药品标签设计规范化及其临床意义

Design Normalization of Drug Labels and Its Clinical Significance

目的为提高药品标签设计规范性,推动制定有关药品标签设计规范(指南),为临床准确用药提供依据。方法通过对欧美和中国药品监管部门发布的药品标签规定进行对比,分析我国药品标签规定与欧美的差距以及可能带来的患者使用风险。结果与结论我国药品标签设计在标签设计布局、标签信息、药品通用名格式等内容与欧美规定相似,但在标签文字格式、文本颜色、文字要求等方面未有明确规定,建议制定并发布药品标签设计指南,加强对药品标签的指导,以利于临床用药安全。

Objective To improve the design normalization of drug labels in our country and promote publishing the guideline of label design, provide foundation for accurate clinical medication. Methods By comparing the difference between provisions of drug labels published by drug administration department in China, Europe and America, analyze the gap between our country and Europe and America as well as possible risk to patients. Results and Conclusion The design of drug labels in our country is similar with the West in design layout, label information, format of generic name and so on, but the text formatting, color, content requirement and other aspects are not explicitly stipulated. So it's recommended to formulate and issue the guideline of drug label design for strengthening guidance to drug label, so as to facilitate the safety of clinical medication.