National network evaluating drug safety reports early results
Prescription medications remain one of the most common causes of severe adverse reactions in clinical medicine, accounting for thousands of deaths annually in Canada. The urgent need for rigorous, scientific drug safety research has been clearly understood for decades, but lacked national coordination until the arrival of the Canadian Network for Observational Drug Effect Studies (CNODES), which today released its first report documenting progress towards its goal of creating a fully operational system for rapid assessment of adverse drug effects in Canada. Studies performed in the first year of operation have examined the effects of cholesterol lowering drugs on the kidney, whether gastric acid inhibiting drugs increase the risk of pneumonia, and whether drugs used to treat psychosis (eg schizophrenia) cause acute onset of diabetes. CNODES is a collaborating centre of the Drug Safety and Effectiveness Network (DSEN), funded by the Canadian Institutes of Health Research (CIHR).
Montreal鈥檚 Lady Davis Institute (LDI) at the Jewish General Hospital hosts CNODES鈥� Coordinating Centre. There are seven Canadian provinces involved, using health data to evaluate post-market drug safety and effectiveness. CNODES also uses data from the United Kingdom and United States, engaging in analyses that incorporate total populations of more than 40 million people.
鈥淭he establishment of CNODES means we can rapidly respond to drug safety concerns in a fraction of the time that it took in the past. For example, investigations of the adverse effects of Vioxx on the heart (withdrawn from world markets in 200X) were conducted by separate teams of researchers using databases in Ontario, Quebec and Saskatchewan. The time taken to respond to the first report on safety concerns, published in November 2000 ranged from three to nine years 鈥� an excessive period, considering the potential threat to public health posed by a widely used drug,鈥� says Dr. David Henry, ICES CEO and lead of the CNODES database team.
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