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

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

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。

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.