Challenges and Considerations in Manipulating Oral Dosage Forms in Paediatric Healthcare Settings: A Narrative Review
Mattias Paulsson, Robert Svendsen, J. A. Andersen, Sofia Kälvemark Sporrong, Yvonne Andersson, Ingunn Tho
Abstract
AIM: To explore the challenges and risks associated with the manipulation of solid oral dosage forms in paediatric healthcare. To compile recommendations to support the safety, efficacy and patient outcomes in paediatric patients. METHODS: A narrative review was conducted based on literature searches in PubMed, Scopus and Web of Science (2000-2024), including regulatory guidelines and clinical case reports. Selection focused on studies involving oral drug manipulation in children, particularly dose extraction, dispersing tablets, and administration via enteral tubes. RESULTS: Between 15%-37% of paediatric oral drug administrations require manipulation due to lack of age-appropriate formulations. Common manipulations include tablet splitting, crushing or dispersing, often resulting in dose inaccuracies, variable solubility and inconsistent pharmacokinetics. Risks are elevated in children using enteral feeding tubes or when manipulating poorly soluble drugs. Studies show manipulation can lead to dosing errors with potential harm. CONCLUSION: Oral drug manipulation in paediatrics is widespread but often unsupported by evidence. Safer practices require improved access to licensed formulations, better training and clinical support tools. Pharmacy compounding, personalised manufacturing and technologies like 3D printing may reduce risks. Regulatory alignment and interdisciplinary collaboration are critical to improving drug safety and outcomes for paediatric patients.