Canadian hospitals are scrambling to find sufficient quantities of certain generic drugs after the manufacturer recently slowed down production at its three Sandoz North American plants, including one in Boucherville, Quebec. The company is doing so to address issues raised by the U.S. Food and Drug Administration.
Last November the U.S. FDA issued a warning letter to Novartis International stating the Canadian plant failed to follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile.
In the November 18, 2011 letter, the FDA stated specifically of the Boucherville plant “your failure to implement corrective actions and prevent future recurrence is indicative of an ineffective quality system.”
So where is Health Canada on this? Health Canada also inspected the plant AFTER the U.S. FDA and said they found no issues.
Health Canada has also dragged its heels on the need for notification, leaving it up to physicians to check individual pharmaceutical company web sites for update lists.
Dr. John Haggie, president of the Canadian Medical Association, told the Globe and Mail the notification system is not practical, but instead “relies on the GP having time to go check the list and see if it is up to date.”
Meanwhile, the shortcomings of a private for-profit company are creating some level of havoc in our public health system.
“This is a very significant concern,” Jeff Valentin, vice-president of communications at Hamilton Health Sciences told the Hamilton Spectator, “Part of the concern is they’re sole-source manufacturers for some of these very important medications.”
According to the newspaper, HHS is expected to run out of at least 10 types of mostly intravenous medications within the next 90 days.
The Globe and Mail reports that “the slowdown is yet another blight for pharmaceutical companies who have been accused of abandoning drugs that are no longer profitable and failing to give proper warning that pharmacy shelves will be empty when patients go to get their prescription filled.”
The Ontario Hospital Association sent out its own release yesterday stating it was unclear what the direct impact will be on patients, but it was looking forward to participating in an unspecified provincial action plan.
With all this turmoil, where is Federal Health Minister Leona Aglukkaq? Steve Outhouse, her director of communications, has told the media that Health Canada will follow-up with the company to determine “the full scope of the company’s actions and what impact, if any, it will have on Canadians.” If any?