11/11/2021 12:00:00 AM
This safety bulletin highlights the medication incidents that can and have occurred due to a lack of commercially available pediatric formulations, particularly in Canada. The current Canadian federal regulations do not require pediatric data from manufacturers for medications likely to be used in children. The low return on investment for manufacturers, the lack of pediatric-specific regulatory guidance for manufacturers, and delayed provincial/territorial reimbursement programs for pediatric formulations may contribute to the lack of commercially available products in Canada. Two incidents are described, one where a 1000-fold error was made when compounding using the active ingredient powder. The other incident involved difficult splitting a small tablet into four when a liquid formulation was not available. This bulletin provides recommendations and strategies for Health Canada, provincial/territorial public drug programs, prescribers, and pharmacy staff, as well as organizations involved in the development of compounding formulas.
Lack of Pediatric Formulations – A Call to Action