Diluted chemotherapy drugs given to 1,200 cancer patients in Ontario and New Brunswick this year likely had no negative impact on their treatment and was the unintentional result of “gaps in communication” and a lack of regulation, according to a commissioned report into the scandal.
The highly anticipated report, released Wednesday, called on Health Canada to regulate companies that mix drugs for hospitals, a sector of the health-care system that has boomed and been operating with virtually no government oversight.
In response, Health Canada issued a statement that said it has been assessing “potential federal actions that may be needed to ensure proper oversight” and that it would work with provinces to develop “a longer-term solution.”
The report absolved of any wrongdoing the private drug-mixing outfit at the heart of the matter, Marchese Hospital Solutions, the bulk-drug supply company that brokered the sale of the drugs, Medbuy, and the hospitals that administered the chemotherapy.
Instead, the report cited “gaps in communication” between them, and offered 12 recommendations that included the Health Canada regulatory role and more transparent and stringent contractual obligations for companies like Medbuy.
“In this story, there is no evidence of any harmful intent to provide diluted products and, thus, underdose patients,” said the author of the report, Jake Thiessen. “The problem boiled down to gaps in communication and its unintended consequences.”
Dr. Thiessen joined Health Minister Deb Matthews at a Queen’s Park news conference, where the minister expressed profound regret and pledged reform, but did not lay or accept blame.
Ms. Matthews proposed bringing hospital pharmacies under the watch of the province’s College of Pharmacists, and said she would press Health Canada to regulate drug-mixing companies.
Her reaction to the report, which she acknowledged having had for weeks before making it public, frustrated the legislature’s health critics.
“How can it be that for so many years this sector was allowed to exponentially grow with no oversight whatsoever?” asked NDP health critic France Gélinas. “No one is answering that question.”
The report offered scant new insight into the scandal than what was divulged during legislative hearings in the spring.
The hearings revealed that the provincial and federal governments thought the other had been overseeing drug-mixing outfits, and that labels on intravenous bags of medication did not precisely detail their contents.
To stem growing criticism, the Ontario government and Health Canada separately implemented a series of stop-gap measures intended to better police the drug supply chain, including giving the college authority to inspect drug-mixing facilities.
At issue was the dilution of two cancer drugs, cyclophosphamide and gemcitabine, in bags prepared by Marchese.
The drugs were watered down by 10 per cent and 7 per cent, respectively, by an excess amount of saline solution that was not accounted for by hospitals because the bags’ labels did not indicate an overfill.
The report did not fault Marchese, however, because it said the company’s contract with Medbuy only required the bags be labelled with the amount of active drugs inside rather than their concentration.
Dr. Thiessen said while it is unknown whether the dilution adversely affected patients, it is unlikely because the under-dosing was of a “relatively low degree” and the drugs would have been given in combination with other medications.
Marchese issued a statement saying it was “pleased” that the report found the company adhered to its contract and that it would comply with any “new regulatory structures.”
While hospitals used to mix their own chemotherapy drugs, many have outsourced the job to entities known as group-purchasing organizations like Medbuy that contract with drug-mixing companies.
In a statement, Medbuy said “we strongly agree that a higher degree of oversight is necessary” and that it would begin implementing the report’s recommendations.