TORONTO – Health Canada should regulate all entities that mix drugs outside a licensed pharmacy, an expert that looked into the chemotherapy drug scare that rocked two provinces recommended Wednesday.
It 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, the 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.
Dr. Jake Thiessen, who investigated the mistake, said he found flaws throughout the cancer drug supply chain.
“All levels of the drug chain had shortcomings,” he said after releasing his report.
Thiessen concluded that there was “no evidence of any malicious or deliberate drug-sparing dilution” by Marchese.
But the hospitals weren’t aware that the bags contained extra saline and didn’t adjust the doses accordingly.
What impact it 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.
To close the oversight gap, Thiessen’s report outlines a clear division between provincial and federal responsibilities.
The college should consider a special licence for entities that provide large volumes of such products and inspect them every year, as well as develop label requirements and specify additional credentials for workers preparing the mixtures, the report said.
Group purchasers like Medbuy, which signed 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.
Such organizations 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 in delivering his 12 recommendations.
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.
Marchese said in a statement that it would outline what changes it planned to make once it reviewed Thiessen’s report.
Ontario Health Minister Deb Matthews promised to introduce a bill this fall that would give the college the powers recommended in Thiessen’s report.
“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.”