试论药品不良反应监测自发报告系统

目的:探讨药品不良反应(ADR)监测自发报告系统的报告形式、优点、局限性、影响因素和作用。方法:综合国内、外相关研究资料,以文献分析为主要方法,结合我国实际对ADR监测自发报告系统在药品安全性监测中的重要意义进行重点评价。结果与结论:ADR监测自发报告系统是药品风险管理的基础,是对上市后药品安全性早期预警最为快速、有力和经济的监管手段。

Analysis on Spontaneous Reporting System of ADR Monitoring

OBJECTIVE:To investigate the form, advantage, limitation, influence factor and effect of spontaneous reporting system of ADR monitoring. METHODS: Based on domestic and foreign literatures and information, the importance of spontaneous reporting system of ADR monitoring was evaluated with the method of literature analysis according to the condition of China. RESULTS&CONCLUSION: Spontaneous reporting system of ADR monitoring is the foundation of drug risk management and is the most rapid, powerful and economi...