HALIFAX – Nova Scotian families and doctors are upset by news that a drug that helps keep juvenile arthritis in remission is no longer easily available.
Aristospan is an injection that helps arthritis patients with their pain and inflammation.
Valeo Pharma is the company responsible for selling Aristospan.
Marc Leger, a company spokesperson, tells Global News that the decision to take the drug off the market came from a third-party manufacturer, who he declined to identify, and not Valeo-Pharma.
He adds that the third-party manufacturer said regulations had changed, which forced it to stop making the drug.
Leger said the Valeo-Pharma wants to bring the drug back and is currently looking for another supplier.
An injection of the drug, which must be performed by a physician, is often a scheduled appointment for younger children who require sedation before receiving injection. Older patients can walk in for their treatment, though.
Emily Bessey, 11, has juvenile arthritis and often received the Aristospan injections when she was younger.
“It definitely allowed her to be more active, playing with friends, riding her bike and doing all those kid activities,” her mother Jennifer said. “After her injections, she was definitely more energetic and running and jumping. Prior to that, she was a little quiet, resting on the couch more, less active.”
Jennifer said that her daughter does not get the injection on a routine basis now, saying it is often a case-by-case basis on how Emily feels, but news of the drug unavailability is worrisome.
“It’s a bit concerning obviously as a parent of a child who has arthritis. It’s hard to know in the future whether Emily will need more joint injections but if she does, it’s definitely concerning that the medication may not be available for that,” she said.
Dr. Suzanne Ramsey, a pediatric rheumatologist at the IWK, calls Aristospan “the gold standard medication.”
“There isn’t a substitute medication that is better than Aristospan,” she said.
Whereas the drug used to be available and accessible in pharmacies, Ramsey said it is now a “headache” to get the medication for patients.
“For every patient that needs a joint injection, we have to order it through Health Canada. We have to write the case for why that individual patients needs it. Sometimes we would have to argue that case. We have to wait for it to be shipped to us for the patient as needed. It leads to delays in case,” Ramsey said.
The paperwork and red tape involved, as result of the Special Access Program from Health Canada, is frustrating for Ramsey, who said she is concerned about the impact that will have on young arthritis patients.
“It puts a delay on young children with arthritis in the knee. Their [one] knee grows much faster than their other knee so they end up with a leg length discrepancy if there’s a delay in their care. It’s really a time sensitive treatment in terms of trying to prevent permanent disability and permanent joint damage in children with arthritis,” Ramsey said.
Ramsey calls the process of getting Aristospan convoluted for doctors and a waste of time for families who may need to make multiple trips to see a physician.
“It’s just more forms and more delay in care for something that should be very simple.”
Nova Scotia Health Minister Leo Glavine said his department will be evaluating the situation in the coming days.
“Any time we have patients that have found it very effective, we will need to respond accordingly,” he said.
“We have the option of asking Health Canada to bring it in from another manufacturer in the U.S. or Europe. We haven’t had that request and if that comes forward, it will certainly be one that we would look at because [Aristospan] is an established protocol in dealing with arthritis.”
Health Canada sent the following statement to Global News when asked what it could do to help patients who need the drug:
“The expedited review process is a discretionary tool Health Canada can use to expedite the review of a drug submission to enable access to, for example, an alternative drug during a shortage. A company could submit a request to market a generic version of this drug product to Health Canada. Once an application for a generic drug submission has been accepted into review, the review target is 180 days. “
According to the Arthritis Society, approximately 1,000 children in Nova Scotia have arthritis.
Executive Director of the Maritimes region Susan Tilley-Russell said only a small portion require Aristospan, but for those who do, it is life-changing.
“I think any time when anyone, whether it’s a young children or anyone living with a disease, is unable to access treatment, it’s of great concern,” Tilley-Russell said.
The Arthritis Society plans to meet with industry representatives and Health Canada. It also has a request to sit down with Federal Health MInister Rona Ambrose.
The drug is also listed as active rather than discontinued on the Health Canada Drug Product Database.
© Shaw Media, 2014