Passive surveillance – spontaneous reporting and case series MCQs With Answer

Introduction: Passive surveillance, including spontaneous reporting and case series, is a cornerstone of pharmacovigilance used to detect adverse drug reactions (ADRs) after medicines are marketed. B. Pharm students should understand spontaneous reporting systems, Individual Case Safety Reports (ICSRs), common data elements, and the strengths and limitations of passive surveillance such as underreporting and reporting bias. Case series aggregate related case reports to suggest possible safety signals and generate hypotheses for further study. Key concepts include signal detection, causality assessment, seriousness, expectedness, national databases (e.g., VigiBase, EudraVigilance), and the pharmacist’s role in reporting. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary purpose of spontaneous reporting in pharmacovigilance?

• To monitor clinical trial endpoints
• To actively follow-up all patients on a drug
• To detect unexpected adverse drug reactions after marketing
• To replace randomized controlled trials

Correct Answer: To detect unexpected adverse drug reactions after marketing

Q2. Which of the following best describes passive surveillance?

• Systematic solicitation of adverse events by researchers
• Unsolicited reports submitted voluntarily by health professionals and patients
• Routine laboratory monitoring of drug levels
• Mandatory scheduled follow-up visits for safety monitoring

Correct Answer: Unsolicited reports submitted voluntarily by health professionals and patients

Q3. An Individual Case Safety Report (ICSR) typically includes which essential element?

• Randomized allocation sequence
• Patient demographics and event description
• Economic cost of the drug
• Double-blinding code

Correct Answer: Patient demographics and event description

Q4. Which global database is commonly used to aggregate spontaneous reports internationally?

• ClinicalTrials.gov
• VigiBase
• PubMed
• FAERS only for Europe

Correct Answer: VigiBase

Q5. A case series differs from a case report because a case series:

• Is always randomized
• Presents multiple similar cases to suggest a pattern
• Proves causality conclusively
• Is collected only in clinical trials

Correct Answer: Presents multiple similar cases to suggest a pattern

Q6. Which is a major limitation of passive surveillance systems?

• They always provide incidence rates
• Underreporting and variable data quality
• They require prospective cohort design
• They eliminate reporting bias

Correct Answer: Underreporting and variable data quality

Q7. Which causality assessment method is commonly used in spontaneous reports?

• Meta-analysis
• WHO-UMC criteria
• Cross-over design
• Kaplan-Meier analysis

Correct Answer: WHO-UMC criteria

Q8. What does seriousness of an adverse event refer to in pharmacovigilance?

• The frequency of the event in the population
• Outcomes like death, hospitalization, disability, or life-threatening situation
• The cost to the healthcare system
• The number of symptoms reported

Correct Answer: Outcomes like death, hospitalization, disability, or life-threatening situation

Q9. Which form is used in the United States for voluntary reporting by health professionals and consumers?

• CIOMS form only
• MedWatch form
• ICH E2B only
• Yellow Card not used in US

Correct Answer: MedWatch form

Q10. Underreporting in spontaneous reporting can be reduced by:

• Making reporting more complex
• Providing education and simplifying reporting systems
• Banning patient reports
• Removing feedback to reporters

Correct Answer: Providing education and simplifying reporting systems

Q11. Which of the following is an example of stimulated reporting?

• Routine passive surveillance without promotion
• A regulatory safety alert that prompts many reports
• Random sampling of electronic health records
• Long-term prospective cohort study

Correct Answer: A regulatory safety alert that prompts many reports

Q12. In a spontaneous report, ‘expectedness’ refers to:

• Whether the event is specified in the product’s labeling or known adverse reaction profile
• How often the drug is prescribed
• The cost of treating the event
• The age of the patient

Correct Answer: Whether the event is specified in the product’s labeling or known adverse reaction profile

Q13. Which metric is commonly used in disproportionality analysis for signal detection?

• Relative Risk in randomized trials
• Proportional Reporting Ratio (PRR)
• Hazard Ratio for cohort studies
• Number Needed to Treat (NNT)

Correct Answer: Proportional Reporting Ratio (PRR)

Q14. Which stakeholder has primary responsibility for reporting adverse drug reactions in many countries?

• Only the patient
• Pharmaceutical companies, healthcare professionals, and patients
• Only regulatory agencies
• Only academic researchers

Correct Answer: Pharmaceutical companies, healthcare professionals, and patients

Q15. A ‘duplicate report’ in a spontaneous reporting database can lead to:

• Improved causality assessment
• Inflated counts and misleading signals if not identified
• Automatic deletion of all records
• Better calculation of incidence rates

Correct Answer: Inflated counts and misleading signals if not identified

Q16. Which element is least likely to be reliably available in spontaneous reports?

• Exact time-to-onset dates
• Clinical description of the event
• Suspected drug name
• Reporter type (physician, patient)

Correct Answer: Exact time-to-onset dates

Q17. How do case series contribute to pharmacovigilance?

• They provide definitive proof of risk magnitude
• They help identify patterns and possible new signals requiring further study
• They eliminate confounding by design
• They are used to calculate drug efficacy

Correct Answer: They help identify patterns and possible new signals requiring further study

Q18. Which is a common reason healthcare professionals do not report ADRs?

• Belief that a single report will not make a difference
• Reporting is mandatory everywhere
• All adverse events are already known
• They always receive high financial incentives

Correct Answer: Belief that a single report will not make a difference

Q19. In causality assessment, ‘dechallenge’ refers to:

• Restarting the drug after stopping it
• Withdrawal of the drug and observing whether the event improves
• Measuring drug plasma concentration
• Administering an antidote

Correct Answer: Withdrawal of the drug and observing whether the event improves

Q20. Which dataset format is standard for electronic transmission of ICSRs internationally?

• ICH E2B(R3)
• CSV only
• PDF images exclusively
• ICH E3 narrative only

Correct Answer: ICH E2B(R3)

Q21. Which of the following best describes a ‘signal’ in pharmacovigilance?

• Conclusive evidence of causality
• Information suggesting a new potentially causal association between a drug and an event
• An unrelated marketing trend
• Only laboratory test abnormalities

Correct Answer: Information suggesting a new potentially causal association between a drug and an event

Q22. Which reporting system is used primarily in the UK for spontaneous adverse reaction reporting?

• MedDRA
• Yellow Card Scheme
• VigiBase exclusively
• FAERS in the UK

Correct Answer: Yellow Card Scheme

Q23. Which coding dictionary is most commonly used to standardize adverse event terms in spontaneous reports?

• SNOMED only
• MedDRA
• ICD-10 exclusively for causality
• Chemical Abstracts Service

Correct Answer: MedDRA

Q24. Which factor increases the value of a case series for signal assessment?

• Heterogeneous case descriptions with missing data
• Consistent clinical features and temporal association across cases
• Only one mild, isolated case
• Data limited to animal studies

Correct Answer: Consistent clinical features and temporal association across cases

Q25. When a serious unexpected ADR is detected, the regulator may require which action from the marketing authorization holder?

• No action is possible
• Submission of expedited reports and risk-minimization measures
• Stopping all manufacturing immediately without review
• Only publication in a journal

Correct Answer: Submission of expedited reports and risk-minimization measures

Q26. Which statistical approach compares the proportion of reports for a drug-event pair to the proportion for all other drugs?

• Proportional Reporting Ratio (PRR)
• Randomized controlled testing
• Survival analysis
• Bayesian evidence synthesis only in trials

Correct Answer: Proportional Reporting Ratio (PRR)

Q27. For vaccines, passive surveillance systems often focus on which specific type of reports?

• Only manufacturing defects
• Adverse Events Following Immunization (AEFI)
• Only immunogenicity data from trials
• Only dosage errors in trials

Correct Answer: Adverse Events Following Immunization (AEFI)

Q28. Which is true about passive surveillance and incidence estimation?

• Passive surveillance reliably provides true incidence rates
• It often underestimates incidence due to underreporting
• It always overestimates incidence
• Incidence can be calculated without denominator data

Correct Answer: It often underestimates incidence due to underreporting

Q29. Which action by a pharmacist improves the quality of spontaneous reports?

• Omits patient age to protect privacy
• Provides complete clinical details, timeline, and concomitant medications
• Only reports suspected drug name without event details
• Delays reporting indefinitely

Correct Answer: Provides complete clinical details, timeline, and concomitant medications

Q30. Which statement about case series is correct?

• They can establish statistical causation on their own
• They are useful for hypothesis generation and early signal recognition
• They always include a control group
• They are identical to randomized trials

Correct Answer: They are useful for hypothesis generation and early signal recognition

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