The WHO international drug monitoring program MCQs With Answer resource is designed for B. Pharm students to build strong pharmacovigilance foundations. This introduction highlights key concepts: pharmacovigilance, adverse drug reaction (ADR) reporting, the Uppsala Monitoring Centre (UMC), VigiBase, ICSR structure, causality assessment (WHO‑UMC, Naranjo), MedDRA and WHODrug coding, disproportionality methods (PRR, IC), signal detection and risk management. Emphasis on spontaneous reporting, data quality, seriousness, preventability, dechallenge/rechallenge and regulatory timelines prepares you for clinical practice and regulatory roles. Study these concepts carefully to improve patient safety. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. What is the primary objective of the WHO international drug monitoring program?
- Early detection of previously unrecognized adverse drug reactions and safety signals
- Regulation of drug prices and reimbursement
- Promotion of generic substitution policies
- Conducting randomized clinical trials for drug approval
Correct Answer: Early detection of previously unrecognized adverse drug reactions and safety signals
Q2. Which organization hosts and manages the global adverse drug reaction database used by the WHO program?
- Uppsala Monitoring Centre (UMC)
- World Health Organization Geneva pharmacovigilance unit
- European Medicines Agency (EMA)
- US Food and Drug Administration (FDA)
Correct Answer: Uppsala Monitoring Centre (UMC)
Q3. What is the name of the global ADR database maintained by the UMC?
- VigiBase
- FAERS
- EudraVigilance
- MedWatch
Correct Answer: VigiBase
Q4. What is the primary source of reports that feed into VigiBase?
- Spontaneous reports submitted by healthcare professionals and patients
- Results from randomized controlled trials only
- Pre‑clinical toxicology studies
- Manufacturing batch release documentation
Correct Answer: Spontaneous reports submitted by healthcare professionals and patients
Q5. Which terminology/dictionary is widely used for adverse event coding in the WHO international drug monitoring program?
- MedDRA
- ICD‑10
- SNOMED CT
- LOINC
Correct Answer: MedDRA
Q6. Which standardized causality assessment method is recommended by WHO for individual case assessment?
- WHO‑UMC causality assessment system
- Naranjo algorithm only
- Hartwig severity scale
- No standardized method is recommended
Correct Answer: WHO‑UMC causality assessment system
Q7. Which of the following best matches the WHO definition of an adverse drug reaction (ADR)?
- A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in humans
- An expected therapeutic effect of a drug at recommended doses
- An allergic reaction occurring only at overdoses
- A medication error that causes no harm
Correct Answer: A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in humans
Q8. Which of the following is NOT a criterion for classifying an adverse event as ‘serious’?
- Death
- Life‑threatening event
- Requires or prolongs hospitalization
- Mild transient rash not requiring hospitalization
Correct Answer: Mild transient rash not requiring hospitalization
Q9. Which statistical disproportionality measure is commonly used in signal detection from spontaneous report databases?
- Proportional Reporting Ratio (PRR)
- Student’s t‑test
- Kaplan–Meier estimator
- Pearson correlation coefficient
Correct Answer: Proportional Reporting Ratio (PRR)
Q10. What does the Information Component (IC) represent in UMC signal detection?
- A Bayesian measure of disproportionality to identify drug‑event associations
- A measure of drug potency
- A scale to grade ADR seriousness
- An economic index for drug utilization
Correct Answer: A Bayesian measure of disproportionality to identify drug‑event associations
Q11. Which of the following is NOT a typical field included in an Individual Case Safety Report (ICSR)?
- Patient age and sex
- Suspect drug name and dose
- Adverse reaction description and outcome
- Local weather conditions at time of event
Correct Answer: Local weather conditions at time of event
Q12. For a fatal or life‑threatening SUSAR (Suspected Unexpected Serious Adverse Reaction) in a clinical trial, what is the usual expedited reporting timeframe to regulators?
- 7 calendar days
- 15 calendar days
- 30 calendar days
- 90 calendar days
Correct Answer: 7 calendar days
Q13. Which body originally developed MedDRA and oversees its international use in drug safety?
- International Council for Harmonisation (ICH)
- World Health Organization (WHO)
- Centers for Disease Control and Prevention (CDC)
- European Medicines Agency (EMA)
Correct Answer: International Council for Harmonisation (ICH)
Q14. Which approach is a primary method for detecting new safety signals in spontaneous reporting systems?
- Disproportionality analysis of spontaneous reports
- Preclinical rodent toxicology only
- Random selection of case reports without analysis
- Patient satisfaction surveys
Correct Answer: Disproportionality analysis of spontaneous reports
Q15. What is VigiRank in the context of the UMC and signal management?
- A scoring algorithm developed by UMC to prioritize potential safety signals
- A clinical trial randomization method
- A pharmacokinetic modeling tool
- An advertising ranking for medicines
Correct Answer: A scoring algorithm developed by UMC to prioritize potential safety signals
Q16. What is the main purpose of a Periodic Safety Update Report (PSUR) or PBRER?
- To present cumulative safety data and benefit‑risk evaluation for regulatory review
- To register a new clinical trial
- To provide manufacturing batch release certificates
- To publish marketing materials
Correct Answer: To present cumulative safety data and benefit‑risk evaluation for regulatory review
Q17. Who is typically allowed to submit adverse event reports to a national pharmacovigilance center?
- Only physicians
- Only pharmacists
- Healthcare professionals and consumers/patients
- Only regulatory inspectors
Correct Answer: Healthcare professionals and consumers/patients
Q18. Which statement correctly describes dechallenge and rechallenge in ADR assessment?
- Dechallenge is withdrawal of the drug leading to improvement; rechallenge is re‑administration that reproduces the reaction
- Dechallenge is giving a new drug; rechallenge is switching to placebo
- Dechallenge is increasing the dose; rechallenge is decreasing the dose
- Dechallenge and rechallenge are synonyms for causality assessment
Correct Answer: Dechallenge is withdrawal of the drug leading to improvement; rechallenge is re‑administration that reproduces the reaction
Q19. Which tool is specifically designed to assess preventability of an adverse drug reaction?
- Schumock and Thornton preventability scale
- Naranjo algorithm
- WHO‑UMC causality categories
- Hartwig severity scale
Correct Answer: Schumock and Thornton preventability scale
Q20. What does a ‘black‑box warning’ signify in drug labeling?
- The most serious safety warning required by regulators to highlight life‑threatening risks
- A marketing slogan for the drug
- An indication of over‑the‑counter status
- A statement of drug efficacy compared to competitors
Correct Answer: The most serious safety warning required by regulators to highlight life‑threatening risks
Q21. What is VigiFlow?
- A web‑based ICSR management and reporting system used by national pharmacovigilance centers
- The global adverse event database itself
- An international randomized trial registry
- A pharmacokinetic simulation software
Correct Answer: A web‑based ICSR management and reporting system used by national pharmacovigilance centers
Q22. In pharmacovigilance terminology, what best describes a ‘signal’?
- Information that arises from one or multiple sources suggesting a new potentially causal association between an intervention and an event
- A confirmed causal relationship between drug and event proven by a randomized trial
- A marketing claim approved by regulators
- A routine laboratory reference value
Correct Answer: Information that arises from one or multiple sources suggesting a new potentially causal association between an intervention and an event
Q23. Which of the following is a principal role of the Uppsala Monitoring Centre (UMC)?
- Collect and analyze global ICSRs, maintain VigiBase and support WHO pharmacovigilance activities
- Approve new drug marketing authorizations worldwide
- Manufacture vaccines for global distribution
- Conduct phase I clinical trials for new drugs
Correct Answer: Collect and analyze global ICSRs, maintain VigiBase and support WHO pharmacovigilance activities
Q24. Which epidemiological term describes the rate of new ADR cases occurring in a population over a specified time?
- Incidence
- Prevalence
- Sensitivity
- Specificity
Correct Answer: Incidence
Q25. Pharmacovigilance uses pharmacoepidemiology to study ADRs. Which study types are central to pharmacoepidemiology?
- Observational studies such as cohort and case‑control studies
- Only in vitro laboratory assays
- Single‑case reports without any analysis
- Marketing surveys
Correct Answer: Observational studies such as cohort and case‑control studies
Q26. The Periodic Benefit‑Risk Evaluation Report (PBRER) is the updated term for which earlier pharmacovigilance document?
- Periodic Safety Update Report (PSUR)
- Individual Case Safety Report (ICSR)
- Clinical Study Report (CSR)
- Risk Management Plan (RMP)
Correct Answer: Periodic Safety Update Report (PSUR)
Q27. What is an expected responsibility of a national pharmacovigilance centre within the WHO Programme?
- Collect national ICSRs, perform initial assessment and forward validated reports to the UMC
- Create marketing campaigns for new drugs
- Manufacture essential medicines locally
- Authorize clinical trial protocols internationally
Correct Answer: Collect national ICSRs, perform initial assessment and forward validated reports to the UMC
Q28. Which dictionary is commonly used to code medicinal product names in global pharmacovigilance databases?
- WHODrug (WHO Drug Dictionary)
- ICD‑10
- MedlinePlus
- ClinicalTrials.gov
Correct Answer: WHODrug (WHO Drug Dictionary)
Q29. How is an ‘unexpected’ adverse drug reaction defined in pharmacovigilance?
- An adverse reaction whose nature or severity is not consistent with the applicable product information or labeling
- A reaction that occurs only with overdoses
- An expected side effect listed in the patient information leaflet
- A laboratory abnormality with no clinical relevance
Correct Answer: An adverse reaction whose nature or severity is not consistent with the applicable product information or labeling
Q30. What is the ethical requirement regarding patient identity when submitting an ICSR to national centers or UMC?
- Patient identity should be de‑identified or anonymized before submission while preserving clinical details
- Full patient identifiers must always be published with the report
- Patient identity is irrelevant and can be omitted even if clinical details are missing
- Patient consent is never required to share identifiable data
Correct Answer: Patient identity should be de‑identified or anonymized before submission while preserving clinical details
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.
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