中国药物警戒 ›› 2017, Vol. 14 ›› Issue (8): 489-492.

• 安全性评价与合理用药 • 上一篇    下一篇

基于药品不良反应监测系统的假冒伪劣医疗产品检测方法

王蒙, 郭晓晶1, 冯红云2, 侯永芳2, 叶小飞1, 张渊1, 张天一1, 贺佳1*   

  1. 1.第二军医大学卫勤系卫生统计学教研室，上海200433；
    2. 国家食品药品监督管理总局药品评价中心，北京100045
  • 收稿日期:2017-05-17 修回日期:2017-09-26 出版日期:2017-08-20 发布日期:2017-09-26
  • 通讯作者: 贺佳，女，博士生导师，药物流行病学及新药评价的统计分析。E-mail：hejia@smmu.edu.cn
  • 作者简介:王蒙，男，在读硕士，卫生统计学。
  • 基金资助:
    国家自然科学基金（81373105）：贝叶斯倾向性评分方法研究及其在药品不良反应信号检测中的应用；上海市公共卫生重点学科（815GWZK0901）：循证公共卫生与卫生经济学；上海市卫计委科研课题（201440379）：药品不良反应信号检测中混杂因素控制的倾向性评分方法研究。

Detection Methods of Substandard/Spurious/Falsely Labelled/Falsified and Counterfeit Medical Products Based on Adverse Drug Reaction Surveillance System

WANG Meng1, GUO Xiao-jing1, FENG Hong-yun2, HOU Yong-fang2, YE Xiao-fei1, ZHANG Yuan1, ZHANG Tian-yi1, HE Jia1*   

  1. 1.Department of Health Statistics, Faculty of Health Service, Second Military Medical University, Shanghai 200433, China;
    2. National Center for ADR monitoring, Beijing 100045, China
  • Received:2017-05-17 Revised:2017-09-26 Online:2017-08-20 Published:2017-09-26

PDF (PC)

251

摘要： 目的 假冒伪劣医疗产品不仅无法保证用药的有效性，还可能导致一些非预期的不良反应/事件，威胁公众的健康安全。当前对药品质量的检测除了依靠药物分析技术之外，还可以通过对药品上市后安全性数据进行挖掘，从而发现药品质量问题。方法 通过查阅相关文献对几种不合格药品的检测方法，包括不相称测定分析，时间变化监测算法，聚类分析，药品不良事件聚集性信号预警系统进行介绍。结果 上述几种检测方法都可以从一定角度发现药品质量问题。结论 假冒伪劣医疗产品的检测方法尚无金标准，针对具体数据可采用不同方法进行分析，以期为药品监管工作提供方向和帮助。

关键词: 劣质, 假造, 标签不当, 伪造, 假冒, 医疗产品, 检测方法

Abstract: Objective Substandard/Spurious/Falsely labelled/Falsified and Counterfeit(SSFFC) medical products can not only guarantee the effectiveness of drugs, but bring about unexpected adverse reactions/events, which may threaten public health. Detecting drug quality defects currently depends on the identification and early-warning of safety signals on post-marketing drugs besides pharmaceutical analysis. Methods In this paper, we introduce four detection Methods by literature review, including Disproportional Filter, Temporal Change Detection Algorithm, Cluster Analysis and Early Warning System on Cluster Adverse Drug Events. Results To some extent, four Methods above-mentioned can find drug quality defects. Conclusion So far, there are no golden standards in detection Methods of SSFFC medical products. Take different Methods to analyze data may be more effective, which may provide references for adverse drug reactions surveillance.

Key words: substandard, spurious, falsely labelled, falsified, counterfeit, medical products, dtectionmethods

中图分类号: