POLITICS
03/05/2012 08:09 EST | Updated 05/05/2012 05:12 EDT

Canada Drug Shortage: Foreign Sources Could Be Sought to Ease Scarcity, Says Health Canada

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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 Monday 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.

"From our perspective, what we've been trying to do is help health-care professionals and patients in terms of dealing with these shortages as they occur," said Connell.

"What we've done is work with Health Canada and others in the supply chain — wholesalers, the brand (-name drug) industry and pharmacy organizations to get lists of products that are short onto centralized websites so the health-care professionals can check these sites and then prescribe an alternative."

"So all of our member companies are participating and reporting," said Connell, referring to specific websites set up to list drug shortages.

Ferdinand said many of his organization's members are also reporting supply shortfalls of drugs they produce, but he would like every pharmaceutical producer to take part so the data is complete.

"I think the things that we have been seeing have created a high level of concern, and rightfully so, among patients and certainly their health-care providers," Ferdinand said.

"We're looking to get to the root causes of shortages and we want to prevent shortages ultimately. But before we can actually get to some very tangible solutions ... we need to know what were talking about."

In an online survey of almost 6,000 adults commissioned by the Canadian Association of Chain Drug Stores, more than 30 per cent of respondents reported they had been affected by drug shortages, often more than once, during the past year.

In a third of cases, respondents said they were unable to fill a prescription or find an alternative therapy on at least one occasion, the Neilsen survey released this week found.

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