‘10,000 die yearly from adverse drug reactions to prescription drugs’
Despite Canada’s extensive drug approval process, an estimated 150,000 Canadians are hospitalized and 10,000 die yearly from adverse drug reactions to prescription drugs. Adverse drug effects were found to account for 12% of emergency department visits. The need for post-approval surveillance of drug safety and effectiveness has been recognized in developed nations. In Canada, the majority of studies on drug safety and effectiveness in the marketplace have been conducted as individual initiatives on a single provincial health care database. As these individual initiatives are often based on relatively small populations, they are limited in what they can achieve – especially when looking for rare serious adverse events, for the study of drugs used to treat infrequent diseases, or for the study of the effects of drugs in new users.
The Drug Safety and Effectiveness Network (DSEN) is addressing these concerns by creating a pan-Canadian collaboration of researchers, the Canadian Network for Observational Drug Effect Studies (CNODES), to expand the skills to study specific drug safety and effectiveness questions using multiple healthcare databases. The overarching aim of CNODES is to use collaborative, population-based approaches to provide rapid answers to questions about drug safety and effectiveness. The goals are to organize sufficient financial and human resources, co-ordinate responses to such safety signals, standardize methodological approaches, and obtain rapid access to data-sets that are large enough to give precise estimates of medication risks and benefits.
‘developing state-of-the-art analytical methods and a widely distributed network’
The CNODES network includes the health and prescription records of over 40 million people and is developing state-of-the-art analytical methods and a widely distributed network of pharmacoepidemiologists, statisticians, data analysts, clinicians, and other researchers able to rapidly evaluate the risks and benefits of drugs on the health of Canadians. In addition to increasing Canada’s capacity for pharmacosurveillance research, CNODES is developing the processes to make research information available to clinicians, patients and decision makers.