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建立儿童用药和治疗委员会,确保为儿童提供基于证据和具有成本效益的医疗。

Establishment of a children's Drugs and Therapeutics Committee to ensure evidence-based and cost-effective medical treatment for children.

机构信息

Department of Clinical Pharmacology, Copenhagen University Hospital, Bispebjerg and Frederiksberg, Copenhagen, Denmark.

Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences University of Copenhagen, Copenhagen, Denmark.

出版信息

Br J Clin Pharmacol. 2024 Feb;90(2):378-387. doi: 10.1111/bcp.15944. Epub 2023 Dec 5.

Abstract

The prevalence of undocumented medical treatments among children is a significant issue, as well as many EU countries lack access to newly developed children-friendly medicines. Consequently, there is a pressing need for supplementary resources that can facilitate informed decision-making regarding children's medication. We therefore aim to describe the process of establishing a children's Drug and Therapeutics Committee (cDTC), as well as the preparing and implementation of recommendations for children in the capital region of Denmark. Following the guidelines outlined by the World Health Organization, we established a cDTC, and recommendations for paediatric medication practice were constructed from assessments of medication use patterns among children in the capital region between 2019 and 2021. The recommendations were meticulously crafted based on evaluation of the current marketing authorization landscape and existing best available evidence. In 2019, the capital region established the first cDTC supported by expert councils and an editorial board. A total of 2429 purchase item numbers covering 1 222 846 defined daily doses and 592 088 purchased packages covering 10 200 000 defined daily doses were identified in the secondary and primary sectors, respectively. Three comprehensive lists covering recommendations for newborns and children were published between 2021 and 2020 totaling 331 recommended pharmaceutical products. The recommendations primarily intended for use in the secondary healthcare sector were implemented through the revision of 38 paediatric- and six neonatal product ranges throughout capital region. In conclusion, recommendation lists for children governed by a cDTC provide a rational auxiliary tool that can be immediately implemented in the clinic.

摘要

儿童未记录治疗方法的流行率是一个重大问题,并且许多欧盟国家无法获得新开发的适合儿童的药物。因此,迫切需要补充资源,以促进针对儿童用药的知情决策。因此,我们旨在描述建立儿童药物和治疗学委员会(cDTC)的过程,以及为丹麦首都地区的儿童制定和实施建议的过程。根据世界卫生组织的指导方针,我们建立了一个 cDTC,并根据 2019 年至 2021 年期间首都地区儿童用药模式的评估,为儿科用药实践制定了建议。建议是根据对当前营销授权情况和现有最佳可用证据的评估精心制定的。2019 年,首都地区在专家委员会和编辑委员会的支持下建立了第一个 cDTC。在二级和一级部门中,分别确定了 2429 个购买项目编号,涵盖了 1 222 846 个定义日剂量和 592 088 个购买包装,涵盖了 10 200 000 个定义日剂量。在 2020 年期间,共发布了三批涵盖新生儿和儿童建议的综合清单,共有 331 种推荐药物。主要针对二级保健部门使用的建议是通过对首都地区的 38 种儿科和 6 种新生儿产品范围进行修订来实施的。总之,cDTC 管理下的儿童建议清单提供了一个合理的辅助工具,可以在临床中立即实施。

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