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9 records – page 1 of 1.

Bill C-224, Good Samaritan Drug Overdose Act

https://policybase.cma.ca/en/permalink/policy11910

Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-40
The Canadian Medical Association supports Bill C-224, Good Samaritan Drug Overdose Act.
Policy Type
Policy resolution
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-40
The Canadian Medical Association supports Bill C-224, Good Samaritan Drug Overdose Act.
Text
The Canadian Medical Association supports Bill C-224, Good Samaritan Drug Overdose Act.
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Canadian guideline for safe and effective use of opioids for chronic pain

https://policybase.cma.ca/en/permalink/policy11901

Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-30
The Canadian Medical Association recommends that the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain include consideration of pharmacokinetic and pharmacodynamic factors specific to older adults.
Policy Type
Policy resolution
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-30
The Canadian Medical Association recommends that the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain include consideration of pharmacokinetic and pharmacodynamic factors specific to older adults.
Text
The Canadian Medical Association recommends that the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain include consideration of pharmacokinetic and pharmacodynamic factors specific to older adults.
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Chalk River National Research Universal reactor

https://policybase.cma.ca/en/permalink/policy9919

Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Text
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
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Health Canada’s Consultation on “Plain and Standardized Packaging”

https://policybase.cma.ca/en/permalink/policy13817

Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation, May 2016. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” Over the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The current Health Canada proposal will help realize that goal and the CMA supports the measures outlined in the consultation paper. There are two elements that the CMA recommend be addressed in this consultation. The CMA recommends that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. In a similar vein, the CMA recommends a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” While the CMA supports these measures, they must be part of the overall goal of further reducing and eliminating smoking. These measures will be an essential element of a sustained, well-funded and comprehensive program to reduce tobacco use, combining policy interventions with educational and social-marketing interventions including mass media campaigns. These programs should reflect current best practices, and be evaluated regularly for effectiveness and impact. To that end, the CMA calls on the federal government to renew the Tobacco Strategy before it expires in March 2017. At the same time, the CMA also recommends that the government allocate adequate funding to ensure implementation of the strategy. Finally, the consultation paper closes with some potential challenges to the implementation of these proposals. With respect to the problem of counterfeit cigarettes, all levels of government should take the strongest possible measures to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. The problem of retailers having difficulty implementing the regulations, resulting in service delays to their customers, is not really an issue related to these proposals. It is very doubtful that the retailers will experience such problems for very long and will find ways of resolving such difficulties. As for the problem of the manufacturers continuing to innovate in order to circumvent these measures, there should be sufficient enforcement tools within the regulations that will enable Health Canada to deal with such infractions. The Canadian Medical Association remains committed to working with governments and stakeholders to address this issue. We reiterate our long-standing support for plain and standardized packaging for tobacco products. In summary, the CMA recommends that: 1) only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed; 2) a single allowable length of cigarette and that a minimum diameter or width be established; 3) the federal government renew the Tobacco Strategy before it expires in March 2017 and that that the government allocate adequate funding to ensure implementation of the strategy. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism
Vice-président, Professionnalisme médicale Canadian Medical Association
Association médicale canadienne

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A Prescription for SUFA : CMA Submission to the F/P/T Ministerial Council on Social Policy Renewal

https://policybase.cma.ca/en/permalink/policy1961

Last Reviewed
2010-02-27
Date
2002-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health systems, system funding and performance
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2010-02-27
Date
2002-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health systems, system funding and performance
Text
It has been over three years since the Social Union Framework Agreement (SUFA) was signed by the federal and provincial/territorial governments, with the exception of Quebec. At the time, it was heralded as an important breakthrough in federal-provincial relations that would clear the way for greater intergovernmental cooperation on pressing social policy issues such as health care renewal. Functional federalism is essential to achieving social policy objectives that will be of benefit to Canadians from coast to coast. While SUFA may not be perfect, it is better than the alternative of federal-provincial paralysis and dysfunction. And as SUFA acknowledges, Canada’s social union is about more that how governments relate to each other: it is about how governments can and should work with external stakeholders and individual Canadians to improve the social policies and programs. The health sector is an important test case for SUFA. It is the most cherished of Canada’s social programs. Canadians want and expect their governments to work together to improve the health care system and ensure its future sustainability. Ironically, it is also the area where government intergovernmental discord has been the greatest. On the eve of the final report of the Commission on the Future of Health Care in Canada, it is timely to reflect on SUFA and its role in the renewal of Canada’s health system. SUFA and the Health Sector – Strengths and Weaknesses The attached table provides a summary of the key elements of SUFA and the CMA’s assessment of how well SUFA provisions have been applied in the health sector. On the positive side, the health sector has fared relatively well in the area of mobility within Canada. Physicians and other regulated health care providers generally enjoy a high degree of mobility. Portability of hospital and medical benefits is largely ensured through interprovincial eligibility and portability agreements. There are, however, two areas of concern. First, there is the longstanding failure to resolve the non-portability of medical benefits for Quebec residents. Second, there is growing disparity in coverage for services that are currently not subject to national standards under the Canada Health Act, particularly prescription drugs and home care. In the area of dispute avoidance and resolution, governments have agreed to a formal process to address concerns with the Canada Health Act. This is a positive step, though few details have been made public. The real test will be whether this new process accelerates the resolution of non-compliance issues (most of which, as the Auditor-General recently pointed out, have remained unresolved for five years or longer), and whether the federal government will have the political will to levy discretionary penalties for non-compliance. There has also been progress on public accountability and transparency as governments have begun reporting results in 14 health indicator areas pursuant to the September 2000 health accord. The CMA is disappointed, however, that governments did not fulfil their pledge to involve stakeholders at all levels in the development of these indicators. Moreover, governments have short-changed Canadians by not providing them with a national roll-up of indicators that would facilitate comparisons across jurisdictions. Looking to the future, it will be critical to put in place a process that moves from benchmarks (indicators) to the bedside (best practices, better outcomes). This must be done in collaboration with health care researchers, providers and health managers—those individuals who understand the importance of taking research and importing it into practice. Clinical researchers across the country are doing this work and must to be supported. Overshadowing these relative successes in the first three years of the Social Union Framework Agreement are three key challenges that must be addressed: * inadequate institutional mechanisms to improve accountability across the system * failure to reduce uncertainty about what the health system will deliver, now and into the future * resistance on the part of governments to engage stakeholders in a true partnership for health system renewal The CMA is concerned that if these fundamental weaknesses are not addressed, they will undermine future attempts to renew Canada’s health system. Improving accountability With the adoption of SUFA, governments have significantly increased emphasis on performance measurement and public reporting. While this is a positive development, it also has the potential to lead towards information overload and paralysis, unless two critical elements are addressed. First, there is a need for a clear accountability framework that sets out the roles, rights and responsibilities of all key players in Canada’s health system: patients, health care providers and governments. This, in turn, requires the creation of a credible arm’s length institution to monitor compliance with this framework and rise above the fray to give Canadians the straight goods on health care. One has to look no further that the recent rekindling of the so-called “shares debate” between the federal and provincial governments as an example of why these changes are necessary. Reducing uncertainty Over the past decade, Canada’s health system has been plagued by an escalating crisis of uncertainty. Patients have faced increasing uncertainty about the accessibility and timeliness of essential health care services. Health care providers have seen working conditions deteriorate. Employers and private insurers have seen their contribution to funding health services increase unpredictably as governments have scaled back their funding commitments. Furthermore, provincial and territorial governments have had to contend with an unstable federal funding partner. Canadians deserve better. They need more certainty that their public health system will care for them when they need it most. They need more transparency from governments about “what’s in” and “what’s out” in terms of public or private coverage. They need their governments to act on their SUFA undertaking to make service commitments for social programs publicly available such as establishing standards for acceptable waiting times for health care. And they need governments to follow through with their SUFA commitment to ensure stable and adequate funding for the health system and other social programs. Fostering real partnerships In the health care field, deliberations and agreements have taken place behind closed doors and governments have discounted the role that non-governmental organizations and citizens should play in decision-making. It is these very providers and patients who are expected to implement and live with the results of such cloistered decision-making. The consequences of this systematic exclusion are all too evident in the current critical and growing shortages of physicians, nurses and other health professionals. If we are to achieve the vision of a sustainable Medicare program, it is critical that governments come clean on their SUFA commitment to work in partnership with stakeholders and ensure opportunities for meaningful input into social policies and programs. CMA’s Prescription for Sustainability – Building on SUFA The Social Union Framework Agreement has created the necessary, but not sufficient, conditions for health system renewal. It has codified the emerging consensus on federal-provincial relations and has clarified the "rules of the game". However, it is an enabling framework that is of limited value in the health sector unless it is given life through institutional mechanisms that establish enduring partnerships not just between governments, but between governments health care providers, and patients. In its final submission to the Commission on the Future of Health Care in Canada entitled “Prescription for Sustainability”, the CMA proposes the implementation of three integrated “pillars of sustainability” that together would improve accountability and transparency in the system: a Canadian Health Charter, a Canadian Health Commission, and federal legislative renewal. Canadian Health Charter A Canadian Health Charter would clearly articulate a national health policy that sets out our collective understanding of Medicare and the rights and mutual obligations of individual Canadians, health care providers, and governments. It would also underline governments’ shared commitment to ensuring that Canadians will have access to quality health care within an acceptable time frame. The existence of such a Charter would ensure that a rational, evidence-based, and collaborative approach to managing and modernizing Canada’s health system is being followed. Canadian Health Commission In conjunction with the Canadian Health Charter, a permanent, independent Canadian Health Commission would be created to promote accountability and transparency within the system. It would have a mandate to monitor compliance with and measure progress towards Charter provisions, report to Canadians on the performance of the health care system, and provide ongoing advice and guidance to the Conference on Federal-Provincial-Territorial ministers on key national health care issues. Recognizing the shared federal and provincial/territorial obligations to the health care system, one of the main purposes of the Canadian Health Charter is to reinforce the national character of the health system. Federal legislative renewal Finally, the CMA’s prescription calls for the federal government to make significant commitments in three areas: 1) a review of the Canada Health Act, 2) changes to the federal transfers to provinces and territories to provide increased and more targeted support for health care, and 3) a review of federal tax legislation to realign tax instruments with health policy goals. While these three “pillars” will address the broader structural and procedural problems facing Canada’s health care system, there is many other changes required to meet specific needs within the system in the short to medium term. The CMA’s Prescription for Sustainability provides specific recommendations in the following key areas: * Defining the publicly-funded health system (e.g. a more rational and transparent approach to defining core services, a “safety valve” if the public system fails to deliver, and increased attention to public health and Aboriginal health) * Investing in the health care system (e.g. human resources, capital infrastructure, surge capacity to deal with emergencies, information technology, and research and innovation) * Organization and delivery of services (e.g. consideration of the full continuum of care, physician compensation, rural health, and the role of the private sector, the voluntary sector and informal caregivers) Conclusion On balance, the Social Union Framework Agreement has been a positive step forward for social policy in Canada, though its potential is far from being fully realized. The CMA’s proposal for a Canadian Health Charter, a Canadian Health Commission and federal legislative review entail significant changes to the governance of Canada’s health system. These changes would be consistent with the Social Union Framework Agreement and would help “turn the corner” from debate to action on health system renewal. The early, ongoing and meaningful engagement of health care providers is the sine qua non of securing the long-term sustainability of Canada’s health system. Canada’s health professionals, who have the most to contribute, and next to patients – who have the most at stake – must be at the table when the future of health and health care is being discussed. The CMA’s Assessment of the Social Union Framework Agreement ANNEX [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] SUFA provisions CMA assessment Principles 1. All Canadians to be treated with fairness and equity 2. Promote equality of opportunity for all Canadians 3. Respect for the equality, rights and dignity of all Canadian women and men and their diverse needs 4. Ensure access for all Canadians to essential social programs and services of reasonably comparable quality 5. Provide appropriate assistance to those in need 6. Respect the principles of Medicare: comprehensiveness, universality, portability, public administration and accessibility 7. Promote the full and active participation of all Canadians in Canada’s economic and social life 8. Work in partnership with stakeholders and ensure opportunities for meaningful input into social policies and programs 9. Ensure adequate, affordable, stable and sustainable funding for social programs 10. Respect Aboriginal treaties and rights [#4] Progress towards the objective of ensuring access to essential health services of reasonably comparable quality is difficult to assess. First, there is no agreed-upon definition of essential health services. Second there the development of indicators and benchmarks of health care quality is still in its infancy. However, the CMA is very concerned that the system is not headed in the right direction, with growing shortages of physicians, nurses and other health care providers. According to Statistics Canada’s recently released survey on access to health care services, an estimated 4.3 million Canadians reported difficulties accessing first contact services and approximately 1.4 million Canadians reported difficulties accessing specialized services. [#6]Although there is broad support for the five principles of Medicare, there continue to be a number of longstanding violations of Canada Health Act that are not being addressed, including the portability of medical benefits for Quebec residents. The emergence of privately-owned clinics that charge patients for medically-necessary MRI scans is also cause for concern. [#8] There is no formal, ongoing mechanism for input from stakeholders and the individual Canadians in debates about national health policy issues. (See also #17 below). [#9] Ensuring adequate, affordable, and stable funding for Canada’s health system is essential to its long-term sustainability. During the 1990s, billions of dollars were siphoned out of the system to eliminate government deficits. To put Medicare back on a sustainable path, governments must make long-term funding commitments to meet the health care needs of Canadians. The CMA has recommended that the federal government should significantly increase its financial contribution to restore the federal-provincial partnership in health care, and increase accountability and transparency through a new earmarked health transfer. Mobility within Canada 11. Removal of residency-based policies governing access to social services 12. Compliance with the mobility provisions of the Agreement on Internal Trade [#11] Residency-based policies are generally not an issue for physician and hospital services, where inter-provincial portability is guaranteed through reciprocal billing arrangements. As noted above, however, the portability of medical benefits for many Quebec residents is limited because the province only reimburses out-of-province services at home-province (as opposed to host-province) rates. [#12] Regulatory authorities initiated work towards meeting the obligations of the Labour Mobility Chapter of the Agreement on Internal Trade in fall 1999. A Mutual Recognition Agreement has been developed and endorsed by all physician licensing authorities. Public accountability & transparency 13. Performance measurement and public reporting 14. Development of comparable indicators to measure progress 15. Public recognition of roles and contributions of governments 16. Use funds transferred from another order of government for purposes agreed and pass on increases to residents 17. Ensure effective mechanisms for Canadians to participate in developing social priorities and reviewing outcomes 18. Make eligibility criteria and service commitments for social programs publicly available 19. Have mechanisms in place to appeal unfair administrative practices 20. Report publicly on appeals and complaints [#13-14] Pursuant to the September 2000 Health Accord, the federal government and provinces have developed common health indicators in 14 areas and have released a first slate of reports. However, the usefulness of these reports is hampered by missing data elements on quality of care (access and waiting times in particular) and the absence of a national roll-up to facilitate inter-provincial comparisons. [#15] Continuing federal-provincial bickering about shares of health funding makes it clear that this provision is not being met. [#16] The CMA’s analysis of the Medical Equipment Fund found that incremental spending by provinces on medical technology accounted for only 60% of the $500 million transferred by the federal government for this purpose. [#17] There is no mechanism in place to ensure ongoing input from Canadians and health care providers in national health policy development. The CMA has recommended the creation of a Canadian Health Commission, with representation from the public and stakeholders to provide advice and input to governments on key national health policy issues. [#18] Although there have been proposals to this effect in a couple of provinces, governments currently do not make explicit commitments about the quality and accessibility of health services. In order to reduce the uncertainty Canadians are feeling with respect to Medicare, the CMA has recommended the creation of a Canadian Health Charter that would set out the rights and responsibilities of patients, health care providers and governments. In particular, the health charter would require all governments to set out care guarantees for timely access to health services based on the best available evidence. [#19-20] The Auditor-General recently reported that Health Canada provides inadequate reporting on the extent of compliance with the Canada Health Act. Governments working in partnership 21. Governments to undertake joint planning and information sharing, and work together to identify priorities for collaborative action 22. Governments to collaborate on implementation of joint priorities when this would result in more effective and efficient service to Canadians. 23. Advance notice prior to implementation of a major policy or program change that will substantially affect another government 24. Offer to consult prior to implementing new social policies and programs that are likely to substantially affect other governments. 25. For any new Canada-wide social initiative, arrangements made with one province/territory will be made available to all provinces/territories. 26. Governments will work with the Aboriginal peoples of Canada to find practical solutions to address their pressing needs [#21-25] The requirement for governments to work together collaboratively is perhaps the most important part of SUFA, yet there it is impossible for organizations and individuals outside of government to assess the degree to which these provisions have been met. This so-called “black box of executive federalism” is not serving Canadians well. In the health sector, there are too many examples of governments developing policy and making decisions with little or no input from those who will ultimately have to implement change. To achieve a true social union, the tenets of good collaborative working relationships – joint planning, advance notice and consultation prior to implementation – must be extended beyond the ambit of federal-provincial decision-making. The CMA’s proposal for a Canadian Health Commission would go some distance in addressing these concerns. A key part of its mandate would be to bring the perspective of health providers and patients into national health policy deliberations and decision-making. Federal spending power 27. Federal government to consult with P/T governments at least one year prior to renewal or significant funding changes in social transfers 28. New Canada-wide initiatives supported by transfers to provinces subject to: a) collaborative approach to identify Canada wide objectives and priorities b) Agreement of a majority of provincial governments c) Provincial discretion to determine detailed design to meet agreed objectives d) Provincial freedom to reinvest funding in related area if objectives are already met e) Jointly developed accountability framework 29. For new Canada-wide initiatives funded through direct transfers to individuals or organizations, federal government to provide 3-months notice and offer to consult [#27-28] There have been three new Canada-wide health initiatives supported by the federal spending power: the $500M Medical Equipment Fund, the $800 Primary Health Care Transition Fund and the $500M fund for health information technology. The Medical Equipment Fund was created to respond to a genuine need for more modern diagnostic and treatment equipment. However, objectives were vague, money was transferred with no strings attached, and there was no accountability framework. The result, as the CMA’s analysis has shown, is that a significant portion of the funding did not reach its destination. The jury is still out in the case of the Primary Care Transition Fund. Delivery of this program through normal government machinery will entail a higher degree of accountability than in the case of the Medical Equipment Fund. However, objectives of this initiative may be too broad to have a significant steering effect on the system as a whole. Canada Infoway Inc. is an arm’s length body created by the federal government to disburse the $500M in health information technology funding. While this model has the advantage of being less politicized than government-run programs; accountability to Parliament and to Canadians is weaker. Dispute avoidance & resolution 30. Governments committed to working together and avoiding disputes 31. Sector negotiations to resolve disputes based on joint fact-finding, including the use of a third party 32. Any government can require a decision to be reviewed one year after it enters into effect 33. Governments will report publicly on an annual basis on the nature of intergovernmental disputes and their resolution [#30-33] Federal and provincial governments have agreed to a formal dispute avoidance and resolution process under the Canada Health Act. The Canadian Health Commission recommended by the CMA could play a useful role as an independent fact-finder. Review of SUFA 34. By the end of the 3rd year, governments will jointly undertake a full review of the Agreement and its implementation. This review will ensure significant opportunities for input and feedback from Canadians and all interested parties, including social policy experts, the private sector and voluntary organizations. [#34] Governments have taken a minimalist approach to the SUFA review by opting for an internet-based consultation and closed meetings with invited external representatives. This approach is not sufficient. Future reviews should be more inclusive of all stakeholders. [TABLE END]

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Regulation of Self-Care Products in Canada

https://policybase.cma.ca/en/permalink/policy13802

Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) appreciates the opportunity to respond to the Health Canada consultations on the regulation of self-care products in Canada. The CMA is encouraged that Health Canada is proposing a framework for the regulation of self-care products that is reliant on scientific proof to support health claims. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA’s comments on the regulation of self-care products, particularly natural health products and non-prescription drugs is based on the CMA Policy on Complementary and Alternative Medicine attached as Appendix 1. Our position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Canadians deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end.1 CMA supports a regulatory approach to self-care products such as natural health products that is based on risk assessment and the development of standards. 2 1 Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf F:\E-sig\JB_Signature.jpg 2 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 3Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf 4 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 5 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. 6 Canadian Medical Association. Brief BR2014-09 - Bill C-17 An Act to amend the Food and Drugs Act. Ottawa: The Association; 2014. Risk Based Approach As noted above CMA has recommended a regulatory approach that is based on risk assessment. We are troubled that the consultation document does not provide enough information on Health Canada’s risk assessment process. We are concerned that the proposal for a risk based approach could place many natural health and homeopathic products in a lower risk category based on whether or not the product makes a health claim which would require no Health Canada review or licensing of these products. As noted in the consultation document all health products have some level of risk and Health Canada’s role is to ensure that the benefits of a product outweigh any know risks. CMA does not believe that a determination of risk can be made based on historical use of a product or on the basis of a philosophical system not supported by science. The CMA has a long standing position that the same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. 3 CMA would recommend that the initial risk assessment of a self-care product should be evidence informed and based on the same standards of proof and efficacy as those for conventional medicines and pharmaceuticals. As such, we are concerned that homeopathic and natural health products are given as examples of lower risk products that would not require Health Canada review or licensing. Health Claims The consultation document redefines a health claim to only those that pertain to diagnosis, treatment, prevention, cure or mitigation of disease or serious health condition. These claims will need to be supported by scientific evidence and only these health claims will be allowed and reviewed by Health Canada. The CMA has recommended that safety and efficacy claims for natural health products, and claims for the therapeutic value of these products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications currently regulated by Health Canada. 4 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.5 Therefore the CMA supports the proposal that two products making similar claims would have to provide the same level of scientific evidence and are held to the same standard. CMA would not be in support of the proposal that products can still make claims “based on traditional systems of medicine or alternate modalities” with only “adequate supporting information” to be maintained by the company without review or licensing by Health Canada. CMA would also recommend that even those products that do not make health claims are held to the same standard as those established for pharmaceutical products. Since our position is that all self-care products from lower risk to higher risk should be reviewed for safety and quality, all products should undergo review by Health Canada. Information It is certainly problematic that, as noted in the consultation document, fewer than 2 in 5 Canadians surveyed rated themselves knowledgeable about the effectiveness of self-care products. Canadians have the right to reliable, accurate information on self-care products to help ensure that choices they make are informed. It is very important that Canadians understand the level of scrutiny a product has undergone by Health Canada. CMA can support the proposal for an authorization number on those products that have been reviewed and approved by Health Canada. Equally, a disclaimer on the product label that indicates that the product has not been reviewed or approved by Health Canada for effectiveness is very important. We must guard against an assumption by the public that if Health Canada did not need to review a product there is no risk associated with the product. The Information provided on self-care products should be user friendly and easy to access and include a list of ingredients, instructions for use, indications that the product has been proven to treat, contraindications, side effects and interactions with other medications. In an era when product claims can be spread vie social media and the internet and cannot be easily monitored it is important to ensure consistent oversight of product marketing. Health claims can only be promoted if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Additional Powers In its submission on Bill C -17 An Act to amend the Food and drugs Act – Protecting Canadians from Unsafe drugs the CMA recommended that the ministerial authorities and measures to address patient safety risks should extend to natural health products.6 We would therefore suggest that Health Canada explore the need for additional powers and tools to require a company to change labels, or order a recall of an unsafe product and institute new penalties to address patient safety issues. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's regulatory framework for self-care products to ensure that the health related products Canadians receive are safe and effective. Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism Canadian Medical Association CMA POLICY COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) This statement discusses the Canadian Medical Association’s (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA’s position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should “consider first the well-being of the patient.”1 The ethical principle of non-maleficence obliges physicians to reduce their patient’s risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM. 1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. 2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies. CAM in Canada CAM has been defined as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.”i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health. analysis, the CMA divides CAM into four general categories: . Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based. . Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products. . Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise. . Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada. Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the “holistic” concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM. Toward Evidence-Informed Health Care Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious. The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA’s Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below: a) Research: Building an Evidence Base To date, much of the public’s information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public. b) An Appropriate Regulatory Framework Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments. i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada. The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products’ safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include: 5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies. 6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. Available: 9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. 12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. * manufacturing processes that ensure the purity, safety and quality of the product; * labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6 The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm’s length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8 The Canadian Medical Association advocates that foods fortified with “natural health” ingredients should be regulated as food products and not as natural health products The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada’s MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada. ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge. Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients. Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to: . Resist any influence or interference that could undermine their professional integrity;9 . Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10 . Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient. c) Information and Promotion Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include: . Instructions for use; . Indications that the product or therapy has been convincingly proven to treat; . Contraindications, side effects and interactions with other medications; . Should advise the consumer to inform their health care provider during any encounter that they are using this product.12 This information should be provided in such a way as to minimize the impact of vested commercial interests on its content. In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims. The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease. The Role of Health Professionals Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients. Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically. The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.

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Regulatory framework for the mandatory reporting of adverse drug reactions and medical device incidents by provincial and territorial healthcare institutions.

https://policybase.cma.ca/en/permalink/policy11814

Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation document Questions related to Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions. Prescription medication has an important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient’s capacity to function productively in the community. In consideration of this important role, the CMA has developed a substantial body of policy on pharmaceutical issues which includes policy on Canada’s post-approval surveillance system for prescription medication. It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA welcomes Health Canada’s consultation on the new legislative authority established by Vanessa’s Law to implement mandatory reporting of adverse drug reactions (ADR) and medical device incidents by provincial and territorial healthcare institutions. The CMA appreciates all opportunities to work with governments, health care professionals and the public in strengthening Canada’s post-approval surveillance system and ensuring that the prescription drugs Canadians receive are safe and effective. The CMA’s submission is organized in three main sections. In the first section, the CMA’s concerns with the current ADR reporting system are identified as critical context for this regulatory development process. The second section provides an overview of the CMA’s recommendations on necessary improvements to this system. Finally, the CMA’s responses to the questions outlined in Health Canada’s discussion document are presented in the third section. Part 1: Context of CMA’s Recommendevices with which they have a concern, and also for research purposes.

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Standardized non-pharmacologic order sets

https://policybase.cma.ca/en/permalink/policy11903

Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-32
The Canadian Medical Association advocates for the development of national standardized non-pharmacologic order sets for the treatment of older adults with delirium.
Policy Type
Policy resolution
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-32
The Canadian Medical Association advocates for the development of national standardized non-pharmacologic order sets for the treatment of older adults with delirium.
Text
The Canadian Medical Association advocates for the development of national standardized non-pharmacologic order sets for the treatment of older adults with delirium.
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Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada

https://policybase.cma.ca/en/permalink/policy13936

Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
Text
Thank you Mr. Chair. I am Dr. Jeff Blackmer, the Vice-President of Medical Professionalism for the Canadian Medical Association. On behalf of the CMA, let me first commend the committee for initiating an emergency study on this public health crisis in Canada. As the national organization representing over 83,000 Canadian physicians, the CMA has an instrumental role in collaborating with other health stakeholders, governments and patient organizations in addressing the opioid crisis in Canada. On behalf of Canada’s doctors, the CMA is deeply concerned with the escalating public health crisis related to problematic opioid and fentanyl use. Physicians are on the front lines in many respects. Doctors are responsible for supporting patients with the management of acute and chronic pain. Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. The CMA has long been concerned with the harms associated with opioid use. In fact, we appeared before this committee as part of its 2013 study on the government’s role in addressing prescription drug abuse. At that time, we made a number of recommendations on the government’s role – some of which I will reiterate today. Since then, the CMA has taken numerous actions to contribute to Canada’s response to the opioid crisis. These actions have included advancing the physician perspective in all active government consultations. In addition to the 2013 study by the health committee, we have also participated in the 2014 ministerial roundtable and recent regulatory consultations led by Health Canada — specifically, on tamper resistant technology for drugs and delisting of naloxone for the prevention of overdose deaths in the community. 3 Our other actions have included: · Undertaking physician polling to better understand physician experiences with prescribing opioids; · Developing and disseminating new policy on addressing the harms associated with opioids; · Supporting the development of continuing medical education resources and tools for physicians; · Supporting the national prescription drug drop off days; and, · Hosting a physician education session as part of our annual meeting in 2015. Further, I’m pleased to report that the CMA has recently joined the Executive Council of the First Do No Harm strategy, coordinated by the Canadian Centre on Substance Abuse. In addition, we have joined 7 leading stakeholders as part of a consortium formed this year to collaborate on addressing the issue from a medical standpoint. I will now turn to the CMA’s recommendations for the committee’s consideration. These are grouped in four major theme areas. 1) Harm Reduction The first of them is harm reduction. Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. Despite the fact that there is broad recognition that we are in a public health crisis, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach rather than a public health approach. In its current form, this strategy does not significantly address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. The CMA strongly recommends that the federal government review the National Anti-Drug Strategy to reinstate harm reduction as a core pillar. Supervised consumption sites are an important part of a harm reduction program that must be considered in an overall strategy to address harms from opioids. The availability of supervised consumption sites is still highly limited in Canada. The CMA maintains its concerns that the new criteria established by the Respect for Communities Act are overly burdensome and deter the establishment of new sites. 4 As such, the CMA continues to recommend that the act be repealed or at the least, significantly amended. 2) Expanding Pain Management and Addiction Treatment The second theme area I will raise is the need to expand treatment options and services. Treatment options and services for both addiction as well as pain management are woefully under-resourced in Canada. This includes substitution treatments such as buprenorphine-naloxone as well as services that help patients taper off opioids or counsel them with cognitive behavioural therapy. Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. The CMA recommends that the federal government deliver additional funding on an emergency basis to significantly expand the availability and access to addiction treatment and pain management services. 3) Investing in Prescriber and Patient Education The third theme I will raise for the committee’s consideration is the need for greater investment in both prescriber as well as patient education resources. For prescribers, this includes continuing education modules as well as training curricula. We need to ensure the availability of unbiased and evidenced-based educational programs in opioid prescribing, pain management and in the management of addictions. Further, support for the development of educational tools and resources based on the new clinical guidelines to be released in early 2017 will have an important role. Finally, patient and public education on the harms associated with opioid usage is critical. As such, the CMA recommends that the federal government deliver new funding to support the availability and provision of education and training resources for prescribers, patients and the public. 4) Establishing a Real-time Prescription Monitoring Program Finally, to support optimal prescribing, it is critical that prescribers be provided with access to a real-time prescription monitoring program. 5 Such a program would allow physicians to review a patient’s prescription history from multiple health services prior to prescribing. Real-time prescription monitoring is currently only available in two jurisdictions in Canada. Before closing, I must emphasize that the negative impacts associated with prescription opioids represent a complex issue that will require a multi-faceted, multi-stakeholder response. A key challenge for public policy makers and prescribers is to mitigate the harms associated with prescription opioid use, without negatively affecting patient access to the appropriate treatment for their clinical conditions. To quote a past CMA president: “the unfortunate reality is that there is no silver bullet solution and no one group or government can address this issue alone”. The CMA is committed to being part of the solution. Thank you.

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