山东省药品不良反应数据标准化的分析与思考

目的：分析山东省药品不良反应数据标准化现状，探讨提高数据标准化的方法和措施。方法对全省2012～2014年度上报的药品不良反应数据的关键参数进行分析，统计在数据标准化方面存在的问题。结果山东省药品不良反应数据标准化程度逐年提高，但存在录入错误、填写不完整、数据库不完善等问题。药品批准文号、通用名称、生产企业名称、不良反应名称的不标准化率分别为4．46％、0．56％、1．24％、1．63％。结论应加强技术培训，建立报告审核制度，开发信息化辅助系统，提升药品不良反应监测数据的标准化。

Analysis and considerations on the data standardization of adverse drug reaction in Shandong Province

Objective To analyze the status of the standardization of drug adverse reaction data in Shandong Province, and considerate the methods and measures to improve the standardization of data.Methods The key parameters of adverse drug reaction data reported by 201 2 ~201 4 in the province were analyzed,and the problems existed in the standardization of data were analyzed.Results The standardization degree of adverse drug reaction data of Shandong province had increased year by year,but there were problems such as input errors,incomplete data,incomplete database and so on.The non -stand-ardized rates of drug approval number,approved drug name,pharmaceutical producing enterprises,adverse reactions were 4. 46%,0.56%,1 .24%,1 .63%,respectively.Conclusion To improve the standardization of drug adverse reaction monito-ring data,we should strengthen the technical training,establish the system of report and audit,develop the information assis-tant system.