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)
