Toronto Chemo Scandal

Chemo scandal: Pharmacists’ regulator refuses to disclose inspection reports for implicated drug supplier
Despite more nearly 1,200 Canadians receiving diluted chemotherapy medication, the public has received little information about what transpired.
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The public agency responsible for licensing pharmacies in Ontario refuses to provide inspection reports for Marchese Hospital Solutions, the company that hospitals say supplied weaker-than-prescribed chemotherapy drugs for nearly 1,200 Canadian patients.

There is almost no information about what Marchese and companies like it do to keep patients safe. One researcher who investigates mistakes in health care has just launched a review of the issue.

“The study we’re doing addresses the question of how much error is occurring in the mixing process because we don’t know that with any degree of reliability,” said Tony Easty, a researcher with Toronto’s University Health Network whose review was prompted by his investigation of a fatal chemotherapy overdose in an Edmonton patient in 2006.

“We don’t know which processes are truly the optimal processes to follow,” said Easty. “We’re trying to bring evidence to that so you’re not just hoping double-checking is effective.”

His study, which focuses on hospitals that perform in-house mixing, could affect quality control in all facilities that compound chemotherapy drugs.

Ontario’s cancer care system was thrust into the spotlight this week when revelations of weakened chemotherapy doses surfaced. Outside of the fact that almost 1,000 patients in Ontario and 186 in New Brunswick were affected, the public has received very little information about what exactly happened.

Windsor Regional Hospital, where 290 people were affected, held its first town hall Friday for patients and their families. The sessions were described as emotional in a memo from hospital president David Musyj to its board of directors.

Three more patients who received the watered-down doses have since died, bringing the total to 20, according to the memo.

Investigations are underway by Cancer Care Ontario and the Ontario College of Pharmacists, in partnership with Health Canada. Premier Kathleen Wynne has also called for a yet-unnamed third-party to conduct a review.

Amani Oakley, a Toronto lawyer who practises health law, called the Ontario College of Pharmacists’ refusal to disclose the inspection reports “ridiculous.”

“The college . . . works for the public and it’s their job to ensure safety for the public and it is ridiculous for them to do an inspection and to indicate that their bosses, who are the members of the public, are not entitled to know the results of those inspections,” she said.

It’s still unclear what led to the diluted drug cocktails being administered, but hospitals have been notifying patients and scheduling rush appointments with oncologists throughout the week.

The drugs — cyclophosphamide and gemcitabine — were mixed by Marchese, a compounding pharmacy with locations in Mississauga, Hamilton and Kitchener. Pharmacies that supply hospitals with custom drug cocktails for patients are supervised by the Ontario College of Pharmacists. The college inspects these facilities every three to five years.

The college said Marchese has passed its most recent inspections at all three sites but would not release copies of the reports, which the Star requested on Thursday.

“We have never encountered a request of this nature and as such it would not be responsible of us to simply disclose this information without doing our due diligence with respect to understanding our obligation under our current legislative framework,” spokeswoman Lori DeCou wrote in an email sent late Friday afternoon.

The college has a sample checklist for inspections but DeCou said its inspectors are not required to follow the form to the letter. One item on the list asks the company to verify whether the final product is quality tested. “If not, describe how you verify quality and accuracy.”

Because the college is keeping the reports secret, the public does not know how, or if, Marchese answered this question.

I can just see my lawyer buddies collectively licking their lips. 
Very sad and horrifying for the patients though.

PharmaGeddon , bro ...

We have been pointing this out relentlessly !

Government regulated and policed !

the College is not government regulated

its qasi government

their procedures follow the "code" - some health something something act

this has nothing to do with PharmaGeddon

Marchese is a compouding pharmacy that initially provided home health care services to outpatients.  they make IV meds and deliver them to the patients home in coordination with CCAC.

the mississauga site is the hospital provider

no it does not have to disclose anything esp to the media.

when the college does an inspection, it does not inspect actaul compounded product.

so i dont understand what the lawyers and everyone wants disclosed.

Statement Marita Zaffiro, President
Marchese Hospital Solutions April 3
Let me say, Marchese Hospital Solutions (Mississauga) deeply regrets the patient concerns and uncertainty regarding the administration of some of the chemotherapy solutions we supply. These concerns have arisen as a result of a difference between the manner of administration used in some hospitals that was not aligned with how the standardized preparation had been contractually specified.
We must emphasize, despite some media characterizations to the contrary, there was never any question of a “defective” medication. This issue involves only the volume and concentration of a high quality preparation, and those exist within very narrow boundaries of variation. Those variations were the result of the use of our preparation, which according to our current understanding was not consistent with the contract, the preparation or its labelling.

We are confident that we fully met all of the contract requirements including both volume and concentrations for these solutions.  However, we share responsibility to ensure that patients and their families are not given any reason for concern about their treatment. We take this responsibility very seriously. 
We therefore will continue to work collaboratively with all of our clients and partners to ensure that we all learn the lessons of this deeply regrettable miscommunication. We are committed to always meeting the expectations of our client hospitals and those of their patients.
Resolving this issue is my very highest priority. Our first priority was to ensure that the right treatments reached patients. That has been done. Secondly, we need to understand how assumptions about product use which were not consistent with the contractually supplied preparation and labelling led to this issue.
We have worked closely with the affected hospitals since we were alerted to the issue and we will continue to work to address the problem.