Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to estimate the prevalence of 59 pre-defined health conditions (using the Centers for Medicare and Medicaid Services' Chronic Conditions Data Warehouse criteria) among individuals with childbearing potential in the Sentinel Distributed Data. The prevalence of the pre-defined health conditions are an essential element to develop a tool to estimate potential medical product utilization upon approval among individuals with childbearing potential. Potential for product utilization upon approval is an important element to consider when determining the types of postmarket pregnancy safety studies. This work commenced to support the Prescription Drug Use Fee Act (PDUFA) VII Pregnancy Demonstration Projects.
The prevalence of the selected health conditions among individual with childbearing potential varied considerably. Anxiety disorder, depression, obesity, and hypertension were the conditions with the highest prevalence. The prevalence of the selected health conditions varied by age group and year.
The findings from this study will be considered to develop an algorithm to estimate potential medical product utilization upon approval among individuals with childbearing potential. This will support identification of the most suitable study approaches to assess medical product safety among pregnant individuals.