Canada’s health regulator is advising Canadians to retain and use expired EpiPen auto-injectors should 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 announced a temporary shortage of 0.3 mg auto-injectors for older children and adults, stating that there is a limited supply of auto-injectors available with distributors and pharmacies. The company says it expects additional inventory in February, “which will be placed under allocation and we will continue to manage supply carefully.”
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, saying that an inspection found that consumer reports of suspected auto-injector device failures were not being adequately reviewed. While the FDA said at the time it wasn’t aware of any defective EpiPens on the market in the U.S., 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).
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.
While the EpiPen is currently the only epinephrine auto-injector available to Canadians, it will soon have a competitor in that marketplace. Taro Pharmaceuticals has received approval from Health Canada for its epinephrine auto-injector, which the company expects to launch later in 2018.