The fact that one of the main treatment modalities in health care — prescription drugs used outside the hospital setting — remains outside the medicare envelope in 2009 perplexes many clinicians, academics and the general public. Canada has an overall public health care system, but the lack of coverage for prescription drugs is a gaping hole in the system with adverse consequences for many Canadians. Moreover, Canada lags behind many comparator nations in issues related to prescription access and affordability, the quality and safety of medication use, and the use of technologies such as e-prescribing that would help to improve the system (Table 1).1–3
The National Pharmaceuticals Strategy, part of the federal, provincial and territorial health accord signed in 2004,4 was an attempt by the participating governments to jointly develop and implement drug policy solutions. More specifically, the prime minister and premiers directed their health ministers to focus on 9 specific action items that dealt with issues related to access and affordability of medications and the quality and safety of the medication-use system (Box 1). Although many solutions had been proposed previously, the National Pharmaceuticals Strategy — one of the critical social safety nets — was hailed as an important milestone in public policy, which would address critical problems related to affordability of pharmacotherapy and safety of medication use to achieve good value for money and, most importantly, improved health. In 2005, the health ministers met, reaffirmed their commitment to the National Pharmaceuticals Strategy and added an action item related to coverage of expensive drugs for rare diseases.
Four and a half years after its launch, many people are left wondering what happened to the National Pharmaceuticals Strategy. On Jan. 30, 2009, the Health Council of Canada, a not-for-profit and nongovernment agency funded by the federal government that aims to foster accountability and transparency of the health care system, released 2 reports that answered this question and provided guidance for the next steps.5,6 The status report is a valuable read for those who wish to refresh themselves on the original commitments and review the progress made in fulfilling the promises. The other report, a commentary on the National Pharmaceuticals Strategy, offers suggestions on how to achieve 4 key elements: catastrophic drug coverage, affordability of prescription drugs, patient safety issues related to better prescribing, and equal access to medications through a common drug formulary. The Health Council of Canada argues that while progress has been made on some of the commitments, overall progress has been less than satisfactory and that it is time for all stakeholders to renew their commitment to the realization of the principles of a national drug policy strategy.
Limited progress has been made on a few of the action items in the original National Pharmaceuticals Strategy document. Although the Common Drug Review was established separately, it complements the National Pharmaceuticals Strategy’s goal of a national common drug formulary. Some progress has been made on providing coverage for expensive drugs for a few rare diseases, including Fabry disease. Several provinces are contributing data to the National Prescription Drug Utilization Information System, although the action item of analysis of the cost-effectiveness and best practices in drug plans remains largely unfulfilled.
The action item for which there appears to be renewed energy and action is the evaluation of real-world drug safety and effectiveness. On Jan. 14, 2009, the federal government announced a commitment of $32 million over 5 years, followed by an annual commitment of $10 million thereafter, to create the Drug Safety and Effectiveness Network.7 The size of this commitment compares favourably, for example, with the annual budget of the Canadian Patient Safety Institute, which addresses all aspects of patient safety. Still, this announcement was made by the federal government and not by the structure of the National Pharmaceuticals Strategy. Moreover, it is odd that there is no mention of how this new network relates to Health Canada’s proposed progressive licensing framework for newly approved pharmaceuticals.
One could excuse those involved with the National Pharmaceuticals Strategy for not delivering on promises were they no longer needed or relevant. Clearly, that is not the case. In-deed, we could argue that the need for a national strategy is even greater in 2009 than it was in 2004. Total expenditures for prescription drugs have increased nearly 37% since 2004, from $21.8 billion in 2004 to $29.8 billion in 2008,8 further straining public and private payers. The affordability of prescription drugs continues to be a challenge for many Canadians. In terms of safety, the Canadian Adverse Events Study9 was released just before the original National Pharmaceuticals Strategy report. Since then, the evidence showing that our medication-use system is unsafe has greatly increased.10 Drug-related morbidity is a major contributor to health care use,11 and the impact of existing drug policies on clinical and humanistic outcomes, such as health status and satisfaction, has been inadequately studied.12 Unfortunately, in 2006, the National Pharmaceuticals Strategy task force decided that some of the action items would take priority over others, and they chose not to include 2 items (influencing prescribing behaviour and e-prescribing) on the priority list.
It would be incorrect to say that drug policy has been a barren wasteland in Canada since 2004. Rather, much has happened in recent years, but most of the activity has been at the provincial or territorial level, outside the structure of the National Pharmaceuticals Strategy. Indeed, legislation or reports related to drug policy in Ontario, Quebec, British Columbia and, most recently, Alberta are all examples of noteworthy initiatives. As a result, the drug policy landscape in Canada has been altered from a National Pharmaceuticals Strategy to provincial and territorial pharmaceuticals strategies. One could argue that this approach is acceptable, given that some of commitments of the strategy are being fulfilled, albeit on a province-by-province basis. However, the spirit and essence of a pan-Canadian approach is that improvements in affordability, safety and the overall quality should be available to all Canadians through a nationwide coordinated effort.
The prevailing approach of decentralized decision-making at the provincial and territorial level may tarnish national collaborations. For example, Ontario’s Transparent Drug System for Patients Act, which ironically includes nontransparent pricing agreements between the province of Ontario and pharmaceutical manufacturers, could affect the credibility of the Common Drug Review process. While the Common Drug Review recommended that the provinces not provide coverage for escitalopram (Cipralex) in November 2008, Ontario’s Committee to Evaluate Drugs decided to provide coverage for this drug on the Ontario Drug Benefit Formulary as a general benefit based on a “subsequent pricing agreement.”13
Renewing the National Pharmaceuticals Strategy with a new mandate and new structure is the right decision for all stakeholders, but especially for the Canadian public. Specifically, we suggest a more effective organizational structure of sufficient size, scale and stability. The current structure of a ministerial task force may be useful for final policy decision-making, but does not seem sufficient to ensure adequate financial and political stability for support staff to make decisions or to achieve timely action. Second, there should be a set of clear goals, objectives and principles to guide priority-setting and decision-making. This is especially critical given that the priorities of the federal government may not be the same as the priorities of the provinces and territories, who are primarily concerned with controlling drug expenditures. Several active nationwide initiatives could serve as examples for structure and format, including the Canadian Strategy for Cancer Control and the Canadian Diabetes Strategy. Finally, there should be a transparent process for monitoring and reporting progress, including timelines and online quarterly reports made available to all Canadians.
What we have proposed is a formidable task, one that will require considerable political will. Moreover, the current decentralized decision-making approach will not be easily reversed. Those involved in the National Pharmaceuticals Strategy deserve praise for the progress made and will require support to see the remaining promises fulfilled. The total cost of the strategy has never been clearly defined and is undoubtedly massive, an especially difficult barrier given current economic conditions. However, without such support, the National Pharmaceuticals Strategy will remain largely a prescription unfilled; yet it is a necessary prescription to achieve a stronger, sustainable and more equitable Canadian health system.
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The National Pharmaceuticals Strategy is a comprehensive and collaborative pan-Canadian approach to address problems related to affordability and safety.
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Two new reports by the Health Council of Canada provide insight into the limited progress achieved to date and offer suggestions on how the National Pharmaceuticals Strategy may be renewed.
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The original commitments in the National Pharmaceuticals Strategy remain relevant today and the need for implementation has increased.
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The recent announcement by the federal government of the creation of the Drug Safety and Effectiveness Network is encouraging; however, decentralized decision-making of drug policy at the provincial and territorial level continues to dominate the drug policy landscape in Canada.
Key points
Footnotes
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Published at www.cmaj.ca on Feb. 3, 2009.
This article has been peer reviewed.
Competing interests: Neil MacKinnon contributed to the 2 Health Council of Canada reports on the National Pharmaceuticals Strategy that are cited in this commentary. Ivan Ip is an employee of the Health Council of Canada.
Contributors: Both authors contributed substantially to conception and design of the commentary. Neil MacKinnon drafted the commentary, and Ivan Ip revised it critically. Both of the authors approved the final version submitted for publication.