FDA www.fda.gov has access to multiple drug utilization databases, some of which contain pediatric use patterns, but it is not always possible for FDA to fully characterize pediatric drug use nationwide. Information is lacking from stand-alone pediatric hospitals where children may receive different therapeutic treatments compared to children treated in general hospitals or in outpatient settings.
FDA is trying to identify data sources that could provide nationally representative inpatient pediatric drug utilization patterns. This would help FDA better understand how drugs are being prescribed to children under real-world conditions.
On May 12th, FDA issued the Request for Information (RFI) titled “Access to Inpatient Pediatric Drug Utilization Data” to find sources available to provide continuous access to specific data on pediatric inpatient drug use that would include pediatric specialty hospitals, emergency departments, and if available treatment procedures and diagnostic information on pediatric patients.