Abstract
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.
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Acknowledgments
This study was supported through funding from contracts HHSF223200510012C, HHSF223200510009C, and HHSF223200510008C from the U.S. Food and Drug Administration (Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research).
Conflict of interest
Dr. Dublin has received has received a Merck/New Investigator Award from the American Geriatrics Society for work unrelated to this project. Other co-authors report no conflicts of interest.
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The views expressed in this paper are those of the authors and are not intended to convey official US Food and Drug Administration (FDA) policy or guidance.
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Andrade, S.E., Davis, R.L., Cheetham, T.C. et al. Medication Exposure in Pregnancy Risk Evaluation Program. Matern Child Health J 16, 1349–1354 (2012). https://doi.org/10.1007/s10995-011-0902-x
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DOI: https://doi.org/10.1007/s10995-011-0902-x