药品说明书安全事项调查分析

目的：探讨药品说明书中安全项目缺项状况及危害。方法：随机抽取临床使用的421份药品说明书,其中国产药品340份,合资药品27份,进口药品54份,对其安全项：成分、辅料、性状、不良反应、禁忌证、注意事项、孕妇及哺乳期妇女用药、儿童用药、老年人用药、药物相互作用、药物过量、药理毒理、药代动力学进行缺项统计。结果：药品说明书安全项缺项程度,依次为：中药——国产药品——合资药品——进口药品。结论：药品说明书中药品的关键安全数据和信息空缺严重,根本起不到指导临床安全、合理用药的目的,潜在危害很大。

Analyses based on a survey of medical instruction safety items

Objective：To research on lacunarity of medical instruction safety items and its possible hazards. Methods：Randomly drawing samples of instructions of 421 clinically-used medicamentss,and performing lacunarity statistics on such safety items as ingredients,accessories,shapes,side effects,contraindications,precautions,drug interactions,overdose,pharmacological toxicity as well as pharmacokinetics. Results：Missing items degree of safety items of drug instruction,followed by：traditional Chinese drugs,domestic-made drugs,joint drugs and imported drugs. Conclusion：Because of lacunarity of safety data and information,some medical instructions cannot safely and reasonably.