Drug Use Among Pregnant Women with Live Births

    Basic Details
    Date Posted
    Friday, January 29, 2016
    Status
    Complete
    Medical Product
    angiotensin-converting enzyme (ACE) inhibitor
    anticonvulsant
    dabigatran
    lisinopril
    methotrexate
    mycophenolate mofetil
    paroxetine
    ribavirin
    selective serotonin reuptake inhibitor (SSRI)
    simvastatin
    sodium valproate
    statin
    valproic acid
    warfarin
    Description

    Development of analytic code to identify pregnant females based on diagnosis and procedure codes indicating a live birth in the Mini-Sentinel Distributed Database (MSDD), and assessment of prevalence of use of specific medications among these women.  A comparison group of age- and date-matched non-pregnant females is also identified.  Analytic code can be re-used by FDA to assess the use of medications during pregnancy.  Specifically, the code is readily adaptable to include different lists of medications for assessment, different time periods/calendar years for assessment, different age ranges of females, different lists of diagnosis and procedure codes to identify deliveries, to allow varying enrollment criteria.  The analytic code also allows the capacity to assess pre-existing conditions (diagnoses) and medications used before pregnancy, and restrict the population according to the presence or absence of these characteristics.

    The cohorts of interest are females ages 10 to 54 delivering a liveborn infant, and age- and date-matched non-pregnant females.

    Additional Details
    FDA Center
    CDER
    Time Period
    2001 - 2012
    Study Type
    Summary Table
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All females 10 to 54 years of age
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)
    Workgroup Leader(s)

    Susan Andrade ScD; Meyers Primary Care Institute, Worcester MA

    Darren Toh ScD; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Workgroup Members

    Noelle Cocoros DSc, MPH; Alison Kawai ScD; Katie Haffenreffer BS; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston MA

    Marsha Reichman PhD; Marilyn Pitts PharmD; Monika Houstoun PharmD, MPH; Katrina Mott MHS; Caren Kieswetter MD, MPH; Carrie Ceresa PharmD, MPH; Miriam Dinatale DO; Center for Drug Evaluation and Research, FDA, Silver Spring, MD