欧盟药监局关于药品不良反应重复报告处理指南简介

摘 要 重复报告是指药品不良反应自发呈报系统数据库中，对同一患者的同一个不良反应的不同报告。由于不良反应报告主要采取自发呈报的方式，难以避免重复报告的问题，这给不良反应信号检测工作带来了挑战。本文基于欧盟药监局药品不良反应重复报告指南，介绍欧盟药监局关于药品不良反应自发呈报系统中重复报告数据的检测、确认和管理提出的指导原则和流程，并提出对我国药品不良反应监测的启示，以期对我国的药物警戒工作提供相关的参考。

Introduction about the European Medicines Agency Guideline on Duplicate Reports

ABSTRACT A duplicate report refered to the same individual cases reported to describe suspected adverse drug reaction related to the same individual patient. Spontaneous reporting system was the main source for adverse drug reaction report collection, duplicate reports would inevitably occur in spontaneous reporting system. Duplicate reports would pose challenge for signal detection. In this article, we introduced the Guideline on Detection and Management of Duplicate Individual Cases and Individual Case Safety Reports issued by European Medicines Agency and illustrate the steps of detection, confirmation and management of duplicate cases. In addition, we discussed what we can learn from this guideline so as to provide reference for pharmacovigilance work in China.