Post marketing surveillance of drug products MCQs With Answer

Post Marketing Surveillance of Drug Products MCQs With Answer

Introduction: Post-marketing surveillance (PMS) is a critical phase of a drug’s lifecycle that monitors safety, effectiveness, and quality after a product has been authorized for use. For M.Pharm students, mastering PMS concepts—such as pharmacovigilance systems, signal detection, risk management plans, Periodic Safety Update Reports (PSUR/PBRER), and post-authorization safety studies (PASS)—is essential for ensuring public health. This quiz collection presents 20 carefully constructed multiple-choice questions with answers to deepen understanding of regulatory requirements, real-world evidence generation, adverse event reporting, and strategies for minimizing risk. Use these items to assess and sharpen applied knowledge needed for careers in drug safety, regulatory affairs, and product lifecycle management.

Q1. Which of the following best defines post-marketing surveillance (PMS) for drug products?

• Systematic monitoring of drug safety and effectiveness after regulatory approval
• Preclinical toxicology testing in animal models
• Batch release testing performed by the manufacturer before distribution
• Marketing activities to increase product uptake in target populations

Correct Answer: Systematic monitoring of drug safety and effectiveness after regulatory approval

Q2. Which document commonly submitted by a marketing authorization holder summarizes cumulative safety information periodically?

• Risk Management Plan (RMP)
• Periodic Benefit-Risk Evaluation Report (PBRER) / PSUR
• Development Safety Update Report (DSUR)
• Clinical Study Report (CSR)

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

Q3. Which of the following is the primary purpose of a Risk Management Plan (RMP)?

• To define manufacturing specifications and stability storage conditions
• To outline safety concerns, pharmacovigilance activities, and risk minimization measures
• To report marketing expenditures and promotional strategies
• To summarize phase I clinical pharmacokinetic data

Correct Answer: To outline safety concerns, pharmacovigilance activities, and risk minimization measures

Q4. Spontaneous adverse event reporting systems are known for which major limitation?

• High cost and need for prospective enrollment of patients
• Robust denominator data enabling precise incidence calculations
• Under-reporting and variable data quality
• Requirement for randomized allocation of exposures

Correct Answer: Under-reporting and variable data quality

Q5. Which method is primarily used for signal detection in large pharmacovigilance databases?

• Spontaneous regression analysis
• Disproportionality analysis (e.g., reporting odds ratio, proportional reporting ratio)
• Prospective cohort randomization
• In vitro receptor-binding assays

Correct Answer: Disproportionality analysis (e.g., reporting odds ratio, proportional reporting ratio)

Q6. A Post-Authorization Safety Study (PASS) is best described as:

• A preclinical safety study required prior to first-in-human trials
• An observational or interventional study conducted after marketing authorization to further evaluate safety
• A stability study to determine shelf life
• A marketing study to assess patient preferences

Correct Answer: An observational or interventional study conducted after marketing authorization to further evaluate safety

Q7. Which regulatory body launched EudraVigilance for managing and analyzing suspected adverse reactions?

• US Food and Drug Administration (FDA)
• European Medicines Agency (EMA)
• World Health Organization (WHO)
• Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Correct Answer: European Medicines Agency (EMA)

Q8. Which of the following is a key characteristic of Real-World Evidence (RWE) used in post-marketing evaluations?

• Strict randomized allocation of treatment in controlled conditions
• Data derived from routine clinical practice such as electronic health records and registries
• Only preclinical animal model outcomes
• Data collected solely from phase III clinical trials

Correct Answer: Data derived from routine clinical practice such as electronic health records and registries

Q9. Which timeline is typically required for reporting a serious unexpected adverse reaction to regulatory authorities (expedited reporting)?

• Within 7 or 15 calendar days depending on regional regulations
• Within 12 months after the event
• Only at the time of the annual report
• When the product is next manufactured

Correct Answer: Within 7 or 15 calendar days depending on regional regulations

Q10. What is the main advantage of cohort event monitoring in pharmacovigilance?

• Provides randomized evidence for causality
• Enables active, prospective collection of all events in a defined treated population to estimate incidence
• Only collects data on severe adverse events reported spontaneously
• Replaces the need for any database signal detection

Correct Answer: Enables active, prospective collection of all events in a defined treated population to estimate incidence

Q11. Which element is essential in assessing causality for an individual adverse drug reaction during PMS?

• Temporal relationship between drug exposure and event onset
• Marketing share of the drug
• Color and packaging of the product
• Patient’s income level

Correct Answer: Temporal relationship between drug exposure and event onset

Q12. Which of these is a core activity of a national pharmacovigilance centre?

• Issuing manufacturing licenses for active pharmaceutical ingredients
• Collecting and analyzing adverse event reports and communicating safety information
• Determining international pricing of medicines
• Performing all batch quality testing for manufacturers

Correct Answer: Collecting and analyzing adverse event reports and communicating safety information

Q13. In the context of PMS, what is a safety signal?

• A confirmed causal relationship between a drug and an adverse event
• Information suggesting a new potentially causal association between a drug and an event that requires further investigation
• A marketing claim verified by clinical trials
• A manufacturing defect discovered during stability testing

Correct Answer: Information suggesting a new potentially causal association between a drug and an event that requires further investigation

Q14. Which post-marketing action is most appropriate when a new serious safety signal is strongly confirmed and benefit-risk becomes unfavorable?

• Change the tablet color to differentiate batches
• Regulatory actions such as restrictions, boxed warnings, or product withdrawal
• Increase the recommended dose to overcome adverse events
• Delay communication until the next marketing meeting

Correct Answer: Regulatory actions such as restrictions, boxed warnings, or product withdrawal

Q15. Which of the following is an example of risk minimization measure?

• Conducting only preclinical studies
• Providing patient education materials, restricted distribution programs, or additional monitoring requirements
• Setting a higher price to reduce usage
• Removing the product information leaflet

Correct Answer: Providing patient education materials, restricted distribution programs, or additional monitoring requirements

Q16. Which dataset is most useful for estimating population-level incidence rates of specific adverse events?

• Spontaneous reporting data without denominator information
• Large electronic healthcare databases or claims databases with exposure denominators
• Only case series published in the literature
• In vitro assay result compilations

Correct Answer: Large electronic healthcare databases or claims databases with exposure denominators

Q17. What distinguishes a Phase IV clinical trial from other post-marketing activities?

• It is always a randomized, double-blind pre-approval study
• It is a post-authorization interventional study intended to answer specific safety or effectiveness questions
• It replaces spontaneous reporting systems entirely
• It is performed only to evaluate packaging improvements

Correct Answer: It is a post-authorization interventional study intended to answer specific safety or effectiveness questions

Q18. Which report is typically required by regulators when a serious unexpected adverse reaction (SUSAR) occurs in a post-authorization clinical study?

• Annual financial report
• Expedited SUSAR report to the competent authority and ethics committee
• Batch manufacturing record
• Routine marketing report sent annually

Correct Answer: Expedited SUSAR report to the competent authority and ethics committee

Q19. In pharmacovigilance, what is the main role of data linkage between different healthcare databases?

• To obscure patient identities permanently
• To combine clinical, prescription, and outcome data for more robust safety analyses
• To reduce the size of datasets for storage savings
• To prioritize marketing campaigns

Correct Answer: To combine clinical, prescription, and outcome data for more robust safety analyses

Q20. Which of the following best describes an important ethical consideration in PMS studies involving patient-level data?

• Publishing raw patient identifiers to enhance transparency
• Ensuring patient confidentiality, informed consent when required, and appropriate data governance
• Transferring data internationally without any legal agreements
• Using data only from healthy volunteers to avoid privacy concerns

Correct Answer: Ensuring patient confidentiality, informed consent when required, and appropriate data governance

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