欧美非处方药药品说明书可读性测试简介及启示

中国药物警戒 ›› 2013, Vol. 10 ›› Issue (8): 464-467.

欧美非处方药药品说明书可读性测试简介及启示

汤韧¹,王晓燕²,杨悦^2*

1.国家食品药品监督管理局药品评价中心,北京100045；
2.沈阳药科大学工商管理学院,辽宁沈阳110016

收稿日期:2013-05-01 修回日期:2016-03-09 出版日期:2013-08-08 发布日期:2016-03-09
通讯作者: 杨悦,女,教授,博士生导师,药事法规与药品政策。E-mail：yyue315@126.com
作者简介:汤韧,男,本科,工程师,药品不良反应监测与评价。

Brief Introduction and Implication of the Package Leaflet Readability Guidelines of FDA and EMA

TANG Ren¹, WANG Xiao-yan², YANG Yue^2*

1.Center for Drug Reevaluation, SFDA, Beijing 100045, China;
2. School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2013-05-01 Revised:2016-03-09 Online:2013-08-08 Published:2016-03-09

摘要/Abstract

摘要： 目的对欧美非处方药（OTC）药品说明书可读性指南进行介绍,以期对我国OTC 药品说明书可读性研究提供借鉴。方法通过查阅国外文献,应用文献研究的方法进行分析对比。结果欧美开展药品说明书可读性测试后的说明书内容和效果与我国有较大差异。结论我国应借鉴欧美OTC 药品说明书可读性研究的相关内容,提高我国OTC药品说明书的可读性。

关键词: 可读性, OTC, 药品说明书

Abstract: Objective To introduce the readability guidelines of package leaflet in FDA and EMA, and put forward suggestions on developing labelling readability of China. Methods Literature study were used to analyze the foreign materials, and contrast the differences between China and them. Results There is a big difference between foreign countries and China on labelling content and effect after readability tests of package leaflet. Conclusion s We should learn achievement from FDA and EMA to improve readability of labelling.

Key words: readability, OTC, package leaflet

中图分类号:

R951

汤韧,王晓燕,杨悦 . 欧美非处方药药品说明书可读性测试简介及启示[J]. 中国药物警戒, 2013, 10(8): 464-467.

TANG Ren, WANG Xiao-yan, YANG Yue . Brief Introduction and Implication of the Package Leaflet Readability Guidelines of FDA and EMA [J]. Chinese Journal of Pharmacovigilance, 2013, 10(8): 464-467.

参考文献

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