Our group has also pioneered the use of advanced epidemiologic analytic methods to study drug safety in pregnancy using large administrative databases to estimate causal effects of in utero drug exposure.
The three large administrative databases that we use are the Medicaid Analytic Extract, the Truven Health Marketscan database, and the International Pregnancy Safety Study consortium.
The three large administrative databases that we use are the Medicaid Analytic Extract, the Truven Health Marketscan database, and the International Pregnancy Safety Study consortium.
Medicaid Analytic eXtract
The Medicaid Analytic eXtract (MAX) is based on the records of Medicaid beneficiaries nationwide. Our group created the MAX pregnancy mother-infant linked cohort as part of an R01-funded study of antidepressant medications in pregnancy (RO1: HS018533-03), and it has subsequently formed the basis for an R01-funded study of the safety of other psychotropic medications in pregnancy (R01: MH100216) and an R01-funded study on the impact of opioid use during pregnancy (R01: DA044293-01A1).
We have used the MAX pregnancy cohort to study the associations between antidepressants, antipsychotics, mood stabilizers and other anticonvulsants, stimulants, and cardiovascular medications and various pregnancy safety endpoints. As it reflects the Medicaid population, the cohort includes an overrepresentation of teens and young women, African-Americans, and disabled persons; groups which are frequently underrepresented in clinical trials and voluntary cohort studies, but are those most at-risk for adverse pregnancy outcomes.
We have used the MAX pregnancy cohort to study the associations between antidepressants, antipsychotics, mood stabilizers and other anticonvulsants, stimulants, and cardiovascular medications and various pregnancy safety endpoints. As it reflects the Medicaid population, the cohort includes an overrepresentation of teens and young women, African-Americans, and disabled persons; groups which are frequently underrepresented in clinical trials and voluntary cohort studies, but are those most at-risk for adverse pregnancy outcomes.
TRUVEN HEALTH MARKETSCAN
The Truven Health MarketScan database is a database of >100 commercial health insurers that provide comprehensive medical coverage for about 25 million members annually with active policies located throughout the US. The database includes medical and pharmacy claims for privately insured patients. The pregnancy cohort is based on data from 2003 to 2014.
International pregnancy safety study
The International Pregnancy Safety Study (InPreSS) consortium is a collaborative between investigators from the Denmark, Finland, Iceland, Norway, and Sweden and our group. All groups have access to high quality data on medication exposure during pregnancy and infant outcomes. The nationwide Scandinavian registers data and US MAX data are analyzed with harmonized protocols in order to provide timely and accurate information on medication safety during pregnancy. This collaboration is funded by the NIH (R21 HD087913-01A1).