Establishing PV centres in hospitals and industry MCQs With Answer

Introduction: Establishing pharmacovigilance (PV) centres in hospitals and industry is essential for detecting, assessing and preventing adverse drug reactions (ADRs). For M.Pharm students, understanding the structural, regulatory and operational aspects of PV centres prepares you to design robust safety systems, implement standard operating procedures, and ensure timely reporting to national and international authorities. This blog-style quiz focuses on practical elements: staffing, training, IT infrastructure, data standards, signal detection, quality assurance, and integration with hospital systems. The questions target the competencies needed to set up and run effective PV units that protect patients, comply with regulations, and support drug safety across clinical and post-marketing settings.

Q1. What is the primary objective of a pharmacovigilance (PV) centre in a hospital?

• Detect, assess, and prevent adverse drug reactions (ADRs)
• Manufacture and distribute medicines to patients
• Promote pharmaceutical products within the hospital
• Conduct routine laboratory diagnostics only

Correct Answer: Detect, assess, and prevent adverse drug reactions (ADRs)

Q2. Which national authority in India is primarily responsible for coordinating adverse drug reaction reporting?

• Central Drugs Standard Control Organization (CDSCO)
• United States Food and Drug Administration (US FDA)
• European Medicines Agency (EMA)
• World Health Organization (WHO) Headquarters

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q3. Which international standard is commonly used for electronic transmission of Individual Case Safety Reports (ICSRs)?

• ICH E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs)
• ICH E6 Good Clinical Practice
• MedDRA coding convention
• CTCAE (Common Terminology Criteria for Adverse Events)

Correct Answer: ICH E2B(R3) electronic transmission of Individual Case Safety Reports (ICSRs)

Q4. Which standardized dictionary is used worldwide for coding adverse event terms in pharmacovigilance?

• Medical Dictionary for Regulatory Activities (MedDRA)
• SNOMED CT (Systematized Nomenclature of Medicine)
• ICD-10 (International Classification of Diseases)
• ATC (Anatomical Therapeutic Chemical classification)

Correct Answer: Medical Dictionary for Regulatory Activities (MedDRA)

Q5. What is an essential IT requirement for a functional PV centre?

• Secure safety database with audit trail and role-based access
• Only a standard email account for receiving reports
• Paper forms stored in open cabinets only
• Fax machine as the sole reporting channel

Correct Answer: Secure safety database with audit trail and role-based access

Q6. Which of the following staff positions is critical to assign when establishing a PV centre?

• Designated Pharmacovigilance Officer (Pharmacovigilance-trained pharmacist/physician)
• Receptionist responsible for ADR causality assessment
• Marketing manager to lead safety signal reviews
• Laboratory technician only

Correct Answer: Designated Pharmacovigilance Officer (Pharmacovigilance-trained pharmacist/physician)

Q7. Which statement best describes SOP requirements for a compliant PV centre?

• Written and regularly reviewed SOPs covering all PV processes are required
• SOPs are optional and can be verbal instructions
• Only one general SOP for the entire hospital is sufficient
• SOPs are not necessary if staff are experienced

Correct Answer: Written and regularly reviewed SOPs covering all PV processes are required

Q8. According to ICH guidance, what is the expedited reporting timeline for fatal or life‑threatening SUSARs compared to other SUSARs?

• Fatal or life‑threatening SUSARs within 7 days; other SUSARs within 15 days
• All SUSARs must be reported within 90 days
• All SUSARs must be reported within 24 hours
• There is no distinction in timeline based on severity

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

Q9. Which is a practical KPI for evaluating PV centre performance in a hospital?

• Number of valid Individual Case Safety Reports (ICSRs) submitted per month
• Total number of patients admitted to the hospital per year
• Monthly pharmaceutical sales value
• Number of cafeteria meals served

Correct Answer: Number of valid Individual Case Safety Reports (ICSRs) submitted per month

Q10. What is the main operational difference between pharmacovigilance during clinical trials and in the post‑marketing setting?

• Clinical trials use active, protocol-driven data collection while post‑marketing relies mainly on spontaneous reporting
• Post‑marketing PV requires no documentation
• Clinical trial PV only collects safety data at the end of the study
• There is no difference; both follow identical processes

Correct Answer: Clinical trials use active, protocol-driven data collection while post‑marketing relies mainly on spontaneous reporting

Q11. Which analytical method is commonly used in databases for signal detection?

• Disproportionality analysis (e.g., reporting odds ratio, PRR)
• Random sample selection without statistical testing
• Qualitative guesswork based on individual cases only
• Relying solely on marketing surveys

Correct Answer: Disproportionality analysis (e.g., reporting odds ratio, PRR)

Q12. In India, to which programme should hospital ADR reports be transmitted for national pharmacovigilance coordination?

• Pharmacovigilance Programme of India (PvPI) at Indian Pharmacopoeia Commission (IPC)
• United States Food and Drug Administration (US FDA)
• European Medicines Agency (EMA)
• World Health Organization (WHO) regional office only

Correct Answer: Pharmacovigilance Programme of India (PvPI) at Indian Pharmacopoeia Commission (IPC)

Q13. What is a key data privacy practice when sharing case reports externally from a hospital PV centre?

• Anonymize or pseudonymize personal identifiers before external sharing
• Publish full patient identifiers in reports for transparency
• Send complete medical records through unsecured email
• No privacy measures are needed for safety data

Correct Answer: Anonymize or pseudonymize personal identifiers before external sharing

Q14. Which infrastructure item is essential for secure long‑term PV data storage?

• Secure servers with regular backups and disaster recovery plans
• Large public bulletin boards for paper forms
• Open shelf filing without locks
• Only personal external hard drives kept by staff

Correct Answer: Secure servers with regular backups and disaster recovery plans

Q15. Which of the following best summarizes the pharmacist’s role in a hospital PV programme?

• All of the above (detecting, documenting, assessing causality, reporting ADRs and educating staff)
• Only dispensing medications without documentation
• Managing billing and insurance claims only
• Performing surgical procedures

Correct Answer: All of the above (detecting, documenting, assessing causality, reporting ADRs and educating staff)

Q16. Which organisation maintains the global pharmacovigilance database VigiBase?

• Uppsala Monitoring Centre (UMC)
• World Health Organization (WHO) Headquarters in Geneva
• European Medicines Agency (EMA)
• United States Food and Drug Administration (US FDA)

Correct Answer: Uppsala Monitoring Centre (UMC)

Q17. What is an appropriate training schedule for PV centre staff to maintain competency?

• Initial induction training plus periodic refresher training at least annually
• Only initial training upon hiring, with no refreshers
• Training only when major incidents occur
• No formal training required for experienced staff

Correct Answer: Initial induction training plus periodic refresher training at least annually

Q18. How often should an internal quality audit of the pharmacovigilance system typically be performed?

• At least annually, with additional audits after major changes
• Never, audits are unnecessary for PV
• Daily full system audits are required
• Once every 20 years

Correct Answer: At least annually, with additional audits after major changes

Q19. What is usually the first step in the signal detection workflow within a PV centre?

• Aggregate and collate case reports and relevant data for analysis
• Immediately recall the product from the market
• Publish a safety bulletin before analysis
• Terminate the PV programme

Correct Answer: Aggregate and collate case reports and relevant data for analysis

Q20. What is a major benefit of integrating the PV centre with the hospital electronic medical record (EMR) system?

• Automated identification and facilitation of ADR reporting from clinical data
• Guaranteed increase in drug sales
• Elimination of all manual documentation permanently
• Removal of need for PV staff training

Correct Answer: Automated identification and facilitation of ADR reporting from clinical data

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