Basic pharmacovigilance terminologies MCQs With Answer

Introduction: Pharmacovigilance is the science and activities related to the detection, assessment, understanding and prevention of adverse drug reactions (ADR) and other drug-related problems. For B.Pharm students, mastering pharmacovigilance terminologies—such as adverse event, seriousness, severity, signal detection, causality assessment (WHO-UMC, Naranjo), MedDRA coding, spontaneous reporting, cohort event monitoring, PSUR/PBRER and risk management plans—is essential for ensuring drug safety and effective post-marketing surveillance. This introduction covers core PV keywords including drug safety, reporting systems, signal validation, benefit-risk assessment and medication errors to prepare you for applied clinical and regulatory practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is pharmacovigilance?

• The process of manufacturing drugs under GMP
• Science and activities related to detection, assessment, understanding and prevention of adverse effects or any other drug-related problems
• The marketing and sales strategy for pharmaceuticals
• A clinical trial design for new drug candidates

Correct Answer: Science and activities related to detection, assessment, understanding and prevention of adverse effects or any other drug-related problems

Q2. Which definition best describes an adverse drug reaction (ADR)?

• A beneficial effect of a drug at therapeutic doses
• A response to a drug which is noxious and unintended and which occurs at doses normally used in humans
• An expected pharmacological effect of a drug
• An error in drug manufacturing

Correct Answer: A response to a drug which is noxious and unintended and which occurs at doses normally used in humans

Q3. How does an adverse event (AE) differ from an ADR?

• An AE requires proof of causality while ADR does not
• An AE is any untoward medical occurrence temporally associated with a medicinal product, whereas ADR implies a causal relationship
• An AE is always more serious than an ADR
• An AE refers only to medication errors

Correct Answer: An AE is any untoward medical occurrence temporally associated with a medicinal product, whereas ADR implies a causal relationship

Q4. Which criterion defines a ‘serious’ adverse event?

• An event causing mild discomfort only
• An event that results in death, is life-threatening, requires hospitalization, results in persistent disability, birth defect, or is medically significant
• An event that is expected and listed in the product leaflet
• An event that occurs only in overdose situations

Correct Answer: An event that results in death, is life-threatening, requires hospitalization, results in persistent disability, birth defect, or is medically significant

Q5. What does ‘severity’ of an adverse reaction refer to?

• The causal relationship between drug and event
• The intensity of an adverse event (mild, moderate, severe) irrespective of seriousness
• Whether the event is expected or unexpected
• The time to onset after drug administration

Correct Answer: The intensity of an adverse event (mild, moderate, severe) irrespective of seriousness

Q6. An ‘unexpected’ adverse reaction means:

• The event is predicted by the drug’s pharmacology
• The reaction is listed in the product information with exact frequency
• The reaction is not consistent with the applicable product information or reference safety information
• The event is always non-serious

Correct Answer: The reaction is not consistent with the applicable product information or reference safety information

Q7. What is a ‘signal’ in pharmacovigilance?

• A marketing alert from pharmaceutical companies
• Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event
• A routine laboratory test required for drug approval
• A type of adverse event uniquely caused by vaccines

Correct Answer: Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event

Q8. Which causality assessment system is widely used globally and by regulators?

• GCP checklist
• WHO–UMC causality assessment system
• Chemical purity index
• ICH safety scoring

Correct Answer: WHO–UMC causality assessment system

Q9. The Naranjo scale is used to:

• Assess drug stability
• Calculate drug dosing for pediatrics
• Estimate the probability that an adverse event is related to a drug
• Code adverse events using MedDRA

Correct Answer: Estimate the probability that an adverse event is related to a drug

Q10. What best describes a spontaneous reporting system?

• A proactive cohort follow-up for all patients on a drug
• A passive system where healthcare professionals and patients voluntarily report suspected ADRs
• A clinical trial database for efficacy endpoints
• An automated dispensing record for pharmacies

Correct Answer: A passive system where healthcare professionals and patients voluntarily report suspected ADRs

Q11. Pharmacovigilance primarily focuses on:

• Studying drug effects only in large populations
• Detection and assessment of drug-related problems using individual case safety reports and other data sources
• Marketing strategies for drug promotion
• Pharmacokinetic modeling only

Correct Answer: Detection and assessment of drug-related problems using individual case safety reports and other data sources

Q12. Which report replaced the PSUR under current ICH guidance?

• Periodic Safety Update Record (PSUR2)
• Periodic Benefit-Risk Evaluation Report (PBRER)
• Individual Case Safety Report (ICSR)
• Annual Safety Synopsis (ASS)

Correct Answer: Periodic Benefit-Risk Evaluation Report (PBRER)

Q13. Phase IV studies are primarily intended to:

• Assess safety and effectiveness in the post-marketing general population
• Replace preclinical toxicology studies
• Determine drug synthesis routes
• Evaluate packaging design

Correct Answer: Assess safety and effectiveness in the post-marketing general population

Q14. MedDRA is:

• A laboratory technique for measuring drug concentration
• Medical Dictionary for Regulatory Activities used for coding adverse events
• A clinical protocol for vaccine trials
• A UK regulatory guideline for marketing

Correct Answer: Medical Dictionary for Regulatory Activities used for coding adverse events

Q15. Most regulatory authorities require expedited reporting of serious unexpected ADRs within how many calendar days?

• 3 days
• 7 days
• 15 days
• 90 days

Correct Answer: 15 days

Q16. ICH E2B guidance deals with:

• Preclinical toxicology study design
• Electronic transmission of Individual Case Safety Reports (ICSRs)
• Good Manufacturing Practices
• Marketing authorization pricing

Correct Answer: Electronic transmission of Individual Case Safety Reports (ICSRs)

Q17. Which step confirms that a detected signal is not due to data quality issues or chance?

• Signal prioritization
• Signal validation
• Risk minimization
• Regulatory submission

Correct Answer: Signal validation

Q18. Which of the following is a common preventable cause of ADRs?

• Genetic idiosyncrasy
• Medication error such as incorrect dosing or dispensing
• Unpredictable immune-mediated reaction
• Spontaneous allergic reaction without prior exposure

Correct Answer: Medication error such as incorrect dosing or dispensing

Q19. A ‘side effect’ is best described as:

• An always harmful unexpected event
• An effect unrelated to pharmacology
• An effect, often predictable, related to the pharmacological action of the drug
• A defect in the drug manufacturing process

Correct Answer: An effect, often predictable, related to the pharmacological action of the drug

Q20. A ‘black box’ warning on a drug label indicates:

• The drug is ineffective
• The strongest safety warning highlighting serious or life-threatening risks
• Only manufacturing changes are required
• No safety concerns have been identified

Correct Answer: The strongest safety warning highlighting serious or life-threatening risks

Q21. Benefit-risk assessment in pharmacovigilance aims to:

• Maximize marketing reach irrespective of safety
• Ensure the therapeutic benefits of a drug outweigh its risks and to guide risk minimization
• Determine manufacturing yield
• Classify drugs by cost

Correct Answer: Ensure the therapeutic benefits of a drug outweigh its risks and to guide risk minimization

Q22. Cohort event monitoring is:

• A passive spontaneous reporting method
• An active surveillance method following a defined group of patients to detect all events after exposure
• A manufacturing quality control process
• A short-term animal study

Correct Answer: An active surveillance method following a defined group of patients to detect all events after exposure

Q23. In causality assessment, ‘dechallenge’ and ‘rechallenge’ refer to:

• Laboratory tests for drug levels only
• Withdrawal of the drug to see if the event subsides and re-administration to see if it recurs
• Steps in clinical trial randomization
• Statistical methods for signal detection

Correct Answer: Withdrawal of the drug to see if the event subsides and re-administration to see if it recurs

Q24. A Risk Management Plan (RMP) is:

• A plan for drug pricing and reimbursement
• A document describing proposed pharmacovigilance activities and risk minimization measures for a medicinal product
• A clinical operations manual
• A marketing authorization application fee schedule

Correct Answer: A document describing proposed pharmacovigilance activities and risk minimization measures for a medicinal product

Q25. Which is the WHO definition of a medication error?

• An unavoidable adverse event due to drug allergy
• Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer
• A laboratory measurement error
• A drug-drug interaction predicted by pharmacokinetics

Correct Answer: Any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer

Q26. Aggregate safety reports such as PSUR/PBRER are used to:

• Provide cumulative safety and benefit-risk information over a defined reporting period
• Replace all individual case reports permanently
• Only report manufacturing defects
• Document marketing strategies

Correct Answer: Provide cumulative safety and benefit-risk information over a defined reporting period

Q27. Is therapeutic failure considered reportable in pharmacovigilance?

• No, therapeutic failure is never related to safety
• Yes, therapeutic failure can be an adverse event and should be reported when suspected to be drug-related
• Only if it results from an overdose
• Only in clinical trials

Correct Answer: Yes, therapeutic failure can be an adverse event and should be reported when suspected to be drug-related

Q28. Should adverse reactions occurring during off‑label use be reported?

• No, off‑label uses are exempt from reporting
• Yes, adverse reactions from off‑label use should be reported to pharmacovigilance systems
• Only if the product is a vaccine
• Only after regulatory approval changes

Correct Answer: Yes, adverse reactions from off‑label use should be reported to pharmacovigilance systems

Q29. What is a ‘near miss’ in medication safety?

• An error that reached the patient and caused harm
• An error that was intercepted before reaching the patient or reached but caused no harm
• A scheduled dose given on time
• An adverse event with confirmed causality

Correct Answer: An error that was intercepted before reaching the patient or reached but caused no harm

Q30. What does PvPI stand for in India?

• Pharmaceutical Validation Program of India
• Pharmacovigilance Programme of India
• Product Verification and Pricing Initiative
• Public Vaccine Policy Initiative

Correct Answer: Pharmacovigilance Programme of India

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