Monitoring and Analysis of Adverse Drug Reactions in A Private Tertiary Care Hospital

Abstract

The detection of ADRs has become increasingly significant because of introduction of a large number of potent drugs in the last two or three decades, especially antimicrobials. ADRs could be monitored through active monitoring or through voluntary reporting system in a hospital set up. This observational prospective study spread over 12 month’s duration, was conducted on admitted patients after obtaining approval of ethics committee of the hospital. 3150 subjects receiving antimicrobial therapy were included in the study. The overall incidence of ADRs to antimicrobials in our study was 6.12%. ADRs related to gastrointestinal tract 117(60.62%) were most frequent. The lowest were blood dyscrasias 02(01.03). The highest incidence local site ADR’s was seen with piperacillin + tazobactum (1.5%) and (1.2%) respectively. Practically all antimicrobial agents cause local irritation at the site of administration. Highest incidence of GI effects was observed with ceftriaxone (10.9%). Diarrhoea occurred maximum with amoxycillin+clavulanic acid (4.1%). Amongst CNS manifestations the highest incidence of headache was with ciprofloxacin (0.9%). Cephalosporins (5.1%) had the highest incidence of development of dermatomucosal effects. Blood dyscrasias were seen in patients treated with metronidazole and cefoperazone+sulbactum. In the analysis of antimicrobial-related ADRs, it was found that most episodes were type A (87.05%). In this study majority of the ADRs episodes 106(54.9%) were judged as probable, 44(22.8%) as possible, and 43(22.3%) as definite. The implementation of adverse event monitoring and notification programs in hospital settings is an important action for the prevention of these events. These programs promote event surveillance and encourage their documentation and notification.