Detection and reporting methods for ADRs MCQs With Answer

Pharmacovigilance focuses on detection and reporting methods for ADRs to ensure patient safety and effective therapy. B.Pharm students should learn spontaneous reporting, active surveillance, cohort event monitoring, signal detection, causality assessment (WHO-UMC, Naranjo), MedDRA coding, CIOMS/ICSR formats, and regulatory timelines. Practical skills include recognizing serious vs. unexpected reactions, completing high-quality ADR reports, using electronic databases (VigiBase, EudraVigilance), and understanding measures like PRR and ROR for signal detection. Emphasis on documentation quality, confidentiality, and interdisciplinary communication improves signal validity and regulatory action. This foundation prepares future pharmacists for clinical, regulatory, and public health roles. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the WHO definition of an adverse drug reaction (ADR)?

• A harmful and unintended response to a medicine at doses normally used in humans
• An adverse event occurring only at overdose or misuse of a drug
• A reaction that is always predictable from the pharmacology of the drug
• An allergy confirmed by skin testing

Correct Answer: A harmful and unintended response to a medicine at doses normally used in humans

Q2. Which term best describes spontaneous reporting systems for ADRs?

• Active surveillance requiring systematic follow-up
• Passive reporting of suspected ADRs by healthcare professionals and patients
• Randomized monitoring of adverse events in clinical trials
• Mandatory laboratory-based toxicity screening

Correct Answer: Passive reporting of suspected ADRs by healthcare professionals and patients

Q3. Which of the following events classifies an ADR as ‘serious’?

• Minor transient headache that resolves without treatment
• Hospitalization, persistent disability, life‑threatening condition, congenital anomaly, or death
• Any adverse reaction reported by a patient
• Mild rash that does not require medical attention

Correct Answer: Hospitalization, persistent disability, life‑threatening condition, congenital anomaly, or death

Q4. What does an ‘unexpected’ ADR mean in pharmacovigilance?

• An adverse reaction that is extremely rare but listed in the label
• An event not consistent with applicable product information such as the label or investigator brochure
• A reaction that is expected in all patients receiving the drug
• An adverse effect occurring only during overdose

Correct Answer: An event not consistent with applicable product information such as the label or investigator brochure

Q5. Which causality assessment methods are commonly used in pharmacovigilance?

• WHO‑UMC scale and Naranjo algorithm
• APACHE II and SOFA scores
• Kaplan–Meier analysis and Cox regression
• Framingham risk score

Correct Answer: WHO‑UMC scale and Naranjo algorithm

Q6. The Naranjo algorithm categorizes causality into which groups?

• Definitely, Probable, Possible, Doubtful
• Confirmed, Rejected, Pending, Unknown
• Certain, Unrelated, Suspected, Proven
• Major, Moderate, Minor, No reaction

Correct Answer: Definitely, Probable, Possible, Doubtful

Q7. What is MedDRA used for in ADR reporting?

• Standardized medical terminology for coding adverse events and indications
• A scoring system for drug toxicity severity
• A database for pharmaceutical pricing
• A guideline for conducting randomized controlled trials

Correct Answer: Standardized medical terminology for coding adverse events and indications

Q8. What does ICSR stand for?

• International Clinical Safety Regulation
• Individual Case Safety Report
• Integrated Causality and Safety Review
• Immediate Clinical Safety Response

Correct Answer: Individual Case Safety Report

Q9. Which are essential elements of a high-quality ICSR?

• Patient identifier or demographics, suspected drug, adverse event description, reporter details
• Only the suspected drug name without event details
• Laboratory values only, with no clinical history
• Marketing authorization holder’s internal comments only

Correct Answer: Patient identifier or demographics, suspected drug, adverse event description, reporter details

Q10. Which of the following are recognized pharmacovigilance databases?

• VigiBase, EudraVigilance, VAERS
• PubMed, Scopus, Web of Science
• ClinicalTrials.gov, Cochrane Library, Embase
• WHO Essential Medicines List, ATC Index, DSM‑5

Correct Answer: VigiBase, EudraVigilance, VAERS

Q11. Which technique is commonly used for quantitative signal detection in spontaneous reporting systems?

• Disproportionality analysis such as PRR or ROR
• Randomized controlled trials
• Descriptive epidemiology without ratios
• Systematic review meta-analysis only

Correct Answer: Disproportionality analysis such as PRR or ROR

Q12. What does PRR stand for in signal detection?

• Proportional Reporting Ratio
• Patient Reaction Rate
• Predictive Risk Regression
• Pharmacovigilance Reporting Requirement

Correct Answer: Proportional Reporting Ratio

Q13. Which factor most contributes to under‑reporting of ADRs?

• High public awareness and training programs
• Lack of awareness, uncertainty about causality, and time constraints for reporters
• Mandatory electronic reporting systems with prompts
• Strong feedback mechanisms to reporters

Correct Answer: Lack of awareness, uncertainty about causality, and time constraints for reporters

Q14. What does a ‘black triangle’ symbol indicate on a medicinal product?

• The medicine is banned for use
• The product is subject to intensive monitoring and new safety information is being collected
• The drug has no adverse reactions reported
• The product is only for veterinary use

Correct Answer: The product is subject to intensive monitoring and new safety information is being collected

Q15. Within how many calendar days should serious and unexpected ADRs be reported in many regulatory systems post‑marketing?

• 15 calendar days
• 90 calendar days
• 1 calendar day
• 180 calendar days

Correct Answer: 15 calendar days

Q16. What is the CIOMS form used for?

• A standardized narrative form for reporting individual serious case reports
• A financial disclosure document for clinical trials
• A prescribing guideline for primary care
• An international drug pricing template

Correct Answer: A standardized narrative form for reporting individual serious case reports

Q17. Which is a primary role of a national pharmacovigilance center?

• Collecting, analyzing, and reporting ADRs to improve medicine safety
• Approving new medicinal products for market authorization
• Conducting all randomized clinical trials in a country
• Manufacturing essential medicines

Correct Answer: Collecting, analyzing, and reporting ADRs to improve medicine safety

Q18. Which method represents active surveillance for detecting ADRs?

• Cohort event monitoring with systematic follow-up of patients on a medicine
• Waiting for spontaneous reports from clinicians only
• Relying solely on case reports published in journals
• Using only preclinical animal safety data

Correct Answer: Cohort event monitoring with systematic follow-up of patients on a medicine

Q19. How should duplicate ADR reports be managed in a database?

• Identify duplicates, reconcile information, and merge to avoid double counting
• Delete all but the first report without review
• Automatically accept all duplicates as separate signals
• Ignore duplicates since they do not affect analysis

Correct Answer: Identify duplicates, reconcile information, and merge to avoid double counting

Q20. What is the modern equivalent name for the Periodic Safety Update Report (PSUR)?

• Periodic Benefit‑Risk Evaluation Report (PBRER)
• Annual Safety Overview (ASO)
• Clinical Trial Safety Summary (CTSS)
• Spontaneous Report Summary (SRS)

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

Q21. What acronym describes a Suspected Unexpected Serious Adverse Reaction in clinical trials?

• SUSAR
• SAE
• ADR
• AEFI

Correct Answer: SUSAR

Q22. Which characteristic improves the utility of an ADR report for causality assessment?

• Detailed chronological narrative, drug dosing and timing, de‑challenge/re‑challenge information
• Only the drug name without timing or description
• Generic statement that ‘patient felt unwell’ with no dates
• Reporter’s opinion without supporting clinical data

Correct Answer: Detailed chronological narrative, drug dosing and timing, de‑challenge/re‑challenge information

Q23. Which organization maintains the global individual case safety report database VigiBase?

• WHO Uppsala Monitoring Centre (UMC)
• US Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• World Bank

Correct Answer: WHO Uppsala Monitoring Centre (UMC)

Q24. Why is MedDRA preferred over free‑text descriptions in ADR databases?

• It standardizes terminology, enabling consistent coding, retrieval, and statistical analysis
• It automatically resolves causality without human review
• It eliminates the need for reporter details
• It translates reports into multiple languages automatically

Correct Answer: It standardizes terminology, enabling consistent coding, retrieval, and statistical analysis

Q25. Which sequence best represents signal management steps after initial detection?

• Detection → Validation → Prioritization → Assessment → Recommendation and dissemination
• Assessment → Detection → Dissemination → Validation → Prioritization
• Dissemination → Detection → Assessment → Validation → Prioritization
• Prioritization → Detection → Validation → Dissemination → Assessment

Correct Answer: Detection → Validation → Prioritization → Assessment → Recommendation and dissemination

Q26. Can patients or caregivers submit ADR reports directly in many pharmacovigilance systems?

• Yes, patient or caregiver reporting is accepted and valuable
• No, only physicians are allowed to report ADRs
• Only pharmaceutical companies can submit reports
• ADR reports must be submitted only through clinical trial investigators

Correct Answer: Yes, patient or caregiver reporting is accepted and valuable

Q27. What minimum information is required for an initial ADR report to be useful?

• Patient identifier (or demographics), description of adverse event, suspect drug name, and reporter details
• Only the manufacturer name without event details
• Complete genetic profile of the patient
• Longitudinal imaging studies only

Correct Answer: Patient identifier (or demographics), description of adverse event, suspect drug name, and reporter details

Q28. What does ROR stand for in disproportionality analysis?

• Reporting Odds Ratio
• Risk Observed Rate
• Relative Outcome Ratio
• Reported Outcome Risk

Correct Answer: Reporting Odds Ratio

Q29. Which statement is NOT a limitation of spontaneous ADR reporting?

• Spontaneous reporting does not usually provide reliable incidence rates
• Under‑reporting and reporting biases affect data quality
• Easily establishing causality and precise incidence from spontaneous reports
• Variation in report quality and missing information are common

Correct Answer: Easily establishing causality and precise incidence from spontaneous reports

Q30. Which practice is recommended when a pharmacist suspects an ADR, even if causality is uncertain?

• Report the suspected ADR to the local pharmacovigilance system or national center
• Only report if causality is proven by rechallenge
• Never report if the reaction is mild
• Wait for a peer‑reviewed publication before reporting

Correct Answer: Report the suspected ADR to the local pharmacovigilance system or national center

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