P77 Pediatric drug data in Canadian drug monographs

Background Optimal drug therapy in children relies on availability of pediatric-specific information. European and American legislative initiatives have resulted in advancement of pediatric pharmacotherapy data. We aim to describe the quality and quantity of pediatric information in drug monographs of New Active Substances (NASs) approved by Health Canada. Design/Methods Canadian drug monographs of NASs approved by Health Canada, from January 2007 until December 2016, were systematically reviewed for pediatric-specific information. Pediatric-specific information defined as: pediatric indication, dosing, pediatric-friendly dosage forms, and pediatric safety data. Results Over the period of the study, Health Canada approved 281 NASs. Of all the non-biologic NASs (205, 74%), 39(19%) were approved for use in pediatric patients. The number of drugs with pediatric approval was lowest in 2008 (1, 8%) and highest in 2016 (8, 32%), following no specific pattern. Neonates had the lowest rate of drug approvals through all pediatric age groups (4, 2%). All drugs with pediatric approval had pediatric-specific dosing information with the majority of them presenting pediatric safety data (79%). Pediatric friendly formulation was only available in 20%(8) of drugs with pediatric approval. Studies in pediatric populations were the source of pediatric information in 59%(23) of drugs with pediatric approval. Conclusion(s) Less than 20% of the NASs approved by Health Canada for use in adults contain pediatric approval. Neonatal populations remain a therapeutic orphan, with severe lack of dosing and safety information. Safe and effective pediatric pharmacotherapy requires well-conducted pediatric research to enhance pediatric drug data. Canadian children are in need for legislative initiatives to promote pediatric drug development. Disclosure(s) Nothing to disclose