我国儿童用药药政法规的规范化探讨

Exploration of the Standardization of Drug Administration Legislation for Pediatric Medication in China

目的:以《中国国家处方集(化学药品与生物制品卷·儿童版)》[简称《中国国家处方集(儿童版)》]为出发点,从政策和法律体系建设方面就完善我国儿童用药药政法规、规范儿童用药提出建议。方法:介绍美国、欧盟、英国、世界卫生组织(WHO)儿童用药药政法规的发展与建立以及我国儿童用药的现状,描述《中国国家处方集(儿童版)》的出台情况与特点,分析我国目前儿童用药现存药政法规存在的问题,探讨如何规范化我国儿童用药药政法规。结果与结论:为了规范儿童用药,美国建立了一套系统的儿童用药安全保障体系,欧盟确立了儿童用药的立法框架,英国出版了《英国国家处方集(儿童卷)》,WHO组织编制了《WHO儿科示范处方集》。我国于2013年出台了《中国国家处方集(儿童版)》,但在政策和法规方面没有制订独立儿童用药管理法规,存在儿童用药品种少,规格、剂型少,不合理用药,药品不良反应发生率高等现象。因此,要从完善政策体系和相关立法方面着手,促进药物研发,严把生产、销售关,推动合理用药,建立儿童用药评价体系以及做好不良反应监测等,以规范儿童用药行为。

OBJECTIVE： To provide suggestions for the improvement of drug administration legislation and the standardization of pediatric medication, using Chinese National Formulary of Chemical Drugs and Biologicals for Children （called Chinese Na- tiond Formulary for Children for short） as a starting point. METHODS： The development and establishment of drug administration legislation for pediatric drugs in USA, European Union, United Kingdom and WHO were introduced as well as pediatric medica- tion in China; the issue and feature of Chinese National Formulary for Children were described; the problems of drug administra- tion legislation for pediatric medication were analyzed in China to explore the way to standardize it. RESULTS ＆ CONCLU- SIONS： To regulate pediatric medication, USA has established a seccurity system for pediatric medication, EU has established leg- islative framework for pediatric medication, UK has published British National Formulary for Children, and WHO has organized WHO Pediatric Demonstration Formulary. Our country has promulgated Chinese National Formulary for Children in 2013, but there is no an independent legislation for pediatric medication, and there are also many phenomena of fewer species, less specifica- tion and dosage fonlqs for pediatric medication, irrational drug use and the high incidence of ADR. So we need standardize pediat- ric medication through improving policy system and related legislation, promoting drug R＆D, supervising production and sale strictly, improving rational use of drugs, establishing pediatric medication evaluation system and ADR monitoring, etc.