Inside Ontario's chemotherapy scandal | Toronto Star - 0 views
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Claudia den Boer Grima, vice-president of cancer services for the hospital and the region, is on the other end of the line. “There is a problem with a chemo drug,” she says. “It looks like the wrong dose has been given. We don’t know how many.”
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Peterborough Regional Health Centre, where the problem that affected all four hospitals had been discovered exactly seven days earlier.
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It would be another seven days before she would learn that all her treatments involving this drug had been diluted by as much as 20 per cent.
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Since the crisis, all the hospitals involved have stopped outsourcing gemcitabine and cyclophosphamide mixtures and brought it in-house, mixing their own medications.
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Their trust would be further hit. Within two weeks, the Star reported that health-care companies are allowed to mix drugs for hospitals without federal or provincial oversight, prompting top health officials — Ontario health minister Deb Matthews and federal health minister Leona Aglukkaq — to scramble to close that regulatory grey area.
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This week Jake Thiessen, the founding director of the University of Waterloo school of pharmacy, submitted a final report of his investigation into the issue. There has been no formal indication when it will be made public. Hospital administrators say they have been told it will be two to three weeks before they or the public see this report.
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The Ontario College of Pharmacists has passed legislation that allows it to inspect any premises where a pharmacist works — not just licensed pharmacies.
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All of the changes taken together would have seen Marchese Hospital Solutions still able to supply drugs as it did but subject to inspection by the college.
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The federal government has new rules defining who can be a drug producer, adding that any facility supervised by a licensed pharmacist can do the job. The province has said that hospitals can only purchase drugs from accredited suppliers.
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There is very little clinical evidence to indicate what might happen to a cancer patient who receives an underdose of chemotherapy.
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At the same time, many of the more recent advances in chemotherapy have been in drugs that alleviate side effects like nausea.
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In an oncology pharmacy, strange is not good. And on March 20, one week before Marley’s last cyclophosphamide treatment, Craig Woudsma, a 28-year-old pharmacy assistant, and a colleague at the Peterborough Regional Health Centre, had a bad feeling.
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In this case, it was a shipment of new gemcitabine chemotherapy bags that required refrigeration, according to the label. Previous batches, from a different supplier, had not.
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Woudsma noticed more differences. The bags from Marchese only had a total volume and concentration on the label — 4 grams of gemcitabine in 100 mL of saline — instead of the specific concentration, the amount of drug per single mL of saline, as the old bags indicated.
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The new bag’s label did not contain enough information for him to accurately mix the patient’s dose. He needed to know the specific concentration.
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When preparing the solution, staff at Marchese Hospital Solutions, in Mississauga, Ont., dissolved the medication into a pre-filled 100 mL bag of saline. These bags typically contain between 3 to 20 per cent more solution than 100 mL,
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“I told the pharmacist in the area. And then it kind of went above me at that point ... They came to me saying, this is kind of a big deal; teleconferencing with the minister of health, that kind of stuff,” said recently, sitting on the front steps of his red-brick, semi-detached home in the village of Millbrook, Ont. “It’s kind of a foreign concept, to think that what we do, in our corner of the hospital, is going to get that kind of exposure.”
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This means that the bag Woudsma was holding contained 4 grams of gemcitabine in more than 100 mL of solution. The concentration of the medication wasn’t what the label would have made him think. It was weaker than advertised.
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People have asked Woudsma why he was able to catch a problem that went undetected at other hospitals for more than a year. Simple, he says. He had something to compare it to.
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The company’s pharmacy workers did not remove the known overfill when mixing the medication because they thought each bag was going to a single patient
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referred to in the industry as overfill, included to account for possible evaporation.
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The hospital had switched that very day to a new supplier — Marchese Hospital Solutions. A bag of the old supply from Baxter CIVA was still on site.
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Medbuy, a group purchasing company for hospitals, starting in 2008, had a contract with Baxter Central Intravenous Admixtures to provide drug-mixing services. The two drugs in question, cyclophosphamide and gemcitabine, were outsourced because they come in powder form and are tricky to mix. It takes about four hours to reconstitute them in liquid, and in that time they must be shaken every 20 minutes.
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As that contract was about to expire, Medbuy issued a request for proposals for drug-mixing services: Baxter CIVA, which wanted its contract renewed, Quebec-based Gentes & Bolduc and Marchese all stepped forward.
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The details of the new arrangement remain known only to Medbuy. It was founded in 1989 to get better deals for hospitals buying products like scalpels, bed pans and even some medications in bulk. The company’s 28 member hospital organizations in Ontario, New Brunswick and Prince Edward Island spent a combined $626-million on contract purchases in 2012.
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Marita Zaffiro, president of Marchese, testified at Queen’s Park that the Medbuy contract did not indicate the hospitals wanted the labels on these drugs to cite a specific concentration. The reason she included it that way in the RFP was simply to show what could be done.
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Sobel ran the calculations in his office. For a single patient to require a 4,000 mg dose of cyclophosphamide, on a common breast cancer treatment regime, that patient would need to be about 7 feet tall and weigh 2,200 lbs.
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“The chance of 1,200 patients getting 4,000 mg exactly — it’s just impossible.”
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Four Marchese pharmacists who played a role in the new contract work revealed to the Queen's Park committee in June that they had either limited or no background in oncology.
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Marchese Hospital Solutions began as Marchese Pharmacy, a Hamilton-area community drugstore that expanded beginning in 1998 when Zaffiro became president. In 1999 the company obtained a contract to supply the Hamilton Niagara Haldimand Brant Community Care Access Centres, business they did until the contract expired in 2011, shortly before it was awarded the Medbuy contract.
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It lost the CCAC contract in 2011, shortly before the Medbuy deal, and shed employees. Fifty-seven were either laid off or left the company during this troubled time, according to internal newsletters. But then things started looking up.
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Zaffiro attempted to get accreditation for the site, according to her Queen’s Park testimony, approaching both the Ontario College of Pharmacists and Health Canada, neither of which took steps to regulate the fledgling business because each thought the other had jurisdiction.
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Medbuy, Marchese and Jake Thiessen have maintained that cost was not a factor in the error. Marchese’s bid on the request for proposal came in at about a quarter of the cost of previous supplier Baxter Corporation. Bags from Marchese cost from $5.60 to $6.60; Baxter charged $21 to $34.
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CEO David Musyj thinks about what went wrong. The problems, he says, go far beyond Marchese and Medbuy. “All of us are culpable,” he says. “We could have done some things internally that could have prevented this. We could have weighed the bags when they came in.”
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Since the crisis, all the hospitals involved have stopped outsourcing gemcitabine and cyclophosphamide mixtures and brought it in-house, mixing their own medications. This week Jake Thiessen, the founding director of the University of Waterloo school of pharmacy, submitted a final report of his investigation into the issue. There has been no formal indication when it will be made public. Four Marchese pharmacists who played a role in the new contract work revealed to the Queen's Park committee in June that they had either limited or no background in oncology."The chance of 1,200 patients getting 4,000 mg exactly - it's just impossible." Marchese lost the CCAC contract in 2011, shortly before the Medbuy deal, and shed employees. Fifty-seven were either laid off or left the company during this troubled time, according to internal newsletters. But then things started looking up. Medbuy, Marchese and Jake Thiessen have maintained that cost was not a factor in the error.
