Establishing pharmacovigilance programs in hospitals MCQs With Answer

Pharmacovigilance in hospitals is the systematic science of detecting, assessing, understanding and preventing adverse drug reactions (ADRs), medication errors, and other drug-related problems to ensure patient safety. Establishing pharmacovigilance programs in hospitals involves setting up ADR reporting systems, individual case safety reports (ICSRs), causality assessment (e.g., Naranjo, WHO‑UMC), MedDRA coding, signal detection, risk management plans, multidisciplinary PV committees, data management and staff training. Strong hospital PV supports active surveillance, quality assurance, regulatory compliance and evidence-based formulary decisions. This introduction highlights practical steps and core components to prepare B. Pharm students for roles in medication safety and pharmacovigilance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of pharmacovigilance in hospitals?

• Detecting, assessing and preventing adverse drug reactions (ADRs)
• Maximizing hospital drug sales
• Reducing nursing staff workload
• Developing new pharmaceutical marketing strategies

Correct Answer: Detecting, assessing and preventing adverse drug reactions (ADRs)

Q2. Which document is commonly used to report a single adverse event case in pharmacovigilance?

• Individual Case Safety Report (ICSR)
• Periodic Safety Update Report (PSUR)
• Risk Management Plan (RMP)
• Clinical Study Protocol

Correct Answer: Individual Case Safety Report (ICSR)

Q3. Which causality assessment tool is frequently used in hospital settings for assessing ADRs?

• Naranjo algorithm
• Kaplan–Meier estimator
• APACHE II score
• Glasgow Coma Scale

Correct Answer: Naranjo algorithm

Q4. Which standardized coding dictionary is used internationally for adverse event terms?

• MedDRA
• ICD-10
• ATC Classification Only
• DSM-5

Correct Answer: MedDRA

Q5. What statistical method is commonly used for signal detection in large pharmacovigilance databases?

• Disproportionality analysis (e.g., PRR, ROR)
• Student’s t-test for paired samples
• Kaplan–Meier survival analysis
• ANOVA for repeated measures

Correct Answer: Disproportionality analysis (e.g., PRR, ROR)

Q6. A hospital pharmacovigilance committee should ideally include which of the following?

• Multidisciplinary members including clinical pharmacists and physicians
• Only administrative staff
• Marketing representatives from pharmaceutical companies
• External auditors only

Correct Answer: Multidisciplinary members including clinical pharmacists and physicians

Q7. For a serious and unexpected ADR, what is the typical immediate reporting timeframe to a national PV centre?

• Within 7 calendar days
• Within 90 days
• Within 1 year
• No reporting required for serious events

Correct Answer: Within 7 calendar days

Q8. What does PBRER stand for in pharmacovigilance?

• Periodic Benefit-Risk Evaluation Report
• Patient-Based Reporting and Evaluation Record
• Primary Biological Risk Evaluation Report
• Pharmacy-Based Risk and Error Registry

Correct Answer: Periodic Benefit-Risk Evaluation Report

Q9. Which four elements are essential in a minimum valid ADR report?

• Identifiable patient, suspect drug, adverse event, and reporter
• Patient’s financial status, hospital bed number, drug price, and pharmacy stamp
• Physician’s opinion only
• Drug batch number only

Correct Answer: Identifiable patient, suspect drug, adverse event, and reporter

Q10. How can B. Pharm students contribute to hospital pharmacovigilance programs?

• Assist in ADR detection, documentation and reporting
• Prescribe medications without supervision
• Perform surgeries
• Avoid participating due to liability concerns

Correct Answer: Assist in ADR detection, documentation and reporting

Q11. Which global database is maintained by the Uppsala Monitoring Centre for individual case safety reports?

• VigiBase
• PubMed
• ClinicalTrials.gov
• Scopus

Correct Answer: VigiBase

Q12. What is the main purpose of performing root cause analysis for medication errors in hospitals?

• To identify system-level causes and implement preventive measures
• To punish the staff involved
• To calculate drug expenditure only
• To transfer blame to external vendors

Correct Answer: To identify system-level causes and implement preventive measures

Q13. Which term refers specifically to adverse events that occur after immunization?

• Adverse Events Following Immunization (AEFI)
• Medication Safety Report (MSR)
• Hospital-Acquired Infection (HAI)
• Drug Utilization Review (DUR)

Correct Answer: Adverse Events Following Immunization (AEFI)

Q14. In pharmacovigilance, what is a ‘signal’?

• Information that suggests a new causal association or a new aspect of a known ADR
• A hospital alarm system
• A marketing term for drug success
• A randomized clinical trial endpoint

Correct Answer: Information that suggests a new causal association or a new aspect of a known ADR

Q15. Which surveillance approaches are recommended in hospital pharmacovigilance?

• Both spontaneous reporting and active surveillance
• Spontaneous reporting only
• Active surveillance only
• No surveillance is necessary

Correct Answer: Both spontaneous reporting and active surveillance

Q16. Device vigilance in hospitals concerns reporting of adverse events associated with what?

• Medical devices and in vitro diagnostics
• Only pharmaceuticals
• Hospital furniture
• Staff scheduling software

Correct Answer: Medical devices and in vitro diagnostics

Q17. What is the correct approach to patient identifiers when sharing ADR data externally?

• De-identify patient information to protect confidentiality
• Share full patient identifiers without consent
• Publish patient photos online
• Send patient lists to pharmaceutical companies

Correct Answer: De-identify patient information to protect confidentiality

Q18. Which of the following is a WHO-UMC causality category?

• Certain, Probable, Possible, Unlikely (and others)
• Definite, Doubtful, Hypothetical only
• Grade I, II, III exclusively
• Confirmed, Rejected only

Correct Answer: Certain, Probable, Possible, Unlikely (and others)

Q19. Which Indian regulatory body primarily oversees pharmacovigilance activities?

• Central Drugs Standard Control Organization (CDSCO)
• Food Safety and Standards Authority of India (FSSAI)
• Reserve Bank of India (RBI)
• National Aeronautics Authority

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q20. What does ‘dechallenge’ indicate in causality assessment?

• Improvement of symptoms after stopping the suspect drug
• Worsening after stopping the drug
• Reappearance of symptoms after restarting the drug
• Laboratory confirmation only

Correct Answer: Improvement of symptoms after stopping the suspect drug

Q21. Which standardized form is commonly used for transmitting detailed safety information internationally (often CIOMS)?

• CIOMS form
• Hospital admission form
• Prescription pad
• Invoice receipt

Correct Answer: CIOMS form

Q22. Which events should hospitals encourage to be reported to improve medication safety?

• All ADRs, serious events and near-misses for learning
• Only events involving high-cost drugs
• Only events that reach the media
• Events that do not involve patients

Correct Answer: All ADRs, serious events and near-misses for learning

Q23. What is the main function of a Risk Management Plan (RMP) for a medicine?

• To identify, characterize and minimize risks associated with the medicine
• To promote off-label use
• To increase drug prices
• To replace clinical trials

Correct Answer: To identify, characterize and minimize risks associated with the medicine

Q24. How does pharmacovigilance data support hospital formulary decisions?

• By informing safety profiles and guiding rational drug selection
• By determining staff salaries
• By increasing inventory regardless of safety
• By eliminating pharmacoeconomic analysis

Correct Answer: By informing safety profiles and guiding rational drug selection

Q25. Which report has largely replaced the traditional PSUR in global pharmacovigilance practice?

• Periodic Benefit-Risk Evaluation Report (PBRER)
• Annual Financial Report
• Clinical Study Report (CSR)
• Case Report Form (CRF)

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

Q26. MedDRA allows coding of adverse events at which hierarchical levels?

• System Organ Class (SOC) and Preferred Term (PT) levels (among others)
• Only ICD Chapter levels
• Only drug strength levels
• Only patient age groups

Correct Answer: System Organ Class (SOC) and Preferred Term (PT) levels (among others)

Q27. Which disproportionality measures are used commonly for signal detection?

• Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR)
• Mean Difference and Standard Deviation only
• Hazard Ratio exclusively
• Chi-square for paired samples only

Correct Answer: Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR)

Q28. Who should lead pharmacovigilance training and awareness activities within a hospital?

• Pharmacovigilance committee with a designated hospital PV officer or clinical pharmacist
• Only external pharmaceutical sales representatives
• Security personnel
• Patients themselves without guidance

Correct Answer: Pharmacovigilance committee with a designated hospital PV officer or clinical pharmacist

Q29. What is the most common reason for under-reporting of ADRs in hospitals?

• Lack of awareness and time constraints among healthcare professionals
• Excessive financial incentives
• Too many ADRs being reported already
• Inability to write prescriptions

Correct Answer: Lack of awareness and time constraints among healthcare professionals

Q30. How do electronic health records (EHRs) support pharmacovigilance in hospitals?

• They enable data extraction for active surveillance and signal detection
• They replace the need for trained staff
• They prevent all adverse events automatically
• They are only used for billing and not safety monitoring

Correct Answer: They enable data extraction for active surveillance and signal detection

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