ADRs: causality, severity, predictability and management MCQs With Answer

Introduction: Adverse drug reactions (ADRs) are a critical topic for M.Pharm students, combining pharmacology, clinical judgment and patient safety. This quiz set focuses on causality assessment (Naranjo, WHO‑UMC), severity and seriousness grading (Hartwig, CTCAE), predictability (Type A–E ADRs) and practical management strategies including withdrawal, rechallenge, desensitization, monitoring and reporting. Each question probes deeper concepts used in pharmacovigilance and clinical decision‑making, preparing students for real‑world situations where identifying, classifying and preventing ADRs is essential. Attempt these MCQs to test knowledge and strengthen skills needed for safe, rational medicine use and effective ADR management.

Q1. Which of the following best matches the WHO definition of an adverse drug reaction (ADR)?

• An intended effect of a drug observed during clinical trials
• An unintended, noxious response to a drug occurring at normal doses used for prophylaxis, diagnosis or therapy
• An adverse outcome due to medication error or overdose
• A side effect that is always mild and predictable

Correct Answer: An unintended, noxious response to a drug occurring at normal doses used for prophylaxis, diagnosis or therapy

Q2. Which causality assessment method uses a structured questionnaire with weighted scores to give a probability category?

• WHO‑UMC qualitative categories
• Naranjo algorithm
• Clinical judgment without scoring
• Schumock and Thornton preventability scale

Correct Answer: Naranjo algorithm

Q3. Which option is NOT one of the standard WHO‑UMC causality categories?

• Certain
• Probable/Likely
• Doubtful
• Unassessable/Unclassifiable

Correct Answer: Doubtful

Q4. According to the Naranjo scale, a total score of 9 or greater categorizes an ADR as which of the following?

• Possible
• Probable
• Definite
• Doubtful

Correct Answer: Definite

Q5. Which statement correctly distinguishes ‘seriousness’ from ‘severity’ of an ADR?

• Severity describes the regulatory classification; seriousness describes the intensity felt by the patient
• Seriousness refers to outcomes like death or hospitalization; severity refers to intensity of the reaction
• Severity and seriousness are synonymous and interchangeable in pharmacovigilance
• Seriousness is measured on a 0–10 scale; severity uses categorical terms only

Correct Answer: Seriousness refers to outcomes like death or hospitalization; severity refers to intensity of the reaction

Q6. Which characteristic is typical of Type A (augmented) ADRs?

• Idiosyncratic and unrelated to dose
• Allergic and immune mediated
• Dose‑related and predictable based on pharmacology
• Occur only after long latency and are not dose related

Correct Answer: Dose‑related and predictable based on pharmacology

Q7. Which tool is commonly used to assess preventability of an ADR?

• WHO‑UMC causality categories
• Hartwig severity assessment
• Schumock and Thornton preventability criteria
• Naranjo adverse event probability scale

Correct Answer: Schumock and Thornton preventability criteria

Q8. Which feature best describes a Type C ADR in the Rawlins and Thomson classification?

• Acute, dose‑related effects appearing immediately
• Allergic reactions due to prior sensitization
• Chronic reactions related to cumulative dose and long‑term therapy
• Unexpected effects unrelated to dose or duration

Correct Answer: Chronic reactions related to cumulative dose and long‑term therapy

Q9. Which ADR is most predictable before drug exposure?

• Idiosyncratic severe cutaneous reaction
• Dose‑related hypotension from an antihypertensive
• Drug‑induced lupus with variable latency
• Type I hypersensitivity immediate anaphylaxis

Correct Answer: Dose‑related hypotension from an antihypertensive

Q10. Rechallenge with the suspected drug is absolutely contraindicated after which of the following reactions?

• Mild transient nausea
• Self‑limited rash resolving without sequelae
• Stevens–Johnson syndrome/toxic epidermal necrolysis
• Asymptomatic laboratory transaminase elevation of 1.5× ULN

Correct Answer: Stevens–Johnson syndrome/toxic epidermal necrolysis

Q11. In a patient with a suspected serious ADR, the immediate first clinical action should be:

• Rechallenge to confirm causality
• Stop the suspected offending drug
• Submit a spontaneous adverse event report and wait
• Ignore if ADR is rare

Correct Answer: Stop the suspected offending drug

Q12. Desensitization is an appropriate management strategy when:

• Safe and effective alternative drugs are readily available
• The reaction was life‑threatening and severe (e.g., SJS)
• The drug is essential, benefit outweighs risk, and no alternatives exist
• The patient has a mild, transient side effect like dry mouth

Correct Answer: The drug is essential, benefit outweighs risk, and no alternatives exist

Q13. Which national pharmacovigilance program is responsible for spontaneous ADR reporting in India?

• FDA MedWatch
• European Medicines Agency EudraVigilance
• Pharmacovigilance Programme of India (PvPI)
• Yellow Card Scheme

Correct Answer: Pharmacovigilance Programme of India (PvPI)

Q14. For which drug class is routine therapeutic drug monitoring commonly used to reduce ADR risk by measuring serum levels?

• Nonsteroidal anti‑inflammatory drugs
• Digoxin and lithium
• Beta blockers
• H2 receptor antagonists

Correct Answer: Digoxin and lithium

Q15. Which patient factor most consistently increases the risk of ADRs?

• Young age with single medication
• Polypharmacy (use of multiple concomitant drugs)
• Excellent renal and hepatic function
• Short duration of therapy (<48 hours)

Correct Answer: Polypharmacy (use of multiple concomitant drugs)

Q16. The Common Terminology Criteria for Adverse Events (CTCAE) used in oncology grades events from 1 to 5. What does Grade 5 indicate?

• Mild symptoms not requiring intervention
• Moderate symptoms requiring minimal intervention
• Severe, life‑threatening consequences
• Death related to the adverse event

Correct Answer: Death related to the adverse event

Q17. A ‘black box’ warning on a drug label indicates:

• The drug is ineffective for its indicated use
• Routine monitoring is unnecessary
• Serious or life‑threatening risks have been identified that clinicians must consider
• The drug has been withdrawn from the market

Correct Answer: Serious or life‑threatening risks have been identified that clinicians must consider

Q18. In causality assessment with Naranjo criteria, which observation most strongly increases the probability that a drug caused an ADR?

• The adverse event occurred before drug administration
• The adverse event resolved when the drug was discontinued (positive dechallenge)
• The adverse event recurred after re‑administration of the drug (positive rechallenge)
• The adverse event is a common symptom of the underlying disease

Correct Answer: The adverse event recurred after re‑administration of the drug (positive rechallenge)

Q19. Who is primarily responsible for performing formal causality assessment of reported ADRs?

• Only the original patient who experienced the ADR
• Trained pharmacovigilance assessors or a multidisciplinary clinical team
• Pharmaceutical sales representatives
• Anyone who reads the original drug label

Correct Answer: Trained pharmacovigilance assessors or a multidisciplinary clinical team

Q20. Which of the following is NOT a primary prevention strategy to reduce the incidence of ADRs?

• Individualizing dose based on renal or hepatic function
• Patient education about drug interactions and adherence
• Pre‑treatment genetic testing where evidence supports benefit (e.g., HLA testing)
• Relying solely on spontaneous ADR reporting to detect problems after they occur

Correct Answer: Relying solely on spontaneous ADR reporting to detect problems after they occur

Download