Author(s)
Shivani Kumari, Prof. Arti Solanki (associate professor)
- Manuscript ID: 140572
- Volume: 2
- Issue: 6
- Pages: 1616–1630
Subject Area: Other
Abstract
Background: Children are a pharmacologically vulnerable population whose unique developmental physiology fundamentally alters how drugs are absorbed, distributed, metabolized, and excreted. Despite constituting nearly 30% of India's population, pediatric patients remain poorly represented in clinical drug trials, leaving clinicians to navigate treatment decisions with limited age-specific evidence.
Objective: This review critically appraises the published literature on drug use patterns in pediatric patients, focusing on WHO prescribing indicators, off-label and unlicensed drug use, adverse drug reactions (ADRs), polypharmacy, and antimicrobial prescribing, with particular emphasis on evidence from Indian tertiary care settings.
Methods: A comprehensive, narrative synthesis of prospective observational studies, systematic reviews, and drug utilization reports published between 2014 and 2026 was performed. Key databases including PubMed, Google Scholar, and IndMED were searched using MeSH terms related to pediatric pharmacotherapy, drug utilization, off-label prescribing, and antimicrobial stewardship. Key Findings: Anti-infective agents, particularly beta-lactam antibiotics, consistently dominate pediatric prescriptions, with antibiotic prescribing rates in Indian settings ranging from 36% to over 90%—substantially exceeding the WHO benchmark of less than 30%. Off-label drug use affects 42%–70% of prescribed medications, driven predominantly by dose modifications and use outside approved age ranges. ADRs occur in 10%–26% of hospitalized children, most frequently involving antibiotics and the gastrointestinal system. Polypharmacy is prevalent in inpatient settings, affecting up to 52% of patients and correlating with prolonged hospitalization and intensive care admission. Conclusion: Significant gaps remain between current pediatric prescribing practices and evidence-based standards. Implementing pediatric antimicrobial stewardship programs, strengthening pharmacovigilance infrastructure, promoting generic prescribing, and integrating clinical pharmacists into care teams are critical steps toward safer and more rational drug use in children.