Health Canada, provinces declined to regulate firm that supplied diluted drugs

TORONTO -- Both Health Canada and provincial regulators declined to regulate Marchese Hospital Solutions before it started supplying chemotherapy drug mixtures to five hospitals in Ontario and New Brunswick, the company's president said Monday.

"Government authorities have always been fully aware of our presence and the kind of work we do," Marchese Hospital Solutions president Marita Zaffiro told a legislative committee.

"MHS has never attempted to operate without regulatory control."

The company went to Health Canada, the Ontario College of Pharmacists and the New Brunswick Pharmaceutical Society to "inquire about the appropriate regulatory approval" before it started sending their products to hospitals, she said.

Her lawyer later clarified that Marchese notified Health Canada in December 2011, after the company won a contract to produce the intravenous drug mixtures.

All three declined to regulate the company, Zaffiro said. So Marchese instituted its own "stringent quality control measures."

"My understanding was that Health Canada and the colleges were in discussions around looking into this gap and how it was going to be addressed," she said.

Marchese Hospital Solutions has been under scrutiny since it was discovered that 1,200 patients received watered down chemotherapy drugs purchased from the company.

There was too much saline in the bags containing cyclophosphamide and gemcitabine, in effect watering down the prescribed drug concentrations by up to 20 per cent.

Zaffiro said the company prepared the drugs the way they were asked to under their contract and under the supervision of a licensed pharmacist. But there was mixup with the hospitals.

In effect, the drug mixture Marchese was producing was completely different from the one the hospitals thought they were buying, the committee heard.

Marchese was mixing the chemotherapy drugs in bags containing saline. Such bags are routinely "overfilled" with more saline than labelled, to account for evaporation and other factors, the committee heard.

Zaffiro said Marchese supplied products that weren't "concentration specific," meaning they only put a set amount of the drug in each bag, rather than creating a mixture that contained a certain concentration of the drug per millilitre of saline.

But the hospitals thought they were getting bags of a certain concentrate -- which would have been adjusted for the extra saline -- and administered it accordingly.

"What we've learned now is that hospitals were using our products in a way that we had no idea," Zaffiro said.

"We did not know that we were using these for multi-patient use. It was not specified or discussed at any time during the year-plus of the contract being serviced."

It's still unclear how the wires got crossed. Medbuy, a group purchasing organization, was the intermediary between the hospitals and Marchese. It put out the request for proposals and signed the contract with Marchese, with input from the hospitals, the committee heard.

Medbuy awarded the contract to Marchese's pharmacy, which is overseen by the Ontario College of Pharmacists, said Sandy Jensen, director of pharmacy services at London Health Sciences Centre.

But the company created a new division -- Marchese Hospital Solutions -- shortly after to do the work.

Zaffiro said Marchese wanted to keep the operations of its pharmacy and homecare operations separate from the drug mixture business.

"It was not created to avoid any kind of regulation," she said.

Before it was awarded the contract Marchese was asked and it confirmed that it was accredited under the college, Jensen said.

"Accreditation was a question in the (request for proposals) and Marchese did state that they were accredited with the Ontario College of Pharmacists," she said.

"So there was nothing to cause us to go back and say, 'Are you sure you're accredited?' because we understood them to be accredited and they provided us documentation."

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.

The problem was discovered by a pharmacy technician in at Peterborough, Ont., hospital, which had just switched to Marchese.

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 college the power to inspect facilities where pharmacists and pharmacy technicians practice, including where drugs are prepared.

Marchese Hospital Solutions fell into a jurisdictional grey area, with Health Canada and the college unable to agree on who was responsible for the facility.

Health Canada regulates and inspects drug manufacturers, while the college is responsible for pharmacists in Ontario, including those who may have been working independently for the company. Hospitals are responsible for the purchase and security of their drugs.