Canada’s children face barriers to accessing safe and effective medications


We must ensure that children and youth have equitable access to safe, effective and affordable prescription medications, just as Canadians of all ages expect to enjoy.

Canadian children do not enjoy the same standards of safety, efficacy, availability, or access to drugs that Canadian adults enjoy.

When it comes to prescription drugs, Canadian children and youth are exposed to a variety of health and safety risks from the drugs that they receive, risks that have been significantly mitigated by other jurisdictions, such as the United States and the European Union.

If we believe that children are to be protected and cared for, this practice should alarm all Canadians. Whether you are a parent, caregiver, physician, pharmacist, policy-maker or regulator—we should all demand better.

Our approach here in Canada is flawed.

The problem is straightforward. Research funding for adult diseases is often prioritized over that for childhood illnesses. This is a problem—children are not just “little adults.” They have unique prescription needs that are not adequately covered under our existing formularies or with our existing product monographs. Without access to paediatric medications or appropriate information on dosage, side effects or interactions, children and youth are put at unnecessary risk.

When a child-friendly formulation (such as a liquid or low-dose mini-tablet) is not available, approved adult drugs are manipulated to achieve the desired dose or to administer the medication in a tolerable form, a process known as compounding. While the precise prevalence of compounding for children in Canada is not known, it is believed that a significant proportion of the 80 per cent of all paediatric prescriptions that fall outside of regulatory approval are due to either pharmacy compounding or modification by caregivers. This erodes quality control standards and significantly increases the risk for dosing errors in a way that would never be acceptable for adults.

In short, while health professionals adhere to best evidence and practice, the status quo in Canada exposes our children and youth to unnecessary risk.

Both the European Medicines Agency and the United States Food and Drug Administration are empowered to demand paediatric studies when a drug is likely to be prescribed for children, and they receive funding to provide incentives for such work.

It is bewildering that Health Canada policies seldom require drug manufacturers to submit paediatric data, even when the data has been made available to other jurisdictions or when use among children and youth is foreseeable.

We must challenge Health Canada to follow the clear best practice to protect our children and youth through research, not from research.

Insofar as it applies to children and youth, Canada’s drug regulatory system is out-of-date. Up to 80 per cent of all medications currently prescribed in Canadian paediatric hospitals are administered off-label, meaning that the prescribed use of the drug deviates from the dose, administration, patient age and/or medical indication that is listed on the Health Canada-approved product monograph. While off-label certainly does not mean “off-evidence,” these practices are less safe than those accepted south of the border.

Reforming our regulatory system to be more proactive in demanding data for children is not a new idea. In 2014, the Standing Senate Committee on Social Affairs, Science and Technology and the Council of Canadian Academies released separate reports that came to the same conclusion—Canadian children are prescribed medications, which have not been proven safe and effective for them.

As nation-wide support for universal pharmacare grows, it is essential that the unique prescription drug needs of children and youth not be overlooked.

Children and youth are our future and our most valued resource. Canada’s national formulary must be evidence-based and child-sensitive. Through regulatory reform that prioritizes the reduction of off-label prescribing in paediatrics, and enables access to child friendly formulations, we can decrease common dosing errors and significantly improve health and safety.

We must ensure that children and youth have equitable access to safe, effective and affordable prescription medications, just as Canadians of all ages expect to enjoy.

Ontario Senator Rosemary Moodie is a member of the Independent Senators Group.

Originally Published in The Hill Times

Ann WatkinsComment