Drug Manipulation in Pediatric Care: A Scoping Review of a Widespread Practice Signaling Systemic Gaps in Pharmaceutical Provision

BACKGROUND: Pediatric patients often receive medicines manipulated from adult formulations due to a lack of age-appropriate products. While such practices are clinically routine, they may reflect deeper systemic deficiencies in pediatric pharmacotherapy.

OBJECTIVE: This scoping review aimed to map the prevalence, definitions, and types of pediatric drug manipulation and to conceptualize manipulation as an indicator of structural gaps in formulation science, regulation, and access.

METHODS: A systematic search of PubMed (January 2014-July 2024) included 10 studies reporting the frequency of drug manipulation in children aged ≤18 years. Eligible studies were synthesized narratively according to PRISMA-ScR guidelines.

RESULTS: Ten studies from nine countries were included, reporting manipulation frequencies ranging from 6.4% to 62% of all drug administrations and up to 60% at the patient level. Manipulated formulations most commonly included oral solid doses, altered through dispersing, splitting, or crushing. Definitions and methodologies varied considerably. The findings revealed five recurring structural gaps: limited pediatric formulations, inconsistent regulatory implementation, lack of standardized definitions and guidance, insufficient evidence on manipulation safety, and inequitable access across regions.

CONCLUSION: Manipulation of finished dosage forms for use in children is a widespread, measurable phenomenon reflecting systemic inadequacies in formulation development, regulation, and access. Recognizing manipulation as a structural indicator may guide policy, innovation, and equitable pediatric pharmacotherapy worldwide.