Both the Ontario College of Pharmacists and Health Canada distanced themselves from Marchese Hospital Solutions on Tuesday. The college said the Mississauga company that provided mixed chemotherapy drugs to hospitals in Ontario and New Brunswick is not an accredited pharmacy and therefore not subject to regular inspections. Health authorities in Ottawa confirmed Marchese holds no federal licences, which would trigger inspections and enforcement.
When the Star asked if there was any provincial regulation or act governing Marchese Hospital Solutions’ operations, the ministry pointed only to general guidelines suggested by Cancer Care Ontario. There are no regular inspections or binding regulations that apply to the company, spokesman David Jensen confirmed.
With Marchese Hospital Solutions operating in a grey zone, and both levels of government denying responsibility, a serious question is raised: Just who is safeguarding patient care in Ontario when it comes to drugs?
When the Star asked Cancer Care Ontario to describe the protocols in place to protect patients, a spokesperson provided no insight, saying simply, “The issue is of deep concern for all parties involved.”
Marchese directed all questions about regulations to the Ministry of Health.
The ministry on Tuesday enlisted Jake Thiessen, founding director of the University of Waterloo’s School of Pharmacy, to lead an independent review of quality assurance in Ontario’s cancer drug supply chain.
“His review will determine how this occurred and provide recommendations to prevent future incidents,” said a statement released by the ministry.
The company has several arms besides Marchese Hospital Solutions, which supplied the drug. There is also Marchese Pharmacy and Marchese Health Care, both of which are accredited pharmacies. The role of those branches in the scandal is unclear.
Medbuy, a group purchaser of drugs for hospitals, handled the contracts for Marchese Hospital Solutions. A spokeswoman for the company refused to disclose the contracts and refused comment, referring to the ongoing investigation.
Diluted doses of cyclophosphamide and gemcitabine were sent to hospitals in Windsor, London, Peterborough, Oshawa and Saint John, N.B., during the past year. Windsor Regional Hospital president David Musyj said 20 patients have died since starting the weaker-than-prescribed treatment.
It’s not clear whether and to what extent the diluted treatment was a factor in those deaths.
London Health Sciences, Peterborough Regional Health Centre and Lakeridge Health have not disclosed information about patient deaths.
A notice of a class action was filed in a Windsor court last week.
Dr. Malcolm Moore, director of the drug development program at Ontario Cancer Institute/Princess Margaret Cancer Centre, spoke with the Star about the potential impact of a diluted treatment on patients.
“When (cyclophosphamide) is used in situations where the goal of cancer treatment is . . . removing the cancer permanently, the change in dosage would have a greater impact,” said Moore. In these cases, maintaining a precise dose throughout treatment is vital.
A lower dose of gemcitabine, he said, is likely not “clinically significant.”
Hospitals have said the medication was shipped in a form weaker than prescribed. Marchese Hospital Solutions says hospitals erred in administering it and that the supplier prepared the concoctions according to contracts.
In January, the college inspected Marchese’s Mississauga pharmacy and found the location met standards for accreditation. But the pharmacy was just one of several companies, including Marchese Hospital Solutions, operating on site.
The Toronto Star has requested copies of the inspection reports. The college has refused to divulge them.
College registrar Marshall Moleschi said internal bylaws prevent him from disclosing the documents.
Provincial and federal privacy regulators see no problem with disclosing the inspection reports.
“The statutes over which my office has oversight responsibility do not prevent the Ontario College of Pharmacists from disclosing such information,” said Ann Cavoukian, Ontario’s information and privacy commissioner.
Moleschi was unsure when the board would meet next to reconsider its bylaw. Later, a spokeswoman said that discussion “is expected to be on the agenda” in June, at the college’s next pre-scheduled public meeting.
In the meantime, the college and Health Canada are working together to sort out exactly what Marchese Hospital Solutions was doing at its Mississauga facility.
A federal spokesman told the Star that two Health Canada investigators were on site with a college inspector to determine whether the company was manufacturing drugs en masse — a process that requires stringent oversight — rather than just filling prescriptions on a patient-by-patient basis.
The company suffered financial hardship in 2011 after losing a long-time contract with Hamilton Niagara Haldimand Brant Community Care Access Centre. By January 2012, nearly 60 employees left the company after theywere laid off or resigned, according to company newsletters.
Marchese won the Medbuy contract a month later.
Original Article
Source: thestar.com
Author: Tim Alamenciak and Diana Zlomislic
No comments:
Post a Comment