EpiPens will be in short supply at Canadian pharmacies throughout August, Health Canada warned this week, but that doesn’t mean the problem will be solved by September.
Even after shipments are sent in late August, “that will take us back to where we were before this acute situation,” said Dr. Supriya Sharma, chief medical adviser at Health Canada. “So there will still be limited supply but it won’t be as extreme as not having any supply at the pharmacy level.”
She expects that this situation will continue for months, possibly into 2019. Throughout 2018, supplies have been limited – just not as limited as they’re expected to be this August.
Pfizer Canada, which manufactures the allergy medication, said that the supply constraints are due to ongoing delays at the manufacturing facility. The company said that earlier this year, it encountered supply interruptions because of delays caused by “the implementation of improvements to the quality validation processes” at their facility, and “insufficient third-party quantities of a component for the product.”
Right now, stock that was supposed to be shipped in early August is being inspected, which is causing a delay, wrote Pfizer spokesperson Kerri Elkas in an emailed statement.
But it could take months to work through the backlog from earlier this year.
“Shipments of EpiPen are building to normal levels at our manufacturing site. The delay is largely a function of the backlog, which will take several months to be fully caught up due to the current peak season,” wrote Elkas.
“It’s gone from inconvenience to concern,” said Jennifer Gerdts, executive director of Food Allergy Canada. Over the last few months, patients might have had to visit two or three pharmacies to find their EpiPens. “But now what we’re hearing from our community is that when they go, they’re actually not finding the inventory.”
This is a problem, she said.
“It is what is used in the event of a severe allergic reaction. It is a lifesaving medication.”
It’s not just adults who use the 0.3 mg EpiPen either, she said, as it’s indicated for anyone who weighs more than 66 pounds.
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Single supplier
Part of the problem is that Pfizer is the only company currently selling epinephrine auto-injectors in Canada, critics say.
“This situation has really exposed the vulnerability that we have as a community on one source of supply,” Gerdts said.
Having only one epinephrine supplier is a serious issue, said Dr. Jacalyn Duffin, a professor emerita at Queen’s University. “When a single supplier has a problem, either they cannot get a raw material or the FDA has shut them down, there’s no backup.”
“Drug companies don’t know if they’re going to have a fire in their plant six months in advance. They can’t know if their supplier in China is suddenly unavailable. They can’t know these kinds of things. And we as a society have decided it’s just fine to let drug companies handle our supply.”
Health Canada has granted several companies licenses to sell epinephrine, said Sharma, but no one but Pfizer is right now.
“With respect to any medication, it’s always best if there are alternatives that are available so that if there is an issue, whether it’s manufacturing or supply issues, that there are alternatives for people to go to. But the decision to market in Canada really rests with the company and their business decisions.”
Federal opposition parties have called on Health Canada to resolve the issue and prevent a future supply crunch. The NDP said the Liberals must do everything necessary to prevent another shortage – even if it means threatening the drug maker with the loss of its patent on the device if it can’t ensure a consistent supply.
The Conservatives, on the other hand, recommended the government encourage companies to manufacture drugs in Canada, to ensure a Canadian supply.
Drug shortages aren’t just a problem with EpiPens either, said Duffin, who has run a website tracking drug shortages for nearly seven years. “At any given time, there are probably about 1,000 shortages going on.”
Although Health Canada maintains a website listing current drug shortages, Duffin doesn’t feel that the data is analyzed to determine what exactly is causing them and how they might be prevented.
She believes that drug shortages are getting worse.
“I’ve been a doctor for a long time and we did not have these problems prior to 2010.”
What to do if you use EpiPens
EpiPens expire on the last day of the month indicated on the package, according to Health Canada. So if your EpiPen has an August expiry date, it is good until Aug. 31.
However, if you have an allergic reaction and only have an expired injector, you should use it anyway and call 911.
— With files from the Canadian Press