Taking Action to Safeguard Hospital Drugs
Ontario remains committed to reinforcing oversight and safety of the drug supply chain in the province's hospitals.
Following the discovery of under-dosing of chemotherapy drugs at four hospitals in Ontario and one hospital in New Brunswick, the government took immediate action by:
- Appointing Dr. Jake Thiessen to determine the causes and provide recommendations to prevent future incidents from occurring;
- Convening a working group to act as a reference for Dr. Thiessen's review;
- Requiring drug compounders to declare their regulatory framework, their accreditation, and their quality assurance practices;
- Requiring all hospitals to attest that quality assurance processes are in place for all drugs either purchased externally or prepared in hospital;
- Working with the Ontario College of Pharmacists, to amend Ontario Regulation 202/94 under the Pharmacy Act, 1991 to allow the college to inspect drug preparation premises where pharmacists and pharmacy technicians engage in or supervise drug preparation activities (such as reconstituting, combining, and mixing two or more substances without a prescription); and
- Amending Regulation 965 under the Public Hospitals Act to require hospitals to purchase or obtain drugs only from regulated or approved entities.
Strengthening Ontario College of Pharmacists' Inspection Powers and the Safety of the Drug Supply in Ontario Hospitals
Ontario moved quickly to increase the oversight and regulation of drug preparation premises once the under-dosing of chemotherapy drugs was discovered. As these drugs were in some cases being supplied by companies that were not actively regulated as a federally licensed drug manufacturer, nor as a pharmacy accredited by the Ontario College of Pharmacists, and because the drugs in question were not prepared in hospital pharmacies, oversight did not clearly fall under the authority of any existing regulatory entity.
The Ontario government, working together with its partners, including the Ontario College of Pharmacists, brought forward new regulations to increase oversight. This includes amending Ontario Regulation 202/94 under the Pharmacy Act, 1991 giving the college the authority to inspect non-pharmacy, "drug preparation premises." Work by the college to develop this inspection framework is well underway and inspections will proceed this month.
Regulatory changes under Regulation 965 under the Public Hospitals Act will also take effect in September requiring that all Ontario hospitals purchase drugs only from regulated or approved entities, including "drug preparation premises" that pass an inspection from the Ontario College of Pharmacists.
Additional Action by Health Canada
In addition to all the safeguards provided by the province, Health Canada has released an interim policy statement that provides direction to entities that compound and admix drugs in Canada. Under this direction, compounding and admixing activities can continue under one of the following three conditions:
- They are done within a hospital, meeting provincial regulatory requirements;
- They are done outside a hospital as a service under the supervision of a provincially licensed pharmacist; or
- They are done in a manner that meets the licensing and manufacturing requirements of the federal Food and Drugs Act.