A STUDY TO ASSESS, MONITOR, AND REPORTING OF ADVERSE DRUG REACTIONS IN A TERTIARY CARE TEACHING HOSPITAL: HIMS, HASSAN

Abstract

Objective: An adverse drug reaction (ADR) is an unwanted, undesirable effect of a medication that occurs during usual clinical use. ADR should be quickly identified and managed to limit their detrimental effects on the patient. This study was undertaken to characterize the pattern of ADRs reported through spontaneous reporting system at ADR reporting unit in a tertiary care teaching hospital. Methods: A prospective, observational study was conducted over 3 years between September, 2017 and August, 2019. The ADRs reported were from patients admitted inpatient department of hospital. Evaluation of patient demographics, drug and ADR characteristics, and outcome of the ADRs. Causality and severity assessment was done by the World Health Organization system and Naranjos scale. Results: 82 cases of ADRs were reported during the study period. More number of ADRs was from General Medicine and Pediatric departments, in which the most affected organ systems were the skin and the gastrointestinal tract. The antibiotic classes mostly accounted were cephalosporins. None of the ADR was fatal. Conclusion: ADRs to antibiotics are common and will be resulted in increased health-care cost due to the need of some interventions and increased length of hospital stay. The health-care system should promote proper documentation and periodic reporting to regional pharmacovigilance centers to ensure drug safety.