Diversifying the FDA’s Sentinel System with Rigorous Quality Inclusion Rules for the U.S. Medicaid Population

The U.S. Medicaid and Children’s Health Insurance Programs (CHIP) insure over 25% of the population and about 40-50% of pregnancies following expansions to the program over the last decade. Adding this low-income population to the U.S. FDA’s Sentinel System is a high priority, but data quality variability among the 50+ contributing jurisdictions requires rigorous preliminary review. 

This poster explores establishing jurisdiction-level, beneficiary-level, and record-level criteria for inclusion of Medicaid/CHIP data into a Sentinel Common Data Model (SCDM)-compliant database and documenting the fit-for-purpose requirements of the Medicaid/CHIP data for Sentinel System regulatory needs. It was presented at the 39th International Conference on Pharmacoepidemiology and Therapeutic Risk Management.