'This is unacceptable': cancer patient speaks out on diluted drugs
Published Wednesday, April 3, 2013 9:20AM EDT
Last Updated Thursday, April 4, 2013 12:30PM EDT
After a trip to the hospital for an ultrasound to determine if her cancer had returned, Tracey Bridgen came home to find a letter telling her she had been given diluted chemotherapy drugs.
“My head was spinning,” said Bridgen, who was treated for non-Hodgkins lymphoma at Windsor Regional Hospital in southwestern Ontario.
“Actually, I really didn’t know what to think. I was baffled.”
Bridgen is one of nearly 1,200 cancer patients in Ontario and New Brunswick who received lower than intended doses of chemo drugs.
As hospitals continue the process of contacting those affected, Ontario Premier Kathleen Wynne says she wants answers on what went wrong.
On Tuesday, Ontario’s cancer care agency, Cancer Care Ontario, announced that two medications purchased by four hospitals in Ontario and one in New Brunswick were mistakenly diluted with too much saline. The agency said that batches of IV bags containing cyclophosphamide and gemcitabine were mistakenly diluted by as much as 20 per cent.
The mistake was caught last week by a pharmacy technician in Peterborough, Ont., after the diluted chemo was unknowingly administered to patients for more than a year in some cases.
“This is unacceptable,” Bridgen told CTV Windsor. “And it’s affecting people in ways that you don’t even know unless you are a cancer patient.”
Wynne said Wednesday her government wants to know what happened.
"It's a very worrisome situation, obviously most worrisome for the patients and their families involved, and we will work to find out how this happened," Wynne told reporters.
"I don't know exactly how this happened, but we obviously need to find out how it happened."
Windsor Regional Hospital CEO David Musyj says it appears the supplier of the IV bags made a critical error when mixing the medication.
He explained that IV bags arrive at the supplier overfilled, to compensate for condensation and evaporation during shipping. The overfill can vary from bag to bag and the drug supplier is supposed to measure out the correct amount of saline.
“You’re supposed to start with a 250 ml bag of saline. And then what you’re supposed to do is extract the saline, and then put it back into the bag with the exact amount of drug and saline so the dosage is the exact amount,” he told CTV News Channel Wednesday.
All five affected hospitals purchased the drugs from the same supplier, Marchese Hospital Solutions.
In a statement posted on the company’s website, president Marita Zaffiro said Marchese “deeply regrets the patient concerns and uncertainty regarding the administration of some of the chemotherapy solutions we supply.”
But she stressed that there was never “any question of a ‘defective’ medication” and that the company is “confident” it met all of its contract requirements as a supplier, including the volume and concentrations of the drug solution.
The issue has arisen “as a result of a difference between the manner of administration used in some hospitals that was not aligned with how the standardized preparation had been contractually specified,” she said.
The Ontario College of Pharmacists was at Marchese Hospital Solutions Wednesday, Health Minister Deb Matthews said.
Cancer Care Ontario and the affected hospitals are also conducting their own investigations.
It’s not clear what effect the diluted drugs might have had on treated patients, some of whom received multiple diluted doses.
Musyj says of the 290 affected patients at Windsor Regional Hospital, 17 have since died. But he says there could be “a multitude of reasons” why the patients died and it’s not known whether the dilution problem was a factor in any of those deaths.
He adds that the other affected hospitals are still gathering information on which affected patients might have died, but says those numbers can be difficult to determine, since some patients move on and don’t have any more contact with the hospital where they were treated.
Cancer Care Ontario says the dilution problem will affect each patient differently because the dilution ranged from three to 20 per cent, and because each patient has a different care plan, relying on different combinations of drugs.
Drugs part of chemotherapy 'cocktails'
One of the affected drugs, cyclophosphamide, is combined with other cancer medications to increase their effectiveness. Both it and gemcitabine are used in the treatment of a multitude of cancer types, including breast, pancreatic and lung cancer, lymphoma, certain types of leukemia, as well as myeloma and non-Hodgkin’s lymphoma.
Musyj said that from what he’s been told, these drugs are not the primary cancer-fighter drugs but are one of many that make up drug “cocktails.”
Dr. Carol Sawka, vice-president of clinical programs and quality initiatives at Cancer Care Ontario, told CTV News Tuesday that the concern with patients receiving lower doses is that over time, it may produce “an inferior outcome.” But she says, “the evidence that links lower doses to inferior outcome are pretty sparse.”
Musyj says his hospital has already contacted about 150 of the 290 affected and urging them to schedule appointments with their oncologists to discuss how the problem might affect them
“Some have told us they’re not interested in coming in; they’re fine. They got the information they need and they don’t want to be contacted any further and they’ll reach out to us again if need be or they’ll wait for a future oncology appointment to talk about it,” he said.
“So we’re getting a wide range of responses.”
The majority of the patients affected were in southwestern Ontario:
- 665 were treated at London Health Sciences Centre since March 1, 2012
- 290 patients were treated at Windsor Regional Hospital since Feb. 24, 2012
- 186 patients were treated at Saint John Regional Hospital since March 2012
- 37 patients were treated at Lakeridge Health in Oshawa since March 12, 2013
- 1 patient was treated at Peterborough Regional Health Centre since March 20, 2013
Hospitals were notified of the problem last week and immediately removed the affected chemo drugs, Cancer Care Ontario said. Each hospital has now secured other supplies of the medications for subsequent treatments, the agency says, and no patients' treatment cycles will need to be interrupted
Dr. Sawka added that these sorts of mistakes are uncommon, noting that 40,000 cancer patients make 300,000 incident-free visits to chemotherapy units every year in Ontario. Chemotherapy preparation and delivery is a complex process, she said, and there is always the potential for mistakes.
“It’s impossible to predict every possible source of error,” she said.
Four of the hospitals have set up call centres for cancer patients who have questions about their cancer treatments:
- London Health Sciences Centre: 519-685-8805, or toll free: 1-855-464-3262
- Windsor Regional Hospital: 519-255-8698
- Lakeridge Health, Oshawa: 905-576-8711, ext. 4655
- Saint John Regional Hospital: 506-649-2766