药品不良反应监测是依法对已批准上市的药品进行安全性监督,有效地减少药品危害重复发生的重要手段,既可提高合理用药水平,又可为上市药品的再评价提供科学依据。基于药品不良反应报告数据库的风险信号挖掘,是进行药品安全性评价的主要手段。保证报告的数量与质量,是做好药品安全性评价工作的前提和基础。笔者对北京市海淀区近几年的药品不良反应报告进行调查,发现报告中存在的一些共性问题。 Adverse drug reactions monitoring is to monitor the safety of drugs that have been approved for listing in accordance with the law and effectively reduce the important means of repeated occurrence of drug hazards, which can not only improve the reasonable level of drug use, but also provide a scientific basis for the re-evaluation of listed drugs. Risk signal mining based on ADR database is the main means to evaluate drug safety. The quantity and quality of assurance reports are the prerequisites and basis for the evaluation of drug safety. The author of Haidian District, Beijing in recent years, reports of adverse drug reactions to investigate and found some common problems in the report.