Predictability, severity, seriousness and preventability assessment of ADRs MCQs With Answer

Introduction: This quiz collection focuses on predictability, severity, seriousness and preventability assessment of adverse drug reactions (ADRs), tailored for M.Pharm students in Clinical Research and Pharmacovigilance. It provides conceptual and applied multiple-choice questions that deepen understanding of ADR classification (Type A/B), regulatory seriousness criteria, commonly used severity and causality scales (Hartwig, Naranjo, CTCAE), and established preventability tools (Schumock & Thornton, Hallas). Questions emphasize real-world examples such as pharmacogenetic predictors, rechallenge interpretation, SUSAR reporting, and hospital-based prevention strategies. Use these MCQs to test knowledge required for clinical trial safety reporting, post-marketing surveillance, and rational mitigation of ADR risk.

Q1. Which statement best describes a predictable adverse drug reaction?

• Type A (dose-dependent) reaction related to the known pharmacologic action of the drug
• Type B (idiosyncratic) immune-mediated reaction unrelated to dose
• Any reaction occurring only after drug withdrawal
• Adverse events that are always genetic in origin

Correct Answer: Type A (dose-dependent) reaction related to the known pharmacologic action of the drug

Q2. According to regulatory definitions, which constellation qualifies an adverse event as “serious”?

• An event causing nausea that resolves without treatment
• Death, life‑threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, or other medically important condition
• An event that is mild but uncomfortable
• An event that is expected and labeled in the product information

Correct Answer: Death, life‑threatening condition, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly, or other medically important condition

Q3. Which tool classifies ADR severity by levels (mild, moderate, severe) and is commonly used in clinical pharmacovigilance?

• Hartwig and Siegel severity scale (levels from mild to severe)
• Naranjo causality algorithm
• Schumock and Thornton preventability criteria
• CTCAE is never used for severity assessment

Correct Answer: Hartwig and Siegel severity scale (levels from mild to severe)

Q4. Which of the following is a validated method to assess preventability of an ADR?

• Schumock and Thornton criteria for preventability
• Naranjo probability score
• WHO-UMC causality categories
• MedDRA coding dictionary

Correct Answer: Schumock and Thornton criteria for preventability

Q5. Which factors most directly determine the predictability of an ADR?

• The known pharmacological mechanism, temporal relationship to dosing, and dose-response characteristics
• The route of drug approval (generic vs innovator)
• Whether the event is listed in the Summary of Product Characteristics only
• The cost of the drug and marketing status

Correct Answer: The known pharmacological mechanism, temporal relationship to dosing, and dose-response characteristics

Q6. Which example is NOT considered a “serious” adverse event by regulatory standards?

• An episode of transient mild nausea that requires no medical intervention
• A myocardial infarction requiring hospitalization
• A congenital malformation following maternal exposure
• A life‑threatening anaphylactic reaction

Correct Answer: An episode of transient mild nausea that requires no medical intervention

Q7. A positive rechallenge (symptoms recur after re-exposure) generally indicates what about an ADR?

• Strong evidence supporting a causal relationship and suggests the reaction is predictable on repeat exposure
• That the event was coincidental and unrelated to the drug
• That the adverse event is always Type A
• That the ADR is definitely preventable with simple counseling alone

Correct Answer: Strong evidence supporting a causal relationship and suggests the reaction is predictable on repeat exposure

Q8. Which of the following is an example of a Type B (bizarre) ADR?

• Immune‑mediated anaphylaxis to penicillin
• Hypotension caused by an antihypertensive at high dose
• Somnolence from therapeutic dose of a sedative antihistamine
• Gastrointestinal upset due to aspirin at high dose

Correct Answer: Immune‑mediated anaphylaxis to penicillin

Q9. Which scenario most clearly represents a preventable ADR?

• Warfarin‑associated bleeding after co‑administration of a known interacting broad‑spectrum antibiotic without INR monitoring
• Stevens-Johnson syndrome occurring in a patient with an unknown HLA risk allele
• Idiosyncratic liver injury with a newly marketed drug with no known risk factors
• Allergic rash in a patient with no prior exposure and no warning signs

Correct Answer: Warfarin‑associated bleeding after co‑administration of a known interacting broad‑spectrum antibiotic without INR monitoring

Q10. Which statement best distinguishes “severity” from “seriousness” of an ADR?

• Severity describes intensity (mild/moderate/severe); seriousness is a regulatory classification based on outcome (death, hospitalization, disability, etc.)
• Severity and seriousness are interchangeable terms in regulatory reporting
• Seriousness describes intensity while severity describes regulatory outcomes
• Severity only applies to laboratory abnormalities and seriousness only to clinical events

Correct Answer: Severity describes intensity (mild/moderate/severe); seriousness is a regulatory classification based on outcome (death, hospitalization, disability, etc.)

Q11. Which instrument is commonly used to assess the probability that a drug caused an adverse event?

• Naranjo adverse drug reaction probability scale
• Schumock and Thornton preventability checklist
• Hallas preventability categories
• MedDRA preferred term dictionary

Correct Answer: Naranjo adverse drug reaction probability scale

Q12. A known limitation of the Schumock and Thornton preventability criteria is:

• They include subjective clinical judgement and may lack reproducibility between assessors
• They provide a quantitative probability score for causality
• They are specific for genetic ADR prediction only
• They were designed only for oncology adverse events

Correct Answer: They include subjective clinical judgement and may lack reproducibility between assessors

Q13. Idiosyncratic ADRs are characteristically:

• Unpredictable, not dose-dependent, and often immune‑mediated or genetically determined
• Always preventable by dose reduction
• Strictly predictable by pharmacodynamic effects
• Only observed with high therapeutic doses

Correct Answer: Unpredictable, not dose-dependent, and often immune‑mediated or genetically determined

Q14. Which classification is used by Hallas to describe preventability of ADRs?

• Definitely preventable, possibly preventable, probably not preventable, definitely not preventable
• Mild, moderate, severe
• Suspected, probable, definite
• Expected, unexpected, labeled, unlabeled

Correct Answer: Definitely preventable, possibly preventable, probably not preventable, definitely not preventable

Q15. In oncology clinical trials, which standardized instrument grades adverse event severity from grade 1 to 5?

• Common Terminology Criteria for Adverse Events (CTCAE)
• Schumock and Thornton preventability scale
• Naranjo probability scale
• Hallas preventability categories

Correct Answer: Common Terminology Criteria for Adverse Events (CTCAE)

Q16. Which type of event must be reported as a SUSAR in a clinical trial?

• A suspected unexpected serious adverse reaction (an event that is both serious and unexpected and suspected to be related)
• Any mild, expected side effect listed in the investigator brochure
• All non-serious adverse events, regardless of causality
• Routine lab abnormalities that are baseline for the population

Correct Answer: A suspected unexpected serious adverse reaction (an event that is both serious and unexpected and suspected to be related)

Q17. According to Hartwig and Siegel, which level of severity is considered “severe” requiring intensive medical care or causing permanent harm?

• Levels 5–7 (events requiring hospitalization, causing permanent harm, or requiring intensive medical care)
• Level 1 only (mild symptoms)
• Levels 2–3 (no change in therapy required)
• Severity is not classified in Hartwig and Siegel

Correct Answer: Levels 5–7 (events requiring hospitalization, causing permanent harm, or requiring intensive medical care)

Q18. Which pharmacogenetic example illustrates a predictable severe ADR?

• HLA‑B*15:02 allele associated with carbamazepine-induced Stevens‑Johnson syndrome/toxic epidermal necrolysis
• CYP2D6 poor metabolizer status causing immediate anaphylaxis to penicillin
• Unknown genetic marker causing random headache with acetaminophen
• Polymorphism that prevents all drug absorption for any medication

Correct Answer: HLA‑B*15:02 allele associated with carbamazepine-induced Stevens‑Johnson syndrome/toxic epidermal necrolysis

Q19. Which institutional strategy is most effective at reducing preventable ADRs in hospitalized patients?

• Medication reconciliation at transitions of care combined with computerized prescribing alerts and regular clinical pharmacy review
• Relying solely on patient self‑report at discharge
• Removing all high‑risk medications from formularies without alternatives
• Increase in paper-based handwritten prescriptions

Correct Answer: Medication reconciliation at transitions of care combined with computerized prescribing alerts and regular clinical pharmacy review

Q20. For regulatory reporting in clinical trials, what are the typical expedited timelines for SUSARs?

• Fatal or life-threatening SUSARs within 7 calendar days (followed by 8 days for additional information); other SUSARs within 15 calendar days
• All SUSARs reported annually only
• Non-serious expected ADRs within 24 hours
• SUSARs are reported only at the end of the study

Correct Answer: Fatal or life-threatening SUSARs within 7 calendar days (followed by 8 days for additional information); other SUSARs within 15 calendar days

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