Thank you, Denis.
Before getting into our recommendations that relate specifically to issues around improving drug safety, I'd like to comment on the concept of mandatory adverse drug reaction reporting, which we believe is being confused with overall steps that need to be taken to improve drug safety.
The Canadian Pharmacists Association is strongly supportive of measures to increase patient safety. We were one of the founding organizations of the Canadian Patient Safety Institute, and we certainly support the need to increase the reporting of adverse drug reactions. However, we believe a multi-pronged approach is needed and are concerned that too much attention is being placed on mandatory ADR reporting as the quick-fix solution.
In terms of making reporting of serious adverse drug reactions mandatory, we question whether all other avenues have in fact been exhausted. Increasing the quality and richness of ADR reports is as important as increasing their number, perhaps even more important, since high-quality reports allow for high-quality analysis.
We feel that mandatory reporting will not improve the quality of ADR reports, it will simply increase their quantity. It may even compromise the system's efficiency and effectiveness by increasing the volume of clinically insignificant reports.
Another concern we have is the issue of enforcement. When you use the word “mandatory”, it often goes with enforcement. We question whether this is feasible and whether Health Canada would be able to devote and maintain sufficient resources for mandatory ADR reporting in terms of compliance or analysis.
We also see the potential for such a development to place significant burdens on already time-pressed health care providers. In fact, we can find no evidence from other jurisdictions that mandatory ADR reporting really supports improved patient safety, and we wonder why mandatory reporting has been singled out for discussion when a more integrated approach to informing Canada's drug safety system is called for. Prior to launching a program whose success is yet to be proven, other viable and perhaps more effective alternatives, we believe, should be examined.
With that in mind, we'd like to make the following recommendations.
We need to establish and aggressively promote education and training programs for health care professionals that focus on better use and better ADR reporting. Health care providers should be encouraged to participate voluntarily in reporting ADRs. An international experience demonstrates meaningful participation when those involved are willing participants. A successful ADR system must be simple to use and must fit into the busy practice of the health care provider. This will also allow for effective expert analysis of the quality data gathered so that we're better able to identify hazards and trends.
We believe that government should invest in innovative research relating to methods of detecting, evaluating, and reporting adverse drug reactions, and support quality decision-making during the prescribing and medication use processes. That's critical to long-term safety and effectiveness. I think a particular focus of the research needs to be the role of the consumer with respect to non-prescription medications and natural health products.
The federal government, through Health Canada, should invest in an electronic ADR reporting system that will integrate reporting forms into the software used by health care professionals at the point of care. These electronic systems should be integrated into prescribers' offices, pharmacies, and hospitals. They essentially should become part of the future developments around the electronic health record.
On another note, we believe that the federal government should fully fund the business plan for the real world safety and effectiveness of medicines in Canada, a project developed as a part of the national pharmaceutical strategy. We need to support the development of the network of centres of excellence proposed in this report.
Pharmacists must also be supported to play a greater role in ensuring the quality use of medications and in reporting adverse drug reactions. Pharmacists are the only health care professionals with a full-time university education devoted entirely to drugs and their use. Better integration of their knowledge and skills into the health care system through collaborative practice arrangements will go a long way to solving many of the problems in medication use in Canada.
Our final recommendation is that we must include the pharmaceutical industry as a partner in establishing programs and processes to ensure the safe and effective use of medications. The pharmaceutical industry possesses considerable data that, when combined with adverse drug reaction data collected by Health Canada, will help decision-makers and health care providers take steps to ensure the safe and effective use of medications. The industry has very effective methods for collecting and disseminating information that can be used to the advantage of Canadians.
On behalf of the Canadian Pharmacists Association, thank you for the opportunity to present our views on this important subject today.