中国台湾地区的药品疗效不等监测

Surveillance for Therapeutic Inequivalence in Taiwan Region of China

目的分享中国台湾地区药品疗效不等监测的经验。方法通过相关资料的分析,介绍中国台湾地区药品疗效不等的定义、通报和评估流程、疑似案件及主动监控机制。结果在2009～2014年间,中国台湾地区共收到药品疗效不等通报案件488件,经过分析评估,只有涉及左甲状腺素片的案件为疑似案件。结论目前,药品疗效不等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,有助于确保民众用药安全与药品品质的提升。

Objective To share the experiences of surveillance for therapeutic inequivalence （TIE） in Taiwan Region of China Methods Based on the related data, TIE related issues such as definition, procedures for report and assessment, suspected reported cases, and active surveillance mechanism in Taiwan Region of China were all introduced. Results There were 488 TIE reported cases from 2009 to 2014 in Taiwan Region of China, only one case was found related to the drug of levothyroxine tablet after assessing all the TIE reported cases. Conclusion Now TIE surveillance is an important part of drug safety surveillance which plays more and more roles in ensuring the safety of drug use as well as improving the quality of drug in Taiwan Region of China.