And it has done so in the very same grey zone that saw more than 1,200 Canadian cancer patients receive diluted drugs from Marchese Hospital Solutions. The medication error, made public earlier this month, left health authorities scrambling to address startling gaps in industry oversight that have gone unaddressed for what now appears to be much longer than officials realized.
Baxter’s Centralized Intravenous Admixture (CIVA) Pharmacy Services, an arm of a multinational, U.S.-based pharmaceutical giant, has been supplying chemotherapy cocktails and other drugs mixed in bulk to hospitals across Canada since 1986.
“To not have any provincial or federal oversight in this area is ludicrous,” said Dr. James Gowing, past co-chair of the Cancer Advocacy Coalition.
He said he considers Baxter a reliable company but questions the protocols.
“Just about everything else has some oversight and certainly the drugs themselves have tremendous oversight. If you’re diluting drugs, why wouldn’t that come under the same oversight?”
Baxter spokeswoman Alison Drinkwater said the company’s drug-mixing facility in Mississauga is “operated with licensed pharmacists and certified technicians and a quality assurance team that specializes in safe and precise processes.”
In recent weeks, the Star exposed a corner of the industry untouched by federal or provincial oversight when it reported that Marchese, which supplied chemo drugs to five hospitals during the past year, was neither an accredited pharmacy nor a federally licensed drug manufacturer. This means the company was not subject to any official inspections.
So far, 137 cancer patients have died since starting their treatments. It is not known what, if any, role the diluted drugs played in their deaths.
The hospitals have claimed Marchese’s supply of the intravenous cancer drugs cyclophosphamide and gemcitabine contained too much saline, diluting the potency by as much as 20 per cent. Marchese said the problem wasn’t how the drugs were prepared but how hospitals administered them.
Health Canada has been aware of this grey zone, where drug-mixing companies operate unregulated, since 1997.
A recent survey by the Ontario Hospital Association revealed just how widespread the practice of contracting out pharmacy services is. The association reported that Baxter CIVA mixes intravenous cancer drugs and other medications for least 33 hospitals in Ontario alone. The OHA surveyed 129 acute-care hospitals.
At least 40 of the 88 hospitals that responded to the survey said they contract out pharmacy services for intravenous medications including chemotherapy, narcotics and epidurals. Marchese Hospital Solutions supplies 11 of the hospitals.
Though Baxter Corp. holds a number of Health Canada licences, none applies to its mixing arm.
“Health Canada did conduct inspections in Baxter’s facility that operated under federal jurisdiction of the Controlled Drugs and Substances Act but did not inspect compounding or admixing facilities, as this was deemed an area of provincial jurisdiction,” said Steve Outhouse, spokesman for federal Health Minister Leona Aglukkaq.
When the Star asked Ontario’s Health ministry how a company was permitted to do business with its hospitals for decades without oversight, it deferred to Health Canada.
“Baxter has been and continues to be an established Canadian drug manufacturer which has been and continues to be regulated by Health Canada serving patients not just in Ontario, but across the country,” said Zita Astravas, spokeswoman for Health Minister Deb Matthews. “This is precisely why we’re pleased that Health Canada has chosen to take leadership on a national scale for a national issue.”
Baxter’s Drinkwater said the company welcomes guidelines introduced by Health Canada on Friday in response to the recent chemotherapy drug error.
A suite of new regulations by federal and provincial bodies will see both Baxter CIVA and Marchese Hospital Solutions placed under the oversight of the Ontario College of Pharmacists.
Regular federal or provincial inspections, which have not occurred for these grey-zone companies, would ensure that quality-assurance processes are being carried out, that the products are sterile, that the facilities have been tested for environmental contamination, and that there are checks and balances in the preparation processes, said Julie Greenall, a project director at ISMP Canada, a national non-profit agency that analyzes medical errors.
“It’s not in any way to say that has not been happening, but there has been no one ensuring this has been happening,” said Greenall.
“Errors can occur and they can be difficult to detect,” added Sylvia Hyland, ISMP Canada’s chief operating officer.
Baxter CIVA provides mixing services for the University Health Network, which includes Toronto General Hospital, Toronto Western Hospital, Princess Margaret Hospital and Toronto Rehab.
Emily Musing, the University Health Network’s director of pharmacy, said she’s confident in Baxter CIVA’s quality assurance processes.
“The fact that there hasn’t always been a way to regulate everything does not necessarily imply that there’s no quality process in place. I think we need to remember that,” she said.
Diana Ermel, a board member at the Canadian Breast Cancer Network and a breast cancer survivor, said it’s easy to be anxious not knowing precisely what patient safeguards are in place.
“Now that we know that things can go wrong . . . we really need to see that there are strict quality controls so that people can have confidence in the system and the treatment they’re receiving.”
Original Article
Source: thestar.com
Author: Diana Zlomislic, Tim Alamenciak
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