Eli Lilly and Company, Indianapolis, Indiana, 46285, USA.
Merck & Co., Inc., Rahway, New Jersey, 07065, USA.
AAPS J. 2024 Apr 4;26(3):43. doi: 10.1208/s12248-024-00896-9.
Medication administration via enteral feeding tubes (EFT) is a necessary practice for patients unable to swallow oral dosage forms due to a medical condition or treatment that affects the ability to swallow or the function of the gastrointestinal tract. Off-label administration of oral drug products via EFT raises concerns for pharmaceutical sponsors, regulators, and healthcare practitioners (HCPs) because of the potential risks this practice introduces to both the patient and the caregiver. These risks can be mitigated by generating data-supported instructions that patients and HCPs can use to ensure safe and accurate administration of oral drug products via EFT. This commentary presents an industry perspective on the testing that should be conducted to enable development of product-specific instructions in the labeling to support or advise against administration of oral drug products via enteral feeding tube. The proposal outlined in this commentary takes a risk-based approach, addressing recommendations from both regulatory agencies as well as considerations for expanding this testing to address needs specific to neonatal and pediatric populations.
经肠饲管（EFT）给药是一种必要的实践，适用于由于医疗状况或治疗而无法吞咽口服剂型的患者，这些状况会影响吞咽能力或胃肠道功能。由于这种给药方式可能会给患者和护理人员带来潜在风险，因此经 EFT 给予非标签药物产品引起了制药赞助商、监管机构和医疗保健从业者（HCP）的关注。可以通过生成数据支持的说明来减轻这些风险，患者和 HCP 可以使用这些说明来确保通过 EFT 安全、准确地给予口服药物产品。本篇评论介绍了一种行业观点，即应该进行哪些测试，以便在标签中为特定产品制定说明，以支持或反对通过肠内喂养管给予口服药物产品。本篇评论中概述的建议采用基于风险的方法，既考虑了监管机构的建议，也考虑了扩大这些测试以解决新生儿和儿科人群特定需求的因素。
