Picking up a prescription has never been easier than it is today. Within a few minutes of leaving the doctor鈥檚 office, a patient can have their antibiotic, oral contraceptive, or asthma inhaler from the local pharmacy and walk away with the medication they need. But how much does that patient really know about the drug they鈥檙e about to take? And how much does the physician really know about the drug they鈥檝e just prescribed?
Fortunately, a pan-Canadian group of researchers is working on decreasing the unknowns involved in taking prescription drugs using observational epidemiology 鈥� the population based study of epidemic diseases using clinical observation, not experiments.听
On October 31, the Government of Canada announced it would provide $17.5 million to fund post-market drug safety and effectiveness research.
Dr. Ingrid Sketris, a professor in the College of Pharmacy at H漫画, is one of 60 researchers across Canada collaborating in various projects over the next five years examining the safety and effectiveness of prescription drugs once they鈥檝e been made available to the public. H漫画 has been awarded $1.975 million for their part in this project, which is being led by Dr. Adrian Levy in the Faculty of Medicine.
Combining expertise
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Before any drug goes on the market, it鈥檚 screened in labs and rigorously tested in various populations through clinical trials. When safety and effectiveness has been established, the drug receives regulatory approval by Health Canada and subsequently is available on the Canadian market.
Unfortunately, clinical trials are usually done in a relatively short period of time with a relatively small and specific selection of people. This, according to researchers, can create problems for patients who don鈥檛 fit in to a specific category that was studied.
鈥淐linical trials may exclude, for example, elderly people, pregnant women, or people with more than one illness and taking more than one prescription drug,鈥� explains Dr. Sketris. 鈥淎ll of a sudden, the drugs that didn鈥檛 have side effects in the clinical trials are available to all types of people with all types of health issues.鈥�
With over 16,000 prescription drugs on the Canadian market, it鈥檚 difficult for clinicians to study large numbers of people over extended periods of time.
鈥淚n some instances, we may know about the side effects of drugs for five years after the initial prescription was given,鈥� says Dr. Sketris. 鈥淏ut what about 10 years from now, 15 years from now?鈥�
鈥淚f a patient starts taking diabetes medication when they鈥檙e 50, who鈥檚 to say that medication is still the right drug 15 years later when they鈥檙e 65? Maybe their condition has changed or they鈥檝e developed new diseases needing other drug therapy. Part of our job as researchers is to help improve the benefits from drug therapy while decreasing the risks.鈥�
In the next several months, the network of researchers across Canada involved in this study will gather anonymous patient data and examine the safety and effectiveness of various prescription drugs.
By combining expertise from multiple centres across Canada, Dr. Sketris is confident the results will make a significant impact on the safety of prescription drugs.
鈥淧rior to this initiative, with thousands of drugs on the market, each individual centre was only able to take on a limited number of projects per year,鈥� explains Dr. Sketris. 鈥淲ith this new funding, we鈥檒l be able to study more drugs in larger populations over longer periods of time.鈥�
Knowledge translation
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Once the information is collected, an equally important component of the research project is the 鈥榢nowledge translation鈥� where researchers synthesize, interpret and circulate that information to various users: doctors, policy makers, educators, community leaders, patient groups, media outlets, and private sector organizations.
鈥淲e provide our findings to Health Canada regulators, for example, who will decide if prescription drugs should have a warning for a specific population,鈥� Dr. Sketris says. 鈥淲e also provide family doctors with this information so they鈥檙e able to say for example, 鈥榶our chances of getting this side effect by taking this drug are one in a thousand鈥� or 鈥榃hen you take this drug, avoid taking this other drug.鈥欌��
鈥淲e鈥檙e giving users more precise information in the most effective way. This project is very exciting and will help place Canada as a leader in post-market observational drug safety studies.鈥�
Safety and effectiveness
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The Canadian network for Observational Drug Effect Studies (CNODES) will be led by Dr. Samy Suissa of McGill University. Each provincial arm will be led by experts in public health, clinical care pharmacy, epidemiology, statistics and computer sciences. CNODES is supported by a larger national initiative known as the Drug Safety and Effectiveness Network (DSEN) coordinated by the Canadian Institutes of Health Research.
Three major objectives that will be carried out over the next few years are:
- capacity building in people with funds to support grad students and highly qualified personnel
- capacity building in data use with new tools and methods developed to better analyze potential problems like drug-drug interactions
- results where drug safety and effectiveness from this research are combined with existing information to help听 inform doctors and pharmacists and improve care of patients across Canada.听听
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