For the latest update on the EpiPen shortage in Canada, see Allergic Living’s article here.
Canada’s health regulator is advising Canadians to keep and use expired EpiPen auto-injectors in case they or a family member experience a severe allergic reaction during a period of supply shortage of the life-saving devices.
Pfizer Canada on January 11, 2018 announced a temporary shortage of 0.3 mg auto-injectors for older children and adults. The company says there is a limited supply of auto-injectors available with distributors and pharmacies. Pfizer Canada expects additional inventory in February 2018, “which will be placed under allocation and we will continue to manage supply carefully.”
Manufacturing Delays
The supply shortage is anticipated to be resolved by early March, said Rebecca Purdy, a media spokesperson for Health Canada. Pfizer Canada distributes the EpiPen in Canada, and obtains the devices through the U.S. distributor Mylan Specialty.
“The supply interruption is due to manufacturing delays related to the implementation of improvements to the quality validation processes that are now in place at the manufacturing facility,” Kerri Elkas, manager of corporate affairs at Pfizer Canada, told Allergic Living.
In September 2017, the FDA issued a warning letter to Meridian Technologies, the division of Pfizer Inc. that manufactures then supplies the EpiPen and EpiPen Jr. to distributors. The letter said an FDA inspection found that consumer reports of suspected auto-injector device failures were not being adequately reviewed.
At the time, the FDA said it wasn’t aware of any defective EpiPens on the market in the U.S. But its warning letter ordered Meridian to undertake a comprehensive review of manufacturing processes.
U.S. consumers are not affected by the current Canadian shortage, which also does not include the supply of EpiPen Jr., for children between 33 and 66 pounds (15 and 30 kilograms).
After Use, Call 911
During the shortage, Health Canada recommends in an anaphylactic emergency that Canadians use an expired auto-injector, if that’s all that is available. The agency reminds of the protocol to use it and then contact 911 immediately.
“As instructed in the labeling of the product, the patient should get to the nearest hospital as soon as possible following the administration of the product,” said Purdy. “In general, it is recommended that individuals have more than one auto-injector with different expiry dates to avoid being in the situation of only having an expired auto-injector.”
In its statement, Pfizer Canada said it “fully realizes the importance of this medicine to our customers and patients, and has taken action to minimize the duration of the supply interruption.”
Canadians can stay up-to-date about the shortage and estimated re-supply dates by visiting Drug Shortages Canada.
The EpiPen is currently the only epinephrine auto-injector marketed in Canada.
Get more news from Allergic Living to your inbox.
