Compounding involves multiple human touchpoints in production which increases the risk of error. Administrating micro-quantities often requires the need to cut the drug more than what is safely allowed.
Children are not small adults
In Canada, many drugs available on the market are not adapted for children. Manufacturers primarily produce adult formulations, but these are not adapted to the pediatric populations because they do not take into consideration the anatomic and physiological specificities of each category, that is, newborns, infants, toddlers, preschool children, school age children and adolescents (aged 0-17). When commercialized pediatric formulations are not available to children, adult forms need to be modified to suit the dosing needs of children, a process known as compounding. This includes crushing a tablet, opening a capsule, or dissolving the medication in liquid, for example. These manipulated medications fall outside of regulatory approval, creating risk of dosage error when administered to children.
Between 75-80% of all medications currently prescribed in Canadian pediatric hospitals are administered off-label, meaning their use deviates from the product monograph approved by Health Canada, including but not limited to dose, route of administration, age or indications.
Key issues with compounded medications
Risk of error
Children often demonstrate resistance to taking a compounded drug that is administered to them due to its bad taste (directly vomiting the medication, for example). This reduces the chances that the child takes their full dose.
While patients do not come back to see their doctors often because of errors in compounding, when they do it is because the health impacts are severe. This will have a larger impact on vulnerable population.
Stability of the product
Compounded products have a shorter shelf life and do not always have clear expiry dates.
Compounding a medication may take varying amounts of time, ranging from 30-60 minutes (in-house) to several days (external compounding pharmacy).
In pharmacies, there are no standardized recipe for compounding drugs. Not all pharmacies use compounding recipes supported by studies, which creates inconsistencies.
What are other countires doing?
Safe and effective alternative solutions to compounding do exist, as proven by examples from Europe and the United States. Both the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) are empowered to demand pediatric studies when a drug is likely to be used in children, and pharmaceutical companies receive funding to develop pediatric formulations. Our organization believes that Health Canada should have comparable financial incentives. Studies from the EU shows that regulations have a substantial impact on the development of pediatric medicines.
We should be more like the EU, which, from 2007 to 2016, developed over 260 new medicines for use by children were authorized, most of them linked to the Regulation’s requirements.
What is causing Canada to lag?
The main reasons why pediatric formulations are not developed in Canada are economic. The markets for pediatric drugs are relatively small and unlike the United States and Europe, there are no commercial incentives and little regulatory protection granted to bring commercialized pediatric formulations to Canada.
Due to these factors, it is less profitable to build a viable business case to bring commercialized pediatrics-adjusted medicines in Canada.3 For example, a recent study indicated that between 2007 and 2016 more than 80% of all new active substances were only approved in adults in Canada4. The economic barriers contribute to the discouragement of the development of pediatric formulations in the Canadian market.
Consequently, Canada trails relative to other developed countries, like the US, the UK and countries members of the EU.
We support the development of pediatric formulations, which are adapted to the specific needs of children and are optimal for their treatment.