The history and development of pharmacovigilance trace how drug safety evolved from the thalidomide tragedy to sophisticated global systems. This introduction covers key milestones, regulatory initiatives, WHO programmes, Uppsala Monitoring Centre, signal detection, causality assessment (Naranjo, WHO‑UMC), MedDRA coding, spontaneous reporting, post‑marketing surveillance (Phase IV), risk management plans, pharmacovigilance legislation and national programmes like PvPI. B. Pharm students will learn essential terms—adverse drug reaction (ADR), signal, disproportionality analysis, PSUR/PBRER, EudraVigilance—and the roles of industry, regulators and healthcare professionals. Practical understanding helps in reporting, analysis and patient safety. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary definition of pharmacovigilance?
- The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug‑related problem
- A branch of pharmacy focused solely on drug marketing and sales
- The study of drug chemistry and formulation stability
- Clinical trial design for new drug approval
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 historical event is most often credited with triggering modern pharmacovigilance?
- The discovery of penicillin
- The thalidomide birth defects tragedy
- The development of vaccines
- The first randomized controlled trial
Correct Answer: The thalidomide birth defects tragedy
Q3. In which year did the World Health Organization formally start the International Drug Monitoring Programme?
- 1952
- 1968
- 1979
- 1995
Correct Answer: 1968
Q4. Where is the Uppsala Monitoring Centre (UMC), which manages the global WHO safety database, located?
- Geneva, Switzerland
- Uppsala, Sweden
- London, United Kingdom
- New York, USA
Correct Answer: Uppsala, Sweden
Q5. What is the main objective of post‑marketing pharmacovigilance?
- To increase drug sales after approval
- To detect, assess and minimize previously unrecognized adverse drug reactions in real‑world use
- To test drug stability under storage conditions
- To design new chemical entities for development
Correct Answer: To detect, assess and minimize previously unrecognized adverse drug reactions in real‑world use
Q6. Which term best defines an adverse drug reaction (ADR)?
- An injury occurring during surgery unrelated to medication
- A harmful and unintended response to a medicine that occurs at normal doses used in humans for prophylaxis, diagnosis or therapy
- A predictable therapeutic effect of a drug
- An outcome of medication error only
Correct Answer: A harmful and unintended response to a medicine that occurs at normal doses used in humans for prophylaxis, diagnosis or therapy
Q7. Which clinical trial phase is mainly concerned with post‑marketing surveillance?
- Phase I
- Phase II
- Phase III
- Phase IV
Correct Answer: Phase IV
Q8. What is the spontaneous reporting system also commonly called in pharmacovigilance?
- Active surveillance
- Passive surveillance
- Clinical trial monitoring
- Preclinical safety testing
Correct Answer: Passive surveillance
Q9. Which causality assessment tool uses a structured questionnaire and score to determine the likelihood that a drug caused an ADR?
- WHO‑UMC qualitative method
- Naranjo algorithm (score‑based causality assessment)
- MedDRA coding system
- Periodic Safety Update Report
Correct Answer: Naranjo algorithm (score‑based causality assessment)
Q10. Which of the following are WHO‑UMC causality categories?
- Definite, Likely, Possible, Unrelated
- Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable
- Positive, Negative, Neutral
- High, Medium, Low
Correct Answer: Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable
Q11. What is MedDRA used for in pharmacovigilance?
- Calculating adverse reaction probabilities
- Standardized medical terminology for coding adverse events and medical information
- Designing clinical trial protocols
- Manufacturing quality control
Correct Answer: Standardized medical terminology for coding adverse events and medical information
Q12. Which statistical method is commonly used for signal detection in large spontaneous report databases?
- Randomized controlled trials
- Disproportionality analysis (e.g., PRR, ROR)
- In vitro toxicology assays
- Pharmacokinetic modeling only
Correct Answer: Disproportionality analysis (e.g., PRR, ROR)
Q13. What does PSUR stand for?
- Post‑marketing Safety Update Review
- Periodic Safety Update Report
- Pharmacovigilance Safety Unified Record
- Patient Safety and Usage Report
Correct Answer: Periodic Safety Update Report
Q14. What does PvPI stand for in the Indian pharmacovigilance landscape?
- Pharmacovigilance Program of India
- Pharmaceutical Validation of Product Information
- Public‑vigilance and Patient Initiative
- Pharmacology Verification of International drugs
Correct Answer: Pharmacovigilance Program of India
Q15. What does ICH stand for?
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
- Institute of Clinical Heterogeneity
- International Committee on Health
- Institute for Chemical Hazards
Correct Answer: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
Q16. In the EU, what does a black triangle symbol next to a medicine indicate?
- The drug is banned
- The drug is under additional monitoring because it is new or under special review
- The drug is only for hospital use
- The drug has no side effects
Correct Answer: The drug is under additional monitoring because it is new or under special review
Q17. Which database is the European system for managing and analyzing information on suspected adverse reactions?
- VigiBase
- EudraVigilance
- FDA Adverse Event Reporting System (FAERS)
- MedDRA
Correct Answer: EudraVigilance
Q18. What does PBRER stand for?
- Periodic Benefit‑Risk Evaluation Report
- Post‑Approval Biological Regulatory Event Record
- Pharmacovigilance Benefit Report
- Periodic Batch Release Evaluation Report
Correct Answer: Periodic Benefit‑Risk Evaluation Report
Q19. What is VigiBase?
- The WHO global database of individual case safety reports managed by UMC
- A European adverse event registry for clinical trials only
- An online pharmacology textbook
- A local hospital ADR logbook
Correct Answer: The WHO global database of individual case safety reports managed by UMC
Q20. What does CIOMS represent?
- Council for International Organizations of Medical Sciences
- Central Institute of Medical Safety
- Clinical Investigation of Medication Safety
- Committee for International Monitoring of Side‑effects
Correct Answer: Council for International Organizations of Medical Sciences
Q21. The specialized monitoring of vaccine safety within pharmacovigilance is commonly called what?
- Pharmacoepidemiology only
- Vaccine pharmacovigilance
- Drug manufacturing surveillance
- Therapeutic monitoring
Correct Answer: Vaccine pharmacovigilance
Q22. Which disproportionality measure compares the proportion of a specific adverse event for a drug to all other drugs?
- Relative Risk from randomized trials
- Proportional Reporting Ratio (PRR)
- Number Needed to Treat
- Bioavailability index
Correct Answer: Proportional Reporting Ratio (PRR)
Q23. Which active surveillance method involves following a cohort of patients prospectively to monitor adverse events?
- Spontaneous reporting
- Cohort event monitoring
- Case report series only
- In vitro toxicology screening
Correct Answer: Cohort event monitoring
Q24. According to WHO, how is an adverse event (AE) defined?
- An expected pharmacological effect of a drug
- Any untoward medical occurrence in a patient administered a medicinal product, not necessarily causally related
- A manufacturing deviation in drug production
- A beneficial therapeutic outcome
Correct Answer: Any untoward medical occurrence in a patient administered a medicinal product, not necessarily causally related
Q25. Who are typical reporters of adverse drug reactions to national pharmacovigilance centres?
- Only pharmaceutical company employees
- Healthcare professionals, patients, and pharmaceutical companies
- Only clinical trial sponsors
- Only drug regulators
Correct Answer: Healthcare professionals, patients, and pharmaceutical companies
Q26. What does “dechallenge” mean in causality assessment?
- Administration of an antidote to reverse effects
- Withdrawal of the suspected drug to see if the adverse event abates
- Deliberate overdose to test toxicity
- Repeating the adverse event intentionally
Correct Answer: Withdrawal of the suspected drug to see if the adverse event abates
Q27. What is the primary purpose of a Risk Management Plan (RMP)?
- To outline marketing strategies for a new drug
- To identify, characterize, prevent or minimize risks related to a medicinal product and assess the effectiveness of risk‑minimization measures
- To replace clinical trials for safety evaluation
- To determine drug pricing
Correct Answer: To identify, characterize, prevent or minimize risks related to a medicinal product and assess the effectiveness of risk‑minimization measures
Q28. What does PSMF stand for in pharmacovigilance?
- Product Safety and Monitoring Form
- Pharmacovigilance System Master File
- Post‑Sales Monitoring File
- Patient Safety Management Framework
Correct Answer: Pharmacovigilance System Master File
Q29. Which source provides the largest volume of individual case safety reports for signal detection?
- Preclinical animal studies
- Spontaneous adverse event reports from healthcare professionals and patients
- Manufacturing batch records
- Drug sales data only
Correct Answer: Spontaneous adverse event reports from healthcare professionals and patients
Q30. Which causality assessment method is score‑based and commonly used in clinical practice?
- WHO‑UMC qualitative categories only
- Naranjo scale (score‑based causality assessment)
- MedDRA coding
- PRR disproportionality test
Correct Answer: Naranjo scale (score‑based causality assessment)
I am a Registered Pharmacist under the Pharmacy Act, 1948, and the founder of PharmacyFreak.com. I hold a Bachelor of Pharmacy degree from Rungta College of Pharmaceutical Science and Research. With a strong academic foundation and practical knowledge, I am committed to providing accurate, easy-to-understand content to support pharmacy students and professionals. My aim is to make complex pharmaceutical concepts accessible and useful for real-world application.
Mail- Sachin@pharmacyfreak.com