EpiPen shortage highlights problem of having just 1 supplier of life-saving medication: experts

An ongoing shortage of EpiPen injectors that has become so dire that the supply is expected to run out in August is ramping up anxiety and raising questions around Canada's reliance on a single drug company to provide life-saving anaphylaxis medication, allergy advocates and pharmacists say.

"We have gone from what I would call an inconvenience to a concern," said Jennifer Gerdts, executive director of Food Allergy Canada and the mother of twin 16-year-old boys who both carry EpiPens.

EpiPen manufacturer Pfizer Canada has repeatedly announced shortages of the product over the past year, but people at risk of anaphylaxis — the most severe form of an allergy that can lead to death — have usually been able to find an EpiPen after going to a few different pharmacies, Gerdts said. 

But this week, Pfizer said it wouldn't have new stock of the injectors containing a 0.3 mg dose of epinephrine — the active ingredient that treats an anaphylactic reaction — until the end of August.  

'We really shouldn't be in a situation where we only have one product available for life-saving medication,' says Jennifer Gerdts, executive director of Food Allergy Canada. (Food Allergy Canada)

Pfizer is the only manufacturer of epinephrine auto injectors — a needle a patient can jab into themselves — in Canada. 

"We really shouldn't be in a situation where we only have one product available for life-saving medication," Gerdts said. "We need to take action … so that we don't continue to be vulnerable to these outages."

The current shortage is deeply concerning, said Phil Emberley, an Ottawa-based pharmacist and spokesperson for the Canadian Pharmacists Association. 

"This comes at a really bad time in our minds, because it's really peak time for demand," he said. 

Contrary to initial media reports, the affected EpiPens are used not only by adults, but also most children aged 10 or older, Emberley said. 

Pfizer has said it can currently continue supplying its EpiPen Jr., a smaller dose of 0.15 mg of epinephrine with a shorter needle for younger children, although those injectors were limited. Children who weigh more than 30 kilograms use the regular EpiPen, Emberley said, which is running out altogether.    

That makes the shortage especially problematic, he said, because this is a time of year when kids go off to camp and need to take more than one EpiPen with them. 

Pfizer and Health Canada have directed pharmacists to ration their current EpiPen stocks by only dispensing one injector per person, so that there are enough to go around for everyone who needs them. 

But each injector delivers a single dose of epinephrine and about 20 per cent of anaphylaxis patients have "biphasic" or two-phase reactions, meaning they need a second dose, Emberley said.

Because patients are supposed to give themselves an injection and then seek medical attention, that second dose can often be administered at a hospital or doctor's office, if needed. 

"If a child is at camp, for example, they're not really close to a hospital," Emberley said. "That could pose a real problem."

In the U.S., EpiPens are available in packages of two. But in Canada, they are just sold as single doses, says pharmacist Phil Emberley. It's usually recommended that patients have more than one of the injectors, but during the current shortage, pharmacists are being asked to ration them. ( Joe Raedle/Getty)

As an emergency measure, Emberley agrees with Health Canada's directive that people should keep and use their expired EpiPens if they are needed during the current shortage, noting that studies have shown they retain some effectiveness even after the expiry date. 

Additionally, the expiry dates refer to the end of the month indicated: so if it says August, the medication is good until the end of August, which is when Pfizer expects to have supplies restored. 

What's causing the shortage?

Dr. Supriya Sharma, chief medical adviser for Health Canada, said Pfizer has faced "a few manufacturing issues" that have caused the ongoing EpiPen shortages over the past several months. 

In the past, Sharma said, there were issues securing epinephrine itself. But the current problem lies with a manufacturing issue that delayed the production of the autoinjector device, she said. 

That, in turn, led to delays in getting them inspected and out the door to pharmacies. 

A spokesperson for Pfizer Canada would not confirm the specifics to CBC News, but said in an email that "supply of epinephrine is not causing the delay."

"This shortage is as a result of manufacturing delays of the product. Stock that was scheduled to be shipped in early August is currently being inspected, which has caused a delay," said Kerri Elkas. 

Health Canada recognizes the problem with having a single supplier of epinephrine autoinjectors, Sharma said, and has already approved similar medications, but they aren't yet manufactured in this country. 

"Absolutely from a Health Canada perspective, we would want to see other products available," she said. "It's always best when you have alternatives."  

According to the department's Drug Product Database, Emerade — an anaphylaxis autoinjector available in several European countries — is among the epinephrine-based medications that have been approved. 

It's not clear why companies whose medications have been approved are not yet distributing those products in Canada. 

Both Health Canada and Food Allergy Canada are trying to "encourage them," Sharma said, but noted that it's up to the individual companies to make that decision. 

What to do if you or your child is an EpiPen user

Health Canada, Food Allergy Canada and the Canadian Pharmacists Association recommend the following:

  • Check your EpiPen to see when it expires. Remember that the expiry date refers to the end of the month.
  • If it has expired, speak to your health-care provider or pharmacist to get a new one before it runs out.
  • If it has not expired, hold off on purchasing new EpiPens or stockpiling until the shortage is resolved so that the limited stock will go to people who need it the most. 
  • If the EpiPen has expired, and you or your child have an anaphylactic reaction, use it anyway and call 911.
  • Be extra vigilant about avoiding allergens (wasps, bees, food, etc.) that trigger anaphylaxis in you or your child.

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