180份口服化学处方药说明书调查分析

目的:了解口服处方西药说明书质量现状,为进一步规范药品说明书提供参考。方法:选取市场流通的口服化学处方药说明书180份,根据国家食品药品监督管理局2001年颁布的《药品说明书规范细则》及其他参考资料对说明书的各项内容进行检查,统计存在问题的说明书数量,并对典型问题加以分析。结果:180份处方药说明书中存在问题的处方药说明书为109份(60.56%),共出现问题167处,以药品名称、贮藏、用法用量为主。结论:药品说明书质量亟待提高。

Research and Analysis of 180 Package Inserts of Oral Chemical Prescription Drug

OBJECTIVE:To probe into the quality of the package inserts of oral chemical drugs to lay a foundation for the further standardization of drug package inserts.METHODS:180 package inserts of oral chemical drugs current on market were selected and subjected to inspection in accordance with the Regulatory Guidelines for the Package Inserts of Drugs announced by SFDA as well as other related references to find out the problems existing in the package inserts,and a statistical analysis was conducted on the typical problems.RESULTS:Among the 180 package inserts,109(60.56%)had problems(totaled 167 defects)predominantly in drug name,storage,usage and dosage.CONCLUSION:It is urgent to improve the quality of the package inserts.