Abstract

ADVERSE DRUG REACTIONS IN TERTIARY CARE: CONCEPTS, BURDEN, AND BEST PRACTICE WORKFLOWS FOR PVPI ALIGNED HOSPITAL PHARMACOVIGILANCE IN INDIA

Nishu*, Dr. Amarjeet Singh, Deepika Chauhan

ABSTRACT

Background: Adverse drug reactions (ADRs) remain a preventable cause of morbidity and healthcare utilization. India's Pharmacovigilance Programme of India (PvPI) standardizes ADR reporting and contributes to WHO's global database, yet under reporting at the bedside persists. Objective: To synthesize core definitions and epidemiology; outline the WHO–UMC/PvPI architecture; and summarize validated assessment frameworks—Naranjo (causality), Modified Hartwig–Siegel (severity), and Schumock–Thornton (preventability)—with a pragmatic workflow for tertiary care teams. Summary: WHO defines ADRs as noxious, unintended responses at normal doses; serious events follow ICH E2A criteria. Hospital cohorts repeatedly implicate antibiotics, NSAIDs/analgesics, antithrombotics, antidiabetics, psychotropics, and anticancer agents; skin and gastrointestinalsystems are frequently involved. Standardizing Triage with Naranjo/Hartwig/Schumock integrated into the PvPI ADR form improves data quality and signal detection and supports safer prescribing. Conclusion: Embedding pharmacist led surveillance, point of care e reporting to PvPI/VigiFlow, and routine use of validated scales can increase reporting volume and quality and generate local real world evidence for national pharmacovigilance.

Keywords: Adverse drug reactions; Pharmacovigilance; PvPI; Naranjo; Hartwig–Siegel; Schumock–Thornton; Tertiary care; India.