A Non-Interventional Data Collection Study on Pharmacovigilance To Improve The Drug Safety in Paediatric Population

Introduction:This non-interventional study aimed to enhance pharmacovigilance and improve the understanding of adverse drug reactions (ADRs) within the paediatric population, a demographic requiring focused drug safety monitoring.Materials and Methods:An observational, cross-sectional design was employed, utilizing passive surveillance and data from hospital records, pharmacovigilance databases (e.g., FAERS, WHO ICSRs), and surveys. The study included paediatric patients (0-18 years) on medication, focusing on spontaneously reported or observed ADRs. Data analysis involved descriptive statistics, comparative analysis, and disproportionality analysis for signal detection.Results:Analysis of 100 subjects (72% male, mean age 22.13±14.38 years) revealed a generally healthy cohort with stable vital signs. The ADR probability scale indicated strong temporal causality for reported events, though objective confirmation was limited. Participant knowledge of pharmacovigilance was moderate to excellent. Reported ADRs were primarily mild to moderate (e.g., nausea, abdominal pain), most commonly associated with Cefixime and Ondansetron, with no severe events observed.Conclusion:The study underscores the mild nature of ADRs for common paediatric medications and highlights a solid foundational knowledge of pharmacovigilance among participants. It reinforces the value of passive surveillance in paediatric safety monitoring and identifies opportunities for enhanced education to improve ADR reporting confidence and practice