全球儿童合理用药国家药物政策现状分析  

Analysis of Global National Drug Policies on Rational Pediatric Drug Use

作　　者：陈敏[1,2,3] 张伶俐[1,2,3] 曾力楠[1,2,3] 李汶睿 刘丹[1,2,3] 

机构地区：[1]四川大学华西第二医院药学部,成都610041 [2]四川大学华西第二医院循证药学中心,成都610041 [3]出生缺陷与相关妇儿疾病教育部重点实验室,成都610041 [4]四川大学华西药学院,成都610041

出　　处：《中国药房》2017年第24期3313-3316,共4页China Pharmacy

基　　金：国家自然科学基金资助项目(No.81373381);四川大学华西第二医院新芽科研基金(No.kx034)

摘　　要：目的:评价全球儿童合理用药国家药物政策现状及实施情况,为建立适合我国国情的儿童合理用药国家药物政策提供决策依据。方法:检索国内外相关数据库,查阅世界卫生组织(WHO)、欧盟以及多个国家和地区的药品管理相关网站,用预先设计的数据提取表收集儿童合理用药政策相关信息,并进行归纳、总结和分析。结果:最终纳入45篇文献,涉及WHO和欧盟、美国、加拿大、英国、爱尔兰、荷兰、德国、西班牙、法国、澳大利亚、新西兰、中国、印度、韩国、日本、南非等多个国家和地区。各国儿童合理用药国家药物政策共同关注的要点包括促进儿童药物临床试验的开展,制定和推广儿童基本药物目录,制定和推广国家儿童处方集、标准治疗指南等用药标准,促进儿童药物上市后的监测等4个方面。美国、欧盟和日本制定了儿童药物临床试验的国家法规政策,WHO、南非和印度制定了儿童基本药物目录,WHO、英国和我国制定了儿童处方集。结论:建议相关部门参考美国和欧盟等国家和地区的经验,建立适合我国儿童疾病负担和用药情况的国家药物政策。OBJECTIVE： To evaluate evidence situation and implementation of global national drug policies on rational pediat- ric drug use, and to provide decision-making reference for setting up national drug policies for rational pediatric drug use which adapt to the situation of China. METHODS： By retrieving domestic and foreign related database, scanning drug management web- sites of WHO, the European Union as well as many countries and regions. A pre-designed data extraction form was used to collect information of the policies of rational pediatric drug use. The information was summarized and analyzed. RESULTS ： A total of 45 literatures were included, involving WHO and the European Union, the United States, Canada, Britain, Ireland, Holland, Germa- ny, Spain, France, Australia, New Zealand, China, India, Korea, Japan, South Africa and many other countries and regions. The main points of concern for the national policies of rational pediatric drug use in all countries included promoting the development of clinical trials of children＇s drugs, formulating and promoting essential medicine list for children, formulating and promoting stan- dard treatment guideline of national pediatric formulary, etc., and promoting pediatric drug monitoring after the listing. The United States, the European Union and Japan had enacted national laws and regulations on pediatric drug clinical trials; WHO, South Afri- ca and India had developed pediatric essential medicine list; WHO, Britain and China had established pediatric formulary. CON- CLUSIONS： It is suggested that the relevant departments should refer to the experiences of the United States and the European Union and other countries and regions to establish national drug policies which adapt to pediatric disease burden and drug use in China

关 键 词：儿童合理用药 国家药物政策 基本药物 处方集 

分 类 号：R983[医药卫生—药品]