Pfizer manufacturers the EpiPen for Mylan and has cited manufacturing delays and problems with the supply of a component of the product from a third-party as reasons behind the shortage.
Update (August 1, 2018): Supply of Mylan’s EpiPen in Canada continues to be affected by a manufacturing-related issue at a Pfizer-owned plant which produces the autoinjectors. Both the 0.3mg and 0.15mg doses will be in short supply through August, though the company told Health Canada more devices could be available by the end of the month.
Update (May 10, 2018): The EpiPen shortage is now affecting patients in the US, with over 400 individuals across 45 states reporting that they’ve had trouble filling their EpiPen prescriptions since the beginning of May. Mylan says the shortage is due to manufacturing issues at the Pfizer-owned facility which makes the device, and the FDA has added the EpiPen, EpiPen Jr and branded generics to their list of drug shortages.
A shortage of potentially life-saving EpiPens has been affecting Canadians with serious allergies since the beginning of 2018. According to a report from Reuters, Health Canada is in talks with Mylan and the US Food and Drug Administration (FDA) to address the EpiPen shortage and secure a more reliable supply of the auto-injectors.
“A shortage does not necessarily mean that there is no supply available in pharmacies,” said a release on the EpiPen shortage from Health Canada. “At this time, the company has indicated that limited inventory of both products remains available and is being carefully managed nationally.”
The shortage affects both the EpiPen 0.3 mg and the EpiPen Jr (0.15 mg), the latter of which is used to treat anaphylaxis in pediatric patients. As no comparable products are available in the country, Health Canada is recommending patients keep more than one auto-injector on-hand, each with a different expiry date, to avoid being without the lifesaving medicine. The regulator is even endorsing the use of an expired auto-injector in the case of an emergency, with the advice that individuals call 911 immediately to get medical attention regardless of whether or not the auto-injector used was past its use-by date.
Last year, researchers out of the University of California published a paper suggesting that the active ingredient in the EpiPen – epinephrine – may retain its potency for up to four years after the printed expiry date. While this could prevent patients from having to replace their EpiPen each year, there’s no guarantee than an expired product would work as expected when it’s need most.
“There’s not a robust supply in Canada. And there may not be for a while,” said David Fischer, president of the Canadian Society of Allergy and Clinical Immunology. “We’re all perplexed about the whole concept of this worldwide shortage that does not involve the US.”
In 2017, Pfizer’s division responsible for manufacturing the EpiPen, Meridian Medical, issued a voluntary recall on certain batches of the auto-injector over concerns that the combination device would fail to activate in an emergency. Over 80,000 devices sold in the US, Canada, New Zealand, Australia, Europe and Japan were affected by the recall.
“Available EpiPen supply in Canada will be managed through measured national allocation to wholesalers,” said Pfizer. “This allocation is intended to support the provision of EpiPen auto-injectors to patients across the country.”
According to Health Canada, Kaleo Pharma, Taro Pharmaceutical Industries, Valeant Pharmaceuticals International and Lincoln Medical have all secured regulatory approval to sell their EpiPen alternatives in the country, but so far, none have launched their auto-injectors on the market.