Medication Exposure in Pregnancy Risk Evaluation Program
Medication Exposure in Pregnancy Risk Evaluation Program
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DOI：
10.1007/s10995-011-0902-x
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发表时间：
2012-10-01
影响因子：
2.3
通讯作者：
Scott, Pamela E.
中科院分区：
文献类型：
--
作者：
Andrade, Susan E.;Davis, Robert L.;Scott, Pamela E.
为了描述一个研究怀孕期间药物安全性的计划，妊娠风险评估计划中的药物暴露(MEPREP)。MEPREP是一个多地点合作研究计划，开发该计划是为了能够对怀孕期间的药物使用和结局进行研究。合作者包括美国食品和药物管理局、HMO研究网络、加州北部和南部Kaiser Permanente以及范德比尔特大学的研究人员。每个站点都创建了数据集，将2001年1月1日至2008年12月31日期间分娩婴儿的妇女及其所生婴儿的医疗保健数据联系起来。标准化数据文件包括9个州内11个健康计划的母婴特征、用药和医疗保健；出生证明数据从州公共卫生部门获得。MEPREP目前有20多名药物安全研究人员参与，包括933,917名母亲接生的1,221,156名儿童的数据。目前的研究包括评估特定药物的流行率和使用模式，以及对行政和出生证明数据文件中的数据要素进行验证研究。MEPREP可以通过提供关于大量不同种族和地理分布的人口的信息来支持多项研究。这一合作伙伴关系结合了临床和研究专业知识以及数据资源，从而能够评估与怀孕期间用药有关的结果。
To describe a program to study medication safety in pregnancy, the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP). MEPREP is a multi-site collaborative research program developed to enable the conduct of studies of medication use and outcomes in pregnancy. Collaborators include the U.S. Food and Drug Administration and researchers at the HMO Research Network, Kaiser Permanente Northern and Southern California, and Vanderbilt University. Datasets have been created at each site linking healthcare data for women delivering an infant between January 1, 2001 and December 31, 2008 and infants born to these women. Standardized data files include maternal and infant characteristics, medication use, and medical care at 11 health plans within 9 states; birth certificate data were obtained from the state departments of public health. MEPREP currently involves more than 20 medication safety researchers and includes data for 1,221,156 children delivered to 933,917 mothers. Current studies include evaluations of the prevalence and patterns of use of specific medications and a validation study of data elements in the administrative and birth certificate data files. MEPREP can support multiple studies by providing information on a large, ethnically and geographically diverse population. This partnership combines clinical and research expertise and data resources to enable the evaluation of outcomes associated with medication use during pregnancy.