INCIDENCE OF ADVERSE EVENTS LINKED TO CLINICAL USE OF ANTIMICROBIAL AGENTS IN A TERTIARY CARE TEACHING HOSPITAL, KERALA, INDIA

Abstract

Background: Antimicrobial agents are essential in treating infections but are frequently associated with adverse drug reactions (ADRs), which can impact patient safety and healthcare costs. Understanding the incidence and nature of antimicrobial-associated ADRs is crucial for optimizing clinical management and antimicrobial stewardship.

Objective: This study aimed to assess the incidence, types, and severity of adverse events linked to antimicrobial use in a tertiary care teaching hospital in Kerala, India.

Methods: A prospective observational study was conducted in the inpatient departments of a tertiary care hospital. Patients receiving systemic antimicrobial therapy were monitored for adverse events. Data were collected on demographics, clinical presentation, suspected antimicrobial agents, and severity using standardized assessment scales. Statistical analysis was performed to identify risk factors associated with ADRs.

Results: A total of 53 antimicrobial-related adverse events were recorded. Hypersensitivity reactions were the most common, accounting for 79.2% of cases, followed by thrombocytopenia (5.7%), hepatitis (3.8%), and rare events such as Redman’s syndrome and tachycardia with tachypnea (1.9% each). The findings highlight the significant burden of antimicrobial-related ADRs and emphasize the importance of careful prescribing and vigilant monitoring.

Conclusion: The study underscores the need for enhanced pharmacovigilance, antimicrobial stewardship programs, and early identification of high-risk patients. Rational prescribing, pre-screening for drug allergies, and close monitoring can mitigate the risks associated with antimicrobial therapy, improving patient safety and treatment outcomes.