Government Of Canada Approves A New Source Of Medical Isotopes

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 07 Jul 2009 - 0:00 PDT

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The Honourable Leona Aglukkaq, Minister of Health, announced the approval of a new source of the medical isotope Iodine-131 (I-131) to treat thyroid cancer in Canada.

Health Canada has authorized Draximage of Montreal to supply I-131 from South Africa's Safari reactor to Canadian health care facilities. This decision comes after the Department determined that I-131 produced by the SAFARI reactor is safe and effective for use by Canadian health care providers. Production of I-131 in Canada was interrupted by the unplanned shutdown of the Chalk River National Research Universal reactor (NRU) in May 2009.

"This is good news for thyroid cancer patients in Canada and their health care providers," said Minister Aglukkaq. "Our Government continues to find solutions to help address the current isotope shortage."

The Minister added that today's approval means that Draximage will continue to supply all of Canada's requirements for the I-131 isotopes. The company has advised that the transition to this new supply source will be seamless and immediate.

Since the shutdown of the Chalk River reactor, health care providers had been using Health Canada's Special Access Programme to access I-131 for patients. Today's approval of I-131 by Health Canada means that the isotope can be directly supplied to health care providers. Rapid approvals for alternate supplies of isotopes were a part of the regulatory tool kit put in place after the 2007 Chalk River shutdown.

Today's announcement is just one more element of the ongoing work the Government of Canada is doing to minimize the impact of the medical isotope shortage on Canadians.

Other measures undertaken by Health Canada include:

Approving Australia as a new source for Technetium-99m for use by Canadian health care providers;

Appointing Dr. Alexander (Sandy) McEwan as Special Advisor on Medical Isotopes for the duration of the isotope shortage. He is providing on-the-ground updates on the situation and how it is affecting patients, advise how Health Canada can best support provinces, territories and the medical community on the use of alternatives and mitigation strategies, and support the Minister in communicating the impact of the current shortage;

Collaborating with the provinces and territories and medical experts to produce guidelines to assist health care professionals in a shortage situation. These include measures to make better use of available isotopes, prioritizing patients who most need testing, and shifting to viable alternatives where safe and effective to do so. These guidelines are based on work undertaken by the province of Ontario and draw on the medical expertise of the Ad Hoc Group of Experts on Medical Isotopes, as well as other health care providers;

Working closely with the Federal, Provincial, Territorial Working Group on Medical Isotopes, which is playing a key role in contingency planning and managing the shortage;

Facilitating communications between isotope suppliers, the Ad Hoc Group of Experts on Medical Isotopes and the Federal, Provincial, Territorial Working Group on Medical Isotopes both to track supply trends and to enable advance planning;

Reviewing regulatory requests for approvals of alternate isotopes on an urgent basis to provide health care providers with options as quickly as possible. This is part of Health Canada's ongoing work on the medical isotope shortage to ensure that Canadians continue to have access to the highest standards of care; and

Investing $6 million for research into alternatives to Technetium-99m.

Other areas of focus include discussions led by the Honourable Lisa Raitt, Minister of Natural Resources, with reactor operators abroad to ramp up production and her appointment of an Expert Review Panel and launching a process to solicit ideas for the alternative production of the key medical isotopes, Molybdenum-99/Technetium-99m, over the medium and long term.

Source
Health Canada

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