TORONTO - Health Canada should regulate all entities that mix drugs outside a licensed pharmacy, said an expert who investigated why more than 1,200 cancer patients in two provinces received diluted chemotherapy drugs.
Ottawa should step in because it's a "cross-border issue," Dr. Jake Thiessen said Wednesday after releasing his report commissioned by the Ontario government.
"I believe in the safe and best interests of the nation of Canada, we need an agency that has national authority to actually regulate all of this," he said.
He also urged Ontario to bring in stronger rules for licensed pharmacies, by inspecting and licensing those in the province's clinics and hospitals as well as pharmacies that prepare large volumes of drug mixtures.
The recommendations come four months after it was discovered that 1,202 patients in Ontario and New Brunswick — including 40 children — received diluted chemo drugs, some for as long as a year.
Extra saline in bags containing cyclophosphamide and gemcitabine effectively watered down the prescribed drug concentrations by up to 10 per cent, his report found.
Marchese Hospital Solutions, which provided the mixture to four hospitals in Ontario and one in New Brunswick, fell in a jurisdictional grey area, with the federal government and Ontario College of Pharmacists unable to agree on who was responsible for the facility.
Hospitals are responsible for the purchase and security of their drugs. Health Canada regulates and inspects drug manufacturers, while the college is responsible for pharmacists in Ontario.
Thiessen said he found flaws throughout the cancer drug supply chain, but concluded that there was "no evidence of any malicious or deliberate drug-sparing dilution" by Marchese.
The hospitals that received the drugs weren't aware that the bags contained extra saline and didn't adjust the doses accordingly.
Group purchaser Medbuy, which arranged the contract with Marchese on behalf of the hospitals, didn't specify the drug concentration in the finished product, which led to the confusion between the hospitals and the company, Thiessen found.
What impact the dilution had on the affected patients — which included a small number who weren't being treated for cancer — isn't known, he said.
But the overall effect was probably small, given that the dilution factor was low and, in most cases, the mixture was combined with other chemo drugs before being administered to the patient, he said.
The risk was probably greater with patients taking gemcitabine, since a quarter of them weren't taking any other chemo drug. Almost all patients who received cyclophosphamide were taking it in combination with other drugs.
To close the oversight gap, Thiessen's 12 recommendations outline a clear division between provincial and federal responsibilities.
It's a national issue, he said. Marchese, which is based in Ontario, shipped its products to New Brunswick, and one of the suppliers who bid on the contract was from Quebec, he noted.
"It doesn't matter whether it is a non-pharmacy enterprise that is doing it, or it happens to be a pharmacy that's engaged in large-volume production of these kind of things," he said.
"If the product goes across the border, Health Canada needs to licence that."
Health Minister Rona Ambrose wouldn't say whether she'd implement his recommendations.
"Dr. Thiessen's report will help to inform the ongoing collaborative federal, provincial and territorial work to help find a long-term solution and ensure patients are protected," she said in a statement.
The federal government has ordered that compounding and admixing can continue if it is done within 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 federal government has to step up to the plate, they have to be proactive, they have to fill this loophole," said NDP health critic Libby Davies.
"The issue of drug safety and Canadians' health is at risk here, as it has been."
On the provincial side, Thiessen is recommending that the college consider a special licence for entities that provide large volumes of drug mixtures and inspect them every year, as well as develop label requirements and specify additional credentials for workers preparing the mixtures.
Bulk purchasers should develop standards for products and services provided by companies like Marchese, and ensure that risk for patients is evaluated when considering bids, he said.
The report also urged Marchese to review and revise the way it prepares its products to ensure they meet all the requirements needed to treat patients safely.
The company said it's pleased that Thiessen confirmed that there was no deliberate dilution and that they supplied the two drugs in accordance with their contract.
"We plan to continue to collaborate with our pharmacy colleagues throughout the chain, comply with any new regulatory structures and work in an environment of greater clarity of accountability to deliver the best care possible for patients," Marchese said in a statement.
Ontario Health Minister Deb Matthews promised Wednesday to introduce a bill this fall that would give the college the powers Thiessen has recommended.
"No one should have to go through what the affected patients and their families have gone through," she said.
"To those patients and their families, I want you to know how deeply sorry I am that you have had to go through this."