Role of pharmacist in pharmacovigilance and QUM MCQs With Answer

Introduction

The following quiz set is designed specifically for M.Pharm students studying Principles of Quality Use of Medicines. It focuses on the pharmacist’s pivotal roles in pharmacovigilance and Quality Use of Medicines (QUM): detecting, assessing and preventing adverse drug reactions, applying causality methods, using coding systems, participating in signal detection, and implementing risk minimization and stewardship activities. Questions probe both conceptual knowledge and practical responsibilities—reporting pathways, regulatory timelines, active surveillance methods, and pharmacist-led interventions to optimise patient safety and therapeutic outcomes. Use these MCQs to test depth of understanding, prepare for examinations, and reinforce the clinical and regulatory responsibilities expected of a pharmacovigilance-ready pharmacist.

Q1. What is the primary responsibility of a pharmacist within routine pharmacovigilance activities in a healthcare setting?

• Prescribing investigational drugs to patients
• Detection, documentation and reporting of adverse drug reactions and medication safety issues
• Designing clinical trial protocols
• Producing promotional materials for new medicines

Correct Answer: Detection, documentation and reporting of adverse drug reactions and medication safety issues

Q2. Which characteristic best describes spontaneous (voluntary) ADR reporting systems?

• They provide accurate incidence rates because denominators are known
• They are high-cost, prospective cohort studies
• They are inexpensive and useful for signal generation but suffer from underreporting
• They always include causality-confirmed cases only

Correct Answer: They are inexpensive and useful for signal generation but suffer from underreporting

Q3. Which causality assessment method is widely used by regulators and recommended for standardized case evaluation internationally?

• Naranjo algorithm only
• WHO-UMC causality categories
• Proportional Reporting Ratio (PRR)
• Number Needed to Harm (NNH)

Correct Answer: WHO-UMC causality categories

Q4. Which terminology dictionary is standard for adverse event coding in pharmacovigilance databases?

• ICD-10
• SNOMED CT
• MedDRA
• ATC only

Correct Answer: MedDRA

Q5. Which of the following events meets regulatory criteria for a ‘serious’ adverse drug reaction?

• A transient mild headache that resolves without treatment
• Hospitalisation for anaphylaxis after drug administration
• Mild injection-site pain lasting one hour
• Temporary taste disturbance

Correct Answer: Hospitalisation for anaphylaxis after drug administration

Q6. What is the usual expedited reporting requirement for a SUSAR (suspected unexpected serious adverse reaction) from clinical trials?

• All SUSARs reported annually
• Fatal or life‑threatening SUSARs within 7 days and other SUSARs within 15 days
• Report within 60 days of occurrence
• No specific timeline; report whenever convenient

Correct Answer: Fatal or life‑threatening SUSARs within 7 days and other SUSARs within 15 days

Q7. Within the Quality Use of Medicines framework, which pharmacist action most directly improves appropriate medicine use?

• Promoting brand switching for marketing gains
• Providing patient counselling, monitoring therapy, and recommending prescriber adjustments based on evidence
• Only dispensing medicines without follow-up
• Substituting medicines without prescriber communication

Correct Answer: Providing patient counselling, monitoring therapy, and recommending prescriber adjustments based on evidence

Q8. Which statistical approach is commonly used for signal detection in large spontaneous reporting databases?

• Randomised controlled trial analysis
• Disproportionality analysis such as PRR or ROR
• Simple case reports without aggregate analysis
• Kaplan-Meier survival curves

Correct Answer: Disproportionality analysis such as PRR or ROR

Q9. What does a regulatory ‘black triangle’ symbol typically indicate about a medicine?

• The drug is contraindicated in pregnancy
• The medicine is under additional monitoring because it is new or has limited safety data
• The medicine is no longer authorised
• The product is a herbal supplement and unregulated

Correct Answer: The medicine is under additional monitoring because it is new or has limited safety data

Q10. Which document supersedes the traditional PSUR and focuses on periodic benefit–risk evaluation for marketed products?

• Investigator’s Brochure
• Periodic Benefit–Risk Evaluation Report (PBRER)
• Individual Case Safety Report (ICSR)
• Prescription Drug Monitoring Program report

Correct Answer: Periodic Benefit–Risk Evaluation Report (PBRER)

Q11. Which activity is NOT a core pharmacovigilance function for a hospital pharmacist?

• Conducting root-cause analysis of medication safety incidents
• Spontaneous ADR reporting and follow-up
• Implementing risk minimization measures and education
• Designing commercial marketing campaigns for hospital products

Correct Answer: Designing commercial marketing campaigns for hospital products

Q12. How does the Naranjo algorithm differ from WHO-UMC qualitative categories?

• Naranjo provides a quantitative score-based algorithm; WHO-UMC uses descriptive qualitative categories
• Naranjo is qualitative and WHO-UMC is numeric
• Both are identical in method and output
• Naranjo is used only for vaccines and WHO-UMC only for drugs

Correct Answer: Naranjo provides a quantitative score-based algorithm; WHO-UMC uses descriptive qualitative categories

Q13. Within the MedDRA hierarchy, which is the most specific (lowest level) term used to describe an adverse event?

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

Correct Answer: Lowest Level Term (LLT)

Q14. What is the major reason for underreporting of ADRs by healthcare professionals?

• Excessive incentives to report ADRs
• Lack of awareness, uncertainty about causality and perceived time constraints
• Mandatory legal reporting requirements
• High sensitivity of spontaneous systems

Correct Answer: Lack of awareness, uncertainty about causality and perceived time constraints

Q15. Which of the following is an example of a regulatory risk minimization measure a pharmacist may help implement?

• Issuing routine discounts on high-risk medicines
• Educational materials for prescribers and patients, restricted distribution and monitoring programmes
• A marketing blitz to increase uptake
• Eliminating all black-box warnings

Correct Answer: Educational materials for prescribers and patients, restricted distribution and monitoring programmes

Q16. In pharmacovigilance terminology, what do ‘dechallenge’ and ‘rechallenge’ describe?

• Dechallenge: initiating a new drug; Rechallenge: switching to a placebo
• Dechallenge: withdrawal of the suspect drug with improvement; Rechallenge: re-exposure that leads to recurrence of the reaction
• Dechallenge: documenting the initial event only; Rechallenge: reporting the event to regulators
• Dechallenge and rechallenge are unrelated to ADR assessment

Correct Answer: Dechallenge: withdrawal of the suspect drug with improvement; Rechallenge: re-exposure that leads to recurrence of the reaction

Q17. Which surveillance method actively collects information on all events in a defined patient cohort to estimate incidence of ADRs?

• Spontaneous reporting
• Cohort event monitoring
• Signal detection by disproportionality only
• Case series without denominator data

Correct Answer: Cohort event monitoring

Q18. How can pharmacists contribute effectively to antimicrobial stewardship as part of QUM?

• Encouraging prolonged broad-spectrum antibiotic use for all infections
• Optimising dose, duration and route (IV to oral switch), reviewing indications and educating prescribers and patients
• Replacing antibiograms with advertising materials
• Dispensing antibiotics without prescriptions to increase access

Correct Answer: Optimising dose, duration and route (IV to oral switch), reviewing indications and educating prescribers and patients

Q19. Why does a reporting rate from a spontaneous reporting system usually not equal true incidence of an ADR?

• Because reports are always verified and represent all events
• Because denominators (exposed population and exposure time) are unknown and underreporting varies
• Because spontaneous systems mandate complete case ascertainment
• Because reporting rate is equivalent to prevalence only

Correct Answer: Because denominators (exposed population and exposure time) are unknown and underreporting varies

Q20. Which regulatory document outlines the safety specification and planned pharmacovigilance activities and risk minimization measures for a medicine?

• Clinical Study Protocol
• Risk Management Plan (RMP)
• Physician’s Desk Reference only
• Marketing Authorisation Application without safety data

Correct Answer: Risk Management Plan (RMP)

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