This research program develops infrastructure to enhance our ability to study the effects of medication exposure during pregnancy on the fetus by creating and maintaining linked data on mothers and infants. Cohorts of women delivering an infant and their children have been identified from two FDA contract sites using large automated databases that include membership, pharmacy, inpatient, and outpatient information. These sites include the Health Care Systems Research Network (with a subcontract to the Vanderbilt University School of Medicine) and Kaiser Permanente in California. Approximately 90,000 analyzable births per year are identified from these sites.
Specific components of the program include:
- Maternal-infant record linkage of all women delivering an infant between 2001 and the most recent date available
- Linkage to birth certificate data and death certificate data
- Development and maintenance of data files on maternal and child enrollment, outpatient drug dispensings, and inpatient and outpatient diagnoses and procedures, in addition to specific data elements obtained from birth certificate data (e.g., gestational age, maternal smoking status)
- Validation of data elements within the datasets, including diagnoses/birth outcomes reported in administrative data as well as data elements included in the birth certificates, through medical chart abstractions
- Potential linkage of the datasets to other internal (e.g. electronic health record) and external datasets (e.g. cancer registries)
- Andrade SE, Davis RL, Cheetham TC, Cooper WO, Li D, Amini T, Beaton SJ, Dublin S, Hammad TA, Pawloski PA, Raebel MA, Smith DH, Staffa JA, Toh S, Dashevsky I, Haffenreffer K, Lane K, Platt R, Scott PE. Medication Exposure in Pregnancy Risk Evaluation Program. Matern Child Health J 2012;16:1349-1354.
- Bobo WV, Davis RL, Toh S, Li DK, Andrade SE, Cheetham TC, Pawloski P, Dublin S, Pinheiro S, Hammad T, Scott PE, Epstein Jr RA, Arbogast PG, Morrow JA, Dudley JA, Lawrence JM, Avalos LA, Cooper WO. Trends in the use of antiepileptic drugs among pregnant women in the US, 2001-2007: a Medication Exposure in Pregnancy Risk Evaluation Program study. Paediatr Perinat Epidemiol 2012;26(6):578-588.
- Lawrence JM, Andrade SE, Avalos LA, Beaton SJ, Chiu VY, Davis RL, Dublin S, Pawloski PA, Raebel MA, Smith DH, Toh S, Wang JQ, Kaplan S, Amini T, Hampp C, Hammad TA, Scott PE, Cheetham TC; for the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) Study Group. Prevalence, trends, and patterns of use of antidiabetic medications among pregnant women, 2001-2007. Obstet Gynecol 2013;121:106-114.
- Andrade SE, Scott PE, Davis RL, Li DK, Getahun D, Cheetham TC, Raebel MA, Toh S, Dublin S, Pawloski PA, Hammad TA, Beaton SJ, Smith DH, Dashevsky I, Haffenreffer K, Cooper WO. Validity of health plan and birth certificate data for pregnancy research. Pharmacoepidemiol Drug Saf 2013;22:7-15.
- Hansen C, Joski P, Freiman H, Andrade S, Toh S, Dublin S, Cheetham C, Cooper W, Pawloski P, Li DK, Beaton S, Kaplan S, Scott P, Hammad T, Davis R. Medication exposure in pregnancy risk evaluation program: the prevalence of asthma medication use during pregnancy. Matern Child Health J 2013;17(9):1611-21.
- Li Q, Andrade SE, Cooper WO, Davis RL, Dublin S, Hammad TA, Pawloski PA, Pinheiro SP, Raebel MA, Scott PE, Smith DH, Dashevsky I, Haffenreffer K, Johnson KE, Toh S. Validation of an algorithm to estimate gestational age in electronic health plan databases. Pharmacoepidemiol Drug Saf 2013;22(5):524-32.
- Toh S, Li Q, Cheetham TC, Cooper WO, Davis RL, Dublin S, Hammad TA, Li DK, Pawloski PA, Pinheiro SP, Raebel MA, Scott PE, Smith DH, Bobo WV, Lawrence JM, Dashevsky I, Haffenreffer K, Avalos LA, Andrade SE. Prevalence and trends in the use of antipsychotic medications during pregnancy in the U.S., 2001-2007: a population-based study of 585,615 deliveries. Arch Womens Ment Health 2013;16:149-57.
- Avalos LA, Chen H, Yang C, Andrade SE, Cooper WO, Cheetham CT, Davis RL, Dublin S, Hammad TA, Kaplan S, Pawloski PA, Raebel MA, Scott PE, Smith DH, Toh S, Li DK. The prevalence and trends of antiviral medication use during pregnancy in the US: a population-based study of 664,297 deliveries in 2001-2007. Matern Child Health J. 2014 Jan;18(1):64-7.
- Hansen C, Andrade SE, Freiman H, Dublin S, Haffenreffer K, Cooper WO, Cheetham TC, Toh S, Li DK, Raebel MA, Kuntz JL, Perrin N, Rosales AG, Carter S, Pawloski PA, Maloney EM, Graham DJ, Sahin L, Scott PE, Yap J, Davis R. Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. Pharmacoepidemiol Drug Saf 2016;25(2):170-8.
Principal Investigators: Richard Platt, MD, MSc, Darren Toh, ScD
Funder: Food and Drug Administration
Project Leader: Susan Andrade