MONTREAL — Canada lags significantly behind the United States and Europe when it comes to forcing drug companies to provide pediatric formulations of certain drugs and related safety data, researchers lamented in a commentary published by the Canadian Medical Journal.
In the absence of formulations appropriate to the needs of children, medicines intended for adults, in hospital or at home, must be modified before being administered to young patients, which is not without risk.
The authors estimate that between 50% and 80% of medications prescribed to Canadian children are ‘off-label’, meaning that they are off-label in terms of dose, age, route of administration, formulation or indication described in the study product.
However, a recent study at Canadian Children’s Hospital found that pediatric formulations are commercially available in Europe and the United States for about half of the frequently changed medications.
“I know it’s a cliché to say it, but children are not miniature adults,” the lead author of the commentary, Dr. Rosalind Family and Maurice Goodman of CHU Ste-Justine launched.
Children go through all kinds of developmental changes during childhood that make how they handle medication and how the medication will act on them will be different from adults. (And then), a one-year-old does not have the ability to swallow adult tablets. There is a risk of suffocation.”
In Europe and the United States, the authors explain, a pharmaceutical company applying to register a new molecule must provide formula and data for both adults and children, or else regulators refuse to approve it. See file.
These jurisdictions are also extending by six months a patent protecting drugs that have also been studied in children — a “carrot and stick” approach, said Dr. Michael Reeder, CIHR-GSK chair holder in pediatric clinical pharmacology at Western University.
“The Americans got things done,” he said. Then the Europeans, smart people, thought it a good idea and did the same.”
In Canada, Health Canada is currently content with adult formula and data, “even if the same drug is offered for pediatric use or has been provided in pediatric formula in other jurisdictions,” we may read in the JAMC.
So Europeans and Americans would have agreed to twice as many new pediatric drugs as Canada between 2007 and 2015.
“We’re clearly far behind, and that’s not insignificant, but important, because right now, there really isn’t any pediatric law in Canada with regard to drug approval,” Dr. Littalin said. There is no obligation, as in the United States and Europe, for a pharmaceutical company (…) to provide pediatric data if pediatric use is foreseen. “
There are many examples of medicines that are approved for use by American and European children, but not Canadian children, and for which pediatric formulations are available in those jurisdictions, but not in Canada.
Levetiracetam, a drug used to treat epilepsy, is often prescribed to children. It’s been approved for use in children — and a baby formula has been made available — in Canada only since 2019, 14 years later than in the United States and Europe.
Intravenous abatacept for the treatment of rheumatoid arthritis in adults and children was permitted in Canada in 2006 and 2008, respectively; The subcutaneous formulation has been approved for adults since 2013.
But in the United States and Europe, subcutaneous injections have been approved for a few years now. Canadian children should therefore continue to undergo intravenous injections of this molecule, as subcutaneous injections are not authorized in the country.
The United States and Europe have allowed sofosbuvir tablets to treat hepatitis C in children 12 years of age and older since 2017, and in children three years of age and older since 2020. Pediatric formulations are also available. In Canada, a study of the product still indicates that its safety and efficacy in children have not been proven.
“Even today, we crush adult tablets, and our pharmacists suspend this in a simple syrup to be able to give it to children, when there is a commercial solution available along the border, with all the advantages that something commercially available can represent,” regrets Dr.
She added that the lack of a license to use children greatly complicates reimbursement for the drug, whether through the public plan or by a private insurance company.
Health Canada is deeply reviewing its rules, and it’s time to take care of the pediatric drug profile, argue the signatories to the comment.
“Health Canada’s current reform to create a more flexible system is an unprecedented opportunity to ensure that children in Canada have access to new medicines and pediatric formulas like those in other countries,” they wrote.
Doctors Lallemand and Rieder are asking Health Canada to show the same flexibility it has shown in responding to the COVID-19 pandemic.
Ils souhaitent notamment que l’agence fédérale mette en place une “règle pédiatrique” qui la verrait, par exemple, accepter les données pédiatriques présentées par la société pharmaceutique aux États-Unis pour oui ref oui é Europe, a job.
Health Canada may also allow the marketing of some drugs, when the need justifies it, based on licenses granted in the United States and Europe.
“It’s going to be the Canadian carrot,” Dr. Reeder said. No need to reinvent the wheel. We can simply rely on what the Americans and Europeans are doing.”
Health Canada seems to understand what the experts are asking of it, Dr. LaLimand emphasized, but no specific action has been taken in this direction so far. Dr. Reeder sees this as a result of the rapid succession of governments in Ottawa over the past few years, and is hopeful that the stability that appears to be taking shape for a few years will allow progress to be made.
“Health Canada is talking to us and listening to us,” Dr. Lallamand said. They showed us that they can be authentic. They did this during COVID. We are simply asking that Canadian children deserve the same standards as adults and that we learn from peer countries.”