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.
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
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