"The idea is for each participating province to produce the same kind of results so that they can be combined in a Canada-wide study that will be unique in the world for this kind of research," Teare said.
Teare is an adjunct professor in the School of Public Health and department of community health and epidemiology with the U of S College of Medicine and director of quality measurement and analysis with Saskatchewan's Health Quality Council (HQC). The HQC is an independent agency focused on the improvement of Saskatchewan health services.
By using such a large and comprehensive data set, researchers will be able to identify and study rare adverse effects and the side effects associated with unusual diseases.
"This national research initiative promises to yield knowledge that will benefit Canadians right across the country," said U of S Vice-President Research Karen Chad. "We're proud to be part of a research collaboration with such broad potential for impact on people's lives."
While Canadian pharmaceuticals are thoroughly tested before their release to the public, too little is known about their effects once they've been officially released. Every year, 150,000 Canadians are hospitalized due to side effects from approved prescription drugs. Nearly 10,000 Canadians die from negative drug reactions.
"We are pleased to participate in this major pan-Canadian research initiative," Teare said. "It will equip decision-makers and health providers with critical information they need to develop policy and deliver safer care for patients."
CNODES will investigate unintended risks and benefits of pharmaceutical drugs by using existing clinical databases. Researchers will use standardized research practices in their province, which will be pooled with data from other centres across the country. The method will allow rapid and extremely detailed results applicable to the entire Canadian population, something previously not achievable by individual provinces.
Initially, CNODES will focus on suspected side effects of two commonly used medications. First up will be a search for evidence of a link between high dose statins, which are used to lower cholesterol, and acute kidney injury. Second will be an attempt to see if people on a type of gastric acid reduction drug called proton pump inhibitors are more susceptible to pneumonia outside of a hospital environment.
The national CNODES research effort is led by McGill University's Samy Suissa, with each provincial arm led by experts in public health and pharmacy.
In Saskatchewan, Teare leads a team of researchers from the U of S and the HQC. Rounding out the team are David Blackburn, an expert in patient adherence to medications from the U of S College of Pharmacy and Nutrition, and Lisa Lix, an expert in analysis of large databases and health services research methodology from the U of S School of Public Health.
Besides furthering Saskatchewan's research capacity, involvement in CNODES will offer training opportunities for as many as four medical graduate students and one or two post-doctoral trainees in Saskatchewan through the HQC and the U of S College of Pharmacy and Nutrition and School of Public Health.
For more information, contact:
Dr. Gary Teare
Director of Quality Measurement and Analysis
Health Quality Council
College of Medicine
University of Saskatchewan
(306) 668-8810 ext. 140
University of Saskatchewan
Health Quality Council
Saskatchewan arm of Canadian Network for Observational Drug Effect Studies (CNODES)
Why is this research important?
While prescription drugs are tested rigorously before they come to market, this testing is done under experimental conditions on patients who are not necessarily representative of all patients who will ultimately use the medications. Our study will examine the effect of drugs on all patients actually using them.
Why hasn't this research been done before?
While data on adverse drug effects has for some time been collected by individual provinces, until now no group has had the mandate to look at things from a national perspective. Serious side effects are infrequent enough that they don't necessarily raise any red flags in analyses at a provincial level. By pooling analyses at a national level, we will be able to identify safety problems that don't necessarily show up in the data until you look at a large number of cases.
What are the tangible benefits for Saskatchewan citizens/patients?
Saskatchewan people, like other Canadian residents, will benefit from more timely identification of drugs that pose a safety risk to patients. The arthritis drug Vioxx appeared to be safe when it was tested before it came to market; once it was put into use in the general population, however, it was found to cause heart failure in many patients. Unfortunately, it took some time to pick up the problem. This project will allow for relatively rapid (4-6 month), systematic analysis of data on the real-world effects of drugs in a large number of patients across Canada.
What is Saskatchewan's unique contribution to this project?
We are one of only a few provinces that capture drug data for all ages of patients; most provinces' databases only contain data on prescription medications used by seniors and people on social assistance. Having drug data on all ages means that Saskatchewan can make a particularly important contribution to studies on adverse effects in children. As well, Saskatchewan will be the only province in which this research function will be housed within a quality improvement organization (the Health Quality Council). Part of HQC's mandate, spelled out in the legislation that founded the organization, is "to research and evaluate prescription drug prescribing practices, prescription drug utilization and existing processes for reviewing and approving prescription drugs analysis." The HQC is collaborating in this work with researchers associated with or working within the University of Saskatchewan, one of Canada's top 15 medical doctoral universities.