The committee further recommends that the Minister of Health, at the next meeting of Canada’s federal, provincial and territorial Ministers of Health, urge all jurisdictions to discuss mechanisms by which health professionals can inform patients of off-label prescription drug use, including disclosure of the information by the prescribing physician or the dispensing pharmacist.

The committee therefore recommends that the Minister of Health direct Health Canada, in collaboration with its provincial and territorial counterparts, to identify common off-label uses of medicines using recent studies and available data on dispensed prescription drugs.

The committee therefore recommends that Health Canada convey information about common off-label drug practices that lack strong scientific evidence identified in Recommendation 1 to the Canadian Institutes of Health Research’s Drug Safety and Effectiveness Network and request that it undertake to study these off-label uses in the most appropriate format including comparative effectiveness research.

The committee further recommends that the Minister of Health look into mechanisms for making information sources such as the Australian Medicines Handbook and the British National Formulary available to Canadian health professionals.

The committee therefore recommends that the Minister of Health direct Health Canada to explore ways to provide focussed and thorough monitoring of the off-label use of prescription drugs among children and youth less than 18 years of age, particularly the use of antipsychotics and antidepressants, including further collaboration with the Canadian Paediatric Society to enhance the Canadian Paediatric Surveillance Program. The committee agrees with those witnesses who raised the serious concern of the widespread use of antipsychotics among the elderly, particularly those in long-term care facilities. As such it would like to see focussed monitoring of these prescribing practices by the appropriate authorities.

The committee therefore recommends that 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.

The committee therefore recommends that Health Canada implement recommendation 1 of the committee’s report entitled Prescription Pharmaceuticals in Canada: Post-Approval Monitoring for Safety and Effectiveness, in order to exercise its authority to require label changes that reflect safety and effectiveness research on off-label drug use.

The committee therefore recommends that Health Canada broaden the scope of information provided through Summary Basis of Decision documents beyond newly approved drugs to new indications for old drugs and that these documents provide information about rejections as well as drug sponsor withdrawals.

The committee further recommends that the Minister of Health direct Health Canada to examine the current prohibition on off-label drug promotion by drug manufacturers in order to identify effective mechanisms of enforcement.