Heavens – even Russia is more sensible than Canada when it comes to paid blood donations.
As Health Canada takes a pause and organizes a roundtable on the issue in Toronto next week (of which we weren’t invited), Russia is now prohibiting paid donation except in cases where rare components and blood groups are being donated.
In Canada the issue has come to a boil within the last six weeks after the media discovered Toronto was about to get two private for-profit plasma donation centers that intended to pay $20 per donation. A third is also planned for Hamilton. This is clearly a major shift in how we handle blood donations in Canada, and there had been precisely no debate (beyond the confines of our little BLOG). It also runs counter to the recommendations of both Canada’s own Krever Inquiry and that of the World Health Organization.
Having been at the center of this debate for the past year, you might say we are a little miffed to be sidelined on this. For Health Canada, us unions can wait and make our submissions at a later date.
Of course this is the same Health Canada that inspected Sandoz’s Boucherville Quebec plant and found no issues, only to have the U.S. FDA come in and tell Sandoz to fix their problems or be prohibited from selling their product south of the border.
While Sandoz knew it had to shut down its line well in advance, it failed to give early notice to Health Canada, resulting in significant shortages of intravenous drugs at hospitals across Canada.
Sandoz may find that demand for its intravenous drugs may not be what it once was.
This winter the multi-national drug company was pressured by the U.S. Food and Drug Administration to fix problems with the production line at its Boucherville, Quebec plant. The result was a dramatic cut in production to retool the line, affecting delivery of intravenous drugs to hospitals across Canada.
Hospitals were left scrambling, wondering why Sandoz hadn’t given them more notice of the problem. Sandoz was aware of the problem in November, but didn’t notify hospitals until February.
Peterborough This Week recently reported that since the shortage began, the Peterborough Regional Health Centre has coped well, including cutting its morphine usage in half. No surgeries have been cancelled.
“Many of the new measures put in place this year will most likely long outlast the shortage,” Arnel Shiratti, director of strategic communications and engagement at PRHC, told the newspaper.
The hospital credits the pharmacy team and the anesthesiologists for guiding the hospital through this unplanned shortage.
Health Canada said it would fast track approvals to import alternate supplies from outside the country.
Production at the plant is not expected to deal with the national shortages until mid to late 2013.
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.