Reduction (ARR)
• Relative Risk (RR) from randomized trials

Correct Answer: Proportional Reporting Ratio (PRR)

Q14. Which method is an example of an active pharmacovigilance approach rather than passive spontaneous reporting?

• Cohort event monitoring (prospective follow-up of patients to collect all events)
• Spontaneous voluntary reporting by clinicians
• Publication-based signal detection only
• Retrospective case-series compilation without active follow-up

Correct Answer: Cohort event monitoring (prospective follow-up of patients to collect all events)

Q15. One of the primary objectives of post-marketing (Phase IV) pharmacovigilance is which of the following?

• Detection of rare and long-term adverse drug reactions not seen in pre-approval trials
• Determining bioavailability in healthy volunteers
• Conducting initial dose-escalation safety in humans
• Manufacturing process validation

Correct Answer: Detection of rare and long-term adverse drug reactions not seen in pre-approval trials

Q16. VigiFlow, developed by UMC, is best described as what type of tool?

• A web-based Individual Case Safety Report (ICSR) management and submission system for national PV centres
• A laboratory assay for drug concentration measurement
• A clinical trial randomization software
• An EMA guideline on signal management

Correct Answer: A web-based Individual Case Safety Report (ICSR) management and submission system for national PV centres

Q17. Which entities are the primary contributors of reports to VigiBase?

• National pharmacovigilance centres (through their national reporting systems)
• Pharmaceutical wholesalers only
• Clinical trial sponsors exclusively
• Hospital pharmacy stock managers

Correct Answer: National pharmacovigilance centres (through their national reporting systems)

Q18. The classical congenital malformation most closely associated with prenatal thalidomide exposure is called what?

• Phocomelia (limb reduction defects)
• Anencephaly
• Spina bifida
• Microcephaly

Correct Answer: Phocomelia (limb reduction defects)

Q19. Which of the following is included within the scope of pharmacovigilance activities?

• Detection and prevention of adverse drug reactions, medication errors and product quality defects
• Only marketing approval decisions without ongoing monitoring
• Manufacture of active pharmaceutical ingredients
• Designing packaging for commercial appeal

Correct Answer: Detection and prevention of adverse drug reactions, medication errors and product quality defects

Q20. Where is the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre for International Drug Monitoring, located?

• Uppsala, Sweden
• Geneva, Switzerland
• London, United Kingdom
• Rockville, United States

Correct Answer: Uppsala, Sweden

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