我国儿童药品目录与数据库相关问题分析及对策

The Problems on the List and Database of Medicines for Children and Corresponding Solutions

目的:我国目前没有《儿童药品基本目录》,本研究旨在通过分析现有儿童药品目录,探讨儿童用药数据库的建立及完善,以期能够为日后儿童用药工作提供建议。方法:结合《国家基本药物目录》、《WHO儿童基本药物标准清单》和已发表文献,通过分析国家药品监督管理局提供的儿童用药批准数据库,梳理现有儿童用药已批准上市情况,对其中问题进行分析,并给予相关对策建议。结果:2002—2019年共有10874个国产儿童药被批准;2014—2019年,共批准了153个进口儿童药。数据分析结果显示,儿童用药以常规片剂为主,儿童专用剂型较少;创新剂型药物缺乏;剂型分类不完整,表述方式不统一;说明书儿童用药剂量不准确;部分药品数据采集错误或缺失等。结论:建议利用国家政策鼓励生产厂家研发、生产适宜儿童使用的剂型;在建立儿童用药的数据库时,建议分出儿童专用药物数据库;对数据库中各列信息进行校准,并规定统一的填写标准,以保证数据库数据准确性。

Objective:At present,there is no Basic List of Children′s Drugs in China.This study aims to explore the establishment and improvement of children′s drug database by analyzing the existing list of children′s drugs,in order to provide suggestions for the work of children′s drug use in the future.Methods:Based on the National Essential Drugs Catalog,WHO Standard List of Essential Drugs for Children and published literature,the author analyzed the database of drug approval for children provided by The National Medical Products Administration,found out the problems and gave some suggestions.Results:A total of 10,874 domestic medicines for children were approved from 2002 to 2019.A total of 153 imported medicines for children were approved between 2014 and 2019.It is suggested that there may be some problems that need to be improved in the catalogue and database of medicines for children in China.Conventional tablets are the main drug for children,and there are few special dosage forms and innovative forms for children.The classification of dosage forms is incomplete and the expression methods are not uniform.The instructions for children′s drug dose is not accurate.There are missing values and outliers in the drug date.Conclusion:It is suggested that national policy should be used to encourage manufacturers to develop and produce dosage forms suitable for children.When establishing a database of medicines for children,it is recommended that the database be separated from that for children,rather than being mixed with medicines for adults.The information of each column should be calibrated and standard to ensure the accuracy of the database.