(Montreal) Canada lags considerably behind the United States and Europe when it comes to compelling pharmaceutical companies to provide pediatric formulations of certain drugs and relevant safety data, researchers lament in a commentary published by the Canadian Medical Association Journal.
Posted at 10:12 a.m.
In the absence of formulations adapted to the needs of children, the drugs for adults must be modified, in the hospital or at home, before being administered to small patients, which is not without risk.
The authors estimate that between 50% and 80% of the drugs prescribed to Canadian children are “off-label”, meaning that they deviate from the dose, age, route of administration, formulation or indication described in the product monograph.
Yet a recent study in a Canadian pediatric hospital found that pediatric formulations are commercially available in Europe and the United States for about half of the medications that are changed most frequently.
“I know it’s cliché to say that, but children are not miniature adults,” said the comment’s lead author, Dr. Rosalind & Morris Goodman family from CHU Ste-Justine.
“Children go through all kinds of developmental changes during childhood that make how they’re going to take on the drug and how the drug is going to affect them is going to vary from the adult. [Et puis], a one-year-old child does not have the ability to swallow adult tablets. There is a risk of suffocation. »
In Europe and the United States, explain the authors, a pharmaceutical company that applies for the registration of a new molecule must provide a formulation and data for both adults and children, failing which the regulatory agencies refuse to approve it. review the file.
These jurisdictions are also extending for six months the patent that protects drugs that have also been studied in children ― the “carrot and stick” approach, said Dr. Michael Rieder, holder of the CIHR-GSK Chair in Pediatric Clinical Pharmacology at Western University.
“The Americans got things done,” he said. Then the Europeans, who are smart people, thought it was a good idea and they did the same thing. »
In Canada, Health Canada is content for the moment with a formulation and data for adults, “even if the same medication is offered for pediatric use or provided in pediatric formulation in other jurisdictions”, perhaps we read in the JAMC.
Europeans and Americans would therefore have approved twice as many new pediatric drugs as Canada between 2007 and 2015.
“It is clear that we are lagging behind that is not negligible, even significant, because at the present time, there is not really any pediatric regulation in Canada in terms of drug approval, said Dr. LItalien. There is no obligation, as is the case in the United States and Europe, for a pharmaceutical company […] to submit pediatric data if pediatric use is anticipated. »
Multiple examples
There are many examples of drugs that are authorized for use by American children and European children, but not Canadian children, and for which a pediatric formulation is available in those jurisdictions, but not in Canada.
Levetiracetam, a drug used to treat epilepsy, is frequently prescribed to children. Its pediatric use has been authorized ― and a pediatric formulation has been available ― in Canada only since 2019, 14 years after the United States and Europe.
Intravenous injections of abatacept to treat rheumatoid arthritis in adults and children were authorized 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 injection has been approved for a few years now. Canadian children must therefore continue to undergo intravenous injections of this molecule, since subcutaneous injections are not authorized in the country.
The United States and Europe have authorized the use of sofosbuvir tablets to treat hepatitis C in children 12 years and older since 2017, and in children three years and older since 2020. A pediatric formulation is there. also available. In Canada, the product monograph still states that its safety and effectiveness have not been established in children.
“Even today, we are crushing adult tablets, our pharmacists suspending this in a simple syrup to be able to administer it to children, when just down the border, there is a commercial solution available , with all the advantages that something commercially available can represent,” lamented Dr.
The lack of authorization for pediatric use also greatly complicates the reimbursement of the drug, whether by the public plan or by a private insurer, she added.
Solutions
Health Canada is reviewing its rules in depth and the time is right to take an interest in the file of pediatric drugs, argue the signatories of the comment.
“The current reform of Health Canada to create a more agile system is an unprecedented opportunity to ensure that children in Canada have the same access to new medicines and pediatric formulations as those in other countries,” they write.
Doctors Lallemand and Rieder are calling on Health Canada to demonstrate the same flexibility it has shown in responding to the COVID-19 pandemic.
In particular, they want the federal agency to put in place a “pediatric rule” which would see it, for example, accept pediatric data presented by the pharmaceutical company in the United States or Europe, to avoid having to redo all the work.
Health Canada could also allow the marketing of certain drugs, when the need justifies it, by relying on the authorizations granted in the United States and Europe.
“That would be the Canadian carrot,” said Dr. Rieder. No need to reinvent the wheel. We could simply rely on what the Americans and the Europeans are doing. »
Health Canada seems to understand what the experts are asking of it, assured Dr. Lallemand, but no specific action has yet been taken in this direction. Dr. Rieder sees this as a consequence of the rapid succession of governments in Ottawa over the past few years, and he hopes that the stability that seems to be shaping up for a few years will allow progress to be made.
“Health Canada talks to us and listens to us,” said Dr. Lallemand. They showed us that they can be original. They did it during COVID. We are simply asking that Canadian children be entitled to the same standards as adults and that we learn from peer countries. »