A profile of adverse drug reactions to antimicrobial agents at a tertiary care hospital

Background: The study was undertaken to identify the Patterns, Predictability, Preventability and Outcomes of Adverse Drug Reactions (ADRs) caused by Antimicrobial agents (AMAs) in a tertiary care hospital. Material and Methods: A retrospective cohort study was carried out to analyze the Adverse Drug Reactions due to AMAs reported spontaneously from Hospitals attached to Bangalore Medical College & Research Institute to ADR Monitoring centre under Pharmaco vigilance Programme of India (PvPI) from 2012 (Jan) to 2015 (Dec). Patient demographics and other relevant details were collected as per Central Drug Standard Control Organization form. Causality was assessed by WHO ADR probability scale, preventability by modified Schumock & Thornton scale and severity by Modified Hartwig and Seigel scale. Results: A total of 505 ADRs were reported spontaneously during the study period, 100 (19.8%) ADRs were caused by AMAs. Male predominance (58%) with majority (57%) from age group of 21-40 years was noted. ADRs reported were mainly dermatological (58%), followed by gastro-intestinal (35%). Maculopapular rash (46%) contributed the most. Cephalosporins (35%), Fluoroquinolones (21%), Penicillins (16%) Antitubercular drugs (14%) and Macrolides (11%) contributed to the ADRs. 78% of the ADRs were of probable causality. 67% of ADRs were unpredictable, 5% were definitely preventable and 72% were of moderate severity. Causative drug was withdrawn in 80% and 79% of the patients recovered after medical treatment. Conclusions: Most of ADRs were caused by Cephalosporins and dermatological system was affected the most. Majority of the patients recovered with medical treatment. Early detection and treatment of ADRs improves patients care and drug safety. This study provides an insight to the healthcare providers on the importance of monitoring and reporting of Adverse Drug Reactions. Keywords: Adverse drug reactions, Antimicrobial agents, Preventability, Severity, Predictability, Cephalospori