Predictability and preventability assessment of ADRs MCQs With Answer

Predictability and preventability assessment of ADRs is a core topic in pharmacovigilance for B. Pharm students. Understanding how to evaluate adverse drug reactions (ADRs) — their predictability (dose-related, time-related, class-related) and preventability (avoidable, partly avoidable, unavoidable) — helps reduce patient harm. Key concepts include causality assessment (Naranjo, WHO-UMC), classification (Type A/B), preventability tools (Schumock & Thornton, Hallas), severity scales (Hartwig), risk factors, drug interactions, and pharmacogenetics. Practical skills include interpreting clinical scenarios, applying assessment algorithms, and recommending risk-minimization strategies. This focused foundation equips students to identify, assess, and help prevent ADRs in clinical practice. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which characteristic best defines a predictable (Type A) ADR?

• Rare immune-mediated response unrelated to dose
• Directly related to pharmacological action and dose-dependent
• Appears only after re-exposure to the drug
• Always life-threatening and idiosyncratic

Correct Answer: Directly related to pharmacological action and dose-dependent

Q2. Which tool is most commonly used for structured causality assessment of ADRs?

• Schumock & Thornton Preventability Scale
• Naranjo Algorithm
• Hartwig Severity Scale
• Beers Criteria

Correct Answer: Naranjo Algorithm

Q3. Schumock and Thornton criteria are primarily used to assess which aspect of ADRs?

• Severity of ADRs
• Predictability from pharmacology
• Preventability of ADRs
• Causality strength

Correct Answer: Preventability of ADRs

Q4. An ADR occurring within minutes after IV administration and related to histamine release is most likely:

• Type B idiosyncratic reaction
• Type A predictable reaction
• An interaction with concomitant oral drugs
• A delayed hypersensitivity reaction

Correct Answer: Type A predictable reaction

Q5. Which statement about unpredictable ADRs (Type B) is correct?

• They are usually dose-dependent and common
• They often involve immunologic or idiosyncratic mechanisms
• They can be prevented by simple dose adjustments in most cases
• They are always detected in pre-marketing clinical trials

Correct Answer: They often involve immunologic or idiosyncratic mechanisms

Q6. Which factor increases the predictability of an ADR?

• Genetic polymorphism unrelated to drug metabolism
• Clear dose-response relationship in clinical data
• Occurrence only on re-challenge
• Absence of known pharmacologic mechanism

Correct Answer: Clear dose-response relationship in clinical data

Q7. The WHO-UMC system is used to assess which dimension of ADRs?

• Preventability classification
• Causality categories (certain, probable, possible, etc.)
• Economic impact of ADRs
• Severity scoring for hospitalization

Correct Answer: Causality categories (certain, probable, possible, etc.)

Q8. Which of the following is an example of a preventable ADR?

• Allergic reaction in a patient with documented penicillin allergy who was prescribed amoxicillin
• Idiosyncratic hepatotoxicity with no known risk factors
• Spontaneous hemorrhagic necrosis due to unknown mechanism
• Genetically-mediated absence of response to therapy

Correct Answer: Allergic reaction in a patient with documented penicillin allergy who was prescribed amoxicillin

Q9. Hartwig and Siegel severity scale assesses which feature of ADRs?

• Likelihood of preventability
• Severity and clinical outcome (mild, moderate, severe)
• Causality probability score
• Pharmacokinetic cause of ADR

Correct Answer: Severity and clinical outcome (mild, moderate, severe)

Q10. Which intervention is most relevant to prevent dose-related predictable ADRs?

• Genetic testing for HLA alleles in all patients
• Adjusting dose according to renal or hepatic function
• Complete avoidance of the drug class in the population
• Mandating rechallenge to confirm ADRs

Correct Answer: Adjusting dose according to renal or hepatic function

Q11. A patient develops severe rash after first exposure to carbamazepine; HLA-B*15:02 is implicated. This ADR is best described as:

• Predictable, dose-dependent reaction
• Idiosyncratic, genetically predisposed reaction
• Drug interaction with concomitant therapy
• Medication error resulting in overdose

Correct Answer: Idiosyncratic, genetically predisposed reaction

Q12. Which is NOT a component of preventability assessment tools like Schumock & Thornton?

• Whether the drug was inappropriate for the clinical condition
• Whether monitoring was inadequate
• Whether the ADR resulted in death
• Whether there was a known drug allergy that was ignored

Correct Answer: Whether the ADR resulted in death

Q13. Rechallenge and dechallenge are primarily used to evaluate which ADR attribute?

• Preventability
• Severity
• Causality
• Cost-effectiveness

Correct Answer: Causality

Q14. Which scenario best exemplifies a time-related ADR?

• Bleeding immediately after IV anticoagulant bolus
• Osteonecrosis of jaw after long-term bisphosphonate use
• Immediate anaphylaxis on first exposure to penicillin
• Underdosing due to poor adherence

Correct Answer: Osteonecrosis of jaw after long-term bisphosphonate use

Q15. Which method is most appropriate for signal detection of unexpected ADRs in a hospital setting?

• Randomized controlled trials
• Spontaneous reporting and case series analysis
• Systematic meta-analysis of textbooks
• Marketing surveys

Correct Answer: Spontaneous reporting and case series analysis

Q16. In preventability assessment, which action represents secondary prevention?

• Routine genetic screening to avoid initial exposure
• Adjusting therapy after early signs of toxicity to prevent progression
• Public education to reduce drug misuse
• Withdrawing a drug from the market

Correct Answer: Adjusting therapy after early signs of toxicity to prevent progression

Q17. Which ADR is most likely dose-related and therefore predictable?

• Serotonin syndrome with excessive SSRI dosing
• Drug-induced lupus with hydralazine after months
• Agranulocytosis from clozapine independent of dose
• Anaphylaxis due to penicillin allergy

Correct Answer: Serotonin syndrome with excessive SSRI dosing

Q18. Which pharmacovigilance activity helps reduce preventable ADRs at the population level?

• Implementing therapeutic drug monitoring for high-risk drugs
• Relying solely on pre-market trials for safety data
• Discouraging reporting of mild ADRs
• Delaying updates to prescribing information

Correct Answer: Implementing therapeutic drug monitoring for high-risk drugs

Q19. A patient on warfarin has elevated INR after starting trimethoprim-sulfamethoxazole. This ADR is best classified as:

• Preventable drug-drug interaction leading to increased effect
• Unpredictable idiosyncratic event
• Medication error unrelated to pharmacology
• Type B immune-mediated reaction

Correct Answer: Preventable drug-drug interaction leading to increased effect

Q20. Which laboratory-based approach can improve predictability of certain ADRs?

• Therapeutic drug monitoring and pharmacogenetic testing
• Ignoring baseline liver function tests
• Random urine color checks
• Eliminating all monitoring to reduce costs

Correct Answer: Therapeutic drug monitoring and pharmacogenetic testing

Q21. Which is a limitation of pre-marketing clinical trials for ADR predictability?

• Large and diverse patient populations are always included
• Rare or long-latency ADRs may not be detected
• They always reveal all idiosyncratic reactions
• They provide complete data on off-label use

Correct Answer: Rare or long-latency ADRs may not be detected

Q22. According to preventability concepts, which prescription practice is considered avoidable?

• Prescribing a contraindicated drug to a patient with known comorbidity
• Prescribing standard dose adjusted for renal impairment
• Titrating dose based on therapeutic monitoring
• Choosing evidence-based first-line therapy

Correct Answer: Prescribing a contraindicated drug to a patient with known comorbidity

Q23. Which action is part of root-cause analysis after a severe preventable ADR?

• Blaming a single clinician without system review
• Reviewing prescribing process, communication, and monitoring gaps
• Removing all similar drugs from formulary without investigation
• Reporting only to marketing department

Correct Answer: Reviewing prescribing process, communication, and monitoring gaps

Q24. Which classification distinguishes ADRs by mechanism such as dose-related or immunologic?

• Rawlins and Thompson classification (Type A/B)
• Schumock & Thornton scale
• Beers criteria
• Framingham classification

Correct Answer: Rawlins and Thompson classification (Type A/B)

Q25. Preventability assessment would classify an ADR as “possibly preventable” if:

• The ADR occurred despite ideal prescribing and monitoring
• There was some failure in monitoring or adherence to guidelines
• The reaction is genetically predetermined and unavoidable
• The drug caused a novel idiosyncratic reaction

Correct Answer: There was some failure in monitoring or adherence to guidelines

Q26. Which reporting practice improves detection of preventable ADR patterns?

• Detailed reports including medication history, timing, and outcome
• Only reporting the drug name without clinical details
• Reporting only fatal cases
• Delaying reports until months have passed

Correct Answer: Detailed reports including medication history, timing, and outcome

Q27. A drug causes hypoglycemia when combined with an insulin secretagogue. Preventability assessment should emphasize:

• Identifying and avoiding risky drug combinations and dose adjustments
• Encouraging higher doses of both drugs
• Assuming interactions are rare and unavoidable
• Stopping all glucose monitoring

Correct Answer: Identifying and avoiding risky drug combinations and dose adjustments

Q28. Which educational measure can reduce preventable ADRs among prescribers?

• Training on drug interactions, renal dosing, and allergy checks
• Discouraging use of clinical decision-support tools
• Promoting unfamiliar off-label prescribing without evidence
• Removing access to patient medication histories

Correct Answer: Training on drug interactions, renal dosing, and allergy checks

Q29. Which example demonstrates a predictable organ-specific ADR requiring monitoring?

• Vancomycin-associated nephrotoxicity monitored by trough levels
• Acute anaphylaxis to penicillin on first exposure
• Unknown idiosyncratic skin reaction with no warning signs
• Random subjective dizziness unrelated to dose

Correct Answer: Vancomycin-associated nephrotoxicity monitored by trough levels

Q30. In a pharmacovigilance audit, a high rate of preventable ADRs suggests which priority?

• Implementing system-level changes: protocols, monitoring, and education
• Accepting ADRs as inevitable and making no changes
• Reducing ADR reporting to avoid scrutiny
• Increasing exposure to high-risk drugs without safeguards

Correct Answer: Implementing system-level changes: protocols, monitoring, and education

Download