Shortage of GLP-1 Agonists: Recommendations for Prescribers

CSEM has been working with Health Canada over the past several weeks regarding ongoing shortages of GLP-1 agonists, including Ozempic (semaglutide), Mounjaro (tirzepatide) and Trulicity (dulaglutide). Please read the full December 6, 2023, update and recommendations developed by Health Canada, CSEM, the Canadian Pharmacists Association, the Neighbourhood Pharmacies Association of Canada, the College of Family Physicians of Canada, and the Canadian Society of Hospital Pharmacists:

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Glucagon Shortage and Impending Discontinuation

April 28, 2023

CSEM and CPEG are concerned about the current supply of injectable glucagon, particularly for pediatric and neonatal patients, and patients in need of testing. We have jointly advocated with Health Canada and Glucagon was determined to be in a tier 3 shortage on April 20, 2023. This will facilitate the implementation of strategies to help mitigate the shortage.

Through meetings with Health Canada’s Drug Shortages Unit and key stakeholders, we have learned:

  • Eli Lilly will be discontinuing their injectable glucagon product globally; Canadian supply is expected to be diminished by the end of summer 2023, but may occur sooner if demand increases. Glucagon nasal powder (Baqsimi) remains available. Current demand for Glucagon injection is much greater than the current demand for the nasal powder. Eli Lilly has reported they could sustain a small demand increase in the nasal powder and will require additional demand planning information from health systems to plan for larger demand increases to avoid a shortage.
  • Novo Nordisk is reporting a shortage of their GlucaGen® HypoKit® due to supply issues. They have supply on-hand for existing customers until Fall-2023. They have indicated they cannot meet any additional needs or demand. The shortage is anticipated to end December 31, 2023. Novo Nordisk indicates that there are no plans nor ability to increase production of GlucaGen once their current production issues are resolved.
  • Glucagon is indicated for emergency treatment of severe hypoglycemia, as well as a diagnostic aid. GlucaGen is indicated for emergency treatment of severe hypoglycemia but is not indicated for intravenous or subcutaneous use and is not indicated as a diagnostic aid. Baqsimi is not indicated for children under 4 and cannot be used as a diagnostic aid.
  • Health Canada is also currently assessing the potential to allow the exceptional importation of foreign authorized product as a further mitigation strategy. It is also closely monitoring current injectable glucagon and nasal glucagon supplies. Health Canada will be providing updates the CSEM and CPEG on a regular basis.

CSEM and CPEG are requesting these mitigation strategies are implemented urgently to preserve supply for patients who need glucagon the most, and to ensure a consistent supply of glucagon beyond 2023.

Drug Safety

From time to time, the CSEM receives notices about drug safety issuees from Health Canada.

Current notices:

  • Taro-Zoledronic acid injection recalled because it may contain particulate matter (August 9, 2022)
  • Summary Safety Review — Nexavar (sorafenib): Health Canada assessing the potential risk of thrombotic microangiopathy (August 10, 2022)
  • Summary Safety Review — methadone: Health Canada assessing potential risk of hypoglycemia (February 8, 2022)
  • Lupron and Lupron Depot: Risk of pseudotumor cerebri/idiopathic intracranial hypertension in pediatric patients (January 4, 2022)
  • One lot of Eli Lilly Glucagon (DIN 02243297, lot D239382A, expiry May 10, 2022) recalled (September 25, 2021):
  • Dopamine agonist withdrawal syndrome (June 7, 2021):

Testosterone Injectable Shortage

March 28, 2024 update:

Health Canada has informed CSEM that Bausch Health has discontinued production of Delatestryl®. For more details, please see the Drug Shortages Canada report. However, a generic version of the same strength will be available through Hikma Canada Limited. Testosterone Enanthate Injection, 200 mg/mL is now available at the wholesale level. Drug formulary coverage in all provinces and territories is expected to be effective by Spring 2024. Please let us know if you have any questions or difficulty accessing this medication.

January 20, 2023 update:

There is a shortage of Delatestryl® starting today, estimated to be resolved April 24, 2023.

November 4, 2022 update:

The shortage of Delatestryl® has been resolved.

November 11, 2022 update:

There is a shortage of Delatestryl® starting today, estimated to be resolved December 9, 2022.

October 27, 2022 update:

There is a shortage of Taro-Testosterone® starting today, estimated to be resolved January 27, 2023.

December 10, 2021 update:

The Depo-Testosterone® shortage has been extended to April 1, 2023.

September 13, 2021 update:

The Delatestryl® shortage has been resolved.

May 12, 2021 update: shortages begin

Health Canada is aware of a possible Testosterone injectable shortage pending and is actively monitoring the situation and working closely with all stakeholders across the drug supply chain to identify mitigation strategies. Two Market Authorization Holders, Bausch Health and Pfizer Canada are currently reporting anticipated shortages on the drugshortagescanada.ca website. For further information on availability, please contact the manufacturer(s) directly.

A third Market Authorization Holder has recently entered the market — Taro Pharmaceuticals — which currently sells testosterone cypionate in Canada (product monograph). Taro is not reporting a shortage and has confirmed that it has adequate supplies available.

Health Canada will continue to monitor Testosterone injectable supply and will keep CSEM informed if any delays are reported for the expected resupplies.

March 31, 2021: testosterone supply issues

CSEM has been meeting with Health Canada's Drug Shortage Unit regarding supply issues for testosterone injections: testosterone cypionate (Depo-Testosterone®) and testosterone enanthate (Delatestryl®). We have learned that supply issues are due to Pfizer prioritizing COVID-19 vaccine production until mid-2022. Bausch Health and Taro Pharmaceuticals have increased their supply to help mitigate any shortages. Note that Taro-testosterone is not currently covered under the Ontario Drug Benefits program. Taro-testosterone is not interchangeable with Depo-Testosterone. If switching products, physicians will need to write new prescriptions as it is not an automatic switch at the pharmacy.

October 2, 2020: testosterone supply issues

CSEM is aware of ongoing and regular shortages of injectable testosterone (Delatestryl® and Depo-Testosterone®). Through multi-stakeholder meetings with Health Canada, we have learned that:

  • Bausch Health (Delatestryl® - testosterone enanthate) has experienced a shortage for several months due to material supply issues as a result of the pandemic. Bausch anticipates releasing supply this week with 2nd and 3rd supply lots arriving by mid-October and a return to normal supply in December. Initially, supply will be limited and allocated across the country as a percentage of sales.
  • Pfizer Canada (Depo-Testosterone - testosterone cypionate) is also experiencing a shortage due to increased demand as result of the Bausch shortage. Pfizer anticipates testosterone will be back in stock by the end of October with enough supply to fill usual demand. Availability may vary depending on the Bausch supply.
  • Health Canada is monitoring the ongoing shortages and will provide us with bi-weekly updates.

CSEM has requested that Health Canada:

  • not only monitor the ongoing shortages but help support industry initiatives to reduce shortages;
  • advocate for all provinces to allow patients to use transdermal testosterone if injectable is not available.

We will update our website with new information as it becomes available.

Drug Shortages

CSEM monitors for shortages and discontinuations of medications that are important to endocrinologists' practice. The major source of this information comes from drugshortages.ca. CSEM actively works with Health Canada and manufacturers to advocate for uninterrupted access to these medications for Canadian patients.

Medications of concern:

Hydrocortisone Tablets and Injectables Shortages

April 13, 2023 update: shortage of Solu-Cortef® Act-o-Vials 100 mg

Estimated date of resolution: June 30, 2023.

medSask has a helpful conservation strategy and dose conversion document here (updated September 2022):

December 13, 2022: shortage of Cortef® 10-mg tablets and anticipated shortage of Cortef® 20-mg tablets

There is currently a shortage of Cortef® 10-mg tablets, beginning today, with an estimated estimated date of return to market of February 13, 2023. There is also an anticipated shortages of Cortef® 20-mg tablets, estimated to begin January 14, 2023 and ending February 17, 2023.

medSask has a helpful conservation strategy document here (updated April 2022):

December 1, 2022: shortages of all Solu-Cortef® Act-o-Vials resolved

All strengths of Solu-Cortef® Act-o-Vials (100, 250, 500 and 1000 mg) are now available.

September 26, 2022: ongoing shortages of all Solu-Cortef® Act-o-Vials

All strengths of the the Solu-Cortef® ActO-Vials (100, 250, 500 and 1000 mg) are now on allocation status. Preventive measures are in place.

medSask has a helpful conservation strategy and dose conversion document here (updated September 2022):

July 6, 2022 update: estimated date of end of shortage

The current (unguaranteed) estimated date of the hydrocortisone 10-mg (Cortef®) tablet shortage is July 25, 2022.

June 6, 2022 update: importation of US-labelled Cortef® 10-mg tablet due to shortage of Canadian-labelled product

See announcement from manufacturer:

May 18, 2022 update: US supply of hydrocortisone

Health Canada has added US-labelled hydrocortisone (Cortef®) 10-mg Oral Tablets to the list of drugs for exceptional importation and sale on May 18. Designated drugs are eligible for exceptional importation into Canada. US-labelled supply should be made available in Canada before Canadian-authorised supply is depleted in June.

April 1, 2022: new shortage reported

Pfizer Canada is reporting a shortage of hydrocortisone (Cortef®) 10-mg tablets from mid-June to end of September, 2022.

CSEM is advocating with Health Canada for a consistent supply of this life-saving medication. The Cortef® 10-mg tablet shortage has been classified as a Tier 3 shortage. Drugs in or at risk of Tier 3 shortages may be eligible for exceptional importation and sale. At present there is no reported shortage of Cortef® 20-mg tablets.

CSEM will continue to advocate for uninterrupted supply to ensure the well-being of patients, and we'll keep you informed. Shortage and discontinuation reports are available on the Drug Shortages Canada website.

medSask has a helpful conservation strategy document here (updated April 2022):

February 4, 2021 update: shortage resolved

The oral hydrocortisone tablet shortage is resolved.

December 21, 2020: possible shortage reported

CSEM is aware of a possible shortage of hydrocortisone (Cortef®) 10 mg. While Pfizer Canada’s stock of hydrocortisone (10-mg tablets) has been depleted, new supply is on track for mid-January, 2021. Additionally, it is anticipated that there is currently enough product at the community pharmacy level to cover the supply gap. Pfizer has issued the following notice to pharmacies informing them of the backlog and suggesting conservation of inventory when possible:

medSask has a helpful conservation strategy document here: https://medsask.usask.ca/documents/drug-shortages-pdfs/hydrocortisone_shortage.pdf.

We will continue to remain in contact with Pfizer Canada and Health Canada's Drug Shortage Unit for regular updates and we will keep you keep you informed.

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