药品已知不良反应信息数据库构建的方法和意义

目的构建药品已知不良反应信息数据库,探讨加强和提高我国药品不良反应监测工作向科学化、规范化、透明化发展的方法和意义。方法以约2.6万份国家食品药品监督管理局(SFDA)批准药品说明书中不良反应信息为对象,对药品说明书中不良反应数据进行了标准化、结构化的信息处理。结果与结论建立了对药品说明书中药品已知不良反应数据进行标准化、结构化处理的技术规范与工作流程,初步构建了一个药品已知不良反应信息数据库,对药品监测与评价及工作质量与效率起到了较好的促进和推动作用。

Methods and Significance of Constructing the Database of Adverse Drug Reaction Information

Objective Construct the database of the adverse drug reaction information and explore the methods and significance which strengthen the efficiency and levels of the adverse drug reaction monitoring and promote it more legislative,more scientific and more transparent.Methods The researched objects are 26,000 pieces of package insert which were approved by SFDA.We dealed with the adverse drug reaction of the package insert in order that the information was more standardized and more structured.Results & Concl...