Optimizing the use of prescription drugs in Canada through the Common Drug Review

• Published in: Canadian Medical Association journal (CMAJ) 2008-02, Vol.178 (4), p.432-435
• Main Authors: Tierney, Mike, Manns, Braden
• Format: Article
• Language: English
• Subjects: Canada; Clinical trials; Cost-Benefit Analysis; Decision making; Drug Costs - standards; Drug policy; Drug Prescriptions - standards; Drug Utilization Review - methods; Drugs; Humans; Laws, regulations and rules; Pharmaceutical industry; Pharmaceuticals; Prescription drugs
• ISSN: 0820-3946; 1488-2329
• DOI: 10.1503/cmaj.070713

The review team then prepares a report for the Canadian Expert Drug Advisory Committee. The committee assesses the medications' effectiveness, safety and cost-effectiveness compared with existing therapies and, on the basis of the assessment, makes a positive or negative recommendation for formulary listing to participating drug plans. The committee is composed of 12 members and a chair and generally includes physicians, pharmacists, pharmacologists and other health care professionals with expertise in clinical trial methodology, health technology assessment, drug policy or health economics. It also includes 2 public representatives who participate as full voting members. Committee terms of reference, member profiles and conflict-of-interest disclosures are available on the Canadian Agency for Drugs and Technologies in Health website (www.cadth.ca). The Canadian Expert Drug Advisory Committee, in its assessment of drug effectiveness, generally considers only evidence from randomized controlled trials because these types of studies represent the highest form of evidence when assessing the effectiveness of new drugs. Specifically, the committee focuses on randomized controlled trials that use clinical outcomes, such as mortality, the occurrence of an adverse clinical event (e.g., myocardial infarction, stroke), or a valid assessment of patient quality of life.6 Unfortunately, studies of new drugs all too often focus on nonclinical outcomes such as surrogate markers or clinical correlates. A valid surrogate marker is a laboratory measurement or physical sign that can be used as a reliable substitute for a clinical outcome (e.g., reduction in blood pressure for reducing stroke).7 A clinical correlate is associated with disease activity but often does not predict clinically meaningful change in response to an intervention (e.g., fever in septicemia).8 A second criticism is that the Common Drug Review's conflict-of-interest guidelines exclude many experts. However, the process in fact includes clinical experts on all drug reviews. The conflict-of-interest guidelines ensure that all participants in the process disclose all potential conflicts with pharmaceutical manufacturers. The purpose of identifying people with close ties to the pharmaceutical industry is imperative to manage the real, potential or perceived conflict of all participants in the Common Drug Review process. Expert participants are not automatically excluded from the process if they have connecti