Evaluation Of The Potential Impact Of Drug-Gene Interaction Risk (Dgir) On Health Resource Utilization (Hru)

Abstract

A113Objectives: Regulatory policies, including economic incentivization through patent extensions, have been implemented to stimulate pediatric research, however disparity exists for the neonatal subpopulation. This analysis was conducted to identify the availability of neonate-specific data for frequently used medications in Neonatal Intensive Care Units (NICUs) and to determine the extent to which pediatric exclusivity has increased information for drugs used in neonates. MethOds: A search was conducted utilizing the FDALabels database to identify all FDAapproved NDA, BLA and ANDAs from 01/01/1980 to 08/01/2013 searching for the terms "neonate", "newborn" and "infant" present in any of the following label sections; "Indication and Usage", "Dosage and Administration" and "Pediatric Use". The results were cross-referenced with a recently published list of 100 frequently prescribed drugs in NICUs and drugs granted pediatric exclusivity by the FDA as of August, 2013. Results: A total of 737 unique labels for 110 distinct drugs were identified (including 18 combination products and 15 modified versions of previously marketed drugs). "Newborn" was identified in 450 labels; "infant" in 414 labels and "neonate" in 167 labels. More than one search term was found in 294 labels. Only 19% of drugs frequently used in NICUs mentioned neonates, newborns or infants on their labels. Mention of neonates, newborns or infants occurred in 4.5% (n= 9) of the drugs with pediatric exclusivity; while 8.7% (n= 17) of drugs granted pediatric exclusivity were used frequently in the NICU. Only two drugs frequently used in NICUs mentioned neonate, newborn or infant on their label and had pediatric exclusivity. cOnclusiOns: Despite regulatory incentives, a paucity of neonatal data exist for drugs frequently used in NICUs. Our data suggest that pediatric exclusivity did not yield sufficient neonatal data.