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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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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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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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Health Canada consultation on edible cannabis, extracts & topicals

https://policybase.cma.ca/en/permalink/policy14020
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association appreciates this opportunity to respond to Health Canada’s consultation on the proposed regulations for edible cannabis, cannabis extracts, and cannabis topicals. The CMA’s approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation, recommendations regarding Bill C-45. As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45. Canada’s physicians have a longstanding concern about the health risks associated with consuming cannabis. , Consumers use these products for both recreational and medical purposes, compelling the need for accuracy in the labeling as well as quality control in the manufacturing process.10 Cannabis Edibles, Extracts and Topicals Cannabis will have a different effect on the user, depending on whether it is smoked or ingested, as in an edible. It has been found that “smoking marijuana results in clinical effects within 10 minutes, peak blood concentrations occur between 30 and 90 minutes, and clearance is complete within 4 hours of inhalation. Oral THC does not reach significant blood concentration until at least 30 minutes, with a peak at approximately 3 hours, and clearance approximately 12 hours after ingestion.” Because of the delay in absorption when ingested, people might consume more to feel the psychoactive effects faster. This might lead to the consumption of very high doses and result in toxic effects, such as anxiety, paranoia and in rare cases, a psychotic reaction with delusions, hallucinations, incoherent speech and agitation. Rates of use of edibles are not well known. A recent study in California high schools found that “polyuse via multiple administration methods was a predominant pattern of cannabis use and report the first evidence, to our knowledge, of triple product polyuse of combustible, edible, and vaporized cannabis among youths.” We are limiting our response to Health Canada’s consultation questions that pertain to the CMA’s position with respect to cannabis and relate to our expertise and knowledge base. Proposed THC limits for the new classes of cannabis products Standardization within all classes of cannabis products in a legal regime is essential. Tetrahydrocannabinol (THC) levels in black market products can vary widely so one can never be assured of the strength being purchased, creating the potential for significant harm. , Experience in jurisdictions where cannabis has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies.2 Prohibition of high potency products is important.3 THC limits should be based on the best available evidence of safety for consumers. The increased potency of cannabis over the years raises concerns about its use in edibles, extracts and topicals, offering a significant challenge with respect to regulating their use. This becomes particularly worrisome with respect to preadolescents and adolescents who should avoid using cannabis due to concerns with the impact on the developing brain.2 Use has been associated with a “significant increased risk of developing depression or suicidality in young adulthood.” More research is needed with respect to the effects of cannabis on all age groups, especially children, adolescents and seniors. Saunders et al describe the case of an elderly patient with a history of coronary artery disease suffering what appears to have been a myocardial infarction after ingesting most of a marijuana lollipop that contained 90 mg of THC. Such cases demonstrate how crucial it is to establish appropriate levels of THC. This is an especially important consideration because “consuming cannabis-infused edibles may inadvertently result in toxicity because absorption can take hours, compared with minutes when smoking. An individual who does not yet feel an effect may over-consume.” Small children and people with cognitive impairment will not be able to read labels, so preventive measures are very important, as with any pharmaceutical. Since legalizing cannabis, Colorado’s Rocky Mountain Poison & Drug Center has reported an increase in calls related to edible exposures. Children can accidentally eat products that contain cannabis, making them ill enough to seek medical assistance. The CMA maintains that the proposed draft regulations of 10 mg per discrete unit and package is too high and should be established at a maximum of 5 mg per dose, given the higher risks of overconsumption with edibles, the risks of accidents in children and the experience in other jurisdictions. Colorado’s limit was set at 10 mg per unit, and health authorities recognize that a lower limit would have been warranted to prevent more accidents. Other preventive measures, such as child proof packaging, are considered in other sections of this brief. The amount of THC must be displayed clearly and prominently on the package to help prevent accidental or overconsumption of the product. Rules addressing the types of ingredients and additives that could be used in edible cannabis, cannabis extracts, and cannabis topicals appropriately address public health and safety risks while enabling sufficient product diversity The CMA concurs with the proposed regulations. Experience in areas such as caffeinated, high-sugar alcoholic beverages provides ample evidence to proceed with restraint concerning the types of ingredients and additives that may be permitted in edible cannabis, cannabis extracts, and cannabis topicals. Proposed new rules for the packaging and labelling of the new classes of cannabis products The CMA reiterates its position with respect to the packaging and labelling of cannabis products as presented in its submission on the proposed approach to the regulation of cannabis.5 This includes:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause an overdose. Plain and standardized packaging is necessary with respect to edibles as their wider availability raises several public health issues, not the least of which is ingestion by young children. It is imperative that the packages and labels of edibles not resemble popular confectionaries, for example. As the Canadian Paediatric Society has noted, “the unintended consumption of edibles manufactured to look like sweets by younger children is particularly concerning.”15 Also, by “restricting the extent to which marijuana edibles can look and taste like familiar sweets, (it) could also keep the psychological barriers to marijuana initiation among children and adolescents from being lowered.” The CMA has adopted similar positions with respect to tobacco and vaping products. , , It is recognized that these regulations are targeted at products meant for the adult market, but the entry of these new classes also creates challenges beyond that audience. Teens are attracted to vaping cannabis rather than smoking it because “smoke is not combusted and also may allow for more covert use given the reduction in odor.” , As well, as “edibles have no odor, they are largely undetectable to parents.”23 The CMA views this as an opportunity to educate Canadians about the health, social and economic harms of cannabis especially in young people. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Inserts should include:5
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. Cannabis topicals, as outlined in the proposed regulations, would fall under the category of health products and be found in non-prescription drugs, natural health products, and cosmetics. The CMA believes that all health claims need to be substantiated with sufficient evidence that meets standards for efficacy, besides safety and quality, to protect Canadians from misleading claims.5 This is important because the level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence for effectiveness is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product.5 Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. More research is required to address the environmental concerns with extra packaging, which would result from single dose packaging. It is critical to put in place measures that make it difficult to ingest large doses of THC. Simply adding grooves to chocolate bars or baked goods, for example, separating different doses, is insufficient to prevent people, particularly children, from ingesting more than a dose (which in of itself is designed for an adult). As well, there is no guarantee that the THC is spread out uniformly throughout the product. More research is needed with respect to “determining risks and benefits through proper clinical trials;” that includes determining the safest level of THC for extracts and topicals to reassure consumers will not be harmed by these products.18 With regards to cannabidiol (CBD), it would seem that “published data from around the world has taught us that misleading labels as well as harmful contaminants are real and actual problems for CBD products.”18 Health claims need to be substantiated via a strong evidentiary process. There will be a need for careful monitoring of the health products released in the market and the health claims made.5 Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Edible cannabis and the requirement for all products to be labelled with a cannabis-specific nutrition facts table Yes. The CMA supports the use of a cannabis-specific nutrition facts table (NFT) as described in the proposed regulations.1 These products should have the same standards and regulations applied to them as traditional food products do under the Food and Drugs Regulations. As such, a cannabis-specific nutrition facts table will help consumers differentiate them from standard food products. The proposal for the labelling of small containers and the option to display certain information on a peel-back or accordion panel The size of the container should not be an impediment to supplying consumers with the necessary information to make informed choices. Manufacturers should be required to use whatever method (peel-back or accordion panel) is most efficient and conveys all the necessary information. As the CMA noted in a recent brief with respect to tobacco labeling the “amount of space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available, like that of a regular cigarette package.”20 Adding warnings on individual cigarettes, as we recommended, illustrates that it is feasible to apply important information to even the smallest surfaces.20 It is important to note that key information should be visible on the external part of the container, including the standardized cannabis symbol, ingredients and warnings. Proposal that the standardized cannabis symbol would be required on vaping devices, vaping cartridges, and wrappers Yes. As noted earlier, the CMA called for strict packaging requirements around both tobacco and vaping products.22 The requirement for the standardized cannabis symbol is an extension of that policy and to the labelling of cannabis products in general.5 Proposed new good production practices, such as the requirement to have a Preventive Control Plan, appropriately address the risks associated with the production of cannabis, including the risk of product contamination and cross-contamination Yes. The CMA concurs with this requirement. The requirement that the production of edible cannabis could not occur in a building where conventional food is produced Yes. The CMA concurs with this requirement. Separate facilities are necessary to prevent cross-contamination for the protection of consumer health and safety. Conclusion The CMA supports the federal government’s commitment to a three-year legislative review as it affords the opportunity to evaluate the regulations’ impact and adjust them as needed. It continues to be important to have good surveillance and monitoring systems, as well as to continue to learn from other jurisdictions where cannabis is legal for recreational purposes. Public education and awareness must accompany the introduction of new forms of cannabis, emphasizing the risks of accidental ingestion and overconsumption. It should also emphasize the need for safe storage of cannabis products, as well as personal possession limits. Much more research is needed into the impact of these new classes across all age groups, and into public health strategies that discourage use and increase harm reduction practices. It is fundamental that profit driven commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls, in a manner that is consistent with a public health approach. Government of Canada. Canada Gazette, Part I, Volume 152, Number 51: Regulations Amending the Cannabis Regulations (New Classes of Cannabis) Ottawa: Health Canada; 2018. Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-12-22/html/reg4-eng.html (accessed 2018 Dec 22). Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed& (accessed 2019 Feb 01). Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Feb 04). Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11138 (accessed 2019 Feb 14). Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://policybase.cma.ca/en/permalink/policy1968 (accessed 2019 Feb 14). Monte A, Zane R, Heard K. The Implications of Marijuana Legalization in Colorado JAMA. 2015 January 20; 313(3): 241–242 Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ (accessed 2019 Feb 15). Peters E, Bae D, Barrington-Trimis J, et al. Prevalence and Sociodemographic Correlates of Adolescent Use and Polyuse of Combustible, Vaporized, and Edible Cannabis Products JAMA Network Open. 2018;1(5): e182765. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703946 (accessed 2019 Feb 15). Wyonch R. Regulation of Edible and Concentrated Marijuana Products Intelligence Memos. Toronto: CD Howe Institute: 2018 Oct 2. Available: https://www.cdhowe.org/sites/default/files/blog_Rosalie_1002.pdf (accessed 2019 Feb 01). Vandrey R, Raber JC, Raber ME, et al. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. Research Letter JAMA 2015 Jun 23-30;313(24):2491-3. Available: https://jamanetwork.com/journals/jama/fullarticle/2338239 (accessed 2019 Feb 06). Cascini F, Aiello C, Di Tanna G. Increasing Delta-9-Tetrahydrocannabinol ( -9-THC) Content in Herbal Cannabis Over Time: Systematic Review and Meta-Analysis. Curr Drug Abuse Rev. 2012 Mar;5(1):32-40. Available: https://www.datia.org/datia/resources/IncreasingDelta9.pdf (accessed 2019 Feb 14). Gobbi G, Atkin T, Zytynski T, et al. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood. A Systematic Review and Meta-analysis JAMA Psychiatry. 2019 Feb 13. doi: 10.1001/jamapsychiatry.2018.4500. Available: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2723657 (accessed 2019 Feb 15). Saunders A, Stevenson RS. Marijuana Lollipop-Induced Myocardial Infarction. Can J Cardiol. 2019 Feb;35(2):229. Available: https://www.onlinecjc.ca/article/S0828-282X(18)31324-2/fulltext (accessed: 2019 Feb 11). Grant CN, Bélanger RE.Cannabis and Canada’s children and youth. Paediatr Child Health. 2017 May;22(2):98-102. Available: https://www.cps.ca/en/documents/position/cannabis-children-and-youth (accessed 2019 Feb 06). Denver Public Heath. Substance Use Exposure Dashboard. Denver: Denver Public Health; 2018. Available: http://www.denverpublichealth.org/community-health-promotion/substance-misuse/substance-use-exposure-dashboard (accessed 2019 Feb 06). Neuwirth, J. (Colorado Department of Public Health and Environment). Personal interview. (2019 Jan 30). Paradis C, April N, Cyr C, et al. The Canadian alcopop tragedy should trigger evidence-informed revisions of federal alcohol regulations. Drug Alcohol Rev. 2019 Feb 4. Available: https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.12896 (accessed 2019 Feb 14). MacCoun, RJ, Mello MM, Half-Baked — The Retail Promotion of Marijuana Edibles. N Engl J Med 2015; 372:989-991. Available: https://www.nejm.org/doi/full/10.1056/NEJMp1416014 (accessed 2019 Feb 5). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Feb 05). Canadian Medical Association (CMA). Health Canada’s Consultation on New Health-related Labelling for Tobacco Products Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13939 (accessed 2019 Feb 05). Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Feb 05). Johnson RM, Brooks-Russell A, Ma M, et al. Usual Modes of Marijuana Consumption Among High School Students in Colorado. J Stud Alcohol Drugs. 2016;77(4):580-8. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987070/pdf/jsad.2016.77.580.pdf (accessed 2019 Feb 06). Friese B, Slater MD, Annechino R, et al. Teen Use of Marijuana Edibles: A Focus Group Study of an Emerging Issue. J Prim Prev. 2016 June 37(3):303–309. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4864086/pdf/nihms-766186.pdf (accessed 2019 Feb 06).
Documents
Less detail

Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products

https://policybase.cma.ca/en/permalink/policy14022
Date
2019-03-22
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-03-22
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products under the authority of the Tobacco and Vaping Products Act (TVPA). 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 supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes. This brief will address the two main issues outlined in the Notice of Intent: the placement of advertising and health warnings. Placement of Advertising The CMA’s approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. This would include the same approach to plain and standardized packaging regulations under consideration for tobacco products.2, The CMA is concerned that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. It is from a public health perspective that the CMA is calling for all vaping advertising to be strictly limited. The CMA supports the provisions proposed for point-of-sale information. The material offered will need to have the health warnings included in this Notice of Intent. However, the sections of the proposed regulations most problematic to the CMA are those encompassing public places, broadcast media, and the publications areas. Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.2 The advertisements permitted currently seem to have managed to find their way to youth, even if they are not directed at them, as claimed. A report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.” Social media provides an easy means of promoting vaping products and techniques, especially to youth.21 A US study found that the landscape is “being dominated by pro-vaping messages disseminated by the vaping industry and vaping proponents, whereas the uncertainty surrounding e-cigarette regulation expressed within the public health field appears not to be reflected in ongoing social media dialogues.” The authors recommended that “real-time monitoring and surveillance of how these devices are discussed, promoted, and used on social media is necessary in conjunction with evidence published in academic journals.”6 The need to address the issue of advertising around vaping is growing more urgent. Vaping is becoming more popular and more attractive to Canadian youth, especially with the arrival of more high-tech versions of electronic cigarettes such as the pod-based JUUL™. , A similar trend has been observed in the United States where a recent study indicated that “use by adolescents and young adults of newer types of e-cigarettes such as pod-based systems is increasing rapidly.” JUUL™ entered the US market in 2015 “with a novel chemistry (nicotine salts) enabling higher concentrations in a limited aerosol plume.” JUUL’s™ nicotine levels contained 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods. Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).10 The nicotine salts are “less harsh and less bitter, making e-liquids more palatable despite higher nicotine levels.”10 It has been noted by researchers that “among adolescents and young adults who use them, pod-based e-cigarettes are synonymous with the brand-name JUUL™ and use is termed “juuling,” whereas “vaping” has typically been used by youths to refer to using all other types of e-cigarettes.”9 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.10, The purpose in doing so is because “smoking is not a natural behavior, like eating or drinking, the manufacturers of these devices commonly add flavoring to the liquid from which the nicotine aerosol is generated, to make the initial exposures more pleasurable. The flavoring enhances the appeal to first-time users — especially teenagers.” The CMA and other expert groups would prefer to see flavours banned to reduce the attractiveness of vaping as much as possible.2, It is very important that the pod-based systems are cited specifically to ensure they are included under the new advertising regulations for all vaping products. Youth vaping has reached the point where the US Food and Drug Administration referred to it as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.” Durham Region Health Department, using data from the Ontario Student Drug Use and Health Survey conducted by CAMH and administered by the Institute for Social Research, York University, noted that 17% of high school students in that region had used an electronic cigarette in the past year (2016-17), numbers that are similar for the rest of Ontario. In the United States, a survey indicated that, among high school students, “current e-cigarette use increased from 1.5% (220,000 students) in 2011 to 20.8% (3.05 million students) in 2018;” between 2017 and 2018 alone it rose 78% (from 11.7% to 20.8%). Concern is growing across Canada among educators seeing a rise in the number of youths turning to vaping. , , The problem has reached the point where a school official resorted to removing the doors from the washrooms to “crack down” on vaping in the school. Youth themselves are aware of the increasing problem; many are turning to YouTube to learn “vape tricks” such as making smoke rings. Some refer to the practice of vaping as “the nic;” as a University of Ottawa student noted “They call it getting light-headed. Sometimes it's cool.” As the Canadian Paediatric Society noted in 2015, efforts to “denormalize tobacco smoking in society and historic reductions in tobacco consumption may be undermined by this new ‘gateway’ product to nicotine dependency.” , Decades of effort to reduce the incidence of smoking are in danger of being reversed. A growing body of evidence indicates that vaping can be considered the prime suspect. A Canadian study provides “strong evidence” that use of electronic cigarettes among youth is leading them to the consumption of combustible tobacco products. In a similar vein, a “large nationally representative study of US youths supports the view that e-cigarettes represent a catalyst for cigarette initiation among youths.” Granting vaping manufacturers scope to advertise will likely exacerbate this problem. Health Warnings The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages.2,3 We support the proposed warning labels being placed on all vaping products. The need for such warnings is important as there is still much that is not known about the effects vaping can have on the human body. Substances that have been identified in e-cigarette liquids and aerosols include “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.” Researchers have noted that there is a “striking diversity of the flavorings in e-cigarette liquids, (and that) the effects on health of the aerosol constituents produced by these flavorings are unknown.” A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.” Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.” , Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.” Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.”32 The need for parents to be educated on the impact of vaping on children is also very important. A study examining how smoke-free and vape-free home and car policies vary for parents who are dual users of cigarettes and e-cigarettes, who only smoke cigarettes, or who only use e-cigarettes demonstrated that these parents may perceive e-cigarette aerosol as safe for children. It noted that “dual users were less likely than cigarette-only smokers to report various child-protective measures inside homes and cars.”33 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. 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. 3. The CMA supports the provisions proposed in this Notice of Intent for point-of-sale information. This should include health warnings. 4. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products. 5. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids. Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products Ottawa: Health Canada; 2019 Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youth-non-users-tobacco-products.html (accessed 2019 Feb 27) Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-06.pdf (accessed 2019 Mar 1). Canadian Medical Association. Health Canada consultation on tobacco products regulations (plain and standardized appearance) Ottawa: CMA; 2018 Sep 6 Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2019 Mar 5) Gagnon E. IMPERIAL TOBACCO: Kids shouldn’t be vaping; our marketing is aimed at adults. Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/opinion/imperial-tobacco-kids-shouldnt-be-vaping-our-marketing-is-aimed-at-adults-289673/ (accessed 2019 Mar 8) U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA-8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. Available https://cancercontrol.cancer.gov/brp/tcrb/monographs/21/docs/m21_complete.pdf (accessed 2019 Mar 8) McCausland K, Maycock B, Leaver T, Jancey J. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review J Med Internet Res 2019;21(2):e11953 Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 Mar 14) Glauser W. New vaping products with techy allure exploding in popularity among youth. CMAJ 2019 February 11;191:E172-3. doi: 10.1503/cmaj.109-5710 Available: http://www.cmaj.ca/content/191/6/E172 (accessed 2019 Mar 1) Crowe K. Canada's 'wicked' debate over vaping CBC News February 2, 2019 Available https://www.cbc.ca/news/health/vaping-juul-vype-health-canada-cigarette-smoking-nicotine-addiction-1.5003164 (accessed 2019 Mar 8) McKelvey K et al. Adolescents’ and Young Adults’ Use and Perceptions of Pod-Based Electronic Cigarettes. JAMA Network Open. 2018;1(6):e183535. doi:10.1001/jamanetworkopen.2018.3535 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2707425 (accessed 2019 Mar 1) Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. doi:10.1136/tobaccocontrol-2018-054796 Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 Mar 12) Reichardt EM., Guichon J. Vaping is an urgent threat to public health The Conversation March 13, 2019 Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 Mar 14) Drazen JM., Morrissey S., Campion, EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680 Available: https://www.nejm.org/doi/full/10.1056/NEJMe1900484 (accessed 2019 Mar 13) Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there CBC News November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 Mar 13) Food and Drug Administration Statement. Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use Media Release February 11, 2019 Available: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631112.htm (accessed 2019 Mar 11) Durham Region Health Department Students’ use of e-cigarettes in the past year, 2016-2017 Quick Facts December 2018 Available https://www.durham.ca/en/health-and-wellness/resources/Documents/HealthInformationServices/HealthStatisticsReports/E-cigaretteAlternativeSmokingDeviceStudents-QF.pdf (accessed 2019 Mar 11) Cullen KA et al. Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018 Morbidity and Mortality Weekly Report November 16, 2018 Vol. 67 No. 45 Available: https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm (accessed 2019 Mar 13) Munro N. Vaping on the rise in Nova Scotia high schools Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/news/local/vaping-on-the-rise-in-nova-scotia-high-schools-289761/ (accessed 2019 Mar 11) Soloducha A. Is your child vaping? Regina Catholic Schools educating parents as trend continues to rise CBC News March 1, 2019 Available https://www.cbc.ca/news/canada/saskatchewan/regins-catholic-schools-vaping-education-1.5039717 (accessed 2019 Mar 11) Emde W. Growth of vaping labelled ‘crisis’ in Vernon. Kelowna Daily Courier Available http://www.kelownadailycourier.ca/life/article_253d6404-4168-11e9-934f-7b6df68fb0fd.html (accessed 2019 Mar 11) Lathem C. Ottawa principal's solution to student vaping: Remove the washroom doors. CTV News January 9, 2019 Available https://www.ctvnews.ca/canada/ottawa-principal-s-solution-to-student-vaping-remove-the-washroom-doors-1.4246317 (accessed 2019 Mar 11)) Calioa D. Vaping an 'epidemic,' Ottawa high school student says CBC News November 27, 2018 Available https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 Mar 11) Schnurr J. New data is showing a worrisome trend about vaping and smoking among teens CTV News January 18, 2019 Available https://ottawa.ctvnews.ca/new-data-is-showing-a-worrisome-trend-about-vaping-and-smoking-among-teens-1.4260008 (accessed 2019 Mar 11) Stanwick R. E-cigarettes: Are we renormalizing public smoking? Reversing five decades of tobacco control and revitalizing nicotine dependency in children and youth in Canada Policy Statement Canadian Paediatric Society March 6, 2015 (Reaffirmed February 28, 2018) Available: https://www.cps.ca/en/documents/position/e-cigarettes (accessed 2019 Mar 12) Fairchild AL., Bayer R., Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med 370:4 January 23, 2014 Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2019 Mar 12) Hammond d. et al. Electronic cigarette use and smoking initiation among youth: a longitudinal cohort study. CMAJ October 30, 2017 189 (43) E1328-E1336; Available: http://www.cmaj.ca/content/189/43/E1328 (accessed 2019 Mar 1) Berry KM et al. Association of Electronic Cigarette Use With Subsequent Initiation of Tobacco Cigarettes in US Youths JAMA Network Open. 2019;2(2):e187794. doi:10.1001/jamanetworkopen.2018.7794 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723425?resultClick=3 (accessed 2019 Mar 12) National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24952. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 Mar 13) Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med 2016;375:1372-81 Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Mar 13) Goniewicz ML. et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes JAMA Network Open. 2018;1(8):e185937 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2718096 (accessed 2019 Mar 13) Chan LF. Et al. Pulmonary toxicity of e-cigarettes Am J Physiol Lung Cell Mol Physiol 313: L193–L206, 2017 Available: https://www.physiology.org/doi/full/10.1152/ajplung.00071.2017?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed (accessed 2019 Mar 13) Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control. 0:1-8, 2019. American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Mar 13) Drehmer JE, Nabi-Burza E, Hipple Walters B, et al. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019;143(4):e20183249 Available: https://pediatrics.aappublications.org/content/early/2019/03/07/peds.2018-3249 (accessed 2019 Mar 13)
Documents
Less detail

Concussion in Sport, Leisure, and Occupational Settings

https://policybase.cma.ca/en/permalink/policy14023
Date
2019-03-02
Topics
Health care and patient safety
Population health/ health equity/ public health
  2 documents  
Policy Type
Policy document
Date
2019-03-02
Replaces
Head injury and sport (2011)
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
Concussions and head injuries are a common occurrence in sport and leisure activities, and frequently occur in occupational settings as well. While the majority of individuals who suffer from a concussion will recover with time, others may be at risk for serious and lasting complications. These include (1) children; (2) previous history of head injury or concussion; (3) prior mental health symptoms; and (4) missed diagnosis and management. This aim of this advocacy and policy document is to improve safety during activity by raising awareness of concussions, and by working to improve the detection and safe management of concussions when they occur. It is not a clinical practice guideline. It should not be perceived as a plea to avoid sports or leisure activities, but rather as a call for safer sporting, leisure, and occupational practices. The documented health benefits that result from establishing an active lifestyle in youth and maintaining it throughout life cannot be overstated. Achieving balance of safe play in sport, leisure and occupational activities while promoting greater physical activity levels for Canadians would have the effect of reducing health care costs in Canada, while promoting a healthier concussion recovery culture for all Canadians. Therefore, to promote better concussion and head trauma awareness and prevention, as well as better management/treatment practices, the following policy recommendations for key target audiences across all levels of sport, leisure, and occupational activity are made. Key Concussion & Head Injury Principles: a) The detection of concussions and head injury should be a shared responsibility and any stakeholder/observer to such an injury should verbally raise their concerns that a concussion may have occurred. i. It is important to understand that individuals with a possible concussion, or head injury, may not be able to recognize that they are suffering from a concussion; ii. It is important to recognize that engrained within popular culture are dangerous notions (e.g., to minimize, ignore, downplay, or play through the pain, etc.) that cause individuals/observers to ignore the real, often hidden, dangers of such injuries. b) Broadly speaking, access to the latest edition of the internationally recognized Concussion Recognition Tool (CRT) should be promoted/available to help identify the signs and symptoms of a possible concussion; c) Any individual who sustains more than a minor head injury should be immediately removed from play, activity, or occupation, and not permitted to return on the same day3 (regardless of whether a concussion is later suspected). i. These individuals should be the subject of observation for developing/evolving concussion symptoms or emergency warning signs (especially within the first 4 hours post-injury, but also up to 48 hours when red-flag symptoms are present). d) Following first aid principles, where an individual displays signs of a serious head or spinal injury, that individual should lie still (not moving their head or neck) until a qualified individual has performed an evaluation; to determine whether emergency evacuation for medical assessment is necessary. e) Any individual with a suspected concussion (especially where red-flag symptoms are present), or more severe traumatic brain injury, should be promptly evaluated by a physician to: i. Either rule-out or confirm a diagnosis via an appropriate medical assessment; and ii. Institute the provision of an age-appropriate follow-up care plan (including progressive return to school, work, and play protocols) if such an injury is confirmed.1 f) Ideally, a physician knowledgeable in concussion management determines when, and how, a concussed individual should progressively return to both cognitive (school or work) and physical activities. g) Following a suspected, or diagnosed concussion, an individual should not return to play, or resume any activity associated with a heightened risk of head trauma, until cleared by a physician to do so.1 Recommendations For: 1. Physicians: Should: a) Where possible, encourage safe play practices in sports, and where appropriate, educate patients about the risks of head injuries (associated with high-risk behavior in sports, leisure and occupational activities). b) Gain/maintain, through relevant continuous medical education, competencies related to the assessment, diagnosis and management of concussion according to most current clinical practice recommendations (e.g., latest edition of the CRT, SCAT, Child SCAT, Acute Concussion Evaluation Tool, etc.). c) Be aware that clinical practice guidelines and assessment tools exist to assist in assessing and treating concussed individuals (e.g., Ontario Neurotrauma Foundation, Parachute Canada, etc.). d) When assessing a patient with a potential concussion: i. Rule out the presence of more severe traumatic brain and musculoskeletal injury; ii. Assess for any previous concussion history, risk factors and newly arising complications; iii. Educate and instruct parents, athletes and any individual that sustains a concussion about what to do, and what to expect, in the post concussive phase. (This should be based on the most current age-appropriate concussion management guidelines);4 iv. Provide individualized recommendations on how to optimally apply the progressive return-to-school, work, and play strategies with consideration for the specificities of the patient’s usual activities and responsibilities;4 v. Work to provide concussed patients timely access for medical reassessment in the event of worsening or persistent symptoms (including mental health); and vi. In the presence of persistent or worsening symptoms (including mental health), consider what external, evidence based, concussion resources may be necessary as well as referral. 2. Medical Colleges & Faculties: Should: a) Promote/support medical education regarding; awareness, detection/diagnosis; and the appropriate management of concussions, throughout the continuum of medical education (undergraduate, post-graduate, and continuing medical education). b) Support research in concussion prevention, detection, and treatment or management. 3. Athletes in Contact/Collision Sports: Should: a) (Prior to the commencement of the sporting season) be given age-appropriate instruction2 to understand: i. How to identify the signs and symptoms of a possible concussion using the latest edition of the internationally recognized CRT (e.g. Concussion Recognition Tool, or Concussion Awareness Training Tool (CATT)); ii. The risks associated with concussion (including long term and mental health); especially, the risks of potentially life-threatening complications associated with continued sport participation, while presenting with signs or symptoms of a possible concussion; iii. What to do/expect if a concussion is ever suspected (including for teammates), and the expected role of the athlete and team members; iv. Removal and progressive returns to school, work and play policies/procedures, and the expected role of the athlete in the recovery process; and v. How to foster a healthy sporting culture (that promotes: safe play practices; fosters concussion/injury prevention and reporting; peer-to-peer support; and combat injury stigmatization). b) Have such instruction reinforced periodically throughout the sporting season as needed. c) Be aware of, and seek treatment for, potentially serious mental health issues that may arise post-concussive injury. 4. Parents with Minors in Contact/Collision Sports: Should: a) Prior to the commencement of a sporting season, request and be open to receiving instruction2 on: i. How to identify the signs and symptoms of a possible concussion using the latest edition of the internationally recognized CRT (e.g. Concussion Recognition Tool, or Concussion Awareness Training Tool (CATT)); ii. The risks associated with concussion; especially, the risks of potentially life-threatening complications associated with continued sport participation, while presenting with signs or symptoms of a possible concussion; iii. What to do/expect if a concussion is ever suspected for an athlete; iv. Removal and progressive returns to school, work and play policies/procedures, and the expected role of the parent(s) in the recovery process; and v. How to foster a healthy sporting culture that promotes: safe play practices; fosters concussion/injury prevention and reporting; peer-to-peer support; and combats injury stigmatization. b) Have such instruction reinforced periodically throughout the sporting season as needed. c) Be prepared to address potentially serious mental health issues that may arise post-concussive injury. 5. Individuals Who Sustain a Head Injury Outside of Organized Sports: Should: a) Be aware of possible signs and symptoms of a possible concussion, and immediately withdraw from activity and seek medical assessment a possible concussion is suspected.1 i. Refer to the latest addition of the internationally recognized CRT (Concussion Recognition Tool) for further guidance on signs and symptoms.3 b) Understand the risks associated with concussion; including the risks of potentially life-threatening complications associated with repeated head injury if signs or symptoms of a possible concussion are present. c) In the event of a diagnosis of concussion, judiciously implement the medical recommendations received regarding their gradual return to cognitive and physical activity (including the need for medical reassessment in the presence of persistent symptoms). d) Openly communicate their recovery needs and work with any group or individual who might support them in their recovery process (e.g., employers, family members, school, etc.). e) Be aware of, and seek treatment for, potentially serious mental health issues that may arise post-concussive injury. 6. Coaches, Trainers, Referees, & First Responders: Should: a) Receive certified emergency first aid training. b) Receive periodic education (ideally annually) on national standards regarding the signs and symptoms, potential long-term consequences, appropriate steps for initial intervention, and immediate management (including: athlete removal-from-play; observation; determining when medical assessment is necessary; and progressive return to school, work and play procedures). c) Be trained in the use of the latest edition of the internationally recognized CRT (Concussion Recognition Tool) – to detect whether an injured individual is suffering from a concussion.2 d) Be knowledgeable and responsible to ensure safety and safe play practices are applied throughout the sporting season. e) Be responsible for fostering a healthy sporting culture (promote safe play practices, foster concussion/injury prevention and reporting, peer-to-peer support and combat injury stigmatization). f) Be prepared to address potentially serious mental health issues that may arise post-concussive injury. 7. Licensed Health Care Providers Involved as Therapists in Sport Environments: Should: a) Be fully licensed in their professional field and pursue continuing professional development to maintain competencies related to concussion and head injuries. b) Promote the implementation of properly adapted concussion management protocols (that comply with the most current clinical recommendations, based on consideration for the specificities of each sport environment and available resources). c) Work with qualified physicians to initiate/implement tailored medically supervised concussion management protocols that define: i. Mutual and shared health professional responsibilities to optimize the quality, and safety of patient care (within one’s scope of practice); and ii. The optimal corridors for timely access to medical (re)assessment with due consideration for available resources. d) Be prepared to address potentially serious mental health issues that may arise post-concussive injury. 8. Educational Institutions & Sports Organizations: Should: a) (Especially in the cases involving minors) implement, and keep updated, prevention strategies to include: i. Safety standards that include safe play policies; and ii. Mandatory safety gear/equipment (tailored to individual sport settings). b) Mandatory concussion and head injury protocols that work to: i. Reduce the occurrence of concussions and head injury by promoting: safe play practices; fostering concussion/injury prevention and reporting; peer-to-peer support, and combatting injury stigmatization; ii. Ensure the prompt detection, and standardized early management of concussion and head injuries, by informing all potential stakeholders (in the preseason phase) about the nature/risks of concussion and head injury, and how any such occurrence will be dealt with should they occur; iii. Enshrine into practice removal-from-play, and post-injury observation of athletes; iv. Progressively reintegrate students back into symptom guided educational and physical activities based on the most current recommendations;2 v. Reintegrate injured athletes back into unrestricted training activities and sport once medical clearance has been obtained; and vi. Foster better lines of communication for injury management/recovery between: parents, athletes, coaches, school personnel, therapists and physicians. vii. Address potentially serious mental health issues that may arise post-concussive injury. 9. Employers (Occupational Considerations) Should: a) Comply with workplace safety laws and implement safety standards to reduce the incidence of head injuries in the work environment. b) Integrate considerations for concussion and head injury in health and safety protocols that work to: i. Reduce the occurrence of concussions and head injury by promoting: safe practices; concussion/injury prevention and reporting; peer-to-peer support, and combats injury stigmatization; ii. Ensure prompt detection and standardized early management of concussion and head injuries by informing potential stakeholders about the nature/risks of concussion and head injury, and how occurrences will be dealt with should they occur; iii. Enshrine into practice/ workplace culture the removal-from-work, and post-injury observation of workers; iv. Progressively reintegrate workers back into symptom guided cognitive and physical activities based on the most current recommendations; v. Reintegrate injured workers with a confirmed diagnosis of concussion, progressively back into work activities only once medical clearance has been obtained; and vi. Foster better lines of communication, and support for, injury management between: employees, employers, medical professionals and insurances. vii. Address the potentially serious mental health issues that may arise post-concussive injury. 10. Governments & Professional Regulatory Bodies: Should: a) Implement comprehensive public health strategies for the Canadian population to: i. Increase awareness that concussions can be sustained in accidents, sports, leisure and occupational contexts; ii. Inform head injuries should be taken seriously; and iii. Explain how and why concussions should be prevented and promptly assessed by a physician where they are suspected to have occurred. b) Define appropriate scopes of practice for all health professionals involved in the field of concussion detection, management, and treatment. c) Work with key stakeholders to develop compensation structures to support physicians to allocate the time necessary to: (1) conduct appropriate assessments to rule out concussions, (2) provide ongoing concussion management, and (3) develop detailed medical clearance plans. d) Work with key stakeholders to develop standardized educational tools for physicians to provide to patients with concussions. i. Ideally this would include contextualized tools for sports teams, schools, and employers. e) Adopt legislation or regulation for educational institutions and community-based sport associations to establish clear expectations/obligations regarding concussion awareness and management for youth in sports (e.g., Ontario’s Rowan’s law). i. To have meaningful impact, such initiatives must also be accompanied by: implementation funding to support the development and implementation of sport specific concussion management protocols; and monitoring/compliance programs. f) Establish a national concussion and sports injury surveillance system (with standardized metrics) to collect detailed head and sport injury related information. Thus, providing the ability to research such injuries in an ongoing and timely manner. g) Provide research opportunities/funding on concussions. Specific examples of research areas to prioritize include: i. Effective prevention strategies for both adults and children in a range of sport, leisure, or occupational environments; ii. The incidence and impact of concussions in children, and how to reduce their occurrence (inside and outside of sport); iii. Address knowledge gaps for concussion identification, management, and medical clearance for physicians not specialized in concussion care; iv. Explore all health professionals’ participation in concussion management providing for respective: competency, expertise, interdisciplinary collaboration, and appropriate roles; v. Evaluate how emerging point of care diagnostics and biomarker testing will be incorporated into sport, leisure and work environments; vi. Continued development of effective, user-friendly, and age appropriate management strategies/tools for physicians regarding concussion identification, management, and medical clearances; and vii. Develop a harmonized understanding of “concussion” and “mild traumatic brain injury” (MTBI) constructs/concepts, so that adults with concussion signs or symptoms, who do not meet the more restrictive MTBI criteria, are properly managed. McCrory P, Meeuwisse W, Dvorak J, et al. Consensus Statement on Concussion in Sport - the 5th International Conference on Concussion in Sport Held in Berlin. Br J Sports Med 2017, 51: 838-847. Parachute Canada. Canadian Guideline on Concussion in Sport. 2017. Available: http://www.parachutecanada.org/injury-topics/item/canadian-guideline-on-concussion-in-sport (accessed 2018 Jul 31). Concussion in Sport Group. Concussion Recognition Tool 5. Br J Sports Med 2017 51: 872. Available: https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097508CRT5.full.pdf (accessed 2018 July 31st). (accessed 2018 Jul 31). Ontario Neurotrauma Foundation. Guidelines for Concussion/Mild Traumatic Brain Injury & Persistent Symptoms. Health Care Professional Version. 3rd Ed, Adults (18 + years of age). Toronto: Ontario Neurotrauma Foundation; 2018. Available: http://braininjuryguidelines.org/concussion/fileadmin/media/adult-concussion-guidelines-3rd-edition.pdf (accessed 2018 Jul 31). Concussion in Sport Group. Sport Concussion Assessment Tool – 5th Ed. Br J Sports Med 2017, 0:1-8. Available: https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097508CRT5.full.pdf (accessed 2018 July 31). Approved by the CMA Board of Directors March 2019
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Health Canada consultation on reducing youth access and appeal of vaping products

https://policybase.cma.ca/en/permalink/policy14078
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures.1 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 supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. 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 all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. The CMA has stated its position to the federal government on electronic cigarettes and vaping clearly in recent years.2,3 In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.2 We also argued that the government should take the same approach to plain and standardized packaging regulations for e-cigarettes as has now been implemented for tobacco products.2 In our most recent brief we addressed the two main issues outlined in the government’s Notice of Intent with respect to the advertising of vaping products: the placement of that advertising and the use of health warnings.3,4 We expressed concerns that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. Further, we reiterated our position that health warnings for vaping should be like those being considered for tobacco packages. This brief will address the issues of greatest concern to the CMA with respect to vaping and youth. This includes marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths. Introduction The Council of Chief Medical Officers of Health have expressed alarm at the rising number of Canadian youths who are vaping, finding this trend “very troubling.”5 The Canadian Medical Association concurs with this assessment and appeals to the federal government to move urgently on this important public health issue. As our knowledge about the risks of using e-cigarettes increases, there is an even greater imperative to dissuade youth from taking up the habit. This is important because those youth “who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes.”6 Marketing The e-cigarette marketplace is evolving quickly as new products emerge. The industry has made clever use of social media channels to promote their wares by taking advantage of the belief that they are a safer alternative to cigarettes.7 They have also promoted “innovative flavoring and highlighted the public performance of vaping.”7 It is no surprise that the United States Food and Drug Administration (FDA) has referred to youth vaping as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.”8 As the US National Academies of Sciences, Engineering, and Medicine has noted “young people who begin with e-cigarettes are more likely to transition to combustible cigarette use and become smokers who are at risk to suffer the known health burdens of combustible tobacco cigarettes.”9 However, some of the efforts employed to convince youth to take up vaping are especially troublesome. As the 4 US Centers for Disease Control and Prevention (CDC) reported, “one in 5 (US) high school students and 1 in 20 middle school students reported using e-cigarettes in the past 30 days in 2018,” a significant rise in the number of high school students between 2011 and 2018.10 The use of social media campaigns employing “influencers” to capture more of the youth and young adult market or influence their choices shows the need to be especially vigilant.11 In an attempt to counter this influence, a group of over 100 public health and anti-tobacco organizations from 48 countries “are calling on Facebook, Instagram, Twitter and Snap to take “swift action” to curb advertising of tobacco products on their platforms.”12 As much as the industry is making major efforts to attract or sway customers through advertising, youth themselves may hold the key to countering that pressure. A recent US study found that “adolescents generally had somewhat negative opinions of other adolescents who use e-cigarettes. Building on adolescents’ negativity toward adolescent e-cigarette users may be a productive direction for prevention efforts, and clinicians can play an important role by keeping apprised of the products their adolescent patients are using and providing information on health effects to support negative opinions or dissuade formation of more positive ones.”13 Health Canada can play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers.14 We reiterate the concerns we expressed in our recent brief on the potential measures to reduce advertising of vaping products and to help diminish their appeal to youth. The CMA noted that the sections most problematic to the Association were those encompassing public places, broadcast media, and the publications areas.3 Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.3 These areas need to be addressed on an urgent basis. Flavours As of 2013, over 7,000 flavours had been marketed in the US.15 The data indicated that “about 85% of youth who used e-cigarettes in the past 30 days adopted non-tobacco flavors such as fruit, candy, and dessert.”15 Flavours are helpful in attracting youth, especially when coupled with assertions of lower harm.13 And they have been successful in doing so, as evidenced by the rise in the rates of vaping among youth.8, 16 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.16,17,18 The concern is that e-cigarettes “may further entice youth to experiment with e-cigarettes and boost e-cigarettes’ influence on increased cigarette smoking susceptibility among youth.”15 More worrisome, flavoured e-cigarettes “are recruiting females and those with low smoking-risk profile to experiment with conventional cigarettes.”19 Limiting the availability of “child-friendly flavors” should be considered to reduce the attraction of vaping to youth.19 In a recent announcement, the US FDA has proposed to tighten e-cigarette sales and “remove from the market many of the fruity flavors …blamed on fueling “epidemic” levels of teen use.”20 As we have noted in previous submissions, the CMA would prefer to see flavours banned to reduce the attractiveness of vaping to youth as much as possible, a sentiment shared by other expert groups. 2,3,21 Nicotine Levels One of the most popular devices to vape with is JUUL™, entering the US market in 2015.22 JUUL’s™ nicotine pods contain 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods.17 Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).17 The CMA is very concerned about the rising levels of nicotine available through the vaping process, especially by the newer delivery systems. 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.”23 Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.15,24 In addition to flavours, and to ease delivery and to make the taste more pleasant, nicotine salts are added to make the e-liquid “less harsh and less bitter” and “more 5 palatable despite higher nicotine levels.”17 Addressing the Rise in Youth Vaping There are many factors that lead youth to experiment with vaping and e-cigarettes. For some it is simple curiosity, for others it is the availability of different flavours while still others perceive vaping as “cool,” especially when they can use the vapour to perform “smoke tricks.”25 The pod devices themselves (e.g., JUUL™) help enhance the allure because of the “unique aesthetic appeal of pod devices, ability to deliver nicotine at high concentrations and the convenience of using them quickly and discreetly.”26 As vaping continues to grow in popularity, it will not be easy to curb youths’ enthusiasm for it. However, it is too important of a public health issue to not intervene More research is needed into how youth perceive vaping and e-cigarettes as they do not hold a universally positive view of the habit.7,13 As well, there is evidence to suggest that many are coming to see vaping as being “uncool” and that there are potential health consequences to continued use.25 In view of the still-evolving evidence of the safety of vaping and e-cigarettes, “strategic and effective health communication campaigns that demystify the product and counteract misconceptions regarding e-cigarette use are needed.”25 Further, “to reduce youth appeal, regulation efforts can include restricting the availability of e-cigarette flavors as well as visible vapors.”25 Another approach to consider is the state of Colorado’s recent creation of “a health advisory recommending that health care providers screen all youth specifically for vaping, in addition to tobacco use, because young people may not necessarily associate tobacco with vaping.”27 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. The CMA recommends the limitation of number of flavours available to reduce the attractiveness of vaping to youth. 3. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth becoming addicted. 4. Health Canada must play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers. 5. Health Canada must develop communication campaigns directed at youth, parents and health care providers to demystify vaping and e-cigarettes and that create a link between tobacco and vaping. 1 Government of Canada. Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-reducing-youth-access-appeal-vaping-products-potential-regulatory-measures.html (accessed 2019 Apr 11). 2 Canadian Medical Association (CMA). CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Nonsmokers’ Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 May 13). 3 Canadian Medical Association (CMA). Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products. Ottawa: CMA; 2019 Mar 22. Available: https://policybase.cma.ca/en/permalink/policy14022 (accessed 2019 May 13). 4 Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youthnon-users-tobacco-products.html (accessed 2019 Feb 27). 5 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 May 14). 6 6 Glantz SA. The Evidence of Electronic Cigarette Risks Is Catching Up with Public Perception. JAMA Network Open 2019;2(3):e191032. doi:10.1001/jamanetworkopen.2019.1032. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2729460 (accessed 2019 May 14). 7 McCausland K., et al. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review. J Med Internet Res 2019;21(2):e11953). Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 May 14). 8 Food and Drug Administration (FDA). Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use. Silver Spring, MD: FDA; February 11, 2019. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-data-demonstrating-rising-youth-use-tobacco (accessed 2019 May 17). 9 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 May 17). 10 Kuehn B. Youth e-Cigarette Use. JAMA. 2019;321(2):138. Available: https://jamanetwork.com/journals/jama/fullarticle/2720740 (accessed 2019 May 14). 11 Kirkum C. Philip Morris suspends social media campaign after Reuters exposes young 'influencers'. New York: Reuters; May 10, 2019. Available: https://www.reuters.com/article/us-philipmorris-ecigs-instagram-exclusiv/exclusive-philip-morris-suspends-social-media-campaign-after-reuters-exposes-young-influencers-idUSKCN1SH02K (accessed 2019 May 13). 12 Kirkham C. Citing Reuters report, health groups push tech firms to police tobacco marketing. New York: Reuters; May 22, 2109. Available: https://www.reuters.com/article/us-philipmorris-ecigs-socialmedia/citing-reuters-report-health-groups-push-tech-firms-to-police-tobacco-marketing-idUSKCN1SS1FX (accessed 2019 May 22). 13 McKelvey K, Popova L, Pepper JK, Brewer NT, Halpern-Felsher. Adolescents have unfavorable opinions of adolescents who use e-cigarettes. PLoS ONE 2018;13(11): e0206352. Available: https://doi.org/10.1371/journal.pone.0206352 (accessed 2019 May 14). 14 Calioa D. Vaping an 'epidemic,' Ottawa high school student says. Ottawa: CBC News; November 27, 2018. Available: https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 May 14). 15 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://doi.org/10.1371/journal.pone.0212353 (accessed 2019 May 17). 16 Drazen JM, Morrissey S, Campion EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMe1900484?articleTools=true (accessed 2019 May 17). 17 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 May 20). 18 Reichardt EM., Guichon J. Vaping is an urgent threat to public health. Toronto: The Conversation; March 13, 2019. Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 May 20). 19 Chen JC. et al. Flavored E-cigarette Use and Cigarette Smoking Susceptibility among Youth. Tob Regul Sci. 2017 January ; 3(1): 68–80. Available: https://www.ncbi.nlm.nih.gov/pubmed/30713989 (accessed 2019 May 20). 20 LaVito A. FDA outlines e-cigarette rules, tightens restrictions on fruity flavors to try to curb teen vaping. New Jersey: CNBC; March 13, 2019 Available: https://www.cnbc.com/2019/03/13/fda-tightens-restrictions-on-flavored-e-cigarettes-to-curb-teen-vaping.html (accessed 2019 Mar 20). 21 Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there. Toronto: CBC News; November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 May 20). 22 Huang J, Duan Z, Kwok J, et al. Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tobacco Control 2019;28:146-151. Available: https://tobaccocontrol.bmj.com/content/tobaccocontrol/28/2/146.full.pdf (accessed 2019 May 21). 23 Barrington-Trimis JL, Leventhal AM. Adolescents’ Use of “Pod Mod” E-Cigarettes — Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 May 20). 24 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 May 20). 25 Kong G. et al. Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults. Nicotine & Tobacco Research, 2015 Jul;17(7):847-54. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674436/pdf/ntu257.pdf (accessed 2019 May 21). 26 Keamy-Minor E, McQuoid J, Ling PM. Young adult perceptions of JUUL and other pod electronic cigarette devices in California: a qualitative study. BMJ Open. 2019;9:e026306. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500190/pdf/bmjopen-2018-026306.pdf (accessed 2019 May 21). 27 Ghosh TS, Et al. Youth Vaping and Associated Risk Behaviors — A Snapshot of Colorado. N Engl J Med 2019; 380:689-690.Available: https://www.nejm.org/doi/full/10.1056/NEJMc1900830 (accessed 2019 May 21).
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Antimicrobial Resistance (AMR)

https://policybase.cma.ca/en/permalink/policy14079
Date
2019-03-02
Topics
Health care and patient safety
Population health/ health equity/ public health
  2 documents  
Policy Type
Policy document
Date
2019-03-02
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
Antimicrobials (which include antibiotics) are a precious public resource and an essential tool for fighting infections in both humans and animals. Their importance to human medical, nutritional and economic security cannot be understated. Yet globally, antimicrobials are losing their effectiveness more quickly than new such drugs, treatments and therapies are being identified and introduced to market.1 Over time, this dynamic has eroded the human antimicrobial arsenal, placing the lives and futures of an unacceptable number of people at risk. Antimicrobial resistance (AMR) occurs when microorganisms such as bacteria, viruses, fungi and parasites come into contact with antimicrobial drugs, such as antibiotics, antivirals, antifungals, antimalarials and anthelmintics, and undergo changes. The drugs are rendered ineffective and cannot eradicate infections from the body. AMR is an international challenge that threatens to reverse over a century of progress in public health, health care and human development attributable to antimicrobial use. Indeed, the effects of AMR are already being felt across Canada’s health care system. Currently, Canada’s dedicated investment in solutions to militate against encroaching AMR in the AMR and antimicrobial stewardship (AMS) fields (both federally and provincially/territorially) can only be viewed as wholly inadequate to address the scope of the problem and the risks it poses for the health of Canadians. Therefore, to: (1) promote awareness of AMR; (2) incentivize investment in AMR mitigation strategies; and (3) support the mobilization of an effective suite of more clinically effective management/treatment practices and policies, the following target audience recommendations are offered.a a All the policy recommendations made in this document are not meant to be interpreted as clinical practice guidelines. Any individual who suspects they may have an infection should promptly consult a physician. 2 Key AMR principle — the “One Health” approach a) The complexity of AMR underscores the need for coordinated action known as the “One Health” approach. The term implies integrated strategies that span the human, animal/agricultural and environmental sectors. Thus, cooperation across a wide variety of stakeholders is necessary to address the collective nature of AMR. These stakeholders include governments, health professionals, private and public partners, and the public at large. b) The One Health approach will require attention and investment in the following domains: (1) surveillance of antimicrobial prescribing and usage; (2) infection prevention and control practices that mitigate the spread of resistant pathogens; (3) stewardship programs and practices that educate health professionals, the public, and the private sector and nudge each into more appropriate patterns of supply and demand; and (4) a program of innovation, research and development focused on diagnostics, vaccines and alternative treatments to reduce reliance on antimicrobials. This includes the development of novel antimicrobials that expand the currently available arsenal. c) Given the global dimensions of AMR, a successful One Health approach will require ambitious investments in global AMR mitigation. Given that health infrastructure and resources are limited in low- to middle-income countries, the impacts of AMR will primarily be felt in those settings. Recommendations 1. Physicians and allied health professionals Should: a) Be aware that AMR is a serious public health crisis. b) Know that various Canadian prescribing aides/guidelines are available to assist physicians in choosing appropriate antibiotics and improving practice (e.g., Choosing Wisely Canada). c) Know that using antibiotics appropriately can help combat AMR and that diagnosis and laboratory testing play a key role. This includes only prescribing antibiotics for conditions that are clinically infectious and of a non-viral nature. Viral infections are the greatest source of antibiotic misuse. d) Consider delayed prescriptions and/or prioritize follow-up for patients when diagnosis is initially undifferentiated or when symptoms worsen, progress or are prolonged. e) Know that prevention of infections through hand hygiene, vaccination and appropriate use of antibiotic prophylaxis is evidence based and effective f) Know that durations of therapy and dosage rates for treating many infections change with time and that you should prescribe antimicrobials for the shortest effective duration (using the narrowest spectrum possible). 3 g) Consider the potential side effects of antibiotics (including C. difficile and allergic reactions) in prescribing and when counselling patients as to their potential side effects. h) Engage in conversations with patients about antimicrobials regarding: i. their appropriate use; ii. their potential risks; iii. when to delay, begin or end an antimicrobial prescription (e.g., delayed prescriptions); and iv. when to seek medical reassessment if symptoms worsen or persist. i) Ask your local hospital or specialty organization about educational initiatives related to antibiotic prescribing. j) Collaborate where possible with colleagues in other prescribing professions to reduce unnecessary antimicrobial use. 2. Patients and the Canadian public Should: a) Be aware that AMR is a significant problem that is linked to the inappropriate use of antimicrobials like antibiotics. Therefore, commit to only taking antibiotics if they are prescribed and only as directed by an authorized health professional. i. Never share, or use, the antibiotics of others as it may contribute to AMR and have serious consequences for your health. b) Consider that your expectations about antimicrobials may unduly pressure physicians, and other prescribers, to provide you a prescription when an antimicrobial would not be appropriate or helpful. c) Engage in a conversation with prescribers about: i. whether an antimicrobial is necessary; ii. the risks associated with taking an antimicrobial; iii. whether there are simpler and safer options to pursue; and iv. when you should take further actions if your symptoms worsen or do not improve. d) Rather than keeping antimicrobials in your medicine cabinet, throwing them in the garbage/toilet or sharing them with family or friends, practise a One Health mindset. Dispose of all unused and expired antimicrobials at your local pharmacy. This will limit the spread of resistance and prevent antimicrobials from finding their way into the environment. e) Help limit resistance by staying up to date with all recommended vaccinations, and practise good hand hygiene. f) If you or a family member have had personal experiences with AMR, consider sharing them with local politicians (provincial/territorial and federal). 3. Governments (federal, provincial/territorial) Should: 4 a) (Including internationally) immediately make substantial, long term, coordinated and directly dedicated financial investments in AMR and AMS. Specific areas to prioritize include: i. AMR and AMS awareness campaigns targeted to the public; ii. campaigns that support health professionals to incorporate AMS principles into their everyday practice; iii. detailed, and integrated, action plans based on clear metrics of success and that address the needs of communities, primary care practitioners, patients and health care organizations (including long-term care facilities); iv. practical surveillance of antimicrobial resistance, purchasing, prescribing and use that maximizes the opportunity to respond to changing landscapes; v. studying in detail the links, and associated risks, between animal health and agricultural practices and human health; vi. scaling up local AMS initiatives at the provincial/territorial and national health care delivery levels; vii. pharmaceutical development pipelines and non-pharmacological treatment options for AMR infections; viii. inexpensive, accurate and timely point-of-care diagnostic tests (usable in the community, at the bedside or in a clinic) to optimize prescribing; and ix. fostering clinical research, development and innovation in the fields of AMR and AMS. b) Scale up coordination between federal and provincial/territorial AMR and AMS activities. c) Hold regular, high-level meetings of ministers of health, agriculture and finance (both federally and provincially/territorially) to discuss the implications of unchecked AMR and how best to mobilize public finances to address it. d) Strongly consider an arms-length, national-level taskforce to address AMR and AMS. e) Strengthen the roles of the chief public health officer and the provincial/territorial chief medical officers in addressing AMR and AMS. f) Undertake a timely review of the Canadian Antimicrobial Resistance Surveillance System (CARRS) with an emphasis on: i. scaling up the system; ii. standardizing all AMR reporting metrics across the country; and iii. injecting adequate resources into AMR surveillance and tracking antimicrobial usage rates. g) Establish a permanent review body on infectious disease, including pharmacists, microbiologist and other experts, to evaluate the forthcoming Pan-Canadian Action Plan on AMR and release regular progress reports. 5 4. Health care institutions and organizations Should: a) Implement strategic AMR plans that are coordinated, cross-departmental and adopted institution wide. These should be premised on: i. standardized and comprehensive reporting metrics for AMR and antimicrobial usage; ii. tailored infection prevention and control programs to screen for and effectively prevent new AMR infections; iii. improving public and professional awareness of AMR organization wide; iv. improving conservation measures such as prescribing practices (audit and feedback, incentives programs, etc.); and v. supporting and incentivizing appropriate prescribing of antimicrobials. b) Evaluate whether existing policies and procedures, diagnostics and testing capacities, and multidisciplinary and organizational cultures are strategically geared toward combatting AMR. c) Where possible, develop collaborations with other local health institutions, clinical researchers and community, public and private partners to promote AMS. 5. Accreditation and regulatory bodies Should: a) Regularly review and establish meaningful criteria for accreditation, ethical codes and regulatory practice standards surrounding AMR and AMS so that practitioners and health institutions can be informed, supported and kept up to date on emerging AMR trends, practices and issues. b) Adopt profession-specific mandatory requirements for AMR and AMS (proper credentialing and training, regular updating of knowledge and competence for prescribing antimicrobials, appropriate data collection regarding antimicrobial usage, etc.) as part of credentialing. c) Work to promote, support and enhance existing AMS practices and programs. d) Collaborate with health institutions, professional health associations and other accreditation and regulatory bodies to implement AMS goals/plans. 6. Colleges and faculties for medicine and allied health professions Should: a) Promote and support more educational resources for AMS and AMR, throughout the continuum of education (undergraduate, postgraduate and continuing education). i. Topics for these resources should include (1) awareness of AMR and AMS, (2) appropriate diagnostic testing, (3) strategies to minimize antimicrobial use and (4) personal prescribing practices. b) Promote and support research on AMR and the implementation and dissemination of effective AMS strategies. 6 1 Public Health Agency of Canada. Tackling antimicrobial resistance and antimicrobial use: a pan-Canadian framework for action. Ottawa: Public Health Agency of Canada; 2017. Available: https://www.canada.ca/content/dam/hc-sc/documents/services/publications/drugs-health-products/tackling-antimicrobial-resistance-use-pan-canadian-framework-action/tackling-antimicrobial-resistance-use-pan-canadian-framework-action.pdf (accessed 2018 Aug 10). BACKGROUND TO CMA POLICY Antimicrobial Resistance See also CMA Policy Antimicrobial Resistance PD19-08 OVERVIEW The world is at the tipping point of a post-antibiotic era. “Worldwide, we are relying more heavily on antibiotics to ensure our medical, nutritional, and economic security; while simultaneously causing the decline of their usefulness with overuse and ill-advised use.” It is estimated that the world’s use of antimicrobials increased by 65% between 2000 and 2015 — mainly in low- to middle-income countries. Dr. Margaret Chan, the former head of the World Health Organization (WHO), described antimicrobial resistance (AMR) as a slow-moving tsunami for public health. Other experts have characterized AMR as a looming “antibiotic apocalypse,” warning that all countries “will face disastrous consequences if the spread of AMR is not contained.” Others are now calling AMR the “climate change” of health care. According to the UK’s review on AMR, an estimated 10 million people globally will die annually by 2050, and AMR will surpass cancer to become the leading cause of death. AMR occurs when “microorganisms (such as bacteria, fungi, viruses, and parasites) change when they are exposed to antimicrobial drugs (such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics). … As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others.” Microorganisms that develop antimicrobial resistance are sometimes referred to as “superbugs.” “Nightmare bacteria,” as they have been dubbed, are bacterial strains that no conventional antimicrobial can effectively treat; their incidence is on the rise. AMR represents a unique challenge for the medical profession as it is estimated that as many as 50% of current antibiotic prescriptions are either inappropriate or unnecessary. In addition, taking an antimicrobial involves potentially considerable exposure to side effects or risk. At stake are many currently routine, and lifesaving, forms of medical treatment. Critically, these include many medications for currently treatable bacterial infections, and many forms of surgery (including cesarean delivery), radiation therapy, chemotherapy and neonatal care.4 THE UNDERLYING DYNAMICS OF AMR AMR is driven by a complex set of interlocking factors. These include: (1) increased global travel and medical tourism; (2) inappropriate, and unnecessarily high, use of antimicrobials in the agrifood sector; (3) poor medical prescribing practices; (4) inadequate implementation of infection prevention and control measures; (5) lack of knowledge, inappropriate expectations and misuse of antimicrobials on the part of the general public; (6) availability of poor-quality antimicrobials; (7) lack of access to rapid, affordable and accurate rapid diagnostic tools and infrastructure; (8) inadequate and underused surveillance data from AMR surveillance systems; (9) international travel rates; and (10) low commercial interest in, or support for, new antimicrobial research and development. To make progress on AMR, we need to carefully think about how to address its various drivers. Antimicrobial stewardship (AMS) is a term describing coordinated efforts, at any program level, to: (1) promote the appropriate use of antimicrobials; (2) improve patient outcomes; (3) reduce microbial resistance and preserve the effectiveness of antimicrobials; and (4) decrease the spread of infections caused by multidrug-resistant organisms. AMS efforts are based on the “One Health” approach. These include: (1) surveillance; (2) conservation of existing AM effectiveness; (3) innovation through research and development; and (4) infection prevention and control. Fundamentally, AMR can be thought of as a collective action problem, similar in character to the problem of climate change.3, While all stakeholders have a role to play in combatting AMR, each has very different resources, abilities and perspectives on AMR. Canada and much of the developed world have the luxury of health infrastructures, finances and regulatory frameworks that can make AMR mitigation possible. But in low- to middle-income countries — places where antibiotics might be the only real health care available — the very discussion of AMS can be perceived as threatening. Simply put, this illustrates the fact that solutions to AMR need to mobilize and leverage a collective strategy that is as broad and as connected as possible. To be successful, these solutions will need to do so in a manner that acknowledges the local reality of health care delivery. Global investment in antimicrobial research and development is underwhelming, a dynamic described as a “drying up” of the pharmaceutical pipeline.8 This is evidenced by the recent large-scale withdrawal of major pharmaceutical companies from antimicrobial research and development, reflecting the lack of profitability in this area. On the pharmaceutical side, there are clear barriers to companies investing in the development of novel antimicrobials. Underlying factors include: (1) 10-year timelines, and an estimated minimum $1 billion price tag for development; (2) high development failure rates for new antimicrobials; (3) the inevitable emergence of resistance to any newly developed antimicrobial; (4) antimicrobials being offered at relatively cheap dosage rates over shorter durations of use; and (5) the need to preserve the efficacy of any antimicrobial’s future use, which limits their economic viability.8 WHAT ARE THE CANADIAN CONTEXTS? AMR is already a major costly public health challenge in both the US and Canada. AMR infections are clearly linked to poorer health outcomes, longer hospital stays and higher mortality rates.3 The Public Health Agency of Canada (PHAC) estimates that roughly 18,000 hospitalized Canadians contract drug-resistant infections per year. The Canadian Patient Safety Institute estimates that 8,000 Canadian patients die annually with an AMR-related infection. It is estimated that close to 23 million antibiotic prescriptions are written annually for patients in Canada, the approximate equivalent to 1.6% of the population being on an antimicrobial on any given day. An action plan in Canada is being developed by PHAC. On the surface, the action plan appears comprehensive in that it outlines a One Health approach.10 However, despite commitments to take comprehensive, measurable action on AMS, Canadian leadership on AMR has historically lagged because of a lack of concrete coordination between PHAC and the provinces and because it has been challenging to implement local initiatives systemically. Previous shortcomings were highlighted in the Auditor General of Canada’s 2015 report and again in a 2017 issue brief by HealthCareCAN.18 Although efforts continue and the action plan is set for release at some point in 2019, concerns remain that: (1) the scope of coordinated efforts with the provinces and territories requires an interest in cooperation that may not exist between the two levels of government; (2) relative to the scope of the problem, sufficient and dedicated resources won’t be allocated; and (3) efforts on the industrial and agricultural fronts may not be sufficiently coordinated with AMR efforts for human health. In the spring of 2018 the House of Commons Standing Committee on Health (HESA) released a report outlining 10 recommendations for action on AMR in Canada. Although the federal government “accepted” most of the committee’s recommendations, no meaningful (and dedicated) AMR funding has been announced in advance of the action plan’s launch. Indeed, the federal government’s response to the HESA report sought to downplay the need for either urgent action or additional resources. This was done by pointing to nominal federal AMR efforts over the span of more than a decade. It should be noted that a small number of excellent localized AMS initiatives exist and have begun yielding promising local AMS results in Canada. AMR and AMS champions such as Choosing Wisely Canada, Do Bugs Need Drugs, and the Association of Medical Microbiology and Infectious Disease Canada have long argued that with proper resourcing, localized initiatives can be scaled up to a systemic level of application within provincial health care systems. GLOBALLY, WHERE DOES AMR STAND? Urgent action is required at an international level to combat AMR. Although AMR remains a complex public health challenge, the benefits of AMS are clear. The preservation of these precious resources will save lives and can positively affect both quality of care and health care delivery costs.7,14 Globally, many higher income nations and, increasingly, middle-income countries have now developed AMR/AMS action plans. Like the situation in Canada, these emerging and existing global action strategies remain largely unimplemented. Initial cash infusions into the AM drug development pipeline are beginning to emerge.8 Despite this, experts warn that such investments are too short term and wholly inadequate to address the scope of the looming AMR crisis.8, This reflects the many complexities that exist in the implementation of AMR action plans, owing in large part to: (1) a general lack of resources or prioritization; (2) complacency about AMR as a pressing public health concern; (3) difficulties in generalizing local AMS efforts; (4) coordination between sectorial actors; and (5) a lack of tangible AMR metrics and evidence. If AMS gains are to be made in low- and middle-income countries, the impact of limited resources in those settings will need to be considered.13 Realistically these countries will require various forms of monetary incentives and assistance to be able to effectively adopt AMR programs. If such support is not provided, human health rights will be affected and global AMS efforts will be undermined. Finally, there are now well-established calls for an international model, even a treaty, to be implemented on AMR/AMS.12,
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Health Canada consultation on vaping products labelling and packaging regulations

https://policybase.cma.ca/en/permalink/policy14124
Date
2019-09-05
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-09-05
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
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 intent to establish a single set of regulations under the authorities of the Tobacco and Vaping Products Act (TVPA) and the Canada Consumer Product Safety Act (CCPSA) with respect to the labelling and packaging of vaping products.1 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 supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. 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 all levels of government 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 In our most recent brief, the CMA expressed its concerns regarding vaping and youth. This included marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths.2 In April 2019, the Council of Chief Medical Officers of Health expressed alarm at the rising number of Canadian youths who are vaping, having found this trend “very troubling.”3 The CMA concurred with this assessment and supports Health Canada’s intention to further tighten the regulations.2 Identifying Vaping Substances The findings of a recent Canadian study indicate an increase in vaping among adolescents in Canada and the United States.4 The growing acceptance of this practice is of concern to the CMA because of the rapidly emerging popularity of vaping products such as JUUL® and similar devices.4 It will be very important to identify clearly on the packaging all the vaping substances contained therein, along with a list of ingredients, as not enough is known about the long-term effects users may face.5,6 Users need to know what they are consuming so they can make informed choices about the contents. Studies have found substances in e-cigarette liquids and aerosols such as “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.”7 Nicotine Content As Hammond et al noted in their recent study, “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.”4 The salts and flavours available to be used with these devices reduce the harshness and bitterness of the taste of the e-liquids. Some of its competition deliver even higher levels of nicotine.8 The CMA has expressed its concerns about the rising levels of nicotine available through the vaping process.2 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.”9 The higher levels of nicotine in vaping devices is also of concern because it “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.”10,11 The CMA has called on Health Canada to restrict the level of nicotine in vaping products to avoid youth (and adults) from developing a dependence.2 4 Health Warnings The CMA reiterates, again, its position that health warnings for vaping should be similar to those for tobacco packages.12,13 We support placing warning labels on all vaping products, regardless of the size of the package. The “space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available.”13 The need for such cautions is important as there is still much that is not known about the effects vaping can have on the human body. A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.”14 Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.”15,16 Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.”17 Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.17 A worrisome development has emerged in the United States. The Centers for Disease Control and Prevention is working in consultation with the states of Wisconsin, Illinois, California, Indiana, and Minnesota regarding a “cluster of pulmonary illnesses linked to e-cigarette product use, or “vaping,” primarily among adolescents and young adults.”18 Additional possible cases have been identified in other states and are being investigated. Child-Resistant Containers The CMA supports the need for child-resistant containers in order to enhance consumer safety; we have adopted a similar position with respect to cannabis in all forms.19,20 The need to include warning labels should reinforce the need for packaging these vaping products such that they will be inaccessible to small children. Recommendations 1. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids. 2. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth and adults from developing a dependence. 3. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products. 4. The CMA recommends that all the vaping substances be identified clearly on the packaging, along with a list of ingredients. 5. The CMA supports the need for child-resistant containers. 5 1 Government of Canada. Canada Gazette, Part I, Volume 153, Number 25: Vaping Products Labelling and Packaging Regulations. Ottawa: Government of Canada; 2019. Available: http://gazette.gc.ca/rp-pr/p1/2019/2019-06-22/html/reg4-eng.html (accessed 2019 Jul 10). 2 Canadian Medical Association (CMA). Health Canada Consultation on Reducing Youth Access and Appeal of Vaping Products. Ottawa: CMA; 2019 May 24. Available: https://policybase.cma.ca/en/permalink/policy14078 (accessed 2019 Jul 10). 3 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Ottawa: Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 Jul 24). 4 Hammond David, Reid Jessica L, Rynard Vicki L, et al. Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross sectional surveys BMJ. 2019; 365:2219. Available: https://www.bmj.com/content/bmj/365/bmj.l2219.full.pdf (accessed 2019 Jul 24). 5 WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization; 2019. Available: https://apps.who.int/iris/bitstream/handle/10665/326043/9789241516204-eng.pdf?ua=1 (accessed 2019 Jul 30). 6 Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med. 2016;375:1372-81. Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Jul 30). 7 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 Jul 29). 8 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. 9 Barrington-Trimis JL, Leventhal AM. Adolescents’ Use of “Pod Mod” E-Cigarettes —Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 Jul 30). 10 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212353 (accessed 2019 Jul 30). 11 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 Jul 30). 12 Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Jul 30). 13 Canadian Medical Association. Health Canada consultation on tobacco products regulations (plain and standardized appearance) Ottawa: CMA; 2018 Sep 6. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Jul 30). 14 Goniewicz ML. et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes JAMA Network Open. 2018;1(8):e185937. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2718096 (accessed 2019 Jul 30). 15 Chan LF. Et al. Pulmonary toxicity of e-cigarettes Am J Physiol Lung Cell Mol Physiol. 313: L193–L206, 2017 Available: https://www.physiology.org/doi/pdf/10.1152/ajplung.00071.2017 (accessed 2019 Jul 30). 16 Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control. 0:1-8, 2019. 17 American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Jul 30). 18 Centers for Disease Control and Prevention. CDC, states investigating severe pulmonary disease among people who use e-cigarettes. Media Statement 2019 Aug 17. Available: https://www.cdc.gov/media/releases/2019/s0817-pulmonary-disease-ecigarettes.html (accessed 2019 Aug 20). 19 Canadian Medical Association (CMA). Health Canada Consultation on Edible Cannabis, Extracts & Topicals Ottawa: CMA; 2019 Feb 20. Available: https://policybase.cma.ca/en/permalink/policy14020 (accessed 2019 Aug 6). 20 Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis Submission to Health Canada. 2018 Jan 19 Available: https://policybase.cma.ca/en/permalink/policy13838. (accessed 2019 Aug 6).
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Health Canada consultation on potential market for cannabis health products that would not require practitioner oversight

https://policybase.cma.ca/en/permalink/policy14125
Date
2019-09-03
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-09-03
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on potential markets for cannabis health products that would not require practitioner oversight.1 The CMA’s approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counseling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines2 and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation,3 and recommendations regarding Bill C-45.4 As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45.5 We also responded to Health Canada’s recent Consultation on Edible Cannabis, Extracts & Topicals.6 Overview The CMA first expressed its concerns about the sale of natural health products containing cannabis in our response to the proposed regulatory approach to the Cannabis Act, Bill C-45.5 We recognize that, in general, health products include prescription health products, non-prescription drugs, natural health products, cosmetics and medical devices. Although all these products are regulated by Health Canada, they are subject to different levels of scrutiny for safety, efficacy and quality, and in some cases, industry does not need to provide scientific evidence to support the claims made on the label. Health Claims As with all health products, the CMA supports an approach in which higher risk products, that is, those for which health claims are made, must be subject to a more meticulous standard of review. Rigorous scientific evidence is needed to support claims of health benefits and to identify potential risks and adverse reactions. We support Health Canada’s proposal that authorized health claims for cannabis health products (CHP) would be permitted for treatment of minor ailments, on the strict condition they are substantiated via a strong evidentiary process. It is the view of the CMA that all such products making a health claim must be reviewed thoroughly for efficacy, as well as safety and quality, for the protection of Canadians.5 Recent experience in the United States supports this approach. A warning letter was sent to Curaleaf Inc. of Wakefield, Massachusetts, by the US Food and Drug Administration (FDA) “for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.”7 This is not the first time it was necessary for the FDA to take such action. The agency had sent letters on previous occasions to other businesses over claims “to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”7 The CMA shares the FDA’s concerns that such claims “can put patients and consumers at risk by leading them to put off important medical care.”7 A study conducted by Dalhousie University found that only 35.8% of respondents were familiar with the biochemical properties of CBD when asked what cannabinoid they thought was potentially a pain killer.8 Systematic reviews and guidelines have highlighted the state of the science and the limited indications for which there is evidence.9,10,11 Both cannabis and CBD specifically have been approved for use in a few conditions, but more research is needed in this rapidly growing field. For example, medical cannabinoids have been approved in several jurisdictions for the treatment of multiple sclerosis but the evidence of how well it works is limited. As the Canadian authors note, “carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.”12 Consumers need to be reassured that health claims are being assessed thoroughly so they can make informed decisions.13 4 Packaging and Labelling Requirements The CMA has laid out its position with respect to packaging and labelling with respect to cannabis products.5,6 Strict packaging requirements are necessary as their wider availability raises several public health issues, not the least of which is ingestion by young children. Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. To reiterate:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause a poisoning Prescription Drugs Containing Cannabis The CMA addressed prescription drugs containing cannabis in a previous brief.5 The level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence to support claims of efficacy is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product. As a result, consumers presently do not have enough information to choose appropriate products. Prescription drugs are subject to Health Canada’s pharmaceutical regulatory approval process, based on each drug’s specific indication, dose, route of administration and target population. Health claims need to be substantiated via a strong evidentiary process. All potential prescription medications containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs (e.g., Marinol® and Sativex®), to protect Canadians from further misleading claims. The CMA urges caution especially around exemptions for paediatric formulations that would allow for traits that would “appeal to youth.” The CMA understands that these products, used under strict health professional supervision, should be child friendly, for example, regarding palatability, but we do not support marketing strategies that would suggest their use is recreational (e.g., producing them in candy or animal formats). Recommendations 1. The CMA recommends that all cannabis health products, including those with CBD, making a health claim must be reviewed thoroughly for efficacy, as well as safety and quality, for the protection of Canadians. 2. The CMA recommends that strict packaging requirements be put in place with respect cannabis health products as their wider availability raises several public health issues, not the least of which is ingestion by young children. 3. The CMA recommends tamper-resistant and child-proof containers need to be in place to enhance consumer safety. 4. The CMA recommends that all potential prescription medications containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs to protect Canadians from further misleading claims. 5 1Health Canada. Document: Consultation on Potential Market for Cannabis Health Products that would not Require Practitioner Oversight. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-potential-market-cannabis/document.html (accessed 2019 Aug 8). 2 Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&. (accessed 2019 Aug 8). 3 Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Aug 8). 4 Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Aug 8). 5 Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Aug 8). 6 Canadian Medical Association (CMA). Health Canada Consultation on Edible Cannabis, Extracts & Topicals Ottawa: CMA; Available: https://policybase.cma.ca/en/permalink/policy14020 (accessed 2019 Aug 8). 7 Food and Drug Administration (FDA). FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety. Media Release. Silver Spring, MD: FDA; 2019 Jul 23. Available: https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer (accessed 2019 Aug 15). 8 Charlebois S., Music J., Sterling B. Somogyi S. Edibles and Canadian consumers’ willingness to consider recreational cannabis in food or beverage products: A second assessment. Faculty of Management: Dalhousie University; May, 2019 Available: https://cdn.dal.ca/content/dam/dalhousie/pdf/management/News/News%20%26%20Events/Edibles%20and%20Canadian%20Consumers%20English_.pdf (accessed 2019 Aug 20). 9 Allan GM. Et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician. Feb 2018;64(2):111. Available: https://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Aug 29). 10 Health Canada. Information for Health Care Professionals. Cannabis (marihuana, marijuana) and the cannabinoids) Dried or fresh plant and oil administration by ingestion or other means Psychoactive agent. Ottawa: Health Canada; October 2018. Available: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-medication/cannabis/information-medical-practitioners/information-health-care-professionals-cannabis-cannabinoids-eng.pdf (accessed 2019 Aug 29). 11 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: Current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017. Available: http://www.nationalacademies.org/hmd/reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx (accessed 2019 Aug 29). 12 Slaven M., Levine O. Cannabinoids for Symptoms of Multiple Sclerosis JAMA Network Open. 2018;1(6):e183484. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706491 (accessed 2019 Aug 26). 13 Food and Drug Administration (FDA). What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD Consumer Updates. Silver Spring, MD: FDA; 2019 July 17. Available: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis (accessed 2019 Aug 29).
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Organ and tissue donation and transplantation

https://policybase.cma.ca/en/permalink/policy14126
Date
2019-12-07
Topics
Ethics and medical professionalism
Health care and patient safety
  2 documents  
Policy Type
Policy document
Date
2019-12-07
Replaces
Organ and tissue donation and transplantation (update 2015)
Topics
Ethics and medical professionalism
Health care and patient safety
Text
Organ and Tissue Donation and Transplantation (OTDT) is a rapidly changing area of medical science and practice. Organ and tissue transplantations represent significant lifesaving and life-enhancing interventions that require careful consideration by multiple stakeholders spanning medical disciplines. Technological and pharmacological advancements have made organ and tissue transplantation increasingly viable for treating related medical conditions. Changing social norms have also led to shifting perceptions of the acceptability of organ and tissue donation. Within this context, there is a need for renewed consideration of the ethical issues and principles guiding organ and tissue donation and transplantation in Canada. The overarching principle that guides OTDT is public trust, which requires that the expressed intent either for or against donation will be honoured and respected within the donation and medical systems, and that the best interests of the potential donor are always of paramount importance; policies and mechanisms that guide OTDT should aim to maintain and foster that public trust. The CMA acknowledges and respects the diverse viewpoints, backgrounds, and religious views of physicians and patients and therefore encourages physicians to confront challenges raised by OTDT in a way that is consistent with both standards of medical ethics and patients’ values and beliefs. SCOPE This policy identifies foundational principles to address the challenges surrounding deceased and living donation. In conjunction with applicable laws and regulations in Canada, the Declaration of Istanbul, the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, and leading clinical practices this policy aims to inform physicians and other interested parties on the guiding principles of OTDT in Canada. This policy is intended to address OTDT in adult populations; the challenges, considerations, legislation, and policy surrounding pediatric and neonatal OTDT are unique and deserve focused attention. Physicians should be aware of relevant legislation, regulatory requirements, and policies in the jurisdiction in which they practice. Physicians are encouraged to refer to the various Canadian specialty societies that deal directly with OTDT for up-to-date information and policy, as well as innovative techniques and approaches. GUIDING PRINCIPLES The practice of OTDT is of great value to patients and society. The CMA supports the continued development of greater capacity, efficiency, and accessibility in OTDT systems in co-ordination with comprehensive and compassionate end-of-life care for Canadians while acknowledging the importance of justice, informed consent, beneficence, and confidentiality to this practice. 1. JUSTICE There is a continuous need to improve the efficiency and effectiveness of OTDT in an effort to narrow the gap between demand and supply in what remains a scarce, lifesaving resource. The principle of justice should continue to guide the equitable allocation of organs and tissues in a manner that is externally justifiable, open to public scrutiny, and balances considerations of fairness (e.g., medical need or length of time on the wait-list) with medical utility (e.g., transplantation success). There should be no discrimination based on social status or perceived social worth. Lifestyle or behavioral factors should only be considered when clear evidence indicates that those factors will impact the medical probability of success. OTDT should also not rely on the patient’s ability to pay; such actions are inconsistent with the principles that underlie Canada’s publicly-funded health system. Of note, living donation to a loved one or acquaintance (via a directed donation) is regarded as ethically acceptable if potential donors are informed of all options, including that of donating in a non-directed fashion. All levels of government should continue to support initiatives to improve the OTDT system, raise public awareness through education and outreach campaigns, and fund ongoing research, such that any Canadian who may wish to donate their tissues or organs are given every reasonable opportunity to do so. Potential donor identification and referral, while legislated in many jurisdictions, is an important area of continued development as failure to identify donors deprives families of the opportunity to donate and deprives patients of potential transplants. To diminish inequities in the rates of organ donation between jurisdictions, federal and provincial governments should engage in consultations with a view to implementing a coordinated, national strategy on OTDT that provides consistency and clarity on medical and legal standards of informed consent and determination of death, and institutes access to emerging best practices that support physicians, providers, and patients. Efforts should be made to ensure adequate engagement with potential donors from communities that have historically had lower living donor rates to help reduce inequities in access to living donation. Policymakers should also continue to explore and appraise the evidence on policy interventions to improve the rates of organ donation in Canada – for example, see a brief overview of opt-in vs. opt-out donation systems in the background to this policy. 2. INFORMED CONSENT AND VOLUNTARINESS Organ and tissue donation must always be an autonomous decision, free of undue pressure or coercion. By law, the potential organ donor, or their substitute decision-maker, must provide informed consent. Physicians should direct patients to appropriate resources if that patient has expressed interest to become a donor after their death. If a potential donor has not made an expression of intent for or against donation, substitute decision-makers, families, or loved ones may be approached to provide authorization for donation. It should also be noted that consent indicates a willingness to donate, but that donation itself hinges on factors such as medical suitability and timing. End-of-life decisions must be guided by an individual's values and religious or philosophical beliefs of what it means to have a meaningful life and death. The autonomy of an individual should always be respected regarding their wish, intent, or registered commitment to become a donor after death. Input from family and loved-ones should always be considered in the context of the potential donor’s wishes or commitments – these situations must be handled on a case-by-case basis with respect for cultural and religious views while maintaining the autonomously expressed wishes of the potential donor. Physicians should make every reasonable effort to be aware and considerate of the cultural and religious views of their patients as they pertain to OTDT. Likewise, Canadian medical schools, relevant subspecialties, and institutions should provide training and continuing professional development opportunities on OTDT, including both medicolegal implications and cultural competency. To protect the voluntariness of the potential donor’s decision, public appeals to encourage altruistic donation should not seek to compensate potential donors through payment and should not subvert established systems of organ allocation. Any exploitation or coercion of a potential donor must be avoided. However, remuneration from officially sanctioned sources for the purpose of reimbursement of costs associated with living donation (e.g., transfer to another location or lost wages during the procedure), may be considered when no party profits financially from the exchange. The CMA supports proposed amendments to the Criminal Code and the Immigration and Refugee Protection Act that criminalizes or otherwise seeks to prevent the coercive collection and transplantation of organs domestically and internationally (i.e., organ trafficking – see relevant guidelines on trafficking ). The CMA also discourages Canadians from participating in organ tourism as either a recipient or donor; physicians should not take part in transplantation procedures where it is reasonable to suspect that organs have been obtained without the donor’s informed consent or where the donor received payment (from WHO Guiding Principle 7); however, in accordance with physicians’ commitment to the well-being of the patient and the professional responsibilities relating to the patient-physician relationship in the CMA Code of Ethics and Professionalism, physicians have an obligation to treat a post-tranplant patient if requested after the patient has participated in organ tourism; physicians should be aware of any legal or regulatory obligations they may have to report a patient’s organ tourism to national authorities, taking into consideration their duties of privacy and confidentiality to the patient. , 3. BALANCING BENEFICENCE AND NON-MALEFICENCE Balancing beneficence and non-maleficence means to: Consider first the well-being of the patient; always act to benefit and promote the good of the patient; provide appropriate care and management across the care continuum; take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm occurs; recognize the balance of potential benefits and harms associated with any medical act; and act to bring about a positive balance of benefits over harms. Deceased Donation Prospective donors can benefit from the knowledge that they can potentially save lives after their own deaths. However, potential donors must not be harmed by the act of donating. In accordance with the Dead Donor Rule, organ or tissue procurement should never be the cause of death. Moreover, the care of the dying patient must never be compromised by the desire to protect organs for donation or expedite death to allow timely organ retrieval. Physicians determining that a potential donor has died should not be directly involved in tissue or organ removal from the donor or subsequent transplantation procedures, nor should they be responsible for the care of any intended recipients of such tissues and organs (from WHO Guiding Principle 2). Leading clinical criteria, in conjunction with legally prescribed definitions of death and procedures, should inform the determination of death before donation procedures are initiated. DCD should be practiced in compliance with the regulations of individual transplant centers, relevant legislation, and leading Canadian clinical guidelines including the national recommendations for donation after cardiocirculatory death in Canada and the guidelines for the withdrawal of life-sustaining measures. Patients undergoing medical assistance in dying (MAiD) may also be eligible for organ and tissue donation – see relevant policy guidelines. Living Donation Living donors are motivated to act primarily for the benefit of the recipient. The perceived acceptability of living donation varies from person to person; living donation is deemed to be ethically acceptable when the potential benefits outweigh the potential risks of living donation; living donation is not ethically acceptable where there is a material risk of death of the donor; living donors must provide informed consent, meet medical and psychological requirements, and receive appropriate follow-up care. It is not necessary for the potential donor to be biologically or emotionally related to the recipient. 4. CONFIDENTIALITY AND PRIVACY Current practice protects the privacy of both donor and recipient and does not allow donation teams, organ donation organizations, or transplant teams to inform either party of the other’s identity. The continuation of this practice is encouraged at the present time to protect the privacy of both donors and recipients. In addition, healthcare providers should consider the privacy and confidentiality implications of practices employed throughout the assessment and post-operative periods – patient consent should be obtained for practices involving any loss of privacy or confidentiality (e.g. group education sessions, etc.). Deceased Donation A person’s choice about whether or not they intend to donate organs and tissues after their death is individual and, like other health-related information, should be considered private. The right to privacy regarding personal health information extends beyond the declaration of death. Living Donation Whenever possible, potential donor and recipients should be cared for and evaluated by separate medical teams. In the case of non-directed donations, it may be necessary for information to be shared between donor and recipient teams (e.g. recipient’s underlying disease and risk for recurrence); however, such information should be limited to what is necessary for making an informed choice. Conversely, the CMA recognizes that the choice and process of directed donation is one that is deeply personal, which is likely to result in the intersection of both donor and recipient pathways of care. In such cases, the same onus of confidentiality may not apply given the choices of the donor and recipient involved. Approved by the CMA Board of Directors December 2019
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Equity and diversity in medicine

https://policybase.cma.ca/en/permalink/policy14127
Date
2019-12-07
Topics
Ethics and medical professionalism
  3 documents  
Policy Type
Policy document
Date
2019-12-07
Topics
Ethics and medical professionalism
Text
The objective of this policy is to provide guidance to physicians and institutions by identifying a set of guiding principles and commitments to promote equity and diversity in medicine (as defined in the Guiding Principles section). We address equity and diversity in medicine to improve circumstances and opportunities for all physicians and learners as part of our efforts to create a more collaborative and respectful culture and practice of medicine. To achieve this, we must redress inequities, bias, and discrimination in learning and practice environments. Individual protection from bias and discrimination is a fundamental right of all Canadians. By embracing the principles of equity and diversity, we can systematically address root causes and reduce structural barriers faced by those who want to enter the medical profession and those practicing medicine. In so doing, we improve their opportunities for advancement, health, and livelihood. The principles of equity and diversity are grounded in the fundamental commitment of the medical profession to respect for persons. This commitment recognizes that everyone has equal and inherent worth, has the right to be valued and respected, and to be treated with dignity. When we address equity and diversity, we are opening the conversation to include the voices and knowledge of those who have historically been under-represented and/or marginalized. It is a process of empowerment—where a person can engage with and take action on issues they define as important. Empowerment involves a meaningful shift in experience that fosters belonging in the profession and draws on community supports. As part of equity and diversity frameworks, inclusion is often articulated to refer to strategies used to increase an individual’s ability to contribute fully and effectively to organisational structures and processes. Inclusion strategies are specific organisational practices or programs focused on encouraging the involvement and participation of individuals from diverse backgrounds to integrate and value their perspectives in decision-making processes. Robust processes for inclusion are a vehicle to achieving equity and diversity. Thus, in this policy, the process of inclusion is understood to be positioned at the nexus of the overarching principles of equity and diversity. Equity and diversity initiatives can be carefully structured to complement and strengthen merit-based approaches. Enhanced support and appropriate methods of evaluation that increase equity of opportunity (for example, equity in training, hiring processes, and in access to resources) provide all physicians and learners with a fair opportunity to cultivate and demonstrate their unique capabilities and strengths, and to realize their full potential. Promoting equity and diversity fosters a just professional and learning culture that cultivates the diverse perspectives within it, reflects the communities physicians serve, and promotes professional excellence and social accountability as means to better serve patients. An increasingly diverse medical population provides opportunities for underserviced populations to receive better access to medical services and bolsters the management of clinical cases through the contribution of different points of view. Evidence indicates that when demonstrably more equity and diversity in medicine is achieved, physicians experience greater career satisfaction, health and wellness, and a sense of solidarity with the profession while patients experience improved care and a more responsive and adaptable health care system. Evidence further indicates that realizing the full potential of human capital is an essential driver of innovation and health system development. This policy is consistent with the CMA Code of Ethics and Professionalism and the CMA Charter of Shared Values and strives to be in the spirit of the recommendations relevant to health made in the report of the Truth and Reconciliation Commission of Canada. The policy is informed by a body of evidence described in the accompanying Background document that includes a Glossary of terms. GUIDING PRINCIPLES A clear set of principles and commitments to improving equity and diversity demonstrates that we hold ourselves accountable to recognizing and challenging behaviours, practices, and conditions that hinder equity and diversity and to promoting behaviours, practices, and conditions that will achieve these goals. Achieving equity in medicine Equity refers to the treatment of people that recognizes and is inclusive of their differences by ensuring that every individual is provided with what they need to thrive, which may differ from the needs of others. It is a state in which all members of society have similar chances to become socially active, politically influential, and economically productive through the absence of avoidable or remediable differences among groups of people (defined socially, economically, demographically, or geographically). Equity in the medical profession is achieved when every person has the opportunity to realize their full potential to create and sustain a career without being unfairly impeded by discrimination or any other characteristic-related bias or barrier. To achieve this, physicians must 1) recognize that structural inequities that privilege some at the expense of others exist in training and practice environments and 2) commit to reducing these by putting in place measures that make recruitment, retention, and advancement opportunities more accessible, desirable, and achievable. To that end, physicians must apply evidence-based strategies and support applied research into the processes that lead to inequities in training and practice environments. Fostering diversity in medicine Diversity refers to observable and non-observable characteristics which are constructed—and sometimes chosen—by individuals, groups, and societies to identify themselves (e.g., age, culture, religion, indigeneity, ethnicity, language, gender, sexuality, health, ability, socio-economic and family status, geography). The barriers to diversity in medicine are broad and systemic. Individuals and groups with particular characteristics can be excluded from participation based on biases or barriers. Even when they are included, they are often not able to use the full range of their skills and competencies. As with improving equity, the benefits of a more diverse medical profession include improved health outcomes, system-level adaptation, and physician health and wellness. To achieve these benefits, the medical profession must become increasingly diverse by striving to create, foster, and retain physicians and learners who reflect the diversity of the communities they serve and it must be responsive to the evolving (physical, emotional, cultural, and socioeconomic) needs of patients. Promoting a just professional and learning culture Physicians value learning and understand that it reflects, and is informed by, the professional culture of medicine. A just professional and learning culture is one of shared respect, shared knowledge, shared opportunity, and the experience of learning together. An environment that is physically and psychologically safe by reducing bias, discrimination, and harassment is critical to creating and sustaining such a culture. To achieve this, the profession must strive to integrate cultural safety by fostering and adopting practices of cultural competence and cultural humility. Physicians and leaders across all levels of training, practice, and health settings, and through formal and informal mentorships, must also promote and foster environments where diverse perspectives are solicited, heard, and appreciated. In this way, diverse individuals are both represented in the professional culture of medicine and actively involved in decision-making processes in all aspects of the profession. Fostering solidarity within the profession Solidarity means standing alongside others by recognizing our commonality, shared vulnerabilities and goals, and interdependence. It is enacted through collective action and aims. To show solidarity within the profession means making a personal commitment to recognizing others as our equals, cultivating respectful, open, and transparent dialogue and relationships, and role modelling this behaviour. Solidarity enables each of us to support our colleagues in meeting their individual and collective responsibilities and accountabilities to their patients and to their colleagues. Being accountable to these goals and to each other means taking action to ensure the principles that guide the medical profession are followed, responding justly and decisively when they are not, and continually searching for ways to improve the profession through practice-based learning and experience. Promoting professional excellence and social accountability Engaged and informed research and action on equity and diversity is critical to promoting professional excellence and social accountability in medicine as means to better serve patients. Professional excellence is a fundamental commitment of the profession to contribute to the development of and innovation in medicine and society through clinical practice, research, teaching, mentorship, leadership, quality improvement, administration, and/or advocacy on behalf of the profession or the public. Social accountability is a pillar of the commitment to professional excellence by focusing those efforts on fostering competence to address the evolving health needs of the patients and communities physicians are mandated to serve. For care to be socially accountable, and to achieve professional excellence, physicians must provide leadership through advocacy and through action: advocacy about the benefits of addressing equity and diversity to achieve equitable health outcomes; and actions to be responsive to patient, community, and population health needs through high-quality evidence-based patient care. RECOMMENDATIONS To accomplish equity and diversity in medicine, organizational and institutional changes will be required across many facets of operation and culture including leadership, education, data gathering/analysis, and continuous improvement through feedback and evaluation of policies and programs. To achieve this, the CMA seeks to provide direction on broad action areas that require further specific actions and development measures in specific recruitment, training, and practice contexts. The CMA recommends: All medical organizations, institutions, and physician leaders: A. Take a leadership role in achieving greater equity and diversity by co-creating policies and processes that apply to them, and the individuals therein, in an accountable and transparent manner. This includes: 1. Identifying and reducing structural inequities, barriers, and biases that exist in training and practice environments to create fair opportunities for all physicians and learners; and providing the appropriate platforms, resources, and training necessary to do so to effect change collaboratively. 2. Practicing and promoting cultural safety, cultural competence, and cultural humility. 3. Providing training on implicit bias, allyship, cultural safety, cultural competence, and cultural humility, structural competence, and the value of diversity in improving health outcomes. 4. Ensuring a process is in place to review all workforce and educational policies, procedures, and practices toward considering their impact on equity and diversity. Areas of consideration include (but are not limited to) recruitment, promotion, pay, leave of absence, parental leave, resources and support, and working/learning conditions and accommodations. 5. Ensuring safe, appropriate, and effective avenues exist for those who may have experienced discrimination, harassment, or abuse in training and practice environments to report these events outside of their supervisory/promotional chain. Those experiencing these events should also be able to seek counselling without the fear of negative consequences. 6. Working towards creating and appropriately funding equity and diversity Chairs, Committees, or Offices with a mandate to investigate and address issues in equity and diversity. 7. Promoting and enabling formal and informal mentorship and sponsorship opportunities for historically under-represented groups. B. Encourage the collection and use of data related to equity and diversity through research and funding, and, specifically, review their data practices to ensure: 1. Historically under-represented groups are meaningfully engaged through the co-development of data practices. 2. Data regarding the representation of under-represented groups is being systematically and appropriately collected and analyzed. 3. Information collected is used to review and inform internal policy and practice with the aim of reducing or eliminating system-level drivers of inequity. 4. Findings relating to these data are made accessible. C. Support equity and diversity in recruitment, hiring, selection, appointment, and promotion practices by: 1. Requesting and participating in training to better understand approaches and strategies to promote equity and diversity, including implicit bias and allyship training that highlights the roles and responsibilities of all members of the community with emphasis on self-awareness, cultural safety, and sensitivity to intersectionalities. 2. Studying organizational environments and frameworks and identifying and addressing hiring procedures, especially for leadership and executive positions, that perpetuate institutional inequities and power structures that privilege or disadvantage people. 3. Adopting explicit criteria to recruit inclusive leaders and to promote qualified candidates from historically under-represented groups in selection processes. Additional recommendations for institutions providing medical education and training: 1. Establishing programs that espouse cultural safety, cultural competence, and cultural humility. 2. Encouraging all instructors develop competencies including non-discriminatory and non-stereotyping communication, awareness of intersectionality, and cultural safety. 3. Providing training programs, at the undergraduate level onwards, that include awareness and education around stereotypes (gender and otherwise), intersectionalities, and the value of diversity in improving health outcomes. 4. Providing diversity mentorship programs that aim to support diverse candidates through education and training to graduation. 5. Promoting and funding student-led programs that create safe and positive spaces for students and principles of equity and diversity. 6. Ensuring recruitment strategies and admission frameworks in medical schools incorporate more holistic strategies that recognize barriers faced by certain populations to enable a more diverse pool of candidates to apply and be fairly evaluated. 7. Developing learning communities (such as undergraduate pipelines described in the background document) to promote careers in medicine as a viable option for individuals from historically under-represented communities. Approved by the CMA Board of Directors December 2019
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Best practices for smartphone and smart-device clinical photo taking and sharing

https://policybase.cma.ca/en/permalink/policy13860
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
  1 document  
Policy Type
Policy document
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
Text
Clinical photography is a valuable tool for physicians. Smartphones, as well as other devices supporting network connectivity, offer a convenient, efficient method to take and share images. However, due to the private nature of the information contained in clinical photographs there are concerns as to the appropriate storage, dissemination, and documentation of clinical images. Confidentiality of image data must be considered and the dissemination of these images onto servers must respect the privacy and rights of the patient. Importantly, patient information should be considered as any information deriving from a patient, and the concepts outlined therefore apply to any media that can be collected on, or transmitted with, a smart-device. Clinical photography can aid in documenting form and function, in tracking conditions and wound healing, in planning surgical operations, and in clinical decision-making. Additionally, clinical photographs can provide physicians with a valuable tool for patient communication and education. Due to the convenience of this type of technology it is not appropriate to expect physicians to forego their use in providing their patients with the best care available. The technology and software required for secure transfer, communication, and storage of clinical media is presently available, but many devices have non-secure storage/dissemination options enabled and lack user-control for permanently deleting digital files. In addition, data uploaded onto server systems commonly cross legal jurisdictions. Many physicians are not comfortable with the practice, citing security, privacy, and confidentiality concerns as well as uncertainty in regards to regional regulations governing this practice.1 Due to concern for patient privacy and confidentiality it is therefore incredibly important to limit the unsecure or undocumented acquisition or dissemination of clinical photographs. To assess the current state of this topic, Heyns et al. have reviewed the accessibility and completeness of provincial and territorial medical regulatory college guidelines.2 Categories identified as vital and explored in this review included: Consent; Storage; Retention; Audit; Transmission; and Breach. While each regulatory body has addressed limited aspects of the overall issue, the authors found a general lack of available information and call for a unified document outlining pertinent instructions for conducting clinical photography using a smartphone and the electronic transmission of patient information.2 The discussion of this topic will need to be ongoing and it is important that physicians are aware of applicable regulations, both at the federal and provincial levels, and how these regulations may impact the use of personal devices. The best practices supported here aim to provide physicians and healthcare providers with an understanding of the scope and gravity of the current environment, as well as the information needed to ensure patient privacy and confidentiality is assessed and protected while physicians utilize accessible clinical photography to advance patient care. Importantly, this document only focusses on medical use (clinical, academic, and educational) of clinical photography and, while discussing many core concepts of patient privacy and confidentiality of information, should not be perceived as a complete or binding framework. Additionally, it is recommended that physicians understand the core competencies of clinical photography, which are not described here. The Canadian Medical Association (CMA) suggests that the following recommendations be implemented, as thoroughly as possible, to best align with the CMA policy on the Principles for the Protection of Patient Privacy (CMA Policy PD2018-02). These key recommendations represent a non-exhaustive set of best practices - physicians should seek additional information as needed to gain a thorough understanding and to stay current in this rapidly changing field. KEY RECOMMENDATIONS 1. CONSENT * Informed consent must be obtained, preferably prior, to photography with a mobile device. This applies for each and any such encounter and the purpose made clear (i.e. clinical, research, education, publication, etc.). Patients should also be made aware that they may request a copy of a picture or for a picture to be deleted. * A patient's consent to use electronic transmission does not relieve a physician of their duty to protect the confidentiality of patient information. Also, a patient's consent cannot override other jurisdictionally mandated security requirements. * All patient consents (including verbal) should be documented. The acquisition and recording of patient consent for medical photography/dissemination may be held to a high standard of accountability due to the patient privacy and confidentiality issues inherent in the use of this technology. Written and signed consent is encouraged. * Consent should be considered as necessary for any and all photography involving a patient, whether or not that patient can be directly recognized, due to the possibility of linked information and the potential for breach of privacy. The definition of non-identifiable photos must be carefully considered. Current technologies such as face recognition and pattern matching (e.g. skin markers, physical structure, etc.), especially in combination with identifying information, have the potential to create a privacy breach. * Unsecure text and email messaging requires explicit patient consent and should not be used unless the current gold standards of security are not accessible. For a patient-initiated unsecure transmission, consent should be clarified and not assumed. 2. TRANSMISSION * Transmission of photos and patient information should be encrypted as per current-day gold standards (presently, end-to-end encryption (E2EE)) and use only secure servers that are subject to Canadian laws. Explicit, informed consent is required otherwise due to privacy concerns or standards for servers in other jurisdictions. Generally, free internet-based communication services and public internet access are unsecure technologies and often operate on servers outside of Canadian jurisdiction. * Efforts should be made to use the most secure transmission method possible. For data security purposes, identifying information should never be included in the image, any frame of a video, the file name, or linked messages. * The sender should always ensure that each recipient is intended and appropriate and, if possible, receipt of transmission should be confirmed by the recipient. 3. STORAGE * Storing images and data on a smart-device should be limited as much as possible for data protection purposes. * Clinical photos, as well as messages or other patient-related information, should be completely segregated from the device's personal storage. This can be accomplished by using an app that creates a secure, password-protected folder on the device. * All information stored (on internal memory or cloud) must be strongly encrypted and password protected. The security measures must be more substantial than the general password unlock feature on mobile devices. * Efforts should be made to dissociate identifying information from images when images are exported from a secure server. Media should not be uploaded to platforms without an option for securely deleting information without consent from the patient, and only if there are no better options. Automatic back-up of photos to unsecure cloud servers should be deactivated. Further, other back-up or syncing options that could lead to unsecure server involvement should be ascertained and the risks mitigated. 4. Cloud storage should be on a Canadian and SOCII certified server. Explicit, informed consent is required otherwise due to privacy concerns for servers in other jurisdictions. 5. AUDIT & RETENTION * It is important to create an audit trail for the purposes of transparency and medical best practice. Key information includes patient and health information, consent type and details, pertinent information regarding the photography (date, circumstance, photographer), and any other important facts such as access granted/deletion requests. * Access to the stored information must be by the authorized physician or health care provider and for the intended purpose, as per the consent given. Records should be stored such that it is possible to print/transfer as necessary. * Original photos should be retained and not overwritten. * All photos and associated messages may be considered part of the patient's clinical records and should be maintained for at least 10 years or 10 years after the age of majority, whichever is longer. When possible, patient information (including photos and message histories between health professionals) should be retained and amalgamated with a patient's medical record. Provincial regulations regarding retention of clinical records may vary and other regulations may apply to other entities - e.g. 90 years from date of birth applies to records at the federal level. * It may not be allowable to erase a picture if it is integral to a clinical decision or provincial, federal, or other applicable regulations require their retention. 6. BREACH * Any breach should be taken seriously and should be reviewed. All reasonable efforts must be made to prevent a breach before one occurs. A breach occurs when personal information, communication, or photos of patients are stolen, lost, or mistakenly disclosed. This includes loss or theft of one's mobile device, texting to the wrong number or emailing/messaging to the wrong person(s), or accidentally showing a clinical photo that exists in the phone's personal photo album. * It should be noted that non-identifying information, when combined with other available information (e.g. a text message with identifiers or another image with identifiers), can lead to highly accurate re-identification. * At present, apps downloaded to a smart-device for personal use may be capable of collecting and sharing information - the rapidly changing nature of this technology and the inherent privacy concerns requires regular attention. Use of specialized apps designed for health-information sharing that help safeguard patient information in this context is worth careful consideration. * Having remote wipe (i.e. device reformatting) capabilities is an asset and can help contain a breach. However, inappropriate access may take place before reformatting occurs. * If a smartphone is strongly encrypted and has no clinical photos stored locally then its loss may not be considered a breach. * In the event of a breach any patient potentially involved must be notified as soon as possible. The CMPA, the organization/hospital, and the Provincial licensing College should also be contacted immediately. Provincial regulations regarding notification of breach may vary. Approved by the CMA Board of Directors March 2018 References i Heyns M†, Steve A‡, Dumestre DO‡, Fraulin FO‡, Yeung JK‡ † University of Calgary, Canada ‡ Section of Plastic Surgery, Department of Surgery, University of Calgary, Canada 1 Chan N, Charette J, Dumestre DO, Fraulin FO. Should 'smart phones' be used for patient photography? Plast Surg (Oakv). 2016;24(1):32-4. 2 Unpublished - Heyns M, Steve A, Dumestre DO, Fraulin FO, Yeung J. Canadian Guidelines on Smartphone Clinical Photography.
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Consultation on proposed front-of-package labelling

https://policybase.cma.ca/en/permalink/policy13882
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Dear Mr. Rodrigue: The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2 1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018 2 Ibid pg.1 3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca 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; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide. Front-of-Packaging Labelling The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage 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. The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important. Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message. As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion. Foods to be exempted from front-of-package nutrition labelling There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium. Nutrient thresholds for sodium, sugar & saturated fat 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.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed 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 consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern. 4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend 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. Nutrient content claims, in relation to Front-of-Packaging Labelling symbol 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. High-intensity sweetener labelling Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal 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. Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine. Consumer education 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
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Canada's Food Guide

https://policybase.cma.ca/en/permalink/policy13920
Date
2018-06-06
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2018-06-06
Topics
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health with respect to its study of Canada’s Food Guide. The CMA supports access to healthy foods to improve individual health and well-being and the overall health status of the population.1 1 Canadian Medical Association (CMA). Obesity in Canada: Causes, consequences and the way forward. Ottawa: CMA; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-12.pdf (accessed 2018 Feb 5). 2 Colapinto C, Graham J, St. Pierre S. Trends and correlates of frequency of fruit and vegetable consumption, 2007 to 2014. Health Reports. 2018 January;29(1):9-14. Available: http://www.statcan.gc.ca/pub/82-003-x/2018001/article/54901-eng.pdf (accessed 2018 Feb 5). 3 Van Vliet B, Campbell N. Efforts to reduce sodium intake in Canada: Why, what, and when? Can J Cardiol. 2011;27(4):437–445. 4 Canadian Medical Association (CMA). Early childhood development. Ottawa: CMA; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Feb 2). 5 Canadian Medical Association (CMA). Health equity and the social determinants of health: A role for the medical profession. Ottawa: CMA; 2013. Available http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-03.pdf (accessed 2018 Jan 30). 6 Health Canada. Eating well with Canada’s food guide. Ottawa: Health Canada; 2007. Available: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/hpfb-dgpsa/pdf/food-guide-aliment/view_eatwell_vue_bienmang-eng.pdf (accessed 2018 Jan 30). 7 Collier R. Calls for a better food guide. CMAJ. 2018 November 18;186(17):1281. Available: https://doi.org/10.1503/cmaj.109-4911 (accessed 2018 Jan 30). 8 Ministry of Health of Brazil. Dietary guidelines for the Brazilian population. 2nd ed. Brazil: Ministry of Health of Brazil; 2014. Available: http://www.foodpolitics.com/wp-content/uploads/Brazilian-Dietary-Guidelines-2014.pdf (accessed 2018 Feb 1). 9 Report of the Standing Committee on Social Affairs, Science and Technology. Obesity in Canada. A whole-of-society approach for a healthier Canada. Ottawa: Senate of Canada; 2016 March. Available: https://sencanada.ca/content/sen/committee/421/soci/rms/01mar16/Report-e.htm (accessed 2018 Feb 2). 10 Health Canada. Evidence review for dietary guidance: summary of results and implications for Canada’s food guide. Ottawa: Health Canada; 2015. Available: https://www.canada.ca/content/dam/canada/health-canada/migration/publications/eating-nutrition/dietary-guidance-summary-resume-recommandations-alimentaires/alt/pub-eng.pdf (accessed 2018 Feb 2). 11 Government of Canada. Guiding principles [Canada’s food guide consultation]. Ottawa: Government of Canada; 2017 April 5. Available: https://www.foodguideconsultation.ca/guiding-principles-detailed (accessed 2018 Feb 5). The CMA has been active on nutritional issues for many years, both directly through its policy and government advocacy as well as through membership in various coalitions. Some of the issues addressed include the nutrition facts table, front-of-package labelling, a ban on the marketing of food and beverages to children younger than 16 years of age, and a levy on the manufacturers of sugar-sweetened beverages. Canadians’ self-reported dietary intakes do not meet national dietary recommendations despite public education efforts concerning healthy eating and healthy diets. Children and adults are consuming fewer than the recommended number of servings of vegetables and fruits, an established proxy for healthy eating habits, and they are exceeding daily recommended intakes of sodium.2,3 The protection of vulnerable populations including children is of paramount concern to the CMA. Access to nutritious food is essential in early childhood development in support of later adult health.4 The availability of food security programs is a key element in preventing children from developing dietary deficiencies that would lead to an increased risk of chronic disease and greater difficulty in disease management later in life.5 The Food Guide has historically been a valued resource for Canadians, and physicians have found it useful in counselling their patients about healthy eating. However, there are serious concerns with the present Food Guide,6 which was released in 2007, and physicians have increasingly called for it to be reviewed.7 Other countries have made significant changes to their dietary guidelines. Brazil, for example, has developed a guideline that incorporates simple-to-follow, common-sense messaging, such as encouraging Brazilians to prepare meals from scratch and promoting the value of family meals.8 A new, modern Canadian guide is needed. Witnesses appearing before the Senate Committee on Social Affairs, Science and Technology characterized the current version as being “at best ineffective, and at worst enabling, with respect to the rising levels of unhealthy weights and diet-related chronic diseases in Canada.”9 Health Canada is in the process of revising the Food Guide, having done an extensive review of the evidence10 and releasing Guiding Principles.11 Recommendations for a revised Food Guide A new approach to a food guide that addresses the larger picture, beyond daily nutrient consumption recommendations, is fundamental to the effort to improve the health of all Canadians and to the larger goal of developing a food policy for Canada. Indeed, “coordinated investments in health promotion and disease and injury prevention, including attention to the role of the social determinants of health, are critical to the future health and wellness of Canadians and to the viability of the health care system.”12 12 Canadian Medical Association (CMA) and Canadian Nurses Association (CNA). Principles for health care transformation in Canada. Ottawa: CMA and CNA; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD1113.pdf (accessed 2018 Jan 30). 13 Nexus H. Primer to action: Social determinants of health. Toronto: Ontario Chronic Disease Prevention Alliance; 2007. Available: http://www.ocdpa.ca/sites/default/files/publications/PrimertoAction-EN.pdf (accessed 2018 Feb 1). 14 Tarasuk V, Mitchell A, Dachner N. Household food insecurity in Canada. Toronto: PROOF; 2016. Available: http://proof.utoronto.ca/resources/proof-annual-reports/annual-report-2014/ (accessed 2018 Feb 5). 15 Rao M, Afshin A, Singh G, et al. Do healthier foods and diet patterns cost more than less healthy options? A systematic review and meta-analysis. BMJ Open. 2013;3:e004277. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855594/pdf/bmjopen-2013-004277.pdf (accessed 2018 Feb 5). 16Lee A, Mhurchu CN, Sacks G, et al. Monitoring the price and affordability of foods and diets globally. Obes Rev. 2013 Oct;14 Suppl 1:82–95. 17 Food Banks Canada. Hungercount2016: A comprehensive report on hunger and food bank use in Canada, and recommendations for change. Toronto: Food Banks Canada; 2016. Available: https://www.foodbankscanada.ca/hungercount2016 (accessed 2018 Jan 30). 18 Raine K. Improving nutritional health of the public through social change: Finding our roles in collective action. Can J Diet Pract Res. 2014;75(3):160-164. Available: https://doi.org/10.3148/cjdpr-2014-017 (accessed 2018 Feb 2). 19 Canadian Medical Association (CMA). CMA’s Support for Bill S-228: An Act to amend the Food and Drugs Act (prohibiting food and beverage marketing directed at children).Ottawa: CMA; 2017.Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-07.pdf (accessed 2018 Feb 2). 20 Howard, C., Culbert I., Food Guide revamp encouraging plant-based, low-meat diet is good for people and the planet CBC February 11, 2018 Available: http://www.cbc.ca/news/canada/manitoba/opinion-canada-food-guide-1.4530058 (accessed 2018 Feb 12) CMA recommendations: 1. The Food Guide must go hand in hand with efforts to increase access to affordable, healthy food Food insecurity does not affect all Canadians equally, and there are very clear social patterns of vulnerability.13 Analyses of population survey data consistently identify low income as a predictor of household food insecurity. In addition, rates of food insecurity are highest among Aboriginal Canadians, households reliant on social assistance, households headed by single mothers, and those renting rather than owning a home.14 More research is needed to understand decisions surrounding the purchase of healthy foods versus unhealthy foods.15,16 Food Banks Canada reported that in March 2016, 863,492 people received food from a food bank, an increase of 1.3% over 2015, with eight of 10 provinces showing an increase.17 As the report notes, “approximately 1.7 million Canadian households, encompassing 4 million people, experience food insecurity each year” with 340,000 of them experiencing severe food insecurity.17 Other determinants of healthy eating include a wide range of contextual factors, such as the interpersonal environment created by family and peers, the physical environment, which determines food availability and accessibility, the economic environment, in which food is a commodity to be marketed for profit, and the social environment. Within the social environment, social status (income, education and gender) and cultural milieu are determinants of healthy eating that may be working "invisibly" to structure food choice.15 2. The Food Guide must be based on sound nutritional research With unhealthy diets consistently linked with chronic disease such as cardiovascular diseases (heart disease, stroke, hypertension, diabetes, dyslipidemia) and with an estimated 60% of Canadian adults and close to one-third of children being overweight or obese, there is a need for evidence-based approaches in the development of healthy eating policies and practices in Canada. As the links between nutrition and disease and other impacts of nutrition on the health of our society are revealed and better understood, it is more important than ever to identify what influences healthy eating behaviours.18 Food choices are structured by a variety of individual determinants of behaviour, including one's physiological state, food preferences, nutritional knowledge, perceptions of healthy eating and psychological factors. The Food Guide needs to incorporate emerging research on nutrition and health, for example, by emphasizing the need to replace saturated fats with unsaturated fats, as opposed to focusing on total fats. It also must take into account the changes in consumer behaviour and in the food supply. 3. The Government of Canada must assure Canadians that the revision process is evidence based Canadians must be able to trust Canada’s Food Guide as a source of unbiased information, based on evidence. The Food Guide must be part of a larger coordinated approach that also looks at other critical issues, such as the role of the marketing of unhealthy foods and beverages to children.19 CMA is concerned that conflict-of-interest situations have arisen in the past where recommendations might favour certain products or food groups over others.20 Canadians must have confidence that their health and wellness is the primary focus of an evidence-based revision process. 4. The Food Guide must reflect changing eating patterns reflective of our evolving and increasingly multicultural society Canadian society is more ethnically diverse than in the past, so it is necessary to keep in mind cultural preferences. The current food groups do not always take into account an understanding of traditional foods and cultural eating practices. These are intrinsically linked to identity and culture and contribute to overall health. Advice needs to be tailored to different ages and cultural groups. There is also a need to emphasize patterns of eating, as opposed to a focus almost exclusively on nutrient requirements. It is important to promote eating as a social undertaking, recognizing the essential role that food has in bringing people together. It is also important to support the development of basic, practical culinary skills, which will reduce Canadians’ dependence on restaurant meals and ultra-processed foods. 5. The Food Guide must encourage Canadians to reduce their reliance on processed foods The production and consumption of ultra-processed foods has increased drastically in the last decades in both higher and lower income countries. Highly or ultra-processed food tends to contain less protein and dietary fibre than less processed foods and include high proportions of free sugar, total saturated fat, trans fat and salt. Typically, processed foods are energy dense (high in calories) but have fewer beneficial nutrients such as vitamins and proteins. Most processed foods encourage unhealthy ways of eating and have become popular because of their accessibility and convenience. These features have changed the way food and in particular these products are consumed compared with unprocessed foods: increased “grazing,” eating alone or eating while carrying out other activities such as work or driving. In addition, many calories consumed come in liquid form. Physicians are concerned with the Food Guide’s support for fruit juices, given the plethora of sugar-sweetened beverages, including milk and milk alternatives. There should be a maximum amount of juice recommended for children, and the Food Guide should instead support the consumption of actual fruit. 6. The Government of Canada must produce simple, practical products for Canadians and clear dietary guidance for health professionals Reliable, trustworthy sources of information are essential to support healthy eating. However, the new Food Guide must not be just another set of rules and lists or a long, cumbersome document. The challenge will be to take the evidence around nutrition and health and make it meaningful and useful. This is the only way that the Food Guide will actually be able to support and even provoke change. To do that it must focus on the needs of the Canadians, with tools that personalize information for different age and cultural groups. It should also be useful to people with certain health conditions who require regulation of their diet to improve health (e.g., people with diabetes or hypertension). It should support couples during pregnancy and breastfeeding. There can’t be only one set of guidance; rather, various versions should be produced that are adapted to different audiences. The Food Guide needs to be practical and simple to use. The concept of the number and size of servings of different foods, for example, has been very confusing. Research has shown that Canadians do not weigh or measure their foods and serving sizes are often underestimated, promoting overconsumption. The Food Guide must support Canadians in deciphering food labels and making informed choices about what they consume. The use of technology will allow information to be more accessible. The guidance must be sensitive to issues related to the social determinants of health and food security, with attention to the cost and accessibility of foods. A focus on good sources of proteins, for example, as opposed to red meats and dairy, could allow for more choice. The Food Guide should provide guidance to food banks and other programs that seek to provide food to low-income families in terms of what foods they should procure for their clients. As one of the most trusted sources of health information, physicians also need to be able to access the latest evidence in a user-friendly manner. Resources must be succinct and easy for physicians to access in a busy practice. They should allow a physician to go into more depth should that be required. As well, point-of-care tools that help clinicians explain technical facts to their patients in an accessible manner are needed. Recommendations 1. The Food Guide must go hand in hand with efforts to increase access to affordable, healthy food 2. The Food Guide must be based on sound nutritional research 3. The Government of Canada must assure Canadians that the revision process is evidence based 4. The Food Guide must reflect changing eating patterns reflective of our evolving and increasingly multicultural society 5. The Food Guide must encourage Canadians to reduce their reliance on processed foods 6. The Government of Canada must produce simple, practical products for Canadians and clear dietary guidance for health professionals
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Health Canada consultation on restriction of marketing and advertising of opioids

https://policybase.cma.ca/en/permalink/policy13921
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to Health Canada in response to the publication of the Notice of Intent to restrict the marketing and advertising of opioids.1 The CMA is very concerned with the high rates of overdose deaths due to opioids2 and supports a comprehensive, multi-pronged approach to address this public health crisis.3 As part of the Government of Canada's strategy, the Minister of Health's 2017 mandate letter committed to "consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies."4 Health Canada is proposing to further restrict drug manufacturers' advertising of opioids and is consulting on the scope and intent of the restrictions. The Food and Drugs Act defines advertisement as "any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device".5 Opioids are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. These medications have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.3 Any measures to address advertising must not restrict appropriate access. Limiting access without appropriate alternatives and careful tapering can lead to undue suffering and seeking of drugs, potentially tainted, on the illegal market. However, of great concern, opioid dispensing levels have been shown to be strongly correlated with increased mortality, morbidity and treatment admissions for substance use.6,7 Many patients were prescribed these medications and developed dependence.8 Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.9,10 However, there is evidence for pain relief in the short term but insufficient evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.11,12,13 There was also a concerted effort by industry to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer pain. While stating that the risk of addiction was less than one percent, many studies have shown that the risk varies from 0 to 50% depending on the criteria used and sub population studied.14 Marketing significantly influences the type and amount of opioids consumed.15 Substantial tension exists between the competitive pressures that manufacturers face to expand product sales and support for limited, evidence-based use of most cost-effective available alternatives.16 Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage.17 Important contributing factors for the increase in opioid prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with patients. Prescriptions also increased due to the availability of new, highly potent opioid drugs.18,19 Addressing advertising is only one component of the issue, and significant efforts need to be made to address issues such as access to alternatives for pain management and treatment of addiction. Presently, advertising of opioids is prohibited to the public, and only permitted to health care professionals if the claims are consistent with the terms of market authorization by Health Canada. Pharmaceutical industry's marketing practices to health care practitioners "can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts."1 As well, industry has sponsored advocacy organizations dedicated to the treatment of pain and key opinion leaders.15,20 Studies have shown that marketing influences prescribing patterns.21 Initiatives to regulate advertising and the promotion of prescription drugs have come from industry, nongovernmental organizations and government. The pharmaceutical industry itself is voluntarily self-regulated in Canada through the Pharmaceutical Advertising Advisory Board (PAAB), pre-clearing marketing initiatives based on a Code of Advertising.22 The CMA recommends that marketing initiatives could be vetted for accuracy and truthfulness through a pre-clearance mechanism such as PAAB. Faced with multiple legal challenges in the U.S., some opioid manufacturers have limited marketing, however, such measures had not been taken in Canada. The federal government has a complaints-based system and hasn't been proactive in the regulation and monitoring of advertising and marketing of opioids. In recently published regulations amending the Food and Drug Regulations,23 the Minister of Health can require companies to develop and implement risk management plans, which include the preclearance of opioid-related materials to be provided to health care professionals. Product information prepared by manufacturers, summarizing scientific evidence on effects and setting out conditions for use, as well as promotional activities are subject to regulatory approval. The authority conferred to the Minister has the objective of allowing Health Canada to "appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use" of opioids. CMA supports such actions. As Van Zee has noted in the case of the United States, "modifications of the promotion and marketing of controlled drugs by the pharmaceutical industry and an enhanced capacity of the Food and Drug Administration to regulate and monitor such promotion can have a positive impact on public health".14 This approach would confer a similar benefit for Canada in that, if effective, could contribute to unbiased, evidence-based prescribing. There are important guidelines and standards in place, developed by physicians, to guide relationships with the pharmaceutical industry. CMA's "Guidelines for Physicians in Interactions with Industry"24 were developed as a resource tool both for physicians, medical students and residents, as well as medical organizations, to support decisions as to appropriate relationships with industry, in conjunction with CMA's Code of Ethics.25 In summary, physicians have a responsibility to ensure that their interaction with the pharmaceutical industry is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible, appropriately managing these situations when necessary. These guidelines include principles for continuing medical education and continuing professional development (CME/CPD) and are the basis for the National Standard for Support of Accredited CPD Activities, developed by the Royal College of Physicians and Surgeons of Canada (RCPSC), the College of Family Physicians of Canada (CFPC) and the Collège des médecins du Québec. According to the Standard, "the interests of organizations that provide financial and in-kind support for the development of accredited CPD activities cannot be assumed to always be congruent with the goal of addressing the educational needs of the medical profession. Therefore, it is essential that the medical profession define and assume their responsibility for setting standards that will guide the development, delivery, and evaluation of accredited CPD activities."26 Physicians must complete CPD credits to maintain their professional license, and the accreditation bodies (such as CFPC, RCPSC) have processes in place to assure that these courses are evidence-based and free from industry bias. In recognition of the importance of opioid prescribing, and the key role that physicians play in this field, the CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids. This funding could include unconditional contribution from the opioid manufacturers, to ensure independence. The CMA appreciates the role that Health Canada has had in funding evidence-based guidelines.27 This has been a key initiative, which sought to provide physicians with unbiased information. Ongoing funding to maintain their currency would be warranted. The CMA supports long overdue actions related to the restriction of the marketing of opioids and looks forward to collaboration between Health Canada and the physician community. Recommendations The CMA supports Health Canada's efforts to place significant restrictions on the ability of drug manufacturers to advertise opioids to health care practitioners. Marketing initiatives should be vetted for accuracy and truthfulness through a pre-clearance mechanism. The CMA recommends that the measures chosen to constrain advertising do not unduly restrict access to opioids for appropriate use. The CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids, and consider unconditional funding from opioid manufacturers. The CMA recommends that the government support keeping the 2017 Opioid Prescribing Guidelines current through ongoing funding. The CMA recognizes that restricting advertising is only one, overdue, measure to address the opioid crisis, and recommends that issues such as access to alternatives for pain management and addiction treatment urgently be addressed. 1 Government of Canada. Notice of intent to restrict the marketing and advertising of opioids. Ottawa: Government of Canada; 2018. Available: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/restrict-advertising-opioids.html (accessed 2018 Jul 17). 2 Public Health Agency of Canada. National report: apparent opioid-related deaths in Canada (released June 2018). Ottawa: Public Health Agency of Canada; 2018. Available: https://www.canada.ca/en/public-health/services/publications/healthy-living/national-report-apparent-opioid-related-deaths-released-june-2018.html (accessed 2018 Jul 17). 3 Canadian Medical Association. Harms associated with opioids and other psychoactive prescription drugs. Ottawa: Canadian Medical Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Jul 17). 4 Trudeau J. Minister of Health mandate letter. Ottawa: Office of the Prime Minister; 2017 Oct 4. Available: https://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2018 Jul 17). 5 Government of Canada. Food and Drugs Act. Ottawa: Government of Canada; 1985. Available: http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html (accessed 2018 Jul 17). 6 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf 2013;22(4):438-42. 7 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q 2011;14(1):22-4. 8 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend 2004;73(2):199-207. 9 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician 2014;17(1):E1-10. 10 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ 2011;343:d5142 DOI: 10.1136/bmj.d5142. 11 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology 2014;83:1277-84. 12 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147-59. 13 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010;(1):CD006605. 14 Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-27. 15 Hamunen K, Paakkari P, Kalso E. Trends in opioid consumption in the Nordic countries 2002-2006. Eur J Pain 2009;13:954-962. 16 Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2018:1-26. 17 Canadian Medical Association. Optimal prescribing. Ottawa: Canadian Medical Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf (accessed 2018 Jul 17). 18 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health 2008;99(3):182-4. 19 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction 2013;109:177-81. 20 Dyer O. OxyContin maker stops marketing opioids, as report details payments to advocacy groups. BMJ 2018;360:k791. 21 Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioethics 2003;3(3):39-46. 22 Pharmaceutical Advertising Advisory Board. PAAB Code. Ottawa: PAAB; 2018. Available: http://code.paab.ca/ (accessed 2018 Jul 17). 23 Regulations Amending the Food and Drug Regulations (Opioids), SOR/2018-77. Canada Gazette, Part II 2018 May 2;152(9). Available: http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html (accessed 2018 Jul 17). 24 Canadian Medical Association. Guidelines for physicians in interactions with industry. Ottawa: Canadian Medical Association; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf (accessed 2018 Jul 17). 25 Canadian Medical Association. CMA Code of Ethics (Update 2004). Ottawa: Canadian Medical Association; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Code_of_ethics_of_the_Canadian_Medical_Association_Update_2004_PD04-06-e.pdf (accessed 2018 Jul 17). 26 Royal College of Physicians and Surgeons of Canada. National standard for support of accredited CPD activities. Ottawa: Royal College of Physicians and Surgeons of Canada; 2017. Available: http://www.royalcollege.ca/rcsite/cpd/providers/tools-resources-accredited-cpd-providers/national-standard-accredited-cpd-activities-e (accessed 2018 Jul 17). 27 Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ 2017;189:E659-66.
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Health Canada consultation on regulatory amendments regarding tramadol

https://policybase.cma.ca/en/permalink/policy13927
Date
2018-08-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-08-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's notice as published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health Canada's intent to amend Schedule 1 to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives.1 Tramadol has been marketed in Canada since 2005 and is available only by prescription.1 The CMA is concerned that, despite tramadol being judged low-risk in terms of addiction, it is nevertheless an opioid and should be placed in the Controlled Drugs and Substances Act, under Schedule 1.2 The Canadian Institute for Health Information reports that tramadol is one of six opioids accounting for 96% of all opioid prescriptions between 2012 and 2016.3 The report noted that there was a significant increase in tramadol prescriptions and Defined Daily Doses (DDDs) in that same 2012 to 2016 timeframe that may have been due in part to a decrease in prescriptions and DDDs for codeine. Tramadol is considered a weak opioid and is used to treat "moderate pain that has not responded to first-line treatments."4 It is regarded as having a lower rate of overdose, misuse and addiction than more powerful opioids.4 However, it is not without risks. The addition of tramadol to the CDSA, Schedule 1, is important because, as with any opioid, dependence on tramadol can occur with use over prolonged periods. According to the World Health Organization "dependence to tramadol may occur when used within the recommended dose range of tramadol but especially when used at supra-therapeutic doses."5 Physical dependence is "distinct from addiction, which includes behavioural elements and harm despite continued drug use." Maintenance of patients on opioids sometimes is only to avoid withdrawal symptoms, caused by physical dependence, as opposed to being used to treat pain.6 Tramadol must be tapered under supervision from a health professional. In addition, tramadol's analgesic effect can be unpredictable depending on a person's genetic capacity to metabolize the drug. Success or failure will be predicated "on it being converted by CYP2D6 to an active metabolite, O-desmethyltramadol."7 If there is a CYP2D6 inhibitor present or if the person's genetic make-up is such that they do not metabolize the enzyme very well, "conversion can be blocked so that little or none of the metabolite is produced and little analgesic effect is achieved."7 These tramadol pathways may also be blocked which could lead to the drug being "present at higher concentrations for longer periods."7 As one expert has noted "when a doctor prescribes tramadol, he or she rolls the dice, not knowing whether the patient will get a bit of opioid, a lot of opioid or none at all."6 The risks associated with tramadol with respect to children are such that the United States Food and Drug Administration (FDA) recently recommended that tramadol (and codeine) should not be given to children under 12.8 Their concern stems from the potential for tramadol (and codeine) to "cause life-threatening breathing problems in children."9 The FDA also recommended that breast-feeding women not be given tramadol because of the potential harm to the child. As well, teens 12 to 18 should not be given the drug "if there is a history of obesity, obstructive sleep apnea, or severe lung disease."9 Further, it warned that it should not "be given to children or adolescents as a pain medication after surgery to remove the tonsils or adenoids."9 It is very important for the health and safety of Canadians that tramadol be placed on CDSA's Schedule 1. As described in the Notice of Intent for this consultation, this change will "prevent diversion of tramadol and protect Canadians from the health risks associated with unauthorized use."1 Further, pharmacists will not be able to follow verbal prescriptions and or provide refills of tramadol, and other controls outlined in the Narcotic Control Regulations within the Controlled Drugs and Substances Act.10 In conclusion, the CMA is concerned that, despite tramadol being judged low-risk in terms of addiction, it is nevertheless an opioid and carries dangers similar to its stronger counterparts. Doctors support patients in the management of acute and chronic pain, as well as addictions, and as such we have long been concerned about the harms associated with opioid use. Therefore, as part of our advocacy, the CMA supports Health Canada's intent to amend Schedule 1 to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives. By doing so it will "help dispel the perception that it's somehow safer than other opioids."6 The CMA continues to urge governments to increase access to services and treatment options for addiction and pain management, as well as harm reduction.11 1 Controlled Drugs and Substances Act: Notice to interested parties - Proposal to add tramadol to Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations Canada Gazette, Part I, 2018 Jun 16 152(24) Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/notice-avis-eng.html#ne2 (accessed 2018 Jun 25) 2 Young JWS, Juurlink DN. Five things to know about Tramadol. CMAJ May 2013 185(5) Available: http://www.cmaj.ca/content/cmaj/185/8/E352.full.pdf (accessed 2018 Jul 31) 3 Canadian Institute for Health Information. Pan-Canadian Trends in the Prescribing of Opioids, 2012 to 2016. Ottawa, ON: CIHI; 2017. 4 Kahan M, Mailis-Gagnon A, Wilson L, et al. Canadian guideline for safe and effective use of opioids for chronic noncancer pain; clinical summary for family physician. Part 1: general population. Can Fam Physician November 2011 011;57:1257-66. Available: http://www.cfp.ca/content/cfp/57/11/1257.full.pdf (accessed 2018 Jul 30) 5 World Health Organization. Tramadol Update Review Report Expert Committee on Drug Dependence. Thirty-sixth Meeting Geneva, 16-20 June 2014 Available: http://www.who.int/medicines/areas/quality_safety/6_1_Update.pdf (accessed: 2018 Aug 1) 6 Juurlink DN. Why Health Canada must reclassify tramadol as an opioid. The Globe and Mail November 27, 2017 7 Flint, A., Merali, Z., and Vaccarino, F. (Eds.). (2018). Substance use in Canada: improving quality of life: substance use and aging. Ottawa, Ont: Canadian Centre on Substance Use and Addiction. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Substance-Use-and-Aging-Report-2018-en.pdf#search=all%28aging%29 (accessed 2018 Aug 1) 8 Jin J. Risks of Codeine and Tramadol in Children. JAMA 2017;318(15):1514. doi:10.1001/jama.2017.13534 Available: https://jamanetwork.com/journals/jama/fullarticle/2657378 (accessed: 2018 Aug 2) 9 United States Food and Drug Administration. Codeine and Tramadol Can Cause Breathing Problems for Children. Consumer Update April 20, 2017 Available: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm315497.htm (accessed: 2018 Aug 14) 10 Minister of Justice. Narcotic Control Regulations C.R.C., c. 1041. Current to July 5, 2018. Last amended on May 20, 2018 Available: http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._1041.pdf (accessed: 2018 Aug 14) 11 Canadian Medical Association. Harms Associated with Opioids and Other Psychoactive Prescription Drugs. CMA Policy, 2015. Ottawa: The Association; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed: 2018 Aug 2).
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Health Canada consultation on tobacco products regulations (plain and standardized appearance)

https://policybase.cma.ca/en/permalink/policy13930
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-09-06
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 proposed regulations entitled Tobacco Products Regulations (Plain and Standardized Appearance) and an Order to amend Schedule 1 to the Tobacco and Vaping Products Act with respect to colouring agents, in Canada Gazette, Part 1. 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 and for 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 CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 in a resolution 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.” We are pleased to support the proposed regulations and that they will apply to the packaging of all tobacco products and that brand colours, graphics and logos will be prohibited on packages. No exceptions, including for cigars and pipe tobacco, should be considered. These measures will assist in promoting harm reduction efforts and further the goal of reducing and eliminating smoking. In 2017, 16.2% of Canadians aged 12 and older smoked either daily or occasionally; this is down from 17.7% in 2015. These proposed regulations will be a significant step in the goal of further reducing the smoking rate. However, there are three areas that the CMA would like to see strengthened and are described below. Slide and Shell Packaging – Minimum package dimensions and warning surface area The CMA supports strongly the concept of tobacco products being sold in standardized packages. We recommended 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 type and allow for the largest possible surface area to be used to convey health warnings and other health-related information. With respect to the draft regulation (s.39) concerning the dimensions of the new packages when closed, the CMA recommends that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.1 The Quebec requirement for a warning surface area of 46.5 sq. cm should be the minimum across Canada. To achieve that, we suggest that the new slide and shell package for regular size cigarettes have the following dimensions when it is closed: (a) its height must be no less than 74 mm and no more than 77 mm; (b) its width must be no less than 84 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. A similar adjustment is recommended for the width of packages of king size cigarettes when closed: (a) its width must be no less than 83 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. In both cases, this is over and above the dimensions in s.39 (1)(a) and (b) for regular size cigarettes and s.39(2)(b) for king size cigarettes. We also recommend that the number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. This would also prohibit manufacturers from adding one or two additional cigarettes as a “bonus” or “premium.” Brand names The appearance of brand names on the packages should be in a manner that is standard for all brands. Tobacco manufacturers should not be able to include terms such as “organic” or “natural” as part of a brand name. These descriptions would convey the perception that these products are somehow better or are healthier for the consumer. As well, they may be used to evoke a lifestyle or are fashionable. Such terms and phrases should be banned in the regulations; the European Union’s Directive 2014/40/EU of the European Parliament and of the Council could serve as the guide is this instance. Leaflets Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to their customers. The CMA has always supported educational and public health initiatives aimed at countering these messages. Permitting a leaflet inside packages “that warns consumers of the health hazards arising from the use of the tobacco product or that provides instructions for its use” (draft regulation s. 36.3) is a positive step but should not provide manufacturers with a potential loophole to exploit. The draft regulation should be amended to indicate that the only instance where any instructions are permitted on the leaflet are when the product has an electronic component. This would prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior. Summary Canada's physicians have been working for decades toward the goal of a smoke-free Canada and we are pleased to support the proposed regulations. We recommend that the draft regulations be strengthened in the following manner: 1) The measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions. 2) The number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. 3) Use of terms and phrases such as “organic” and “natural” in brand names should be banned in the regulations. 4) The only instance where any instructions are permitted on the proposed leaflets are when the product has an electronic component. Tobacco and Vaping Products Act: Tobacco Products Regulations (Plain and Standardized Appearance) Canada Gazette, Part I, 2018 Jun 23 152(25). Available: http://gazette.gc.ca/rp-pr/p1/2018/2018-06-23/html/reg9-eng.html (accessed 2018 Aug 7). Statistics Canada. Smoking, 2017 Health Fact Sheets Cat. No. 82-625-X June 26, Ottawa, Ont.: Statistics Canada, 2018. Available: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2018001/article/54974-eng.pdf?st=7HkJdkUB (accessed 2018 Sep 5). Canadian Medical Association (CMA). Letter 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. Ottawa: CMA; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Aug 29). The European Parliament and The Council of the European Union. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive. 2001/37/EC. Brussels: Official Journal of the European Union, 2014. Available: https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf (accessed 2018 Sep 4).
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Implementation of National Pharmacare

https://policybase.cma.ca/en/permalink/policy13933
Date
2018-10-02
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-10-02
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes this opportunity to provide input to the Advisory Council on the Implementation of National Pharmacare (Advisory Council) on the issues set out in its discussion paper.1 The striking of the Advisory Council by the federal government is long overdue. We will focus on the questions set out in the discussion paper and draw attention to more specific issues that the Advisory Council should consider as it develops its final report. At the outset, Canada’s physicians are very concerned about their patients’ access to prescription medicines. A June 2018 survey of the CMA member e-panel found the following:
71% reported that they always/often ask their patients if they have prescription drug coveragebefore writing a prescription;
60% reported that greater than 20% of their patients are either uncovered or inadequatelycovered for prescription drugs; and
79% reported that copayments pose affordability challenges among their patients with drugcoverage and that they resort to a variety of strategies to help them. Indeed, when asked to pick one of three options for a national prescription program, the results were as follows:
57% - a single, national, public pharmacare plan operated by the federal government and fundedby taxes collected by the federal government;
34% - a mix of private prescription drug plans operated by private insurance companies andpublic drug plans run by the provinces and territories, supplemented by a prescription drug planprovided by the federal government for persons with high out-of-pocket drug costs; and
9% - separate regional, public pharmacare plans in each province and territory, funded by taxescollected by both the federal government and the provincial governments. Who should be covered under national pharmacare? / How should national pharmacare be delivered? The CMA’s position is that all Canadians should have access to medically necessary drugs regardless of their ability to pay. The challenge is how to resolve the issue of the most expedient and affordable means of achieving this in a manner that is acceptable to the provincial/territorial governments. At the present time there are two main options that are being discussed. The first is the approach recommended by the Standing Committee on Health (HESA) that calls for the development of a common national prescription drug formulary and the amendment of the Canada Health Act to include out-of-hospital prescription drugs in the definition of insured health services; essentially a universal, single public payer program.2 The second is the “closing the gap” or “catastrophic coverage” approach recommended previously by the Kirby and Romanow commissions, and which was one of the unfulfilled commitments that First Ministers made in the 2003 Health Accord. There is a large difference in the cost of these two approaches. Regarding the first, the federal Parliamentary Budget Office (PBO) has estimated the net cost to the federal government of assuming the cost of a pharmacare program modelled on the Quebec drug formulary at $19.3 billion in 2015-16, increasing to $22.6 billion in 2020-21.3 Regarding the second approach, in 2002 the Kirby commission suggested that a catastrophic drug program with a cap of 3% of family income would cost $500 million per year.4 A 2015 study by the Conference Board estimated that a program with a cap of 3% of household income or $1,500 would cost the federal government $1.6 billion in 2016, increasing to $1.8 billion in 2020.5 There are parallels between the present situation with insurance coverage for prescription drugs and the insurance coverage for medical services that existed at the time of the Hall Commission (1961-1964). 4 In 1961 there were 9.6 million Canadians with some form of medical insurance or prepayment coverage, representing 53% of the population.6 Almost one-half of this number (4.5 million) were covered by the physician-sponsored not-for-profit Trans-Canada Medical Plans.7 In its 1962 brief to the Hall Commission the CMA projected that this percentage would increase to 67% by 1970 and it recommended a “closing the gap” approach for the uninsured and under-insured: That, for the 1,520,000 persons, or approximately 8% of Canada’s population who may adjudged to be medically indigent, tax funds be used to provide comprehensive medical insurance on services…for persons in economic circumstances just superior to the identifiable indigent we recommend the application of tax funds on proof of need to permit the partial assistance which they require.8 After Hall reported in 1964 with the recommendation of first dollar public Medicare, as they say, the rest is history. More than 50 years after the initial passage of the Medical Care Act in 1966, virtually nobody would suggest that Canada got it wrong. In the case of pharmacare today, the circumstances are somewhat different. First the prevalence of prescription drug insurance is much higher today than medical insurance was back in the early 1960s. A 2017 report from the Conference Board estimates that just 5.2% of Canadians are uninsured for prescription drugs.9 Other survey estimates indicate that roughly one in 10 Canadians report financial difficulty in filling prescriptions10, although some surveys have yielded higher results, such as a September, 2018 Abacus Data poll that found that 23% of Canadians reported that the medicines they need are unaffordable.11 Second, the role of the provincial/territorial (PT) governments paying for prescription drugs today is much greater than their role in paying for medical services prior to Medicare. In 1961 it was estimated that all public sources accounted for 12.4% of medical care expenditures.12 In 2017, PT governments accounted for an estimated 37% of prescription drug spending.13 It is also instructive to consider how Medicare ramped up from its initial spending under the Hospital Insurance and Diagnostic Services Act in 1958-59 through to the first payments under the Medical Care Act a decade later, shown in Table 1. The table shows clearly that Medicare payments increased gradually over the two stages. Medicare as a share of total federal program spending increased from 1% in 1958-59 to a high of 11% in 1971-72. Interestingly, federal spending on Medicare never reached the 50/50 cost-sharing that was offered, reaching 36% in 1976-77, the year prior to the Established Programs Financing Act coming into effect. As an aside, according to the 2017 Fall Economic statement the Canada Health Transfer, valued at $37.1 billion in 2017-18 represents 12.2% of program spending.14 This history highlights the need to consider how the federal government might phase in the program recommended by HESA given the cost estimated by the PBO at $19.3 billion. This appears a daunting challenge in light of the recent increases in federal health funding, which amount to annual increases in the Canada Health Transfer of just over $1 billion plus the $11 billion allocated in the 2017 federal budget over a 10-year period for home care and mental health.15 There is no disagreement that at the present time the fiscal prospects are better for the federal than the PT governments. In its 2018 Fiscal Sustainability Report, the PBO reported that over the 2018-92 projection period the federal government could either increase annual spending or reduce taxes by 1.4% of Gross Domestic Product ($29 billion) and maintain its net debt at the current (2017) level.16 However, the government has many other spending priorities. Conversely, sub-national governments would be required to either increase taxes or reduce spending by 0.8% of GDP or ($18 billion) to maintain net debt at the current level. The CMA has previously recommended that the federal government pursue a “close the gap” approach in partnership with the PT governments and the private insurance industry. This approach could be scaled up toward a full national public pharmacare by either or both of lowering the household income threshold or raising the level of federal contribution.17 However this has never developed any serious momentum. While the first Ministers committed in their 2003 Accord to take measures, by the end of 2005/06 to ensure that Canadians, wherever they live, have reasonable access to catastrophic coverage,18 this ran aground with the first and only progress report of the National Pharmaceuticals Strategy in 2006.19 It was 5 evident in the report that much of the current public funding had been shifted into the catastrophic category, ranging from $6.6 billion to $10.3 billion across the four scenarios presented. The only further public PT government pronouncement on a catastrophic drug plan was a three-point proposal set out in a backgrounder for the PT health Ministers meeting in 2008 calling for a funding formula that would: protect the autonomy of the PTs in program design; set a ceiling of 5% of income; and recognize the federal government’s role as an equal partner with 50/50 cost sharing of a total estimate cost of $5.03 billion (2006).20 The amount of $5.03 billion would have represented 62% of PT spending on prescription drugs in 2006. More recently, an “essential medicines” approach to universal pharmacare has been put forward by Morgan and colleagues, modelled on 2015 data. Essential medicines are defined by the World Health Organization (WHO) as those that satisfy the priority health care needs of the population.21 WHO maintains a model list of essential medicines, and the 2017 version contains some 430 medications.22 Using a multi-step review process, Taglione and colleagues adapted the 2013 version of the WHO list to produce a shorter list of 125 medications that they assessed against the prescription audits of two Toronto-based family health teams comprising 4,777 and 35,554 patients in 2014. They reported 90.8% and 92.6% coverage with the preliminary list of 125 medications in the two sites respectively.23 The list is now called the CLEAN Meds list (http://cleanmeds.ca/). Morgan and colleagues used 117 items from the CLEAN Meds list to model the impact of adding universal public coverage of an essential medicines list to the existing public drug plans in Canada, based on 2015 data. They reported the following base case results:
Total public expenditure would increase by $1.229 billion to $11.99 billion;
Total private expenditure would decrease by $4.272 billion to $11.172 billion; and
Public expenditure on essential medicines would be $6.14 billion, representing 51% of the total$12 billion in total public expenditure.24 In further research conducted for the Patented Medicine Prices Review Board (PMPRB), Morgan examined the listing of the CLEAN Meds list across the public formularies in Canada for 2015 and found that the public plans listed 93% on average of the 125 medicines, and that this increased to 98% when weighted by drug plan costs.25 The Institute of Fiscal Studies and Democracy at the University of Ottawa has done a similar analysis of 128 medications on the CLEAN Meds list and coverage ranged across provinces from Manitoba at the bottom (with 88 covered completely and 8 requiring special authorization) to Quebec at the top with coverage of 121 items.26 This would suggest that one approach would be for the federal government to offer to cover universal coverage for essential medicines, which would cost at least $6 billion. There would be coordination issues with both public and private plans, as was the case when Ontario introduced OHIP + in early 2018 to extend coverage to persons under 25.27 This could be subsequently scaled up by adding coverage for additional medications. In terms of how pharmacare should be delivered, that will depend on how far the federal government wants to go. Could the federal government administer a national pharmacare program? It already controls levers including drug approval by Health Canada and price-setting through the PMPRB, and it provides the majority (70%) of funding to the Canadian Agency for Drugs and Technologies and Health which oversees the Common Drug Review.28 In May, 2015 Canadian Blood Services (CBS) CEO Dr. Graham Sher proposed that CBS could be considered as a model for national pharmacare, given its history of running a national (except Quebec) formulary of plasma protein drugs at no cost to patients.29 In his subsequent testimony to the HESA pharmacare study Sher described CBS’ success in negotiating price reductions through public tendering and bulk purchasing’ although he did also note that their formulary includes 45 brands and classes of plasma protein products, far fewer than the thousands of items in PT formularies.30 More recently Flood et al. have suggested that one option for pharmacare could involve the PT governments delegating authority to an arm’s-length agency similar to CBS that would purchase drugs and administer drug benefits.31 6 However, in the comuniqué following their June 2018 meeting the PT health Ministers emphasized that provinces and territories must retain responsibility for the design and delivery of public drug coverage…Quebec will maintain its own program and will receive comparable compensation if the federal government puts a pan-Canadian program in place.32 This was repeated by the Premiers in their communiqué three weeks later, which would suggest that a national agency approach is a non-starter. Moreover, none of the PT drug plans testified to the HESA pharmacare study. One issue that has received scant attention in all of the discussions about pharmacare since 2015 is the future role of private supplementary health insurance. When Medicare came in in the late 1960s, while the expenditures increased steadily, enrolment in non-profit medical insurance plans disappeared virtually overnight, dropping from 8.3 million enrollees in 1968 to 1.1 million in 1970 and none thereafter.33 This appears unlikely to happen to private insurance in the foreseeable future. For example, in the essential medicines modeling done by Morgan et al. the essential medicines would represent just 27% of total prescription drug expenditures and all public drug expenditures would account for 52% of the total.24 If the federal and PT governments were able to collectively “wave a magic wand” and come up with the PBO’s $19.3 billion and a purchasing and distribution strategy it seems likely that this would raise questions about the continued viability of the health insurance benefits industry. In their testimony to HESA, the Canadian Life and Health Insurance Association did allude to an impact on the industry should prescription drugs become a public program but was not specific.34 We have been unable to locate any international comparative literature on the structure of the health benefits industry. In 2017 CLHIA’s members paid out $11.3 billion in drug benefits, representing 44% of the $25.5 billion total. Dental benefits accounted for $8.1 billion, or 32% of the total.35 Dental benefits paid by CLHIA members accounted for two-thirds (65%) of the estimated total expenditures on dental benefits in Canada in 2017; just 6% were publicly funded.13 Socio-economic inequalities in access to dental care are well-documented36, but this issue is nowhere on the public policy agenda. In addition, any transition from private to public coverage will require some administrative coordination. As noted above, Morgan et al. estimated that an essential medicines approach would reduce private spending by $4.2 billion, a large proportion of which would be currently paid for by private insurance.24 Which drugs should be covered/how much variability across jurisdictions should there be? In terms of which drugs should be covered, the CMA believes that optimal prescribing is the prescription of a drug that is:
The most clinically appropriate for the patient’s condition;
Safe and effective;
Part of a comprehensive treatment plan; and
The most cost-effective drug available to meet the patient’s needs.37 There is no dispute that private insurance companies offer wider formularies than the public drug programs. In their 2017 study the Conference Board compiled information on the number of drugs dispensed in 2015 through: both public and private plans, public plans only; and private plans only. This was presented for nine provinces, excluding PEI. Across the nine provinces, the following averages were observed:
4,878 drugs were dispensed from both public and private plans;
336 drugs were dispensed from public plans only;
1,938 drugs were dispensed from private plans only.9 On the 2018 CMA member e-panel survey, physicians were much more likely to report formulary coverage issues with their patients who with public coverage than they were for their patients with Private coverage. More than five in 10 (54%) physicians reported that they always/often have formulary coverage 7 issues with their publicly insured patients versus just over one in 10 (13%) for their privately insured patients. If the federal government plans to pursue national pharmacare Canadians should be well-informed about the range of prescription drugs that will be available to them. In terms of the variability of coverage, if pharmacare or some portion of it becomes a publicly insured service it should be offered to all Canadians under uniform terms and conditions, as specified in the CHA. In practical terms, Morgan and colleagues have previously demonstrated that there is a high degree of commonality in the formularies across the public drug programs. Based on a review of 2006 formulary listings of 796 drugs across all provincial formularies except PEI, they found that coverage ranged from 55% to 73%, but when weighted by national retail sales the measure of formulary coverage exceeded 86% in all 9 provinces.38 More recently, in the 2017 PMPRB study of formulary coverage Morgan studied 729 drugs across all provinces and the Non-Insured Health Benefits Plan for 2015. The public plans listed an average of 79% of the 729 drugs, and this increased to 95% when drug costs were factored in.25 These findings would lend further support to the case for an essential medicines approach to national pharmacare. Should patients pay a portion of the cost of drugs/should employers continue to play a role? If the federal government intends to define out-of-hospital prescription drugs as an insured service under the CHA it will be necessary to address the feasibility of first dollar coverage in light of the accessibility criterion that prohibits user charges. The CMA addressed this issue in our 2016 brief to the HESA pharmacare study with reference to Scotland, which eliminated prescription charges in April, 2011.39 There are now more recent data. In the four years leading up to the elimination of prescription charges the volume of prescriptions dispensed increased by 3.6% annually. In the seven years since the charges were eliminated, the annual increase has been 1.8%; indeed between 2016/17 and 2017/18 there was a decrease of 0.06%.40 It should be added however that dispensing charges only accounted for 3% of prescription costs in 2008/09. Wales and Northern Ireland have also eliminated prescription charges for their citizens. The experiences of these countries should be examined more closely. There has been very little research on how employers would react to the implementation of a full or partial public pharmacare plan. Ipsos conducted research among the employer community in 2012. Just under one in two (47) of respondents indicated that they would support a public program for supplementary benefits introduced by the federal government that was funded by increased taxes, but nearly nine in ten agreed that even if the government implemented a program I would recommend that our company/organization still offer a supplementary health benefits program (over and above the government offer) because it would give us an advantage in recruiting/retaining employees.41 If some form of a public pharmacare program is implemented, this will reduce the amount of drug benefits that private insurance companies are required to pay out, which should result in lower premiums for those employers who provide supplementary benefits. The implications of this in terms of how a pharmacare program might be funded have not received much scrutiny to date. However, regardless of the notionally ear-marked health taxes or premiums that are levied against businesses or individuals, Medicare has been paid for out of general tax revenues. Conclusion In conclusion, the initial modeling study published by Morgan et al. in 201542 has resulted in welcome attention to the longstanding issue of access to prescription drugs for Canadians who are either uninsured or under-insured. However the discussions have been light on how we could transition to a situation where Canadians can access prescription drugs on the same basis as they access medical and hospital services. This would require concerted discussion between the federal and PT governments and 8 the health insurance benefits industry and this has not yet occurred. The discussions since 2015 have mainly ignored the issue of highly expensive drugs for rare diseases and very expensive drugs for more common diseases, such as biologic drugs for rheumatoid arthritis. The CMA is pleased to see that HESA is launching a study on the barriers to access to treatment and drugs for Canadians with rare diseases and disorders.43 Recommendations The Canadian Medical Association recommends that the Advisory Committee on the Implementation of National Pharmacare: 1.Engage with the federal and provincial/territorial governments and the health insuranceindustry on the feasibility of a universal federally funded “essential medicines”prescription drug plan as a scalable approach to the implementation of a nationalpharmacare plan. 2.Engage the business community and the health insurance industry on the question of thecontinued viability of the provision of supplementary health benefits (e.g. dental care)should a national pharmacare plan be implemented. 3.Study the international experience of Scotland and other countries with respect to theprovision of first dollar coverage of prescription drugs. 9 Table 1. The Evolution of Medicare ($ million) Year HIDS Medical Care Act Total program spend Medicare as a % of total program Total hospital spend Total physician spend Medicare as a % of total H&P 1958-59 54.7 0 4716 1% 640.608 301.337 6% 1959-60 150.6 0 4919.4 3% 735.626 325.689 14% 1960-61 189.4 0 5160.5 4% 834.932 355.014 16% 1961-62 283.9 0 5681.6 5% 930.568 388.305 22% 1962-63 336.7 0 5652.5 6% 1031.749 406.075 23% 1963-64 392.2 0 5878.7 7% 1150.306 453.395 24% 1964-65 433.9 0 6167 7% 1273.38 495.657 25% 1965-66 319.6 0 6623.9 5% 1434.274 545.056 16% 1966-67 397.4 0 7589.2 5% 1637.647 605.2 18% 1967-68 468.6 0 8497 6% 1880.699 686.189 18% 1968-69 561.9 33 9258 6% 2179.906 788.089 20% 1969-70 635.9 181 10204 8% 2456.687 901.435 24% 1970-71 734.3 400.5 11262 10% 2775.391 1031.555 30% 1971-72 844.6 576.5 12831 11% 3095.367 1239.775 33% 1972-73 960.5 630.8 16324 10% 3384.801 1375.127 33% 1973-74 1065.7 677.9 20247 9% 3803.61 1471.971 33% 1974-75 1307.6 762.7 26037 8% 4579.041 1647.025 33% 1975-76 1709.2 795.8 30023 8% 5533.707 1900.483 34% 1976-77 2030.5 1003.6 34209 9% 6357.3 2071 36% Sources: Hospital Insurance and Diagnostic Services (HIDs) and Medical Care Act – Public Accounts of Canada Issues 1958-59 – 1976-77. Spending by National Health and Welfare. Total program spend – Public Accounts of Canada Issues 1958-59-1976-77. Budgetary Expenditures Classified by Function – Total spend less public debt charges. Total hospital and physician spend – calendar year data 1958 – 1975 in Statistics Canada, Historical Statistics of Canada. Series B504-513 Health expenditures, Canada, 1926 to 1975. 1976 – Canadian Institute for Health Information. National Health Expenditures Data Tables Table A.3.1.1. 1 Government of Canada. Towards implementation of national pharmacare. Discussion paper. https://www.canada.ca/content/dam/hc-sc/documents/corporate/publications/council_on_pharmacare_EN.PDF. Accessed 10/02/18. 2 House of Commons Standing Committee on Health. Pharmacare now: prescription medicine coverage for all Canadians. http://www.ourcommons.ca/Content/Committee/421/HESA/Reports/RP9762464/hesarp14/hesarp14-e.pdf. Accessed 10/02/18. 3 Office of the Parliamentary Budget Officer. Federal cost of a national pharmacare program. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2017/Pharmacare/Pharmacare_EN_2017_11_07.pdf. Accessed10/02/18. 10 4 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. https://sencanada.ca/content/sen/committee/372/soci/rep/repoct02vol6-e.pdf. Accessed 10/-2/18.5 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 10/02/18.6 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965.7 Clarkson G. The role of Trans-Canada Medical plans in Canadian medical insurance. News & Views on the Economics of Medicine 1966, Number 136.8 Canadian Medical Association. Submission of the Canadian Medical Association to the Royal Commission on Health Services. Toronto, 1962.9 Conference Board of Canada. Understanding the gap: a pan-Canadian analysis of prescription drug insurance coverage. https://www.conferenceboard.ca/temp/7bef4501-6ba6-4527-8b99-8b788c461d14/9326_Understanding-the-Gap__RPT.pdf. Accessed 10/02/18.10 Canadian Institute for Health Information. How Canada compares: Results from the Commonwealth Fund’s 2016 International Health Policy Survey of Adults in 11 Countries.https://www.cihi.ca/sites/default/files/document/commonwealth-fund-2016-chartbook-en-web-rev.pptx. Accessed10/02/18.11 Abacus Data. Canadian perspectives on pharmacare. http://abacusdata.ca/canadian-perspectives-on-pharmacare/. Accessed 10/02/18.12 Royal Commission on Health Services. 1964—Report Volume 1. Ottawa: Queen’s Printer, 1964.13 Canadian Institute for Health Information. National health expenditure trends 1975 to 2017: data tables.https://www.cihi.ca/sites/default/files/document/series_b-nhex2017-en.xlsx. Accessed 10/02/18.14 Department of Finance Canada. Progress for the middle class. Fall economic statement 2017.https://www.budget.gc.ca/fes-eea/2017/docs/statement-enonce/fes-eea-2017-eng.pdf. Accessed 10/02/18.15 Department of Finance Canada. Building a strong middle class. Budget plan 2017. https://www.budget.gc.ca/2017/docs/plan/budget-2017-en.pdf. Accessed 10/02/18. 16 Office of the Parliamentary Budget Officer. Fiscal sustainability report 2018. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2018/FSR%20Sept%202018/FSR_2018_25SEP2018_EN_2.pdf. Accessed 10/02/18. 17 Canadian Medical Association. Funding the continuum of care. https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD10-02-e.pdf. Accessed 1-/-2/18. 18 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ Accord on Health Care Renewal. http://www.scics.ca/wp-content/uploads/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 10/02/18. 19 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. June 2006. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 10/02/18. 20 Canadian Intergovernmental Conference Secretariat. Annual conference of provincial-territorial Ministers of health. Backgrounder: National pharmaceutical strategy decision points. http://www.scics.ca/en/product-produit/backgrounder-national-pharmaceutical-strategy-decision-points/. Accessed 10/02/18. 21World Health Organization. Essential medicines and health products. http://www.who.int/medicines/services/essmedicines_def/en/. Accessed 10/02/18. 22World Health Organization. WHO model list of essential medicines. 20th list (Amended August 2017). http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017.pdf?ua=1. Accessed 10/02/18. 23 Taglione M, Ahmad H, Slater M, Aliarzadeh B, Glazier R, Laupacis A, Persaud N. Development of a preliminary essential medicines list for Canada. CMAJ Open 2017, 5(1):E137-43. 24 Morgan S, Li W, Yau B, Persaud N. Estimated effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada. CMAJ 2017;189(8):E295-302. 25 Patented Medicine Prices Review Board. Alignment among public formularies in Canada. Part 1: General overview. http://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/NPDUIS_formulary_report_part_1_en.pdf. Accessed 10/02/18. 26 Institute for Fiscal Studies and Democracy. National pharmacare in Canada: Choosing a path forward. http://www.ifsd.ca/web/default/files/Presentations/Reports/18006%20-%20National%20Pharmacare%20in%20Canada-%20Choosing%20a%20Path%20Forward%20-%2016%20July%202018%20-%20Final.pdf. Accessed 10/02/18. 27 CTV News. Ottawa dad raising red flag about OHIP+. https://ottawa.ctvnews.ca/ottawa-dad-raising-red-flag-about-ohip-1.3759115. Accessed 10/02/18. 28 Canadian Agency for Drugs and Technologies in Health. Financial statements March 31, 2018. https://www.cadth.ca/sites/default/files/corporate/planning_documents/CADTH-FS-FY17-18-e.pdf. Accessed 10/02/18. 29 Sher G. Canadian Blood Services as a model for national pharmacare. National Post, April 15, 2015. https://blood.ca/en/media/graham-sher-canadian-blood-services-as-a-model-for-national-pharmacare. Accessed 10/02/18. 11 30 House of Commons Standing Committee on Health. Evidence. Monday, May 2, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8226056/HESAEV09-E.PDF. Accessed 10/02/18. 31 Flood C, Thomas B, Moten A, Fafard P. Universal pharmacare and federalism: policy options for Canada. http://irpp.org/wp-content/uploads/2018/09/Universal-Pharmacare-and-Federalism-Policy-Options-for-Canada.pdf. Accessed 10/02/18. 32 Canadian Intergovernmental Conference Centre. Conference of provincial and territorial Ministers of health. Provincial/territorial health Ministers meeting communiqué. June 28, 2018. http://www.scics.ca/en/product-produit/news-release-provincial-territorial-health-ministers-meeting-communique/. Accessed 10/02/18. 33 Statistics Canada. Historical Statistics of Canada. Series 8514-516. Estimated enrolment in non-profit medical insurance plans, Canada, at 31 December, 1937 to 1975. https://www150.statcan.gc.ca/n1/en/pub/11-516-x/pdf/5500093-eng.pdf?st=W5ksoTqs. Accessed 10/02/18. 34 House of Commons Standing Committee on Health. Evidence. Monday, May 9, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8251913/HESAEV10-E.PDF. Accessed 10/02/18. 35 Canadian Life and Health Insurance Association. Canadian life and health insurance facts 2018 edition. https://www.clhia.ca/web/clhia_lp4w_lnd_webstation.nsf/resources/Factbook_2/$file/2018+FB+EN.pdf. Accessed 10/02/18. 36 Farmer J, Phillips R, Singhal S, Quinonez C. Inequalities in oral health: understanding the contributions of education and income. Canadian Journal of Public Health 2017;108(3):3240-5. 37 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 10/02/18. 38 Morgan S, Hanley G, Raymond C, Blais R. Breadth, depth and agreement among provincial formularies in Canada. Healthcare Policy 2009;4(4):e162-84. 39 Canadian Medical Association. National pharmacare in Canada: getting there from here. https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/national-pharmacare-canada-e.pdf. Accessed 10/02/18. 40 ISD Scotland. Data Tables Prescribing and Medicines. Volume and cost (NHSScotland) (Financial years 2008-09-2017/18). http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Publications/data-tables2017.asp?id=2204#2204. Accessed 10/02/18. 41 Ipsos Reid. Two in ten (18%) Canadians have no supplementary health coverage. https://www.ipsos.com/sites/default/files/publication/2012-08/5714.pdf. Accessed 10/02/18. 42 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ 2015;187(7):491-7. 43 House of Commons Standing Committee on Health Minutes of Proceedings, Meeting No. 100 April 18, 2018. http://www.ourcommons.ca/DocumentViewer/en/42-1/HESA/meeting-100/minutes. Accessed 10/02/18.
Documents
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CMA Code of Ethics and Professionalism

https://policybase.cma.ca/en/permalink/policy13937
Date
2018-12-08
Topics
Population health/ health equity/ public health
  3 documents  
Policy Type
Policy document
Date
2018-12-08
Replaces
Code of ethics of the Canadian Medical Association (Update 2004)
Topics
Population health/ health equity/ public health
Text
CMA CODE OF ETHICS AND PROFESSIONALISM Compassion A compassionate physician recognizes suffering and vulnerability, seeks to understand the unique circumstances of each patient and to alleviate the patient’s suffering, and accompanies the suffering and vulnerable patient. Honesty An honest physician is forthright, respects the truth, and does their best to seek, preserve, and communicate that truth sensitively and respectfully. Humility A humble physician acknowledges and is cautious not to overstep the limits of their knowledge and skills or the limits of medicine, seeks advice and support from colleagues in challenging circumstances, and recognizes the patient’s knowledge of their own circumstances. Integrity A physician who acts with integrity demonstrates consistency in their intentions and actions and acts in a truthful manner in accordance with professional expectations, even in the face of adversity. Prudence A prudent physician uses clinical and moral reasoning and judgement, considers all relevant knowledge and circumstances, and makes decisions carefully, in good conscience, and with due regard for principles of exemplary medical care. The CMA Code of Ethics and Professionalism articulates the ethical and professional commitments and responsibilities of the medical profession. The Code provides standards of ethical practice to guide physicians in fulfilling their obligation to provide the highest standard of care and to foster patient and public trust in physicians and the profession. The Code is founded on and affirms the core values and commitments of the profession and outlines responsibilities related to contemporary medical practice. In this Code, ethical practice is understood as a process of active inquiry, reflection, and decision-making concerning what a physician’s actions should be and the reasons for these actions. The Code informs ethical decision-making, especially in situations where existing guidelines are insufficient or where values and principles are in tension. The Code is not exhaustive; it is intended to provide standards of ethical practice that can be interpreted and applied in particular situations. The Code and other CMA policies constitute guidelines that provide a common ethical framework for physicians in Canada. In this Code, medical ethics concerns the virtues, values, and principles that should guide the medical profession, while professionalism is the embodiment or enactment of responsibilities arising from those norms through standards, competencies, and behaviours. Together, the virtues and commitments outlined in the Code are fundamental to the ethical practice of medicine. Physicians should aspire to uphold the virtues and commitments in the Code, and they are expected to enact the professional responsibilities outlined in it. Physicians should be aware of the legal and regulatory requirements that govern medical practice in their jurisdictions. Trust is the cornerstone of the patient–physician relationship and of medical professionalism. Trust is therefore central to providing the highest standard of care and to the ethical practice of medicine. Physicians enhance trustworthiness in the profession by striving to uphold the following interdependent virtues: A. VIRTUES EXEMPLIFIED BY THE ETHICAL PHYSICIAN 2 B. FUNDAMENTAL COMMITMENTS OF THE MEDICAL PROFESSION Consider first the well-being of the patient; always act to benefit the patient and promote the good of the patient. Provide appropriate care and management across the care continuum. Take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm has occurred. Recognize the balance of potential benefits and harms associated with any medical act; act to bring about a positive balance of benefits over harms. Commitment to the well-being of the patient Promote the well-being of communities and populations by striving to improve health outcomes and access to care, reduce health inequities and disparities in care, and promote social accountability. Commitment to justice Practise medicine competently, safely, and with integrity; avoid any influence that could undermine your professional integrity. Develop and advance your professional knowledge, skills, and competencies through lifelong learning. Commitment to professional integrity and competence Always treat the patient with dignity and respect the equal and intrinsic worth of all persons. Always respect the autonomy of the patient. Never exploit the patient for personal advantage. Never participate in or support practices that violate basic human rights. Commitment to respect for persons Contribute to the development and innovation in medicine through clinical practice, research, teaching, mentorship, leadership, quality improvement, administration, or advocacy on behalf of the profession or the public. Participate in establishing and maintaining professional standards and engage in processes that support the institutions involved in the regulation of the profession. Cultivate collaborative and respectful relationships with physicians and learners in all areas of medicine and with other colleagues and partners in health care. Commitment to professional excellence Value personal health and wellness and strive to model self-care; take steps to optimize meaningful co-existence of professional and personal life. Value and promote a training and practice culture that supports and responds effectively to colleagues in need and empowers them to seek help to improve their physical, mental, and social well-being. Recognize and act on the understanding that physician health and wellness needs to be addressed at individual and systemic levels, in a model of shared responsibility. Commitment to self-care and peer support Value and foster individual and collective inquiry and reflection to further medical science and to facilitate ethical decision-making. Foster curiosity and exploration to further your personal and professional development and insight; be open to new knowledge, technologies, ways of practising, and learning from others. Commitment to inquiry and reflection 3 C. PROFESSIONAL RESPONSIBILITIES The patient–physician relationship is at the heart of the practice of medicine. It is a relationship of trust that recognizes the inherent vulnerability of the patient even as the patient is an active participant in their own care. The physician owes a duty of loyalty to protect and further the patient’s best interests and goals of care by using the physician’s expertise, knowledge, and prudent clinical judgment. In the context of the patient–physician relationship: 1. Accept the patient without discrimination (such as on the basis of age, disability, gender identity or expression, genetic characteristics, language, marital and family status, medical condition, national or ethnic origin, political affiliation, race, religion, sex, sexual orientation, or socioeconomic status). This does not abrogate the right of the physician to refuse to accept a patient for legitimate reasons. 2. Having accepted professional responsibility for the patient, continue to provide services until these services are no longer required or wanted, or until another suitable physician has assumed responsibility for the patient, or until after the patient has been given reasonable notice that you intend to terminate the relationship. 3. Act according to your conscience and respect differences of conscience among your colleagues; however, meet your duty of non-abandonment to the patient by always acknowledging and responding to the patient’s medical concerns and requests whatever your moral commitments may be. 4. Inform the patient when your moral commitments may influence your recommendation concerning provision of, or practice of any medical procedure or intervention as it pertains to the patient’s needs or requests. 5. Communicate information accurately and honestly with the patient in a manner that the patient understands and can apply, and confirm the patient’s understanding. 6. Recommend evidence-informed treatment options; recognize that inappropriate use or overuse of treatments or resources can lead to ineffective, and at times harmful, patient care and seek to avoid or mitigate this. 7. Limit treatment of yourself, your immediate family, or anyone with whom you have a similarly close relationship to minor or emergency interventions and only when another physician is not readily available; there should be no fee for such treatment. 8. Provide whatever appropriate assistance you can to any person who needs emergency medical care. 9. Ensure that any research to which you contribute is evaluated both scientifically and ethically and is approved by a research ethics board that adheres to current standards of practice. When involved in research, obtain the informed consent of the research participant and advise prospective participants that they have the right to decline to participate or withdraw from the study at any time, without negatively affecting their ongoing care. 10. Never participate in or condone the practice of torture or any form of cruel, inhuman, or degrading procedure. Physicians and patients Patient-physician relationship 4 11. Empower the patient to make informed decisions regarding their health by communicating with and helping the patient (or, where appropriate, their substitute decision-maker) navigate reasonable therapeutic options to determine the best course of action consistent with their goals of care; communicate with and help the patient assess material risks and benefits before consenting to any treatment or intervention. 12. Respect the decisions of the competent patient to accept or reject any recommended assessment, treatment, or plan of care. 13. Recognize the need to balance the developing competency of minors and the role of families and caregivers in medical decision-making for minors, while respecting a mature minor’s right to consent to treatment and manage their personal health information. 14. Accommodate a patient with cognitive impairments to participate, as much as possible, in decisions that affect them; in such cases, acknowledge and support the positive roles of families and caregivers in medical decision-making and collaborate with them, where authorized by the patient’s substitute decision-maker, in discerning and making decisions about the patient’s goals of care and best interests. 15. Respect the values and intentions of a patient deemed incompetent as they were expressed previously through advance care planning discussions when competent, or via a substitute decision-maker. 16. When the specific intentions of an incompetent patient are unknown and in the absence of a formal mechanism for making treatment decisions, act consistently with the patient’s discernable values and goals of care or, if these are unknown, act in the patient’s best interests. 17. Respect the patient’s reasonable request for a second opinion from a recognized medical expert. Physicians and the practice of medicine Patient privacy and the duty of confidentiality 18. Fulfill your duty of confidentiality to the patient by keeping identifiable patient information confidential; collecting, using, and disclosing only as much health information as necessary to benefit the patient; and sharing information only to benefit the patient and within the patient’s circle of care. Exceptions include situations where the informed consent of the patient has been obtained for disclosure or as provided for by law. 19. Provide the patient or a third party with a copy of their medical record upon the patient’s request, unless there is a compelling reason to believe that information contained in the record will result in substantial harm to the patient or others. 20. Recognize and manage privacy requirements within training and practice environments and quality improvement initiatives, in the context of secondary uses of data for health system management, and when using new technologies in clinical settings. 21. Avoid health care discussions, including in personal, public, or virtual conversations, that could reasonably be seen as revealing confidential or identifying information or as being disrespectful to patients, their families, or caregivers. Medical decision-making is ideally a deliberative process that engages the patient in shared decision-making and is informed by the patient’s experience and values and the physician’s clinical judgment. This deliberation involves discussion with the patient and, with consent, others central to the patient’s care (families, caregivers, other health professionals) to support patient-centred care. In the process of shared decision-making: Decision-making 5 22. Recognize that conflicts of interest may arise as a result of competing roles (such as financial, clinical, research, organizational, administrative, or leadership). 23. Enter into associations, contracts, and agreements that maintain your professional integrity, consistent with evidenceinformed decision-making, and safeguard the interests of the patient or public. 24. Avoid, minimize, or manage and always disclose conflicts of interest that arise, or are perceived to arise, as a result of any professional relationships or transactions in practice, education, and research; avoid using your role as a physician to promote services (except your own) or products to the patient or public for commercial gain outside of your treatment role. 25. Take reasonable steps to ensure that the patient understands the nature and extent of your responsibility to a third party when acting on behalf of a third party. 26. Discuss professional fees for non-insured services with the patient and consider their ability to pay in determining fees. 27. When conducting research, inform potential research participants about anything that may give rise to a conflict of interest, especially the source of funding and any compensation or benefits. 28. Be aware of and promote health and wellness services, and other resources, available to you and colleagues in need. 29. Seek help from colleagues and appropriate medical care from qualified professionals for personal and professional problems that might adversely affect your health and your services to patients. 30. Cultivate training and practice environments that provide physical and psychological safety and encourage help-seeking behaviours. 31. Treat your colleagues with dignity and as persons worthy of respect. Colleagues include all learners, health care partners, and members of the health care team. 32. Engage in respectful communications in all media. 33. Take responsibility for promoting civility, and confronting incivility, within and beyond the profession. Avoid impugning the reputation of colleagues for personal motives; however, report to the appropriate authority any unprofessional conduct by colleagues. 34. Assume responsibility for your personal actions and behaviours and espouse behaviours that contribute to a positive training and practice culture. 35. Promote and enable formal and informal mentorship and leadership opportunities across all levels of training, practice, and health system delivery. 36. Support interdisciplinary team-based practices; foster team collaboration and a shared accountability for patient care. Physicians and self Physicians and colleagues Managing and minimizing conflicts of interest 6 38. Recognize that social determinants of health, the environment, and other fundamental considerations that extend beyond medical practice and health systems are important factors that affect the health of the patient and of populations. 39. Support the profession’s responsibility to act in matters relating to public and population health, health education, environmental determinants of health, legislation affecting public and population health, and judicial testimony. 40. Support the profession’s responsibility to promote equitable access to health care resources and to promote resource stewardship. 41. Provide opinions consistent with the current and widely accepted views of the profession when interpreting scientific knowledge to the public; clearly indicate when you present an opinion that is contrary to the accepted views of the profession. 42. Contribute, where appropriate, to the development of a more cohesive and integrated health system through interprofessional collaboration and, when possible, collaborative models of care. 43. Commit to collaborative and respectful relationships with Indigenous patients and communities through efforts to understand and implement the recommendations relevant to health care made in the report of the Truth and Reconciliation Commission of Canada. 44. Contribute, individually and in collaboration with others, to improving health care services and delivery to address systemic issues that affect the health of the patient and of populations, with particular attention to disadvantaged, vulnerable, or underserved communities. Approved by the CMA Board of Directors Dec 2018 37. Commit to ensuring the quality of medical services offered to patients and society through the establishment and maintenance of professional standards. Physicians and society
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