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Building a Comprehensive Post-Market Surveillance System : Canadian Medical Association Response to Health Canada’s Discussion Paper “Designing a Mandatory System for Reporting Serious Adverse Reactions”

https://policybase.cma.ca/en/permalink/policy1951
Last Reviewed
2012-03-03
Date
2005-07-28
Topics
Health systems, system funding and performance
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2012-03-03
Date
2005-07-28
Topics
Health systems, system funding and performance
Text
Building a Comprehensive Post-Market Surveillance System Canadian Medical Association Response to Health Canada’s Discussion Paper “Designing a Mandatory System for Reporting Serious Adverse Reactions” Submitted to Health Canada July 28, 2005 Overview The CMA believes that all stakeholders should work together to improve adverse drug reaction (ADR) reporting, in the interests of improving patients’ safety and health. However, we believe that activity in pursuit of this end must be based on two fundamental premises: a) Reporting is only one part of a comprehensive post-market surveillance system. In order to effectively monitor the safety of Canada’s drug supply, this system should include: * a simple, comprehensive and user-friendly reporting process; * rigorous analysis of reports to identify significant threats to drug safety; * a communications system that produces useful information, distributed to health care providers and the public in a timely, easily understood manner. There is no point in enacting a mandatory reporting requirement until all of these elements are in place. We wonder why mandatory reporting has been singled out for discussion when a holistic approach to reforming Canada’s drug safety system is called for. b) Health care providers should be encouraged to participate willingly and voluntarily in the reporting process. To be successful, Canada’s post-market surveillance system will depend on the active participation of physicians and other health professionals. Experience with health system quality and safety improvement efforts over the past several years has demonstrated that meaningful acceptance is most effectively obtained when those involved are willing participants. If you build a comprehensive, efficient and effective post-market surveillance system, physicians will participate actively in it. Forcing them to participate before the system has been built will result in alienation, frustration and failure. Comments on Discussion Paper a) Is Mandatory Reporting Necessary? This is a fundamental question and the discussion paper does not satisfactorily address it. There are two reasons why we question the necessity for imposing an ADR reporting requirement on health professionals. First, as awareness of the drug-safety system’s importance has increased, the number of ADR reports has increased along with it - more than 10% in 2004, as the discussion paper notes - without a mandatory reporting requirement. Given this trend, it is highly probable that time, education, adequate resources and increasing familiarity with the surveillance system will raise reporting rates to the desired level (however defined) without mandatory reporting. Second, as the discussion paper points out, there is no evidence that mandatory reporting has been effective in other jurisdictions where it has been implemented. The paper offers no clear explanation for this lack of success. More importantly, it does not indicate how Health Canada plans to ensure that mandatory reporting will succeed in this country when it has proven ineffective elsewhere. A primary principle of any system change is that we should not repeat the mistakes of others. Before launching a program whose success has not been proven, other viable, and possibly more effective, alternatives should be examined. b) Addressing known barriers to reporting The CMA acknowledges that ADRs are under-reported, in Canada and worldwide. The discussion paper identifies a number of barriers to reporting, and its list mirrors the observations and experiences of our own members. We believe most of these barriers can, and should, be overcome. We also agree that it is necessary to raise health professionals’ awareness of the importance of, and process for, ADR reporting. But we question the curious assertion that “Mandatory reporting could raise awareness of the value of reporting simply by virtue of the public debate.” Surely there are more positive ways to raise awareness than publicly speculating about the punitive consequences of non-compliance. We suggest that instead, Health Canada work with physicians and other health professionals to address the existing barriers to reporting. Specifically, we recommend that Health Canada implement: * a well-funded and targeted awareness-raising campaign focused on provider education and positive messaging, * a user-friendly reporting system, including appropriate forms, efficient processes and adequate fees. These measures are within Health Canada’s purview in the existing policy and legislative environment. We believe they would increase reporting without the need for coercive measures. At a minimum, positive system improvements should be tried first before considering a mandatory-reporting requirement. With regard to specific questions posed in the discussion paper: Question 1: Health professionals should be explicitly protected from any liability as a result of reporting an adverse drug reaction. This should be the case regardless of whether reporting is voluntary or mandatory. Question 2: Professionals should be compensated for all meaningful work including the completion of forms and any follow-up required as a result of the information they have provided. We would be happy to expand further on this issue on request. Question 3: Issues of confidentiality should be covered in legislation. The CMA has developed an extensive and authoritative body of knowledge on privacy issues in health care, which we would be pleased to share with Health Canada. c) Improved report quality We agree that increasing the quality and richness of ADR reports is as important as increasing their number. Perhaps it is even more important, since high-quality reports allow for high-quality analysis. 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. Experience elsewhere has taught us that true quality cannot be legislated or imposed; any attempt to do so would be pointless. If ADR reports included the information listed in Table 4, this would improve their usefulness and the effectiveness of the overall surveillance process. However, it is unrealistic to expect all reports to contain this level of information. The treating physician may not be able to provide all of it, especially if he or she is not the patient’s regular primary care provider. Some of this information, particularly about outcomes, may not be available at the time of the reporting, and gathering it would require follow-up by Health Canada. Health Canada should consider measures other than mandatory reporting to improve the quality of ADR reports. The CMA suggests that consideration be given to: * Improving follow-up capacity. We agree that it should be made easier for Health Canada officials to contact reporters and request details on follow-up or outcomes. This should be considered as part of a comprehensive initiative to improve Health Canada’s capacity to analyze ADR reports. * Establishing a sentinel system. Another option for increasing high-quality reports would be to establish a “sentinel” group of practicing physicians who would contract to report all ADRs in detail. These physicians, because of their contractual obligation, would be committed to assiduous reporting. Sentinel systems could be established concurrently with efforts to increase voluntary ADR reporting by the broader health professional community. In addition to the current information provided, consideration should be given to including on reporting forms the option to allow Health Canada officials to act on information the physician provides; for example, in the reporting of sexually transmitted diseases physicians provide certain information and have the option to request that public health officials undertake follow-up and contact tracing. d) Minimize administrative burden We agree that Health Canada should give consideration to making the ADR reporting system user-friendly, non-complex and easy to integrate into the patient-care work stream. These reforms can and should be implemented regardless of whether a mandatory requirement is in place. They do not need mandatory reporting to make them work; in fact, they are more likely to encourage ADR reporting than any form of coercive legislation. Rather than making a mandatory reporting requirement “fit” with the traditional patient-care framework, we invite Health Canada to work with us to increase health professionals’ capacity to report ADRs voluntarily. We are already working with Health Canada to improve physicians’ access to drug safety material. Health Canada’s ADR reporting form can now be downloaded from the cma.ca web site, which also posts the latest drug alerts from Health Canada and from the Food and Drug Administration in the U.S. We have developed an on-line course in partnership with Health Canada, to teach physicians when and how to make ADR reports. We hope to build on this collaboration, with the goal of making it possible for physicians to report ADRs online via cma.ca. This will permit them to fit reporting more conveniently into their daily workflow. (Note: the “MedEffects” Web portal now being developed at Health Canada does not fit well into the workflow and therefore will not make reporting easier for health professionals.) In the future, we hope that ADR reporting can be built directly into the Electronic Medical Record (EMR). We think this will be a critical element in the bi-directional communicating that ADR reporting requires. It will also enable rapid integration of advisories into the EMR so that they can be available to physicians at the time they are writing a prescription. Before electronic ADR reporting can work, a standard for electronic data should be in place (at present it is not) and Health Canada should develop the capacity to accept data electronically. Health Canada’s discussion paper makes reference to cost-benefit analysis. We recommend that you take great care not to over-emphasize cost-benefit when it comes to enhancing patient safety. Meaningful improvements in the post-market surveillance system will be costly whatever solution Health Canada eventually embraces, and it is impossible to measure financially the value of safety. What is an acceptable cost for one life saved? e) Minimize Over-Reporting The discussion paper acknowledges that not all adverse reactions need be reported. We strongly agree that one of the dangers of mandatory reporting is its potential to overwhelm the system with an unmanageable flood of reports. There is no reason to require reports of minor side effects that are already known to be associated with given drugs. We agree that the reactions Health Canada most needs to know about are those which are severe and/or unexpected. If Health Canada insists on implementing a mandatory reporting system, it should be limited to these reactions (possibly with the corollary that well known serious ADRs would not need to be reported). However, the operating definitions may need clarification, and we recommend that Health Canada consult with health professionals and others on operational guidelines for defining “serious adverse reaction.” Health Canada’s desire to encourage reports on drugs approved within the last 5 years is understandable (though some drugs may be on the market for longer than this before their true risks are known). In practice, however, many physicians do not know which drugs these are, and seeking out this information may impose a heavy administrative burden. As we move toward an EMR-based reporting system, a tag on the Drug Identification Number to tell when the drug was approved will allow physicians to identify which medications require special vigilance. Appropriate reporting could be encouraged, and over-reporting discouraged, by clear guidelines as to what should be reported as well as appropriate compensation for reporting. f) Match Assessment Capacities In our opinion, this is one of the most important sections in the document. What happens once the reports have been received is crucial if we want to identify a serious drug risk as quickly as possible. Under the current system, one of the most significant barriers to physicians’ reporting is lack of confidence that anything meaningful will be done with their reports. Enhancements to the analysis function must be made concurrently with efforts to increase ADR reporting. ADR reports are only cyber-bytes or stacks of paper unless we can learn from them. This requires rigorous data analysis that can sort “signal from noise” – in other words, sift through thousands of reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. This requires substantial resources, including an adequate number of staff with the expertise and sensitivity required for this demanding task. Unless Health Canada has this capacity, increasing the number of reports will only add to the backlog in analysts’ in-boxes. The CMA recommends that Health Canada allocate sufficient resources to enable it to effectively analyze and respond to ADR reports and other post-market surveillance information. g) Respect privacy Privacy of both patient and physician information is a significant concern. Physicians’ ethical obligation to maintain patient confidentially is central to the patient-physician relationship and must be protected. We acknowledge that issues of privacy and confidentiality must be resolved when designing an ADR reporting system, particularly as we work toward electronic communication of drug surveillance data and its incorporation into an EMR. For example, regulations should explicitly state that ADR reports are to be used only for the purpose for which they were submitted, i.e. for post-market drug surveillance. In addition, Health Canada should ensure that any privacy provisions it develops meet the legislative test outlined in Section 3.6 of CMA’s Health Information Privacy Code (Attachment I). Health Canada can be assured that physicians take their privacy obligations seriously. The CMA has been a strong and pro-active player in debate on this issue, and our Privacy Code lays the groundwork on which we believe any privacy policies involving ADR reporting should be based. h) Compliance through sanctions Physicians are motivated to report ADRs by their concern for public health and their patients’ well-being. In addition, they are guided by the CMA Code of Ethics and governed by regulatory authorities in every province. A clear ethical and professional obligation already exists to report anything that poses a serious threat to patient safety. If physicians do not comply with this obligation, sanctions are available to the provincial regulatory authorities. In fact, the most serious threat for physicians is loss of standing with the professional regulatory authority, not the courts or any external judicial system. It would be superfluous to add a second level of regulation or scrutiny when remedies already exist. The discussion paper presents few alternatives to the existing self-regulatory system. As the paper itself acknowledges, it is unrealistic to impose sanctions based on failure to report an ADR, since it is not always easy to determine whether an adverse effect is attributable to a health product. But the only suggested alternatives - requiring physicians to demonstrate knowledge, or to have the required reporting forms in their office - seem intrusive, crude and unreasonable; they are also meaningless since they have no direct relation to a physician’s failure to report. If Health Canada is considering a large outlay of taxpayers’ dollars for post-market surveillance, we suggest they target those funds to education and awareness raising, and to enhancing the system’s ability to generate and communicate meaningful signal data, rather than to enforcing a mandatory reporting system based on weak compliance measures, with no evidence of its effectiveness in other jurisdictions. Physicians who are in serious breach of their ethical and legal responsibility to report are subject to sanctions by provincial regulatory authorities. Most provincial colleges have policies or guidelines regarding timely reporting and appropriate enforcement mechanisms. Medicine’s tradition of self-regulation has served it well, and we recommend that Health Canada respect and support existing regulatory authorities as they maintain the standards for appropriate professional behaviour. As we have said before - the preferred quality improvement tools to enhance performance and encourage compliance are education and positive reinforcement, not legislation and the threat of sanctions. Conclusion In its discussion paper Health Canada has invited stakeholders to provide their input on how best to develop a mandatory system for reporting ADRs. The Canadian Medical Association believes that the best way to do this is not to develop one at all. Instead, we believe stakeholders should concentrate on building a sustainable, robust and effective post-market surveillance system which: * encourages and facilitates voluntary reporting, by designing a simple and efficient process that can be incorporated into a physician’s daily workflow; * effectively uses reporting data to identify major public health risks; * communicates drug safety information to providers and the public in a timely, meaningful and practical way. The CMA is committed to working, in partnership with Health Canada and other stakeholders, toward the ultimate goal of a responsive, efficient and effective post-market drug surveillance system. This is part of our long-standing commitment to optimizing Canadians’ safety and health, and achieving our vision of a healthy population and a vibrant medical profession.
Documents
Less detail

Capacity of the medical educational and training infrastructure

https://policybase.cma.ca/en/permalink/policy1888
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Health systems, system funding and performance
Resolution
GC05-68
The Canadian Medical Association calls on the federal government to commission an independent body to assess and report on the capacity of the educational and training infrastructure across Canada to expand enrolment in medicine and nursing programs.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Health systems, system funding and performance
Resolution
GC05-68
The Canadian Medical Association calls on the federal government to commission an independent body to assess and report on the capacity of the educational and training infrastructure across Canada to expand enrolment in medicine and nursing programs.
Text
The Canadian Medical Association calls on the federal government to commission an independent body to assess and report on the capacity of the educational and training infrastructure across Canada to expand enrolment in medicine and nursing programs.
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Clinical faculty

https://policybase.cma.ca/en/permalink/policy1896
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Population health/ health equity/ public health
Resolution
GC05-76
The Canadian Medical Association calls upon the federal/provincial/territorial governments, in conjunction with practicing physicians, to immediately develop a joint comprehensive plan with practicing physicians for recruiting, retaining, and adequately compensating clinical faculty.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Population health/ health equity/ public health
Resolution
GC05-76
The Canadian Medical Association calls upon the federal/provincial/territorial governments, in conjunction with practicing physicians, to immediately develop a joint comprehensive plan with practicing physicians for recruiting, retaining, and adequately compensating clinical faculty.
Text
The Canadian Medical Association calls upon the federal/provincial/territorial governments, in conjunction with practicing physicians, to immediately develop a joint comprehensive plan with practicing physicians for recruiting, retaining, and adequately compensating clinical faculty.
Less detail

Community-based physician teachers

https://policybase.cma.ca/en/permalink/policy1887
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Physician practice/ compensation/ forms
Resolution
GC05-67
The Canadian Medical Association urges medical faculties to compensate and recognize community-based physician teachers appropriately to reflect the value of their contributions to medical education.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Physician practice/ compensation/ forms
Resolution
GC05-67
The Canadian Medical Association urges medical faculties to compensate and recognize community-based physician teachers appropriately to reflect the value of their contributions to medical education.
Text
The Canadian Medical Association urges medical faculties to compensate and recognize community-based physician teachers appropriately to reflect the value of their contributions to medical education.
Less detail

Family medicine residency positions

https://policybase.cma.ca/en/permalink/policy1901
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Health systems, system funding and performance
Resolution
GC05-81
The Canadian Medical Association urges governments to assign targeted funding to increase the number of family medicine residency positions to meet recent increases in medical school enrolment and other demand factors.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Health systems, system funding and performance
Resolution
GC05-81
The Canadian Medical Association urges governments to assign targeted funding to increase the number of family medicine residency positions to meet recent increases in medical school enrolment and other demand factors.
Text
The Canadian Medical Association urges governments to assign targeted funding to increase the number of family medicine residency positions to meet recent increases in medical school enrolment and other demand factors.
Less detail

Family medicine training

https://policybase.cma.ca/en/permalink/policy1895
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Resolution
GC05-75
The Canadian Medical Association will call on the Association of Faculties of Medicine of Canada and the College of Family Physicians of Canada to ensure that all medical students undergo a significant period of family medicine training in community settings that are representative of real-world general and family practice.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Resolution
GC05-75
The Canadian Medical Association will call on the Association of Faculties of Medicine of Canada and the College of Family Physicians of Canada to ensure that all medical students undergo a significant period of family medicine training in community settings that are representative of real-world general and family practice.
Text
The Canadian Medical Association will call on the Association of Faculties of Medicine of Canada and the College of Family Physicians of Canada to ensure that all medical students undergo a significant period of family medicine training in community settings that are representative of real-world general and family practice.
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International Medical Graduates : Notes for an address by Dr. Albert J. Schumacher, President, Canadian Medical Association : Presentation to the Standing Committee on Citizenship and Immigration

https://policybase.cma.ca/en/permalink/policy2006
Last Reviewed
2012-03-03
Date
2005-02-17
Topics
Health human resources
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2012-03-03
Date
2005-02-17
Topics
Health human resources
Text
Good afternoon, I am Dr. Albert Schumacher, President of the Canadian Medical Association (CMA) and a family physician from Windsor, Ontario. With me today is Dr. Todd Watkins, Director, Office of Professional Services at CMA and also a family physician. It is estimated that some 4.5 million Canadians have had trouble finding a family doctor, while more than 3 million Canadians do not have regular access to one. Long waiting lists for consultations and specialized diagnostic and therapeutic procedures suggest there is a shortage of specialists. Including time spent on call, Canada’s physicians worked an average of 70 to 80 hours a week. Of the 21,000 physicians surveyed in the recently released National Physicians’ Survey, over a quarter said they plan to reduce their work week within the next two years. 60% of family doctors either limit the number of new patients they see or have closed their practices. At the same time, the average age of physicians in Canada is 48 years with 32% 55 years of age or older. Almost 4000 physicians may retire in the next two years. There is a “perfect storm” brewing in terms of health human resource in Canada. The message I hope to leave with you today is that the valuable participation of International Medical Graduates (IMGs) in our medical workforce must be part of a coordinated pan-Canadian plan that strives to address the double imperatives of immigration policies that are fair and policies that in the short, medium and longer term will ensure greater self-sufficiency in the education and training of physicians in Canada. Today I am going to focus on three things: Number one: clarify some of the myths about IMGs in Canada; Number two: stress the need for greater capacity in Canada’s medical education and training infrastructure; and Lastly: emphasize the importance of a national standard for licensure. Myths There are a few myths that abound about IMGs in Canada. If you were to believe some of what you read or hear in the media you might gather that it is next to impossible for international medical graduates to enter the practice of medicine in Canada. Nothing could be further from the truth. As of last month, almost one quarter of the physicians working in our health care system received their medical degree in a country other than Canada. This proportion has declined by only 2% since the 1960s. Estimates peg the number of IMGs arriving in Canada with pre-arranged employment licensed to practice each year at 400. Quite simply, our health care system could not function without the critical contributions of qualified international medical graduates (IMGs). Also, many IMGs access the postgraduate training system in Canada. As of December 2004 there were 316 IMGs who were either Canadian citizens or permanent residents in their first year of postgraduate residency training – this represents 15% of the total number of first-year trainees. In the past few years only a few provinces have greatly expanded opportunities for assessing the clinical skills of IMGs and providing supplementary training and practice opportunities. Just two weekends ago some 550 IMG’s participated in the Ontario Provincial IMG Clinical Assessment which was offered at four medical schools across the province. This will lead to some 200 IMGs being licensed to practice in Ontario. Other provinces have similar programs. I would note that the initiatives of the federal government announced by the Honourable Hedy Fry in March 2004 have been very helpful in communicating information about and raising awareness of the requirements to practice medicine in Canada. Some $3 million announced at that time was provided to assist provinces and territories in assessing IMGs and will add at least 100 internationally trained physicians into the system. I am optimistic that her continued collaborative efforts with the medical community will result in positive changes. So, has Canada closed its borders to IMGs? Hardly. Can more be done to achieve fairness? Absolutely. Capacity I can not stress strongly enough the need to increase the capacity of Canada’s undergraduate medical education and postgraduate training system. There are some who think that the fastest and least expensive way of meeting our medical workforce requirements is to simply recruit medical graduates from other countries. In the short term this is a major part of the fix. It is, however, no substitute for a “made in Canada” solution for the long term. As a long-term policy it fails to recognize the fact that the countries from which we poach these IMGs can ill afford to lose them. We are simply not pulling our weight as a country in educating and training future physicians. As my predecessor, Dr. Sunil Patel told his Committee last April, in 2002 there were roughly 6.5 first year medical school places per 100,000 population in Canada – just over one-half of the UK’s rate of 12.2 per 100,000. The CMA has recommended a 2007 target of 2500 first year medical positions and at the moment we are tracking toward 2300. Over reliance on IMGs also fails to appreciate the critical role played by Canada’s academic health science centres. These institutions have a three-fold mission of teaching, research and the provision of a great deal of patient care and these three components are inextricably linked. Expanded capacity will work to the benefit of both Canadians aspiring to attain a medical education and IMGs. For example, in 2004 of the 657 IMGs entering second iteration of the residency match, just 87 or 13% were successful. We need to expand capacity not only within academic health sciences centres themselves, but we need to recruit and support clinical teachers out in the community. This is crucial, especially for the IMG assessment programs now being rolled out. But most importantly, an enhanced education and training infrastructure will help meet the future health needs of Canadians. The goal that had been identified in the 2004 First Minister’s Agreement, specified $250 million a year beginning in 2009-10 through 2013-14 “primarily for health human resources” training and hiring. However, Bill C-39, which was recently tabled to implement provisions of the 10-year plan by creating the Wait Times Reduction Fund, falls short of what Canadians deserve and expect. Specifically, it stipulates theses dollars may be used for multiple purposes. This failure to recognize the critical shortage of health care professionals by dedicating specific dollars to the issue now could mean the promised investments may never be made to enhance health human resources. The temptation will be to continue to rely on “beggar thy neighbour” policies. However, Canada can and must do better to pull its own weight. Importance of a National Standard As the national organization representing Canada’s physicians we have a direct interest in working with government to ensure Canadians have access to health care when they need it. The CMA has a role in medical and health education in the accreditation of undergraduate medical education and the accreditation of the training programs of some 15 health disciplines. However, the CMA is not a regulator. We do not grant credentials or license physicians. Regulation of medicine falls under the purview of the provincial and territorial colleges of physicians and credentials are granted by the College of Family Physicians of Canada, the Royal College of Physicians and Surgeons of Canada and the College des Médecins du Quebec. If medicine has a lesson to offer other professions and occupations it is in the value of having a national standard. While health is the constitutional responsibility of the provinces and territories, medicine has been able to realize a national standard for portable eligibility for licensure across Canada. Beginning in 1992 the basis for licensure in all provinces/territories except Quebec has been the successful completion of the two-part Qualifying Examination of the Medical Council of Canada plus certification by either the College of Family Physicians of Canada or the Royal College of Physicians and Surgeons of Canada. The procedures in place in Quebec are very similar. To be sure there can be interpretation around the application of the standard, but without a doubt it has provided a significant degree of transparency and uniformity about what is required to practice medicine in Canada. This not only promotes a concordance between the programs offered by our 16 (soon to be 17) medical schools but also provides a basis for the assessment of international programs. On this latter point, the Institute for International Medical Education has a database that contains information on more than 1,800 medical schools in 165 countries around the world. Conclusion During pre-budget hearings last fall, I submitted to the Standing Committee on Finance our plan to address health human resources shortages. As was the case then, IMGs are a critical part of the CMA plan. A plan that has as its core the belief that Canada must adopt a policy of increased self-sufficiency in the production of physicians in Canada. This involves: * increased opportunities for Canadians to pursue medical education in Canada; * enhanced opportunities for practising physicians to return for additional training; * strategies to retain physicians in practice and in Canada; and * increased opportunities for IMGs who are permanent residents or citizens of Canada to access post-MD training leading to licensure/certification and the practice of medicine in Canada. This set of imperatives needs to be balanced against a need for fairness. Fairness to ensure those who need to obtain further medical training are able to do so. And, fairness to young Canadians who deserve a chance to pursue a career in medicine. I appreciate the opportunity of entering into a dialogue with members of the Committee and look forward to your questions. Thank you.
Documents
Less detail

International medical students

https://policybase.cma.ca/en/permalink/policy1898
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Physician practice/ compensation/ forms
Resolution
GC05-78
The Canadian Medical Association will approach international medical associations to determine best practices for attracting medical students to family medicine and methods for securing a strong professional and adequately compensated future for general and family practitioners.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2005-08-17
Topics
Health human resources
Physician practice/ compensation/ forms
Resolution
GC05-78
The Canadian Medical Association will approach international medical associations to determine best practices for attracting medical students to family medicine and methods for securing a strong professional and adequately compensated future for general and family practitioners.
Text
The Canadian Medical Association will approach international medical associations to determine best practices for attracting medical students to family medicine and methods for securing a strong professional and adequately compensated future for general and family practitioners.
Less detail

Letter on cross-border pharmacy control

https://policybase.cma.ca/en/permalink/policy1947
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs. The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat. In summary, our response to the Minister’s three proposals is as follows: * Supply monitoring network: We support supply monitoring as a necessary activity. * Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed. * Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate. Our detailed comments on the proposals are below. 1) Drug supply monitoring system The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow: * 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence. * 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme. * 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members. The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada. * 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages. 2) Export Restriction CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow: * 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction. * 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation. 3) Requiring a Patient-Practitioner Relationship The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons: * The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress. * Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported. * The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality. In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them. * Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention. In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour. We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation. Yours truly, Briane Scharfstein, MD, CCFP, MBA Associate Secretary General, Professional Affairs cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate, Health Canada CMA Provincial/Territorial Divisional CEO’s
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Letter to the International Joint Commission on the 2004 Progress Report addressing air quality

https://policybase.cma.ca/en/permalink/policy1952
Last Reviewed
2012-03-03
Date
2005-02-11
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2012-03-03
Date
2005-02-11
Topics
Population health/ health equity/ public health
Text
On behalf of Canada’s physicians, the Canadian Medical Association (CMA) would like to take this opportunity to provide comments to the International Joint Commission on the 2004 Progress Report addressing air quality. The Association, first founded in 1867, currently represents more than 59,000 physicians across the country. Our mission includes advocating for the highest standard of health and care for all Canadians and we are committed to activities that will result in healthy public policy which support health and the environment. The environment, as a determinant of health, is a major concern for the general public as well as health care providers. Air pollution affects the health of all Canadians, but particularly children, the elderly and those with respiratory and cardiac conditions. Poor air quality can provoke devastating health effects. Every day physicians come face to face with the reality of an unhealthy environment and its effects on our patients. The impact can be seen in terms of increased frequency of symptoms, medication use, physician visits, emergency room visits, hospitalizations and premature deaths. Canadians and Americans breathe the same air, drink the same water, and share a common responsibility to provide future generations with a healthy environment. This is why the Canada-U.S. agreement to address and resolve environmental issues is so important. The U.S.-Canada Air Quality Agreement established a formal and flexible method of addressing trans-boundary air pollution and laid the groundwork for cooperation between the United States and Canada on very important air quality issues. Under the Air Quality Agreement of 1991, both countries have made progress in coordinating and implementing their acid rain control programs and have focused activities on ground level ozone since 2000. The improvements, as described in the 2004 Progress Report are commendable. But while many of the parties’ emission reduction commitments are on-track, dangerous air pollution continues to blow both ways across our borders. This suggests that the measures included in this agreement are not sufficient to ensure that Canadians have clean air to breathe. In fact, we believe that future evaluations should describe air quality improvement as the outcome of interest, in addition to cataloguing emission reduction initiatives, as is done in the 2004 Progress Report. The 2004 Progress Report, prepared by Environment Canada and the United States Environmental Protection Agency, is the seventh biennial report compiled under the 1991 United States-Canada Air Quality Agreement. Ground level ozone, a primary component of smog, directly contributes to air quality and health. The commitment to reduce ground level ozone under the 2000 Agreement has the potential to improve air quality and the quality of life of literally millions of people. As indicated in the Progress Report 2004, Canada is “on track to implement all of its commitments for vehicles, engines and fuels” in order to reduce ground level ozone. However, the stationary emissions of NOx remain above target levels. An aggressive strategy to reduce NOx and VOC to lessen smog, and the adverse health impact on Canadians and Americans is urgently required. Smog and climate change are not distinct problems. In fact, a large proportion of the smog pollutants that cause serious cardiac and respiratory problems in Canada are emitted from the same tailpipes and industrial smokestacks as the greenhouse gases, which the Kyoto agreement aims to reduce. Canada’s commitment to the Kyoto Accord provides an opportunity to significantly reduce smog and achieve cleaner air for all Canadians to breathe. The purchasing of emission credits from foreign countries to make up for a shortfall in the reductions of greenhouse-gas emissions Canada agreed to in the Kyoto accord is clearly short-term thinking that does not address the long term goals outlined in the accord. Climate change measures under the Accord will yield additional benefits through improved local and regional air quality. But more can and needs to be done. Canada must bring air pollution down to safe levels and to cut greenhouse gas emissions to halt climate change. For these reasons, CMA recommended that the Prime Minister commit to choosing a climate change strategy that satisfies Canada’s international commitments while maximizing the clean air co-benefits and smog–reduction potential of any greenhouse gas reduction initiatives. Canada’s physicians are concerned about the pollutants that are affecting the health of Canadians, and believe that there should be appropriate mechanisms to warn those who are vulnerable and at risk, so that they can act to protect themselves from contaminants in the air, water, or food. We have called on the government of Canada to establish a national Air Quality Index so that real-time air quality information and predictive forecasting is made available to all Canadians. Health-based reporting about pollutants is a way to allow Canadians to partner in their own health protection, while such pollutants are being addressed by policies aimed at producing cleaner air. Environment Canada and Health Canada have long been developing a health-based Air Quality Index, which would incorporate the most recent health science and make air quality forecasts and current ambient conditions available across the nation. We contend this is a key initiative and we urge this work be expedited. CMA reaffirms our support for the Kyoto protocol and in the best interest of Canadians, urges the government to establish a national Air Quality Index. There is a fundamental role for governments in preventing and controlling smog and poor air quality through healthy public policy and regulations. There remains much work to be done. CMA’s vision of a healthy population for Canada underpins our commitment to advocate for clean air. I would like to thank you and the IJC for your continued commitment to improving air quality for Canadians and Americans. It is through efforts like this, that our mutual goal for a clean, healthy and safe environment may be realized. We look forward to your next report demonstrating even further gains in achieving high air quality. Yours truly, Albert J. Schumacher, MD President AJS/jns
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