Post-marketing surveillance and prescription event monitoring MCQs With Answer

Post-marketing surveillance and prescription event monitoring MCQs With Answer

This collection of multiple-choice questions is designed for M.Pharm students studying clinical research and pharmacovigilance. It focuses on post-marketing surveillance (PMS) and prescription event monitoring (PEM), exploring methods, data sources, signal detection, causality assessment, regulatory frameworks and practical challenges. Questions range from definitions and study designs to analytical techniques (disproportionality analysis, cohort monitoring), international systems (WHO-UMC, VigiBase, MedDRA), and ethical/regulatory considerations (RMPs, REMS). Each question includes four options and the correct answer to help students consolidate knowledge for exams and real-world pharmacovigilance practice.

Q1. What is the primary definition of post-marketing surveillance (PMS)?

• Monitoring of a drug’s safety and effectiveness after it has been marketed.
• Preclinical testing of drug toxicology in animals.
• Phase I clinical trials assessing pharmacokinetics in healthy volunteers.
• Manufacturing quality control for active pharmaceutical ingredients.

Correct Answer: Monitoring of a drug’s safety and effectiveness after it has been marketed.

Q2. What is the main purpose of prescription event monitoring (PEM)?

• Collecting safety data by monitoring adverse events in patients prescribed a medicine in routine practice.
• Randomized allocation of patients to measure efficacy in controlled trials.
• Evaluating drug stability under accelerated conditions.
• Auditing prescription practices for pharmacy reimbursement.

Correct Answer: Collecting safety data by monitoring adverse events in patients prescribed a medicine in routine practice.

Q3. Post-marketing surveillance activities are mainly conducted during which clinical phase?

• Phase IV clinical studies (post-marketing).
• Phase I clinical trials.
• Preclinical safety testing.
• Phase II dose-finding studies.

Correct Answer: Phase IV clinical studies (post-marketing).

Q4. Which statement correctly distinguishes active surveillance from passive surveillance?

• Active surveillance involves proactive, systematic collection of safety data (e.g., PEM, cohort event monitoring).
• Active surveillance relies solely on voluntary spontaneous reports from healthcare professionals.
• Passive surveillance always uses electronic health records exclusively.
• Passive surveillance requires mandatory prospective follow-up of a defined cohort.

Correct Answer: Active surveillance involves proactive, systematic collection of safety data (e.g., PEM, cohort event monitoring).

Q5. What is the most widely recognized limitation of spontaneous adverse event reporting systems?

• Underreporting of adverse events and reporting bias.
• Excessive cost of randomized allocation.
• Requirement for long-term prospective consent in all cases.
• Inability to code events using standardized dictionaries.

Correct Answer: Underreporting of adverse events and reporting bias.

Q6. Which methods are commonly used for statistical signal detection in large spontaneous reporting databases?

• Disproportionality analysis methods such as PRR and ROR applied to large spontaneous reporting databases.
• Double-blind randomized placebo-controlled trials for each suspected event.
• Accelerated stability testing and impurity profiling.
• Pharmacokinetic modeling using compartmental equations exclusively.

Correct Answer: Disproportionality analysis methods such as PRR and ROR applied to large spontaneous reporting databases.

Q7. Which global causality assessment system is commonly recommended in pharmacovigilance?

• WHO-UMC causality assessment system.
• GCP phase I causality checklist.
• ICH Q9 risk-based causality index.
• ICH E6 pharmacokinetic causality matrix.

Correct Answer: WHO-UMC causality assessment system.

Q8. What is the primary role of MedDRA in post-marketing surveillance?

• Medical Dictionary for Regulatory Activities (MedDRA) is used to code and standardize adverse event terms.
• MedDRA defines manufacturing batch release specifications.
• MedDRA provides clinical trial randomization schedules.
• MedDRA is a pharmacokinetic modeling software package.

Correct Answer: Medical Dictionary for Regulatory Activities (MedDRA) is used to code and standardize adverse event terms.

Q9. Prescription event monitoring (PEM) was first developed in which country as a formal post-marketing method?

• United Kingdom
• United States
• Japan
• Australia

Correct Answer: United Kingdom

Q10. Which description best matches cohort event monitoring (CEM)?

• A prospective, observational method monitoring a defined cohort of drug users for all medical events over a defined period.
• A randomized controlled trial comparing two active treatments with blinding.
• A retrospective drug-drug interaction study based on in vitro metabolism.
• A spontaneous reporting campaign encouraging voluntary submissions from the public.

Correct Answer: A prospective, observational method monitoring a defined cohort of drug users for all medical events over a defined period.

Q11. What is the purpose of a Risk Evaluation and Mitigation Strategy (REMS) required by the FDA?

• Program required by FDA for certain drugs to ensure benefits outweigh risks through specific risk mitigation measures.
• A randomized monitoring program for marketing authorization holders only in Europe.
• A clinical pharmacology protocol for preclinical dose escalation.
• A manufacturing quality audit schedule for contract manufacturers.

Correct Answer: Program required by FDA for certain drugs to ensure benefits outweigh risks through specific risk mitigation measures.

Q12. Which of the following is an example of passive surveillance in pharmacovigilance?

• Spontaneous reporting systems where healthcare professionals submit reports voluntarily.
• Active follow-up of a defined cohort to ascertain all events.
• Prospective prescription event monitoring with targeted questionnaires.
• Cohort studies with systematic data collection from electronic health records.

Correct Answer: Spontaneous reporting systems where healthcare professionals submit reports voluntarily.

Q13. After initial statistical signal detection in a safety database, what is the next recommended step?

• Signal validation to determine if the finding is robust and not due to artefact or data quality issues.
• Immediate market withdrawal without further assessment.
• Automatically changing the approved label without regulatory consultation.
• Initiating Phase I healthy volunteer studies.

Correct Answer: Signal validation to determine if the finding is robust and not due to artefact or data quality issues.

Q14. What does proportional reporting ratio (PRR) compare in signal detection?

• The proportion of a specific adverse event among reports for the suspect drug compared to the same proportion among all other drugs.
• The absolute number of adverse events in clinical trials versus spontaneous reports.
• The ratio of drug sales to the number of adverse events reported.
• The difference in mean time-to-onset between two drugs in randomized trials.

Correct Answer: The proportion of a specific adverse event among reports for the suspect drug compared to the same proportion among all other drugs.

Q15. What is a recognized limitation specific to prescription event monitoring studies?

• Lack of detailed clinical information and limited capacity for definitive causality assessment in some PEM implementations.
• Inability to capture any adverse events in routine practice.
• Requirement that all patients be randomized into treatment and control groups.
• Exclusive focus on pharmacokinetic endpoints only.

Correct Answer: Lack of detailed clinical information and limited capacity for definitive causality assessment in some PEM implementations.

Q16. Which centre maintains the global adverse reaction database VigiBase?

• Uppsala Monitoring Centre (WHO-UMC).
• European Medicines Agency (EMA) headquarters in London.
• Food and Drug Administration (FDA) Center for Drug Evaluation.
• International Council for Harmonisation (ICH) secretariat.

Correct Answer: Uppsala Monitoring Centre (WHO-UMC).

Q17. What is the primary content of a Risk Management Plan (RMP) required by regulatory authorities?

• A description of the known and potential risks of a medicine and measures to minimize and monitor those risks.
• A manufacturing batch release certificate and expiry dating protocol.
• A randomized trial protocol for Phase II efficacy testing.
• A financial plan for marketing and distribution channels.

Correct Answer: A description of the known and potential risks of a medicine and measures to minimize and monitor those risks.

Q18. Which statistical method is commonly used for adjusted time-to-event analysis in post-marketing cohort studies?

• Cox proportional hazards model for adjusted time-to-event analysis.
• Fisher’s exact test for all time-to-event outcomes.
• Student’s t-test comparing two cumulative incidence curves.
• ANOVA for comparing hazard functions across multiple time points.

Correct Answer: Cox proportional hazards model for adjusted time-to-event analysis.

Q19. Which factor most reduces the sensitivity of signal detection in spontaneous reporting systems?

• Underreporting of adverse events.
• Use of standardised coding such as MedDRA.
• Large volume of high-quality reports.
• Active follow-up of reported cases.

Correct Answer: Underreporting of adverse events.

Q20. Which ethical consideration is essential when conducting post-marketing surveillance using patient-level healthcare data?

• Ensuring data anonymization and confidentiality in accordance with data protection regulations.
• Publishing individual patient identifiers to improve traceability.
• Requiring signed informed consent in all passive spontaneous reports.
• Exempting studies from any institutional review if industry-funded.

Correct Answer: Ensuring data anonymization and confidentiality in accordance with data protection regulations.

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