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Presentation to the Standing Committee on Finance Pre-Budget Consultations : Securing Our Future . . . Balancing Urgent Health Care Needs of Today With The Important Challenges of Tomorrow

https://policybase.cma.ca/en/permalink/policy2013
Last Reviewed
2020-02-29
Date
2001-11-01
Topics
Health systems, system funding and performance
Health human resources
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2020-02-29
Date
2001-11-01
Topics
Health systems, system funding and performance
Health human resources
Text
The Canadian Medical Association (CMA) values the open, constructive and ongoing dialogue afforded by the Standing Committee on Finance’s Pre-Budget Consultations process. As a society, it is essential that we make every effort to work together to find lasting solutions to what are a series of complex and interdependent policy issues, especially during these turbulent times. Last August, the Committee set out objectives for this year’s consultations. You asked for advice on how to ensure that Canada remains a major player in the New Economy while providing Canadians with equal opportunities to succeed and create a socio-economic environment where they can enjoy the best quality of life and standard of living. However, world events have intervened and the urgent has crowded out the important. The CMA has suspended, for the most part, what we consider important longer term issues in an effort to do our part in helping guide the government’s deliberations in this time of national need. We support the government’s commitments, to date, in response to the events of September 11 and their aftermath. We are cognizant of the economic forecasts that show a slowing economy as a result and the need to re-focus our national attention on security issues. The overriding challenge for this Committee therefore, will be to develop recommendations for the next budget that address the current and future situation with respect to national security without losing sight of internal needs such as pursuing the innovations necessary to ensure the long-term sustainability of our health care system. Indeed, we see the latter as supporting the former. The CMA is committed to working closely with the federal government to ensure that Canada’s health care system can respond to immediate health security challenges. Our members are committed to continuing to ensure that Canadians’ confidence is restored by developing and implementing policy initiatives that serve to strengthen Canadians’ access to quality health care when they need it. To this end and building on our efforts since September 11, the CMA has put together a to meet these objectives. Specifically, the CMA has examined and developed recommendations that address national preparedness in terms of security, health and capacity; the capacity of our health human workforce in addressing current and future demands; and a look beyond the urgent to the necessary, in the form of a proposed process to review tax policy in support of health policy. II. PREPAREDNESS Health and Security The events of September 11, 2001 have had a profound impact on the lives of Canadians. Anxiety over the openness of our borders, the safety of our airlines and our vulnerability to attacks filled the media and our conversations in the days following the tragedies in the United States. A Canadian Ipsos Reid Express survey taken for the Canadian Medical Association October 23-25, 2001 indicated that 31% of respondents report ongoing sadness, anger, disturbed sleep, or are overprotective of their children. 1 This confirms what our members are telling us, based on everyday practice. A GPC International survey indicates that three-quarters of Canadians have a moderate to strong fear that the US-led anti-terrorist campaign will lead to Canada being a possible terrorist target. 2 An earlier Canadian Ipsos Reid Express survey taken October 1, 2001 shows that the attacks have risen to the top of the list of issues (73%) that should receive the greatest attention among our leaders. 3 Social issues, including health, are the second rated (49%) concern among Canadians. The Canadian Medical Association’s response following the terrorist attack was immediate and is ongoing. Working through and with our provincial/territorial Divisions and Affiliates, the Association began collecting names of those physicians willing to offer assistance to US agencies dealing with the tragedy should it have been requested. As well, we spearheaded the development of the Canadian Mental Health Support Network (www.cma.ca/cmhsn), which includes Health Canada and twelve other national health associations, to help Canadians and Canada’s health professionals cope with the mental health aftermath of the attack. The work of this network continues in terms of a series of public security announcements to be released very soon and in terms of ensuring that the information available through health professionals is clear, concise and consistent. We also provided continuous updated advice to Canadian doctors about bioterrorist threats. In the early days of the anthrax scare, before Health Canada had materials available for the public, hundreds of calls for information to 1-800-OCanada were referred daily by Health Canada to the CMA. However, there is an aspect of this issue requiring urgent attention given the current environment. It is the ability of our health system to respond to a disaster, be it a terrorist attack, a natural disaster or a large scale accident. As the Canadian Medical Association and others have documented, the people and the infrastructure of our system is already stretched in its capacity to deal with everyday demands. We have seen that emergency rooms across this country can barely cope with the increased demands brought on by the annual flu season. The system is already operating at or beyond capacity. Devastation approaching the scale of September 11 has not been seen in Canada since December 6, 1917 with the Halifax explosion. While no health system can ever be fully prepared to meet such a staggering level of destruction, it must have the confidence, the resources and, the disaster planning and referral systems to rise to the challenge if Canadians are to be reassured that help will be there if and when they need it. Public Health and Safety The challenge – if and when it comes – will require a local response that is supported nationally. To appreciate the scope of the work necessary to prepare the health system for the threats brought by terrorism it will be useful to understand the challenges currently facing public health in Canada. We have long enjoyed the benefits of a solid public health system through the various health protections, health promotion, and disease prevention and control programs created to maintain and improve the health of the population. The essential role of the medical officer of health in the public health system must be acknowledged, supported, and respected. Their credibility provides the community and health care professionals, particularly physicians, with balance and specialized medical expertise on public health matters. When the board of health is performing its mandated duties successfully, few are even aware that it is at work. Yet when a public health crisis strikes, the community expects rapid, knowledgeable, expert and quality attention to matters. But it can only do that if there is a strong infrastructure in place to meet the challenge. A clear and present danger is the emergence of new diseases or the re-appearance of old ones. An editorial in the April 27, 2000 issue of the New England Journal of Medicine expresses concern about the ability of public health infrastructures to cope with this problem without the resources needed to respond. 4 Increased trade, rising migration rates, and changes in the environment have led to worries over the revival of diseases thought to be under control or near extinction (e.g., human plague, tuberculosis and malaria) and even the recognition of some new “bugs”. The need to be vigilant about the re-emergence of infectious diseases was brought home to governments with a large outbreak of human plague in India in 1994. 5 Out of 876 cases reported, characterized as presumptive plague, 56 were fatal. A large outbreak of Ebola in Zaire in 1995 led to as many as 233 people dying from the disease and further strengthened the case for devoting resources to this problem. 6 West Nile Virus The New York City area got a first-hand look at this problem in 1999 with the appearance of the West Nile virus in North America. As the New York Times reported, it may have come in the blood of a traveler returning from Africa or Europe. 7 It may have arrived in an infected bird smuggled in baggage or even in a mosquito that got onto a jet. In spite of efforts to contain the disease, it has now begun to spread through the eastern portion of the continent, as far north as southern Ontario and as deep as Florida. Tuberculosis Tuberculosis remains one of the world’s two deadliest infections and it is feared to be on the verge of a major comeback. The disease kills 1.5 million to 2 million people a year, almost as many as AIDS. Experts say that toll could increase in the coming years because TB bacteria are evolving dangerous new strains that are increasingly drug-resistant. 8 Health Canada reports that there have been some cases (and deaths) in Canada of multiple drug-resistant TB (MDR-TB) strains. 9 Only Newfoundland, PEI and the territories have not had cases of drug-resistant TB. Latvia and Russia are considered “hot spots” in the world for MDR-TB. However, one in three reported isolates in New York City in recent years was MDR-TB. As well, highly resistant strains spread from New York to Florida, Nevada, Georgia and Colorado in less than two years. Malaria The World Health Organization estimates that one million die from malaria a year and 90% of those deaths are Africans (2500 African children under five die from malaria each day). 10 The disease seems to be dying back in other continents but growing stronger across Africa. The WHO report on infectious diseases describes malaria as having the power to “overwhelm a young child causing high fever, convulsions and breathing difficulties. With the onset of cerebral malaria the child lapses into a coma and may die within 24 hours.” 11 AIDS According to the WHO, there are over 33 million people worldwide living with HIV/AIDS. 12 The hardest hit area is sub-Saharan Africa where one in four of the adult population has HIV/AIDS. In South Africa, 10% of the population is now infected with HIV. 13 The problem among pregnant women is worse, with 22% infected with HIV. In May, 2000, the US National Security Council declared that the spread of AIDS across the world is a threat to national security. 14 The concern, like many of the infectious diseases, is that eventually it will overwhelm the ability of governments to cope with the disease. The US government has sought to double to $254 million to combat AIDS overseas. Readiness Post-September 11 The tragic events of September 11 provided a grim reminder of the necessity of having a strong public health infrastructure in place at all times. As was demonstrated quite vividly that day, we do not have the luxury of time to prepare for these events. While it is not possible to plan for every contingency, certain scenarios can be sketched out and prepared for. To succeed, all communities must maintain a certain consistent level of public health infrastructure to ensure that all Canadian residents are protected from threats to their health. These are only some of the external threats. The Canadian public health system must also cope with domestic issues such as diseases created by environmental problems (e.g., asthma), sexually transmitted diseases, and influenza, among many others. Even before the spectre of bioterrorism this country’s public health experts were concerned about the infrastructure’s ability to deal with multiple crises. There are many vacancies among the public health physician and nursing staffs, particularly in rural and northern Canada as well as the First Nations units. This workforce is also aging and efforts to attract and retain staff have been lagging. The announcement of October 18, 2001 by the federal government of a $11.59 million investment was welcome news to Canadians in the aftermath of September 11. It provided for the “basics” in terms of stockpiling of necessary antibiotics, the purchase of sensor and detection equipment to help respond to radio-nuclear incidents, enhancing a laboratory network to better equip them to detect biological agents, and provide training to front-line health care professionals to help them recognize, diagnose and treat suspicious illnesses. However, far more needs to be done to improve our ability to respond to health and security contingencies of all kinds. The Walkerton water crisis is an example of the difficulties often faced by public health officials. Without the full resources (legislative, physical, financial, human) to do the job properly, the health of Canadians is potentially jeopardized. The Ontario Medical Association emphasized this point in its brief to the Walkerton Inquiry: “Unstable and insufficient resources hamper the Ontario public health system. Steps must be taken by the provincial government to enhance the ability of boards of health to deliver public health programs and services that promote and protect health and prevent disease and injury. Sufficient and reliable public health funding is critical.” 15 The CMA reinforced that message in a resolution passed at its 2001 Annual General Meeting: “That CMA recommend all levels of government across Canada urgently review legislation governing all aspects of drinking water from source to consumption to ensure that comprehensive programs are in place and being properly implemented, with effective linkages to local, provincial and territorial public health officials and Ministries of Health.” In a recent broadcast in the United States, Dr. Jeffrey Koplan, Director of the US Centers for Disease Control and Prevention laid out seven priority areas for building capacity and preparedness within a public health system: 16 * A well trained, well staffed public health workforce * Laboratory capacity to produce timely and accurate results for diagnosis and investigation * Epidemiology and surveillance to rapidly detect health threats * Secure, accessible information systems to help analyze and interpret health data * Solid communication to ensure a secure two-way flow of information * Effective policy evaluation capability * A preparedness and response capability which includes a response plan and testing and maintaining a high state of preparedness These points apply whether the threat is a natural disaster or a terrorist attack. Public health must be ready for all such threats. And, at present, we are told, that responding to a crisis like Walkerton or North Battleford, not to mention the possibility of co-ordinated bioterrorism, effectively results in public health units shutting down many core programs that are the building blocks of the health care system. As the long shadow of bioterrorism rises over Canada and menaces our health and wellbeing, these issues take on even more significance to Canadians. This Committee must do its part to provide for an “act locally by thinking nationally” with regard to public health support systems. The Current Context As noted above, prior planning and preparation is one of the keys to ameliorating the effects of such sudden and calamitous occurrences. It must be remembered that a catastrophic event of the nature that occurred on September 11 is a local event in that it happens within the jurisdiction of a specific municipality. The quality and level of the response depends on how well prepared the local authorities are for such actions. The local capacity to respond varies across Canada with some area health services (e.g., the larger urban centres) better prepared and equipped than others (there may be jurisdictions that do not have plans). Regardless of how well prepared any municipality is there is always the very strong possibility that public health officials will be overwhelmed and need to turn to the province or territory for help. It is also possible that the event is so massive that even the provincial or territorial resources are besieged and it must call on the federal government with their stockpiles of medical supplies and access to epidemiologists and laboratory services. That assumes good planning before hand between the federal and provincial/territorial governments and that is not necessarily the case. There is an important role for the federal government to urgently improve the coordination among authorities and reduce the variability among the various response plans in cooperation with provincial authorities (and assist those in preparing plans where none exist). Health Canada must help facilitate efforts to rationalize preparations and make it easier for jurisdictions to assist one another in a time of disaster. This could include measures such as transferring patients quickly to facilities outside the affected area when the immediate hospitals are full or even to transferring them to other provinces or territories if necessary. Disease surveillance is another component of these measures. To be effective there must be, at the provincial and territorial level, linked electronic surveillance mechanisms that are standardized and the staff available to analyze and report the data. At the federal level, the government must be ready to provide data in a timely fashion, especially in an emergency. However, very few of Canada’s doctors will have seen the disease entities that threaten Canadians at the moment (e.g., anthrax, smallpox). The CMA has expressed its willingness to assist Health Canada in bringing together stakeholders to develop quickly a curriculum that would train health care professionals to recognize, diagnose and treat the new threats we face as a society. The government must also aid in the development of volunteer teams of health professionals and other experts that can be mobilized rapidly in response to disasters wherever and whenever they occur. The concept would be similar to the military's Disaster Assistance Response Team (DART). 17 DART consists of medical, engineering, logistics, communications and security personnel ready to deploy at short notice to anywhere in the world from their support base at Canadian Forces Base Trenton. It is crucial, that the federal government build and maintain its supplies for emergency use, its public health laboratories for early detection, its capacity to rapidly train and inform frontline health workers of emerging threats, its ability to assist the provinces and territories, and co-ordinate provincial responses in the event of overwhelming or multiple simultaneous threats. In this area, the CMA recommends that: 1. The federal government immediately provide a minimum of $15 million for an assistance fund to municipal and provincial authorities to improve the co-ordination of their emergency responses among public health officials, police, fire and ambulance services, hospitals and other services. This fund should be over and above a similar sized investment to ensure that Health Canada’s Centre for Emergency Preparedness can function even only at a minimal level of effectiveness. The announcement of October 18 by the Minister of Health that $11.59 million would be spent to enhance our response to a potential attack is an important step toward reassuring Canadians that help will be there when they need it. However, far more must be done to further expand the federal government’s ability to assist municipalities, provinces and territories in dealing with disasters. The vital role played by disease surveillance cannot be stressed enough. In the event of an unusual or particularly feared illness, or an outbreak of a preventable disease, the public’s attention can quickly focus on the public health unit’s response. The medical officer of health communicates with physicians (specialists and, general and family practices physicians) in the community. Physicians, especially general and family practice physicians, depend upon their medical officers of health and the health units as an important resource. This includes information on contact tracing, interpretation of unusual clinical symptomatology, vaccination, communicable disease control, outbreak control, environmental health, cluster investigation, epidemiology, travel medicine etc. An effective and efficient surveillance system must be in place in order to provide this data quickly to stop the spread of a disease as fast as possible. Unfortunately, a weak link in the existing surveillance system is communications. This has had an impact on health professionals’ ability to receive timely information regarding changes in disease incidence in their community. Regional, provincial/territorial and federal authorities must work to improve the coordination of communications at all levels to protect the health and wellbeing of Canadians in times of crisis. The CMA recommends that: 2. The federal government continue to invest, at a minimum, $25 million in the coming year in the resources and infrastructure (i.e., medical supplies, equipment, laboratory facilities, and training for health care professionals), needed to anticipate and respond to disasters. The sale of Connaught Laboratories meant that Canada lost much its residual capacity to manufacture vaccines. If this were a “normal” war, Canadians would be looking to divert our manufacturing capacity toward meeting the threat. Given the biological threat, the Government of Canada should be negotiating with the pharmaceutical industry to increase our capacity to produce a secure supply of vaccine on Canadian soil. This would include the need for more than one supplier and the capacity to increase quickly the production of the vaccine. The CMA recommends that: 3. That the federal government undertake an immediate review of Canada’s self-sufficiency in terms of critical medical supplies (e.g., vaccines) required in the event of disasters with a view to short term self sufficiency. Surge Capacity Among the first points of contact with the health system for Canadians in the event of a significant attack on our population it will be the doctors offices and the emergency rooms of our hospitals. As noted earlier, we have witnessed in recent years the enormous strain these facilities can be placed under when even something quite routine like influenza strikes a community hard. The media abounded with stories of patients waiting hours to be examined, of stretchers lining corridors and of ambulances being redirected from hospital to hospital. Canadians themselves experienced first-hand how the resources of the hospitals, particularly the human resources, were stretched to the breaking point. The acute care occupancy rates of Ontario public hospitals across the Ontario Hospital Association regions in 1999-00 illustrate this point. In three of the five regions (Eastern Ontario, Central and South West) the occupancy rate ranged from 94% to 97% 18. The highest rate was found in the very heavily populated Central region. A British Medical Journal study suggests that an occupancy rate over 90% indicates that the hospital system is in a regular bed crisis 19. This problem is not unique to Ontario: “the decrease in the number of acute care beds across Canada over the past decade, coupled with an aging population and our extraordinary success in extending the survival of patients with significant chronic illness, has eliminated any cushion in bed occupancy in the hospital system.” 20 With this in mind, picture a catastrophe similar in scale to the destruction seen in New York or Washington D.C. occurring in downtown Toronto, Vancouver or Montréal; or perhaps the release of smallpox or botulism over Fredericton or Winnipeg. As noted earlier, the public health system and medical diagnostic and treatment systems in the community and hospitals could become overwhelmed very quickly without the ability to absorb the extra caseload. Like our hydro system, that is why surge capacity must be built into the system nationally to enable hospitals to open beds, purchase more supplies, and bring in the health care professionals it requires to meet the need. An element of surge capacity that is seriously lacking is the federal government’s contribution to emergency bed space. With the closure of most of the Canadian Force’s hospitals and the severe loss of experienced health professionals in the military, the government’s ability to assist local and provincial/territorial civilian authorities should their systems become overwhelmed is limited. Currently the National Emergency Stockpile System can supply up to 40,000 cots, as well as medical supplies and relatively rudimentary hospital equipment. Reports indicate, however, that much of the equipment is decades old, and that protocols for logistical management (e.g., transport and rapid deployment) are outdated. There is an urgent need to reassess and reaffirm capacity in this context. The CMA is in close contact with the American Medical Association as they advise their government on coordinating the use of civilian and federal facilities in an emergency. Most hospitals work on a just-in-time inventory basis for the purchase of drugs. Without some sort of plan to quickly re-supply their pharmacies and expand their capacity, patient care will suffer. The federal government must assure Canadians that municipal and provincial plans are in place with an overarching national plan to support these jurisdictions if their service capacities are overwhelmed. As mentioned earlier, the announcement by the federal government of the $11.59 million investment to enhance our response to a potential attack is a good step. But the government must help further by making available an emergency fund that would enable hospitals to plan and organize their surge capacity. The CMA recommends: 4. The federal government provide, in the coming year, $25 million in specific earmarked funding to the provinces and territories to enable health care facilities to plan, build and maintain surge capacity (e.g., open more beds, purchase emergency supplies) into their systems. The purpose of having such elaborate response plans and stockpiles of supplies and equipment is to be ready for the possibility that, in spite of all efforts to prevent a catastrophe from occurring, it nevertheless happens. That is when responsibility for dealing with the aftermath of the event falls largely to the public health system where a strong and viable infrastructure must already be in place to meet the challenge. Without the resources and the preparations, the crisis might well deteriorate and spread beyond “ground-zero.” That notion is often very difficult for non-health sector agencies and organizations to appreciate and can be an impediment to improving our capacity to help Canadians in times of disaster. No one can be completely prepared but you can prepare for certain scenarios. That is where the federal government can facilitate the health system’s readiness and reassure Canadians that help will be there when they need it. The federal government has taken several steps to reassure Canadians that their physical safety is enhanced. This includes the introduction of the Anti-Terrorism Act and the development of an Anti-Terrorism Plan. As well, there is increased funding to the Canadian Security and Intelligence Service and the Communications Security Establishment to help those agencies do their jobs more effectively. The health system must be considered an integral component of any plan to combat terrorism. It too requires assistance, especially the public health infrastructure, in strengthening its ability to counter the effects of an attack, whomever or whatever is responsible. III. THE CAPACITY OF OUR HEALTH HUMAN WORKFORCE Although the right mix of physical infrastructure and sustainable, long-term funding is necessary, in and of itself, it is not sufficient to ensure that all Canadians have timely access to quality medical services. We must also have an adequate supply of physicians and other health personnel or the system will not have the flexibility or adaptability to respond to basic societal needs or a crisis in times of disaster. We believe that the health workforce in general is facing a major sustainability challenge, and as such, this section of the brief proposes initiatives that are not solely focused on physicians but the entire health human workforce. Reports produced by several health professional organizations show that although overall numbers may be increasing, it is not sufficient to meet future demands. In 2000, there was a moderate 1.7% increase in the nurse population 21; however, a 1997 Canadian Nurses Association report projected that the supply of nurses must grow by 2.1% per year to meet future demand. 22 Similarly, the number of physicians per 100,000 population appears to be increasing slightly each year (187 in 2000), but it remains below the 1993 level of 191 per 100,000 population. The physician to population ratio can be misleading in that it does not necessarily represent full time physicians. CMA figures show that a larger proportion of physicians fall into the older age groups and may not be working full time or indeed may not be providing patient care at all. Also, one needs to factor in the demographics of the current physician workforce. Female physicians, who tend to work fewer hours per week than their male colleagues, now represent 30% of the practising pool. This means that more physicians will be needed to provide the same number of services. But this may not be possible, as approximately two-thirds of all family physicians are no longer routinely accepting new patients. 23 This is placing considerable pressure on those currently working within the health care system with little hope for relief. For example, data gathered through the CMA’s annual Physician Resource Questionnaire (PRQ) substantiates anecdotal evidence that physicians are working harder. Over half the respondents to the 2001 PRQ (53.7%) indicated that their workload had increased over the past year. Looking at specific areas that have caused physicians the greatest degree of stress, 63.7% indicated that their workload is heavier than they would like (up from 62% in 1998), while 58.1% felt that their family and personal life had suffered from choosing medicine as a profession (up from 55% in 1998). There are a number of short-term and longer term initiatives that can be implemented to reverse the shortage in our health care personnel and alleviate the stress they are feeling from trying to keep the system operating as best it can. What follows is a description of the short-term initiative the CMA is proposing for consideration by the Standing Committee. For a detailed description of the longer term initiatives and recommendations, please refer to Appendix A. What Can be Done Today? Given the immediate need for more physicians and other health professionals in Canada and the time lag involved in training, especially for physicians, the CMA proposes that a variation on the strategy adopted by the Canadian Forces (CF) 24 be used to repatriate physicians and other professionals. The CF announced the implementation of a Medical and Dental Direct Entry Officer Recruitment Allowance effective April 1, 1999 to recruit licensed family physicians, general practitioners and dentists. Recruitment incentives involve a lump-sum signing bonus/recruitment allowance of $80,000 per direct entry medical officer and $25,000 per direct entry dental officer after a successful completion of 3 months of basic officer training. The commitment is for a duration of 4 years and retention incentives involve an adjustment to medical and dental rates of pay that are competitive with private sector net earnings. The CMA concurs with the concept of an incentive program as proposed by the CF and suggests that a similar approach be implemented for recruiting and retaining Canadian physicians and other health care professionals currently practising outside of Canada. Presently there are some 10,500 Canadian physicians practicing in the US as well as tens of thousands of Canadian nurses. Of these physicians, close to 1,000 are considered active physicians both in Canada and the US. 25 Some of these physicians are no doubt practising in border towns where dual licensure is common, but many may be expatriates who have maintained their licensure in Canada hopefully with plans to either return or at least leave their future options open. Rather than proposing a lump sum approach as an incentive the CMA proposes that the incentive come through graduated federal income tax relief by reducing federal income tax payable by 50% for 3 years for Canadian physicians and health care professionals who return to practice in Canada. Such an approach provides direct relief and over a period of 3 years would provide incentives similar in size to those proposed by the CF in their recruitment and retention program. It is estimated that such a program would cost approximately $45 million over 3 years to repatriate an estimated 5% or 500 physicians back to Canada. If repatriation of other health care providers were included then it is estimated that the total cost of such an initiative could increase to $85 million over 3 years. The CMA therefore recommends: 5. That the federal government seriously consider implementing a 3-year graduated tax relief and re-allocation policy to encourage expatriate physicians and other health professionals to return to Canada. IV. TAX POLICY IN SUPPORT OF HEALTH POLICY The federal government has played a key role in the development of our health care system, primarily through a variety of measures or policy levers such as: spending; taxation; regulation; and information. Up until now, Canada’s health care system has made extensive use of only two federal policy levers, namely spending, in the form of cost-sharing arrangements between the federal and provincial/territorial governments; and by regulation, through the Canada Health Act. However, the degree to which the government can continue to rely on these levers must be examined. In the not-too-distant future, our health care system will face a number of pressures that will challenge its sustainability. Namely, an aging and more demanding population in terms of the specialty care services and technology they will seek; the cry for expanding the scope of medicare coverage to include homecare and pharmacare; and a shortage of health personnel. Several national health care studies, namely the Prime Minister’s Forum on Health and more recently, the Senate Standing Committee on Social Affairs, Science and Technology’s Study of the Health Care System have raised the need to look at alternative health care funding sources. We can not and should not wait any longer to explore and act upon the options available to us. Looking at Alternatives One of the lesser-explored options has been the strategic use of Canada’s taxation system. A public discussion of tax policy has not been seen in Canada since at least 1966. 26 Nor have we seen a major assessment of tax policy in relation to social policy since the 1980’s Macdonald Commission. In fact, the last major overall tax policy review was that of Benson in 1971. There is an urgent need to more fully consider the role that the tax system can play in supporting the health care system. Several proposals have been put forward over time in this areas, such as earmarked taxes for health; health-related excise taxes; input tax credits for health care services; medical savings accounts; saving for long-term care; social insurance; and refundable tax credits. This list is not exhaustive. In fact, the CMA has done some preliminary work in this area by commissioning a discussion paper on taxation and health policy. 27 In the paper, the author puts forth 10 “real world” proposals where the tax system can be used to support health policy. The CMA has initiated detailed discussion with Health Canada, Statistics Canada and others to model some of the possible scenarios. Of course, some of these are more promising than others. It is for this reason that the CMA is recommending the federal government to establish a National Task Force to review the tax system with the purpose of developing innovative tax-based mechanisms that better synchronize tax policy with health policy. In this area, the CMA recommends: 6. That the Federal Government establish a blue ribbon National Task Force to study the development of innovative tax-based mechanisms to better synchronize tax policy and health policy. First and foremost this Task Force would study: a) increasing the reach of the medical expense deduction (i.e., increasing the threshold from the current 3% of taxable expenditures) b) extending the medical expense deduction from a non-refundable tax credit to a refundable tax credit so that those not having income tax payable are afforded easier access to those services not covered under universal health “programs” c) dealing with the untoward inequities arising out of the application of the GST. The CMA envisions the mandate of the Task Force as being – to conduct a thorough policy and costing analysis of all potential tax-based mechanisms (not limited to those outlined in the above recommendations) that can be developed to assist in the financing and management of the health care system. The Task Force would be comprised of representatives from government, the health care system, private sector, and the public and it would issue its findings and recommendations within 2 years of its conception. V. SUMMARY OF RECOMMENDATIONS In closing, the CMA has offered a powerful and strategic combination of policy initiatives designed to re-vitalize Canada’s health care system as well as to restore Canadians’ confidence that they will be taken care of in times of disaster. The proposals are realistic and practical. They give the provinces and territories full flexibility in terms of policy implementation while ensuring full recognition to the federal government for its essential investments. These proposals emphasize the need for the federal government to continue its leadership to ensure that our health care system, Canada’s most cherished social program, is available to meet the health care needs of all Canadians. No one group can address all of the issues and challenges facing the health care system. The CMA reiterates its commitment to work with the federal government and others to ensure that our health care system will be there for all Canadians in the future and in times of crisis. The Summary of Recommendations is as follows: 1. The federal government immediately provide a minimum of $15 million for an assistance fund to municipal and provincial authorities to improve the co-ordination of their emergency responses among public health officials, police, fire and ambulance services, hospitals and other services. 2. The federal government continue to invest, at a minimum, $25 million in the coming year in the resources and infrastructure (i.e., medical supplies, equipment, laboratory facilities, and training for health care professionals), needed to anticipate and respond to disasters. 3. That the federal government undertake an immediate review of Canada’s self-sufficiency in terms of critical medical supplies (e.g., vaccines) required in the event of disasters with a view to short term self sufficiency. 4. The federal government provide, in the coming year, $25 million in specific earmarked funding to the provinces and territories to enable health care facilities to plan, build and maintain surge capacity (e.g., open more beds, purchase emergency supplies) into their systems. 5. That the federal government seriously consider implementing a 3-year graduated tax relief and re-allocation policy to encourage expatriate physicians and other health professionals to return to Canada. 6. That the Federal Government establish a blue ribbon National Task Force to study the development of innovative tax-based mechanisms to better synchronize tax policy and health policy. First and foremost this Task Force would study: a) increasing the reach of the medical expense deduction (i.e., increasing the threshold from the current 3% of taxable expenditures) b) extending the medical expense deduction from a non-refundable tax credit to a refundable tax credit so that those not having income tax payable are afforded easier access to those services not covered under universal health “programs” c) dealing with the untoward inequities arising out of the application of the GST. APPENDIX A The Capacity of Our Health Human Workforce Looking to the Future There are some signs that governments have begun to acknowledge that we are in a sustained shortage situation. In November 1999, several health ministers met with members of the Canadian Medical Forum Task Force on Physician Supply in Canada which recommended 2000 first year medical school places for 2000. Since then, governments have been very active in committing to increases in both undergraduate and postgraduate medical training. Enrolment of new medical students in 2000/2001 reached 1763 for an increase of 12% since 1997/98. This closely matches the promised increases to undergraduate enrolment made by governments. Approximately 140 more positions have been promised for the school years beginning 2001 and 2002. In this area, the CMA recommends that: 7. That the federal government immediately establish a Health Human Resources Education and Training Fund in the amount of $500 million per year for 5 years to fund: (1) increased enrolment in undergraduate and postgraduate education; and (2) the expanded infrastructure (both human and physical resources) required at Canada’s 16 health science centres as a result of increased enrolment. While the outlook for the future supply of physicians in Canada seems brighter, it will be quite a few years before we can benefit from the current increases in undergraduate enrolment. These initiatives must not only continue, but be enhanced to ensure that our health care system is sustainable into the future. However, there is one factor that may keep us from attaining the optimal level of medical school enrolment – high and rising medical school tuition fees. In August 2000, at the Conference of Premiers, Prime Minister Chretien said, “It is indeed important in the new knowledge-based economy that Canadians … have access to high quality post-secondary education without excessive debt loads, and that every child get the best possible start in life. This is all part of the Canadian competitive advantage.” 28 This sounds well and good, but the facts tell us otherwise. Since 1980, medical school tuition costs have increased by almost 880%, or more than twice as fast as the general cost of living. 29 The average tuition for students entering first year medical school in September 2001 was $12,840, a 158% increase over the 1997 average fee of $4,977. This means that over the course of four years, an undergraduate medical student is likely to spend approximately $110,000 in tuition, academic and living expenses. 30 Many students have had to resort to bank loans to cover the shortfall from their government-sponsored student loan, but the growing amount of debt accumulating for medical students is starting to worry the banks. The CIBC says that rising medical education costs have resulted in debt loads growing much faster than medical students’ potential income and so, it will no longer grant medical students preferred lending rates. The CIBC sets limits on the amount of debt that they feel students can repay in the years following their training. Unfortunately, medical students are now reaching these limits – which are in the $100,000 - $130,000 range. 31 Unlike the government-sponsored loans, interest on bank loans begin accruing immediately, up to a decade before a medical student starts earning a full income. This trend raises serious concerns that access to medical education will be restricted solely on the basis of personal financial resources. High debt loads will discourage capable and qualified students – particularly those from modest financial backgrounds – from applying to medical school. Canada’s health care system needs individuals from different socio-economic, cultural, rural and urban backgrounds to serve an equally diverse population of patients. First and foremost, the government must address the situation concerning the high and rising tuition fees and the insufficient financial support systems available to medical students. It must also consider purchasing additional training positions in Canada’s medical schools specifically targeted for groups, such as Aboriginal, Indian and Inuit populations. These measures will foster the education and training of a diverse population of health care givers, and will support the culturally and socially sensitive health care needs of all Canadians. The CMA sees a strong role for the federal government in ensuring that medicine remains a rewarding and affordable career accessible to students based on their passion and academic performance, not their financial status. The CMA therefore recommends: 8. That, in order to alleviate some of the pressures driving tuition fee increases, the federal government increase transfer payments to the provinces/territories with targeted amounts for post-secondary education. 9. That the federal government create and fund a national health services student bursary program to encourage students who have limited financial resources to apply for an education in health care services. 10. That the federal government develop financial support systems for health services students that are: (a) non-coercive; (b) developed concomitantly or in advance of any tuition increase; (c) in direct proportion to any tuition fee increase; and (d) provided at levels that meet the needs of the students. 11. That the federal government purchase additional training slots in Canadian medical schools for particular segments of our population, such as aboriginals. REFERENCES 1 Canadian Ipsos Reid Express. Terrorist Effect. October 23-25, 2001. 2 GPC International. Canadians split on the best response to the terrorist attacks and fear reprisals at home. Media Release October 18, 2001. www.gpcinternational.com/media/releases/20011018.html 3 Canadian Ipsos Reid Express. The Public Agenda Post September 11, 2001. October 1, 2001 4 Osterholm M. Emerging infections – another warning. NEJM 2000; 342(17) http://www.nejm.org/content/2000/0342/0017/1280.asp. 5 World Health Organization. Plague Manual – Epidemiology, Distribution, Surveillance and Control. The Organization: 1999. http://www.who.int/emc-documents/plague/docs/whocdscsredc992a.pdf 6 Sanchez A. et al. Reemergence of Ebola virus in Africa. Emerging Infectious Diseases Vol. 1(3); July-September 1995. http://www.cdc.gov/ncidod/eid/vol1no3/sanchez.htm. 7 Revkin A. Mosquito virus exposes the hole in the safety net. New York Times Oct. 4, 1999. http://www.nytimes.com/library/national/regional/100499ny-pest.html 8Okie S. Tuberculosis is threatening to make a comeback. International Herald Tribune Aug. 11, 1999. http://www.iht.com/IHT/TODAY/WED/IN/tb.2.htm 9 Health Canada. When anti-tuberculosis drugs don’t work. Tuberculosis Epi Update January 2000. http://www.hc-sc.gc.ca/hpb/lcdc/bah/epi/tbdrug_e.html. 10 BBC News Online. Africa confronts malaria. Apr. 25, 2000. http://www.bbc.co.uk/hi/english/world/africa/newsid_724000/724445.stm 11World Health Organization. World Health Organization Report on Infectious Diseases – Removing Obstacles to Healthy Development. Geneva: The Organization, 1999. http://www.who.int/infectious-disease-report/pages/textonly.html 12 Ibid. 13 BBC News Online. South Africa AIDS crisis worsens. Apr. 19, 2000. http://www.bbc.co.uk/hi/english/health/newsid_719000/719183.stm 14 Richwine L. US declares AIDS a threat to security. National Post May 1, 2000 A1. 15 Ontario Medical Association. Ontario Medical Association Input to Walkerton Inquiry Part II: Protecting the Public’s Health. Toronto. April 2001 16 Koplan JP. Building Infrastructure to Protect the Public’s Health. Public Health Training Network Broadcast September 21, 2001 (Downloaded from Web: October 19, 2001 www.phppo.cdc.gov/documents/KoplanASTHO.pdf ) 17 Dept. of National Defence. Canadian Forces Disaster Assistance Relief Team. BG-99-051 (Amended) October 10, 2001. (Downloaded from Web: October 25, 2001 [www.dnd.ca/eng/archive/2001/oct01/28DART_b_e.htm] 18 Ontario Hospital Reporting System, 2001. Acute Care Occupancy Rates, Ontario Public Hospitals by OHA region, 1999/00. Ontario Ministry of Health and Long Term Care. 19 Bagust A, Place M, Posnett J. Dynamics of bed use in accommodating emergency admissions: stochastic simulation model. BMJ; 319: 155-158 July 17, 1999. 20 Nicolle L. Viruses without borders. Can J Infect Dis Vol. 11, Issue 3, May/June 2000 (Downloaded from Web: October 23, 2001: www.pulsus.com/Infdis/11_03/nico_ed.htm) 21 CIHI. Canadian Institute for Health Information Reports Moderate Rise in Register Nurses Workforce, Fewer RNs Working on Casual Basis, More Working Full-time, Media Release, May 23, 2001. 22 Canadian Medical Association. Specialty Care In Canada: Issue Identification and Policy Challenges, October 2001. 23 Canadian NewsWire. Not enough family-physicians to meet patient needs, October 25, 2001 [www.cnw.ca/releases/October2001/25/c0304.html] 24 Incentive Programs for the Recruitment and Retention of Medical and Dental Officers, http://www.dnd.ca/eng/archive/1999/jul99/05DocIncen_b_e.htm 25 Based on a linkage done by Canadian Institute for Health Information of data from Southam Medical Data Base and the America Medical Association’s Masterfile. 26 Carter K. Royal Commission on Taxation, Canada, 1966. 27 Thompson A. Taxation and Health Policy: A Discussion Paper, August 2001. 28 Letter from Prime Minister Jean Chretien to the Honorable Gary Doer, Premier of Manitoba, Chair, Conference of Premiers, August 4, 2000. 29 Ontario Medical Association. Medical Education Fact Sheet, 2001. 30 Admissions/Student and Equity Affairs, Faculty of Medicine, University of Western Ontario. Budgeting Guide for Medical Students: 1999-2000. 31 Banks no longer banking on earning potential of medical students, Canadian Medical Association Journal, June 12, 2001; 164(12) 1735
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Rural and remote health in Canada : Presentation to the Standing Senate Committee on Social Affairs, Science and Technology

https://policybase.cma.ca/en/permalink/policy2017
Last Reviewed
2019-03-03
Date
2001-05-31
Topics
Health human resources
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2019-03-03
Date
2001-05-31
Topics
Health human resources
Text
As Secretary General and Chief Executive Officer of the Canadian Medical Association (CMA), I am here today representing our members, more than 50,000 physicians from across Canada. The Association has a two-fold mission, namely to provide leadership for physicians and to promote the highest standards of health and health care for Canadians. The CMA wants to expand significantly on part of its May 16th presentation to this Committee on health human resources. The issue of rural and remote health is of concern to the CMA and we commend the Committee for tackling this complex and very important aspect of Canada's health care system. Our presentation will focus primarily on physician workforce issues in rural and remote practice locations. Most would agree that the health care infrastructure and level of professional support in rural and remote areas of Canada are insufficient to provide appropriate care, and contribute significantly to the difficulty in recruiting and retaining qualified physicians in sufficient numbers (relative to community needs). I will address the following elements: 1. the distribution of physicians practising in rural and remote Canada; 2. their practice profile; 3. what rural physicians are telling us; 4. the CMA Policy on Rural and Remote Practice Issues; and 5. the role for the Federal Government in ensuring reasonable access to health care in these parts of the country. 1. Distribution of physicians practising in rural and remote Canada As you know, Statistics Canada informs us that approximately 25% of Canadians live in rural areas. This number varies from 15% in British Columbia and Ontario to 45% in Atlantic Canada and as high as 60% in the territories. The distribution of physicians is somewhat different. The following data are derived from the CMA physician resources database: * Approximately 10% of Canadian physicians practise outside census metropolitan areas or census agglomerations. This roughly translates to communities of 10,000 or less and for research purposes we consider this cohort to be rural physicians. * There are about 5,700 rural physicians, 87% of which are family physicians. The male/female split is similar to the overall physician pool in Canada but, among those under 35 years of age, half are female. This reflects the current breakdown of the postgraduate output and implies that females are just as likely to seek out rural practice as males. * While Quebec and Ontario are home to almost half of all rural physicians in Canada, Newfoundland has the highest proportion of rural doctors (31%) followed by New Brunswick at 23% and Nova Scotia at 21%. The territories are considered separately since one could argue that even those physicians living in northern cities would be considered to be practising in a remote area. * The majority of rural physicians are graduates of Canadian medical schools (72%) but it varies greatly by region. In Newfoundland, one in three rural physicians is a Canadian graduate; in Saskatchewan, it is only one in five. In contrast, 95% of Quebec rural physicians were trained in this country. 2. Practice profile The CMA routinely surveys the Canadian physician population. Response rates for the surveys mentioned in this brief are shown in Table 1. The following data from CMA's 2000 Physician Resource Questionnaire will be of interest to the Committee: * rural physicians are more likely to be in group practice than urban physicians (68% vs. 58%); * 78% of rural physicians take call (compared to 75% of urban physicians); * excluding their on-call time commitments, rural physicians report spending the same number of hours on direct patient care as urban physicians; * however, rural physicians are on-call for more hours in a month than their urban colleagues; not only do they see more patients while on-call but they also spend more hours providing services; * rural physicians are more likely to be compensated for being on-call, whether it is for carrying a phone or pager (37% are compensated vs 10% of urban physicians) or being available on-site (60% are compensated vs 31% of urban physicians); * while more than half of rural physicians are paid primarily on a fee-for-service basis, proportionately fewer physicians are remunerated this way (53%) compared with 63% of urban physicians. Rural physicians are more likely than their city colleagues to be paid with a salary or some type of blended arrangement. When asked how they would prefer to be paid, 40% selected blended compared to 30% of urban doctors. Less than a third (31%) preferred fee-for-service. Please see Table 2 for an overview of these results. 3. What rural physicians are telling us In the last ten years, in addition to CMA's annual general physician resource questionnaire, two surveys (in 1991 and 1999) were specifically designed to address issues pertaining to physicians practising in rural and remote areas of Canada. I would like to highlight some results from both these surveys. 1991 Survey * Over half of the survey respondents selected desire for rural practice as a very important factor in the decision to locate in a rural area (Figure 1). Only 11% reported financial incentives as being very important. * The physicians who moved from a rural to an urban area were asked about the importance of selected professional considerations (Figure 2). Hours of work was by far the most frequently cited as very important (39%), followed by the need for professional backup (28%) and access to specialty services (24%). * The physicians who moved from a rural to an urban area were asked about the importance of selected personal considerations (Figure 3). Children's educational opportunities was the most frequently cited (by 36%) as very important among the personal considerations, followed by career opportunities for their spouse. * The physicians who moved from a rural to an urban area indicated that there were a number of professional factors that might have influenced them to stay (Figure 4). These factors include additional colleagues (56%), locum tenens (48%), opportunity for group practice (41%) and specialist services (36%). 1999 Survey * In a tracking question from the survey conducted eight years previously, the 1999 survey found that, while rural physicians' level of personal satisfaction with their choice to practise and live in rural communities has remained constant, their level of professional satisfaction - i.e., how they are able to meet the health care needs of their patients - fell significantly since the early 1990s. In a striking example, only 17% reported being very satisfied with the availability of hospital services in 1999 compared to 40% in 1991. * Rural physicians identified the following five factors as being most important in defining their practice community as rural: (1) a high level of on-call duty; (2) the long distance to a community health centre or hospital; (3) lack of services from medical specialists; (4) an insufficient number of family physicians or general practitioners; and (5) the long distance to a teaching hospital (tertiary health care centre). CMA's findings were supported by the 1999 report from Barer and colleagues 1 that identified the following barriers to recruiting and retaining physicians in underserviced communities in Canada: (1) lack of adequate training for the unique circumstances associated with practising medicine in rural environments; (2) remuneration issues; (3) onerous on-call duties and, more generally, heavy workload leading to burnout; (4) professional isolation; (5) lack of spousal employment opportunities; (6) children's education and extracurricular opportunities; (7) climate, recreational and cultural opportunities; and (8) distance from family and friends. CMA 2001 Physician Resource Questionnaire To illustrate some of these findings and highlight some of the positive events, the following quotes are taken from CMA's most recent survey of physicians (the response rate is unavailable for this survey which is still in the field): I know one of the biggest problems my rural colleagues suffer from is lack of locums and difficulty replacing doctors in the community leading to heavier patient loads and responsibilities. This has particularly become worse since medical students have had to choose earlier about specialties with less options to return later. Somehow students and residents should be exposed to more rural medicine. Rural surgical specialists have onerous responsibilities placed upon them with little backup, expectations for 24/7 call coverage ad no financial compensation or recognition for their unwavering devotion to their communities and their profession. My colleagues and I are a dying breed and do not expect that we will be replaced. There is little incentive to practise in a rural environment yet the need continues to grow. Although Fort Frances is rural/remote, we have managed to recruit and retain excellent physicians. We service a catchment area of 22,000 and have 10 MD's on the call rotation. We are an example of how you can live rural/remote, practise interesting medicine and have great quality of life. Most people would think we are over-doctored here but it is the only way we can sustain a healthy lifestyle. Nonetheless the lifestyle of on-call, long irregular hours, and a physician spouse has been hard on the family and relationship. I dream of having regular hours and never having to answer the phone in the middle of the night. 4. CMA Policy on Rural and Remote Practice Issues In October of last year, the CMA released its Policy on Rural and Remote Practice Issues. A copy of this policy is appended to this presentation. The policy contains 28 specific recommendations in the three key areas of training requirements for physicians practising (or wanting to practise) in rural and remote Canada, compensation, and work and lifestyle support issues. The policy illustrates the breadth of issues that need to be addressed before we can hope to alleviate the shortage of the rural physician workforce. The CMA believes that strategies developed to recruit and retain physicians to rural and remote Canada must be comprehensive, flexible and varied to meet and respond to local needs and interests; they must also include, from the outset, community and physician input. The CMA also believes that, as a general rule, these strategies should not be coercive in nature, for example mandatory return-in-service contracts with new medical students. However, this is not to say that strong, positive incentive programs would not work. The Nova Scotia Department of Health, for example, developed a successful incentive program for physicians (including a guaranteed minimum income, a signing bonus and moving expenses, among others) and, importantly, hired a full-time recruiter to implement it. Under this program, 52 physicians were recruited in 1999, 50 in 2000 and 15 so far in 2001; none of these physicians were actively recruited from other Atlantic Canada provinces. There are also examples from the international scene. In Australia, the National Rural Health Strategy involved funding a rural incentives program and the creation of the Australian Rural Health Research Institute (a consortium of five universities with rural campuses). The Australian Journal of Rural Health was also funded through this strategy. The incentive program included relocation grants, grants for continuing medical education and funding for temporary replacements (locums). While this strategy has been well received, there are still many problems of reasonable access to primary care in many parts of rural Australia. In the United States, a financial incentive program, with its roots in the HMO act of 1973, uses an index of medical underservice to determine which areas receive the most funding. The CMA developed an index of rurality in 1999 which could be used in a similar fashion should the federal government decide to become involved in a similar program. 5. Role for the Federal Government The CMA and others have identified a number of issues that need to be addressed to increase physician recruitment and retention in rural and remote Canada. While our presentation appropriately focuses on the physician workforce issue, this situation applies to other health care professions as well. On this note, the CMA has recently embarked on a study, in collaboration with the Society of Rural Physicians of Canada and the Canadian Nurses Association, that will examine the rural workforce of a number of health care professions. We understand that, constitutionally, it is the role and responsibility of the provincial and territorial governments to oversee the provision of health care within their respective jurisdictions. Nonetheless, the CMA has identified five major leadership opportunities for the Federal Government in ensuring that Canadians who live in rural and remote areas have access to appropriate health care. These opportunities are in delivery, evaluation, immigration, planning and funding. Allow me to expand on each of these: i) Delivery: the Federal Government already has a health care delivery role in rural and remote Canada through the Indian and Northern Health Services Directorate of Health Canada. It would be important and valuable to identify lessons learned from this role and share this knowledge with all jurisdictions and players (for example, how physicians can best work with out-post nurses). ii) Evaluation: the CMA applauds the creation of the federal Office of Rural Health within Health Canada. We encourage the Federal Government to expand the role of this office so it can carry out an ongoing evaluation and roll-up of rural health and workforce status; this would become a reliable source of information for researchers, planners and decision-makers. iii) Immigration: in order to meet the short-term health care needs of Canadians, the CMA encourages the Federal Government, through Bill C-11, to develop an immigration policy that is friendly towards qualified international medical graduates. At the same time, any such policy must recognize the need for Canada to strive for reasonable self-sufficiency in the production of physicians. iv) Planning: we need a national planning approach for the short, medium and long term. Again, the CMA encourages the Federal Government to expand the role of its Office of Rural Health, with adequate support and funding, to carry out a comprehensive workforce needs assessment in rural and remote Canada. This information is critical to a successful planning process. v) Funding: finally, there is a role for the Federal Government in funding a mechanism whereby physicians and other health care professionals who want to prepare for practice in rural and remote Canada can obtain the appropriate training and experience. This is one of the main identified barriers to recruitment and retention in rural and remote areas. There is a precedent for the Federal Government in providing one time only funding to create capacity: this was in the 1966 Health Resources Fund Act, whereby the Federal Government funded the creation of new medical schools and the expansion of existing ones. The Federal Government could do the same thing now for the rural and remote workforce capacity. As you know, the Government of Ontario has recently announced the creation of its Northern Ontario Rural Medical School. This begs the question about the rest of the country and opens the door to the Federal Government to work with the Association of Canadian Medical Colleges, the CMA and other relevant medical education organizations to address this issue on a national scale. I want to thank the Committee for inviting us to appear today and we trust that we will have further opportunities to appear before this Committee and work with you during the course of this study. [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] Table 1 - Response Rates of CMA Surveys to Rural Physicians Year Response rate Sample size of respondents Accuracy level (19 times out of 20) 1991 CMA survey Rural cohort Rural to urban cohort 55% 49% n = 1320 n = 196 +/- 2.7% +/- 7.0% 1999 CMA Rural survey 31% n = 1658 +/- 2.5% 2000 CMA Physician Resource Questionnaire 40% (rural respondents) n = 253 rural respondents +/- 6.2% [TABLE END] [TABLE CONTENT DOES NOT DISPLAY PROPERLY. SEE PDF FOR PROPER DISPLAY] Table 2 - Results of the CMA 2000 Physician Resource Questionnaire Rural Urban Take call 78.3% 75.4% Hours of shared call per month 175 hrs/month 139 hrs/month Patients attended while on call 73 per month 41 per month Hours spent providing service while on call 56 hrs/month 34 hrs/month Group Practice 68.4% 58.2% Remuneration 90%+ professional income from fee-for-service Preference for fee-for-service mode Preference for blended mode 52.6% 30.8% 40.3% 63.0% 38.1% 29.7% [TABLE END] 1 Barer M. et al. Toward Improved Access to Medical Services for Relatively Underserved Populations: Canadian Approaches, Foreign Lessons. Centre for Health Services and Policy Research, University of British Columbia, May 1999.
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Management of physician fatigue

https://policybase.cma.ca/en/permalink/policy11127
Last Reviewed
2019-03-03
Date
2014-05-24
Topics
Health human resources
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2014-05-24
Topics
Health human resources
Text
Health systems around the world are struggling with how to best meet the health needs of their populations. Health leaders speak with urgency about the need to improve the individual experience of care, improve the health of populations, and maximize return on investments. Physicians concur - they are continually focused on providing better care to their patients. Concurrently, concerns over patient safety have arisen over the last two decades, rooted in studies of adverse events. The incidence of adverse events (AEs) in acute care hospitals has been reported in the United States (US),1,2,3 Australia,4 United Kingdom,5 and Canada.6 Between 5% and 20% of patients admitted to hospital experience one or more AEs; between 36.9% - 51% of these AEs are preventable; and AEs contribute billions of dollars through additional hospital stays as well as other costs to the system, patients and the broader society.7 Leape et al. maintain that more than two-thirds of AEs are preventable.8 These outcomes have prompted decision makers, policy makers and healthcare providers to examine contributing factors, including the increasingly complex health system and its impact on the well-being of providers. Patient safety and physician well-being are the key drivers leading to restrictions on resident and/or physician duty hours aimed at reducing their fatigue. The European Working Time Directive (EWTD) was first established in 1993 to place limits on all workers' hours throughout Europe under the umbrella of health and safety legislation. That directive included physicians but excluded doctors in training. In 2000, a new directive passed to include the "junior doctor" constituency accompanied by a requirement that by 2009 all health systems in the European Union limit resident work to a maximum of 48 hours averaged per week. The intention was to improve the working lives of doctors in training and to increase patient safety. A systematic review on the impact of the EWTD on postgraduate medical training, patient safety, or clinical outcomes found studies to be of poor quality with conflicting results.9 In 2003, the Accreditation Council for Graduate Medical Education (ACGME) in the US adopted a set of duty hour regulations for physicians in training. The ACGME issued revised regulations that went into effect in July 2011, reflecting the recommendations of a 2008 Institute of Medicine report Resident Duty Hours: Enhancing Sleep, Supervision, and Safety, calling for elimination of extended duty shifts (more than 16 hours) for first year residents, increasing days off, improving sleep hygiene by reducing night duty and providing more scheduled sleep breaks, and increasing oversight by more senior physicians.10 The Institute of Medicine's report bases its recommendations on the growing body of research linking clinician fatigue and error. In 2013, the National Steering Committee on Resident Duty Hours released Canada's first comprehensive, collaborative and evidence-based report on fatigue and duty hours for Canada's approximately 12,000 residents. The Committee stresses that a comprehensive approach is necessary in order to enhance safety and wellness outcomes. Fatigue risk management is a predominant theme in the recommendations. Fatigue management systems are in place in other sectors/industries that have a low threshold for adverse outcomes including aviation, transportation, and the Department of National Defence. In 2010, the Canadian Nurses Association released a position statement Taking Action on Nurse Fatigue that speaks to system, organizational and individual level responsibilities of registered nurses. There are currently no specific policies in Canada for physicians in practice with respect to fatigue management. Given the heterogeneity of medical practice (i.e. various specialties) and of the practice settings (i.e. rural and remote versus urban, clinic versus hospital, etc.), the solutions emanating from a fatigue management policy may be different - one size will not fit all. Impact of Physician Fatigue Patient Safety Sleep deprivation is the condition of not having enough sleep and can be either chronic or acute. It impairs cognitive and behavioural performance. "Sleep is required for the consolidation of learning and for the optimal performance of cognitive tasks. Studies of sleep deprivation have shown that one night without sleep negatively affects the performance of specific higher cognitive functions of the prefrontal cortex and can cause impairment in attention, memory, judgment, and problem solving."(p. 1841)11 A seminal study by Williamson and Feyer found that after 17-19 hours without sleep, performance on some cognitive and motor performance tests was equivalent or worse than that at a blood alcohol concentration (BAC) of 0.05%.12 Wakefulness for 24 hours is equivalent to a blood alcohol level of 0.10%.13 A chronic sleep-restricted state can cause fatigue, which is a subjective feeling of tiredness, lack of energy and motivation. A large body of research exists linking sleep deprivation/fatigue, performance and adverse patient outcomes, particularly for medical residents. 14,15,16,17,18,19, 20, 21,22, 23,24 However, literature on the impact on performance varies based on a number of factors. There are significant inter-individual differences in the global response to sleep loss, as well as significant intra-individual variations in the degree to which different domains of neurobehavioral function (e.g., vigilance, subjective sleepiness, and cognitive performance) are affected. Inter-individual differences are not merely a consequence of variations in sleep history. Rather, they involve trait-like differential vulnerability to impairment from sleep loss. 25 Evidence suggests an inconclusive relationship between duty hour reductions (primarily those implemented in the US) and patient safety, suggesting that restrictions on consecutive duty hours have not had the anticipated impact on this crucial outcome as anticipated.26 Several large studies have revealed only neutral or slightly improved patient mortality and other clinical parameters since implementation of the ACGME work hour limits in the US.27,28, 29,30 In complex and ever changing health systems, it is difficult to isolate the impact of restricted duty hours alone. Research on the effects of practicing physician sleep deprivation and extended work shifts on clinical outcomes is limited and inconclusive.31, 32 The issue of physician fatigue is complex, and is affected by much more than duty hours. Other contributing factors affect performance including work patterns, individual response to sleep loss, experience of the worker, the context of which sleep deprivation is necessary, hours of actual sleep, patient volume, patient turnover and patient acuity, environmental factors, personal stressors, workload, etc. Limiting work hours alone is not sufficient to address sleep deprivation among physicians. Reduced or disturbed periods of sleep, more consecutive days or nights of work, shift variability, and the volume of work all increase fatigue and thus can contribute to errors. One of the biggest concerns with a fatigue management strategy is continuity of care, linked to the number of transfers of care (handover) among providers. Transfers of care inevitably increase in an environment of work hour limitations.33, 34 Handovers are considered critical moments in the continuity of patient care and have been identified as a significant source of hospital errors, often related to poor communication. There is a growing body of literature on how to do these well and how to teach this well. This is an important skill for physicians in the context of a fatigue management strategy: "Standardization of the handover process has been linked to a reduction in the number of errors related to information transfers. In addition, effective mechanisms for the transfer of information at transition points have been recognized as patient safety enablers."35 Provider Well-being Provider well-being (physical, mental, occupational) is linked to system performance and patient outcomes. It is affected by fatigue and work patterns including night shift and extended hours. Comprehensive, systematic reviews of the health effects of on-call work in 2004 showed that nighttime work interrupted sleep patterns, aggravated underlying medical conditions, and increased the risk of cardiovascular, gastrointestinal, and reproductive dysfunction.36,37.38 Other research suggests an elevated risk of breast cancer,39,40 prostate cancer,41 colorectal cancer,42 asthma43, diabetes,44 and epilepsy45 for shift workers. Disruption of the body's circadian rhythms is thought to be one of the main pathways for adverse health effects from shift work, particularly for work schedules that involve night work. Given that 24-hour work is unavoidable in various industries, including healthcare, researchers have evaluated different shift schedules designed to reduce some of the negative health effects of working at night. Optimal shift schedules are aligned as much as possible with the circadian rhythm, promote adaptation of the circadian rhythm with shift work, reflect workers' needs and preferences, and meet organizational or productivity requirements. The following interventions appear to have the most beneficial effects on the health of shift workers:46 * Schedule changes including changing from backward (counterclockwise) to forward (clockwise) rotation, from eight hour to 12 hour shifts, and flexible working conditions, self-scheduling, and ergonomic shift scheduling principles * Controlled exposure to light and day; * Behavioural approaches such as physical activity, scheduled naps and education about sleep strategies; and * Use of pharmacotherapy (i.e. caffeine and melatonin) to promote sleep, wakefulness, or adaptation Sleep deprivation and on-call shifts consistently point to deterioration of mood resulting in depression, anger, anxiety, hostility, and decreased vigilance.47 ,48, 49 A Canadian study found that shift workers reported significantly higher burnout, emotional exhaustion, job stress and psychosomatic health problems (e.g. headaches, upset stomach, difficulty falling asleep) than workers on a regular day schedule.50 Prolonged duty hours by residents has been found to contribute to marital problems, pregnancy complications, depression, suicide and substance abuse,51 as well as serious conflicts with attending physicians, other residents, and nurses, in addition to increased alcohol use and instances of unethical behaviour.52 Surprisingly however, the abolishment of 24-hour continuous medical call duty for general surgery residents at one facility in Quebec was associated with self-reported poorer quality of life.53 In contrast to other recommendations on the health benefits of 8 hr shifts, the risk of a work safety incident increases markedly after more than eight hours on duty. The risk in the twelfth hour is almost double than in the eighth hour (and more than double the average risk over the first eight hours on duty).54 Extended work duration and nighttime work by interns is associated with an increased risk of reported percutaneous injuries (PIs).55 Fatigue was reported more often as a contributing factor for nighttime compared with daytime injuries. Fatigue was also more commonly reported as a contributing factor to PIs that occurred after extended work than those that occurred after non-extended work.56 Other research found that residents were most exposed to blood-borne pathogens through needle punctures or cuts during overnight duty periods.57 Health care facilities that have physicians working in them have a role in supporting and promoting provider well-being, including providing enablers of extending and continuing resiliency such as nutritious food, on call rooms, appropriate numbers of staff, locums, etc. They also have a role in working jointly and collaboratively with physicians to ensure that on-call schedules do not place work demands on individual physicians that prevent the physicians from providing safe patient care and service coverage. For example, research with emergency physicians suggests that a nap at 3 AM improves performance in physicians and nurses at 7:30 AM compared to a no-nap condition despite the fact that memory temporarily worsened immediately after the nap.58 Individual resilience, intergenerational differences, illness-related issues, as well as family commitments also need to be considered. Physicians should also be encouraged to take the necessary time to rest and recover on their time off. The obligation of physicians to provide after hour coverage and care is unavoidable and should be considered by an individual when they choose a career in medicine, and as a physician in managing their schedule/call. A review of 100 studies from around the world indicates the culture of medicine contributes to doctors ignoring the warning signs of fatigue and stress and in many cases suffering from undiagnosed ailments such as stress and depression, or from burnout.59 The authors suggest the culture of medicine is such that doctors feel they don't need help; they put their patients first. Of the 18% of Canadian doctors who were identified as depressed, only a quarter of them considered getting help and only two per cent actually did. The report suggests that burnout from working long hours and sleep deprivation because of understaffing seems to be the biggest problem worldwide.60 The Canadian Medical Protective Association (CMPA) states that physicians should consider their level of fatigue and if they are clinically fit to provide treatment or care.61 Fatigue is not a sign of weakness. All members of the health care team should support their colleagues in recognizing and managing sleep deprivation and fatigue. Physician fatigue has several ethical dimensions. The Canadian Medical Association Code of Ethics states that physicians have an ethical responsibility to self-manage their fatigue and well-being. 62 However, physicians must be trained and competent to know their own limits and evaluate their own fatigue level and well-being. The system must then support physicians in this recognition. The doctrine of informed consent is another dimension of physician fatigue. If physician fatigue is an added risk for any aspect of patient care, whether it is surgical or medical, elective or emergent, then some have argued that the doctrine of informed consent suggests that physicians have an obligation to inform patients of that risk.63 ,64 "The medico-legal considerations for physicians centre on the ethical duty to act in the best interests of their patients. This may mean that if a physician feels that his or her on-call schedule endangers or negatively impacts patient care, reasonable steps are taken to ensure patients do not suffer as a result and that the physician is able to continue providing an adequate level of care for patients."65 System Performance Addressing physician fatigue may have workforce implications. Physician workload is multifaceted comprised of clinical, research, education and administrative activities. If physician workload or duty hours are reduced, any one of these activities may be impacted. It has been suggested that implementing fatigue management strategies such as a workload ceiling for physicians may result in a greater need for physicians and thus increase system costs. However, new models of team based care delivery that incorporate technology, reduce redundancy, utilize a team based approach, and optimize the role of physicians offer an opportunity to better manage physician fatigue without necessarily requiring more physicians. Other strategies also need to be explored to improve the on-the-ground efficiency of physicians. Some of the strategies to address practicing physician sleep deprivation/fatigue such as scheduling changes and reduced workload may affect access to care, including wait times. Surgeons or others may have to cancel surgeries or other procedures because of fatigue and hours of work, forcing rescheduling of surgery/procedures and potentially increasing wait times. This is particularly relevant given Canada's large geography and varied distribution of physicians. Therefore, flexibility in strategies to address physician sleep deprivation/fatigue are needed to reflect the variety of practice types and settings in existence across the country, in particular solo practices; rural, remote and isolated sites; community locations; etc. The same holds true for smaller specialties, which has been the experience in the UK with the implementation of the EWTD. Fatigue management is a competency that needs to be taught, modelled, mentored, and evaluated across the medical education continuum, from medical student to practicing physician. Recommendations 1. Educate physicians about the effects of sleep deprivation and fatigue on the practice of medicine and physician health, and how to recognize and manage their effects. 2. Create a national tool-box of self-awareness tools and fatigue management strategies and techniques. 3. Advocate for the integration of fatigue management into the continuum of medical education. 4. Advocate for the creation of system enablers with the flexibility to: * Consider the full workload of physicians (clinical, teaching, administrative, research, etc.); * Optimize scheduling to coordinate on call and other patient care following call; and * Implement organizational/institutional level fatigue risk management plans. 5. Develop and advocate for implementation of standardized handover tools. 6. Enhance and reaffirm a culture within medicine that focuses on patient-centered care. 7. Reaffirm the culture shift within medicine that encompasses physician well-being. 8. Encourage physicians treating physicians to be aware of the aggravating effects of fatigue on their well-being and practice. Conclusion Physicians are interested in how to best meet the needs of the population, in continually improving the care provided to Canadians. To do so requires that they also care for themselves including managing the effects of sleep deprivation and fatigue. It is a complex issue that requires multifaceted solutions. Strategies must address physician fatigue at an individual, organizational/institutional and system level. References 1 Leape, LL, Brennan, TA, Laaird, N, Lawthers, AG, Logalio, AR, Barnes, BA et al. (1991).The nature of adverse events in hospitalized patients. New England Journal of Medicine 324 (6): 377-384 2 Brennan, TA, Leape, LL, Nan, M, et al. (1991). Incidence of adverse events and negligence in hospitalized patients: Results of the Harvard Medical Practice Study I. New England Journal of Medicine 324:370-376. 3 Thomas, E., Studdert, D., Burstin, H., et al. (2000). Incidence and types of adverse events and negligent care in Utah and Colorado. Medical Care 38(3): 261-71. 4 Wilson, RL, Runciman, WB, Gibberd, RW, et al. (1995). The Quality in Australian Health Care Study. Medical Journal of Australia 163: 458-471. 5 Vincent, C, Neale, G, & Woloshynowych, M. (2001). Adverse events in British hospitals: preliminary retrospective record review. British Medical Journal 322: 517-9. 6 Baker, G., Norton, P., Flintoft, V., Balis, R., Brown, A., Cox, J., et al. (2004). The Canadian adverse event study: the incidence of adverse events among hospitalized patients in Canada. Canadian Medical Association Journal, 170(11): 1678-1686. 7 Jeffs, L., Law, M., Baker, G., & Norton, P. (2005). Patient Safety Research in Australia, United Kingdom, United States and Canada: A Summary of Research Priority Areas, Agenda-Setting Processes And Directions for Future Research in the Context of their Patient Safety Initiatives. Retrieved from http://www.patientsafetyinstitute.ca/English/news/eventProceedings/Documents/2005%20Research%20Retreat%20-%20Patient%20Safety%20Research%20Backgrounder%20Paper.pdf 8 Leape, L., Brennan, T., Laaird, N., Lawthers, A., Logalio, A., Barnes, B. et al. (1991). The nature of adverse events in hospitalized patients. New England Journal of Medicine 324 (6): 377-384. 9 Moonesinghe, S., Lowery, J., Shahi, N., Millen, A., & Beard, L. (2011). Impact of reduction in working hours for doctors in training on postgraduate medical education and patients' outcomes: systematic review. BMJ 342:d1580. 10 Ulmer, C., Wolman, D., & Johns, M. (eds.) Committee on Optimizing Graduate Medical Trainee (Resident) Hours and Work Schedule to Improve Patient Safety, Institute of Medicine. (2008). Resident Duty Hours: Enhancing Sleep, Supervision, and Safety. Washington, DC: The National Academies Press. 11 Krueger, K. & Halperin, E. (2010). Perspective: Paying Physicians to Be On Call: A Challenge for Academic Medicine. Academic Medicine 85 (12); 1840-1844. 12 Williamson, A. & Feyer, A. (2000). Moderate Sleep Deprivation Produces Impairments in Cognitive and Motor Performance Equivalent to Legally Prescribed Levels of Alcohol Intoxication. Occupational and Environmental Medicine 57: 649-655. 13 Dawson, D. & Reid, K. (1997). Fatigue, Alcohol and Performance Impairment. Nature 388: 235. 14 Arnedt, J., Owens, J., Crouch, M., et al. (2005). Neurobehavioral Performance of Residents After Heavy Night Call vs After Alcohol Ingestion. Journal of American Medical Association 294(9): 1025-33. 15 Howard, S., Gaba, D., Smoth, B., et al. (2003). Simulation Study of Rested Versus Sleep-deprived Anesthesiologists. Anesthesiology 98:1345-1355 16 Philbert, I. (2005). Sleep Loss and Performance in Residents and Nonphysicians: A Meta-analytic Examination. Sleep 28: 1392-1402. 17 Lockley, S., Barger, L., Ayas, N., Rothschild, J., Czeisler, C. et al. (2007). Effects of Health Care Provider Work Hours and Sleep Deprivation on Safety and Performance. The Joint Commission Journal on Quality and Patient Safety 3(11): 7-18. 18 Eastridge, B., Hamilton, E., O'Keefe, G., Rege, R., Valentine, R. et al. (2003). Effect of sleep deprivation on the performance of simulated laproscopic surgical skill. The American Journal of Surgery 186: 169-174 19 Taffinder, N., McManus, I., Hul, Y., Russell, R., & Darzi, A. (1998). Effect of Sleep Deprivation on Surgeon's Dexterity on Laparsoscopy Simulator. The Lancet 352: 1191. 20 Rothschild, J., Keohane, C., Rogers, S., et al. (2009). Risks of Complications by Attending Physicians After Performing Nighttime Procedures. JAMA 302:1565-72. 21 Lockley, S., Cronin, J., Evans, E., Cade, B., Lee, C., et al. (2004). Effect of Reducing Interns' Weekly Work Hours on Sleep and Attentional Failures. N Engl J Med 351: 1829-1837. 22 Landrigan, C., Rothschild, J., Cronin, J., Kaushal, R., Burdick, E., et al. (2004). Effect of Rreducing Interns' Work Hours on Serious Medical Errors in Intensive-care Units. N Engl J Med 351: 1838-1848. 23 Barger, L., Ayas, N., Cade, B., Cronin, J., Rosner, B., et al. (2006). Impact of Extended-Duration Shifts on Medical Errors, Adverse Events, and Attentional Failures. PLoS Med 3(12): 2440-2448. 24 Landrigan, C., Rothschild, J., Cronin, J., et al. (2004). Effect of Reducing Interns' Work Hours on Serious Medical Errors in Intensive Care Units. New England Journal of Medicine 351:1838-48. 25 Van Dongen, H., Baynard, M., Maislin, G., et al. (2004). Systematic interindividual differences in neurobehavioral impairment from sleep loss: evidence of a trait-like differential vulnerability. Sleep 27: 423-433. 26 Philibert,I., Nasca, T., Brigham, T., & Shapiro, J. (2013). Duty-Hour Limits and Patient Care and Resident Outcomes: Can High-Quality Studies Offer Insight into Complex Relationships? Annu. Rev. Med 64: 467-83. 27 Volpp, K., Rosen, A., Rosenbaum, PR., et al. (2007). Mortality Among Hospitalized Medicare Beneficiaries in the First 2 Years Following the ACGME Resident Duty Hour Reform. JAMA 298: 975-983. 28 Volpp, K., Rosen, A., Rosenbaum, P., et al. (2007). Mortality Among Patients in VA Hospitals in the First 2 Years Following ACGME Resident Duty Hour Reform. JAMA 298(9): 984-992. 29 Antiel, R., Reed, D., Van Arendonk, K., Wightman, S., Hall, D., Porterfield, J., et al. (2013). Effects of Duty Hour Restrictions on Core Competencies, Education, Quality of Life, and Burnout Among General Surgery Interns. JAMA Surg 148(5):448-455. 30 Drolet, B., Sangisetty, S., Tracy, T., & Cioffi, W. (2013). Surgical Residents' Perceptions of 2011 Accreditation Council for Graduate Medical Education Duty Hour Regulations. JAMA Surg 148(5): 427-433. 31 Chang, L., Mahoney, J., Raty, S., Ortiz, J., Apodaca, S., & De La Garza II, R. (2013). Neurocognitive effects following an overnight call shift on faculty anesthesiologists. Acta Anaesthesiol Scand 57: 1051-1057. 32 Sharpe, J., Weinberg, J., Magnotti, L., Nouer, S., Yoo, W., Zarzaur, B. et al. (2013). Outcomes of Operations Performed by Attending Surgeons after Overnight Trauma Shifts. J Am Coll Surg 216:791- 799. 33 Olsen, E., Drage, L., Auger, R. (2009). Sleep Deprivation, Physician Performance, and Patient Safety. Chest 136: 1389-1396. 34 Choma, N., Vasilevskis, E., Sponsler, K., Hathaway, J., & Kripalani, S. Effect of the ACGME 16-Hour Rule on Efficiency and Quality of Care: Duty Hours 2.0. JAMA INTERN MED 173 (9): 819-821. 35 Canadian Medical Protective Association. (2013). CMPA Risk Fact Sheet: Patient Handover. Retrieved January 13, 2014 from https://oplfrpd5.cmpa-acpm.ca/documents/10179/300031190/patient_handovers-e.pdf 36 Nicol, A., Botterill, J., (2004). On-call Work and Health: A Review. Environmental Health 3: 1-11. 37 Knutsson, A. & Boggild, H. (2010). Gastrointestinal disorders among shift workers. Scand J Work Environ Health 36(2): 85-95. 38 Vyas, M., Garg, A., Iansavichus, A., Costella, J., Donner, A., Laugsand, L., et al. (2012). Shift work and vascular events: systematic review and meta-analysis. British Medical Journal 345: e4800 doi: 10.1136/bmj.e4800 39 Shields, M. (2002). Shift work and health. Health Reports 13(4):11-33. 40 Fritschi, L., Glass, D., Heyworth, J., Aronson, K., Girschik, J., Boyle, T., et al. (2011). Hypotheses for mechanisms linking shiftwork and cancer. Medical Hypotheses 77:430-436. 41 Kubo, T., Ozasa, K., Mikami, K., Wakai, K., Fujino, Y., Watanabe, Y., et al. (2006). Prospective cohort study of the risk of prostate cancer among rotating-shift workers: findings from the Japan Collaborative Cohort Study. American Journal of Epidemiology 164(6): 549-555. 42 Schernhammer, E., Laden, F., Speizer, F., Willett, W., Hunter, D., Kawachi, I., et al. (2003). Night-shift work and risk of colorectal cancer in the Nurses' Health Study. Journal of the National Cancer Institute 95(11):825-828. 43 Shields, M. (2002). Shift work and health. Health Reports 13(4):11-33. 44 Ibid 45 Ibid 46 Occupational Cancer Research Centre and the Institute for Work & Health. Can the health effects of shift work be mitigated? A summary of select interventions. Retrieved March 10, 2013 from http://www.occupationalcancer.ca/wp-content/uploads/2012/09/Summary_intervention-research_FINAL.pdf 47 Eastridge, B., Hamilton, E., O'Keefe, G., Rege, R., Valentine, R. et al. (2003). Effect of Sleep Deprivation on the Performance of Simulated Laproscopic Surgical Skill. The American Journal of Surgery 186: 169-174. 48 Krueger, K. & Halperin, E. (2010). Perspective: Paying Physicians to Be On Call: A Challenge for Academic Medicine. Academic Medicine 85(12); 1840-1844. 49 Haines, V., Marchand, A., Rousseau, V., & Demers, A. (2008).The mediating role of work-to-family conflict in the relationship between shiftwork and depression. Work & Stress 22(4):341-356. 50 Jamal, M. (2004). Burnout, stress and health of employees on non-standard work schedules: a study of Canadian workers. Stress and Health 20:113-119. 51 Woodrow, S., Segouin, C., Armbruster, J., Hamstra, S., & Hodges, B. (2006). Duty Hours Reforms in the United States, France and Canada: Is It Time to Refocus our Attention on Education? Academic Medicine 81(12): 1045-1051. 52 Baldwin, D., Daugherty, S., Tsai, R., et al. (2003). A National Survey of Residents' Self-reported Work Hours: Thinking Beyond Specialty. Academic Medicine 78:1154-1163. 53 Hamadani, F., Deckelbaum, D., Sauve, D., Khwaja, K., Razek, T., & Fata, P. (2013). Abolishment of24-HourContinuousMedical Call Duty in Quebec: A Quality of Life Survey of General Surgical Residents Following Implementation of the New Work-Hour Restrictions. J Surg 70: 296-303. 54 Folkard, S. & Tucker, P. (2003). Shift work, safety and productivity. Occupational Medicine 53: 95-101. 55 Ayas, N., Barger, L., Cade, B., et al. (2006). Extended Work Duration and the Risk of Self-reported Percutaneous Injuries in Interns. JAMA 296(9): 1055-62. 56 Ayas, N., Barger, L., Cade, B., et al. (2006). Extended Work Duration and the Risk of Self-reported Percutaneous Injuries in Interns. JAMA 296(9): 1055-62. 57 Parks, D., Yetman, R., McNeese, M., Burau, K., & Smolensky, M. (2000). Day-night pattern in accidental exposures to blood-borne pathogens among medical students and residents. Chronobiology International 17(1): 61-70. 58 Smith-Coggins, R., Howard, S., Mac D., Wang, C., Kwan, S., Rosekind, M., Sowb, Y., Balise, R., Levis, J., Gaba, D. (2006). Improving alertness and performance in emergency department physicians and nurses: the use of planned naps. Ann Emerg Med, 48(5): 596-604. 59 Wallace, J., Lemaire, J., & Ghali, W. (2009). Physician wellness: a missing quality indicator. The Lancet 374 (9702): 1714-1721. 60 Wallace, J., Lemaire, J., & Ghali, W. (2009). Physician wellness: a missing quality indicator. The Lancet 374 (9702): 1714-1721. 61 Canadian Medical Protective Association. The new realities of medical care. Originally published September 2012. Retrieved January 12, 2014 from https://oplfrpd5.cmpa-acpm.ca/en/duties-and-responsibilities/-/asset_publisher/bFaUiyQG069N/content/the-new-realities-of-medical-care 62 Canadian Medical Association. (2011). Canadian Medical Association Code of Ethics. Ottawa: Author. 63 Mercurio. M. & Peterec, S. (2009). Attending Physician Work Hours: Ethical Considerations and the Last Doctor Standing. Pediatrics 124:758-762. 64 Czeisler, C., Pellegrini, C., & Sade, R. (2013). Should Sleep-Deprived Surgeons Be Prohibited From Operating Without Patients' Consent? Ann Thorac Surg 95:757-766. 65 Canadian Medical Protective Association. The new realities of medical care. Originally published September 2012. Retrieved January 12, 2014 from https://oplfrpd5.cmpa-acpm.ca/en/duties-and-responsibilities/-/asset_publisher/bFaUiyQG069N/content/the-new-realities-of-medical-care
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Drug testing in the workplace (Update 2001)

https://policybase.cma.ca/en/permalink/policy194
Last Reviewed
2018-03-03
Date
2001-05-28
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2018-03-03
Date
2001-05-28
Replaces
Drug testing in the workplace (1992)
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law). The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public. Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general. Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another. Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents. Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit). Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice. Testing: Any discussion of drug testing must take the following into account: If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed. The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing. The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work. If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen. The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law). Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons: Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society. The mass, low-cost screening tests may not be reliable or valid. The circumstances may not justify possible human rights violations. Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing. CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job. Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job. These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
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Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act)

https://policybase.cma.ca/en/permalink/policy11297
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1 Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety. Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite. The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3 In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.* CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult. Public health approach to addiction Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components. Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program). Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5 Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Harm reduction is part of health practice Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms. Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs. The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9 Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10 Supervised Consumption Sites are evidence-based Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment. Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12 Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services. Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15 Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been: * A reduction in the overall rate of needle sharing in the area;19 * A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21 * Increased access to addiction counseling and increased enrolment in detox programs;22 23 * Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24 * Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and * No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26 * Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28 Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence. Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety. Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation. The CMA has the following concerns with Bill C-2: 1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation." 2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation. 3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances". 4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need. It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services. * "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services. 1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4 2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23 5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967 6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf 8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf 9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf 10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm 14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services 15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics 16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf 17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404. 19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18. 20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351. 21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7. 22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919. 23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence. 24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36. 25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34. 26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76. 28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36. 29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. 30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction. 31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374. 32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136 33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) 34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
Documents
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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.
Documents
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Delivery of quality palliative end-of-life care throughout Canada

https://policybase.cma.ca/en/permalink/policy11219
Date
2014-08-20
Topics
Health human resources
Resolution
GC14-23
The Canadian Medical Association will engage in physician human resource planning to develop an appropriate strategy to ensure the delivery of quality palliative end-of-life care throughout Canada.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health human resources
Resolution
GC14-23
The Canadian Medical Association will engage in physician human resource planning to develop an appropriate strategy to ensure the delivery of quality palliative end-of-life care throughout Canada.
Text
The Canadian Medical Association will engage in physician human resource planning to develop an appropriate strategy to ensure the delivery of quality palliative end-of-life care throughout Canada.
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Integration of sex/gender diversity education into medical school curricula and programs

https://policybase.cma.ca/en/permalink/policy11228
Date
2014-08-20
Topics
Health human resources
Ethics and medical professionalism
Resolution
GC14-48
The Canadian Medical Association calls for the integration of sex/gender diversity education into medical school curricula and programs.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health human resources
Ethics and medical professionalism
Resolution
GC14-48
The Canadian Medical Association calls for the integration of sex/gender diversity education into medical school curricula and programs.
Text
The Canadian Medical Association calls for the integration of sex/gender diversity education into medical school curricula and programs.
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National and provincial/territorial legislation to address drug-impaired driving

https://policybase.cma.ca/en/permalink/policy11247
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-75
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-75
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
Text
The Canadian Medical Association calls for the review of national and provincial/territorial legislation to address drug-impaired driving.
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Opioid overdose prevention tools and services

https://policybase.cma.ca/en/permalink/policy11248
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-55
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
Text
The Canadian Medical Association supports community-based programs that offer access to opioid overdose prevention tools and services.
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Importing medications

https://policybase.cma.ca/en/permalink/policy11255
Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-56
The Canadian Medical Association recommends that the federal government amend its laws and regulations so that in urgent cases medication can be more readily imported into Canada when shortages occur.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-56
The Canadian Medical Association recommends that the federal government amend its laws and regulations so that in urgent cases medication can be more readily imported into Canada when shortages occur.
Text
The Canadian Medical Association recommends that the federal government amend its laws and regulations so that in urgent cases medication can be more readily imported into Canada when shortages occur.
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Comprehensive regulatory standard authorizing the use of marijuana for medical purposes

https://policybase.cma.ca/en/permalink/policy11256
Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-57
The Canadian Medical Association urges that a comprehensive regulatory standard authorizing the use of marijuana for medical purposes be adopted by all Canadian medical licensing bodies.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC14-57
The Canadian Medical Association urges that a comprehensive regulatory standard authorizing the use of marijuana for medical purposes be adopted by all Canadian medical licensing bodies.
Text
The Canadian Medical Association urges that a comprehensive regulatory standard authorizing the use of marijuana for medical purposes be adopted by all Canadian medical licensing bodies.
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Physician resource trends among specialties that focus on seniors’ care

https://policybase.cma.ca/en/permalink/policy11270
Date
2014-08-20
Topics
Health human resources
Resolution
GC14-73
The Canadian Medical Association will examine physician resource trends among specialties that focus on seniors’ care.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health human resources
Resolution
GC14-73
The Canadian Medical Association will examine physician resource trends among specialties that focus on seniors’ care.
Text
The Canadian Medical Association will examine physician resource trends among specialties that focus on seniors’ care.
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Educational material for students who are considering attending medical school outside Canada

https://policybase.cma.ca/en/permalink/policy11278
Date
2014-08-20
Topics
Health human resources
Physician practice/ compensation/ forms
Resolution
GC14-81
The Canadian Medical Association supports development of educational material for students who are considering attending medical school outside Canada.
Policy Type
Policy resolution
Date
2014-08-20
Topics
Health human resources
Physician practice/ compensation/ forms
Resolution
GC14-81
The Canadian Medical Association supports development of educational material for students who are considering attending medical school outside Canada.
Text
The Canadian Medical Association supports development of educational material for students who are considering attending medical school outside Canada.
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Proposed amendments to the marihuana for medical purposes regulations

https://policybase.cma.ca/en/permalink/policy11293
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-07-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the proposed regulatory amendments to the Narcotic Control Regulations and the Marihuana for Medical Purposes Regulations of the Controlled Drugs and Substances Act, published in the Canada Gazette Part I, on June 14, 2014. The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix A). While recognizing the needs of those suffering from terminal illness or chronic disease, and for whom marijuana may provide relief, the CMA has raised significant concerns and objections to the regulatory framework since it was first proposed in 2001. Put simply, the CMA has significant and grave concerns with the regulatory framework governing medical marijuana. Of particular concern to physicians is the scarcity of evidence- based information about the use of marijuana as medical therapy, including on dosage, risks and benefits, and contraindications. While several amendments to the regulatory framework have been promulgated since its initial establishment, the CMA's primary concerns have yet to be addressed. In brief, as the CMA's position on the regulatory framework is detailed in Appendix A, the CMA opposes the approach placing physicians in the role of gatekeepers for a product whose medical benefits have not been sufficiently researched. The CMA continues to recommend that marijuana for medical purposes be held to the same standards as prescription pharmaceutics, including the clinical trial process required for therapeutic products under the Food and Drugs Act and be subject to the same safety and efficacy standards as pharmaceuticals if used for medical purposes. There remain fundamental concerns about quality, safety and efficacy of marijuana used for medical purposes, and the Canadian Medical Protective Association has advised physicians who are uncomfortable with the regulations to refrain from authorizing marijuana to their patients due to potential liability. The CMA advocates for education and licensing programs, clinical guidance and practice supports for health care practitioners who decide to authorize the use of marijuana for patients. The CMA recommends that Health Canada further revise the proposed amendments to the Marihuana for Medical Purposes Regulations to: 1) Enable consistent and best practice oversight In the CMA's submission to Health Canada as part of its review of the Controlled Drugs and Substances Act, as well as in parliamentary briefs on the prescription pharmaceutical regulatory framework, the CMA has recommended high regulatory standards for prescription medication; and even more stringent requirements for controlled substances, both during the approval and the post-approval phases. These recommendations are driven by the potential for harm to patients and the possibility for misuse or abuse of medications, particularly opioids and other such substances. For these reasons, the CMA advocates for an inter-operable, pan-Canadian system of real-time prescription monitoring and surveillance for controlled substances. Robust monitoring and surveillance programs facilitate professional regulatory bodies' oversight and intervention, by enabling the identification of prescribing outliers which include fraudulent attempts to access controlled medications. Prescription monitoring programs also gather information to improve the understanding of prescription drug abuse and to support the development and adoption of best practices. In order to be streamlined and optimized, such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases, and accessible as a point-of-care tool for health care practitioners. Currently, marijuana for medical purposes is exempt from the regulatory requirements of the Food and Drugs Regulations that apply to prescription pharmaceuticals in Canada. Under the Marihuana for Medical Purposes Regulations there is no system in place to monitor the authorization of marijuana for medical purposes. It is in this context that CMA supports the underlying principle of the proposed amendment to the Marihuana for Medical Purposes Regulations which requires licensed producers to provide information to the provincial professional licensing authorities for health practitioners regarding authorizations for marijuana for medical purposes in response to a request by the licensing authority. However, aligned with the CMA's support of a pan-Canadian prescription monitoring system, the CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. Finally, the CMA recommends that Health Canada support the integration marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 2) Safeguard protection of privacy As articulated in the CMA's Code of Ethics, physicians consider protecting the privacy of patient information to be paramount, and as such, the CMA has developed policy guidance concerning patient as well as physician information. The CMA's Principles for the Protection of Patients' Personal Health Information (see Appendix B) emphasizes that privacy, confidentiality and trust are cornerstones of the patient-physician relationship. Recognizing that health information is highly sensitive, this policy statement articulates foundational privacy principles that must be adhered to with respect to patient information. In addition to the provision of patient information, authorizations include physician information. The CMA's Principles Concerning Physician Information (see Appendix C) specify 11 conditions that must be met including with respect to the collection, use, access, storage and disclosure of physician information. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. The CMA is concerned with the fact that licensed producers, not Health Canada, are the custodians of patient and licensed health practitioner information, in that they collect, use, have access to or disclose this information. For example, security safeguards, written privacy policies and designated accountable privacy officers, must be in place to protect personal health information and licensed practitioner identification in order to ensure that only authorized collection, use and disclosure or access occurs. The text of the proposed amendment addresses "secure transmission" of data, but it must also address secure storage. Safeguards must ensure that there is the same rigour as required for pharmacies as custodians of sensitive private information. The proposed period of record retention of two years should be reviewed in consultation with the professional licensing bodies, to ensure it is sufficient or if it should be extended. In recognition of the importance of health information privacy, including privacy of patient and physician information, the CMA strongly reiterates its recommendation that Health Canada undertake a privacy impact assessment of the proposed amendment. It is of the utmost importance that the proposed amendments to the Marihuana for Medical Purposes Regulations must conform to privacy laws, and protect patient confidentiality while enabling oversight by licensing authorities. The CMA recommends Health Canada to engage stakeholders as part of its consultation process as part of this privacy assessment. 3) Clarify and enforce consumer advertising requirements Regarding direct-to-consumer advertising, while marijuana for medical purposes is exempt from the Food and Drug Regulations, it is subject to requirements specified in the Narcotic Control Regulations and the Food and Drug Act. The CMA is concerned that licensed producers are circumventing existing direct-to-consumer advertising legislative and regulatory standards. Marijuana for medical purposes is subject to the following sections of the Food and Drugs Act: 3. (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A. 9. (1) No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety. (2) A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1). Marijuana for medical purposes is subject to the following section of the Narcotic Control Regulations: 70. No person shall (a) publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than one page, on the first page thereof; (b) publish or cause to be published or furnish any advertisement to the general public respecting a narcotic; or (c) advertise in a pharmacy a preparation referred to in section 36. While the legislative and regulatory requirements appear consistent with the requirements governing the advertising of prescription and non-prescription medication, it appears that licensed producers are in gross contravention of these standards. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. To this end, the CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards and ensure enforcement of these regulations. The CMA welcomes the consultation and review of the amendments to the Marihuana for Medical Purposes Regulations with the view of promoting quality care to improve patient safety and public health. The CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. Overview of recommendations 1. The CMA recommends that the provision of relevant information to licensing authorities should be part of required regular reporting procedures for the licensed producers, consistent with the prescription monitoring program requirements of the respective provincial and territorial jurisdictions. 2. The CMA recommends that Health Canada support the integration of marijuana for medical purposes within provincial/territorial prescription monitoring programs, including facilitating the availability of a point-of-care access tool for health care practitioners. 3. The CMA recommends that the proposed amendments to the Marihuana for Medical Purposes Regulations be reviewed and revised as necessary to ensure it meets the standards of the CMA's Principles for the Protection of Patients' Personal Health Information and the CMA's Principles Concerning Physician Information. 4. The CMA recommends that Health Canada undertake a privacy impact assessment of the proposed amendments to the Marihuana for Medical Purposes Regulations. 5. The CMA recommends additional effort and action on the part of Health Canada to ensure compliance and enforcement of direct-to-consumer advertising provisions of the Food and Drugs Act and Narcotic Control Regulations. 6. The CMA recommends that Health Canada issue guidance documentation outlining compliance with these standards. List of Appendices: * Appendix A - CMA Policy Statement: Medical Marijuana * Appendix B - CMA Policy Statement: Principles for the Protection of Patient ' s Personal Health Information * Appendix C - CMA Policy Statement: Principles Concerning Physician Information
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Bill C-17 An Act to amend the Food and Drugs Act

https://policybase.cma.ca/en/permalink/policy11196
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act. The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription medication has a very 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. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 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 supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end. 1) Clarify ministerial authority and responsibility The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety. The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3): * Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening. * Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety. Recommendation 1 In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority. Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3. 2) Oversight of natural health products The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting. To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety. Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products. 3) Comprehensive post-market surveillance and response system The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings. A) Increasing accountability and public transparency Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks. Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4 Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear. The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data. Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication. Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks. B) Improving the reporting and communication system The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness. When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting. In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes: * Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care. * Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line. * Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting. * Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis. Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health. In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report. Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it. Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes: * Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records; * Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and * Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public. Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting. Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution". Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective. 1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf 2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada. http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30) 3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21) 4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2) 5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/oag-bvg-eng.php
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The Health risks and harms associated with the use of marijuana

https://policybase.cma.ca/en/permalink/policy11138
Date
2014-05-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study on the health risks and harms associated with the use of marijuana. Marijuana, or cannabis, is a Schedule II drug under the Canadian Controlled Drugs and Substances Act, and growing, possessing, distributing and selling marijuana is illegal, subject to penalties. Despite that, according to the latest Canadian Alcohol and Drug Use Monitoring Survey1, about 10% of Canadians ages 15 years and over had used marijuana at least once in the past year. It is the second most used substance, following alcohol (at 78%). Even though there has been a decrease in marijuana use among youth (ages 15 to 24) in recent years, usage is still double that of the general population, at 20%. A quarter of youth that had used marijuana in the past 3 months, used it daily, however most use is infrequent and experimental. The average age of initiation is 16.1 years, and it is very concerning that continued use is most common among those who initiate use early. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.2 The 2012 Canadian Community Health Survey - Mental Health3 reported that 1.3% of people aged 15 and over met the criteria for cannabis abusea or dependenceb - double that of any other drugs. The lifetime risk of dependence is estimated at about 9%, increasing to almost 17% in those who initiate use in adolescence.4 Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. CMA has longstanding concerns about the health risks associated with smoking marijuana. While our comments have more recently been made in the context of medical marijuana, the core issue is the same: marijuana usage poses serious health risks5. Teenagers are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. It is estimated that marijuana contains more than 400 active chemicals, including over 60 cannabinoids, of which delta-9 tetra-hydrocannabinol (THC) is the most often studied due to its psychoactive properties. The concentration of the various chemicals varies for different plants, batches and growth locations, and has varied over time. There is the potential for contamination by pesticides or other substances. Rates and quantities of components absorbed will also vary depending on whether the drug is smoked, used in food, inhaled with a vaporizer or applied topically. This is challenging for research on the health effects of marijuana. When marijuana is smoked, THC and other components are inhaled and absorbed through the lungs, rapidly entering the bloodstream. Effects are perceptible within seconds and fully apparent in a few minutes. The main feature of its use is that it produces a feeling of euphoria (or 'high') and sensory alterations, but it is also sought out to reduce pain, relieve anxiety, decrease vomiting and increase appetite. Adverse reactions can occur, such as drowsiness, sedation, blurred vision, photophobia, difficulty breathing and vomiting. However, its acute toxicity is extremely low, as no deaths directly due to acute cannabis use have been reported. Toxic dose-related effects that can occur include anxiety, panic, depression, paranoia or psychosis. Acute impairment typically clears 3-4 hours after use. Marijuana slows reaction times, impairs motor coordination and concentration as well as the completion of complex tasks. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Student Alcohol and Drug Use6 report states that 14-21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Chronic use is more common among those that start using as young teens; those that are tobacco smokers and heavy alcohol consumers and have used other illegal drugs. People with a number of pre-existing diseases who are chronic smokers of marijuana are probably at increased risk of exacerbating the symptoms of their diseases. For example, adults with hypertension, ischaemic or cerebrovascular disease could be at increased risk due to the cardiovascular stimulatory effects of marijuana. There is an increased risk of psychosis, depression and anxiety, particularly among those who have a personal or family history. A persistent lack of energy in chronic users has been referred to as an "amotivational syndrome". Although cognitive impairments (loss of memory, focus and the ability to think and make decisions) are likely reversible a few weeks after discontinued use, this seems not to be true for those who began using in early teen years, while the brain is still developing. Smoke from marijuana preparations contains many of the same compounds as tobacco cigarettes including increased levels of tar. Smoking marijuana may be more harmful than tobacco, as it often involves unfiltered smoke and deeper, longer inhalation. Chronic users often have shortness of breath after exercise, coughing and chest tightness. It is probably associated with bronchitis and emphysema and may have risks for chronic lung disease and lung cancer, comparable to cigarette smoking. This is less of a problem for those that use vaporizers, as a harm reduction strategy. The use of marijuana during pregnancy has been shown to affect the development and learning skills of children, more noticeably from the age of three, with these effects lasting into the teen years. Studies have shown an increase in hyperactivity, inattention and impulsivity. These children will be more prone to addiction and mental health issues as well as decreased cognitive functioning, and could require supports when in school. Some studies point to a lower birth weight. Besides health concerns, marijuana use can lead to social and interpersonal problems, including difficulties at school, in relationships and with the law. Awareness of Canadians of the harms of marijuana is generally low. 7 Youth tend to emphasize the drug's ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There were also many myths, such as that it would counter cigarette effects, preventing cancer. Many stated that they did not consider marijuana as a drug because it was "natural" and relatively benign compared to other drugs. It is concerning that some teens said that marijuana actually made people better drivers by increasing their focus. There seems to be skepticism around prevention programs which aim exclusively at abstinence. Feedback has been that effective approaches would involve providing more fact-based information at an earlier age and using programs that aim at reducing the harms of using marijuana. It is essential that youth and users from other age groups be involved in the conceptualization and development of any such programs. CMA makes the following recommendations to the Committee: 1) Public Health Approach to Psychoactive Substance Use The CMA recommends that the federal government adopt a public health approach to increase the focus on preventing drug abuse, on treatment of addiction, on monitoring, surveillance and research and on harm reduction. Addiction should be recognized and treated as a serious, relapsing chronic disease, and substance use is a complex behaviour influenced by many factors. Therefore, a comprehensive multi-factorial strategy is necessary, and lessons can be learned from work that has been done to decrease tobacco and alcohol use and to reduce the harms related to these substances. A public health approach would place an increased focus on preventing drug abuse and dependence; on the availability of assessment, counselling and treatment services for those who wish to stop using; and on harm reduction to increase the safety for those that are using. It would seek to ensure the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. The CMA believes that resources currently devoted to combating simple marijuana possession through the criminal law could be diverted to public health strategies, particularly for youth. A public health approach also includes efforts around the monitoring, surveillance and research of marijuana use to better inform the strategy. This is essential to better understand the short and long term harms as well as policy options to address prevention, treatment, harm reduction and enforcement. 2) Comprehensive Education and Awareness Program to Address Marijuana Use The CMA recommends that the federal government develop, in collaboration with the provinces and territories and key stakeholders, a comprehensive education and awareness program to minimize marijuana use. A comprehensive program to minimize marijuana use should include, but not be limited to: - Education and awareness raising of the known and potential harms of marijuana; - Strategies to prevent early use in adolescence; - Support for programs that decrease stigma associated with mental health and addiction; and - Support for health professionals' awareness and evidence-informed practice in the prevention, management and treatment of drug use. A specific focus on youth is essential, as they are not only more likely than adults to engage in risky drug use, particularly boys, but also disproportionately experience greater harms from that use. It is also particularly important for women of child bearing age, due to the risk to the fetus during pregnancy. Information that is tailored to the needs of specific populations will help people make informed choices. Efforts to prevent, reduce or delay the use of marijuana could result in a reduction of suffering and costs to the health care system. Health professionals must be involved and supported in this area, and it is important to ensure the availability of evidence informed clinical practice guidelines, practice tools and continuing medical education resources. 3) Driving Under the Influence Prevention The CMA recommends that the federal government continue to support, in collaboration with the provinces and territories and key stakeholders, strategies for the prevention of impaired driving. The CMA believes that comprehensive long-term efforts that incorporate both deterrent legislation and public awareness and education constitute the most effective approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers due to marijuana. Efforts to prevent, reduce or delay marijuana use, especially in youth, are particularly important. Education is also important as many are not aware that marijuana affects driving ability or even that there are procedures that the police can use to identify impairment due to psychoactive substances. The CMA supports a similar multidimensional approach such as has been adopted with alcohol and driving. However, the specificities of impairment due to marijuana must be understood and investments made in research. Collaboration with key stakeholders such as schools, drivers' education and licensing bodies, as well as enforcement organizations is essential. In conclusion, the Canadian Medical Association reiterates the concern of Canada's physicians around marijuana use, particularly by young people. We are committed to working with governments and stakeholders to address this issue. a Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. b Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. 1 Health Canada (2013) Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Retrieved from: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php 2 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 3 Statistics Canada (2013) Canadian Community Health Survey - Mental Health. Retrieved from: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm 4 Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf 5 Beirness, D.J., & Porath-Waller, A.J. (2009). Clearing the smoke on cannabis: Cannabis use and driving. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11789-2009.pdf. Diplock, J., & Plecas, D. (2009). Clearing the smoke on cannabis: Respiratory effects of cannabis smoking. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa-11797-2009.pdf. Gordon, A.J., Conley, J.W. & Gordon, J.M. (2013) Medical consequences of marijuana use: a review of the current literature. Curr Psychiatry Rep 15:419. Hall, W. & Degenhardt, L. (2009) Adverse health effects of non-medical cannabis use. The Lancet, 374; October 17. Retrieved from: http://mobile.legaliser.nu/sites/default/files/files/Adverse%20health%20effects%20of%20non-medical%20cannabis%20use.pdf Holmes, E., Vanlaar, W. & Robertson, R. (2014) The problem of youth drugged driving and approaches to prevention: a systematic literature review: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://ccsa.ca/Resource%20Library/CCSA-Youth-Drugged-Driving-technical-report-2014-en.pdf Kalant, H., & Porath-Waller, A.J. (2012). Clearing the smoke on cannabis: Medical use of cannabis and cannabinoids. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2012%20CCSA%20Documents/CCSA-Medical-Use-of-Cannabis-2012-en.pdf. Porath-Waller, A.J. (2013). Clearing the smoke on cannabis: Highlights. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2013%20CCSA%20Documents/CCSA-Clearing-Smoke-on-Cannabis-Highlights-2013-en.pdf. Porath-Waller, A.J. (2009a). Clearing the smoke on cannabis: Chronic use and cognitive functioning and mental health. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0115422009_e.pdf. Porath-Waller, A.J. (2009b). Clearing the smoke on cannabis: Maternal cannabis use during pregnancy. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from http://www.ccsa.ca/2009%20CCSA%20Documents/ccsa0117832009_e.pdf. 6 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf 7 Cunningham, J.A., Blomqvist, J., Koski-Jannes, A., & Raitasalo, K. (2012). Societal Images of Cannabis use: Comparing Three Countries. Harm reduction journal, 9(1), 21-7517-9-21. Retrieved from: http://www.biomedcentral.com/content/pdf/1477-7517-9-21.pdf Porath-Waller, A., Brown, J., Frigon, A., & Clark, H. (2013). What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf Racine, S., Flight, J., & Sawka, E. (Eds.). (2006). Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Canadian Centre on Substance Abuse. Retrieved from: http://publications.gc.ca/site/eng/349980/publication.html
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Canadian Medical Association submission to the Standing Senate Committee on Banking, Trade and Commerce: Higher rate now: Why excise tax on tobacco is long overdue for an increase

https://policybase.cma.ca/en/permalink/policy11129
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation. Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke. Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs. Impact of Price on Smoking Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required. Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii Excise Tax Adjustments The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future. The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy. Unintended Consequences There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. Investing Tobacco Taxes in Health Promotion The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required. A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations. Research For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues. Conclusion The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada. Summary of Recommendations The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis Pearl Bader, David Boisclair, Roberta Ferrence Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118 PMCID: PMC3228562 iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology as part of its study on prescription pharmaceuticals: Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety

https://policybase.cma.ca/en/permalink/policy11125
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences. In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan. In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage. 1) Addressing shortages in the supply of prescription medication Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication. Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all. The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting. The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care. To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) Addressing the misuse and abuse of prescription medication The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. Opioid prescription pharmaceuticals are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. It must be recognized that it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. Such a strategy should include: a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include: * Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose; * Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy. b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response. c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain. d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. This should include the development of national standards for prescription monitoring, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects, including: * Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * Deterring inter-provincial fraud. * Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. 3) Improving post-market surveillance and reporting tools Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes: a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future. 4) Supporting Optimal Prescribing In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA encourages collaborative efforts toward the achievement of this ideal. For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences: * The risk of adverse drug reactions is several-fold higher for older patients than for younger; * Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and, * Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors. It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. This strategy should include, among other elements: a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow. At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways: * Well-crafted online continuing medical education (CME), funded by objective sources. * Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them. * Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records. * Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour. Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use. b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could: * List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud; * Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. * Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and * Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error. The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 5) Addressing gaps in insurance coverage for prescription medication Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost. The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Conclusion As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety. The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada. Summary of Recommendations 1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. 3) The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. 4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports * Analyze the data that has been gathered, in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. 5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. 6) The CMA supports the development and dissemination of prescribing information that is: * based on the best available scientific evidence; * relevant to clinical practice; and, * easy to incorporate into a physician's workflow. 7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing. 8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
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Review of Controlled Drugs and Substances Act: Canadian Medical Association submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations

https://policybase.cma.ca/en/permalink/policy11114
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements." The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety. The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds. Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy. In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy. A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach. It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration. In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach. A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination. Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers. Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested. The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways: i) Improving the approval, labelling and safety monitoring of controlled substances The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require: * More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies); * Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals. * Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse. * Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions. ii) Establishing consistent requirements for prescription monitoring In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse. While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by: * Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled. * Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled. * Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring. * Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues. Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should: * Enable inter-jurisdictional accessibility and operability; * Ensure that practitioners have real-time access to the monitoring system; * Enable electronically-based prescription monitoring; and; * Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2). B) Supporting harm reduction as a component of a drug strategy The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition. Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive. In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites. C) Developing clinical knowledge base about the medical use of marijuana The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. Part 2: Ensuring protection of patient privacy In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework. As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information. The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. Part 3: Enabling e-prescribing As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers. For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D). Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section. Part 4: Establishing a mechanism for changes to scope of practice The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us. Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety. To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change: * Demonstration that it will improve public health and patient safety; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. Part 5: Recognizing the authority of physician regulatory colleges As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes. Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action. In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession. Conclusion The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety. In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail. List of Appendices: * Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada * Appendix B: CMA Policy Statement - Medical Marijuana * Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information * Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association * Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012) Overview of recommendations The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety. The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication. The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring. To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body". The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians. The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework. The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions. The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations. The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change: * Demonstration of public health and patient safety improvement; * Meaningful consultation with professional organizations and regulatory authorities; and, * Support of provincial and territorial ministers of health. The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require: * That new classes of prescribers have conflict of interest policies; * That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and * That a mandatory five-year review be established for new classes of prescribers. The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
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