浅谈处方药说明书不良反应项存在问题及相关分析  

Analysis and suggestions on problems existing in adverse reaction section of labeling for prescription drug

作　　者：高永艳[1] 陈永[2] 

机构地区：[1]广东省中医院药学部,510370 [2]广东药学院附属第一医院药学部

出　　处：《中国现代药物应用》2013年第12期27-28,共2页Chinese Journal of Modern Drug Application

摘　　要：目的对我国处方药说明书不良反应项描述存在的问题作一分析,并提出相应的建议与对策。方法对照我国法规有关处方药说明书不良反应项的要求,阅读本院处方药说明书共575张,对不良反应项描述存在的问题进行分析。结果我国处方药说明书不良反应项描述存在较多不完善之处,相关的法规及指导原则内容相对简单,缺乏约束力。结论建立合理的规范说明书工作程序,完善处方药说明书不良反应项描述,从而更好地指导临床安全合理用药。Objective To analysis the problems existing in the adverse reaction section of labeling for prescription drug and provide corresponding suggestions for current drug labeling in China. Methods A survey was conducted by reviewing 575 labeling of prescription drug in our hospital, and the problems existing in the adverse reactions section of labeling was analyzed by compared with relevant laws and regulations. Results The survey indicated that most of drug labeling description on the adverse reactions was imperfect. Guiding principles for prescription drug labeling were relatively simple, and relevant laws and regulations were lack of binding. Conclusion A standard operation procedure should be developed to guide the description of the adverse reactions for prescription drug labeling so as to provide better service for rational use of drugs in clinical practice.

关 键 词：处方药 说明书 不良反应 分析 

分 类 号：R95[医药卫生—药学]