New Oversight to Safeguard Hospital Drugs
Ontario is taking action to safeguard care for patients through new regulations to improve the oversight and safety of the drug supply chain in the province's hospitals. This is in response to the discovery of under-dosing of chemotherapy drugs at four hospitals in Ontario and one hospital in New Brunswick.
Strengthening Ontario College of Pharmacists' Inspection Powers
The government worked with the Ontario College of Pharmacists to amend Ontario Regulation 202/94 under the Pharmacy Act, 1991 that allows the college to inspect drug preparation premises where pharmacists and pharmacy technicians engage in or supervise drug preparation activities (such as reconstituting, combining, mixing two or more substances without a prescription).
After an inspection of a drug preparation premises, the college will issue a report with a grade (pass, pass with conditions or fail). A failing grade will prohibit pharmacists and pharmacy technicians from engaging in or supervising drug preparation activities while a pass with conditions grade will only permit them to engage in or supervise drug preparation activities under those conditions issued by the college.
In addition, hospitals may only obtain drugs prepared in premises that pass, as a result of the amendments to regulations under the Public Hospitals Act.
Ensuring the safety of Hospital Drug Suppliers
The government has amended Regulation 965 under the Public Hospitals Act to only allow hospitals to purchase or obtain drugs from certain entities including:
- An accredited pharmacy under Ontario's Drug and Pharmacies Regulation Act
- A person licenced under the federal Food and Drugs Act
- An accredited pharmacy in another Canadian jurisdiction
- A drug preparation premises that passes an inspection by the Ontario College of Pharmacists
- A wholesaler who has bought the drug from a regulated entity (as above)
- A corporation that procures products on behalf of a hospital and has procured from a regulated entity (as above)
- The Government of Ontario or the Government of Canada
- Another Ontario hospital
- A person conducting a clinical trial or named in a letter of authorization under the Food and Drugs Act
- Other situations provided under the regulation
Safeguarding the Drug Supply
In addition to the regulations above, the following actions have been taken to safeguard the drug supply in the province:
- Patients in affected hospitals were notified by each hospital and provided access to an oncologist to discuss their personal plan of care
- A working group was established to resolve the issue, made up of the affected hospitals, the Ontario Hospital Association, Health Canada, the Ontario College of Pharmacists, the Canadian Cancer Society, and Cancer Care Ontario
- Dr. Jake Thiessen, a pharmacy expert, was appointed to conduct and independent review of Ontario's cancer drug supply chain
- Health Canada put in place a new policy requiring drug facilities to be regulated under either:
a) the federal Food and Drugs Act
b) the supervision of a provincially licensed pharmacist
c) in a hospital
- The Ontario government wrote drug compounders, requiring them to declare their regulatory framework, their accreditation, and their quality assurance practices
- The Ontario government wrote our hospitals to confirm that quality assurance processes are in place for all drugs either purchased externally or prepared in hospital
- Ontario will continue to work with Health Canada to develop a long-term solution to this national issue