An organization that arranged a contract with a company that supplied diluted chemotherapy drugs to cancer patients says the labels on the drugs didn’t accurately describe their contents.
Officials from Medbuy, which arranged the contract between Marchese Hospital Solutions and four Ontario hospitals, say the company should have provided exact specifications on its labels.
They told a legislative committee that the pharmacist overseeing the production of the saline-and-drug mixtures should have accounted for the extra saline in the bags.
The extra saline in the bags containing cyclophosphamide and gemcitabine supplied to four hospitals in Ontario and one in New Brunswick effectively watered down the prescribed drug concentrations by up to 20 per cent.
Some of the 1,200 cancer patients were receiving the diluted drugs for as long as a year.
The committee has heard that the drug mixture Marchese was producing was completely different from the one the hospitals thought they were buying.
Marchese said it prepared the drugs the way it was asked to under its contract with Medbuy and under the supervision of a licensed pharmacist.
But the bags didn’t account for the so-called “overfill” of saline, thinking they were being administered to a single patient.
The hospitals were actually extracting fluid from the bag to prepare chemotherapy treatments for different patients, unaware that the drug mixture had too much saline.
A pharmacy assistant at a Peterborough, Ont., hospital that had just started using the Marchese products noticed that the label only listed the amount of the drug gemcitabine in the bag, not the final concentration of the drug per millilitre of saline. According to hospital officials, the labels on products from Baxter, their previous supplier, listed both.
Ontario and Health Canada have acknowledged that there was no oversight of the company and don’t know how many others like Marchese are operating in Canada.
Both the federal and provincial governments have taken steps to close the gap until a more permanent solution is found.
Health Canada said compounding and admixing can continue if it is done within a hospital meeting provincial requirements, outside a hospital under the supervision of a provincially licensed pharmacist, or in a manner that meets the licensing and manufacturing requirements of the Food and Drugs Act.
The Ontario government has posted a new regulation to ensure that hospitals purchase drugs only from accredited, licensed or otherwise approved suppliers.
The province also wants to give the Ontario College of Pharmacists the power to inspect facilities where pharmacists and pharmacy technicians practice, including where drugs are prepared.