Drug Safety Alerts Issued by the National Coordination Centre for Pharmacovigilance Programme of India: Current Practices and Future Recommendations

Abstract

Background: Adverse drug reactions (ADRs) due to drug therapy are inevitable and prior knowledge of their causative agents can avoid unnecessary economic burden on patients as well as on the health-care system. Objectives: To create awareness among health-care professionals about the drug safety alerts (DSAs) issued by the National Coordination Centre for Pharmacovigilance Programme of India (NCC-PvPI) till December 2022 and to reiterate the importance of spontaneous reporting of adverse events for better patient care. Methodology: A retrospective analysis of 141 DSAs issued from March 2016 to December 2022 was done. The ADRs were analyzed for the type of reactions, system organ class, and according to drug class. Microsoft Office 2007 was used to formulate the data and presented it in a descriptive manner using numbers and percentages. Results: Out of 141 DSAs under analysis, 101 individual drugs, 2 drug classes, and 7 drug combinations have developed 144 ADRs. These ADRs were compressed into 86 different types as similar ADRs were caused by more than one drug. Drug Reaction with Eosinophilia and Systemic Symptoms is the most common ADR noticed, followed by skin manifestations such as toxic epidermal necrolysis, acute generalized exanthematous pustulosis, skin hyperpigmentation, fixed drug eruption, symmetrical drug-related intertriginous and flexural exanthema, and photosensitivity reaction. The most common causative drugs for ADRs were antimicrobial agents, cephalosporins being the most commonly implicated medication class. Conclusions: Most of the ADRs advised to closely monitor by the NCC-PvPI through DSAs were treatable by early and appropriate management. Due to the high number of skin manifestations observed in the analysis, the role of dermatologists in taking detailed drug history is critical when making a differential diagnosis of skin lesions. Motivation and creating awareness among health-care professionals and patients to spontaneously report adverse events can only strengthen the pharmacovigilance system in India.