Issue link: http://clhia.uberflip.com/i/406567
8 drug manufacturer to raise concerns with Health Canada. Health care professionals and consumers may also report adverse reactions, although on a voluntary basis. The Canadian life and health insurance industry believes that a robust post-marketing surveillance regime is needed in Canada. While there is no clear consensus on the best approach, globally, countries are moving to establish systems to track the safety and effectiveness of drugs post launch. We believe Canada should also move in this direction and that we can leverage the important work that has been done abroad in this regard. THEREFORE, THE CLHIA RECOMMENDS THAT: • HEALTH CANADA ESTABLISH A NEW, ROBUST POST-MARKET SURVEILLANCE OF PRESCRIPTION DRUGS AND THAT IN DOING SO, HEALTH CANADA LEVERAGE LESSONS LEARNED FROM INTERNATIONAL EXPERIENCE. a.2.3 Off-Label Use Off-label use of a prescription drug refers to a situation where medications are dispensed to treat conditions other than those for which they have received regulatory approval. Off-label use can also include prescribing different dosages or frequencies, lengthening or shortening the duration of treatments, or using different routes of administration than is indicated on the drug label. Health Canada does not regulate off-label use of medications and takes the position that physicians' prescribing practices fall under the jurisdiction of provincial and territorial medical regulatory authorities. Roughly 11 per cent of medications are being prescribed off-label in Canada. 5 A recent study led by researchers at McGill University raises some concerns with widespread off-label prescribing in Canada as, according to this study, nearly 80 per cent of off-label use lacked scientific evidence backing. 6 5 Tewodros Eguale; David L. Buckeridge; Nancy E. Winslade; Andrea Benedetti; James A. Hanley; Robyn Tamblyn. Drug, Patient, and Physician Characteristics Associated with Off-Label Prescribing in Primary Care. JAMA Internal Medicine. May 28, 2012. 6 ibid.