2009年上海市药品不良反应/事件报告质量评估研究报告

来源 :上海食品药品监管情报研究 | 被引量 : 0次 | 上传用户:congmingwangzi
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为提高药品不良反应病例报告质量,促进药品不良反应监测工作规范开展,充分发挥药品不良反应监测的科学预警作用,对上海市辖区范围内各相关单位提交的药品不良反应/事件报告表填写质量情况进行摸底,于2010年4月至6月进行了对2009年收集的药品不良反应/事件报告质量评估(以下简称“报表质量评估”)工作。结果显示:2009年被抽样进行质量评估的报表总体质量一般,真实性方面未发现问题,规范性和完整性方面亟待加强,报告加分率低。 In order to improve the quality of adverse drug reaction reports and promote the standardization of adverse drug reactions monitoring work, give full play to the role of scientific early warning of adverse drug reactions monitoring, and fill in the quality of adverse drug reaction reports submitted by relevant agencies within the scope of Shanghai Municipality Conducted a thorough review and carried out the quality assessment of adverse drug reaction / incident reports (hereinafter referred to as “report quality assessment”) collected in 2009 from April to June 2010. The results showed that the quality of the reports sampled in 2009 was of general quality, no problems were found in the aspects of authenticity, normativeness and completeness needed to be strengthened, and the reporting rate was low.
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