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Health Canada should regulate drug prep firms in wake of chemo scare: report


 

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.”


 
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Health Canada should regulate drug prep firms in wake of chemo scare: report

  1. Forget more bureaucratic bloat that doesn’t work.

    Why not fine these companies say $500,000 (or more) as losing money always gets people to fix problems?

    How many more union governemtn employees not doing there job do we need? CFIA didn’t inspect meat, USDA did. Same here.

    Sorry, maybe we need someone in existing governemtn to get off their chair and do something without the BS, stalling, deflection and crap. Just fine them good.

    But we know what Chopra says about Health Canada, “Corrupt to the Core”. The book is a good read. Shows how corrupt and useless the system has become.

  2. it is sad to say that more government will lead to less government but we do need full disclosure and accountability at all levels, so some random inspection and screening by approved agencies is a must. all our government and non government agencies must go through random inspections for quality control and compliance to the rules with heavy fines, which would be more than enough to pay for such agency…..due to the nature of the beast..Now to be more Specific Health Canada…..whom everyone should have the highest trust……has somehow lost 10% of a so called drug / treatment substituted by useless drugs and salt hmm a toxin of sodium and chlorine…..got to be good for your body. salt blasts your blood pressure up causing heart attacks as well…..did not seen them listed…..the other two drugs mentioned i am not familiar with…..however…so what is chemo therapy……it is a chemical that attacks d.n.a. in a given area, nothing being zoned in the body…so it kills you ……….nothing more nothing less, and hopefully kills some cancer cells with it……similar to using a axe….and just about as bright., and then those dead cells have to wash from your system…..they sometimes add other drugs to make a cocktail out of it……….great for extra billing…..as no one tracks the extras………..the system is not only bad, its corrupt, and sickning…….and now we are forced to babysit them to keep them honest……….how sad…..but true.

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