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.
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.
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.
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.
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 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.).
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.
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
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.
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.
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
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.
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
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
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.
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.
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.
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).
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
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.
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
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).
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.
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).
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.
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
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
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.
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
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
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
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 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).
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.
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
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)
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
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:
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:
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:
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:
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:
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:
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:
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)
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:
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
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.
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.
1. Physicians and allied health professionals
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).
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
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)
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.
4. Health care institutions and organizations
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
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
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.
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
See also CMA Policy Antimicrobial Resistance PD19-08
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,
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.
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).
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Medical professionalism (Update 2005)
The environment in which medicine is practised in Canada is undergoing rapid and profound change. There are now continued opportunities for the medical profession to provide leadership for our patients, our communities and our colleagues through strengthened professionalism. The Canadian Medical Association (CMA) is strongly committed to medical professionalism and has developed this policy both to inform physicians and others about its meaning and value and to promote its preservation and enhancement. This document outlines the major features of medical professionalism, the opportunities which exist in this area and the challenges which lie before us.
Why Medical Professionalism?
The medical profession is characterized by a strong commitment to the well-being of patients, high standards of ethical conduct, mastery of an ever-expanding body of knowledge and skills, and a high level of clinical independence. As individuals, physicians' personal values may vary, but as members of the medical profession they are expected to share and uphold those values that characterize the practice of medicine and the care of patients.
Medical professionalism includes both the relationship between a physician and a patient and a social contract between physicians and society. Society grants the profession privileges, including exclusive or primary responsibility for the provision of certain services and a high degree of self-regulation. In return, the profession agrees to use these privileges primarily for the benefit of others and only secondarily for its own benefit. Three major features of medical professionalism - the ethic of care, clinical independence and self-regulation - benefit physicians, their patients and society:
Ethic of care: This is characterized by the values of compassion, beneficence, nonmaleficence, respect for persons and justice (CMA's Code of Ethics). Society benefits from the ethic of care whereby, in the provision of medical services, physicians put the interests of others ahead of their own. Dedication and commitment to the well-being of others is clearly in the interests of patients, who are the primary beneficiaries.
Clinical independence: Medicine is a highly complex art and science. Through lengthy training and experience, physicians become medical experts and healers. Whereas patients have the right to decide to a large extent which medical interventions they will undergo, they expect their physicians to be free to make clinically appropriate recommendations. Although physicians recognize that they are accountable to patients, funding agencies and their peers for their recommendations, unreasonable restraints on clinical autonomy imposed by governments and administrators, whether public or private, are not in the best interests of patients, not least because they can damage the trust that is an essential component of the patient-physician relationship. Conversely, physicians are not morally obliged to provide inappropriate medical services when requested by patients despite their respect for patient autonomy.
Self-regulation: Physicians have traditionally been granted this privilege by society. It includes the control of entrance into the profession by establishing educational standards and setting examinations, the licensing of physicians, and the establishment and ongoing review of standards of medical practice. In return for this privilege, physicians are expected to hold each other accountable for their behaviour and for the outcomes they achieve on behalf of their patients. Self-regulation is exercised by many different professional organizations, from medical practice partnerships to the statutory provincial/territorial licensing bodies. It has evolved into a partnership with the public. Self-regulation benefits society by taking the best advantage of the professional expertise needed to appropriately set and maintain standards of training and practice, while providing suitable accountability in matters of professional behaviour. The profession's commitment to the maintenance of those standards is demonstrated by its willingness to participate in outcomes review at many levels, from institutional quality assurance activities to formal prospective peer review, and to actively support their statutory and legislated licensing authorities.
Opportunities in Medical Professionalism
Over the past few years much has been written about the issue of medical professionalism in both the lay and scientific media. The practice of medicine has changed considerably, and with these changes have come challenges but also opportunities. The medical profession continues to be a greatly respected one, and it is still generally seen as being distinct from many others because of the unique nature of the physician-patient relationship. There exists now an opportunity to reinforce the professional values and priorities that have sustained medicine for so long, and to embrace new approaches which will serve it well in the years to come.
Medical professionals must recognize that patients have a wide variety of resources available for their health care needs, from traditional physician services to paramedical practitioners, to complementary medicine and to information obtained from the internet. While maintaining responsibility for care of the patient as a whole, physicians must be able to interact constructively with other health care providers within an interdisciplinary team setting, and must be able to interpret information for patients and direct them to appropriate and accurate resources.
The relationship of physicians with their colleagues must be strengthened and reinforced. Patient care benefits when all health care practitioners work together towards a common goal, in an atmosphere of support and collegiality.
Although there are some challenges to professionalism, as outlined below, the greatest opportunity before us may be to remind physicians of the reasons they chose a career in medicine to begin with - for many, it is a calling rather than a job. In spite of the numerous recent changes in the health care system and the practice of medicine, the primary reason most physicians entered the field remains the same - the sanctity of the fiduciary relationship between physicians and their patients. The renewal of medical professionalism must be led from within the profession itself, and the CMA and its members are in a unique position to take advantage of the many opportunities which exist and to respond to the challenges we face.
Challenges to Medical Professionalism
Medical professionalism is being challenged from within and without. These challenges arise from pressures that may serve to undermine the ethic of care, clinical independence and self-regulation and may result, for individual physicians and the medical profession, in diminished morale and changes in lifestyle and practice patterns. These changes may have a detrimental impact on the health of physicians, and also on the quality of patient care.
Resource restraints: The CMA has identified scarcity of resources, whether human or material, as undermining the ability of physicians to maintain excellence in clinical care, research and teaching. Although much attention has been paid recently to the insufficient number of physicians in Canada, and although recent developments indicate some limited cause for optimism, much work remains to be done. Issues of access to continuing professional development, workforce sustainability, inadequate numbers of training positions for new doctors, the integration of foreign-trained physicians into the workforce and the apparent inability of governments to resolve inadequacies in health care funding continue to frustrate physicians' attempts to achieve their professional goals and care for their patients. These factors all have the potential for contributing to the decline of professional morale.
Bureaucratic challenges: This refers to the introduction of layers of management and policy directives between the physician and the patient. It is a result of changes that have taken place in the organization and delivery of medical care, especially the involvement of governments in all aspects of health care. The traditional one-on-one relationship of physician and patient is now set within a context of government and corporate interests, in which the physician may sometimes assume the status of an employee, that pose considerable challenges to the exercise of the professional values of clinical autonomy and self-regulation. Moreover, while the responsibility for organizing the delivery of scarce resources has been increasingly transferred from physicians to managers, physicians are still ultimately responsible, both morally and legally, for providing quality care. Although the increasing complexity of health care delivery requires recourse to sophisticated management systems, there is a danger that as physicians become increasingly answerable to or constrained by third parties, their ability to fulfill their commitment to their individual patients can be seriously compromised.
Unprofessional conduct: Some physicians do not uphold the values of the profession. A few put their interests or the interests of third parties ahead of the interests of their patients. The profession needs to meet this challenge by demonstrating its ability to uphold its values and its commitment to doing so. Supporting strong and transparent self-regulatory systems will be a key component of this endeavor.
Commercialism: In recent years the market mentality has expanded its influence to many areas formerly outside its domain, including governments, universities and the professions. Health care has become a major industry, one in which physicians play a central role, and commercial interests, whether private or public, may pressure physicians to compromise their responsibilities to their patients, research subjects and society. The potential for physicians and medical associations to become drawn into conflict-of-interest situations is increasing. Commercialism may compromise both the ethic of care and clinical independence by its reinterpretation of medical care as a commodity and the patient-physician relationship as something less than a fiduciary relationship. There is an inherent opportunity for the profession to address the issue of conflict of interest and to re-affirm its primary obligation and dedication to the patients it cares for.
Consumerism: Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others. There is a proliferation of health information and advertising in the popular media and on the Internet that may be inaccurate or poorly understood. Taken to its extreme, consumerism can be detrimental not just to professionalism but to the well-being of patients and the interests of society.
Industrialization: This refers to the increased division and specialization of labour in the delivery of health care, whereby the delivery of health care may become fragmented. There is increasing pressure within medicine to improve efficiency and optimize cost savings. While these may be important goals in the broader context of health care, we must ensure that they do not impact negatively on the doctor-patient relationship.
Realizing Opportunities and Dealing with Challenges
Individual physicians should protect, enhance and promote professionalism in medicine by reflecting the values of the medical profession in their practice and by contributing to the efforts of organized medicine to maintain and enhance the ethic of care, clinical autonomy and self-regulation. These efforts require action in 3 areas: policy, education and self-regulation.
Policy: All those involved in health care - physicians, patients, other health care providers, administrators, governments and the general public (as taxpayers, potential patients, relatives of patients, etc.) - should be informed about the values of the medical profession and where it stands on issue related to accountability, clinical autonomy and self-regulation. Policies of medical associations should reflect these values and should speak clearly on topics such as conflict of interest. Policies should be reviewed frequently and updated when necessary, in order to take account of the rapidly changing environment in which medicine is practiced. The topic of professionalism should be granted increasing importance in policy discussions. Policies should be developed and updated in related areas, such as conflict of interest and physician-industry interactions.
In order to be consistent and trustworthy, medical associations should adhere to the same high standards of behaviour that they require of individual physicians. The challenges posed by resource restraints, bureaucratization, unprofessional conduct, commercialism and consumerism are no less serious for associations than for individuals and require sound harmonized policies for both. The CMA has an opportunity for leadership in this regard.
Education: However professional values and policies are established, they must be transmitted to current and future members of the profession in order to have any effect.
Like most other aspects of medical education, the values of professionalism are both taught and modeled. Professionalism should be an essential component of the formal medical curriculum at the undergraduate and postgraduate training levels. Moreover, active demonstration of professionalism such as role modeling by physicians, and in the internal culture of the medical schools and hospitals where students receive their training, should be used to advantage and challenged when necessary. Likewise for physicians in practice, formal continuing professional development programs and role modeling by other physicians are important for the maintenance of professionalism.
Physicians need to communicate and test their understanding of their professional role with others involved in patient care at numerous levels. Such initiatives, which would engage patients, other professionals and policy-makers, require further development.
The CMA and other medical organizations have taken leadership roles in assisting patients and health care providers in making informed decisions by creating numerous continuing professional development opportunities and readily available clinical information for physicians, effective patient education materials, self-help books and validated Web sites, including www.cma.ca. These efforts need to continue and be strengthened.
Self-regulation: In order to maintain self-regulation in an environment that is increasingly suspicious of such privileges, the medical profession has to demonstrate that self regulation benefits society in general. This requires, among other things, that the medical profession continue to demonstrate its commitment to the tasks required by self-regulation, including setting and enforcing high standards of behaviour for both individual physicians and medical associations.
Physicians continue to value medical professionalism highly. They believe that it benefits patients greatly and that it should be preserved and enhanced. Professionalism will continue to be based on the relationship of trust between patients and physicians, and the primacy of the physician-patient relationship. It encompasses the values of compassion, beneficence, nonmaleficence, respect for persons and justice. As professionals, physicians will strive to maintain high standards of ethics, clinical practice and education and demonstrate a capacity for social responsibility through self-regulation and accountability (see CMA Policy Statement The Future of Medicine).
The CMA welcomes opportunities to engage in dialogue with others as to how professionalism in health care can be preserved and enhanced for the benefit of patients, physicians and society in general.
The Role of Physicians in Recognizing and Supporting
Treatment of Gambling Addiction
(Update November 2005)
Gambling is a common activity in our society. For a small percentage, this behaviour can become pathological, affecting the well-being of gamblers as well as their families and workplaces. This disorder has been described in the "Diagnostic and Statistical Manual of Mental Disorders" Fourth Edition, (DSM IV) and is recognized as an illness by physicians.
Physicians have a role in identifying pathological gambling behaviour and being aware of the resources that exist to treat and support addicted individuals and their families. To assist them in performing this role, the CMA makes the following recommendations:
* The CMA supports the development of core curricula in gambling disorders to be offered at undergraduate and post-graduate levels and through CME programs. These could include inter-professional or interdisciplinary curricula developed in partnership with other health professionals.
* The CMA supports the development and dissemination of resources to help practising physicians screen patients to identify those with gambling addiction and to provide appropriate treatment.
* Governments should ensure the timely availability of quality treatment services appropriate to the age, culture and background of client groups.
* The CMA encourages research into gambling addiction, which could include:
identifying the biological basis for gambling;
identifying best-practice interventions to reduce the prevalence of problem gambling;
measuring the social and economic impacts of gambling on individuals and communities; and
dispelling the myths surrounding gambling addiction.
* Governments and others should work together to implement educational and policy strategies to reduce the prevalence of problem gambling. These could include:
elementary school programs to help prevent pathological gambling disorders;
limiting the number of gambling establishments, particularly video lottery terminals (VLTs) and casinos;
placing age limits on accessibility to VLTs so that children and adolescents are restricted from their use; and
promoting lower risk gambling approaches for primary prevention and harm reduction such as gambling only with a predetermined loss limit and not gambling alone.
On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs.
The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat.
In summary, our response to the Minister’s three proposals is as follows:
* Supply monitoring network: We support supply monitoring as a necessary activity.
* Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed.
* Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate.
Our detailed comments on the proposals are below.
1) Drug supply monitoring system
The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow:
* 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence.
* 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme.
* 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members.
The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada.
* 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages.
2) Export Restriction
CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow:
* 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction.
* 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation.
3) Requiring a Patient-Practitioner Relationship
The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons:
* The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress.
* Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported.
* The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality.
In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them.
* Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention.
In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour.
We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation.
Briane Scharfstein, MD, CCFP, MBA
Associate Secretary General, Professional Affairs
cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate,
CMA Provincial/Territorial Divisional CEO’s