ADRs: definitions, classification, assessment and management MCQs With Answer

Introduction

This quiz collection on adverse drug reactions (ADRs) is designed for M.Pharm students taking Clinical Research and Pharmacovigilance. It covers essential definitions, classification schemes (Type A–F and others), causality assessment tools (Naranjo, WHO‑UMC), severity and preventability scales, and practical management and reporting strategies. Each question emphasizes applied knowledge — recognizing ADR patterns, deciding appropriate clinical responses (dechallenge/rechallenge, dose adjustments), and understanding pharmacovigilance processes (spontaneous reporting, signal detection, risk minimization). Use these MCQs to test and deepen your understanding of how ADR assessment informs patient safety, regulatory reporting, and risk management in real-world clinical practice.

Q1. Which of the following best defines an adverse drug reaction (ADR) according to the WHO?

• A harmful and unintended response to a medicine occurring at doses normally used for prophylaxis, diagnosis, or therapy
• An expected pharmacological effect produced by an overdose of a medicine
• A therapeutic failure due to drug interactions
• An adverse event that occurs only during clinical trials

Correct Answer: A harmful and unintended response to a medicine occurring at doses normally used for prophylaxis, diagnosis, or therapy

Q2. Which ADR classification describes reactions that are dose-related and predictable from the known pharmacology of the drug?

• Type B (Bizarre)
• Type A (Augmented)
• Type C (Chronic)
• Type D (Delayed)

Correct Answer: Type A (Augmented)

Q3. A rash appearing weeks after starting a drug and persisting requires which ADR category in Rawlins–Thompson classification?

• Type A (Augmented)
• Type B (Bizarre)
• Type C (Chronic)
• Type D (Delayed)

Correct Answer: Type D (Delayed)

Q4. Which causality assessment method uses a structured questionnaire with weighted scores to categorize likelihood of an ADR?

• WHO‑UMC system
• Naranjo algorithm
• Hartwig severity scale
• Schumock and Thornton preventability scale

Correct Answer: Naranjo algorithm

Q5. In WHO‑UMC causality terms, which category describes a reaction with a plausible time relationship to drug intake and which cannot be explained by disease or other drugs, but lacks definitive re-challenge information?

• Certain
• Probable/Likely
• Possible
• Unassessable/Unclassifiable

Correct Answer: Probable/Likely

Q6. Which of the following is the primary goal of dechallenge in ADR management?

• To confirm patient compliance with therapy
• To observe whether the adverse event abates after stopping the suspected drug
• To replace the drug with a more potent alternative
• To immediately administer antidote irrespective of cause

Correct Answer: To observe whether the adverse event abates after stopping the suspected drug

Q7. A clinician restarts a suspected drug to see whether the adverse event recurs; this procedure is called:

• Dechallenge
• Rechallenge
• Desensitization
• Substitution

Correct Answer: Rechallenge

Q8. Which severity scale classifies ADRs into levels such as mild, moderate, and severe and helps guide management intensity?

• Naranjo algorithm
• WHO‑UMC causality categories
• Hartwig and Siegel severity assessment
• WHO ICD coding

Correct Answer: Hartwig and Siegel severity assessment

Q9. Which scale is commonly used to assess preventability of an ADR?

• Schumock and Thornton preventability criteria
• Hartwig severity scale
• WHO‑UMC causality system
• Naranjo algorithm

Correct Answer: Schumock and Thornton preventability criteria

Q10. Which ADR type is characterized by immunologically mediated reactions such as anaphylaxis or serum sickness?

• Type A (Augmented)
• Type B (Bizarre)
• Type C (Chronic)
• Type F (Failure of therapy)

Correct Answer: Type B (Bizarre)

Q11. Spontaneous reporting systems primarily contribute to which pharmacovigilance activity?

• Randomized controlled trials for new safety hypotheses
• Signal detection and hypothesis generation for potential ADRs
• Phase I dose‑finding studies
• Routine therapeutic drug monitoring

Correct Answer: Signal detection and hypothesis generation for potential ADRs

Q12. Which of the following actions is most appropriate when a serious, unexpected ADR is suspected?

• Ignore if patient is improving
• Report immediately to the national pharmacovigilance centre and consider regulatory expedited reporting requirements
• Wait for publication confirmation before reporting
• Only document in hospital notes without external reporting

Correct Answer: Report immediately to the national pharmacovigilance centre and consider regulatory expedited reporting requirements

Q13. Which monitoring approach actively follows a defined group of patients to detect ADRs prospectively and estimate incidence?

• Spontaneous reporting
• Cohort event monitoring
• Case series publication
• Meta‑analysis of RCTs

Correct Answer: Cohort event monitoring

Q14. An ADR that occurs because the therapeutic effect of a drug is absent or insufficient is classified as:

• Type A (Augmented)
• Type E (End of use)
• Type F (Failure of therapy)
• Type D (Delayed)

Correct Answer: Type F (Failure of therapy)

Q15. Which of the following best describes a ‘signal’ in pharmacovigilance?

• A confirmed causal relationship between a drug and an ADR
• Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event
• An ADR that is already listed in the product label
• A single anecdotal report that cannot be followed up

Correct Answer: Information that suggests a new potentially causal association or a new aspect of a known association between an intervention and an event

Q16. For dose‑related Type A ADRs, which management approach is most appropriate when the drug is essential and ADR is mild?

• Immediate permanent discontinuation and ban of the drug
• Dose reduction or symptomatic management while continuing therapy
• Switch to an unrelated class without dose adjustment
• Ignore the ADR as it will always resolve spontaneously

Correct Answer: Dose reduction or symptomatic management while continuing therapy

Q17. In causality assessment, which factor strengthens a causal link between drug and event?

• Multiple alternative explanations present
• Event occurs long after stopping the drug without plausible latency
• Clear temporal relationship, positive dechallenge, and recurrence on rechallenge
• Lack of previous reports and no pharmacological plausibility

Correct Answer: Clear temporal relationship, positive dechallenge, and recurrence on rechallenge

Q18. Which laboratory monitoring is most appropriate to detect an early ADR of aminoglycosides?

• Liver function tests
• Serum creatinine and auditory function tests
• Fasting blood glucose
• Coagulation profile (INR)

Correct Answer: Serum creatinine and auditory function tests

Q19. Which regulatory action is used to communicate new serious ADR information and recommend changes in clinical practice?

• Routine labeling that remains unchanged
• Risk Communication/Drug Safety Update or Dear Healthcare Professional letter
• Withholding all safety information from prescribers
• Only updating internal company records without public release

Correct Answer: Risk Communication/Drug Safety Update or Dear Healthcare Professional letter

Q20. An idiosyncratic ADR is best characterized by which description?

• Predictable, dose‑dependent reaction related to known pharmacology
• Unpredictable reaction not related to dose and often with immune or genetic basis
• Reaction that occurs exclusively on drug withdrawal
• Common and minor side effect that requires no action

Correct Answer: Unpredictable reaction not related to dose and often with immune or genetic basis

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