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Winnipeg Free Press - PRINT EDITION

Shortages have Canada looking for drugs abroad

By: Sheryl Ubelacker

Posted: 03/7/2012 1:00 AM | Comments: 0

TORONTO -- The federal government says it is working with pharmaceutical companies to address shortfalls in the supply of some prescription drugs, including a request that they seek alternative sources of the medications outside Canada.

And the head of Health Canada's drug directorate said the government would expedite approval of offshore medications for use by Canadians as long as they meet regulatory standards for quality and efficacy.

Hospitals in several provinces are reporting looming supply gaps for dozens of medications used in operating rooms, emergency departments and intensive care units.

While shortages of many different kinds of drugs have been occurring more frequently in the last two to three years, recent production cuts by Quebec-based generic pharmaceutical company Sandoz has created an even tighter pinch in the medication supply.

The Sandoz plant in Boucherville, Que., has stopped making a number of commonly used painkillers, antibiotics and anesthetics while it upgrades its manufacturing standards to meet concerns raised by the U.S. Food and Drug Administration.

"What you see here is we've had an interruption of the supply chain," said Dr. Robert Cushman, director general of Health Canada's Biologic and Genetic Therapies Directorate.

"People want a collective solution to this. We can work with industry and the purchasers -- the provinces -- in terms of looking at alternative sources of supply... and how can we best bring them into Canada in short order," Cushman said Monday from Ottawa.

"We can clear these alternate sources of supply very quickly if they meet our standards, which we assume they will because these are known medications and our sister organizations would have probably approved them in other domains," he said, referring to the FDA and government regulatory bodies in Europe, for instance.

Mark Ferdinand, senior director of health and economic policy for Rx & D, the association of Canada's brand-name pharmaceutical companies, said Health Canada has to make critical decisions in conjunction with drug makers when it comes to alternative sources of supply.

"Sometimes the issue is we've found another plant somewhere else in the world, but they haven't been inspected by the FDA or Health Canada and so Health Canada has to decide whether they can do an accelerated review of that foreign source before they would allow that foreign source to be imported into Canada," he said.

"So it's certainly true that our members, certainly all pharmaceutical companies that find themselves in this situation, will work with Health Canada to see what can be done in order to find an alternate supply that can meet Health Canada's standards."

But exactly where these medications would come from isn't clear, given that drug shortages are occurring around the globe.

"This is not a Canadian issue," said Jeff Connell, vice-president of corporate affairs for the Canadian Generic Pharmaceutical Association, which represents about 95 per cent of the country's generic drug manufacturers. "These drug shortages have been a problem worldwide and they're far worse in the U.S."

Supply gaps are being blamed on a number of factors, including a diminished supply of raw materials -- many of them from countries such as China and India -- and a burgeoning global patient demand for medications.

-- The Canadian Press

Republished from the Winnipeg Free Press print edition March 7, 2012 C1

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