Health Canada update on the tamoxifen shortage

Starting date:
November 20, 2019
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Identification number:
RA-71656

Last updated:

Issue

OTTAWA - Health Canada is providing Canadians with an update on the supply of tamoxifen, a breast cancer drug, and information on efforts to resolve the national shortage as quickly as possible, recognizing the potentially significant impact that the shortage could have on patients.

For the past several weeks, the three Canadian companies that supply tamoxifen in Canada-Apotex Inc., AstraZeneca Canada Inc., and Teva Canada Ltd.-have all reported shortages on the Drug Shortages Canada website. The reasons have included unexpected manufacturing disruptions and increased demand.

While product remains available within the healthcare system, supply levels have been lower than normal. Companies have implemented distribution management strategies to conserve supply during the shortage and to help ensure product remains available for patients. This is why some patients may find that they are dispensed less supply than usual at their pharmacy (e.g., enough for one month instead of three).

Health Canada has worked collaboratively with the companies, provinces and territories, and stakeholders, such as the Canadian Association of Provincial Cancer Agencies and health care professionals, to share information and identify mitigation measures. These measures have included exploring access to international supply and facilitating efforts by companies, whenever possible and appropriate, to make additional Canadian supply available as soon as possible so that the patients who need it can access it.

As a result of these shared efforts, AstraZeneca Canada Inc. and Apotex Inc. have been able to expedite supply and are now reporting earlier anticipated shortage end dates of December 6, 2019, and December 31, 2019, respectively, instead of the previously reported shortage end date of January 31, 2020. Teva Canada Ltd. continues to report an anticipated shortage end date of January 31, 2020.

Health Canada expects that patients who need tamoxifen between now and the expected shortage end dates will be able to access it. Should periodic gaps occur at the local pharmacy level, Health Canada expects that these will be quickly resolved, as pharmacies should be able to access the drug from their supplier or elsewhere in the supply chain, provided careful distribution management strategies remain in place.

Health Canada is aware of the strain that shortages can place on patients and the health care system. The Department continues to use all available tools to assess and manage national shortages when they happen.

When national drug shortages occur, the Department assesses their severity and potential impact on Canadians. Many shortages can be resolved through supply management measures without their effect ever being felt by patients. Health Canada works closely with the Canadian companies that supply drugs, the provinces and territories, and health stakeholders across the supply chain to identify and facilitate mitigation measures, as needed.

While Health Canada is the federal regulator responsible for the safety, efficacy and quality of health products in Canada, companies are ultimately responsible for the supply of their products.

For more information on drug shortages and Health Canada's role,consult the Drug Shortages in Canada section of the Canada.ca website.

For additional information regarding these specific shortages, visit the Drug Shortages Canada website or contact the companies directly:

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Health Canada
(613) 957-2983
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