试论FDA“哨点行动”对我国药品不良反应监测工作的启示

通过全面介绍美国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、数据安全及隐私保护等方面内容,分析了哨点系统这种主动监测模式对于我国开展药品不良反应监测工作的现实意义和启发,并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。

Discussion on the Inspiration for the Practice of Adverse Drug Reaction Monitoring in China by FDA "Sentinel Initiative"

By introducing the executive summary of sentinel initiative,the sentinel system vision,progress building the sentinel system,progress ensuring security and privacy,to analyse the practical meaning and inspiration for Adverse Drug Reaction(ADR) monitoring in China by the sentinel system and try to establish the fundamental principle and developmental trend of ADR monitoring in the current period.