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Diluted chemotherapy supplier to testify at Queen’s Park

Health Minister Deb Matthews says a good question to ask is whether the privatization of the preparation of the chemo drugs was a contributing factor to the problem

Kevin Van Paassen/The Globe and Mail

The head of the drug-compounding company linked to diluted chemotherapy treatments given to 1,200 cancer patients is scheduled to testify before a Queens Park committee next week.

Marita Zaffiro, president of Marchese Hospital Solutions, which supplied the chemotherapy drugs in question to five hospitals in Ontario and New Brunswick, will undergo questioning on Monday by the legislature's Standing Committee on Social Policy.

Her appearance would mark the first time Ms. Zaffiro has spoken publicly about her company's role in how the watered-down treatments reached patients since news of them broke in early April. Her most recent remarks on the matter came in the form of a prepared statement posted on the company's website on April 3.

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Ms. Zaffiro is scheduled to appear at 4:40 p.m., following officials from Cancer Care Ontario and London Health Services, the hospital that discovered the diluted treatments.

"She's got a good, long slot," said Marchese spokesman Greg Wilkinson. "That's very encouraging for us because we think she has a lot to add to the discussion."

Among the topics Ms. Zaffiro will likely be asked to address were comments made this week to the committee by the head pharmacist at another affected hospital, Windsor Regional Hospital, that Marchese mislabelled the bags of intravenous chemotherapy drugs.

Christine Donaldson testified that Windsor Regional immediately quarantined its chemotherapy supply from Marchese after being alerted to the dilution in late March by London Health Sciences Centre.

"After being notified, the fluid from one sample IV bag was extracted and it was verified that extra fluid was present in the bag beyond the labelled volume," Ms. Donaldson said, according to a transcript of the proceeding.

Her remarks, made Monday, were significant because they appeared to counter earlier suggestions by Ms. Zaffiro that the problem stemmed not from Marchese, but rather from the manner in which the chemotherapy was administered by hospitals.

"These concerns have 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 [of the drugs] had been contractually specified," read the statement from Ms. Zaffiro on her company website.

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According to a draft transcript of Monday's hearing, Ms. Donaldson testified that labels on intravenous bags showed each bag contained four grams of the drug cyclophosphamide dissolved in 200 millilitres of saline solution. In fact, she testified, the bags contained more saline.

Drug-compounding companies like Marchese operate in a regulatory grey area. They are not considered pharmacies, which would warrant oversight by the Ontario College of Pharmacists, nor are they considered drug manufacturers, which Health Canada regulates and inspects.

Health Canada and the province last week moved to narrow the jurisdictional gap, but it has yet to be sealed.

There also remains the question of how many drug-compounding companies exist. A recent survey by the Ontario Hospitals Association suggested there are two main suppliers of chemotherapy drugs, Marchese and Baxter CIVA. But Ottawa and the province have both acknowledged they have no idea how many companies like them exist and are supplying drugs to hospitals.

During the hearing, the assistant deputy minister of accountability with the Ministry of Health and Long-Term Care, Catherine Brown, said the province has written to "businesses that it knows of, which might possibly be selling compounded drugs, to obtain more information about their processes and oversight."

Hearings were scheduled for Monday and Tuesday, and transcripts of later sessions are expected to emerge in the coming days or weeks.

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