An estimated 2.6 million Canadians suffer from serious allergies and about 630,000 of them carry an epinephrine auto-injector, a medication used for the emergency treatment of life-threatening allergic reaction.
Only one brand of auto-injector, EpiPen, is available in this country and it is in such short supply that, “in the coming days or weeks,” there could be none available for purchase, according to Health Canada.
Severe allergy sufferers are alarmed, and rightfully so. It’s disconcerting (to say the least) to go to your local pharmacy and be told your lifesaving medicine is out-of-stock.
It should be noted that only the “adult” version of the EpiPen is in short supply; the EpiPen Jr., generally used by kids under the age of 10, is still available.
What is troubling though is that there is no obvious and easy solution to this supply problem.
EpiPens are distributed by Pfizer Canada Inc. But the product itself is manufactured at a Meridian Medical Technologies plant just outside St. Louis, Mo.
That plant has been beset by manufacturing problems. In the past year, there have been slowdowns in production, recalls, repeated shortages and now, the risk of running out of stock.
“Obviously, this is not a situation we’re happy with,” Rhonda O’Gallagher, vice-president of corporate affairs at Pfizer Canada, said in an interview. “We’re doing everything we can to try and meet Canadian demand.”
Demand for epinephrine auto-injectors is growing tremendously as the number of people with allergies soars and many opt to have an EpiPen just in case. The product is too popular for its own good.
It’s easy to vilify Pfizer, but manufacturing problems happen.
The larger problem is that EpiPen has no competitors in Canada.
Twinject, a brand made by Paladin, and Allerject, by Auvi-Q, were two other available brands but were discontinued after repeated recalls, manufacturing problems, and poor sales. (Manufacturing an auto-injector is obviously complex, and regulators also have to be unforgiving - this is a product that has to work 100 per cent of the time.)
Four other companies – Kaleo Pharma, Taro Pharmaceuticals, Valeant Canada, Lincoln Medical – have epinephrine auto-injectors that have been approved for sale in Canada but they have opted to not enter the market. They can’t be compelled to do so.
Opposition parties, as they are wont to do, blame the Liberal government for the crisis. The New Democrats say the manufacturer should be threatened with loss of their patent if the product is not available – but that would resolve nothing. The Conservatives, for their part, have demanded a “Canadian-based supply chain,” which is easier said than done.
As troubling as the EpiPen shortage is, it’s part of a much larger problem of global drug shortages. Essential drugs like antibiotics, painkillers, blood thinners, vaccines, antidepressants and anesthetics are routinely unavailable.
The explanations are many and varied: industry consolidation (meaning less competition), scarcity of raw ingredients, manufacturing glitches, reduced production or discontinuation of products that are not profitable enough, stricter government monitoring and regulation, more regulation of prices, industry greed – to name only a few.
In this volatile global marketplace, a small country like Canada is vulnerable, and the on-going list published by Drug Shortages Canada is disconcerting reading for patients and clinicians alike.
Canada also strictly regulates drug prices, which can create a disincentive to enter the market. An EpiPen sells for about $100 in this country; in the U.S., the same product sells for about $600 for a two-pack. The U.S. price has increased six-fold in the past decade.
Consumer groups like Food Allergy Canada, medical professionals like pharmacists and the regulator Health Canada have acted responsibly in reaction to the threat posed by the EpiPen shortage.
They have alerted the public and urged practical steps, like rationing sales to one EpiPen per person and hanging on to expired products.
The good news is that research shows EpiPens are effective up to four years after the expiration date. There is a small window on the device where the liquid (epinephrine) is visible; if it’s clear, the product is still good but, if it’s brownish-yellow, it likely won’t work.
It’s not clear how many people actually have life-threatening allergic reactions from exposure to foods, drugs, insects, animals and other sources. The Canadian Institute for Health Information estimates that 171,000 people annually are treated in emergency departments for allergic reactions, but only eight per cent of those patients actually suffered anaphylaxis.
Deaths from anaphylaxis are thankfully rare – about 15 a year in Canada. But all these deaths are preventable, and we should do all we can to ensure that the EpiPen, an essential prevention tool, is available when and where it’s needed.
Editor’s note: An earlier version of the story misidentified the manufacturer Twinject. It was made by Paladin.
André Picard