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欧洲儿科配方倡议研讨会报告:使用给药注射器和肠内附件改善儿科口服液体药物的管理。

European Paediatric Formulation Initiative workshop report: Improving the administration of oral liquid medicines in paediatrics using dosing syringes and enteral accessories.

机构信息

Jenny Walsh Consulting Ltd, BioCity Nottingham, UK.

Medicines Evaluation Board, Utrecht, the Netherlands.

出版信息

Eur J Pharm Biopharm. 2020 Jun;151:91-97. doi: 10.1016/j.ejpb.2020.04.007. Epub 2020 Apr 11.

Abstract

Accurate dosing of the right medicine to the right patient is a key element of safe and efficacious pharmacotherapy, yet prone to technical challenges and human error when dosing involves the administration of small volumes of liquid medicines. For this reason, the topic has gained increased attention over the last decade from multiple stakeholder parties e.g. academia, hospital pharmacy, the medical device and pharmaceutical industry, and regulatory agencies. It is now well acknowledged that spoons and cups are not suitable for the measurement of small volumes of oral liquid medicines and that syringes are a better alternative, but syringes for parenteral use should not be used for oral dosing in order to avoid accidental parenteral delivery of oral products. However, dosing accuracy of very small volumes of liquid medicines to young children, and especially pre-term neonates, is still not sufficiently ensured. A workshop was organised in 2018 by the European Paediatric Formulation Initiative to reflect on current status and challenges (first part) and possible strategies to improve the present situation (second part). A voting system (n = 24) was used to consider the most favourable solutions. The harmonisation and/or standardisation of the technical design of oral syringes (including e.g. female/male connection) was considered a key priority.

摘要

准确地给患者使用正确剂量的药物是安全有效的药物治疗的关键要素,但在给小体积的液体制剂进行给药时,容易出现技术挑战和人为错误。出于这个原因,过去十年间,学术界、医院药剂科、医疗器械和制药行业以及监管机构等多个利益相关方越来越关注这个话题。现在人们已经充分认识到,勺子和杯子不适合测量小体积的口服液体制剂,注射器是更好的选择,但不能将用于注射的注射器用于口服给药,以避免意外将口服产品进行注射给药。然而,对于婴幼儿,尤其是早产儿,非常小体积的液体制剂的剂量准确性仍不能得到充分保证。欧洲儿科配方倡议于 2018 年组织了一次研讨会,以反思当前的现状和挑战(第一部分),并探讨改善现状的可能策略(第二部分)。投票系统(n=24)用于考虑最有利的解决方案。口服注射器的技术设计的协调和/或标准化(包括例如阴/阳接头)被认为是一个关键的优先事项。

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