More Information Needed on Safety and
Effectiveness of Off-Label Drug Uses in Canada
says Senate Committee Report
Ottawa (January 30, 2014) – Health Canada needs to implement additional measures to further enhance the safety and effectiveness of prescription drugs for all Canadians when they are used for off-label purposes, says the latest report by the Standing Senate Committee on Social Affairs, Science and Technology. The report, entitled: Prescription Pharmaceuticals in Canada: Off-Label Use, outlines the Committee’s assessment of the off-label use of pharmaceuticals and contains 18 recommendations to balance innovative drug use with patient safety.
As the Committee heard during witness testimony, without formal, structured studies to examine the safety and efficacy of approved drugs for off-label purposes, there is an unknown level of risk involved when patients are prescribed drugs for off-label use. To that end, the Committee would like Health Canada to request that the Canadian Institutes of Health Research’s Drug Safety and Effectiveness Network undertake safety and effectiveness research of identified off-label practices.
The Committee also recommends that the Minister of Health urge the provinces and territories to implement electronic reporting formats for medical records, health records and dispensed prescription drugs, as outlined in the Committee’s previous report on Post-Approval Monitoring, and to further implement electronic prescribing that includes a requirement for information about indication and patient age, pregnancy or nursing status.
Additionally, the Committee calls on the Minister of Health to direct Health Canada to explore ways to provide focused and thorough monitoring of the off-label use of prescription drugs among certain vulnerable groups in the population such as children, youth and the elderly. In particular, the report calls attention to the use of antipsychotics and antidepressants for treating children and youth and the importance of collaborating with the Canadian Paediatric Society to enhance the Canadian Paediatric Surveillance Program.
Furthermore, the report draws attention to concerns raised by witnesses regarding the widespread use of antipsychotics among the elderly, particularly those in long-term care facilities. The Committee calls for focused monitoring of these prescribing practices by the appropriate authorities within their respective jurisdictions and with the intent of updating prescribing guidelines in this regard.
Finally, the Committee recommends Health Canada request that the Canadian Agency for Drugs and Technologies in Health regularly conduct assessments of off-label drug uses to facilitate increased uniformity of formulary listings and prescribing guidelines across jurisdictions.
“There are many Canadians who can benefit from innovative uses of off-label pharmaceuticals, but more needs to be done to balance innovation with patient safety, especially when it comes to the health of vulnerable groups like children and the elderly,” says Senator Kelvin K. Ogilvie, chair of the committee. “We need more research on off-label uses of prescription pharmaceuticals here in Canada. We need better information systems in place so that the extent of off-label use can be measured and common off-label uses properly assessed for safety and effectiveness, and we need an effective electronic process for monitoring the effects of pharmaceuticals in the general population.”
“The extent of off-label prescribing is not known” says Senator Art Eggleton, deputy chair of the committee. “Far too little is known about the most common types of off-label use and often doctors are unaware that they are prescribing off-label. We need improved physician awareness and data collection by Health Canada to ensure Canadians are protected.”
Prescription Pharmaceuticals in Canada: Off-Label Use is the third report in the Committee’s four phase study on prescription pharmaceuticals. To read the report and recommendations or to learn more about the previous activities and reports of the committee, please visit: http://senate-senat.ca/soci-e.asp.
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