【摘要】 目的 调查我国药品不良反应监测哨点发现现状，为优化管理制度、提升监测能力提供建议。方法 梳理我国药品不良反应监测哨点管理制度，并于2023年8—10月，采用问卷调查法，面向国家级药品不良反应监测哨点开展哨点建设及运行现状调研；检索并分析欧盟和美国关于药品不良反应监测管理体系的官方文件，总结药品不良反应监测哨点工作管理经验。结果 共回收问卷308份，除宁夏、西藏外，我国已经建立国家药品不良反应监测哨点366家，多数可以根据现有管理制度完成相关资源配备、制度建立、监测报告上报和沟通协调等工作。2020—2022年，监测哨点上报的年度药品不良反应报告总数整体呈现增长趋势，245家（79.5%）监测哨点已经配备了信息化系统，182家（59.1%）监测哨点主动开展了药物警戒相关研究工作。美国和欧盟在药品不良反应监测方面起步较早，相关制度建立总体较为完善。结论 国家药品不良反应监测哨点建设经多年发展总体成效显著，但是仍然存在主动监测工作开展不足、信息化程度和数据分析能力较弱、医务人员上报积极性不高等问题。建议参考欧美经验对国家药品不良反应监测哨点进行标准化管理，建立高效能信息化系统，完善考核机制与奖惩制度，以提升监测水平。更多还原

【Abstract】 AIM To provide suggestions for optimizing the management system of drug adverse reaction(ADR) monitoring sentinel sites in China and enhancing the monitoring capacity. METHODS The management system of ADR monitoring sentinel sites in China was reviewed. From August to October 2023, a questionnaire survey was conducted among national ADR monitoring sentinel sites to investigate the construction and operation status of the sentinel sites. Official documents on ADR monitoring management systems from the European Union(EU) and the U.S. were retrieved and analyzed to provide references for China’s ADR monitoring sentinel site management system. RESULTS A total of 308 questionnaires were collected. Except for Ningxia and Tibet, 366 national ADR monitoring sentinel sites had been established in China, and most of them can complete the relevant resource allocation, system establishment, monitoring report submission, and communication coordination according to the existing management system. From 2020 to 2022, the total number of ADR reports submitted by the sentinel sites showed an overall increasing trend. Among the sentinel sites, 245(79.5%) have equipped with information systems for reporting ADRs, and 182(59.1%) actively conducted pharmacovigilance-related research. The U.S. and the EU started earlier in ADR monitoring, and their relevant systems were generally more well-established. CONCLUSION After years of development, the construction of China’s national ADR monitoring sentinel sites has achieved remarkable results. However, there were still some problems, such as insufficient active monitoring, weak information technology application and data analysis capabilities, and low enthusiasm of medical staff for reporting. It is suggested that China should refer to the experience of the EU and the U.S. to standardize the management of national ADR monitoring sentinel sites, establish high-performance information systems, and improve the assessment and reward-punishment mechanisms to enhance the level of monitoring.更多还原