|Back to full list|
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’s Lady Davis Institute (LDI) at the Jewish General Hospital hosts CNODES’ 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.
“The 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 For example, investigations of the adverse effects of Vioxx on the heart (withdrawn from world markets in 200X) were conducted by separate teams of researchers using databases in Ontario, Quebec and Saskatchewan.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 — an excessive period, considering the potential threat to public health posed by a widely used drug,” says Dr. David Henry, ICES CEO and lead of the CNODES database team.
Canada holds a rich resource in administrative health data, largely residing in provinces and territories. The CNODES offers an opportunity to coordinate access to these data resources and use them to answer important questions about serious side effects of drugs in a timely fashion. CNODES is an academically based network of Canadian researchers and data centres that is a commitment to rapid and sophisticated analysis of emerging drug safety signals.
“There are a number of important features of this unique collaboration,” says Dr Samy Suissa, head of the CNODES national network, Director of the Centre for Clinical Epidemiology at the LDI, and Professor at McGill University in Montreal. “This is a distributed network, which means that the data analyses are first carried out at the provincial centres and are then combined to give Canadian estimates. The data remain in the provinces, where they belong. No provincial data will cross borders. All of the data are de-identified; meaning the privacy of Canadian patients is protected. CNODES offers an opportunity to coordinate access to these data resources and use them to answer significant research questions for the health of Canadians.”
Authors: Samy Suissa, David Henry, Patricia Caetano, Colin R. Dormuth, Pierre Ernst, Brenda Hemmelgarn, Jacques LeLorier, Adrian Levy, Patricia J. Martens, J. Michael Paterson, Robert W. Platt, Ingrid Sketris and Gary Teare.
The study “CNODES: the Canadian Network for Observational Drug Effect Studies,” is officially published in Open Medicine.
For further information, and to arrange interviews, contact:
Research Communications Officer
Lady Davis Institute for Medical Research
Tel.: 514-340-8222 x 8661
Citation: Dormuth CR, Hemmelgarn BR, Paterson JM, James MT, Teare GF, Raymond CB, Levy A, Garg AX, Ernst P and the Canadian Network for Observational Drug Effect Studies (CNODES)*. High Potency Statins and Acute Kidney Injury. Submitted for publication with the BMJ.
*CNODES Investigators: Samy Suissa (Principal Investigator, McGill University); David Henry and Michael Paterson (Ontario); Colin Dormuth (British Columbia); Brenda Hemmelgarn (Alberta); Gary Teare (Saskatchewan); Patricia Martens and Patricia Caetano (Manitoba); Pierre Ernst, Jacques LeLorier, and Robert Platt (Québec); and Adrian Levy and Ingrid Sketris (Atlantic Provinces). For more about CNODES: www.cnodes.ca
For more about the Drug Safety and Effectiveness Network (DSEN): www.cihr-irsc.gc.ca/e/40269.html