Stimulated reporting methods MCQs With Answer

Stimulated reporting methods MCQs With Answer provide B. Pharm students a focused way to learn pharmacovigilance beyond spontaneous reporting. This introduction explains key concepts such as stimulated reporting, targeted spontaneous reporting, cohort event monitoring, active surveillance, and adverse drug reaction (ADR) signal detection. Emphasis is on practical steps: minimum data set, causality assessment (e.g., Naranjo), reporting timelines, underreporting challenges, electronic reporting systems, and regulatory responsibilities. Understanding differences between stimulated and spontaneous systems, methods to improve reporting quality, and interpreting disproportionality measures (PRR, ROR, IC) is essential for safe medicine use and patient care. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What best defines stimulated reporting in pharmacovigilance?

• Voluntary reporting by healthcare professionals without prompts
• Active encouragement and targeted collection of ADR reports in specific settings
• Automated data mining of electronic health records
• Mandatory national reporting of all adverse events

Correct Answer: Active encouragement and targeted collection of ADR reports in specific settings

Q2. Which of the following is a common objective of stimulated reporting methods?

• To replace causality assessment methods
• To increase the quantity and quality of ADR reports in defined populations
• To eliminate the need for regulatory oversight
• To anonymize all pharmacovigilance data permanently

Correct Answer: To increase the quantity and quality of ADR reports in defined populations

Q3. Targeted spontaneous reporting (TSR) is best described as:

• Random sampling of hospital patients for ADRs
• Focused spontaneous reporting from specific units, medicines, or patient groups with targeted prompts
• Genome-based adverse event prediction
• Passive collection of ADRs from social media only

Correct Answer: Focused spontaneous reporting from specific units, medicines, or patient groups with targeted prompts

Q4. Which stimulated method involves following a cohort of patients exposed to a medicine to record all events?

• Spontaneous reporting
• Targeted spontaneous reporting
• Cohort event monitoring (CEM)
• Signal detection using PRR

Correct Answer: Cohort event monitoring (CEM)

Q5. Which advantage is most associated with cohort event monitoring?

• Lowest cost among all methods
• Ability to estimate incidence rates of ADRs in a defined cohort
• Requires no follow-up or data management
• Automatically detects signals without analysis

Correct Answer: Ability to estimate incidence rates of ADRs in a defined cohort

Q6. Which measure is commonly used in signal detection and mentioned in stimulated reporting contexts?

• Naranjo score
• Proportional Reporting Ratio (PRR)
• Body Mass Index (BMI)
• Glomerular Filtration Rate (GFR)

Correct Answer: Proportional Reporting Ratio (PRR)

Q7. Intensive monitoring typically refers to:

• Passive collection of spontaneous reports nationwide
• Enhanced follow-up, frequent contact, and detailed data capture for a selected group
• Exclusive electronic mining of insurance claims
• Only pre-marketing clinical trial safety monitoring

Correct Answer: Enhanced follow-up, frequent contact, and detailed data capture for a selected group

Q8. Which of the following is a limitation commonly associated with stimulated reporting?

• Complete elimination of underreporting
• Potential selection bias towards the targeted population
• Inability to collect detailed clinical information
• Universal applicability to all medicines without resources

Correct Answer: Potential selection bias towards the targeted population

Q9. In stimulated reporting, what is the role of awareness campaigns?

• To censor adverse event reports
• To encourage healthcare professionals and patients to report suspected ADRs and improve report quality
• To reduce the number of ADRs occurring
• To automate causality assessment

Correct Answer: To encourage healthcare professionals and patients to report suspected ADRs and improve report quality

Q10. Which element is part of the minimum data set for an ADR report?

• Detailed genomic sequence of the patient
• Patient identifier, suspected drug, reaction description, date of onset
• Predicted sales data of the drug
• Pharmacy inventory levels

Correct Answer: Patient identifier, suspected drug, reaction description, date of onset

Q11. What does the Naranjo algorithm assess?

• Severity grading of ADRs only
• Causality between a suspected drug and an adverse event
• Economic impact of ADRs on healthcare
• Drug stability under storage

Correct Answer: Causality between a suspected drug and an adverse event

Q12. Which stimulated reporting approach is best when a new drug enters a market and close safety monitoring is needed?

• Spontaneous reporting with no follow-up
• Cohort event monitoring or intensive monitoring
• Capture-recapture without active data collection
• Only social media surveillance

Correct Answer: Cohort event monitoring or intensive monitoring

Q13. Targeted spontaneous reporting is particularly useful for monitoring ADRs in:

• Entire national populations simultaneously
• Specific high-risk groups like pediatrics, TB, or HIV patients
• Only veterinary medicines
• Non-medical product complaints

Correct Answer: Specific high-risk groups like pediatrics, TB, or HIV patients

Q14. Which data-mining metric compares the proportion of reports for a specific reaction with that for all other drugs?

• Relative Risk for randomized trials
• Proportional Reporting Ratio (PRR)
• Number Needed to Treat (NNT)
• Kaplan-Meier estimator

Correct Answer: Proportional Reporting Ratio (PRR)

Q15. Capture-recapture methods in pharmacovigilance are used to:

• Estimate the true number of ADRs by combining multiple data sources
• Directly assign causality scores
• Perform laboratory confirmation of ADRs
• Standardize reporting forms internationally

Correct Answer: Estimate the true number of ADRs by combining multiple data sources

Q16. Which practice helps improve completeness and quality of stimulated ADR reports?

• Removing patient identifiers entirely
• Training reporters, using structured forms, and follow-up for missing data
• Limiting reports to one sentence only
• Waiting for periodic summaries before collecting data

Correct Answer: Training reporters, using structured forms, and follow-up for missing data

Q17. Electronic reporting systems (e-reporting) in stimulated methods provide which benefit?

• Slower data transmission compared to paper forms
• Real-time data capture, easier follow-up, and integration with signal detection tools
• Automatic causality confirmation without review
• Guaranteed elimination of duplicate reports

Correct Answer: Real-time data capture, easier follow-up, and integration with signal detection tools

Q18. Which regulatory obligation may drive stimulated reporting for certain medicines?

• Requirement for no post-marketing safety studies
• Conditional approval requiring post-marketing safety surveillance or risk management plans
• Obligation to stop all reporting after approval
• Mandatory advertisement of ADRs

Correct Answer: Conditional approval requiring post-marketing safety surveillance or risk management plans

Q19. Which population-level benefit arises from effective stimulated reporting programs?

• Immediate cure of ADRs across the population
• Earlier detection of safety signals and improved public health response
• Replacement of clinical trials altogether
• Higher drug prices due to surveillance costs

Correct Answer: Earlier detection of safety signals and improved public health response

Q20. In evaluating a stimulated reporting study, which bias is particularly important to consider?

• Observer-expectancy bias and selection bias due to targeted populations
• Bias from genetic sequencing errors
• Bias from international currency fluctuations
• Bias from weather conditions only

Correct Answer: Observer-expectancy bias and selection bias due to targeted populations

Q21. Which action is appropriate when a stimulated program identifies a potential safety signal?

• Immediately withdraw the drug without further evaluation
• Conduct signal validation, further pharmacoepidemiologic studies, and regulatory assessment
• Ignore the signal unless reported in newspapers
• Publish unverified patient identifiers for transparency

Correct Answer: Conduct signal validation, further pharmacoepidemiologic studies, and regulatory assessment

Q22. Which is a practical step to implement targeted spontaneous reporting in a hospital ward?

• Ban all ADR reporting to reduce workload
• Designate focal persons, provide simple reporting forms, and brief staff regularly
• Only accept reports from pharmacists and exclude nurses
• Collect reports only once every five years

Correct Answer: Designate focal persons, provide simple reporting forms, and brief staff regularly

Q23. Which indicator suggests improved reporting after a stimulated reporting intervention?

• Increased number and improved completeness of ADR reports from the targeted area
• Decreased number of reported ADRs to zero
• No change in report numbers but worse data quality
• Increased time delay in submitting reports

Correct Answer: Increased number and improved completeness of ADR reports from the targeted area

Q24. Which of the following is NOT a stimulated reporting method?

• Cohort event monitoring
• Targeted spontaneous reporting
• Randomized controlled trial safety monitoring
• Intensive monitoring in sentinel sites

Correct Answer: Randomized controlled trial safety monitoring

Q25. What is the importance of follow-up in stimulated reporting schemes?

• Follow-up is unnecessary if initial report is filed
• Allows collection of outcome data, dechallenge/rechallenge information, and lab results to improve causality assessment
• Only used to verify the reporter’s identity
• Primarily to advertise new drugs

Correct Answer: Allows collection of outcome data, dechallenge/rechallenge information, and lab results to improve causality assessment

Q26. Which stakeholder is essential for successful stimulated reporting implementation?

• Only the drug manufacturer without healthcare engagement
• Multidisciplinary collaboration between clinicians, pharmacists, regulators, and patients
• Only media companies for publicity
• Only IT vendors with no clinical input

Correct Answer: Multidisciplinary collaboration between clinicians, pharmacists, regulators, and patients

Q27. Which statement about underreporting in spontaneous systems is true and addressed by stimulated methods?

• Underreporting is rare and not a concern
• Underreporting is common; stimulated methods aim to reduce it in targeted settings
• Underreporting can be fixed by ignoring reports
• Underreporting only affects vaccine monitoring

Correct Answer: Underreporting is common; stimulated methods aim to reduce it in targeted settings

Q28. Disproportionality analysis using reporting odds ratio (ROR) helps to:

• Prove causality definitively
• Identify drug-reaction pairs reported more frequently than expected for further assessment
• Estimate absolute incidence rates in the general population
• Replace clinical judgment in safety decisions

Correct Answer: Identify drug-reaction pairs reported more frequently than expected for further assessment

Q29. Which ethical consideration is important in stimulated reporting programs?

• Mandatory public disclosure of patient identities
• Maintain patient confidentiality and obtain consent for follow-up when required
• Refuse care to patients who report ADRs
• Monetize patient data without oversight

Correct Answer: Maintain patient confidentiality and obtain consent for follow-up when required

Q30. For a B. Pharm student implementing a stimulated reporting pilot, which initial metric is most useful?

• Total national drug sales in the first year
• Number of ADR reports received from the pilot site and completeness score of reports
• Number of press releases issued about the pilot
• Number of medications removed from formularies

Correct Answer: Number of ADR reports received from the pilot site and completeness score of reports

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