[REG-04] Pharmacovigilance Programme of India (PvPI), ADR Causality Assessment, Materiovigilance & Medication Safety

REG-04 • 10. Clinical & Hospital Pharmacy

Learning Objectives

Trace the institutional framework of the Pharmacovigilance Programme of India (PvPI — National Coordination Centre at IPC Ghaziabad, AMC network, VigiFlow, WHO-UMC Uppsala).; Apply the WHO-UMC Causality Assessment Scale (Certain, Probable/Likely, Possible, Unlikely, Conditional, Unassessable) and Naranjo ADR Probability Scale (Score ≥9 Definite, 5–8 Probable, 1–4 Possible, ≤0 Doubtful).; Classify ADRs (Rawlins–Thompson Types A to F: Augmented, Bizarre, Chronic, Delayed, End-of-use, Failure) and Preventability (Modified Shumock & Thornton).

Chapter Overview & Core Explanation

Pharmacovigilance is the continuous safety watch kept over medicines after they reach the public—detecting, investigating, and preventing Adverse Drug Reactions (ADRs) so that newly discovered risks prompt label updates, dose restrictions, or market withdrawals.

Key Exam & Clinical Takeaways

• The National Coordination Centre (NCC) for the Pharmacovigilance Programme of India (PvPI) is the Indian Pharmacopoeia Commission (IPC), Ghaziabad.
• On the Naranjo ADR Probability Scale: ≥9 = Definite, 5–8 = Probable, 1–4 = Possible, and ≤0 = Doubtful.

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