New chemotherapy oversight plan proposed
Health Canada discussing regulation of outsourced chemotherapy preparation with provinces
The Ontario government is proposing a new regulation to ensure hospitals buy drugs only from provincially accredited pharmacies or federally approved suppliers, following the underdosing of the chemotherapy treatments of 1,200 cancer patients.
"No hospital shall, directly or indirectly, purchase or otherwise obtain a drug except from … a specified person other than a pharmacy that has passed an inspection conducted by the Ontario College of Pharmacists," the Ontario Ministry of Health said in statement on Friday.
Marchese Hospital Solutions is the Mississauga, Ont.-based company that prepared the premixed chemotherapy drugs for the hospitals.
Also on Friday, Dr. Supriya Sharma, senior medical advisor at Health Canada, said she believes that Marchese Hospital Solutions was properly regulated.
Sharma told reporters that — based on information obtained from Marchese Health Soultions — Health Canada believes there was "appropriate oversight in place" for the company.
In a statement, Health Canada said companies could continue to provides services if they meet one of these three conditions:
- The work is done within hospitals meeting provincial standards.
- The service is done outside of a hospital under a provincially licensed pharmacist.
- Under a manner that meets the requirements of the federally licensed facility under Food and Drug Act.
The announcement came following a conference call between federal, provincial and territorial health officials. They discussed how to close a regulatory gap after 1,200 cancer patients received overdiluted chemotherapy treatments that had been outsourced by five hospitals in Ontario and New Brunswick.
The Ontario College of Pharmacists oversees pharmacists and pharmacies in the province, while Health Canada licenses drug manufacturers.
Under Ontario's proposed regulations, the college would be allowed to inspect "certain non-pharmacy premises where pharmacists and pharmacy technicians practice," such as those where drugs are "compounded" or mixed.
The province is consulting for 17 business days on the proposed changes to its Public Hospitals Act.
Patients in the Ontario communities of Oshawa, Peterborough, London and Windsor, as well as in Saint John, N.B., were given lower than intended doses of cyclophosphamide and gemcitabine. The chemotherapy is part of a regime for breast and lung cancer as well as lymphoma and leukemia.
Too much saline was added to the IV chemotherapy bags, overdiluting them by between three and 20 per cent, according to Cancer Care Ontario, which notified the Ontario government of the issue on March 28. Some patients were taking the drugs for as long as a year. Since each case is patient-specific, the agency and hospitals are encouraging affected patients to discuss the possible effects of the under-dosing with their oncologists.
The Hamilton, Ont-based owner of Marchese Hospital Solutions has said the problem occurred due to how the intravenous bags of chemotherapy were administered at the five hospitals, not in how they were prepared at the company.
It's not known how many companies like Marchese were mixing cancer drugs for hospitals under the regulatory grey zone.
With files from CBC's Amina Zafar