Publication:

A prospective study on identification, assessment, and spontaneous reporting of adverse drug reactions at a tertiary care hospital

Background Adverse drug reactions (ADRs) significantly contribute to global morbidity and mortality. Voluntary ADR reporting is crucial for the Pharmacovigilance Programme of India (PvPi), which identifies and quantifies medication risks. This study monitors ADRs from various departments of a tertiary care hospital, assessing them for causality, preventability, and severity before reporting to the Indian Pharmacopoeia Commission (IPC).

Methods This prospective study was conducted over six months at a tertiary care hospital, which is an approved ADR Monitoring Centre (AMC). Data was collected by PharmD students, who assessed each ADR for causality, severity, and preventability using the World Health Organization (WHO) scale, Hartwig’s severity scale, and Schumock and Thornton scales. Descriptive statistics were used for analysis.

Results A total of 358 suspected ADRs were evaluated. Most reactions (87.98%) were classified as "moderate" in severity, with 45.53% considered not preventable. The majority of ADRs were categorized as probable (84.07%), with Class J drugs (Anti-infectives) being the most associated (29.89%). Most reports came from General Medicine (53.35%), and the primary affected organ systems were metabolic and nutritional (21%).

Conclusions Most ADRs in this study were caused by antimicrobials, highlighting the need for careful prescribing and patient monitoring. Type A ADRs were often underreported, with healthcare professionals focusing primarily on Type B and H reactions. This study emphasizes the importance of voluntary ADR reporting and the vital role of clinical pharmacists in assessing and documenting these reactions.