A PAN-CANADIAN STUDY ON THE COMPOUNDED MEDICINES MOST IN NEED OF COMMERCIALIZED ORAL PEDIATRIC FORMULATIONS

Abstract

Abstract BACKGROUND A large number of drugs administered to children have no commercially available formulations. As a result, health care providers and parents manipulate dosage forms designed for adults. Although compounding is essential to increase access to medicines for children, it can result in adverse events or therapeutic failure. There is an urgent need to undertake a mapping of the needs for child-friendly medicines in Canada. OBJECTIVES To determine: 1) the most frequently compounded medicines in Canadian paediatric hospitals; 2) the challenges associated with drug compounding; and 3) medicines most in need of commercialized oral paediatric formulations. DESIGN/METHODS Sixteen Canadian paediatric academic hospitals were contacted to participate in a telephone survey including 12 open-, close-ended or Likert-scale questions. RESULTS Thirteen centers participated in the survey (81.3%). Fifty-three drugs were identified as most in need of a commercialized oral paediatric formulation. Of those, 12 were reported by ≥4 hospitals as a priority (Table). The most frequently reported compounding challenges were: lack of standardization, bad taste, lack of awareness of prescribers, stability of the formulation, and availability of compounding pharmacies. CONCLUSION This study highlights which drugs are most needed for paediatric oral formulations in Canada. For compounded medicines with paediatric formulations available in other countries we are currently assessing their adequacy and partnering with pharmaceutical industry to bring them to the Canadian market. As for those medicines without paediatric formulations in Canada or abroad we are looking for partners interested in developing such formulations. Furthermore, harmonized regulations and data-sharing should be pursued to facilitate access to child-friendly medicines.