Question Period Note: EpiPen Shortage

A shortage of EpiPen (0.3 mg) auto-injectors is currently being reported in Canada with an unknown end date. EpiPen Jr (0.15mg) is not impacted by this shortage. EpiPen is used to deliver an emergency treatment of adrenaline (epinephrine) to patients who are at risk or have a history of serious life-threatening allergic reactions (anaphylaxis). While Health Canada has authorized other epinephrine auto-injector products, they are not currently being marketed in Canada.

What is Health Canada doing about the shortage of this critical drug?

• Our government’s top priority is the health and safety of Canadians.

• I recognize how important EpiPens are to people with life-threatening allergies and their loved ones.

• My department continues to work with manufacturers to secure a long-term, uninterrupted supply so that Canadians can trust that the life-saving auto-injectors they depend on will be available when needed.

IF PRESSED ON THE ONGOING SHORTAGE OF EPIPENS…

• Supply of EpiPen 0.3 mg is currently available and is being managed by Pfizer Canada to help conserve existing supply so that those who need it have access to it. EpiPen Jr is not impacted by this shortage.

• Canadians are encouraged to visit drugshortagescanada.ca or to contact Pfizer Canada directly for up-to-date information about the shortage and estimated re-supply date.

IF PRESSED ON HEALTH CANADA’S ROLE IN ADDRESSING DRUG SHORTAGES…

• Drug shortages are a global challenge and concern. My department works with manufacturers and other governments to identify shortages early and to try to prevent them.

• When critical national shortages occur, Health Canada works with stakeholders across the drug supply chain to identify mitigation measures.

• These measures can include facilitating access to international supply and expediting the review of new drug applications.

Mylan Specialty LP, the market authorization holder, has been reporting shortages due to manufacturing disruptions of EpiPen (0.3 mg) and EpiPen Jr (0.15 mg) on drugshortagescanada.ca since April 5, 2017. The current reported shortage only impacts EpiPen (0.3mg) and not EpiPen Jr (0.15 mg). Although the end date of the current shortage is unknown, Pfizer, the Canadian importer and distributor of EpiPens, has informed Health Canada that it continues to distribute available EpiPens using strategies that help conserve existing supply.

Alternative epinephrine auto-injectors
Kaléo (Allerject), Taro Pharmaceuticals (Taroclick Epinephrine & Taroclick Epinephrine Junior), Bausch Health, Canada Inc. (Emerade), and Lincoln Medical (Anapen & Anapen Junior) have all received authorization from Health Canada for their epinephrine auto-injector products but are not currently marketing them in Canada. Health Canada has been in communication with these companies as part of our continued efforts to secure an adequate, consistent and sustainable supply of authorized auto-injectors for Canadians over the long term. Based on ongoing discussions, some of the companies have indicated plans to bring product to the Canadian market in 2020.

On August 27, 2018, the Minister of Health signed an Interim Order that facilitated the import and sale of a U.S. product, Auvi-Q, for one year as an emergency measure to help minimize the impact of the EpiPen shortage on Canadians. The Interim Order was signed as an extraordinary measure to address an urgent need at a time when supplies of both EpiPen 0.3mg and EpiPen Jr 0.15mg were critically low.

While Health Canada authorizes drugs for sale on the basis of safety, efficacy and quality, the decision to market a product in Canada is at the discretion of the manufacturer. Health Canada cannot compel a company to market and supply a product.

Health Canada’s role
Health Canada recognizes that drug shortages can have a significant impact on patients and health care professionals and is committed to doing its part to address them when they occur.

Addressing the complex issue of drug shortages is a multi-stakeholder responsibility requiring collaborative action from provinces and territories, manufacturers, distributors, practitioners, and the federal government. When national shortages occur, Health Canada works with provinces and territories and stakeholders across the drug supply chain to determine the details and status of the shortage, coordinate information-sharing, and identify mitigation strategies, which includes exploring access to international supply or alternative products.

Factors such as whether the shortage is national in scope, whether alternative supplies are available and whether the product is considered medically necessary are all considered in determining the potential impact and any necessary actions by Health Canada.

On March 14, 2017, federal regulations came into force requiring drug companies to publicly report drug shortages and discontinuations, including the reasons for the shortage or discontinuation, within a specified timeframe on a third-party reporting website, drugshortagescanada.ca. Timely public communication of drug shortages and discontinuations by drug companies is an essential part of preventing and managing shortages. It helps the drug supply chain and the healthcare system respond appropriately, in order to minimize the impact on patients.

Health Canada also co-chairs the Multi-Stakeholder Steering Committee on Drug Shortages, which mobilizes provinces and territories and key stakeholder groups to play a lead role in advancing tools to address drug shortages.

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