Spontaneous reporting systems and pharmacovigilance linkage MCQs With Answer

Spontaneous reporting systems and pharmacovigilance linkage MCQs With Answer

This quiz set is designed for M.Pharm students to deepen understanding of spontaneous reporting systems and their integration with broader pharmacovigilance activities. It covers core principles such as individual case safety reports (ICSRs), signal detection methods (disproportionality metrics and Bayesian approaches), causality assessment tools, regulatory timelines, and limitations like underreporting and reporting biases. Emphasis is placed on practical linkage between spontaneous reports and other data sources (electronic health records, literature) to validate signals and improve follow-up. These carefully crafted multiple-choice questions test both conceptual knowledge and applied pharmacovigilance skills needed for post-marketing safety surveillance and regulatory practice.

Q1. Which of the following best defines a spontaneous reporting system in pharmacovigilance?

• Mandatory active surveillance of all patients receiving a medication
• Voluntary reporting of suspected adverse drug reactions by healthcare professionals and patients
• Pre-authorization clinical trial adverse events collection
• Routine electronic extraction of safety data from hospital billing records

Correct Answer: Voluntary reporting of suspected adverse drug reactions by healthcare professionals and patients

Q2. What is the primary objective of spontaneous adverse event reporting systems?

• To provide accurate incidence and prevalence estimates for adverse events
• Early detection of rare, serious, or previously unrecognized adverse drug reactions (signal detection)
• Replacement for randomized controlled trials for safety evaluation
• To ensure complete patient-level exposure data for all marketed drugs

Correct Answer: Early detection of rare, serious, or previously unrecognized adverse drug reactions (signal detection)

Q3. Which factor is most commonly cited as a major contributor to underreporting in spontaneous reporting systems?

• Overabundance of trained pharmacovigilance staff
• Lack of awareness or perceived complexity of reporting among healthcare professionals
• The requirement for electronic submission only
• Mandatory financial incentives for reporting

Correct Answer: Lack of awareness or perceived complexity of reporting among healthcare professionals

Q4. According to pharmacovigilance definitions, which criterion classifies an adverse event as “serious”?

• Any event that causes mild discomfort lasting less than 24 hours
• Any event leading to death, life-threatening situation, hospitalization, disability, or congenital anomaly
• Events only observed in clinical trials but not post-marketing
• All adverse events reported by patients regardless of outcome

Correct Answer: Any event leading to death, life-threatening situation, hospitalization, disability, or congenital anomaly

Q5. What does the acronym ICSR stand for in pharmacovigilance?

• International Clinical Study Record
• Individual Case Safety Report
• Immediate Causality Safety Review
• Integrated Clinical Safety Registry

Correct Answer: Individual Case Safety Report

Q6. Which disproportionality metric is based on a Bayesian shrinkage method widely used by the WHO-UMC signal detection system?

• Proportional Reporting Ratio (PRR)
• Reporting Odds Ratio (ROR)
• Information Component (IC) from the BCPNN approach
• Chi-square statistic

Correct Answer: Information Component (IC) from the BCPNN approach

Q7. What is the primary purpose of the ICH E2B(R3) standard in pharmacovigilance?

• Guidance for clinical trial design
• Standardized electronic transmission format for ICSRs
• Regulatory timelines for marketing applications
• Methodology for benefit-risk assessment

Correct Answer: Standardized electronic transmission format for ICSRs

Q8. Which of the following is NOT one of the WHO-UMC causality assessment categories?

• Certain
• Probable/Likely
• Definite
• Unassessable/Unclassifiable

Correct Answer: Definite

Q9. What is “stimulated reporting” in the context of spontaneous adverse event reports?

• A reduction in reporting due to regulatory changes
• An increase in reporting following media attention, label changes, or regulatory alerts
• Standardized electronic prompting that eliminates all reporting bias
• Mandatory industry-funded reporting campaigns that always reflect true incidence

Correct Answer: An increase in reporting following media attention, label changes, or regulatory alerts

Q10. Which of the following sources is LEAST appropriate for primary signal detection in routine pharmacovigilance?

• Spontaneous reporting databases
• Randomized controlled trials with small sample sizes and limited follow-up
• Published case reports in the scientific literature
• Electronic health records linked to spontaneous reports

Correct Answer: Randomized controlled trials with small sample sizes and limited follow-up

Q11. In routine disproportionality screening using PRR, which threshold is commonly used as a criterion suggesting a potential signal?

• PRR < 0.5
• PRR between 0.8 and 1.2
• PRR ≥ 2 (with supporting chi-square and minimum case count)
• PRR exactly equal to 1

Correct Answer: PRR ≥ 2 (with supporting chi-square and minimum case count)

Q12. Why is linking spontaneous reports with electronic health records (EHR) valuable in pharmacovigilance?

• It eliminates the need for causality assessment
• It allows validation of reports, provides longitudinal clinical context, and helps ascertain denominators and confounders
• It replaces all spontaneous reporting systems entirely
• It is only used to increase report counts for regulatory submissions

Correct Answer: It allows validation of reports, provides longitudinal clinical context, and helps ascertain denominators and confounders

Q13. Which organization maintains the global pharmacovigilance database VigiBase?

• European Medicines Agency (EMA)
• Uppsala Monitoring Centre (UMC), affiliated with the World Health Organization (WHO)
• Food and Drug Administration (FDA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)

Correct Answer: Uppsala Monitoring Centre (UMC), affiliated with the World Health Organization (WHO)

Q14. For post-marketing serious unexpected adverse reactions, what is a commonly applied expedited reporting timeline to regulatory authorities?

• 48 hours for all events
• 15 calendar days for serious unexpected adverse reactions (with shorter timelines for fatal/life‑threatening cases in some contexts)
• One year in the periodic safety update report only
• No expedited reporting is required post-marketing

Correct Answer: 15 calendar days for serious unexpected adverse reactions (with shorter timelines for fatal/life‑threatening cases in some contexts)

Q15. The Naranjo algorithm is primarily used to:

• Quantify the cost-effectiveness of safety interventions
• Provide a structured probabilistic causality assessment for suspected adverse drug reactions
• Determine the reporting timeline for serious events
• Calculate disproportionality metrics like PRR

Correct Answer: Provide a structured probabilistic causality assessment for suspected adverse drug reactions

Q16. What does a “positive dechallenge” indicate in a spontaneous case report?

• The adverse event began after stopping the suspect drug
• The adverse event improved or resolved after the suspect drug was withdrawn
• The adverse event recurred upon re-exposure to the suspect drug
• The adverse event is unrelated to drug exposure

Correct Answer: The adverse event improved or resolved after the suspect drug was withdrawn

Q17. Which of the following is a key limitation of spontaneous reporting systems?

• They provide comprehensive randomized data for causality
• They allow precise estimation of incidence rates due to known denominators
• They suffer from underreporting and inability to reliably estimate event incidence
• They are free of all reporting biases

Correct Answer: They suffer from underreporting and inability to reliably estimate event incidence

Q18. What is the main purpose of a Periodic Safety Update Report (PSUR) / Periodic Benefit-Risk Evaluation Report (PBRER)?

• To request a new marketing authorization application
• To provide a cumulative update of safety data and a periodic benefit–risk evaluation for a medicinal product
• To replace spontaneous reporting obligations
• To publish clinical trial protocols

Correct Answer: To provide a cumulative update of safety data and a periodic benefit–risk evaluation for a medicinal product

Q19. What term describes the bias where media attention or regulatory warnings cause a transient surge in adverse event reports for a drug?

• Channeling bias
• Notoriety (or publicity) bias
• Confounding by indication
• Survivor bias

Correct Answer: Notoriety (or publicity) bias

Q20. Which empirical Bayesian method is commonly used by regulatory agencies (e.g., FDA) for disproportionality screening of spontaneous report databases like FAERS?

• Reporting Odds Ratio (ROR)
• Empirical Bayes Geometric Mean (EBGM) from MGPS
• Simple incidence proportion
• Odds ratio from randomized trial meta-analysis

Correct Answer: Empirical Bayes Geometric Mean (EBGM) from MGPS

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