Adverse drug reaction reporting and management systems MCQs With Answer

Adverse drug reaction reporting and management systems MCQs With Answer

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Adverse drug reaction reporting and management systems are core elements of pharmacovigilance that help detect, assess, and prevent harmful drug effects. This short overview for B. Pharm students covers essential keywords such as adverse drug reaction, pharmacovigilance, ADR reporting, causality assessment (Naranjo, WHO‑UMC), signal detection, MedDRA coding, ICSRs and regulatory reporting systems (Yellow Card, MedWatch, CIOMS). You will learn about spontaneous reporting, seriousness and preventability, risk minimization, data handling, and the pharmacist’s role in patient safety. Clear understanding of these systems prepares you for clinical practice and regulatory roles. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the WHO definition of an adverse drug reaction (ADR)?

  • An unintended and harmful response to a drug at normal doses used in humans
  • A predictable side effect related to drug pharmacology
  • An overdose effect due to medication error
  • A beneficial therapeutic effect of a drug

Correct Answer: An unintended and harmful response to a drug at normal doses used in humans

Q2. Which type of ADR is dose-dependent and related to the known pharmacological action of the drug?

  • Type A (augmented)
  • Type B (bizarre)
  • Type C (chronic)
  • Type D (delayed)

Correct Answer: Type A (augmented)

Q3. Which reporting system is primarily associated with the UK for collecting suspected ADRs from healthcare professionals and patients?

  • MedWatch
  • Yellow Card Scheme
  • CIOMS Form
  • VigiBase

Correct Answer: Yellow Card Scheme

Q4. What does an Individual Case Safety Report (ICSR) typically contain?

  • Patient details, suspected drug, adverse event description, outcome and reporter information
  • Only aggregate safety statistics for marketed drugs
  • Clinical trial protocol and study design
  • Marketing materials and promotional claims

Correct Answer: Patient details, suspected drug, adverse event description, outcome and reporter information

Q5. Which causality assessment system uses categories like Certain, Probable, Possible and Unlikely?

  • Naranjo algorithm
  • WHO‑UMC causality categories
  • Schumock and Thornton scale
  • MedDRA terminology

Correct Answer: WHO‑UMC causality categories

Q6. The Naranjo algorithm is used to:

  • Code adverse events using a standardized dictionary
  • Quantitatively score the likelihood that a drug caused an adverse reaction
  • Assess seriousness based on hospitalization
  • Determine regulatory timelines for reporting

Correct Answer: Quantitatively score the likelihood that a drug caused an adverse reaction

Q7. Which dictionary is widely used for standardized coding of adverse event terms in pharmacovigilance?

  • ICD‑10
  • MedDRA
  • SNOMED CT
  • LOINC

Correct Answer: MedDRA

Q8. Which of the following is NOT a criterion for classifying an event as a serious adverse event (SAE)?

  • Results in death
  • Causes hospitalization or prolongation of hospitalization
  • Causes minor transient headache
  • Causes persistent or significant disability

Correct Answer: Causes minor transient headache

Q9. Spontaneous ADR reporting systems are most useful for:

  • Identifying rare or unexpected adverse reactions and generating safety signals
  • Providing precise incidence rates for ADRs
  • Replacing clinical trials for efficacy data
  • Ensuring 100% capture of all ADRs in a population

Correct Answer: Identifying rare or unexpected adverse reactions and generating safety signals

Q10. Under‑reporting in spontaneous reporting systems is commonly due to:

  • Excessive public awareness campaigns
  • Fear of legal consequences, lack of time and uncertainty about causality
  • Perfect adverse event capture in hospitals
  • Automated electronic reporting by all devices

Correct Answer: Fear of legal consequences, lack of time and uncertainty about causality

Q11. Which form is commonly used internationally to report individual ADR cases between marketing authorization holders and regulators?

  • CIOMS Form
  • FDA 1572
  • Case Report Form for clinical trials only
  • Prescription pad

Correct Answer: CIOMS Form

Q12. What is “signal detection” in pharmacovigilance?

  • Identification of a new or changing causal association between a drug and an adverse event
  • Marketing of a new drug to target populations
  • Routine clinical monitoring of blood levels only
  • Scheduling promotional events for drugs

Correct Answer: Identification of a new or changing causal association between a drug and an adverse event

Q13. Which disproportionality measure is used to detect signals from spontaneous reporting databases?

  • Relative Risk Ratio (RRR)
  • Reporting Odds Ratio (ROR)
  • Absolute Risk Reduction (ARR)
  • Number Needed to Treat (NNT)

Correct Answer: Reporting Odds Ratio (ROR)

Q14. ICSR electronic transmission standard developed by ICH for safety data exchange is known as:

  • ICH E2B
  • ICH Q10
  • ICH M4
  • ICH S9

Correct Answer: ICH E2B

Q15. Which assessment tool is specifically designed to evaluate preventability of an ADR?

  • Schumock and Thornton criteria
  • Naranjo algorithm
  • WHO‑UMC categories
  • MedDRA hierarchy

Correct Answer: Schumock and Thornton criteria

Q16. Pharmacovigilance Risk Management Plan (RMP) typically includes:

  • Only marketing strategies
  • Risk identification, characterization, mitigation and post‑marketing activities
  • Clinical efficacy endpoints exclusively
  • Manufacturing batch release records only

Correct Answer: Risk identification, characterization, mitigation and post‑marketing activities

Q17. Which stakeholder is primarily responsible for reporting ADRs observed in clinical practice to regulatory authorities?

  • Patients only
  • Marketing authorization holders (MAHs) and healthcare professionals
  • Pharmaceutical sales representatives exclusively
  • Only the national pharmacovigilance center

Correct Answer: Marketing authorization holders (MAHs) and healthcare professionals

Q18. Vaccine safety events are managed under a specialized subset of pharmacovigilance known as:

  • AEFI (Adverse Events Following Immunization) surveillance
  • GCP monitoring
  • Therapeutic drug monitoring
  • Biostatistics only

Correct Answer: AEFI (Adverse Events Following Immunization) surveillance

Q19. Which of the following best describes a “signal” that requires regulatory assessment?

  • An isolated well‑documented case with no plausibility
  • Information suggesting a new causal relationship, or a new aspect of a known association, that warrants further investigation
  • Every expected labeled side effect
  • Only laboratory anomalies without clinical relevance

Correct Answer: Information suggesting a new causal relationship, or a new aspect of a known association, that warrants further investigation

Q20. Which of these is an advantage of electronic ADR reporting systems over paper forms?

  • Slower data transfer to regulators
  • Improved data quality, faster transmission, and easier signal detection
  • Increased paperwork burden
  • Elimination of the need for causality assessment

Correct Answer: Improved data quality, faster transmission, and easier signal detection

Q21. In clinical trials, a SUSAR is:

  • A suspected unexpected serious adverse reaction that must be reported expeditedly
  • An expected side effect listed in the protocol
  • A non‑serious event of no regulatory importance
  • A marketing term for adverse events

Correct Answer: A suspected unexpected serious adverse reaction that must be reported expeditedly

Q22. Which organization houses VigiBase, the global database of individual case safety reports?

  • FDA
  • EMA
  • WHO Uppsala Monitoring Centre (UMC)
  • PhRMA

Correct Answer: WHO Uppsala Monitoring Centre (UMC)

Q23. What role should a pharmacist play in ADR reporting?

  • Identify, document and report suspected ADRs; counsel patients and implement preventive measures
  • Only dispense medicines without recording ADRs
  • Advise patients to stop all medications on slightest discomfort
  • Delegate all ADR responsibilities to sales representatives

Correct Answer: Identify, document and report suspected ADRs; counsel patients and implement preventive measures

Q24. Which of the following best describes “expectedness” in ADR reporting?

  • Whether the adverse event is listed in the product’s reference safety information or label
  • Whether the event occurs in healthy volunteers only
  • Only events that are lethal are considered expected
  • Events that are reported only in the media

Correct Answer: Whether the adverse event is listed in the product’s reference safety information or label

Q25. Which activity is part of signal management after a potential signal is detected?

  • Ignoring the signal until marketing stops
  • Validation, prioritization, assessment and recommendation of regulatory actions
  • Immediate market withdrawal without assessment
  • Publishing promotional material to contradict the signal

Correct Answer: Validation, prioritization, assessment and recommendation of regulatory actions

Q26. Which of the following is a limitation of spontaneous ADR reporting systems?

  • High sensitivity for estimating true incidence rates
  • Under‑reporting and reporting biases that limit quantitative risk estimates
  • Complete capture of every event in a defined population
  • Guaranteed early detection of all adverse effects

Correct Answer: Under‑reporting and reporting biases that limit quantitative risk estimates

Q27. MedDRA is organized into hierarchical levels. Which is the broadest (highest) level?

  • Lowest Level Terms (LLT)
  • System Organ Class (SOC)
  • Preferred Term (PT)
  • High Level Group Terms (HLGT)

Correct Answer: System Organ Class (SOC)

Q28. Which entity is primarily responsible for post‑marketing pharmacovigilance of an approved drug?

  • Marketing authorization holder (MAH)/sponsor
  • Only the manufacturing plant
  • Retail pharmacies exclusively
  • Patients without any regulatory oversight

Correct Answer: Marketing authorization holder (MAH)/sponsor

Q29. Which of the following best describes a “preventability assessment” of an ADR?

  • Determining whether an ADR could have been avoided by appropriate measures such as dose adjustment, monitoring or avoiding drug interactions
  • Estimating the cost of ADR management only
  • Classifying an ADR as expected or unexpected
  • Identifying the molecular mechanism of toxicity exclusively

Correct Answer: Determining whether an ADR could have been avoided by appropriate measures such as dose adjustment, monitoring or avoiding drug interactions

Q30. Which of the following is a common regulatory action taken after a significant safety signal is confirmed?

  • Label change including new warnings, restricted use, risk management measures or market withdrawal
  • Permanently banning all clinical research on the drug worldwide
  • Increasing promotional advertising to counteract the signal
  • Ignoring the signal if the drug is profitable

Correct Answer: Label change including new warnings, restricted use, risk management measures or market withdrawal

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