摘要
目的:调查分析药品说明书记载项目和内容的完整性,为完善药品说明书提供参考依据。方法:随机收集我院各药房药品说明书507份,其中包括中药、天然药物药品说明书56份,并根据国家食品药品监督管理局2006年颁布的《药品说明书和标签管理规定》及其他参考资料对说明书的各项内容进行调查,并分析每份说明书所应记载项目和内容的完整性。结果:507份药品说明书中,国内化学药品和生物制品厂家生产的365种药品的说明书中儿童用药、老年用药和药物过量的标注率分别为62.7%、64.7%、60.5%;国内中药厂家生产的56种中成药的说明书中,其中药理作用、不良反应、禁忌症、注意事项、药物相互作用的标注率分别为19.6%、16.1%、25.0%、66.1%、23.2%,均未完全达到国家规定标准。结论:药品说明书仍需要不断完善。药品说明书中儿童用药项目缺项严重,应当引起重视,加强管理。
Objective ：To investigate and analyze the items and contents so as to consummate the package inserts of drugs. Methods： Five hundred and seven package inserts were randomly sampled, among them including 56 Chinese formulated products, to inspect the integrity according to the ＂Regulations Guidelines for the Package Inserts of Drugs＂ announced by SFDA in 2006 as well as other related references and to find out the problems. Results： Among three hundred and sixty five package inserts of chemicals and biologicals producted domestically, marked rate were 62.7%, 64.7% and 60.5% respectively in drug use for children, drug use for the aged and overdose. Among fifty six package inserts of Chinese formulated products, marked rate were 19.6%, 16. 1%, 25.0%, 66. 1% and 23.2% respectively in pharmacologic actions, adverse reactions, contraindications, announcements and drug interactions; all failed to meet the state standards. Conclusions ： The package inserts need improving further. Great importance should be attached to the incomplete mark of drug use for children.
出处
《儿科药学杂志》
CAS
2009年第4期45-47,共3页
Journal of Pediatric Pharmacy
关键词
药品说明书
儿童用药
调查
分析
Package inserts of drug
Drug use for children
Investigation
Analysis
