Publication:

Evaluation of adverse drug reactions in a tertiary care hospital in India

Background Adverse drug reaction (ADR) is a major concern in the healthcare system and has been a persistent issue in the health sector. This study aimed to evaluate and assess the ADRs reported, the system organ class (SOC) affected, seriousness, outcomes, causality.

Methods A retrospective observational study in a tertiary care hospital from April 2021 to May 2024. A descriptive analysis of reactions, causality of suspected drugs was carried out according to the setting analysed.

Results Out of 7,396 individual case safety report (ICSR) reported, the highest number of ADRS was reported in the age group of 18-65 years (57.8%) and male patients (51.1%). Using World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment scale, 67.1% events were possible. A significant majority of drug reported as ‘certain’ were of anti-infective class (51.03%). Most frequently affected SOC was blood and lymphatic system disorders (15.9%), Of all events, greater part of the reactions was non-serious (95.3%), the most drugs causing ADRs was anti neoplastic and immunodulating agents (40.4%) and 47.2% of drugs were high alert medications. The greater part of ADRs reporting was carried out by clinical pharmacists (95.9%).

Conclusions The results highlighted the importance of clinical pharmacist in monitoring and spontaneous reporting of ADRs. Awareness and educational programs may help in active reporting among all healthcare providers.