Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to characterize the utilization of ingestible sodium fluoride drug products among pediatric Medicaid patients, in preparation for a public meeting held to discuss the use, benefits, risks, and evidence gaps related to ingestible sodium fluoride drug products. The study assessed the amount of dispensing for orally ingestible sodium fluoride drug products among both pediatric and adult Medicaid patients, as well as the distribution of product National Drug Codes (NDCs) dispensed to Medicaid patients in the Sentinel System. The study also assessed the amount of dispensing for ingestible dietary supplements that contain sodium fluoride for background context.
Results showed that from 2018 to 2021, the use of ingestible sodium fluoride drug products decreased over time among the various pediatric age groups and that these products were most frequently dispensed to pediatric patients aged three to nine years. The analysis identified 21 ingestible sodium fluoride drug product NDCs dispensed during the study period among the Sentinel Medicaid patients.
The study provided information on how ingestible sodium fluoride drug products are used among pediatric patients in the Medicaid population, which represents a subset of the broader U.S. population exposed to ingestible sodium fluoride drug products. The Sentinel Medicaid analysis results supported FDA’s preparation for the public meeting.