Health product shortages in Canada: Fiscal year 2024 to 2025 in review

On this page

• Health product shortages
• Drugs
  • What is a drug shortage
  • How are drug shortages reported
  • Drug shortages in 2024 to 2025
  • Drug shortages with the highest impact
  • Highlights of 3 high-impact drug shortages
• Medical devices
  • What is a medical device shortage
  • How are medical device shortages reported
  • Medical device shortages in 2024 to 2025
  • Medical device shortages with the highest impact
  • Highlights of 2 high-impact medical device shortages

Health product shortages

Health Canada's Health Product Shortages Directorate (HPSD) plays a leadership role in addressing drug and medical device shortages in Canada.

It's our top priority to try to prevent shortages when possible. We also take actions to mitigate their most severe impacts when they present a significant risk to patients and the healthcare system.

To help prevent, mitigate and resolve shortages, we work closely with:

• provincial and territorial governments
• manufacturers
• the healthcare system
• healthcare professionals
• patient groups
• global partners

Drugs

What is a drug shortage

A drug shortage is when a manufacturer is unable to meet the demand for a drug in Canada. As a result, patients may face delays in receiving their medication or be unable to access the medication altogether. The words drug, medication and medicine are often used interchangeably.

Over 10,000 prescription drugs and nearly 2,000 over-the-counter drugs are approved for sale in Canada. These numbers vary as new drugs are approved and others are discontinued.

Shortages will have varying impacts based on the duration of the shortage and the availability of alternatives.

How are drug shortages reported

For certain drugs, manufacturers must report all actual or anticipated shortages and discontinuations, of any duration, via the Drug Shortage Reporting website. Reporting timelines are as follows:

• Anticipated shortage: at least 6 months before you anticipate the shortage will begin or within 5 calendar days of becoming aware of an anticipated shortage that is expected to happen in less than 6 months
• Actual shortage: within 5 calendar days of becoming aware of the shortage
• Discontinuation: at least 6 months before you intend to permanently stop sale or within 5 calendar days from the day you made the decision to discontinue your drug if you intend to permanently stop sale in less than 6 months

Drug shortages in 2024 to 2025

In 2024-25, 2,588 new drug shortage reports were submitted. This is a decrease of around 20% relative to 2023-24. At the end of 2024-2025, 1,772 drug shortages reports were still active (un-resolved or anticipated).

For the same reporting period, 140 drugs were discontinued, which represents a reduction of 14% relative to the previous period.

Not all shortages and discontinuation are a cause for concern for patients, as often the same drugs are available in different formats or from other manufacturers. Most shortages are successfully managed before they impact patients and the health care system.

The top 3 reasons for shortages were:

1. Disruption of the manufacture of the drug (65%)
2. Increase in demand for the drug (15%)
3. Delay in shipping of the drug (9%)

Drug shortages with the highest impact

Drug shortages with the highest potential impact on patients and the healthcare system are called Tier 3 shortages.

In 2024-25, there were 22 drugs that were deemed to be a Tier 3 shortage.

Of those shortages:

• 11 were resolved within the reporting period

• 11 remained active, with mitigation efforts underway to resolve them
  During this reporting period, Health Canada:

• conducted active monitoring and shared information when we needed to take exceptional measures, and confirmed these measures were effective

• identified alternative drugs and sped up the review process for new drugs to support patients

• permitted the importation of similar drugs approved in foreign jurisdictions by trusted partners through exceptional importation and sale measures

• facilitated continued access to these drugs through conservation and shelf-life extension with supporting data

Highlights of 3 high-impact drug shortages

Three examples of high-impact shortages over this period are:

• Carbamazepine
• PEGASYS (Peginterferon alfa-2a) injection
• Loxapine

Carbamazepine

Carbamazepine is used to treat epilepsy, nerve pain, and bipolar disorders. Controlled release carbamazepine tablets were in shortage from May 2024 to January 2025 due to manufacturing disruptions.

We took the following actions to mitigate the impacts of the shortage:

• mobilized and shared supply information regularly with impacted stakeholders
• worked with the manufacturers and others to monitor supply
• supported the development of shortage management recommendations for health care providers, led by the Canadian League Against Epilepsy and the Canadian Pharmacists Association
• permitted the exceptional importation and sale of U.S.-authorized supply to help meet demand until the shortage was resolved
• Published a supply notice to communicate shortage information and supply updates

PEGASYS (peginterferon alfa-2a) injection

PEGASYS (peginterferon alfa-2A) injection is used to treat chronic hepatitis B and C. It is also prescribed off-label for other conditions. This means that is used in a different way than what it has been approved for. PEGASYS (peginterferon alfa-2A) injection has been in shortage in Canada since October 2024 due to a manufacturing disruption.

To date, we have taken the following actions to mitigate the impacts of the shortage:

• mobilized and shared supply information regularly with impacted stakeholders
• worked with the manufacturers and others to monitor supply
• supported the development of shortage management recommendations for health care providers, led by the Canadian Myeloproliferative Neoplasms Network and the Canadian Pharmacists Association
• permitted the exceptional importation and sale of US-authorized BESREMi (ropeginterferon alfa-2b) injection, an alternative drug for certain uses, and of EU-authorized PEGASYS (peginterferon alfa-2A) injection to help meet demand until the shortage is resolved
• Published a supply notice to communicate shortage information and supply updates

Loxapine

Loxapine is used to manage schizophrenia. Loxapine injection was in shortage from May to October 2024 due to manufacturing disruptions.

We took the following actions to mitigate the impacts of the shortage:

• mobilized and shared supply information regularly with impacted stakeholders
• worked with the manufacturer and others to monitor supply
• worked with the market authorization holder to extend the shelf-life date of supply remaining on this market to increase the availability of the drug

Medical devices

What is a medical device shortage

A medical device shortage is when a manufacturer of a medical device is unable to meet the demand for the medical device or its components, accessories or parts in Canada.

Over 34,000 medical device licences are active in Canada. This number varies as new device licences are issued, and others are discontinued.

Shortages will have varying impacts based on the duration of the shortage and the availability of substitutes.

How are medical devices shortages reported

For certain categories of medical devices, manufacturers of Class I to IV devices and importers of Class I devices must report actual or anticipated shortages and discontinuations that will lead to a shortage. Reports are made to Health Canada and posted on our website. Reporting timelines are as follows:

• anticipated shortages: within 5 business days of becoming aware of an anticipated shortage
• actual shortages: within 5 business days of becoming aware of the shortage
• discontinuations: within 5 business days after the day of making the decision to discontinue sale in Canada if it will lead to a shortage

Medical device shortages in 2024 to 2025

Shortage reporting requirements only apply to certain medical device categories that are included in the List of Medical Devices - Notification of shortages ("list of specified medical devices"). At the end of 2024-25, the list included 20 medical device categories. Relative to the previous year, 11 device categories were maintained, 6 were removed, and 9 were added. Companies can also voluntarily report shortages for medical devices that are not included in the categories in the list of specified medical devices to Health Canada.

In 2024-25, Health Canada received 69 reports of medical device shortages. This is an increase of 19% relative to 2023-24. Of these reports, 51 were mandatory reports while the other 18 were submitted voluntarily. These reports represented a total of 1,439 medical devices.

During the same period, Health Canada received 59 reports of medical device discontinuations. Of these reports, 21 were mandatory reports while the other 38 were submitted voluntarily. These reports represented 421 devices.

Not all reports are cause for concern for patients, as often substitute devices are available. Most shortages are successfully managed before they impact patients and the healthcare system.

The top 3 reasons for shortages were:

• Disruption of the manufacture of the medical device (54 %)
• Increase in demand for the medical device (20 %)
• Medical device was subject to a recall (10 %)

Medical device shortages with the highest impact

The highest-impact medical device shortages are those where there are no readily available authorized substitute devices which may result in harm to patients or disruptions in the healthcare system.

During this reporting period, for critical medical device shortages, Health Canada:

• conducted active monitoring and shared information when we needed to take exceptional measures and confirmed these measures were effective
• identified substitute devices and authorized new medical devices to support patients
• permitted the importation of substitute devices approved in foreign jurisdictions by trusted partners through exceptional importation and sale measures

Highlights of 2 high-impact medical device shortages

Two examples of high-impact medical device shortages over this period are:

• Absorbable mechanical hemostatic sponges
• Control syringes with luer lock tip

Absorbable mechanical hemostatic sponges

Absorbable mechanical hemostatic sponges are used during surgical procedures to control or stop the bleeding. These devices are made from gelatin, collagen or cellulose and are absorbed by the body within four to six weeks. The shortage of absorbable mechanical hemostatic sponges began in October 2024 due to a manufacturing disruption followed by an increase in demand.

We took the following actions to mitigate the impacts of the shortage:

• added "Absorbable mechanical hemostatic sponges" to the list of specified medical devices to require mandatory shortage reporting by industry
• mobilized and shared supply information regularly with impacted stakeholders
• worked with manufacturers and others to monitor supply levels
• permitted the exceptional importation and sale of European Union-authorized CuraSpon to help meet demand until the shortage was resolved

Control syringes with Luer lock tip

Control syringes are sterile syringes used to deliver fluids and drugs using only one hand. A Luer lock tip has a threaded connection that permits a needle or intravenous port to be screwed into the syringe preventing leaks, ensuring accurate delivery of the contents. The shortage of these syringes began in October 2024, due to a manufacturing disruption.

We took the following actions to mitigate the impacts of the shortage:

• added "Control syringes with Luer lock tip" to the list of specified medical devices to require mandatory shortage reporting by industry
• mobilized and shared supply information regularly with impacted stakeholders
• worked with manufacturers and others to monitor supply levels
• authorized a new Control syringe with Luer lock tip

Liens connexes

• Health Canada's plan to address health product shortages, 2024 to 2028
• Infographic: Helping Canadians deal with drug shortages

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2026-01-26