Diluted chemo supplier testifies, says lack of gov't oversight played role
Published Monday, April 29, 2013 5:11PM EDT
Last Updated Tuesday, April 30, 2013 12:55PM EDT
The head of a company at the centre of a chemotherapy drug scandal says a lack of provincial oversight led to the error that saw cancer patients in two provinces receive watered-down medication.
Marchese Hospital Solutions president Marita Zaffiro testified before an Ontario legislative committee Monday, deflecting responsibility from the Hamilton-based company, saying Marchese was not aware of how the hospitals were using their products.
“We did not know that they were using these for multi-patient use,” she said. “It was not specified or discussed at any time during the year-plus of the contract being serviced."
Zaffiro told the committee she’s “deeply distressed” about the error that saw 1,100 cancer patients in five hospitals in Ontario and New Brunswick receive diluted chemotherapy medication manufactured by Marchese.
“My heart breaks for the patients and families trying to process and understand what they’ve been hearing,” Zaffiro told the committee. “We are deeply distressed to learn that some patients did not receive our preparations in the manner we expected.”
Zaffiro said the drugs supplied by Marchese were prepared under the supervision of a licensed pharmacist and in the manner stipulated under their contract with the hospitals. The contract was arranged through MedBuy, a group purchasing organization.
Marchese mixed the chemo drugs in bags containing saline, which are “overfilled” with more saline to account for evaporation.
Zaffiro said the Marchese-supplied products weren’t “concentration specific.”
Hospitals, however, thought they were receiving bags of a certain concentrate and adjusted the solution accordingly.
It was later discovered that there was too much saline in the bags containing cyclophosphamide and gemcitabine, which diluted the drug concentrations by up to 20 per cent.
Zaffiro also told the committee her company approached federal and provincial regulators to receive regulatory oversight, but was declined.
But she said even with regulatory oversight, the error would still have happened, as her company fell into a grey area that meant neither the federal nor the provincial government was regulating it or inspecting it.
The province and Health Canada have since acknowledged that there was no company oversight for Marchese.
NDP MPP France Gélinas, critic for Health and Long-Term Care, said Monday the provincial ministry’s lack of oversight is hard to forgive.
“Here you have a Ministry of Health that has known for years that we have this grey area. We now know that we have companies operating in that grey area and nothing is done.”
Both levels of government have taken stop-gap measures before a permanent solution is found, including new regulations to ensure that hospitals buy drugs from accredited, licensed or otherwise approved suppliers. Ontario wants to give the college power to inspect facilities where drugs are prepared.
With a report from CTV Toronto’s Queen’s Park Bureau Chief Paul Bliss and with files from The Canadian Press