摘要
通过介绍美国FDA的哨点行动概况、哨点系统的特点和作用、哨点系统的建设进程等方面内容,分析了哨点系统这种分散数据库形式的主动监测模式对我国开展药品不良反应监测工作的现实意义和启发,尝试提出现阶段我国药品不良反应监测工作发展的基本原则和方向,设想构建以国家药品不良反应监测哨点联盟和数据源合作研究为具体内容的我国药品安全数据合作伙伴项目。
This article introduces the executive summary of sentinel initiative, the sentinel system vision, progress building the sentinel system. Then it analyses the practical meaning and inspiration for ADR monitoring in China by the sentinel system and tries to establish the fundamental principle and developmental trend of ADR monitoring in the current period. This article suggests the project of drug safety data partner cooperation in China, which includes China adverse drug reaction sentinel union and data source cooperation.
出处
《中国药物警戒》
2016年第12期737-739,744,共4页
Chinese Journal of Pharmacovigilance
关键词
哨点系统
主动监测
数据合作伙伴
国家药品不良反应监测哨点联盟
数据源合作研究
sentinel system
active surveillance
project of drug safety data partner cooperation
China adverse drug reaction sentinel union
data source cooperation
