中国药物警戒 ›› 2015, Vol. 12 ›› Issue (8): 476-478.

• 政策与法规研究 • 上一篇    下一篇

中国台湾地区药品不良品监测的现状

陈志东   

  1. 上海交通大学附属第六人民医院,上海 200233
  • 收稿日期:2015-06-30 修回日期:2015-09-02 出版日期:2015-08-08 发布日期:2015-09-02
  • 作者简介:陈志东,男,本科,副主任药师,药品不良反应监测。

Current Status of Surveillance for Medical Product Defects in Taiwan Area of China

CHEN Zhi-dong   

  1. Sixth People's Hospital Affiliated to Shanghai Jiaotong University, Shanghai 200233, China
  • Received:2015-06-30 Revised:2015-09-02 Online:2015-08-08 Published:2015-09-02

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摘要： 目的 介绍中国台湾地区的药品不良品监测,为中国大陆地区的药物安全性监测提供借鉴。方法 结合相关资料和作者在中国台湾地区的学习体会,介绍中国台湾地区药品不良品的概念、风险等级、作业流程及监测所取得的成效。结果 从2004~2013年,中国台湾地区药品不良品通报数量持续增长,平均每年通报500多件,其主要缺陷为药品包装和外观异常。结论 目前,药品不良品监测已成为中国台湾地区药物安全性监测的重要组成部分,在确保民众用药安全和药品品质提升方面发挥着越来越重要的作用。

关键词: 药品不良品, 监测, 中国台湾地区

Abstract: Objective To introduce surveillance for medical product defects (MPD) in Taiwan area of China, and to offer references for drug safety surveillance in Mainland China. Methods Based on the related data with the author's learning experience in Taiwan area of China, MPD related issues such as the concept, risk categories, operating procedure, and surveillance Results were all introduced. Results The number of MPD reports continues to grow, the annual average number is more than 500 from 2004 to 2013 in Taiwan area of China, and the major defects of MPD are abnormal drug packaging and appearance. Conclusion Now MPD surveillance is an important part of drug safety surveillance, which plays more and more role in ensuring the safety of drug use as well as improving the quality of drug in Taiwan area of China.

Key words: medical product defects, surveillance, Taiwan area of China

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