s35_ab6

Mandatory pharmacosurveillance — A Canadian model for access to therapy and research

S.G. Barr, L. Martin, C. Chung1, W.P. Maksymowych1

Department of Medicine, University of Calgary and 1Department of Medicine, University of Alberta, Alberta. Canada.

ABSTRACT
Regulatory authorities in Canada have expressed a vital need for pharmacoepidemiological data on long-term effectiveness, safety, and cost-benefit of new therapies, particularly in comparison to currently available therapies, in routine clinical practice to allow informed decision making in listing new therapies on formulary. We describe the evolution of a new model of pharmacosurveillance involving a partnership between academic and community rheumatologists, government, and industry whereby access to therapy is conditional on participation in an industry-funded pharmacosurveillance study that assesses long-term effectiveness, safety, and cost-benefit. Though funded by industry, the program is administered by government and designed and operated at arms length from industry. The clinic data sheets are available at www. altarheum.com. The program also provides a sustainable model for promoting observational research on therapeutics in general.

Key words
Rheumatoid arthritis, pharmacovigilance, observational study, biological therapy.

Please address correspondence to: Prof. Walter P. Maksymowych, 562 Heritage Medical Research Building, University of Alberta, Edmonton, Alberta, Canada T6G 2S2.
E-mail: walter.maksymowych@ualberta.ca