Prescription event monitoring and post-marketing surveillance MCQs With Answer

Introduction: Prescription event monitoring and post-marketing surveillance MCQs With Answer is designed for M.Pharm students to strengthen practical understanding of real-world drug safety methods. This blog focuses on active and passive surveillance strategies, regulatory obligations, signal detection metrics, causality assessment, and pharmacoepidemiologic study designs used after a medicine is marketed. Questions emphasize interpretation of surveillance outputs, common biases in observational safety studies, and regulatory reporting timelines and documents such as PSUR/PBRER. These targeted multiple-choice questions go beyond definitions to test application, critical thinking, and decision-making skills required for pharmacovigilance roles in industry, hospitals, and regulatory agencies.

Q1. Which statement best describes prescription event monitoring (PEM)?

• An active, non-interventional cohort event monitoring system that collects data on events after new prescriptions
• A randomized controlled trial design for assessing drug safety in the pre-marketing phase
• A global spontaneous reporting database managed by WHO for signal detection
• A method to evaluate pharmacokinetics in healthy volunteers

Correct Answer: An active, non-interventional cohort event monitoring system that collects data on events after new prescriptions

Q2. Which of the following is a primary difference between active and passive post-marketing surveillance?

• Active surveillance relies on unsolicited reports from health professionals, passive surveillance contacts patients directly
• Active surveillance proactively collects data (e.g., registries, PEM); passive relies on spontaneous reports (e.g., Yellow Card)
• Passive surveillance always provides incidence rates, while active surveillance only gives signal strength
• Passive surveillance requires informed consent from all reporters, active surveillance does not

Correct Answer: Active surveillance proactively collects data (e.g., registries, PEM); passive relies on spontaneous reports (e.g., Yellow Card)

Q3. Which signal detection measure uses the ratio of observed-to-expected reports and has a commonly used threshold of ≥2 with a chi-square ≥4 and at least 3 reports?

• Reporting Odds Ratio (ROR)
• Proportional Reporting Ratio (PRR)
• Observed-to-Expected (O/E) rate ratio
• Bayesian Confidence Propagation Neural Network (BCPNN) Information Component (IC)

Correct Answer: Proportional Reporting Ratio (PRR)

Q4. The WHO-UMC causality categories include which of the following sets?

• Definite, Likely, Possible, Unlikely, Unclassifiable
• Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable
• Definite, Probable, Doubtful, Conditional
• Confirmed, Suspected, Unrelated

Correct Answer: Certain, Probable/Likely, Possible, Unlikely, Conditional/Unclassified, Unassessable/Unclassifiable

Q5. Which observational design is most appropriate to estimate a relative risk for an adverse outcome following drug exposure?

• Case-control study
• Cross-sectional survey
• Cohort study
• Ecologic study

Correct Answer: Cohort study

Q6. In a case-control study of a rare ADR, which measure is the preferred estimator of association between exposure and outcome?

• Risk difference
• Odds ratio
• Hazard ratio
• Incidence rate

Correct Answer: Odds ratio

Q7. Which of the following best describes a Self-Controlled Case Series (SCCS) design?

• An active surveillance registry comparing exposed and unexposed cohorts
• A within-person design comparing incidence during risk windows after exposure to other times, controlling for fixed confounders
• A randomized trial where each subject receives both drug and placebo
• A cross-sectional comparison of prevalence across groups

Correct Answer: A within-person design comparing incidence during risk windows after exposure to other times, controlling for fixed confounders

Q8. Which of the following is a common reason for under-reporting in spontaneous reporting systems?

• High sensitivity of spontaneous systems
• Reports are automatically generated from electronic health records
• Lack of time, uncertainty about causality, and fear of legal consequences
• Mandatory real-time reporting by all clinicians

Correct Answer: Lack of time, uncertainty about causality, and fear of legal consequences

Q9. Which regulatory pharmacovigilance document replaced the classical PSUR concept and focuses on benefit–risk evaluation?

• Clinical Study Report (CSR)
• Periodic Benefit-Risk Evaluation Report (PBRER)
• New Drug Application (NDA)
• Periodic Safety Update Report (PSUR) without modification

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

Q10. For expedited reporting of a serious and unexpected adverse drug reaction by a marketing authorization holder within the EU, the typical initial reporting timeline is:

• Within 7 calendar days for all serious ADRs
• Within 15 calendar days for serious and unexpected ADRs
• Within 30 days for all ADRs
• No time limit for unexpected ADRs

Correct Answer: Within 15 calendar days for serious and unexpected ADRs

Q11. Which method is an example of active post-marketing surveillance that collects outcome data prospectively on a defined cohort?

• Spontaneous reporting to a national database
• Prescription event monitoring (PEM) and disease registries
• Retrospective case series based on published case reports
• Signal detection using disproportionality in spontaneous reports only

Correct Answer: Prescription event monitoring (PEM) and disease registries

Q12. Which bias is most closely associated with confounding by indication in pharmacoepidemiologic studies?

• Information bias due to misclassification of outcome
• Selection bias from differential loss to follow-up
• Confounding where patients prescribed a drug differ systematically in baseline risk because of the indication
• Publication bias in the medical literature

Correct Answer: Confounding where patients prescribed a drug differ systematically in baseline risk because of the indication

Q13. The Naranjo algorithm is primarily used for which activity in pharmacovigilance?

• Quantitative signal detection using disproportionality metrics
• Causality assessment of individual adverse drug reactions using a structured questionnaire
• Estimating incidence rates from claims databases
• Designing randomized controlled safety trials

Correct Answer: Causality assessment of individual adverse drug reactions using a structured questionnaire

Q14. Which signal refinement step involves verification of case reports and clinical review to exclude duplicates and obvious data errors?

• Signal detection
• Signal prioritization
• Signal validation/verification
• Regulatory action

Correct Answer: Signal validation/verification

Q15. Which indicator from spontaneous report databases is a Bayesian disproportionality metric commonly used by WHO Uppsala Monitoring Centre?

• Reporting Odds Ratio (ROR)
• Empirical Bayes Geometric Mean (EBGM)
• Information Component (IC)
• Proportional Reporting Ratio (PRR)

Correct Answer: Information Component (IC)

Q16. Which of the following is NOT typically considered a risk minimization measure?

• Educational materials for prescribers (Dear Healthcare Professional letters)
• Restriction of product distribution to specialized centers
• Label change and contraindication update
• Increasing spontaneous report under-reporting to reduce signal noise

Correct Answer: Increasing spontaneous report under-reporting to reduce signal noise

Q17. Which data source is most suitable for calculating denominator-based incidence rates of adverse events in a defined population?

• Spontaneous reporting system
• Electronic health records and administrative claims databases
• Case reports in literature
• Signal detection outputs only

Correct Answer: Electronic health records and administrative claims databases

Q18. In pharmacoepidemiology, which statistical model is appropriate to analyse time-to-event data adjusting for covariates?

• Logistic regression
• Cox proportional hazards model
• Chi-square test only
• Kaplan-Meier without covariate adjustment

Correct Answer: Cox proportional hazards model

Q19. Which statement about Periodic Safety Update Reports (PSUR) and PBRERs is correct?

• PSURs focus solely on numerical global sales; PBRERs ignore benefit information
• PBRERs integrate periodic safety information with benefit–risk analysis and have largely superseded classical PSURs under ICH guidance
• PSUR and PBRER are identical in format and content with no regulatory differences
• PBRERs are only required during pre-clinical development

Correct Answer: PBRERs integrate periodic safety information with benefit–risk analysis and have largely superseded classical PSURs under ICH guidance

Q20. Which approach helps control for measured confounding in observational post-marketing safety studies?

• Randomization in spontaneous reporting
• Propensity score methods (matching, stratification, weighting)
• Ignoring baseline differences and relying on large sample size
• Using case reports as the primary analytic dataset

Correct Answer: Propensity score methods (matching, stratification, weighting)

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