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CMA Statement on Racism

https://policybase.cma.ca/en/permalink/policy14245

Date
2020-06-02
Topics
Ethics and medical professionalism
Health care and patient safety
  1 document  
Policy Type
Policy document
Date
2020-06-02
Topics
Ethics and medical professionalism
Health care and patient safety
Text
Racism is a structural determinant of health and drives health and social inequities. The recent incidents of anti-Black violence, racism and discrimination in the US and Canada also shed light on the structural inequities and racism that exist within the medical profession and the health system. The profession of medicine is grounded in respect for all people. This commitment recognizes that everyone has equal and inherent worth, the right to be valued and respected, and the right to be treated with dignity. It’s critical that our medical culture – and society more broadly – upholds these values. But today, we’re reminded that there’s much more to do as a profession, and as a global community, to get us there. Earlier this year, we launched our first-ever policy on equity and diversity in medicine Opens in a new window to help break down the many broad and systemic barriers that remain, to reduce discrimination and bias within our profession, and to create physically and psychologically safe environments for ourselves, our colleagues and our patients. Alongside this policy comes a commitment to holding ourselves accountable to recognizing and challenging behaviours, practices and conditions that hinder equity and diversity, including racism. Instances of racism, intolerance, exclusion, violence and discrimination have no place in medicine, and no place in our society. The Canadian Medical Association condemns racism in all its forms. Today, we stand alongside all those who have been affected by these appalling and inexcusable actions and beliefs. Dr. Sandy Buchman President, Canadian Medical Association

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Framework for Ethical Decision Making During the Coronavirus Pandemic

https://policybase.cma.ca/en/permalink/policy14133

Date
2020-04-01
Topics
Ethics and medical professionalism
Health care and patient safety
  1 document  
Policy Type
Policy document
Date
2020-04-01
Topics
Ethics and medical professionalism
Health care and patient safety
Text
The current global pandemic caused by the novel coronavirus has presented the international medical community with unprecedented ethical challenges. The most difficult of these has involved making decisions about access to scarce resources when demand outweighs capacity. In Canada, it is well accepted that everyone should have an equal opportunity to access and receive medical treatment. This is possible when there are sufficient resources. But in contexts of resource scarcity, when there are insufficient resources, difficult decisions have to be made about who receives critical care (e.g., ICU beds, ventilators) by triaging patients. Triage is a process for determining which patients receive treatment and/or which level of care under what circumstances in contexts of resource scarcity. Priority-setting for resource allocation becomes more ethically complex during catastrophic times or in public health emergencies, such as today’s COVID-19 pandemic, when there is a need to manage a potential surge of patients. Physicians from China to Italy to Spain to the United States have found themselves in the unfathomable position of having to triage their most seriously ill patients and decide which ones should have access to ventilators and which should not, and which allocation criteria should be used to make these decisions. While the Canadian Medical Association hopes that Canadian physicians will not be faced with these agonizing choices, it is our intent, through this framework, to provide them with guidance in case they do and enable them to make ethically justifiable informed decisions in the face of difficult ethical dilemmas. Invoking this framework to ground decisions about who has access to critical care and who does not should only be made as a last resort. As always, physicians should carefully document their clinical and ethical decisions and the reasoning behind them. Generally, the CMA would spend many months in deliberations and consultations with numerous stakeholders, including patients and the public, before producing a document such as this one. The current situation, unfortunately, did not allow for such a process. We have turned instead to documents, reports and policies produced by our Italian colleagues and ethicists and physicians from Canada and around the world, as well as provincial level documents and frameworks. The CMA is endorsing and recommending that Canadian physicians use the guidance provided by Emmanuel and colleagues in the New England Journal of Medicine article dated from March 23rd, as outlined below. We believe these recommendations represent the best current approach to this situation, produced using the highest current standard of evidence by a panel of internationally recognized experts. We also recognize that the situation is changing constantly, and these guidelines may need to be updated as required. The CMA will continue to advocate for access to personal protective equipment, ventilators and ICU equipment and resources. We also encourage physicians to make themselves aware of any relevant provincial or local documents, and to seek advice from their regulatory body or liability protection provider. It should be noted that some provinces and indeed individual health care facilities will have their own protocols or frameworks in place. At the time of its publication, this document was broadly consistent with those protocols that we were given an opportunity to review. The CMA recognizes that physicians may experience moral distress when making these decisions. We encourage physicians to seek peer support and practice self-care. In addition, the CMA recommends that triage teams or committees be convened where feasible in order to help separate clinical decision making from resource allocation, thereby lessening the moral burden being placed on the individual physician. The CMA recommends that physicians receive legal protection to ensure that they can continue providing needed care to patients with confidence and support and without fear of civil or criminal liability or professional discipline. In this time of uncertainty, physicians should be reassured that their good faith efforts to provide care during such a crisis will not put them at increased medical-legal risk. Providing such reassurance is needed so that physicians have the confidence to continue to provide care to their patients. Recommendations: Recommendation 1: In the context of a pandemic, the value of maximizing benefits is most important. This value reflects the importance of responsible stewardship of resources: it is difficult to justify asking health care workers and the public to take risks and make sacrifices if the promise that their efforts will save and lengthen lives is illusory. Priority for limited resources should aim both at saving the most lives and at maximizing improvements in individuals’ post-treatment length of life. Saving more lives and more years of life is a consensus value across expert reports. It is consistent both with utilitarian ethical perspectives that emphasize population outcomes and with nonutilitarian views that emphasize the paramount value of each human life. There are many reasonable ways of balancing saving more lives against saving more years of life; whatever balance between lives and life-years is chosen must be applied consistently. Limited time and information in a Covid-19 pandemic make it justifiable to give priority to maximizing the number of patients that survive treatment with a reasonable life expectancy and to regard maximizing improvements in length of life as a subordinate aim. The latter becomes relevant only in comparing patients whose likelihood of survival is similar. Limited time and information during an emergency also counsel against incorporating patients’ future quality of life, and quality-adjusted life-years, into benefit maximization. Doing so would require time-consuming collection of information and would present ethical and legal problems. However, encouraging all patients, especially those facing the prospect of intensive care, to document in an advance care directive what future quality of life they would regard as acceptable and when they would refuse ventilators or other life-sustaining interventions can be appropriate. Operationalizing the value of maximizing benefits means that people who are sick but could recover if treated are given priority over those who are unlikely to recover even if treated and those who are likely to recover without treatment. Because young, severely ill patients will often comprise many of those who are sick but could recover with treatment, this operationalization also has the effect of giving priority to those who are worst off in the sense of being at risk of dying young and not having a full life. Because maximizing benefits is paramount in a pandemic, we believe that removing a patient from a ventilator or an ICU bed to provide it to others in need is also justifiable and that patients should be made aware of this possibility at admission. Undoubtedly, withdrawing ventilators or ICU support from patients who arrived earlier to save those with better prognosis will be extremely psychologically traumatic for clinicians — and some clinicians might refuse to do so. However, many guidelines agree that the decision to withdraw a scarce resource to save others is not an act of killing and does not require the patient’s consent. We agree with these guidelines that it is the ethical thing to do. Initially allocating beds and ventilators according to the value of maximizing benefits could help reduce the need for withdrawal. Recommendation 2: Irrespective of Recommendation 1, Critical Covid-19 interventions — testing, PPE, ICU beds, ventilators, therapeutics, and vaccines — should go first to front-line health care workers and others who care for ill patients and who keep critical infrastructure operating, particularly workers who face a high risk of infection and whose training makes them difficult to replace. These workers should be given priority not because they are somehow more worthy, but because of their instrumental value: they are essential to pandemic response. If physicians and nurses and RTs are incapacitated, all patients — not just those with Covid-19 — will suffer greater mortality and years of life lost. Whether health workers who need ventilators will be able to return to work is uncertain but giving them priority for ventilators recognizes their assumption of the high-risk work of saving others. Priority for critical workers must not be abused by prioritizing wealthy or famous persons or the politically powerful above first responders and medical staff — as has already happened for testing. Such abuses will undermine trust in the allocation framework. Recommendation 3: For patients with similar prognoses, equality should be invoked and operationalized through random allocation, such as a lottery, rather than a first-come, first-served allocation process. First-come, first-served is used for such resources as transplantable kidneys, where scarcity is long-standing, and patients can survive without the scarce resource. Conversely, treatments for coronavirus address urgent need, meaning that a first-come, first-served approach would unfairly benefit patients living nearer to health facilities. And first-come, first-served medication or vaccine distribution would encourage crowding and even violence during a period when social distancing is paramount. Finally, first-come, first-served approaches mean that people who happen to get sick later on, perhaps because of their strict adherence to recommended public health measures, are excluded from treatment, worsening outcomes without improving fairness. In the face of time pressure and limited information, random selection is also preferable to trying to make finer-grained prognostic judgments within a group of roughly similar patients. Recommendation 4: Prioritization guidelines should differ by intervention and should respond to changing scientific evidence. For instance, younger patients should not be prioritized for Covid-19 vaccines, which prevent disease rather than cure it, or for experimental post- or pre-exposure prophylaxis. Covid-19 outcomes have been significantly worse in older persons and those with chronic conditions. Invoking the value of maximizing saving lives justifies giving older persons priority for vaccines immediately after health care workers and first responders. If the vaccine supply is insufficient for patients in the highest risk categories — those over 60 years of age or with coexisting conditions — then equality supports using random selection, such as a lottery, for vaccine allocation. Invoking instrumental value justifies prioritizing younger patients for vaccines only if epidemiologic modeling shows that this would be the best way to reduce viral spread and the risk to others. Epidemiologic modeling is even more relevant in setting priorities for coronavirus testing. Federal guidance currently gives priority to health care workers and older patients but reserving some tests for public health surveillance could improve knowledge about Covid-19 transmission and help researchers target other treatments to maximize benefits. Conversely, ICU beds and ventilators are curative rather than preventive. Patients who need them face life-threatening conditions. Maximizing benefits requires consideration of prognosis — how long the patient is likely to live if treated — which may mean giving priority to younger patients and those with fewer coexisting conditions. This is consistent with the Italian guidelines that potentially assign a higher priority for intensive care access to younger patients with severe illness than to elderly patients. Determining the benefit-maximizing allocation of antivirals and other experimental treatments, which are likely to be most effective in patients who are seriously but not critically ill, will depend on scientific evidence. These treatments may produce the most benefit if preferentially allocated to patients who would fare badly on ventilation. Recommendation 5: People who participate in research to prove the safety and effectiveness of vaccines and therapeutics should receive some priority for Covid-19 interventions. Their assumption of risk during their participation in research helps future patients, and they should be rewarded for that contribution. These rewards will also encourage other patients to participate in clinical trials. Research participation, however, should serve only as a tiebreaker among patients with similar prognoses. Recommendation 6: There should be no difference in allocating scarce resources between patients with Covid-19 and those with other medical conditions. If the Covid-19 pandemic leads to absolute scarcity, that scarcity will affect all patients, including those with heart failure, cancer, and other serious and life-threatening conditions requiring prompt medical attention. Fair allocation of resources that prioritizes the value of maximizing benefits applies across all patients who need resources. For example, a doctor with an allergy who goes into anaphylactic shock and needs life-saving intubation and ventilator support should receive priority over Covid-19 patients who are not frontline health care workers. Approved by the CMA Board of Directors April 2020

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Front-of-package labelling consultation

https://policybase.cma.ca/en/permalink/policy13800

Date
2016-10-31
Topics
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Health care and patient safety
Text
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices. In this regard, CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans fat and calorie content of processed foods and prepared meals; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels.1 We commend Health Canada on recent work on updating the nutrition facts table and the current revision of the Canada Food Guide and are very pleased to provide a response to the consumer questionnaire on the Health Canada proposal for front-of-package (FOP) nutrition labelling. FOP nutrition labelling approach and possible symbols Do you support Health Canada's proposal to use a symbol to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. In 2011, appearing before the House of Commons Standing Committee on Health, the CMA supported a standard "at a glance" approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices.2 There is a growing body of evidence linking the consumption of diets high in saturated fats, sugars or sodium to cardiovascular and chronic disease (hypertension, dyslipidemia, diabetes mellitus, obesity, cancer, and heart disease and stroke) - leading preventable risk factors and causes of death and disability within Canada and worldwide. Therefore, the CMA does support the proposal to use a symbol for "high in" FOP labelling of foods high in sugar, sodium or saturated fats. FOP labelling on packaged foods may help Canadians make healthier food choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. Which symbol would help you recognize foods high in sodium, sugars and/or saturated fat? Please explain. Of the proposed symbols, we believe that those that resemble a stop sign would send a strong and recognizable signal of a food to avoid. The triangle yield sign shape is too similar to the shape often used to indicate a hazard such as poison. We would recommend holding focus groups with Canadians to better understand how the proposed symbols will be understood by consumers. Foods that do not have nutrition labelling Do you think these foods should be exempt from FOP symbols even if they're high in sodium, sugars and/or saturated fat? Please explain. The CMA can support the exemption of FOP labelling for products in very small packages but we would like to see a provision to include information on "high in" sugar, salt or saturated fats on foods such as sausages, bakery products, prepared dishes from the deli produced and prepackaged by grocery stores/retailers as they are categories of foods often high in these nutrients. A "high in" sticker could be added to the retailer's packaging to be consistent with other packaged foods. Nutrient levels for a "high in" FOP label Do you think the proposed nutrient levels make sense to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. The CMA supports the proposed nutrient levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring that the "high in" threshold and the 15% "a lot" daily value (DV) message are consistent delivers a clear message of concern. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we suggest that the threshold for "high in" sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Updating nutrient content claims and other nutrition-related statements Do you support not allowing a "no added sugars" claim on foods high in sugars? Please explain. Allowing a food that qualifies for a "high in" sugar FOP symbol to also display a "no added sugars" claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing "no added sugar" claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. Labelling of foods that have sweeteners Do you support that these sweeteners be declared in the list of ingredients only, rather than in the list of ingredients and the front of the package? Please explain. We do not support the elimination of the labelling requirement for artificial sweeteners on the principle display panel. For products that have high intensity sweeteners added and which bear claims such as "unsweetened" or "no sugar added," a declaration of "artificially sweetened" should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn't need to be on the principal display. For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government's Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism 1 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. 2 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca --------------- ------------------------------------------------------------ --------------- ------------------------------------------------------------

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Health Canada consultation on proposed vaping products promotion regulations

https://policybase.cma.ca/en/permalink/policy14128

Date
2020-01-20
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2020-01-20
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
Since 1867, the Canadian Medical Association has been the national voice of Canada’s medical profession. We work with physicians, residents and medical students on issues that matter to the profession and the health of Canadians. We advocate for policy and programs that drive meaningful change for physicians and their patients The Canadian Medical Association (CMA) appreciates this opportunity to respond to the notice as published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health Canada’s proposed Vaping Products Promotion Regulations “that would (1) prohibit the promotion of vaping products and vaping product-related brand elements by means of advertising that is done in a manner that can be seen or heard by young persons, including the display of vaping products at points of sale where they can be seen by young persons; and (2) require that all vaping advertising convey a health warning about the health hazards of vaping product use.” Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always, and will continue to support, strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on governments in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. Introduction It is imperative that the regulations concerning the promotion of vaping products be tightened sooner rather than later. While the CMA views Health Canada’s proposed regulations as a step in the right direction, they should only be considered as the start of extensive regulatory, policy and public health work required to effectively address the harms associated with vaping. Vaping is not without risks. Evidence continues to grow about the hazards associated with the use of e-cigarettes, especially for youth and young adults. The emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI) in the United States and to a lesser extent in Canada, illustrates the danger these products can pose. The Centers for Disease Control and Prevention (CDC) reported that as of January 7, 2020 that there were 2,602 cases of hospitalized EVALI or deaths (57 so far) reported by all 50 states, the District of Columbia, and 2 U.S. territories (Puerto Rico, and the U.S. Virgin Islands). In an update published in the CDC’s Morbidity and Mortality Weekly Report, “younger age was significantly associated with acquiring THC-containing and nicotine-containing products through informal sources.” The report concludes with this warning: “Irrespective of the ongoing investigation, e-cigarette, or vaping, products should never be used by youths, young adults, or pregnant women.”3 In Canada, as of January 7, 2020, 15 cases of severe pulmonary illness associated with vaping have been reported to the Public Health Agency of Canada. A recent public opinion survey conducted by the Angus Reid Institute (ARI) indicates that Canadians are growing more concerned about the safety of vaping as more information on the potential harms becomes available. The survey found that the number of people saying that vaping does more harm than good rose from 35% in 2018 to 62% in 2019.5 Further, 17% of parents with children under 19 said their child either vaped or had tried it; 92% of those parents considered vaping harmful.5 Significant to this discussion is the fact that 90% of respondents support “banning advertisements of vaping products in areas frequented by young people. This includes areas such as bus shelters or parks, and digital spaces like social media.”5 As public unease continues to rise, the need for further tightening of regulations becomes vital. Unfortunately, the federal government is still behind the curve when it comes to the proliferation of vaping and the vaping industry. Health Canada will have to step up surveillance and enforcement if tightening of the regulations is to be effective. This brief will address the planned regulations as well as discuss important issues not covered such as nicotine levels and flavours. We have expressed concerns about these topics in previous consultations and will be reiterating them here. Promotion of Vaping Products The CMA appreciates Health Canada’s intent to tighten the regulations but this proposal is not sufficient, and we must reiterate our long-held position that the restrictions on the promotion of all vaping products and devices be the same as those for tobacco products. , The proposed regulations provides the vaping industry with too much latitude in their promotion activities to ensure youth are protected. As we noted in our response to Health Canada’s consultation on The Impact of Vaping Products Advertising on Youth and Nonusers of Tobacco Products, the advertisements that have been permitted to this point seem to have managed to find their way to youth, even if they are not directed at them, as has been asserted.7, We recommended vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions. The CMA stands by that recommendation.7 The methods used by the vaping industry in the past succeeded in attracting more and more youth and young adults and it will no doubt continue efforts to find novel approaches for promoting their products, including the use of popular social media channels. , , , Indeed, “JUUL’s™ advertising imagery in its first 6 months on the market was patently youth oriented. For the next 2 ½ years it was more muted, but the company’s advertising was widely distributed on social media channels frequented by youth, was amplified by hashtag extensions, and catalyzed by compensated influencers and affiliates.”10 The vaping industry’s efforts to circumvent marketing restrictions in other jurisdictions are evident in view of some recent developments. A US study outlines an e-cigarette marketing technique that involves the promotion of scholarships for students. The study found 21 entities (manufacturers, e-cigarette review websites, distributors) offering 40 scholarships, ranging in value from $300 to $5000 (US).13 Most of the scholarships required “an essay submission, with most listing prompts related to e-cigarettes or eliciting information about the benefits of vaping.”13 The authors suggest “that prohibitions on e-cigarette scholarships to youth are also needed, as many of these scholarships require youth under the age of 18 years (for whom use of e-cigarettes are illegal) to write positive essays about vaping.”13 Health Warnings The CMA reiterates, yet again, its position that all health warnings for vaping products and devices should be similar to those presently required for tobacco packages in Canada.6, The need for such cautions is important in that we still do not understand fully the effects vaping can have on the human body. Harms More research is needed into the potential harms of using electronic cigarettes to understand the long-term effects users may face. , , The proposed health warnings are not strong enough in light of the research and knowledge that has emerged to date about the harms caused by e-cigarettes. For example, a recent US study highlighted the potential link between e-cigarette use and depression. It found “a significant cross-sectional association between e-cigarette use and depression, which highlights the need for prospective studies analyzing the longitudinal risk of depression with e-cigarette use.”18 As the authors note, “the potential mental health consequences may have regulatory implications for novel tobacco products.”18 Further, with respect to respiratory issues, a US study found that “use of e-cigarettes appears to be an independent risk factor for respiratory disease in addition to all combustible tobacco smoking.” The authors also don’t recommend the use of e-cigarettes as a smoking cessation tool because “for most smokers, using an e-cigarette is associated with lower odds of successfully quitting smoking.”19 Nicotine Levels Nicotine levels and flavours are not addressed in this consultation. However, the CMA considers these issues to be vital in the effort to protect youth and young adults from the harms associated with e-cigarettes and will therefore provide comment in effort to speed movement toward resolving these problems. The CMA remains very concerned about the rising levels of nicotine available through the vaping process. They supply “high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences.” Hammond et al noted in their 2019 study that “JUUL® uses benzoic acid and nicotine salt technology to deliver higher concentrations of nicotine than conventional e-cigarettes; indeed, the nicotine concentration in the standard version of JUUL® is more than 50 mg/mL, compared with typical levels of 3-24 mg/mL for other e-cigarettes.”9 The salts and flavours available to be used with these devices reduce the harshness and bitterness of the taste of the e-liquids with some of the competition delivering even higher levels of nicotine. The CMA called on Health Canada to restrict the level of nicotine in vaping products to avoid youth (and adults) from developing a dependence.20 Health Canada set the maximum level at 66 mg/ml while a European Union (EU) directive of 2014 indicates the level should not exceed 20 mg/ml. , Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment. , Utilizing the EU level as an interim measure until more scientific research is available to determine an optimal level is acceptable. Flavours On December 5, 2019, the Government of Nova Scotia became the first province or territory to announce it would institute a ban on sale of flavoured e-cigarettes and juices, as of April 1, 2020. The CMA recommends that flavours banned to reduce the attractiveness of vaping to youth as much as possible; others share this sentiment.6,7, Flavours are strong factors in attracting youth, especially when coupled with assertions of lower harm. Their success in doing so is evidenced by the rise in the rates of vaping among youth.9, A recent US study found that “perceiving flavored e-cigarettes as easier to use than unflavored e-cigarettes may lead to e-cigarette use progression among youth never tobacco users. Determining the factors (including e-cigarette marketing and specific e-cigarette flavors) that lead to perceived ease of using flavored e-cigarettes would inform efforts to prevent and curb youth e-cigarette use.” The CMA recommends that flavours be banned to reduce the attractiveness of vaping to youth as much as possible. Recommendations 1. The CMA recommends that vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions. 2. The CMA reiterates its position that all health warnings for vaping products and devices should be similar to those for tobacco packages. 3. The CMA believes that the European Union 2014 directive indicating the nicotine concentration not exceed 20 mg/ml should be adopted as an interim measure until more scientific research is available to determine an optimum level. 4. CMA recommends flavours be banned to reduce the attractiveness of vaping to youth as much as possible.

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Health Canada’s Consultation on “Plain and Standardized Packaging”

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

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

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Joint Canadian Medical Association & Canadian Psychiatric Association Policy - Access to mental health care

https://policybase.cma.ca/en/permalink/policy11890

Date
2016-05-20
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Policy document
Date
2016-05-20
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
One in five Canadians suffer from a mental health problem or illness in any given year. Mental illness costs Canada over $50 billion annually in health care costs, lost productivity and reductions in health-related quality of life. The social costs of poor mental health are high; a person with serious mental illness is at high risk of experiencing poverty, homelessness and unemployment. Despite the widespread prevalence of mental health disorders, it is estimated that fewer than one-third of people affected by them will seek treatment. This is due in large part to the stigma society attaches to mental illness, which can lead to discriminatory treatment in the workplace or the health care system. In recent years, awareness of mental health issues has risen considerably in Canada. However, much still needs to be done to ensure that Canadians who require mental health care have timely access to the treatment and support they need. The Canadian Medical Association (CMA) and Canadian Psychiatric Association (CPA) recommend that all stakeholders, and governments at all levels, work together toward developing a mental health care system that incorporates the following elements:
Comprehensive, patient-centred care and evidence-based treatment for mental health disorders. This includes enhancing collaboration and teamwork among health professionals, patients and their families; providing education and resources for health professionals; and supporting ongoing research to identify and disseminate best clinical practices.
Timely access to mental health services. The health care system should ensure an appropriate supply, distribution and mix of accredited mental health professionals, ensure equitable coverage of essential mental health care and treatment, and provide appropriate services for populations with unique needs, such as children and older Canadians.
Adequate supports in the community, for example in schools and workplaces, to promote mental health, identify mental health issues in a timely manner and support people with mental illness as they seek to function optimally.
Reduction of stigma and discrimination faced by Canadians with mental health disorders, in the health care system and in society. Summary of recommendations Comprehensive, patient-centred care and evidence-based treatment Governments and health care systems 1. Develop and support a continuum of evidence-based, patient-centred services for the promotion of mental health and treatment of mental illness, in the community and in hospitals, with smooth transitions and linkages between each level. 2. Develop and implement models of collaborative mental health care in the community, with input from key stakeholders including the public, patients and their families, evaluate their effectiveness and encourage the adoption of those that demonstrate success. 3. Develop and implement a national caregiver strategy and expand the financial and emotional support programs currently offered to informal caregivers. 4. Continue to develop, implement and monitor mental health indicators that reflect both health system performance and population health, regularly report the results to the public and use them to improve the delivery of mental health services in Canada. 5. Increase funding for mental health research so that it is proportionate to the burden of mental illness on Canada’s health care system. Medical faculties, professional associations and the health care systems 6. Continue to develop evidence-based guidelines and professional development programs on mental health treatment and management, for all health care providers. 7. Continue to conduct research into best practices in mental health care and treatment and communicate the results of this research promptly to health care providers and the public. Appropriate provision and funding of mental health services Governments and health care systems Address current gaps in access to mental health services in the following ways: 8. Ensure that mental health services are appropriately funded to effectively meet the needs of Canadians. 9. Make mental health a priority with all levels of government and ensure stable and appropriate funding. 10. Establish standards for access to mental health services, including appropriate maximum wait times, and measure and report them on an ongoing basis. 11. Fund and support primary health care delivery models that include mental health promotion and mental illness treatment among the services they provide and identify and address the barriers to their implementation. 12. Increase funding for access to evidence-based psychotherapies and counselling services for mental disorders. 13. Establish a program of comprehensive prescription drug coverage to ensure that all Canadians have access to medically necessary drug therapies. 14. Continue to develop linkages between remote communities and larger health centres, including telehealth and e-health services, to ensure adequate access to mental health services by people in smaller communities. Health professional associations 15. Work with governments and other stakeholders to develop a mental health human resources plan that optimizes the scope of practice of every health professional, is culturally appropriate and takes into account Canada’s diverse geography. 16. Undertake a national study of ways to optimize the supply, mix and distribution of psychiatrists in Canada and present its findings/recommendations to governments. Adequate community supports outside the health sector Governments 17. Ensure the availability of school-based mental health promotion and mental illness prevention programs, and programs that address school-related problems, such as bullying, that are associated with mental distress. 18. Work with employers and other stakeholders to support mental health programs for workplaces. 19. Provide programs and services to improve the interface between people with mental illnesses and the criminal justice system. 20. Expand programs that provide housing for people with mental illness. Reduction of stigma and discrimination Governments and the health care system 21. Incorporate identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. 22. Implement and evaluate national public awareness and education strategies to counteract the stigma associated with mental illness. 23. Enforce legislation and regulations to guard against discrimination against people with mental illness. Professional education 24. Incorporate effective anti-stigma education into the entire medical education continuum (medical school, residency and continuing professional development) for all physicians and other health professionals. 25. Incorporate effective anti-stigma education into professional development programs at hospitals and other health care facilities. Introduction Mental health disorders impose a heavy burden on Canadians and their health care system. In any given year, one in five Canadians will suffer from a mental health problem or illness. It is estimated that 10% to 20% of Canadian youth are affected by a mental health disorder. By age 40, 50% of Canadians will have had a mental illness. Mental illness can shorten life expectancy; for example, people with schizophrenia die as much as 20 years earlier than the population average. This is due both to higher rates of suicide and substance abuse and to a poorer prognosis for conditions such as heart disease, diabetes and cancer. Suicide is the second leading cause of death (after injuries) for Canadians aged 15 to 34. For people with mental health disorders, the effect on their lives goes beyond their interaction with the health care system; a person with serious mental illness is at high risk of experiencing poverty, homelessness and unemployment. Mental health disorders are costly to Canada’s health care system and to its economy. A third of hospital stays in Canada and 25% of emergency department visits are due to mental health disorders. It is estimated that mental illness costs Canada over $50 billion per year, including health care costs, lost productivity and reductions in health-related quality of life. Despite the widespread prevalence of mental health disorders, it is estimated that only one- quarter to one-third of people affected by them will seek treatment. This could be due in part to the stigma society attaches to mental illness, which deters many people from seeking needed treatment because they fear ostracism by their friends or discriminatory treatment in the workplace or the health care system. Those who do seek treatment may have a difficult time finding it. According to Statistics Canada, in 2012 almost a third of Canadians who sought mental health care reported that their needs were not met or only partially met. Lack of access to family physicians, psychiatrists and other health care providers contributes to this deficit. Though mental illnesses constitute more than 15% of the disease burden in Canada, the country spends only about seven cents of every public health care dollar on mental illness (7%), below the 10% to 11% of spending devoted to mental illness in countries such as New Zealand and the United Kingdom.4 Since 2000, however, Canadians’ awareness of mental health issues has risen considerably. The seminal 2006 report entitled Out of the Shadows at Last by the Standing Senate Committee on Social Affairs, Science and Technology, chaired by Senator Michael Kirby, made a number of recommendations aimed at increasing awareness, improving access to mental health services and reducing the stigma of mental illness. As a result of this report, in 2007 the federal government established the Mental Health Commission of Canada (MHCC) to be a catalyst for improving the mental health system and changing the attitudes and behaviours of Canadians around mental health issues. In 2012, the MHCC released Canada’s first mental health strategy, “Changing Directions, Changing Lives.” As part of her mandate from the prime minister following the 2015 federal election, Canada’s health minister has been asked to “engage provinces and territories in the development of a new multi-year Health Accord [that will] make high quality mental health services more available to Canadians who need them.” Nearly all provincial governments have also developed mental health strategies for their own jurisdictions. Much still needs to be done to translate heightened awareness into improvements in service provision to give Canadians who require mental health care timely access to the evidence-based, patient-centred treatment and support they need. The Canadian Medical Association (CMA) and Canadian Psychiatric Association (CPA) agree it is time to make mental health a high priority in Canada. The CMA and CPA recommend that all stakeholders, and governments at all levels, work together toward developing a mental health care system that is driven by needs-based plans with clear performance measures and that receives an appropriate share of health care funding. This position statement discusses and makes recommendations on issues relating to access to mental health care, with a focus on:
comprehensive, patient-centred care and evidence-based treatment for mental health disorders;
appropriately funded primary, specialty and community mental health treatment and support services;
adequate community supports for people with mental health disorders; and
reduction of the stigma and discrimination faced by Canadians with mental health disorders. Comprehensive, patient-centred care and evidence-based treatment The goal of mental health care in Canada should be to allow patients’ needs to be met in the most appropriate, timely and cost-effective manner possible. Current best practice suggests that care for patients with mental health disorders should be provided using models that incorporate the following principles. Patient-centred care One of the fundamental principles of health care is that it be patient centred. CMA defines patient-centred care as “seamless access to the continuum of care in a timely manner … that takes into consideration the individual needs and preferences of the patient and his/her family and treats the patient with respect and dignity.” For treatment of mental health disorders, it is essential that patients be core members of the health care team, working with health care providers to address their individual needs, preferences and aspirations and to seek their personal paths to well-being. Physicians and other health professionals can help patients make choices about their treatment and can provide information and support to patients and their families as they seek to cope with the effects of their illnesses and live functional lives. A continuum of mental health services Mental health disorders can be complex and can vary in severity. A patient may have short-term coping difficulties that can be resolved with counselling or a severe psychotic illness that requires frequent hospital care and intensive, lifelong support. This range of needs requires that the health care system provide different levels of care, including:
community-based programs to promote and maintain mental health and to facilitate early identification of problems requiring intervention;
community-based primary health care, including collaborative care teams, which focus on providing mental health maintenance programs and on treating high-prevalence conditions such as anxiety disorders, mood disorders and addictions;
specialized services in the community for patients with greater needs, which can be delivered through a variety of means, including community-based psychiatrists, interdisciplinary family health teams that incorporate psychiatric services and specialized interdisciplinary teams such as assertive community treatment (ACT) teams ;
acute-care mental health services including community crisis teams and beds, psychiatric emergency services and inpatient beds in community hospitals, and specialized psychiatric hospitals;
a continuum of residential care services including long-term care facilities;
seamless, integrated transitions from one level of care to another, and across age groups (e.g., from youth to adult to senior mental health services);
appropriate services for special populations, including children and adolescents, and adults with dementia;
specialized psychiatric services for patients with complex mental illnesses such as eating disorders, post-traumatic stress disorder and personality disorders; and
community-based programs that provide housing, vocational support and other services to optimize community integration of people with mental illness. Mental health care should ideally be provided in the context of caring for the patient’s overall health, taking into account any physical conditions for which the patient is receiving or may receive treatment. Collaborative and team-based mental health care Within this continuum, a variety of health care professionals with different skills and education provide mental health services in Canada. They include:
primary care physicians (family physicians and general practitioners);
psychiatrists (hospital and community based);
other specialist physicians (including emergency physicians, paediatricians, geriatricians);
other health professionals (psychologists, nurses, pharmacists, occupational therapists, social workers); and
case managers, peer support workers and system navigators. Collaborative models enable a variety of mental health care providers to work with patients and their families to provide effective, coordinated care according to a mutually agreed plan. Collaborative partnerships in mental health care have demonstrated benefits including symptom and functional improvement, reduced disability days and improved adherence to medication. Elements of a successful collaborative partnership include:
effective linkages among psychiatrists, primary care providers and other mental health professionals, including a seamless process for consultation and referral;
effective communication and information flow;
use of technology, such as electronic health records and telemedicine, to facilitate collaboration among providers in all health care settings;
coordination of care plans and clinical activities to ensure the most effective care and efficient use of resources; and
integration of mental health and primary care providers within a single service or team (in some cases, providers may work in the same practice setting).13 Education and resources for health professionals Since mental health disorders are pervasive and are often associated with other chronic conditions such as heart disease, health care providers of all disciplines and specialties often encounter them while caring for their patients. The Mental Health Core Competencies for Physicians report, prepared collaboratively by the Royal College of Physicians and Surgeons of Canada, the MHCC, the College of Family Physicians of Canada, CMA and CPA, proposes goals, principles and core mental health competencies to provide guidance to physicians of all specialties. The intent is to improve access to mental health services; improve the experience of care, including reducing stigma; recognize and address the interaction between physical and mental health; and provide practice support for physicians. To support physicians and other health care providers in treating mental health disorders, clinical and practice resources should be available to them, including:
early education in medical school and residency on mental health promotion, diagnosis and treatment of mental health conditions, and liaison with other community resources, for all specialties;
clinical practice tools including practice guidelines, clinical pathways and online decision support including prescribing guidelines for the appropriate use of psychiatric drugs;
online continuing professional development (CPD) programs ;
enhanced interprofessional education for all providers (psychiatrists, family physicians, nurses, social workers, occupational therapists, peer support workers, patients, their family members and others as relevant) ; and
evidence-based, user-friendly education and support tools for patients, which physicians can recommend to help them manage their conditions. Support for informal caregivers Often the burden of caring for a person with mental illness falls heavily on family or friends, and the role of the informal caregiver can be demanding financially, physically and/or emotionally. Though governments have instituted tax credits and other forms of support for caregivers, more help is required. A national caregiver strategy, developed by governments and other key stakeholders, could define a national standard of support for informal caregivers and expand the financial and emotional support programs that are currently offered. Research and evaluation Thanks to ongoing research, our knowledge of how to treat and manage mental health disorders is constantly growing and developing. However, there are still gaps in this knowledge, and research needs in the area remain substantial. CMA and CPA encourage a continued commitment to research into best practices in early identification, care and treatment of mental health disorders and to funding this research so that it is proportionate to the burden of mental illness on Canada’s health care system. Results of this research should be communicated to health professionals and the public as quickly and widely as possible, so that it can be rapidly incorporated into clinical practice. Mental health care interventions should also be routinely evaluated for their effectiveness in improving patient care, enhancing the sustainability of the health care system and increasing the overall health and well-being of Canadians. The MHCC has developed a set of 63 mental health indicators that focus on 13 specific areas, including access and treatment, the economy and workplace, and special populations such as seniors, children and youth. Other projects are underway to develop indicators to monitor and report more specifically on mental health system performance, such as use of emergency departments for mental health care, and physician follow-up after hospital treatment. Such indicators should be used on an ongoing basis to monitor the performance of the mental health care system and provide mental health professionals, planners and governments with reliable information that they can use to better meet the needs of Canadians. Recommendations Governments and health care systems 1. Develop and support a continuum of evidence-based, patient-centred services for the promotion of mental health and treatment of mental illness, in the community and in hospitals, with smooth transitions and linkages between each level. 2. Develop and implement models of collaborative mental health care in the community, with input from key stakeholders including the public, patients and their families, evaluate their effectiveness and encourage the adoption of those that demonstrate success. 3. Develop and implement a national caregiver strategy and expand the financial and emotional support programs currently offered to informal caregivers. 4. Continue to develop, implement and monitor mental health indicators that reflect both health system performance and population health, regularly report the results to the public and use them to improve the delivery of mental health services in Canada. 5. Increase funding for mental health research so that it is proportionate to the burden of mental illness on Canada’s health care system. Medical faculties, professional associations and health care systems 6. Continue to develop evidence-based guidelines and professional development programs on mental health treatment and management, for all health care providers. 7. Continue to conduct research into best practices in mental health care and treatment and communicate the results of this research promptly to health care providers and the public. Appropriate provision and funding of mental health services Appropriate provision of mental health services requires that people be able to access the right care in the right place at the right time, in both hospital and community settings. Unfortunately, because of the underfunding of the mental health care system, limited resources are available to accommodate all of those who need such services. The exact extent of lack of access to hospital and community mental health services is not well documented; for instance, provinces do not report wait times for psychiatric services. According to the 2015 Wait Time Alliance Report Card, no jurisdiction is measuring what proportion of patients is being seen within the benchmark time periods. In December 2015 the CPA expressed disappointment that “no visible progress has been made in measuring how well the health system meets the psychiatric needs of Canadians.” In the absence of community-based services, patients may have their discharge from hospital delayed. Once they are back in the community, they may be unable to find appropriate assistance, or assistance may be available but beyond their financial means. They may abandon treatment or rely on emergency departments for episodic crisis care.4 Canada should work to remedy the current deficiencies in access to mental health services so that people with mental health disorders have timely access to seamless, comprehensive care in the most appropriate setting. This includes ensuring an appropriate supply, distribution and mix of accredited mental health professionals, ensuring equitable coverage of essential health services and making appropriate services and supports available to populations with unique needs. Access to physician services Primary care For the majority of patients who seek treatment for a mental health problem, the first (often the only) point of contact is their primary care physician. As part of the comprehensive care they provide to patients, family physicians and general practitioners can provide mental health promotion and wellness counselling, detect and treat mental health disorders in their early stages and monitor the patient’s progress in the context of his or her overall health and well-being, referring to psychiatrists and other mental health professionals as needed.13 CMA has long recommended that every Canadian have an established professional relationship with a family physician who is familiar with his or her condition, needs and preferences. However, some Canadians may have difficulty finding primary medical care, since the proportion of family physicians and general practitioners to the population is not consistent across Canada. All stakeholders should continue working to ensure that every Canadian has access to comprehensive first-point-of-contact medical care. Psychiatric services Psychiatrists are physicians who complete five to seven years of specialty and subspecialty training to diagnose, treat and provide ongoing care for mental illnesses, particularly to people with complex illnesses that cannot be managed within a primary care setting alone. In addition to providing specialty treatment, psychiatrists are also active in the areas of education, research and advocacy about the importance of mental health promotion and mental illness prevention. They provide care across the lifespan, in both hospital and community settings. Patient access to psychiatrists is often limited by long wait times. It has been suggested that this is due to a shortage of psychiatrists, which is more severe in some parts of Canada than others. Recent surveys report that a number of specialists, including psychiatrists, are in the latter half of their careers, and there are concerns that the number of psychiatrists per Canadian population is declining. Though the Royal College notes that the number of psychiatric residency positions has increased in recent years, it is unclear if this is sufficient to meet current and future population needs. The CPA recommends the development of strategies to attract, train and retain practitioners in clinical psychiatry. Access to services not funded by provincial and territorial health systems Though Canada’s public health care system covers many mental health services and treatments, including physician consultations and hospital care, it does not cover all aspects of optimal treatment and care, and access to some therapies may be limited by the patient’s ability to pay. Psychiatric drugs, especially those that must be taken over many years, can pose a heavy financial burden for patients who do not have drug coverage through employer-provided benefit programs or provincial or territorial drug plans. Psychotherapies delivered by non-physician health care practitioners are generally not covered by government health plans and must, therefore, in most cases be paid for out of pocket or through private insurance plans, to which many Canadians do not have access. Federal, provincial and territorial governments should work to increase access to accredited psychological and counselling services that are evidence based and to provide comprehensive coverage of medically necessary prescription drugs for all Canadians. Some primary health care practices, such as family health teams in Ontario, have funding envelopes that they can use to contract with skilled mental health professionals to provide psychotherapy, stress management programs and other services that are not ordinarily funded through provincial health budgets. Models such as these help to make publicly funded mental health care available to patients who might otherwise have been unable to afford it. Access to mental health services for special populations For some populations, access to mental health services may be particularly problematic. For example, stakeholders should consider the needs of the following populations:
Children and youth: As up to 70% of mental health conditions first appear in adolescence or young adulthood, it is important that young people have access to mental health promotion and to appropriate assessment and treatment of mental health disorders. At present only one out of four children who need mental health services receives them.1,3 CMA and CPA particularly recommend increased supports for children in high-risk situations, such as those in foster care. The transition from the youth to the adult mental health service sectors should be smooth and well organized.
Remote areas: People in the North and other remote parts of Canada may have to travel many miles to access mental health and other health care services. This gap should be remedied by using technologies such as telehealth and e-mental health services and by strengthening communication and coordination between small communities and the larger health centres to which their residents travel for care.
Immigrants and refugees: New arrivals to Canada may have problems understanding our language and culture and may also face mental health problems as a result of traumatic experiences in their countries of origin or the stress of relocation.
Indigenous Peoples. Rates of mental health disorders, addictions and suicide are high among Canada’s First Nations, Inuit and Métis. Much of this is linked to past experience of forcible separation from their traditional languages and culture. Health service providers should work with Indigenous communities to address their distinct mental health needs appropriately.
Seniors: An estimated 10% to 15% of seniors report depression, and the rate is higher among those with concomitant physical illness and those living in long-term care facilities. Depression among older people may be under-recognized and under-treated or dismissed as a normal consequence of aging. Poor mental health is often associated with social isolation, a common problem among seniors. The majority of older adults in long-term care settings have dementia or another mental health condition. Recommendations Governments and health care systems Address current gaps in access to mental health services in the following ways: 8. Ensure that mental health services are appropriately funded to effectively meet the needs of Canadians. 9. Make mental health a priority with all levels of government and ensure stable and appropriate funding. 10. Establish standards for access to mental health services, including appropriate maximum wait times, and measure and report them on an ongoing basis. 11. Fund and support primary health care delivery models that include mental health promotion and mental illness treatment among the services they provide and identify and address the barriers to their implementation. 12. Increase funding for access to evidence-based psychotherapies and counselling services for mental disorders. 13. Establish a program of comprehensive prescription drug coverage to ensure that all Canadians have access to medically necessary drug therapies. 14. Continue to develop linkages between remote communities and larger health centres, including telehealth and e-health services, to ensure adequate access to mental health services by people in smaller communities. Health professional associations 15. Work with governments and other stakeholders to develop a mental health human resources plan that optimizes the scope of practice of every health professional, is culturally appropriate and takes into account Canada’s diverse geography. 16. Undertake a national study of ways to optimize the supply, mix and distribution of psychiatrists in Canada and present its findings/recommendations to governments. Adequate community supports outside the health sector People with mental health disorders often require not only treatment and care from the health sector but also support from the community at large to function optimally. Ideally, the community should provide an environment that supports patients as they work toward recovery and well-being. In addition, schools, workplaces and other community agencies can play an important role in promoting mental health and identifying problems that require attention. Schools Education and information should be made available to parents, teachers and health professionals to help them identify signs of mental illness or distress in children and adolescents, so they can intervene early and appropriately. School health education programs should include the promotion of mental health and incorporate self-management techniques such as mindfulness training to help young people develop resilience. Schools should also ensure that they minimize possible threats to children’s mental health, such as bullying, that may occur on their premises. Workplaces Unlike many other chronic conditions, mental illness frequently affects younger people and those in their most productive years, so the burden it imposes on Canada’s economy is high. Mental health disorders account for 30% of short-term workplace disability claims,1 and the Conference Board of Canada has estimated that six common mental health disorders cost the country’s economy more than $21 billion a year and predicts that this cost will increase to $30 billion by 2030. However, often employees do not disclose mental health problems to their employers for fear of losing their jobs, being ostracized by colleagues, or other negative consequences. Workplaces can support the mental health of their employees by:
offering mental health promotion assistance through stress management seminars, employee assistance and other programs;
training managers to identify potential mental health issues in their staff and to intervene early and appropriately;
eliminating stigma and discrimination and providing an environment in which employees feel safe disclosing their mental health issues; and
offering adequate benefits, including supplementary health insurance and supportive leave-of-absence programs. The MHCC’s Standard for Psychological Health and Safety in the Workplace, released in 2013, provides guidance to employers on how to promote the mental health of their staff and intervene in cases of mental distress. Correctional services People with mental illnesses are overrepresented in the criminal justice system. Estimates suggest that rates of serious mental illness among federal offenders upon admission have increased by 60% to 70% cent since 1997.4 This places a heavy burden on corrections and law enforcement staff, who are often inadequately trained to deal with mental illness. Programs and services are needed to ensure that people with mental health disorders who run afoul of the law are identified early, given appropriate treatment throughout their incarceration and followed up on release. These could include:
training for police and other frontline criminal justice and corrections workers in how to interact with people with mental illnesses;
diversion programs, such as mental health courts, to redirect people with mental illnesses who are about to enter the criminal justice system;
comprehensive psychiatric screening, assessment and treatment for incarcerated patients with mental illnesses and common co-occurring conditions such as addiction; and
Careful handover of clinical care at the point of release from custody with engagement by mental health services in the community. Housing Mental illness increases a patient’s risk for poverty and homelessness. It is estimated that two- thirds of Canada’s homeless population have a serious mental illness. Homelessness and poverty can exacerbate existing mental health and addiction problems, hinder access to treatment and reduce life expectancy. Programs such as the MHCC’s Housing First research demonstration project can improve the social and economic circumstances of people with mental illness. The MHCC project provided no-strings-attached supportive housing for people with chronic mental health problems, giving them a secure base from which they could pursue their treatment and recovery goals. Evaluation showed that this approach reduced the rate of homelessness, improved access to treatment and support services and led to cost savings, particularly for the program participants who had the highest service-use costs. Recommendations Governments 17. Ensure the availability of school-based mental health promotion and mental illness prevention programs, and programs that address school-related problems, such as bullying, that are associated with mental distress. 18. Work with employers and other stakeholders to support mental health programs for workplaces. 19. Provide programs and services to improve the interface between people with mental illnesses and the criminal justice system. 20. Expand programs that provide housing for people with mental illness. Reduction of stigma and discrimination Many believe that the primary reason for the underfunding of the mental health care system and for the reluctance of people with mental health disorders to seek treatment is the stigma attached to their conditions. Mental illness is the most stigmatized disease state in Canada, and discriminatory behaviour toward people with mental health disorders is widespread. This can include ostracism and lack of support from peers, discrimination in the workplace and distorted public perceptions, such as the tendency to equate mental illness with violent behaviour. Discriminatory behaviour can also occur in the health care system. Experts acknowledge that stigma affects health care providers’ attitude toward patients with mental health problems.29 Though many health care providers are unaware that their language or actions can be harmful, their attitude may have negative effects on the treatment their patients receive. For example, if a patient who has been treated for a psychiatric condition reports physical symptoms, these symptoms might be attributed to the mental illness rather than to a physical condition, and as a result the patient may not receive necessary treatment. This is known as diagnostic overshadowing. , CMA and CPA recommend comprehensive efforts to change the culture of stigmatization of mental illness, in the health care system and in society. A number of interventions are underway to help reduce stigma and discrimination related to mental illness. These include public awareness programs such as the Bell Let’s Talk campaign, Mental Illness Awareness Week, sponsored by the Canadian Alliance on Mental Illness and Mental Health, and the Opening Minds program of the MHCC, which focuses on specific populations including youth and health care providers. The current consensus among experts is that the most effective interventions are those that:
are aimed at changing behaviour rather than modifying attitudes;
are ongoing rather than time limited;
are targeted to specific groups rather than to the general population; and
involve direct contact with people with mental illness. Within the health care system, professional education is a potentially important means of addressing stigma and discrimination. It has been recommended that anti-stigma education be incorporated into the medical education continuum at all levels (including residency and CPD) and for all specialties and that this education incorporate direct contact with people with mental illness, to share their stories of recovery.27 All health professionals and their associations should be encouraged to address the elimination of stigma in their educational programs. CMA and CPA have worked with partners to provide education to physicians, through workshops, online materials and other means. Recommendations Governments and the health care system 21. Incorporate identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. 22. Implement and evaluate national public awareness and education strategies to counteract the stigma associated with mental illness. 23. Enforce legislation and regulations to guard against discrimination against people with mental illness. Professional education 24. Incorporate effective anti-stigma education into the entire medical education continuum (medical school, residency and CPD) for all physicians and other health professionals. 25. Incorporate effective anti-stigma education into professional development programs at hospitals and other health care facilities. Conclusion Despite increased public awareness about mental illness, ensuring access to effective mental health services and supports remains a challenge in Canada, and the stigma and discrimination associated with mental illness remain high. CMA and CPA believe that change is possible. In an ideal future, all Canadians would feel safe acknowledging their mental health problems and seeking help for them, a range of effective, evidence-based treatments would be available for every Canadian who needs them, and communities would support Canadians as they work to promote and maintain their mental health or to recover from mental illness. It is our hope that health care providers, governments, communities, patients and their families will work together toward realizing this future. References Mental Health Commission of Canada. The Facts. Calgary (AB): The Commission; 2012. Available: http://strategy.mentalhealthcommission.ca/the-facts/ (accessed 2015 May 05). Mental Health Commission of Canada. Making the case for investing in mental health in Canada. Calgary (AB): The Commission; 2013. Chesney E, Goodwin GM, Fazel S. Risks of all-cause and suicide mortality in mental disorders: a meta-review. World Psychiatry 2014; 13 (2):53–60. Mental Health Commission of Canada. Changing directions, changing lives: the Mental Health Strategy for Canada. Calgary (AB): The Commission; 2012. Available: https://strategy.mentalhealthcommission.ca/download (accessed 2014 Sep 07). Centre for Addiction and Mental Health. Mental illnesses and addictions: facts and statistics. Toronto (ON): The Centre; 2016. Available: www.camh.ca/en/hospital/about_camh/newsroom/for_reporters/Pages/addictionmentalhealthstatistics.aspx (accessed 2016 Mar 9). Mental Health Commission of Canada. Opening minds. Ottawa (ON): The Commission; 2016. Available: http://www.mentalhealthcommission.ca/English/initiatives/11874/opening-minds (accessed 2016 Mar 9). Statistics Canada. Canadian Community Health Survey: mental health, 2012 [media release]. Ottawa (ON): Statistics Canada; 2013 Sep 18. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm?HPA (accessed 2015 Sep 08). Mental Health Commission of Canada. About MHCC. Ottawa (ON): The Commission; 2016. Available: www.mentalhealthcommission.ca/English/who-we-are (accessed 2016 Mar 10). 9 Prime Minister of Canada. Minister of Health Mandate letter to the Hon. Jane Philpott, Minister of Health, November 2015. Ottawa (ON): Office of the Prime Minister of Canada; 2015. Available: http://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2016 Apr 14). Canadian Medical Association. Health care transformation in Canada: change that works. Care that lasts. Ottawa (ON): The Association; 2010. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD10-05.PDF (accessed 2015 Sep 14). Neilson G, Chaimowitz G. Informed consent to treatment in psychiatry. A position paper of the Canadian Psychiatric Association. Can J Psychiatry. 60 (4):1-12. Available: http://publications.cpa-apc.org/media.php?mid=1889 (accessed 2016 Mar 9). Ontario ACT Association. ACT model: the team approach. [Place unknown]: The Association; 2015. Available: http://ontarioacttassociation.com/act-model/ (accessed 2015 Mar 25). Kates N, Mazowita G, Lemire F, et al. The evolution of collaborative mental health care in Canada: a shared vision for the future. A position paper developed by the Canadian Psychiatric Association and the College of Family Physicians of Canada. Can J Psychiatry. 2011; 56(5): 1-10. Available: http://www.cfpc.ca/uploadedFiles/Directories/Committees_List/Collaborative%20mental%20health%20care-2011-49-web-FIN-EN.pdf (accessed 2014 Oct 16). Whiteman H. Mental illness linked to increased risk of heart disease, stroke. Medical News Today. 2014, Oct 27. Available: www.medicalnewstoday.com/articles/284461.php (accessed 2015 Mar 25). Mental Health Core Competencies Steering Committee. Mental health core competencies for physicians. Ottawa (ON): Royal College of Physicians and Surgeons of Canada, Mental Health Commission of Canada, College of Family Physicians of Canada, Canadian Psychiatric Association and Canadian Medical Association; 2014. Available: www.royalcollege.ca/portal/page/portal/rc/common/documents/policy/mhcc_june2014_e.pdf (accessed 2016 Mar 9). Canadian Collaborative Mental Health Initiative. Toolkits. Mississauga (ON): The Initiative; n.d.. Available: www.shared-care.ca/page.aspx?menu=69&app=266&cat1=745&tp=2&lk=no (accessed 2014 Oct 16) Curran V, Ungar T, Pauzé E. Strengthening collaboration through interprofessional education: a resource for collaborative mental health care educators. Mississauga (ON): Canadian Collaborative Mental Health Initiative; 2006 Feb. Available: www.shared-care.ca/files/EN_Strengtheningcollaborationthroughinterprofessionaleducation.pdf (accessed 2016 Mar 9). Canadian Medical Association. Health and health care for an aging population: policy summary of the Canadian Medical Association. Ottawa (ON): The Association; 2013 Feb. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-03.pdf (accessed 2014 Sep 14). Mental Health Commission of Canada. Informing the future: mental health indicators for Canada. Ottawa (ON): The Commission; 2015 Jan. Available: www.mentalhealthcommission.ca/English/document/68796/informing-future-mental-health-indicators-canada (accessed 2016 Mar 09). Wait Time Alliance. Time to close the gap: report card on wait times in Canada. Ottawa (ON): The Alliance; 2014 June. Available: www.waittimealliance.ca/wta-reports/2014-wta-report-card/ Canadian Psychiatric Association. Tracking access to psychiatric care needed to chart a way forward say psychiatrists [media release]. Ottawa (ON): The Association; 2015 Dec 8. Available: www.cpa-apc.org/media.php?mid=2385 (accessed 2016 Mar 09). CMA Physician Data Centre. Canadian physician statistics: general practitioners/family physicians per 100,000 population by province/territory, 1986-2014. Ottawa (ON): Canadian Medical Association; 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/14-FP_per_pop.pdf (accessed 2016 Mar 09). Canadian Collaborative Centre for Physician Resources. Psychiatry: a recent profile of the profession [bulletin]. Ottawa (ON): Canadian Medical Association; 2012 Apr. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/25-Psychiatry.pdf#search=psychiatry%20a%20recent%20profile (accessed 2016 Mar 09). Sargeant JK, Adey T, McGregor F, et al. Psychiatric human resources planning in Canada: a position paper of the Canadian Psychiatric Association. Can J Psychiatry 2010; 55 (9): 1-20. Available: http://publications.cpa-apc.org/media.php?mid=1015 (accessed 2015 Sep 14). Conference Board of Canada. Mental health issues in the labour force: reducing the economic impact on Canada. Ottawa (ON): The Board; 2012 Jul. Mental Health Commission of Canada, Canadian Standards Association. CAN/CSA-Z1003-13/BNQ 9700-803/2013 - Psychological health and safety in the workplace — prevention, promotion, and guidance to staged implementation. Toronto (ON): CSA Group; 2013. Available: http://shop.csa.ca/en/canada/occupational-health-and-safety-management/cancsa-z1003-13bnq-9700-8032013/invt/z10032013 (accessed 2014 Oct 10). Mental Health Commission of Canada. Turning the key: Assessing housing and related supports for persons living with mental health problems and illnesses. Ottawa (ON): The Commission; 2012. Available: www.mentalhealthcommission.ca/English/media/3055 (accessed 2014 Oct 10). Mental Health Commission of Canada. National final report: Cross-Site At Home/Chez Soi Project. Ottawa (ON): The Commission; 2014. Available: www.mentalhealthcommission.ca/English/document/24376/national-homechez-soi-final-report (accessed 2015 May 15). Hawthorne D; Major S; Jaworski M; et al. Combatting stigma for physicians and other health professionals. Ottawa (ON): MDcme.ca; 2011. Available https://www.mdcme.ca/courseinfo.asp?id=143 (accessed 2015 May 15). Abbey SE, Charbonneau M, Tranulis C, et al. Stigma and discrimination. Can J Psychiatry 2011; 56(10): 1-9. Available: http://publications.cpa-apc.org/media.php?mid=1221 (accessed 2015 Aug 4). Pietrus M. Opening Minds interim report. Calgary (AB): Mental Health Commission of Canada; 2013. Available: www.mentalhealthcommission.ca/English/document/17491/opening-minds-interim-report (accessed 2015 Aug 4). Mental Health Commission of Canada. Together against stigma: changing how we see mental illness: a report on the 5th International Stigma Conference, Ottawa (ON), 2012 Jun 4–6. Ottawa (ON): The Commission; 2013. Available: www.mentalhealthcommission.ca/English/media/3347 (accessed 2014 Oct 14).

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Regulation of Self-Care Products in Canada

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

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

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

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

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

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8 records – page 1 of 1.