Review Article: Role of Pharmacovigilance in Over-the-Counter (OTC) Medications for the Pediatric Population

Abstract

Over-the-counter (OTC) medications are widely used in children for the symptomatic management of minor ailments such as cough, cold, fever, and pain. However, children are not "small adults" — differences in body composition, organ maturity, metabolic capacity, and the near-total absence of pediatric-specific clinical trial data make this population uniquely vulnerable to adverse drug reactions (ADRs) and medication errors from products that are freely available without a prescription. Pharmacovigilance (PV), defined as the science of detecting, assessing, understanding, and preventing adverse effects of medicines, plays a pivotal role in safeguarding pediatric patients from the risks associated with unsupervised or inappropriate OTC drug use. This article reviews the rationale for pediatric pharmacovigilance, the specific vulnerabilities of children to OTC-related harm, landmark regulatory events that shaped current safety practices, the tools and reporting systems used for pediatric ADR surveillance, and the persistent challenges and future directions for strengthening drug safety monitoring in this population.