Paulsson M, Hamre Svendsen R, Andersen J K N, Kälvemark Sporrong S, Andersson Y, Tho I
Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden.
Children's Hospital, Uppsala, Sweden.
Acta Paediatr. 2025 Oct;114(10):2480-2489. doi: 10.1111/apa.70199. Epub 2025 Jul 2.
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.
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.
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.
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.
探讨儿科医疗中固体口服剂型操作相关的挑战和风险。汇编相关建议以支持儿科患者的安全性、有效性及患者治疗结果。
基于在PubMed、Scopus和Web of Science（2000 - 2024年）中进行的文献检索开展叙述性综述，包括监管指南和临床病例报告。选择重点为涉及儿童口服药物操作的研究，特别是剂量提取、分散片剂以及通过肠内管给药。
由于缺乏适合儿童年龄的剂型，15% - 37%的儿科口服药物给药需要进行操作。常见操作包括片剂分割、碾碎或分散，这常常导致剂量不准确、溶解度可变以及药代动力学不一致。使用肠内喂养管的儿童或操作难溶性药物时风险会升高。研究表明，操作可能导致给药错误并带来潜在危害。
儿科口服药物操作很普遍，但往往缺乏证据支持。更安全的做法需要改善获得许可剂型的途径、更好的培训以及临床支持工具。药学配制、个性化生产和3D打印等技术可能会降低风险。监管协调和跨学科合作对于提高儿科患者的药物安全性和治疗结果至关重要。
