Pharmacovigilance Programme of India (PvPI) MCQs With Answer

Pharmacovigilance Programme of India (PvPI) MCQs With Answer

The Pharmacovigilance Programme of India (PvPI) is India’s national system for monitoring drug safety and adverse drug reactions (ADRs). Designed for B.Pharm students, this introduction covers core concepts: ADR reporting, Adverse Drug Reaction Monitoring Centres (AMCs), the National Coordination Centre at the Indian Pharmacopoeia Commission (IPC), signal detection, Individual Case Safety Reports (ICSRs), causality assessment (WHO-UMC, Naranjo), VigiFlow/VigiBase integration, and roles of pharmacists in drug safety, risk minimization and regulatory action. Understanding PvPI helps future pharmacists contribute to safer medication use and evidence-based pharmacovigilance. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is the primary objective of the Pharmacovigilance Programme of India (PvPI)?

• To promote pharmaceutical manufacturing
• To monitor and improve patient safety by identifying and evaluating adverse drug reactions
• To regulate drug prices
• To provide clinical trials approval

Correct Answer: To monitor and improve patient safety by identifying and evaluating adverse drug reactions

Q2. Which organization acts as the National Coordination Centre (NCC) for PvPI?

• Central Drugs Standard Control Organization (CDSCO)
• Indian Pharmacopoeia Commission (IPC)
• World Health Organization (WHO) India Office
• National Institute of Pharmacology

Correct Answer: Indian Pharmacopoeia Commission (IPC)

Q3. Which of the following best defines an adverse drug reaction (ADR) as used in pharmacovigilance?

• A beneficial effect of a drug at therapeutic doses
• An unintended and harmful response to a drug at normal doses used for prophylaxis, diagnosis or therapy
• An overdose deliberately taken by the patient
• A manufacturing defect in the drug product

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

Q4. What is an Individual Case Safety Report (ICSR)?

• A database of clinical trial protocols
• A detailed report of a single adverse event associated with a medicinal product
• A marketing authorization application
• A periodic financial statement of a pharmaceutical company

Correct Answer: A detailed report of a single adverse event associated with a medicinal product

Q5. Which reporting system or tool is commonly used by PvPI for case collection and transmission to global databases?

• EudraVigilance
• VigiFlow
• MedDRA Browser
• FDA Adverse Event Reporting System (FAERS)

Correct Answer: VigiFlow

Q6. What is the role of an Adverse Drug Reaction Monitoring Centre (AMC) under PvPI?

• Manufacture generic medicines
• Collect, evaluate and report ADRs to the NCC and maintain local pharmacovigilance activities
• Grant marketing authorizations
• Perform only clinical trials

Correct Answer: Collect, evaluate and report ADRs to the NCC and maintain local pharmacovigilance activities

Q7. Which causality assessment methods are commonly taught for evaluating ADRs in PvPI context?

• WHO-UMC scale and Naranjo algorithm
• Bradford Hill criteria and CONSORT
• ANOVA and Chi-square tests
• Kaplan-Meier and Cox regression

Correct Answer: WHO-UMC scale and Naranjo algorithm

Q8. Which type of pharmacovigilance reporting is most emphasized for spontaneous detection of unknown ADRs?

• Mandatory routine surveillance reports
• Spontaneous (voluntary) reporting by healthcare professionals and patients
• Only clinical trial reporting
• Annual marketing reports

Correct Answer: Spontaneous (voluntary) reporting by healthcare professionals and patients

Q9. Which global database receives safety reports from national programs like PvPI?

• VigiBase maintained by WHO-UMC
• PubMed Central
• SCOPUS
• ClinicalTrials.gov

Correct Answer: VigiBase maintained by WHO-UMC

Q10. What is a “signal” in pharmacovigilance?

• A confirmed causal relationship requiring no further action
• Information that suggests a new potentially causal association between a drug and an adverse event that warrants further evaluation
• A passive advertisement for a drug
• A statistical method for drug pricing

Correct Answer: Information that suggests a new potentially causal association between a drug and an adverse event that warrants further evaluation

Q11. Which stakeholders are primarily involved in PvPI activities?

• Only pharmaceutical companies
• Healthcare professionals, patients, AMCs, regulatory authorities (CDSCO/IPC) and industry
• Only patients and consumer groups
• Only international organizations

Correct Answer: Healthcare professionals, patients, AMCs, regulatory authorities (CDSCO/IPC) and industry

Q12. Which of the following is a key responsibility of pharmacists in pharmacovigilance?

• Only dispensing drugs without counseling
• Recognizing, reporting ADRs, counseling patients and contributing to risk minimization strategies
• Setting medication prices
• Performing surgery

Correct Answer: Recognizing, reporting ADRs, counseling patients and contributing to risk minimization strategies

Q13. Which classification describes Type A and Type B ADRs?

• Type A: Predictable and dose-related; Type B: Unpredictable and not dose-related
• Type A: Bacterial infections; Type B: Viral infections
• Type A: Allergic reactions only; Type B: Toxic reactions only
• Type A: Chronic effects; Type B: Acute effects

Correct Answer: Type A: Predictable and dose-related; Type B: Unpredictable and not dose-related

Q14. Which data elements are essential in a minimum ADR report?

• Patient details, suspected drug, adverse event description, reporter details and outcome
• Only the drug name
• Only the patient’s address and phone number
• Only the marketing authorization number

Correct Answer: Patient details, suspected drug, adverse event description, reporter details and outcome

Q15. What is signal validation in the context of PvPI?

• Distributing promotional material
• Confirming whether an observed association is real and not due to bias, confounding or chance
• Registering a drug in the market
• Calculating the cost-effectiveness of a drug

Correct Answer: Confirming whether an observed association is real and not due to bias, confounding or chance

Q16. Which source contributes to pharmacovigilance data besides spontaneous reporting?

• Preclinical animal studies only
• Clinical trials, literature reports, electronic health records and patient registries
• Only manufacturing records
• Only marketing surveys

Correct Answer: Clinical trials, literature reports, electronic health records and patient registries

Q17. What does risk minimization aim to achieve in drug safety?

• Maximize product sales
• Reduce the occurrence or impact of adverse drug reactions while preserving therapeutic benefits
• Eliminate all side effects completely
• Increase the frequency of dosing

Correct Answer: Reduce the occurrence or impact of adverse drug reactions while preserving therapeutic benefits

Q18. Which regulatory body in India uses PvPI data for safety-related regulatory decisions?

• Reserve Bank of India
• Central Drugs Standard Control Organization (CDSCO)
• Meteorological Department
• Ministry of Finance

Correct Answer: Central Drugs Standard Control Organization (CDSCO)

Q19. What is the importance of causality assessment in pharmacovigilance?

• To assign blame to manufacturers
• To determine the likelihood that a drug caused the observed adverse event and guide regulatory and clinical decisions
• To calculate drug prices
• To measure marketing effectiveness

Correct Answer: To determine the likelihood that a drug caused the observed adverse event and guide regulatory and clinical decisions

Q20. Which terminology is used internationally to code adverse event terms in pharmacovigilance?

• ICD-10 only
• MedDRA (Medical Dictionary for Regulatory Activities)
• DSM-5
• SNOMED CT only

Correct Answer: MedDRA (Medical Dictionary for Regulatory Activities)

Q21. How should a B.Pharm student contribute to improving PvPI reporting?

• Avoid discussing ADRs with patients
• Learn ADR recognition, encourage reporting, participate in AMC activities and educate peers and patients
• Only focus on dispensing prescriptions
• Only work in manufacturing

Correct Answer: Learn ADR recognition, encourage reporting, participate in AMC activities and educate peers and patients

Q22. What is periodic safety update reporting (PSUR) concerned with?

• Annual financial audits of a hospital
• Regular assessment of a drug’s benefit-risk profile over time
• Only the marketing plan of a drug
• Clinical trial recruitment metrics

Correct Answer: Regular assessment of a drug’s benefit-risk profile over time

Q23. Which attribute enhances the usefulness of an ADR report submitted to PvPI?

• Incomplete patient details
• Timely, accurate and detailed information including dechallenge/rechallenge and concomitant medications
• Only generic statements without specifics
• Only the reporter’s opinion without clinical data

Correct Answer: Timely, accurate and detailed information including dechallenge/rechallenge and concomitant medications

Q24. Why is patient/consumer reporting encouraged in pharmacovigilance?

• Patients never provide useful information
• Consumers can report adverse events directly, providing real-world perspectives and increasing signal detection
• It replaces healthcare professional reports entirely
• It is only for marketing research

Correct Answer: Consumers can report adverse events directly, providing real-world perspectives and increasing signal detection

Q25. What is dechallenge and rechallenge information in ADR reports?

• Information about marketing campaigns
• Observations about event resolution after stopping the drug (dechallenge) and recurrence after reintroducing it (rechallenge)
• Only laboratory batch numbers
• Patient demographic information only

Correct Answer: Observations about event resolution after stopping the drug (dechallenge) and recurrence after reintroducing it (rechallenge)

Q26. Which term describes an adverse event that is unexpected in nature or severity compared to the product information?

• Expected adverse event
• Unexpected adverse reaction
• Manufacturing defect
• Labelled side effect

Correct Answer: Unexpected adverse reaction

Q27. Which training topics are important for pharmacovigilance capacity building in B.Pharm curriculum?

• Only pharmaceutical chemistry
• ADR detection, reporting procedures, causality assessment, signal detection and regulatory pharmacovigilance
• Only marketing skills
• Only hospital administration

Correct Answer: ADR detection, reporting procedures, causality assessment, signal detection and regulatory pharmacovigilance

Q28. What does data confidentiality mean in the context of PvPI reporting?

• Public disclosure of personal patient information
• Protecting patient identity and sensitive information while using clinical data for safety analysis
• Sharing reports on social media without consent
• Publishing raw patient identifiers in databases

Correct Answer: Protecting patient identity and sensitive information while using clinical data for safety analysis

Q29. Which outcome may result from signal assessment by PvPI and regulatory authorities?

• No action is ever taken
• Regulatory actions such as label changes, safety alerts, risk minimization measures or further studies
• Automatic withdrawal of all drugs
• Only marketing promotions

Correct Answer: Regulatory actions such as label changes, safety alerts, risk minimization measures or further studies

Q30. Which practice improves the overall quality of pharmacovigilance outputs from an AMC?

• Irregular reporting and poor documentation
• Regular training, standardized case processing, timely reporting and quality assurance
• Reporting only severe cases and ignoring mild ADRs
• Keeping data siloed and not sharing with NCC

Correct Answer: Regular training, standardized case processing, timely reporting and quality assurance

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