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目的:分析国产药品使用说明书所记载内容的完整性等,为临床使用及完善药品说明书提供参考。方法:随机抽取安徽省立医院临床应用的500种药品说明书,按国家食品药品监督管理局颁布的《药品说明书和标签管理规定》等,对说明书的完整性、规范性进行分析,采用Excel2003版录入统计。结果:500种药品说明书总合格率为50.60%(253/500),其中西药441种合格率为55.10%(243/441),中成药59种合格率16.95%(10/59)。说明书不合格的主要原因为项目缺项严重,如:儿童、老年用药与药物过量、药物不良反应、禁忌证等;说明书的纸张大小、字号等不统一。结论:药品说明书记载内容有待完善,印刷纸张、字体与字号、项目顺序与印刷颜色等有待统一。
OBJECTIVE: To analyze the integrity of contents recorded in the manual of domestic drugs and provide reference for clinical use and improvement of drug specification. Methods: Random selection of Anhui Provincial Hospital clinical application of 500 kinds of drugs manual, according to the State Food and Drug Administration promulgated the “Drugs and Labeling Regulations” and other instructions on the integrity, normativity analysis using Excel2003 entry statistics. Results: The total qualification rate of 500 kinds of medicine manuals was 50.60% (253/500), of which, the qualified rate of 441 kinds of western medicine was 55.10% (243/441), and the rate of 59 kinds of Chinese traditional medicine was 16.95% (10/59). The main reason for the failure of the manual is the lack of items serious, such as: children, older drugs and overdose, adverse drug reactions, contraindications; instructions paper size, size, etc. are not uniform. Conclusion: The contents of the drug documentation need to be improved, printing paper, fonts and font size, project order and printing color to be unified.