Vol. 7, Issue 2, Part H (2025)

Introduction: Over-the-counter (OTC) pediatric medications, particularly cough and cold preparations, continue to cause preventable adverse events despite regulatory advisories. Current pharmacovigilance systems are fragmented and lack adequate postmarket surveillance mechanisms.
Aim and Objective: To systematically examine how strengthened pharmacovigilance can address regulatory gaps in OTC pediatric medication oversight through comprehensive analysis of current surveillance mechanisms, adverse event patterns, and international best practices in drug safety.
Methods: Systematic review of 87 peer-reviewed publications (2015-2025) from SciSpace, PubMed, and Google Scholar databases using PRISMA guidelines. Data extraction focused on regulatory frameworks, pharmacovigilance system performance, adverse event profiles, stakeholder knowledge gaps, and policy interventions.
Results: Analysis revealed: (1) fragmented postmarket surveillance with variable data quality (72.6% evaluable cases from poison centers vs. 0.2% from media); (2) 188 fatalities associated with OTC pediatric medications, 60% in children <2 years; (3) inadequate age-based restrictions (35-45% of products carry ambiguous labeling); (4) low caregiver awareness (20-45% demonstrate adequate dosing knowledge); (5) significant geographic inequalities in surveillance capacity. Countries implementing mandatory age restrictions documented 35-50% reduction in adverse event rates within 2 years. Engineering controls and multi-source surveillance integration proved effective.
Discussion: Advisory approaches are insufficient for protecting vulnerable pediatric populations. The contrast between mandatory restriction approaches (showing measurable adverse event reduction) and voluntary recommendations (showing minimal compliance) demonstrates that regulatory enforcement is necessary. Stakeholder knowledge gaps, fragmented surveillance systems, and implementation barriers in resource-limited settings require comprehensive, phased approaches.
Conclusions: Strengthening pharmacovigilance for OTC pediatric medications requires mandatory regulatory requirements, integrated surveillance systems, enforced compliance mechanisms, and enhanced stakeholder engagement. Implementation of these evidence-based recommendations can substantially reduce preventable pediatric morbidity and mortality.