The introduction of high-purity products in Canada.

In October 1993, the Canadian Blood Agency, the agent for the provinces/territories in Canada, agreed to the introduction of high-purity coagulation products, either recombinant or highly purified factor concentrates, for the management of coagulation deficiencies. This represented a cost increase of approximately $30 million (40%) for the national coagulation product inventory. Representatives of the relevant recipients of the products, some of the treaters, the distributor and the funders met on a regular basis in order to monitor the impact of these new products. The Association of Hemophilia Clinic Directors of Canada also agreed to include some specific outcome studies over a longer period of time to include evaluation of inhibitor formation, prophylaxis regimens, immune status and the incidence of thrombosis. The 'Hemophilia and Von Willebrand's Disease' clinical practice guidelines were also developed under their auspices. A usage monitoring system has been implemented and has been continuously managed by the Canadian Blood Agency. This resulted in trends of practice and rationales for unexpected use being identified early for planning and funding purposes. The Working Group set up under the auspices of the Canadian Blood Agency was an effective vehicle to evaluate the conversion and the impact of these new products in the country and can serve as a model for future endeavours.