国内外药品说明书和标签管理中有关警示语的比较研究

Comparison of Related Content of Warnings in Drug Labels and Package Inserts at Home and Abroad

目的:为进一步改进和完善我国药品说明书和标签中警示语的管理提供参考。方法:通过查阅国内外有关药品说明书和标签管理的法规和文献,比较分析其中关于警示语的内容和管理规定。结果与结论:与国外相比,我国药品说明书和标签在警示语内容上力求最大程度地确保用药安全和有效,尽可能地提供准确、充分、全面、清晰的药品信息,但在增强清晰性和易读性方面尚需提高;在管理与法规方面没有明确具体的标准,尚需细化和完善。建议健全警示语的相关管理规范、强化相关法律责任、改进表达形式,用更形象易懂的文字或图形提醒用药人群。

OBJECTIVE： To provide reference for further improvement and perfection of the management of warnings in drug labels and package inserts in China. METHODS： By reviewing the related regulations of drug package inserts and labels and some literatures at home and abroad, the related content and regulations of warnings were analyzed comparatively. RESULTS ＆ CONCLUSIONS： Compared with foreign countries, the content of warnings in drug labels and package inserts strive to guarantee the safety and effectiveness of drug use furthest and provide accurate, enough, complete and clear drug information as much as possible in China; but there still is a long way to go to improve both the clarity and legibility of format related to the drug warnings. There is no definite management standard and laws, which should be refined and improved. It is suggested that we could further standardize the management of the warnings, strengthen the legal responsibility and improve expression so as to present the warnings more popular and easy to understand in image mode.