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首页> 美国卫生研究院文献>Clinical Pharmacology and Therapeutics >Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee
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Ability of Primary Care Health Databases to Assess Medicinal Products Discussed by the European Union Pharmacovigilance Risk Assessment Committee

机译：欧盟药物警戒风险评估委员会讨论的初级保健健康数据库评估药品的能力

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摘要

This study measured the exposure to different categories of medicinal products discussed by the European Union (EU) Pharmacovigilance Risk Assessment Committee from September to November 2018 in four electronic primary care health databases: IQVIA Medical Research Data‐UK, IQVIA Medical Research Data‐France, IQVIA Medical Research Data‐Germany, and Clinical Practice Research Datalink Aurum, in the entire lifespan of each database until August 31, 2018. The assessment of 83 centrally authorized products and 45 nationally authorized products showed that coverage was better for products marketed for longer duration and worse for orphan drugs. The ability to detect associations against hypothetical comparators was better for more common events and for larger effect sizes. Coverage of advanced therapies was worse for those typically administered in a specialized rather than primary care setting. This study shows that to enable better informed regulatory decisions there is a need to access complementary data sources, particularly capturing secondary care prescribing.
机译：这项研究测量了欧盟（EU）药物警戒风险评估委员会于2018年9月至11月在四个电子基层医疗健康数据库中讨论的不同类别药品的暴露程度：IQVIA Medical Research Data‐UK，IQVIA Medical Research Data‐France，直到2018年8月31日，在每个数据库的整个生命周期中，IQVIA Medical Research Data-Germany和Clinical Practice Research Datalink Aurum。对83种集中授权产品和45种国家授权产品的评估表明，覆盖范围较长的产品销售范围更好对孤儿药更糟。对于更常见的事件和更大的效应量，检测与假设比较者的关联的能力更好。对于那些通常在专门而非基础医疗机构中进行治疗的患者而言，先进疗法的覆盖范围更差。这项研究表明，为了更好地做出明智的监管决策，需要访问补充数据源，尤其是获取二级保健处方的信息。

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