Parents worry as kids head back to school amid EpiPen shortage
Epinephrine autoinjectors needed by people at risk for anaphylaxis being rationed
As Michelle Miskell gets her seven-year-old son ready to head back to school, there's one very important item on her shopping list: EpiPens.
Her child's peanut allergy puts him at risk for anaphylaxis so he always needs to have two epinephrine autoinjectors at hand.
That means two EpiPens — the brand name for the only autoinjector sold in Canada — on his person, two with a parent, two at his school and two at his after-school program.
"The word coming from Health Canada is that we may have to realize that we can't have all the EpiPens we need," she said.
"We have to be cognizant of all individuals who require EpiPens and I understand that, but my priority is for my child and my child must be covered at all times."
Keeping those EpiPens in stock has become more difficult in recent years due to consistent shortages across Canada. It's an ongoing source of stress for Miskell.
There have been shortages of the medical device in Canada throughout 2018, beginning in the spring, and the manufacturer informed Health Canada in July that supply would be very limited in August.
He doesn't recognise the severity of the consequences.- Michelle Miskell
That's a big worry for affected parents as they get kids ready for the start of classes, which can mean buying extra autoinjectors to ensure that they are available at home and at school.
Miskell's son's school requires there be two EpiPens on hand for every child who needs them, she said, and at his age he can't be responsible for transferring them between school and home.
"He doesn't recognise the severity of the consequences," she said of her son.
"He is not able to assess risk at seven years of age, so to give him the responsibility of ensuring that as he moves through his day, when I'm not present with him, is unacceptable."
Pharmacists asking for patience
The shortage means that some parents are being asked to hold on to EpiPens that have only recently expired, or to do with fewer pens than they'd like to have, said Keith Bailey, a pharmacist at Shoppers Drug Mart in Conception Bay South.
"We're kind of working with each person as they come in to manage inventory," he said.
"We're just asking them to hold on to just the one EpiPen for now and not get the second one, so we can kind of manage our own supply."
Health Canada advised in a July statement that people who have to use an expired EpiPen call emergency services immediately after administering the medication.
Bailey said parents are concerned about the issue but have largely been patient with pharmacists who are trying to manage supply during a shortage.
But Miskell said the ongoing shortages aren't acceptable to her, as a parent with a child who risks death if he has an allergic reaction.
"My child is at risk for anaphylaxis, and an anaphylactic reaction can cause death," she said.
"If the medication is not immediately available at all times, consistently, when it is required, then it means that he may not survive such a reaction."
Reason for shortage unknown
The specific reason for the EpiPen shortages isn't clear, Bailey said, though drug shortages generally can be caused by difficulty accessing a vital ingredient or the equipment needed to deliver the medication, or problems with manufacturing.
Pfizer Inc., which manufacturers EpiPens, has been the sole supplier for autoinjectors in Canada since 2015. The epinephrine the injectors deliver can be life-saving when someone has an anaphylactic reaction to an allergen, which can include foods, insect stings or other triggers.
Ongoing shortages have meant that pharmacies have had to ask patients to hold on to nearly expired or recently expired EpiPens, or have fewer on hand than they normally would, in order to maintain supply for those who are really in need.
"The supply directly from Pfizer has been short, so we've basically had the month of August with no new supply of EpiPens," said Bailey, who said his pharmacy would normally have eight to 10 of the injectors on hand but now can only order one or two daily.
Possible alternatives to EpiPen
Health Canada has allowed Kaléo's Auvi-Q epinephrine autoinjectors to be imported from the United States and sold in Canada for up to a year to help relieve the shortage. The devices — approved by the FDA in the U.S. — will be available in Canadian pharmacies by Sept. 7 and sold for $170. That's more than the $100 retail price for EpiPen in Canada.
The device also contains epinephrine, like EpiPen, and offers the same dosages of medication but differs in that it has a retractable needle and guided voice instructions. The adult dosage of Auvi-Q should soon be available in Canadian pharmacies, Health Canada's statement said, and a junior version with half the dosage may be made available under the interim order in the future.
Kaléo has said they hope to sell their epinephrine autoinjectors in Canada permanently, and if the company gets that approval the device would be sold under the name Allerject starting in 2019 at an undetermined price.
Meanwhile, Bausch Health Companies previously told CBC News that it also hoped to be able to sell its autoinjector Emerade in Canada in the future.
Miskell said that allowing other manufacturers of the device into the Canadian market would relieve some of the anxieties faced by parents like her.
"A temporary supply is not acceptable. We must have a second supplier, so that when shortages occur the medicine can be obtained elsewhere."
With files from David Gonzales