Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (8): 489-492.

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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

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

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