Evaluation of drug safety in pediatric epileptic patients: A prospective interventional study with clinical pharmacist intervention at a tertiary care teaching hospital

Abstract

Abstract: CONTEXT: Epilepsy is a neurological disorder that is frequently observed among the pediatric populations, with a global prevalence of 7.5% per 1000 children. The main objectives of the therapy are to prevent or manage seizures, enhance the quality of life, and provide treatment without adverse drug reactions (ADRs). However, for children with epilepsy, the treatment goals also encompass improving learning abilities and daily living routines, in addition to eliminating the root cause, as childhood represents a hazardous phase of brain development. AIMS: The aims of this study were to evaluate, monitor, and manage ADRs for antiepileptic drugs (AEDs) in the pediatric population by clinical pharmacists’ intervention. SETTINGS AND DESIGN: A 1-year prospective interventional study was conducted at a tertiary care teaching hospital among pediatric epileptic patients. SUBJECTS AND METHODS: Patients n = 141 those who were satisfied with the abovementioned study criteria and taken their informed assent and consent of the patients before initiating the study were enrolled. STATISTICAL ANALYSIS USED: Data were analyzed using Excel-MS-Window Version-12. RESULTS: n = 141 patients were observed in this study, with the male population comprising the majority at 57%, whereas the female population accounted for 42.5%. The age group between 1 and 5 years was found to be the most prevalent. A further analysis revealed that monotherapy involving sodium valproate (23%) and levetiracetam (16%) was predominantly administered. The maximum number of ADRs was related to polytherapy, with generalized neurological and gastrointestinal tract discomfort being the most common at 31%. All observed ADRs were categorized as mild in nature and 97% were deemed preventable. CONCLUSION: Sodium valproate and levetiracetam are commonly employed AEDs as a solitary therapy, wherein the likelihood of encountering an ADR is amplified in the context of polytherapy. Timely identification and perpetual vigilance in monitoring ADRs can effectively mitigate the development of medical complications, and ultimately facilitate the attainment of predetermined therapeutic outcomes.