2015-2019年我国药品说明书修订通告发布情况及相关现状分析
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篇名: 2015-2019年我国药品说明书修订通告发布情况及相关现状分析
TITLE:
摘要: 目的:分析我国药品说明书修订现状,促进药品说明书的规范性。方法:回顾我国药品说明书管理相关法律法规,查询2015年1月-2019年5月国家药品监督管理部门网站公布的与药品说明书有关的公告通知等,分析其中涉及的药品种类、修订项目等资料,总结药品说明书及其修订过程中的内容与不足。结果:5年间共发布药品说明书修订通告112个(2015-2019年分别有20、28、19、34、11个),涉及270个品种。其中处方药109个、非处方药161个,中药158个、化学药品105个、生物制品2个,修订项目以【注意事项】、【不良反应】、【禁忌】、增加“警示语”等安全性信息为主,分别为100、85、103、52个。但笔者结合临床实践,发现仍存在药品说明书书写不规范、修订落实情况缺乏监管、厂家修订后没有通知相关使用单位等情况,严重威胁着患者用药安全。结论:纳入的药品说明书内容书写规范性欠佳、修订后的执行情况落实不到位,权利、义务划定不清晰,法律约束力不强。我国药品说明书的规范性有待进一步完善。
ABSTRACT: OBJECTIVE: To analyze the situation of drug instruction revision and promote the standardization. METHODS: By reviewing the laws and regulations on the management of drug instructions in China, inquiring the official documents of drug instruction revision during Jan. 2015 to May 2019, the types of drugs involved and the revised items were analyzed, and the contents and shortcomings of the drug instructions and their revision process were summarized. RESULTS: A total of 112 revision notices were issued in 5 years (20, 28, 19, 34, 11 revision notices in 2015-2019, respectively), involving 270 varieties. There were 109 prescription drugs, 161 OTC, 158 Chinese medicines, 105 chemicals, and 2 biological products. The revised items mainly focus on safety information such as precautions, adverse reactions, contraindications, and additional warnings, including 100, 85, 103, 52 items. However, in combination with clinical practice, the author found that there were still some problems, such as non-standard writting drug instructions, lack of supervision on the implementation of the revision, and no notification to the relevant users after the revision, which seriously threatened the safety of drug use. CONCLUSIONS: The included specifications of drug instructions are not well regulated, the implementation of the revised instructions is not doing well, the delineation of rights and obligations is confused, and the legal binding force is not strong. The standardization of drug instructions in China needs further improvement.
期刊: 2019年第30卷第21期
作者: 刘艳秋,王重娟,梁月琴
AUTHORS: LIU Yanqiu,WANG Zhongjuan,LIANG Yueqin
关键字: 药品说明书;修订通告;管理;分析
KEYWORDS: Drug instructions; Revision notice; Management; Analysis
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