全国省级药品不良反应监测机构建设现状研究及对策

Research of the Present Situation of Construction and Countermeasures in Nationwide Provincial Adverse Drug Reaction Monitoring Organizations

目的对全国省级药品不良反应监测机构建设现状进行调研,了解当前省级监测机构设置的基本情况,为省级药品监督管理部门推进省级监测机构建设提供参考。方法通过问卷调研的形式对当前全国药品不良反应监测体系建设现状进行了研究。结果省级药品监督管理部门完成机构改革工作的有29个,占93.55%;全国目前设立了35个省级药品不良反应监测机构;有13个机构经当地编办批复,占41%;事业单位设置的有25个,占73.52%;全国省级监测机构经当地编办核准批复的编制总数为544人,实际现有人员队伍461人。结论进一步推进省级机构批复进程;建立独立法人的监测机构;全国省级监测机构职能应当统一,应开展药品不良反应监测、医疗器械不良事件监测、药物滥用监测、化妆品不良反应监测4项基本职能;至少应确保每百万人口配备1名专职人员。

Objective Conduct research on the construction status of the national adverse drug （provincial level） reaction monitoring organization, understand the basic situation of the current provincial monitoring organization setting, and provide reference for the provincial medicine supervision and administration department to develop provincial level monitoring organizations. Methods The author used questionnaire survey to conduct research on the construction status of the national adverse drug reaction monitoring system. Results 29 provincial level medicine supervision and admin-istration departments have completed the organization reform, which is 93.55% of all departments; 35 provincial level adverse drug reaction monitoring organizations are established currently in the country; 13 organizations have been approved by local authority, which accounts 41%; 25 organizations are government affiliated institutions, which accounts 73.52%; the total head counts approved by local authorities of the provincial level monitoring organizations in the country is 544, actual employed staff quantity is 466. Conclusion Further develop provincial organization approval process; setup monitoring organization as separate legal entity; the provincial level monitoring organization should have unified functions, the basic four functions should be adopted： adverse drug reaction monitoring, medical device adverse events monitoring, drug abuse monitoring, adverse cosmetic products reaction monitoring; ensure at least one special personnel per one million population.