Pediatric Amikacin Therapy: Unveiling Adverse Drug Reactions through a Pharmacovigilance Study at AIIMS, Bathinda

Amikacin is commonly prescribed to pediatric patients as a bactericidal antibiotic. However, limited scientific data is available to determine safe and toxic levels in this population. This study aims to raise awareness among healthcare professionals about the adverse drug reactions associated with Amikacin therapy in pediatric patients and improve patient care and safety. The study involved a pharmacovigilance awareness program for healthcare professionals at the Pharmacovigilance unit of All India Institute of Medical Sciences (AIIMS), Bathinda. Patients reported adverse drug reactions (ADRs) through various means, such as phone or WhatsApp. The ADR reports were evaluated for demographic and ADR attributes such as date of onset, management description, causality, and overall event outcome. The causality of each ADR was determined using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale and Naranjo algorithm, and the severity was determined using the Modified Hartwig and Siegel Scale. Out of 60 pediatric patients given Amikacin, 5 reported adverse drug reactions. Most patients reporting ADRs were female, with a median age of 9 years and a median duration of one day. The adverse drug reactions were primarily skin-related and non-serious. The study highlights the need for a national-level control of preventable adverse drug reactions and a pediatric pharmacovigilance system in healthcare facilities. The data collected from this study will be used by the National Coordination Centre, Pharmacovigilance Programme of India, to create a drug alert and improve patient care and safety at the national level.