Medication Exposure in Pregnancy Risk Evaluation Program

Susan E. Andrade, University of Massachusetts Medical School
Robert L. Davis, Kaiser Permanente
T. Craig Cheetham, Kaiser Permanente
William O. Cooper, Vanderbilt University
De-Kun Li, Kaiser Permanente
Thushi Amini, U.S. Food and Drug Administration
Sarah J. Beaton, LCF Research
Sascha Dublin, Group Health Center for Health Studies
Tarek A. Hammad, U.S. Food and Drug Administration
Pamala A. Pawloski, HealthPartners Research Foundation
Marsha A. Raebel, Kaiser Permanente
David H. Smith, Kaiser Permanente
Judy A. Staffa, U.S. Food and Drug Administration
Sengwee Toh, Harvard Medical School
Inna Dashevsky, Harvard Medical School
Katherine Haffenreffer, Harvard Medical School
Kimberly Lane, Harvard Medical School
Richard Platt, Harvard Medical School
Pamela E. Scott, U.S. Food and Drug Administration

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.