我国药品不良反应监测模式的趋势探析  

Ideas on Trend of ADR Monitoring Model in China

作　　者：沈璐[1] 刘巍[1] 郭雪[1] 彭丽丽[1] 孔繁瑶[1] 李馨龄[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2017年第5期295-297,308,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的研究探索我国上市后药物警戒工作的发展趋势。方法采用现状分析方法,针对现有问题,构想警戒工作发展的趋势和方向。结果针对报告质量参差不齐、企业责任落实不到位、医疗机构主渠道优势不明显等现状问题,设想通过强化现有不良反应监测系统、组建国家药品不良反应监测哨点联盟、探索数据源合作研究、开展企业培训和检查、升级PSUR模块、研究企业药品安全性监测与评价系统等方式,不断深化我国上市后药物警戒工作。结论不断强化企业意识、提升企业能力、落实企业责任和持续提升药品不良反应监测体系自身的监测评价能力。Objective To research and explore the trend of post-marketing pharmacovigilance in China. Methods The status analysis method was adopted, in view of the existing problems, the trend of post-marketing pharmacovigilance in China was conceived. Results In view of the uneven quality reports, corporate responsibility not in position, the main channel of medical institutions advantage not obvious ,and other current situations,this article suggested that we should strengthen the existing ADP,. monitoring system, establish national ADI（ monitoring sentinel union, study data source cooperation, train and inspect enterprise, upgrade PSUR. model, research on enterprise drug safety monitoring and evaluation system, and other methods to constantly deepen work of the post-marketing pharmacovigilance. Conclusion It would be the inevitable trend of post-marketing pharmacovigilance in China to constantly strengthen corporate responsibility, enhance the ability of enterprise, implement the responsibility of enterprise, and raise up the monitoring system＇s own ability of drug safety monitoring and evaluation.

关 键 词：药品不良反应 监测模式 发展趋势 

分 类 号：R994.11[医药卫生—毒理学]