欧盟药品安全监测系统概述及启示

doi:10.19803/j.1672-8629.2021.11.13

摘要/Abstract

摘要： 目的分析欧盟药品安全监测系统（EudraVigilance）,为升级我国药品不良反应监测系统提供思路和参考。方法从个例安全性报告、数据管理、数据分析3个环节研究欧盟药品安全监测系统,分析其关键功能和实现方式。结果欧盟药品安全监测系统通过网关传输报告、网页应用程序报告方式数据收集药品个例安全性报告,应用《监管活动医学词典》（MedDRA）、药品等字典和术语并通过重新编码和重复病例报告监测保障数据质量。结论建议借鉴欧盟药品安全监测系统完善我国监测系统,建立网关传输报告、网页应用程序报告等多种报告途径,通过应用术语字典、重复病例监测提升数据质量,建立数据仓库支持风险信号识别。

关键词: 药品安全：欧盟药品安全监测系统, 监测, 网关, 重复病例

Abstract: Objectiv eTo offer some tips about upgrading adverse drug reaction monitoring systems in China by analyzing the EU's drug safety monitoring system (EudraVigilance). Methods EudraVigilance was studied from three perspectives: case reporting, data management, and data analysis. The key functions and methods of implementation of EudraVigilance were analyzed. Results EudraVigilance collected individual case safety reports(ICSR) through gateway reporting and web reporting. Methods of data quality control in EudraVigilance included MedDRA, drugs dictionaries, case recoding and monitoring of duplicates. Conclusion It is recommended that the Chinese counterpart learn from EudraVigilance to improve adverse drug reaction monitoring systems in China by establishing gateway reporting, web reporting and other reporting channels, improving data quality using terminology dictionaries and duplicate monitoring, and establishing a data warehouse to support risk signal identification.

Key words: drug safety, EudraVigilance, monitoring, gateway, duplicates

中图分类号:

R994.11

侯永芳, 刘红亮, 漆燕. 欧盟药品安全监测系统概述及启示[J]. 中国药物警戒, 2021, 18(11): 1058-1061.

HOU Yongfang, LIU hongliang, QI Yan. An Overview of EudraVigilance and Implications for China[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1058-1061.

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