Spontaneous Adverse Drug Reaction Monitoring in A Tertiary Care Hospital in Northern India.

ABSTRACT

The present study was conducted to evaluate the spontaneous ADR monitoring in a tertiary care hospital. A total of 150 ADRs reports were collected. The WHO definition of an ADR was adopted. Evaluation of the data was done for various parameters which included types, severity and seriousness of reactions. Naranjo score was used for causality assessment. Overall occurrence of ADRs was more in males. Type A reactions (77%) accounted for majority of the reports. Gastrointestinal system (33%) was the most commonly affected organ system. Antibiotics (32%) were the drug class most commonly involved in ADRs. The suspected drug was withdrawn for the management of the ADR in the majority (82%) of the reports. Upon causality assessment, majority of the ADRs were rated as possible (64%). Mild and moderate reactions accounted for 23 and 65% of ADRs, respectively. The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital set up elsewhere, although there are few differences. Our evaluations revealed opportunities for interventions especially for the preventable ADRs to ensure safer drug use.