The Canadian Medical Association (CMA) provides this submission in response to Finance Canada’s consultation on Legislative Proposals Relating to Income Tax, Sales Tax and Excise Duties (Draft Tax Legislative Proposals).
The CMA is the national voice of Canadian physicians. On behalf of its more than 83,000 members and the Canadian public, the CMA’s mission is helping physicians care for patients. In fulfillment of this mission, the CMA’s role is focused on national, pan-Canadian health advocacy and policy priorities.
As detailed in this brief, the CMA is gravely concerned that by capturing group medical structures in the application of Clause 13 of the Draft Tax Legislative Proposals, the federal government will inadvertently negatively affect medical research, medical training and education as well as access to care.
To ensure that the unintended consequences of this federal tax policy change do not occur, the CMA is strongly recommending that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction in Clause 13 of the Draft Tax Legislative Proposals.
Relevance of the Canadian Controlled Private Corporation Framework to Medical Practice
Canada’s physicians are highly skilled professionals, providing an important public service and making a significant contribution to our country’s knowledge economy. Due to the design of Canada’s health care system, a large majority of physicians – more than 90% – are self-employed professionals and effectively small business owners.
As self-employed small business owners, physicians typically do not have access to pensions or health benefits, although they are responsible for these benefits for their employees. Access to the Canadian-Controlled Private Corporation (CCPC) framework and the Small Business Deduction (SBD) are integral to managing a medical practice in Canada. It is imperative to recognize that physicians cannot pass on any increased costs, such as changes to CCPC framework and access to the SBD, onto patients, as other businesses would do with clients.
In light of the unique business perspectives of medical practice, the CMA strongly welcomed the federal recognition in the 2016 budget of the value that health care professionals deliver to communities across Canada as small business operators. Contrary to this recognition, the 2016 budget also introduced a proposal to alter eligibility to the small business deduction that will impact physicians incorporated in group medical structures.
What’s at risk: Contribution of group medical structures to health care delivery
The CMA estimates that approximately 10,000 to 15,000 physicians will be affected by this federal taxation proposal. If implemented, this federal taxation measure will negatively affect group medical structures in communities across Canada. By capturing group medical structures, this proposal also introduces an inequity amongst incorporated physicians, and incentivizes solo practice, which counters provincial and territorial health delivery priorities.
Group medical structures are prevalent within academic health science centres and amongst certain specialties, notably oncology, anaesthesiology, radiology, and cardiology. Specialist care has become increasingly sub-specialized. For many specialties, it is now standard practice for this care to be provided by teams composed of numerous specialists, sub-specialists and allied health care providers. Team-based care is essential for educating and training medical students and residents in teaching hospitals, and for conducting medical research.
Put simply, group medical structures have not been formed for taxation or commercial purposes. Rather, group medical structures were formed to deliver provincial and territorial health priorities, primarily in the academic health setting, such as teaching, medical research as well as optimizing the delivery of patient care. Over many years, and even decades, provincial and territorial governments have been supporting and encouraging the delivery of care through team-based models.
To be clear, group medical structures were formed to meet health sector priorities; they were not formed for business purposes. It is equally important to recognize that group medical structures differ in purpose and function from similar corporate or partnership structures seen in other professions. Unlike most other professionals, physicians do not form these structures for the purpose of enhancing their ability to earn profit.
It is critical for Finance Canada to acknowledge that altering eligibility to the small business deduction will have more significant taxation implication than simply the 4.5% difference in the small business versus general rate at the federal level. It would be disingenuous for Finance Canada to attempt to argue that removing full access to the small business deduction for incorporated physicians in group medical structures will be a minor taxation increase. As taxation policy experts, Finance Canada is aware that this change will impact provincial/territorial taxation, as demonstrated below in Table 1.
Table 1: Taxation impacts by province/territory, if the federal taxation proposal is implemented
In Nova Scotia, for example, approximately 60% of specialist physicians practice in group medical structures. If the federal government applies this taxation proposal to group medical structures, these physicians will face an immediate 17.5% increase in taxation. In doing so, the federal government will establish a strong incentive for these physicians to move away from team-based practice to solo practice. If this comes to pass, the federal government may be responsible for triggering a reorganization of medical practice in Nova Scotia.
Excerpts from physician communiques
The CMA has received as well as been copied on a significant volume of correspondence from across our membership conveying deep concern with the federal taxation proposal. To provide an illustration of the risks of this proposal to health care, below are excerpts from some of these communiques:
“Our Partnership was formed in the 1970s…The mission of the Partnership is to achieve excellence in patient care, education and research activities….there would be a serious adverse effect on retention and recruitment if members do not have access to the full small business deduction…The changes will likely result in pressure to dissolve the partnership and revert to the era of departments services by independent contractors with competing individual financial interests.”
Submitted to the CMA April 15, 2016 from a member of the Anesthesia Associates of the Ottawa Hospital General Campus
“The University of Ottawa Heart Institute is an academic health care institution dedicated to patient care, research and medical education…To support what we call our “academic mission,” cardiologists at the institute have formed an academic partnership…If these [taxation] changes go forward they will crippled the ability of groups such as ours to continue to function and will have a dramatic negative impact on medical education, innovative health care research, and the provision of high-quality patient care to our sickest patients.”
Submitted to the CMA April 19, 2016 from a member of the Associates in Cardiology
“We are a general partnership consisting of 93 partners all of whom are academic anesthesiologists with appointments to the Faculty of the University of Toronto and with clinical appointments at the University Health Network, Sinai Health System or Women’s College Hospital…In contrast to traditional business partnerships, we glean no business advantage whatsoever from being in a partnership…the proposed legislation in Budget 2016 seems unfair in that it will add another financial hardship to our partners – in our view, this is a regressive tax on research, teaching and innovation.”
Submitted to the CMA April 14, 2016 from members of the UHN-MSH Anesthesia Associates
The CMA recommends that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction, as proposed in Clause 13 of the Draft Tax Legislative Proposals.
Below is a proposed legislative amendment to ensure group medical structures are exempted from Clause 13 of the Draft Tax Legislative Proposals:
Section 125 of the Act is amended by adding the following after proposed subsection 125(9):
125(10) Interpretation of designated member – [group medical partnership] – For purposes of this section, in determining whether a Canadian-controlled private corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician is a designated member of a particular partnership in a taxation year, the term "particular partnership" shall not include any partnership that is a group medical partnership.
125(11) Interpretation of specified corporate income – [group medical corporation] – For purposes of this section, in determining the specified corporate income for a taxation year of a corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician, the term "private corporation" shall not include a group medical corporation.
Subsection 125(7) of the Act is amended by adding the following in alphabetical order:
"group medical partnership" means a partnership that:
(a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and
(b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice;
"group medical corporation" means a corporation that:
(a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and
(b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice.
"medical practice" means any practice and authorized acts of a physician as defined in provincial or territorial legislation or regulations and any activities in relation to, or incidental to, such practice and authorized acts;
"physician" means a health care practitioner duly licensed with a provincial or territorial medical regulatory authority and actively engaged in practice;
CHILD AND YOUTH HEALTH IN CANADA
THEIR CHARTER — OUR CHALLENGE
“There can be no keener revelation of a society’s soul than the way it treats its children.”
“One generation plants the trees; another gets the shade.”
Children and youth have always been a priority for the doctors of Canada — the Child and
Youth Health Initiative of the Canadian Medical Association, the Canadian Paediatric
Society and the College of Family Physicians of Canada is evidence of that. We three
organizations joined together in November 2006 to launch the Child and Youth Health
In September 2004, Canada’s first ministers committed to “improving the health status of Canadians through a collaborative process.” This led to an agreement on health goals for Canada. The first of them is “Our children reach their full potential, growing up happy, healthy, confident and secure.” At the international level, the United Nations Convention on the Rights of the Child sets out the wider rights of all children and young people, including the right of the child to the enjoyment of the highest attainable standard of health and to facilities for the treatment of illness and rehabilitation of health. We now owe it to our children and youth to develop tangible health goals and targets.
From the outset of the partnership, we were acutely aware that only a broad societal
coalition could achieve the overarching goal of excellence in child and youth health in
Canada. Making the health of children and youth a national priority requires a coalition of
child and youth health champions, including governments, parents, health providers,
businesses, schools, teachers and communities.
To start that process, we created Canada’s Child and Youth Health Charter. An action
framework was then developed called Canada’s Child and Youth Health Challenge because a charter alone will not deliver on the vision of the children and youth of Canada being among the healthiest in the world. Together, we believe they will help to build a coalition of child and youth health champions because they give the people who can make a difference in children and youth health a rallying point.
The credibility and success of the Charter and the Challenge require broad, inclusive
consultation and a commitment to child and youth health from society at large. The Child
and Youth Health Summit, held April 25-26, 2007, was about consultation and commitment
to making a difference to the health and well-being of children and youth.
This document contains Canada’s Child and Youth Health Charter, which was one of the
focuses of the summit. Canada’s Child and Youth Health Challenge and Canada’s Child and Youth Health Declaration, are the other components of our commitment and promise to take action for the children of Canada. These documents can be found at www.ourchildren.ca.
Canada’s Child and Youth Health Charter
In 2005, Canada’s federal, provincial and territorial governments created pan-Canadian
health goals. The first of them is “Canada is a country where: Our children reach their full
potential, growing up happy, healthy, confident and secure.”
To reach their potential, children and youth need to grow up in a place where they can thrive
— spiritually, emotionally, mentally, physically and intellectually — and get high-quality
health care when they need it. That place must have three fundamental elements: a safe and
secure environment; good health and development; and a full range of health resources
available to all. Children and youth of distinct populations in Canada, including First Nations, Inuit and Métis, must be offered equal opportunities as other Canadian children
and youth through culturally relevant resources.
Canada must become:
1. A place with a safe and secure environment:
a) Clean water, air and soil;
b) Protection from injury, exploitation and discrimination; and
c) Healthy family, homes and communities.
2. A place where children and youth can have good health and development:
a) Prenatal and maternal care for the best possible health at birth;
b) Nutrition for proper growth, development and long-term health;
c) Early learning opportunities and high-quality care, at home and in the community;
d) Opportunities and encouragement for physical activity;
e) High-quality primary and secondary education;
f) Affordable and available post-secondary education; and
g) A commitment to social well-being and mental health.
3. A place where a full range of health resources is available:
a) Basic health care including immunization, drugs and dental health;
b) Mental health care and early help programs for children and youth;
c) Timely access to specialty diagnostic and health services;
d) Measurement and tracking the health of children and youth;
e) Research that focuses on the needs of children and youth; and
f) Uninterrupted care as youth move to adult health services and between acute,
chronic and community care, as well as between jurisdictions.
1. The principles of this charter apply to all children and youth in Canada regardless of
race, ethnicity, creed, language, gender, physical ability, mental ability, cultural history, or
2. Principles enshrined in all the goal statements include:
a. Universality: The charter applies equally to all children and youth residing in
Canada and covers all children and youth from 0-18 years of age.
b. Without financial burden: All children and youth in Canada should have access
to required health care, health services and drugs regardless of ability to pay.
c. Barrier-free access: All children and youth, regardless of ability or circumstance
should have appropriate access to optimal health care and health services.
d. Measurement and monitoring: Appropriate resources will be available for
adequate ongoing collection of data on issues that affect child and youth health
e. Safe and secure communities: Communities in Canada must create an
environment for children and youth to grow that is safe and secure.
3. The purpose of this charter is to facilitate development of specific goals, objectives,
actions and advocacy that will measurably improve child and youth health throughout
4. Success will be identified as simple, measurable, achievable, and timely goals and
objectives for each of the 16 statements in this charter.
5. The initial draft of this charter has been developed by Canada’s physicians focusing on
what they can best do to improve child and youth health; however, the support and
participation of all individuals and groups interested in child and youth health is
encouraged and desired.
6. The primary audience for actions and advocacy arising from this charter will be
governments, agencies or individuals who, by virtue of legislation, regulation or policy
have the ability to effect change for children and youth.
7. This charter is not a legal document; it represents a commitment by champions of child
and youth health in Canada to the health and well-being of all children and youth in
The following organizations have endorsed the Child and Youth Health Charter, as of
October 9, 2007.
Association of Canadian Academic Healthcare Organizations
Boys and Girls Clubs of Canada
Breakfast for Learning
Canadian Association of Paediatric Health Centres
Canadian Child and Youth Health Coalition
Canadian Healthcare Association
Canadian Institute of Child Health
Canadian Medical Association
Canadian Paediatric Society
Canadian Pharmacists Association
Canadian Psychological Association
Centre of Excellence for Early Childhood Development
Centre for Science in the Public Interest
College of Family Physicians of Canada
Landon Pearson Resource Centre for the Study of Childhood and Children's Rights
National Alliance for Children and Youth
National Anti-Poverty Organization
Newfoundland and Labrador Medical Association
Paediatric Chairs of Canada
Safe Kids Canada, The National Injury Prevention Program of The Hospital for Sick Children
Silken's ActiveKids Movement and Silken and Company Productions
The Royal College of Physicians and Surgeons of Canada
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health with respect to its study of Canada’s Food Guide. The CMA supports access to healthy foods to improve individual health and well-being and the overall health status of the population.1
1 Canadian Medical Association (CMA). Obesity in Canada: Causes, consequences and the way forward. Ottawa: CMA; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-12.pdf (accessed 2018 Feb 5).
2 Colapinto C, Graham J, St. Pierre S. Trends and correlates of frequency of fruit and vegetable consumption, 2007 to 2014. Health Reports. 2018 January;29(1):9-14. Available: http://www.statcan.gc.ca/pub/82-003-x/2018001/article/54901-eng.pdf (accessed 2018 Feb 5).
3 Van Vliet B, Campbell N. Efforts to reduce sodium intake in Canada: Why, what, and when? Can J Cardiol. 2011;27(4):437–445.
4 Canadian Medical Association (CMA). Early childhood development. Ottawa: CMA; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Feb 2).
5 Canadian Medical Association (CMA). Health equity and the social determinants of health: A role for the medical profession. Ottawa: CMA; 2013. Available http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-03.pdf (accessed 2018 Jan 30).
6 Health Canada. Eating well with Canada’s food guide. Ottawa: Health Canada; 2007. Available: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/hpfb-dgpsa/pdf/food-guide-aliment/view_eatwell_vue_bienmang-eng.pdf (accessed 2018 Jan 30).
7 Collier R. Calls for a better food guide. CMAJ. 2018 November 18;186(17):1281. Available: https://doi.org/10.1503/cmaj.109-4911 (accessed 2018 Jan 30).
8 Ministry of Health of Brazil. Dietary guidelines for the Brazilian population. 2nd ed. Brazil: Ministry of Health of Brazil; 2014. Available: http://www.foodpolitics.com/wp-content/uploads/Brazilian-Dietary-Guidelines-2014.pdf (accessed 2018 Feb 1).
9 Report of the Standing Committee on Social Affairs, Science and Technology. Obesity in Canada. A whole-of-society approach for a healthier Canada. Ottawa: Senate of Canada; 2016 March. Available: https://sencanada.ca/content/sen/committee/421/soci/rms/01mar16/Report-e.htm (accessed 2018 Feb 2).
10 Health Canada. Evidence review for dietary guidance: summary of results and implications for Canada’s food guide. Ottawa: Health Canada; 2015. Available: https://www.canada.ca/content/dam/canada/health-canada/migration/publications/eating-nutrition/dietary-guidance-summary-resume-recommandations-alimentaires/alt/pub-eng.pdf (accessed 2018 Feb 2).
11 Government of Canada. Guiding principles [Canada’s food guide consultation]. Ottawa: Government of Canada; 2017 April 5. Available: https://www.foodguideconsultation.ca/guiding-principles-detailed (accessed 2018 Feb 5).
The CMA has been active on nutritional issues for many years, both directly through its policy and government advocacy as well as through membership in various coalitions. Some of the issues addressed include the nutrition facts table, front-of-package labelling, a ban on the marketing of food and beverages to children younger than 16 years of age, and a levy on the manufacturers of sugar-sweetened beverages.
Canadians’ self-reported dietary intakes do not meet national dietary recommendations despite public education efforts concerning healthy eating and healthy diets. Children and adults are consuming fewer than the recommended number of servings of vegetables and fruits, an established proxy for healthy eating habits, and they are exceeding daily recommended intakes of sodium.2,3
The protection of vulnerable populations including children is of paramount concern to the CMA. Access to nutritious food is essential in early childhood development in support of later adult health.4 The availability of food security programs is a key element in preventing children from developing dietary deficiencies that would lead to an increased risk of chronic disease and greater difficulty in disease management later in life.5
The Food Guide has historically been a valued resource for Canadians, and physicians have found it useful in counselling their patients about healthy eating. However, there are serious concerns with the present Food Guide,6 which was released in 2007, and physicians have increasingly called for it to be reviewed.7
Other countries have made significant changes to their dietary guidelines. Brazil, for example, has developed a guideline that incorporates simple-to-follow, common-sense messaging, such as encouraging Brazilians to prepare meals from scratch and promoting the value of family meals.8
A new, modern Canadian guide is needed. Witnesses appearing before the Senate Committee on Social Affairs, Science and Technology characterized the current version as being “at best ineffective, and at worst enabling, with respect to the rising levels of unhealthy weights and diet-related chronic diseases in Canada.”9
Health Canada is in the process of revising the Food Guide, having done an extensive review of the evidence10 and releasing Guiding Principles.11
Recommendations for a revised Food Guide
A new approach to a food guide that addresses the larger picture, beyond daily nutrient consumption recommendations, is fundamental to the effort to improve the health of all Canadians and to the larger goal of developing a food policy for Canada. Indeed, “coordinated investments in health promotion and disease and injury prevention, including attention to the role of the social determinants of health, are critical to the future health and wellness of Canadians and to the viability of the health care system.”12
12 Canadian Medical Association (CMA) and Canadian Nurses Association (CNA). Principles for health care transformation in Canada. Ottawa: CMA and CNA; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD1113.pdf (accessed 2018 Jan 30).
13 Nexus H. Primer to action: Social determinants of health. Toronto: Ontario Chronic Disease Prevention Alliance; 2007. Available: http://www.ocdpa.ca/sites/default/files/publications/PrimertoAction-EN.pdf (accessed 2018 Feb 1).
14 Tarasuk V, Mitchell A, Dachner N. Household food insecurity in Canada. Toronto: PROOF; 2016. Available: http://proof.utoronto.ca/resources/proof-annual-reports/annual-report-2014/ (accessed 2018 Feb 5).
15 Rao M, Afshin A, Singh G, et al. Do healthier foods and diet patterns cost more than less healthy options? A systematic review and meta-analysis. BMJ Open. 2013;3:e004277. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855594/pdf/bmjopen-2013-004277.pdf (accessed 2018 Feb 5).
16Lee A, Mhurchu CN, Sacks G, et al. Monitoring the price and affordability of foods and diets globally. Obes Rev. 2013 Oct;14 Suppl 1:82–95.
17 Food Banks Canada. Hungercount2016: A comprehensive report on hunger and food bank use in Canada, and recommendations for change. Toronto: Food Banks Canada; 2016. Available: https://www.foodbankscanada.ca/hungercount2016 (accessed 2018 Jan 30).
18 Raine K. Improving nutritional health of the public through social change: Finding our roles in collective action. Can J Diet Pract Res. 2014;75(3):160-164. Available: https://doi.org/10.3148/cjdpr-2014-017 (accessed 2018 Feb 2).
19 Canadian Medical Association (CMA). CMA’s Support for Bill S-228: An Act to amend the Food and Drugs Act (prohibiting food and beverage marketing directed at children).Ottawa: CMA; 2017.Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-07.pdf (accessed 2018 Feb 2).
20 Howard, C., Culbert I., Food Guide revamp encouraging plant-based, low-meat diet is good for people and the planet CBC February 11, 2018 Available: http://www.cbc.ca/news/canada/manitoba/opinion-canada-food-guide-1.4530058 (accessed 2018 Feb 12)
1. The Food Guide must go hand in hand with efforts to increase access to affordable, healthy food
Food insecurity does not affect all Canadians equally, and there are very clear social patterns of vulnerability.13 Analyses of population survey data consistently identify low income as a predictor of household food insecurity. In addition, rates of food insecurity are highest among Aboriginal Canadians, households reliant on social assistance, households headed by single mothers, and those renting rather than owning a home.14 More research is needed to understand decisions surrounding the purchase of healthy foods versus unhealthy foods.15,16
Food Banks Canada reported that in March 2016, 863,492 people received food from a food bank, an increase of 1.3% over 2015, with eight of 10 provinces showing an increase.17 As the report notes, “approximately 1.7 million Canadian households, encompassing 4 million people, experience food insecurity each year” with 340,000 of them experiencing severe food insecurity.17
Other determinants of healthy eating include a wide range of contextual factors, such as the interpersonal environment created by family and peers, the physical environment, which determines food availability and accessibility, the economic environment, in which food is a commodity to be marketed for profit, and the social environment. Within the social environment, social status (income, education and gender) and cultural milieu are determinants of healthy eating that may be working "invisibly" to structure food choice.15
2. The Food Guide must be based on sound nutritional research
With unhealthy diets consistently linked with chronic disease such as cardiovascular diseases (heart disease, stroke, hypertension, diabetes, dyslipidemia) and with an estimated 60% of Canadian adults and close to one-third of children being overweight or obese, there is a need for evidence-based approaches in the development of healthy eating policies and practices in Canada.
As the links between nutrition and disease and other impacts of nutrition on the health of our society are revealed and better understood, it is more important than ever to identify what influences healthy eating behaviours.18 Food choices are structured by a variety of individual determinants of behaviour, including one's physiological state, food preferences, nutritional knowledge, perceptions of healthy eating and psychological factors.
The Food Guide needs to incorporate emerging research on nutrition and health, for example, by emphasizing the need to replace saturated fats with unsaturated fats, as opposed to focusing on total fats. It also must take into account the changes in consumer behaviour and in the food supply.
3. The Government of Canada must assure Canadians that the revision process is evidence based
Canadians must be able to trust Canada’s Food Guide as a source of unbiased information, based on evidence. The Food Guide must be part of a larger coordinated approach that also looks at other critical issues, such as the role of the marketing of unhealthy foods and beverages to children.19 CMA is concerned that conflict-of-interest situations have arisen in the past where recommendations might favour certain products or food groups over others.20 Canadians must have confidence that their health and wellness is the primary focus of an evidence-based revision process.
4. The Food Guide must reflect changing eating patterns reflective of our evolving and increasingly multicultural society
Canadian society is more ethnically diverse than in the past, so it is necessary to keep in mind cultural preferences. The current food groups do not always take into account an understanding of traditional foods and cultural eating practices. These are intrinsically linked to identity and culture and contribute to overall health. Advice needs to be tailored to different ages and cultural groups.
There is also a need to emphasize patterns of eating, as opposed to a focus almost exclusively on nutrient requirements. It is important to promote eating as a social undertaking, recognizing the essential role that food has in bringing people together.
It is also important to support the development of basic, practical culinary skills, which will reduce Canadians’ dependence on restaurant meals and ultra-processed foods.
5. The Food Guide must encourage Canadians to reduce their reliance on processed foods
The production and consumption of ultra-processed foods has increased drastically in the last decades in both higher and lower income countries. Highly or ultra-processed food tends to contain less protein and dietary fibre than less processed foods and include high proportions of free sugar, total saturated fat, trans fat and salt. Typically, processed foods are energy dense (high in calories) but have fewer beneficial nutrients such as vitamins and proteins.
Most processed foods encourage unhealthy ways of eating and have become popular because of their accessibility and convenience. These features have changed the way food and in particular these products are consumed compared with unprocessed foods: increased “grazing,” eating alone or eating while carrying out other activities such as work or driving.
In addition, many calories consumed come in liquid form. Physicians are concerned with the Food Guide’s support for fruit juices, given the plethora of sugar-sweetened beverages, including milk and milk alternatives. There should be a maximum amount of juice recommended for children, and the Food Guide should instead support the consumption of actual fruit.
6. The Government of Canada must produce simple, practical products for Canadians and clear dietary guidance for health professionals
Reliable, trustworthy sources of information are essential to support healthy eating. However, the new Food Guide must not be just another set of rules and lists or a long, cumbersome document. The challenge will be to take the evidence around nutrition and health and make it meaningful and useful. This is the only way that the Food Guide will actually be able to support and even provoke change.
To do that it must focus on the needs of the Canadians, with tools that personalize information for different age and cultural groups. It should also be useful to people with certain health conditions who require regulation of their diet to improve health (e.g., people with diabetes or hypertension). It should support couples during pregnancy and breastfeeding. There can’t be only one set of guidance; rather, various versions should be produced that are adapted to different audiences.
The Food Guide needs to be practical and simple to use. The concept of the number and size of servings of different foods, for example, has been very confusing. Research has shown that Canadians do not weigh or measure their foods and serving sizes are often underestimated, promoting overconsumption. The Food Guide must support Canadians in deciphering food labels and making informed choices about what they consume. The use of technology will allow information to be more accessible.
The guidance must be sensitive to issues related to the social determinants of health and food security, with attention to the cost and accessibility of foods. A focus on good sources of proteins, for example, as opposed to red meats and dairy, could allow for more choice. The Food Guide should provide guidance to food banks and other programs that seek to provide food to low-income families in terms of what foods they should procure for their clients.
As one of the most trusted sources of health information, physicians also need to be able to access the latest evidence in a user-friendly manner. Resources must be succinct and easy for physicians to access in a busy practice. They should allow a physician to go into more depth should that be required. As well, point-of-care tools that help clinicians explain technical facts to their patients in an accessible manner are needed.
1. The Food Guide must go hand in hand with efforts to increase access to affordable, healthy food
2. The Food Guide must be based on sound nutritional research
3. The Government of Canada must assure Canadians that the revision process is evidence based
4. The Food Guide must reflect changing eating patterns reflective of our evolving and increasingly multicultural society
5. The Food Guide must encourage Canadians to reduce their reliance on processed foods
6. The Government of Canada must produce simple, practical products for Canadians and clear dietary guidance for health professionals
Canada’s Lower-Risk Cannabis Use Guidelines (LRCUG)
Cannabis use has health risks best avoided by abstaining
Delay taking up cannabis use until later in life
Identify and choose lower-risk cannabis products
Don’t use synthetic cannabinoids
Avoid smoking burnt cannabis—choose safer ways of using
If you smoke cannabis, avoid harmful smoking practices
Limit and reduce how often you use cannabis
Don’t use and drive, or operate other machinery
Avoid cannabis use altogether if you are at risk for mental health problems or are pregnant
Avoid combining these risks
Fischer, B., Russell, C., Sabioni, P., van den Brink, W., Le Foll, B., Hall,
W., Rehm, J. & Room, R. (2017). Lower-Risk Cannabis Use Guidelines (LRCUG): An evidence-based update. American Journal of Public Health, 107(8). DOI: 10.2105/AJPH.2017.303818.
The LRCUG have been endorsed by the following organizations:
Council of Chief Medical Officers of Health
The Lower-Risk Cannabis Use Guidelines (LRCUG) are an evidence-based intervention project by the Canadian Research Initiative in Substance Misuse (CRISM), funded by the Canadian Institutes of Health Research (CIHR).
A longer evidence summary of the guidelines, aimed at health professionals, is available at camh.ca.
Cannabis use is a personal choice,
but it comes with risks to your
health and well-being. Follow
these recommendations to reduce your risks.
Cannabis use is a personal choice,
but it comes with risks to your
health and well-being. Follow
these recommendations to reduce your risks.
Health risks of cannabis use
There is strong scientific evidence that cannabis use is associated with a variety of health risks. The risks depend on your constitution, which kinds of cannabis products you use and how or how often you use them. Some of the main health risks are:
problems with thinking, memory or physical co-ordination
impaired perceptions or hallucinations
fatal and non-fatal injuries, including those from motor-vehicle accidents, due to impairment
Homeless and vulnerably housed populations are heterogeneous
and continue to grow in numbers in urban and
rural settings as forces of urbanization collide with gentrification and austerity policies.2
Collectively, they face dangerous living conditions and marginalization within health care systems.3
However, providers can improve the health of people who
are homeless or vulnerably housed, most powerfully by following
evidence-based initial steps, and working with communities and
adopting anti-oppressive practices.1,4,5
Broadly speaking, “homelessness” encompasses all individuals without stable, permanent and acceptable housing, or lacking the immediate prospect, means and ability of acquiring it.6
Under such conditions, individuals and families face intersecting
social, mental and physical health risks that significantly increase
morbidity and mortality.7,8 For example, people who are homeless
and vulnerably housed experience a significantly higher prevalence of trauma, mental health conditions and substance use disorders than the general population.7,9 Canadian research reports
that people who experience homelessness face life expectancies
as low as 42 years for men and 52 years for women.7
A generation ago, homeless Canadians were largely middleaged, single men in large urban settings.10 Today, the epidemiology has shifted to include higher proportions of women, youth,
Indigenous people (Box 1), immigrants, older adults and people
from rural communities.13,14 For example, family homelessness
(and therefore homelessness among dependent children and
youth) is a substantial, yet hidden, part of the crisis.15 In 2014, of
the estimated 235 000 homeless people in Canada, 27.3% were
women, 18.7% were youth, 6% were recent immigrants or
migrants, and a growing number were veterans and seniors.10
Practice navigators, peer-support workers and primary care
providers are well placed to identify social causes of poor health
and provide orientation to patient medical homes.16,17 A patient’s
medical home is “a family practice defined by its patients as the
place they feel most comfortable presenting and discussing their
personal and family health and medical concerns.”18 Medical
care is “readily accessible, centred on the patients’ needs, provided throughout every stage of life, and seamlessly integrated
with other services in the health care system and the community”
(https://patientsmedicalhome.ca). Primary care providers are
also well positioned to mobilize health promotion, disease prevention, diagnosis and treatment, and rehabilitation services.19
GUIDELINE VULNERABLE POPULATIONS CPD
Clinical guideline for homeless and vulnerably
housed people, and people with lived
Kevin Pottie MD MClSc, Claire E. Kendall MD PhD, Tim Aubry PhD, Olivia Magwood MPH,
Anne Andermann MD DPhil, Ginetta Salvalaggio MD MSc, David Ponka MDCM MSc, Gary Bloch MD,
Vanessa Brcic MD, Eric Agbata MPH MSc, Kednapa Thavorn PhD, Terry Hannigan, Andrew Bond MD,
Susan Crouse MD, Ritika Goel MD, Esther Shoemaker PhD, Jean Zhuo Jing Wang BHSc, Sebastian Mott MSW,
Harneel Kaur BHSc, Christine Mathew MSc, Syeda Shanza Hashmi BA, Ammar Saad, Thomas Piggott MD,
Neil Arya MD, Nicole Kozloff MD, Michaela Beder MD, Dale Guenter MD MPH, Wendy Muckle BScN MHA,
Stephen Hwang MD, Vicky Stergiopoulos MD, Peter Tugwell MD
n Cite as: CMAJ 2020 March 9;192:E240-54. doi: 10.1503/cmaj.190777
CMAJ Podcasts: author interview at https://soundcloud.com/cmajpodcasts/190777-guide
See related article at www.cmaj.ca/lookup/doi/10.1503/cmaj.200199
Clinical assessment and care of homeless and vulnerably housed
populations should include tailoring approaches to a person’s
gender, age, Indigenous heritage, ethnicity and history of
trauma; and advocacy for comprehensive primary health care.
As initial steps in the care of homeless and vulnerably housed
populations, permanent supportive housing is strongly
recommended, and income assistance is also recommended.
Case-management interventions, with access to psychiatric
support, are recommended as an initial step to support primary
care and to address existing mental health, substance use and
Harm-reduction interventions, such as supervised consumption
facilities, and access to pharmacologic agents for opioid use
disorder, such as opioid agonist treatment, are recommended
for people who use substances.
MARCH 9, 2020
ISSUE 10 E241
However, the social and health resources available to homeless
and vulnerably housed people may vary based on geographic
setting, municipal resources, housing coordination, and patients’
mental health and substance use–related care needs. In addition, many physical and mental health disorders remain undiagnosed or inconsistently treated because of missed opportunities
for care, patient mistrust of the health care system or limited
access to health services.3
Homeless and vulnerably housed people can benefit from
timely and effective health, addiction and social interventions.
Our guideline provides initial steps for practice, policy and future
research, and is intended to build collaboration among clinicians, public health providers and allied health providers. Values
such as trauma-informed and patient-centred care, and dignity
are needed to foster trust and develop sustainable therapeutic
relationships with homeless and vulnerably housed people.20,21
The purpose of this clinical practice guideline is to inform providers
and community organizations of the initial priority steps and effective interventions for homeless and vulnerably housed people. The
guideline addresses upstream social and health needs (i.e., housing), as well as downstream health-related consequences of inadequate housing. The target audiences are health providers, policymakers, public health practitioners and researchers.
Our guideline does not aim to address all conditions associated with homelessness, nor does it aim to discuss in depth the
many etiologies of homelessness, such as childhood trauma, the
housing market, or the root causes of low social assistance rates
and economic inequality. Rather, this guideline aims to reframe
providers’ approach toward upstream interventions that can
prevent, treat and work toward ending the morbidity and mortality associated with homelessness.
A parallel set of Indigenous-specific clinical guidelines is currently being developed by an independent, Indigenous-led
team.22 This process recognizes the distinct rights of Indigenous
Peoples, including the right to develop and strengthen their own
economies, social and political institutions; the direct links
between historic and ongoing colonial policies and Indigenous
homelessness; and the need for Indigenous leadership and participation in research that is about Indigenous Peoples.
The steering committee and guideline panel members developed
and approved recommendations to improve social and health
outcomes for homeless and vulnerably housed people. The order
of these recommendations highlights priority steps for homeless
health care. We list a summary of the recommendations in Table 1
and we present our list of good practice statements in Table 2.
These good practice statements are based on indirect evidence
and support the delivery of the recommendations.
The methods used to develop the recommendations are
described later in this document. A summary of how to use this
guideline is available in Box 2.
Permanent supportive housing
Identify homelessness or housing vulnerability and willingness to consider housing interventions.
Ensure access of homeless or vulnerably housed individuals to
local housing coordinator or case manager (i.e., call 211 or
via a social worker) for immediate link to permanent supportive housing and/or coordinated access system (moderate certainty, strong recommendation).
Our systematic review (Tim Aubry, University of Ottawa, Ottawa,
Ont.: unpublished data, 2020) identified 14 trials on permanent
supportive housing (PSH).30–43 Several trials across Canada and the
United States showed that PSH initiatives house participants more
rapidly compared with usual services (73 v. 220 d; adjusted absolute difference 146.4, 95% confidence interval [CI] 118.0 to 174.9);30
increase the number of people who maintain stable housing at
2 years (pooled odds ratio [OR] 3.58, 95% CI 2.36 to 5.43);30,40 and
significantly increase the percentage of days spent stably
housed.41 No trials showed a significant improvement in mental
health symptoms compared with standard care.30,31,33,34,41,42
Two studies found that the mental health of PSH participants did
not improve as much as that of usual care participants (e.g., mean
difference –0.49, 95% CI –0.85 to –0.12).30,31
The At Home/Chez Soi trial showed small improvements in quality
of life for high-needs (adjusted standardized mean difference 0.15,
95% CI 0.04 to 0.24)30 and moderate-needs (mean difference 4.37,
95% CI 1.60 to 7.14) homeless participants in patients receiving PSH.41
Youth receiving PSH saw larger improvements in their quality of life
during the first 6 months (mean difference 9.30, 95% CI 1.35 to 17.24),
which diminished over time (mean difference 7.29, 95% CI –1.61 to
16.18).44 No trials showed a significant improvement in substance use
compared with standard care.30,33,41–43 Most trials reported no effect of
PSH on acute care outcomes (e.g., number of emergency department
visits and percentage of participants admitted to hospital).30,41 However, 2 trials suggest that PSH participants had lower rates of hospital
admission (rate reductions of 29%, 95% CI 10 to 44) and time in hospital (e.g., mean difference –31, 95% CI –48 to –14).34,38,45 One trial found
no effect of PSH on job tenure, hours of work per week or hourly wage
compared with standard care.46 Participants receiving PSH may have
increased odds of employment, but this depends on the severity of
participant needs.46 One trial found no effect on income outcomes.46
Box 1: Indigenous homelessness
Indigenous homelessness is a term used to describe First Nations,
Métis and Inuit individuals, families or communities who lack
stable, permanent and appropriate housing, or the immediate
prospects, means or ability to acquire such housing. However, this
term must be interpreted through an Indigenous lens to
understand the factors contributing to this condition. These
factors include individuals, families and communities isolated
from their relationships to land, water, place, family, kin, each
other, animals, cultures, languages and identities as well as the
legacy of colonialism and genocide.11 It is estimated that urban
Indigenous people are 8 times more likely to experience
homelessness than the general population.11,12
The certainty of the evidence was rated moderate, because
blinding of participants and personnel was not feasible in any of
the trials we examined as a result of the nature of the intervention. Furthermore, several trials did not employ allocation concealment or blinding of outcome-assessment procedures, which
could introduce high risks of detection and performance biases.
Identify income insecurity.
Assist individuals with income insecurity to identify incomesupport resources and access income (low certainty, conditional recommendation).
We identified 10 trials on income-assistance interventions, including
rental assistance,47–56 financial empowerment,47 social enterprise
interventions,48 individual placement and support,48,54 and compensated work therapy.52 Our systematic review showed the benefit that
income-assistance interventions have on housing stability (Gary
Bloch, University of Toronto, Toronto, Ont., and Vanessa Brcic, University of British Columbia, Vancouver, BC: unpublished data, 2020).
Rental assistance increased the likelihood of being stably housed
(OR 4.60, 95% CI 3.10 to 6.83).56 Rental assistance combined with
case management increased the number of days in stable housing
per 90-day period compared with case management alone (mean
Table 1: Summary of evidence-based recommendations
Recommendations and clinical considerations Grade rating*
Recommendation 1: A homeless or vulnerably housed person Moderate certainty
Ensure access for homeless or vulnerably housed individuals to local housing coordinator or case manager (i.e., call
211 or via a social worker) for immediate link to permanent supportive housing and coordinated access system.
Clinical considerations: Many jurisdictions will provide alternative housing services for specific marginalized
populations, for example, Indigenous people, women and families, youth, those who identify as LGBTQ2+, those
with disabilities, refugees and migrants.
Recommendation 2: A homeless or vulnerably housed person with experience of poverty, income instability or
living in a low-income household
Assist individuals with income insecurity to identify income-support resources and access income.
Clinical considerations: Consult poverty screening tools when needed (e.g., https://cep.health/clinical-products
Recommendation 3: A homeless or vulnerably housed person with multiple comorbid or complex health needs
(including mental illness and/or substance use)
Identify history of severe mental illness, such as psychotic or mood and anxiety disorders, associated with
substantial disability, substance use, or multiple/complex health needs.
Ensure access to local community mental health programs, psychiatric services for assessment, and linkage to
intensive case management, assertive community treatment or critical time intervention where available.
Clinical considerations: Call 211 or consult primary care providers, social workers or case managers familiar
with local access points and less intensive community mental health programs.
Recommendation 4: A homeless or vulnerably housed person currently using opioids Very low certainty
Identify opioid use disorder.
Ensure access within primary care or via an addiction specialist to opioid agonist therapy (OAT), potentially in
collaboration with a public health or community health centre for linkage to pharmacologic interventions.
Clinical considerations: Encourage all patients taking opioid medication to have a naloxone kit. Though barriers
to prescribing methadone and buprenorphine remain, be aware of new regulations that aim to facilitate OAT
access and options in your jurisdiction, in particular for buprenorphine.
Recommendation 5: A homeless or vulnerably housed person with substance use disorder Very low certainty
Identify, during history or physical examination, problematic substance use, including alcohol or other drugs.
Identify the most appropriate approach, or refer to local addiction and harm-reduction/prevention services
(e.g., supervised consumption facilities, managed alcohol programs) via appropriate local resources such as
public health or community health centre or local community services centre.
Clinical considerations: In case of active opioid use disorder, facilitate patient access to OAT. Patients should be
made aware of supervised consumption facility locations (Appendix 1, available at www.cmaj.ca/lookup/suppl/
Note: LGBTQ2+ = lesbian, gay, bisexual, transgender, questioning and two-spirited.
*See Box 2 for definitions.
†211 is a special abbreviated telephone number reserved in Canada and the United States as an easy-to-remember 3-digit telephone number meant to provide information and
referrals to health, human and social service organizations.
ISSUE 10 E243
difference 8.58, p < 0.004).55 Compensated work therapy was found
to reduce the odds of homelessness (OR 0.1, 95% CI 0.1 to 0.3).52 No
income interventions showed an effect on mental health
The impact of these interventions on substance use outcomes
were mixed. Provision of housing vouchers did not affect substance
use over 3 years;55 however, compensated work therapy showed
immediate reductions in drug (reduction: –44.7%, standard error [SE]
12.8%; p = 0.001) and alcohol use problems (–45.4%, SE 9.4%; p =
0.001), as well as the number of substance use–related physical
symptoms (–64.4%, SE 8.0%; p = 0.001).52 These differences, however, tended to decline with time. No significant effects were found
on overall quality-of-life, finances, health and social relations scores.
Provision of housing vouchers resulted in higher family-relations
score and satisfaction, and quality of housing compared with standard care.55 One trial reported that rental assistance was associated
with reduced emergency department visits and time spent in hospital, but this reduction was not significantly different than in the comparator group.56 Individual placement and support was found to
improve employment rates only when there was high fidelity to the
model (OR 2.42, 95% CI 1.13 to 5.16).54 Financial-empowerment education and provision of housing vouchers had no effect on employment outcomes.47,55 Financial-empowerment education and individual placement and support had no effect on hourly wages.47,54
Provision of housing vouchers had no effect on monthly income.55
The certainty of the evidence was rated low because several
trials introduced high risk of detection and performance bias. Furthermore, 1 trial reported low consent rates of 47% and a 1:4 sampling ratio that further limited statistical power.52 As well, participants in the control group wanting to enter income-assistance
programs after completing the study had incentives to underreport
symptoms, which introduced high risk for measurement bias.
Identify history of severe mental illness, such as psychotic or
mood and anxiety disorders, associated with substantial disability, substance use disorders, or multiple or complex
Ensure access to local community mental health programs,
psychiatric services for assessment and linkage to intensive
case management, assertive community treatment or critical
time intervention where available (low certainty, conditional
Our systematic review examined the effectiveness of standard
case management, as well as specific intensive casemanagement interventions, such as assertive community treatment, intensive case management and critical time intervention
among homeless and vulnerably housed populations and corresponding level of need (David Ponka, University of Ottawa,
Ottawa, Ont.: unpublished data, 2020). We included a total of
56 citations, of which 10 trials reported on standard case management,51,57–65 8 trials on assertive community treatment,66–73
16 trials on intensive case management74–89 and 5 trials on critical
Box 2: How to use and understand this GRADE guideline
This guideline supplies providers with evidence for decisions
concerning interventions to improve health and social outcomes
for people who are homeless or vulnerably housed. This guideline
is not meant to replace clinical judgment. Statements about
clinical considerations, values and preferences are integral parts of
the recommendations meant to facilitate interpretation and
implementation of the guideline. Recommendations in this
guideline are categorized according to the Grading of
Recommendations Assessment, Development and Evaluation
(GRADE) system as strong or conditional recommendations.
Strong recommendations indicate that all or almost all fully
informed patients would choose the recommended course of
action, and indicate to clinicians that the recommendation is
appropriate for all or almost all individuals. Strong
recommendations represent candidates for quality-of-care criteria
or performance indicators.
Conditional recommendations indicate that most informed
patients would choose the suggested course of action, but an
appreciable minority would not. With conditional
recommendations, clinicians should recognize that different
choices will be appropriate for individual patients, and they should
help patients arrive at a decision consistent with their values and
preferences. Conditional recommendations should not be used as
a basis for standards of practice (other than to mandate shared
Good practice statements represent common-sense practice, are
supported by indirect evidence and are associated with assumed
large net benefit.
Clinical considerations provide practical suggestions to support
implementation of the GRADE recommendation.
GRADE certainty ratings
High: further research is very unlikely to change our confidence in
the estimate of effect.
Moderate: further research is likely to have an important impact on
the confidence in the estimate of effect and may change the estimate.
Low: further research is very likely to have an important impact
on our confidence in the estimate of effect and is likely to change
Very low: any estimate of the effect is very uncertain.
Table 2: Good practice statements to support delivery of care
Good practice statement
1. Homeless and vulnerably housed populations
should receive trauma-informed and personcentred care.
2. Homeless and vulnerably housed populations
should be linked to comprehensive primary
care to facilitate the management of multiple
health and social needs.
3. Providers should collaborate with public health
and community organizations to ensure
programs are accessible and resources
appropriate to meet local patient needs.
Of 10 trials on standard case management, 10 evaluated
housing stability. Only 3 reported significant decreases in homelessness,57,62,63 an effect that diminished over time in 1 trial of a
time-limited residential case management in which participants
in all groups accessed substantial levels of services.57 A program
tailored to women reduced the odds of depression at 3 months
(OR 0.38, 95% CI 0.14 to 0.99), but did not show improvements in
the women’s overall mental health status (mean difference 4.50,
95% CI –0.98 to 9.98).64 One trial reported higher levels of hostility (p < 0.001) and depression symptoms (p < 0.05) among female
participants receiving nurse-led standard case management
compared with those receiving standard care.60 Few studies
reported on substance use, quality of life, employment or
Findings of assertive community treatment on housingstability, quality-of-life and hospital-admission outcomes are
mixed. Two trials found that participants receiving the treatment
reported fewer days homeless (p < 0.01)71 and more days in community housing (p = 0.006),70 whereas 2 trials reported no effect
on episodes of homelessness or number of days homeless.66,73
Further, these interventions showed an added benefit in reducing the number of participants admitted to hospital (mean difference –8.6, p < 0.05) and with visits to the emergency department
(mean difference –1.2, p = 0.009).67 Most trials of assertive community treatment reported no significant differences in mental
health outcomes, including psychiatric symptoms, substance
use, or income-related outcomes between the treatment and
Intensive case management reduced the number of days
homeless (pooled standardized mean difference –0.22, 95% CI
–0.40 to –0.03), but not the number of days spent in stable housing.78,80,89 In most studies, there was no major improvement in
psychological symptoms between the treatment and control
groups. However, 1 trial reported significantly greater reductions
in anxiety, depression and thought disturbances after 24 months
(mean difference change from baseline –0.32, p = 0.007), as well
as improved life satisfaction (mean difference 1.23, p = 0.001)
using intensive case management.86 One trial reported no significant difference in quality of life.83 Findings on substance use
were mixed. Six of the 10 trials reported that intensive case management was associated with improvements in substance use
behaviours.74,78,82,84,87,88 Participants receiving intensive case management reported fewer visits to the emergency department
(mean difference 19%, p < 0.05) but did not have shorter hospital
stays compared with control groups.85 Intensive case management had no effect on the number of days of employment, or on
income received from employment; however, income received
by participants through public assistance increased (e.g., mean
difference 89, 95% CI 8 to 170).78,85
Critical time intervention was beneficial in reducing the number of homeless nights (mean difference –591, p < 0.001) and the
odds of homelessness (OR 0.23, 95% CI 0.06 to 0.90) during the
final 18 weeks of follow-up.91 Participants receiving the treatment were rehoused sooner than those receiving standard
care,95 but did not spend more days rehoused.90 Adults receiving
critical time intervention showed significant improvements in
psychological symptoms (mean difference –0.14, 95% CI –0.29 to
0.01).90 However, findings for children’s mental health were
mixed: children aged 1.5–5 years showed improvements in internalizing (ß coefficient –3.65, 95% CI –5.61 to –1.68) and externalizing behaviours (ß coefficient –3.12, 95% CI –5.37 to –0.86),
whereas changes for children aged 6–10 years and 11–16 years
were not significant.93 There were no significant effects of critical
time intervention on substance-use,90 quality-of-life90,92 or
income-related outcomes.96 Two trials reported mixed findings
on hospital admission outcomes; in 1 study, allocation to critical
time intervention was associated with reduced odds of hospital
admission (OR 0.11, 95% CI 0.01 to 0.96) and total number of
nights in hospital (p < 0.05) in the final 18 weeks of the trial.97
However, another study reported a greater total number of
nights in hospital for the treatment group compared with usual
care (1171 v. 912).98
The certainty of the evidence was rated low because several
trials introduced high risk of detection and performance bias.
Opioid agonist therapy
Ensure access to opioid agonist therapy in primary care or by
referral to an addiction specialist, potentially in collaboration
with public health or community health centre for linkage to
pharmacologic interventions (low certainty, conditional
We conducted a review of systematic reviews on pharmalogic
interventions for opioid use disorder.99 Twenty-four reviews,
which included 352 unique primary studies, reported on pharmacologic interventions for opioid use disorder among general
populations.100–123 We expanded our inclusion criteria to general
populations, aware that most studies among “general populations” had a large representation of homeless populations in
their samples. We did not identify any substantial reason to
believe that the mechanisms of action of our interventions of
interest would differ between homeless populations who use
substances and the general population of people who use substances. Reviews on pharmacologic interventions reported on
the use of methadone, buprenorphine, diacetylmorphine (heroin), levo-a-acetylmethadol, slow-release oral morphine and
hydromorphone for treatment of opioid use disorder.
We found pooled all-cause mortality rates of 36.1 and 11.3 per
1000 person years for participants out of and in methadone
maintenance therapy, respectively (rate ratio 3.20, 95% CI 2.65 to
3.86), and mortality rates of 9.5 per 1000 person years for those
not receiving buprenorphine maintenance therapy compared
with 4.3 per 1000 person years among those receiving the therapy (rate ratio 2.20, 95% CI 1.34 to 3.61).116 Overdose-specific
mortality rates were similarly affected, with pooled overdose
mortality rates of 12.7 and 2.6 per 1000 person years for participants out of and in methadone maintenance therapy, and rates
of 4.6 and 1.4 per 1000 person years out of and in buprenorphine
maintenance therapy.116 Compared with nonpharmacologic
approaches, methadone maintenance therapy had no significant
ISSUE 10 E245
effect on mortality (relative risk 0.48, 95% CI 0.10 to 2.39).110 With
respect to morbidity, pharmacologic interventions for opioid use
disorder reduced the risk of hepatitis C virus (HCV) acquisition
(risk ratio 0.50, 95% CI 0.40 to 0.63)112 and HIV infection.103
Adverse events were reported for all agents.100,109,119,122 Treatment with methadone and buprenorphine was associated with
reduced illicit opioid use (standardized mean difference –1.17,
95% CI –1.85 to –0.49).109 Availability of buprenorphine treatment
expanded access to treatment for patients unlikely to enrol in
methadone clinics and facilitated earlier access for recent initiates to opioid use.117 The relative superiority of one pharmacologic agent over another on retention outcomes remains unclear;
however, use of methadone was found to show better benefits
than nonpharmacologic interventions for retention (risk ratio
4.44, 95% CI 3.26 to 6.04).110
The certainty of evidence ranged from very low to moderate,
primarily because of inconsistency, high risk of bias and evidence
from nonrandomized studies.
Identify problematic substance use, including alcohol or other
Identify the most appropriate approach or refer to local addiction and harm reduction/prevention services (e.g., supervised
consumption facilities, managed alcohol programs) via appropriate local resources, such as public health or community
health centre or les centres locaux de services communautaires (low certainty, conditional recommendation).
We conducted a review of systematic reviews on supervised
consumption facilities and managed alcohol programs.99 Two
systematic reviews, which included 90 unique observational
studies and 1 qualitative meta-synthesis reported on supervised
consumption facilities.124–126 For managed alcohol programs,
1 Cochrane review had no included studies,127 and 2 greyliterature reviews reported on 51 studies.128,129
Establishment of supervised consumption facilities was associated with a 35% decrease in the number of fatal opioid overdoses within 500 m of the facility (from 253.8 to 165.1 deaths per
100 000 person years, p = 0.048), compared with 9% in the rest of
the city (Vancouver).124 There were 336 reported opioid overdose
reversals in 90 different individuals within the Vancouver facility
over a 4-year period (2004–2008).125 Similar protective effects
were reported in Australia and Germany. Observational studies
conducted in Vancouver and Sydney showed that regular use of
supervised consumption facilities was associated with decreased
syringe sharing (adjusted OR 0.30, 95% CI 0.11 to 0.82), syringe
reuse (adjusted OR 2.04, 95% CI 1.38 to 3.01) and public-space
injection (adjusted OR 2.79, 95% CI 1.93 to 3.87).125 These facilities mediated access to ancillary services (e.g., food and shelter)
and fostered access to broader health support.125,126 Attendance
at supervised consumption facilities was associated with an
increase in referrals to an addiction treatment centre and initiation of methadone maintenance therapy (adjusted hazard ratio
1.57, 95% CI 1.02 to 2.40).125
Evidence on supervised consumption facilities was rated very
low to low, as all available evidence originated from nonrandomized studies.
There was a lack of high-quality evidence for managed alcohol
programs. Few studies reported on deaths among clients of these
programs.128 The effects of managed alcohol programs on hepatic
function are mixed, with some studies reporting improvement in
hepatic laboratory markers over time, and others showing
increases in alcohol-related hepatic damage;129 however, this may
have occurred regardless of entry into such a program. This evidence suggested that managed alcohol programs result in stabilized alcohol consumption and can facilitate engagement with
medical and social services.128 Clients experienced significantly
fewer social, health, safety and legal harms related to alcohol
consumption.129 Individuals participating in these programs had
fewer hospital admissions and a 93% reduction in emergency service contacts.128 The programs also promoted improved or stabilized mental health128 and medication adherence.129
Cost effectiveness and resource implications
Permanent supportive housing
We found 19 studies assessing the cost and net cost of housing
interventions.30,41,45,130–145 In some studies, permanent supportive
housing interventions were associated with increased cost to the
payers, and the costs of the interventions were only partially offset by savings in medical and social services as a result of the
intervention.30,41,131–134,142 Six studies showed that these interventions saved payers money.135,137,139,141,144,145 Four of these studies,
however, employed a pre–post design.135,139,141,145 Moreover,
1 cost-utility analysis of PSH suggested that the provision of housing services was associated with increased costs and increased
quality-adjusted life years, with an incremental cost-effectiveness
ratio of US$62 493 per quality-adjusted life year.136 Compared
with usual care, PSH was found to be more costly to society (net
cost Can$7868, 95% CI $4409 to $11 405).138
Two studies55,146 focused on the cost effectiveness of incomeassistance interventions. Rental assistance with clients receiving
case-management intervention had greater annual costs compared with usual care or groups receiving only case management.55 For each additional day housed, clients who received
income assistance incurred additional costs of US$58 (95% CI $4
to $111) from the perspective of the payer, US$50 (95% CI –$17 to
$117) from the perspective of the health care system and US$45
(95% CI –$19 to $108) from the societal perspective. The benefit
gained from temporary financial assistance was found to outweigh its costs with a net savings of US$20 548.146
Twelve publications provided evidence on cost and costeffectiveness of case-management interventions.44,55,67,69,73,75,88,96,147–150
Findings of these studies were mixed; the total cost incurred by
clients of standard case management was higher than that of
clients receiving usual or standard care61,88 and assertive
community treatment,67,147 but lower compared with a US clinical
case-management program that included housing vouchers and
intensive case management.55 Cost-effectiveness studies using a
societal perspective showed that standard case management
was not cost effective compared with assertive community
treatment for people with serious mental disorders or those with
a concurrent substance-use disorder, as it was more expensive.67
For intensive case management, the cost of supporting housing
with this program could be partially offset by reductions in the use
of emergency shelters and temporary residences.41 Intensive case
management is more likely to be cost effective when all costs and
benefits to society are considered.41 A pre–post study showed that
providing this program to high-need users of emergency departments resulted in a net hospital cost savings of US$132 726.150
Assertive community treatment interventions were associated with lower costs compared with usual care.66,67,73,148,149 We
identified only 1 study on the cost effectiveness of critical time
intervention that reported comparable costs (US$52 574 v.
US$51 749) of the treatment compared with the usual services
provided to men with severe mental illness.96
Interventions for substance use
We identified 2 systematic reviews that reported findings from
6 studies in Vancouver on the cost effectiveness of supervised
consumption facilities;124,125 5 of these 6 studies found the facilities to be cost effective. After consideration of facility operating
costs, supervised consumption facilities saved up to Can$6 million from averted overdose deaths and incident HIV cases. Similarly, Can$1.8 million was saved annually from the prevention of
incident HCV infection.
Providers can, in partnership with directly affected communities,
employ a range of navigation and advocacy tools to address the
root causes of homelessness, which include poverty caused by
inadequate access to social assistance, precarious work, insufficient access to quality child care, social norms that allow the
propagation of violence in homes and communities, inadequate
supports for patients and families living with disabilities or going
through life transitions, and insufficient and poor-quality housing stock.151 In addition, providers should tailor their approach to
the patient’s needs and demographics, taking into account
access to services, personal preferences and other illnesses.152
Providers should also recognize the social and human value
of accepting homeless and vulnerably housed people into their
clinical practices. The following sections provide additional evidence for underserved and marginalized populations.
A scoping review of the literature on interventions for homeless
women (Christine Mathew, Bruyère Research Institute, Ottawa,
Ont.: unpublished data, 2020) yielded 4 systematic reviews153–156
and 9 randomized controlled trials (RCTs)36,60,92,95,157–161 that focused
specifically on homeless and vulnerably housed women. Findings
showed that PSH was effective in reducing the risk of intimate partner violence and improving psychological symptoms.158 For women
with children experiencing homelessness, priority access to permanent housing subsidies can reduce child separations and foster
care placements, allowing women to maintain the integrity of their
family unit.158 As well, Housing First programs for families, critical
time interventions during times of crisis, and therapeutic communities are associated with lower levels of psychological distress,
increased self-esteem and improved quality of life for women and
their families.92,155 A gender-based analysis highlighted the importance of safety, service accessibility and empowerment among
homeless women. We suggest that providers focus on patient
safety, empowerment among women who have faced genderbased violence, and improve access to resources, including
income, child care and other social support services.
A systematic review on youth-specific interventions reported
findings from 4 systematic reviews and 18 RCTs.162 Permanent
supportive housing improved housing stability. As well, individual cognitive behavioural therapy has been shown to result in
significant improvements in depression scores, and family-based
therapies are also promising, resulting in reductions in youth
substance use through restoring the family dynamic. Findings on
motivational interviewing, skill building and case-management
interventions were inconsistent, with some trials showing a positive impact and others not identifying significant benefits.
Refugee and migrant populations
A qualitative systematic review on homeless migrants (Harneel
Kaur, University of Ottawa, Ottawa, Ont.: unpublished data,
2020) identified 17 qualitative articles that focused on the experiences of homeless migrants.163–179 Findings indicated that discrimination, limited language proficiency and severed social networks negatively affected homeless migrants’ sense of belonging
and access to social services, such as housing. However, employment opportunities provided a sense of independence and
improved social integration.
Composition of participating groups
In preparation for the guideline, we formed the Homeless Health
Research Network (https://methods.cochrane.org/equity/
projects/homeless-health-guidelines), composed of clinicians,
academics, and governmental and nongovernmental stakeholders. The Homeless Health Guideline Steering Committee (K.P.
[chair], C.K., T.A., A.A., G.S., G.B., D.P., E.A., V.B., V.S. and P.T.) was
assembled to coordinate guideline development. Expert representation was sought from eastern and western Canada, Ontario,
Quebec and the Prairie provinces for membership on the steering committee. In addition, 5 people with lived experience of
homelessness (herein referred to as “community scholars”180)
were recruited to participate in the guideline-development activities. A management committee (K.P., C.K. and P.T.) oversaw the
participating groups and monitored competing interests.
The steering committee decided to develop a single guideline
publication informed by a series of 8 systematic reviews. The
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steering committee assembled expert working groups to operationalize each review. Each working group consisted of clinical
topic experts and community scholars who were responsible for
providing contextual expertise.
The steering committee also assembled a technical team,
which provided technical expertise in the conduct and presentation of systematic reviews and meta-analyses. Finally, the steering committee assembled the guideline panel, which had the
responsibility to provide external review of the evidence and
drafted recommendations. The panel was composed of 17 individuals, including physicians, primary care providers, internists,
psychiatrists, public health professionals, people with lived
experience of homelessness, medical students and medical residents. Panel members had no financial or intellectual conflicts of
interest. A full membership list of the individual teams’ composition is available in Appendix 2, available at www.cmaj.ca/lookup/
Selection of priority topics
We used a 3-step modified Delphi consensus method (Esther
Shoemaker, Bruyère Research Institute, Ottawa, Ont.: unpublished
data, 2020) to select priority health conditions for marginalized
populations experiencing homelessness or vulnerable housing.
Briefly, between May and June 2017, we developed and conducted
a survey (in French and English), in which we asked 84 expert providers and 76 people with lived homelessness experience to rank
and prioritize an initial list of needs and populations. We specifically asked participants, while answering the Delphi survey, to
keep in mind 3 priority-setting criteria when considering the
unique challenges of implementing health care for homeless or
vulnerably housed people: value added (i.e., the opportunity for a
unique and relevant contribution), reduction of unfair and preventable health inequities, and decrease in burden of illness (i.e.,
the number of people who may have a disease or condition).181
The initial top 4 priority needs identified were as follows: facilitating access to housing, providing mental health and addiction care,
delivering care coordination and case management, and facilitating
access to adequate income. The priority marginalized populations
identified included Indigenous people; women and families; youth;
people with acquired brain injury, or intellectual or physical disabilities; and refugees and other migrants (Esther Shoemaker, Bruyère
Research Institute, Ottawa, Ont.: unpublished data, 2020). Each
working group then scoped the literature using Google Scholar and
PubMed to determine a list of interventions and terms relating to
each of the priority-need categories. Each working group came to
consensus on the final list of interventions to be included (Table 3).
We followed the GRADE (Grading of Recommendations Assessment, Development and Evaluation) approach for the development
of this clinical guideline, including the identification of clinical
questions, systematic reviews of the best available evidence,
Table 3: Descriptions of priority-need interventions
Permanent supportive housing
Long-term housing in the community with no set preconditions for access. Housing may be paired with the
provision of individualized supportive services that are tailored to participants’ needs and choices,
including assertive community treatment and intensive case management.
This guideline groups the Housing First model (a homeless assistance approach that prioritizes providing
housing) with permanent supportive housing.
Benefits and programs that improve socioeconomic status. This may include assistance that directly
increases income and programs that help with cost reduction of basic living necessities.
This guideline also groups employment programs (e.g., individual placement and support, and
compensated work therapy) in this category.
Standard case management allows for the provision of an array of social, health care and other services
with the goal of helping the client maintain good health and social relationships.
Intensive case management offers the support of a case manager who brokers access to an array of
services. Case-management support can be available for up to 12 hours per day, 7 days a week, and each
case manager often has a caseload of 15–20 service users.
Assertive community treatment offers team-based care to individuals with severe and persistent mental
illness by a multidisciplinary group of health care workers in the community. This team should be available
24 hours per day, 7 days per week.
Critical time intervention supports continuity of care for service users during times of transition. Case
management is administered by a critical time intervention worker and is a time-limited service, usually
lasting 6–9 months.
Pharmacologic interventions for
substance use disorder
Pharmacologic interventions for opioid use disorder, including methadone, buprenorphine,
diacetylmorphine, levo-a-acetylmethadol and naltrexone.
Pharmacologic agents for reversal of opioid overdose: opioid antagonist administered intravenously or
intranasally (e.g., naloxone).
Harm reduction for substance
Supervised consumption facilities: facilities (stand-alone, co-located or pop-up) where people who use
substances can consume preobtained substances under supervision.
Managed alcohol programs: shelter, medical assistance, social services and the provision of regulated
alcohol to support residents with severe alcohol use disorder.
assessment of the certainty of the evidence and development of
recommendations.182 We conducted a series of systematic reviews
to answer the following clinical question:
Should PSH, income assistance, case management, pharmacologic agents for opioid use, and/or harm-reduction interventions
be considered for people with lived experience of homelessness?
Systematic reviews for each intervention were driven by a logic
model. A detailed description of the methods used to compile evidence summaries for each recommendation, including search
terms, can be found in Appendix 3, available at www.cmaj.ca/
lookup/suppl/doi:10.1503/cmaj.190777/-/DC1. We sought evidence on questions considering population, interventions and
comparisons according to published a priori protocols.183–186 We
used relevant terms and structured search strategies in 9 bibliographic databases for RCTs and quasi-experimental studies. The
technical team reviewed titles, abstracts and full texts of identified
citations, selected evidence for inclusion and compiled evidence
reviews, including cost-effectiveness and resource-use data, for
consideration by the guideline panel. The technical team collected
and synthesized data on the following a priori outcomes: housing
stability, mental health, quality of life, substance use, hospital
admission, employment and income. Where possible, we conducted meta-analyses with random effects and assessed certainty
of evidence using the GRADE approach. Where pooling of results
was not appropriate, we synthesized results narratively.
In addition to the intervention and cost-effectiveness reviews,
the technical team conducted 3 systematic reviews to collect
contextual and population-specific evidence for the populations
prioritized through our Delphi process (women, youth, refugees
and migrants) (Christine Mathew, Bruyère Research Institute,
Ottawa, Ont.: unpublished data, 2020; Harneel Kaur, University
of Ottawa, Ottawa, Ont.: unpublished data, 2020).162 Additionally,
we conducted 1 qualitative literature review to capture patient
values and preferences, focused on the experiences of people
who are homeless in engaging with our selected interventions.20
Drafting of recommendations
The steering committee hosted a 2-day knowledge-sharing
event, termed the “Homeless Health Summit,” on Nov. 25–26,
2018. Attendees included expert working group members, community scholars, technical team members, and other governmental and nongovernmental stakeholders. Findings from all
intervention reviews were presented and discussed according to
the GRADE Evidence to Decision framework.187 After the meeting,
the steering committee drafted GRADE recommendations (Box 2)
through an iterative consensus process. All steering-committee
members participated in multiple rounds of review and revision
of the drafted clinical recommendations.
Guideline panel review
We used the GRADE Evidence to Decision framework to facilitate
the development of recommendations187–189 (Appendix 4, available
We used GRADEpro and the Panel Voice software to obtain input
from the guideline panel.190 Panellists provided input on the wording and strength of the draft recommendations. They also provided
considerations for clinical implementation. We required endorsement of recommendations by 60% of panel members for acceptance
of a recommendation. After review by the guideline panel, the steering committee reviewed the final recommendations before sign-off.
Good practice statements
We developed a limited number of good practice statements to support the delivery of the initial evidence-based recommendations. A
good practice statement characteristically represents situations in
which a large and compelling body of indirect evidence strongly
supports the net benefit of the recommended action, which is
necessary for health care practice.191–193 Guideline-development
groups consider making good practice statements when they have
high confidence that indirect evidence supports net benefit, there
is a clear and explicit rationale connecting the indirect evidence,
and it would be an onerous and unproductive exercise and thus a
poor use of the group’s limited resources to collect this evidence.
The steering committee came to a consensus on 3 good practice
statements based on indirect evidence.
Identification of implementation considerations
We completed a mixed-methods study to identify determinants
of implementation across Canada for the guideline (Olivia
Magwood, Bruyère Research Institute, Ottawa, Ont.: unpublished
data, 2020). Briefly, the study included a survey of 88 stakeholders and semistructured interviews with people with lived experience of homelessness. The GRADE Feasibility, Acceptability, Cost
(affordability) and Equity (FACE) survey collected data on guideline priority, feasibility, acceptability, cost, equity and intent to
implement. We used a framework analysis and a series of meetings (Ottawa, Ont., Jan. 13, 2020; Hamilton, Ont., Aug. 16, 2019;
Gatineau, Que., July 18, 2019) with relevant stakeholders in the
field of homeless health to analyze our implementation data.
Management of competing interests
Competing interests were assessed using a detailed form adapted
from the International Committee of Medical Journal Editors Uniform Disclosure Form for Potential Conflicts of Interest194 and the
Elsevier sample coauthor agreement form for a scientific project,
contingencies and communication.195 These forms were collected
at the start of the guideline activities for the steering committee,
guideline panel and community scholars. All authors submitted
an updated form in June 2019 and before publication.
The management committee iteratively reviewed these statements and interviewed participants for any clarifications and
concerns. A priori, the management committee had agreed that
major competing interests would lead to dismissal. There were
no competing interests declared.
Our mixed-methods study (Olivia Magwood, Bruyère Research
Institute, Ottawa, Ont.: unpublished data, 2020) looking at guideline priority, feasibility, acceptability, cost, equity and intent to
implement, identified the following concerns regarding implementation of this guideline.
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Stakeholders highlighted the importance of increasing primary care providers’ knowledge of the process of applying to
PSH programs and informing their patients about the resources
available in the community.
The major concerns regarding feasibility arose around the limited availability of existing services, such as housing, as well as
administrative and human resources concerns. For example, not
all primary care providers work in a team-based comprehensive
care model and have access to a social worker or care coordinator
who can help link the patient to existing services. Furthermore,
wait lists for PSH are frequently long. Despite this, all stakeholders agreed that access to PSH was a priority and is a feasible
Allied health practitioners and physicians do not always agree
with their new role in this area. Some feedback suggested pushback from family physicians who have limited time with patients
and less experience exploring social determinants of health, such
as housing or income. The initial steps outlined in this guideline
would come at an opportunity cost for them. Stigma attached to
the condition of homelessness was recognized as an important
barrier to care for homeless populations.
Many stakeholders recognized that successful implementation of these recommendations may require moderate costs to
increase the housing supply, income supports and human
resources. However, supervised consumption facilities, with their
range of benefits, were perceived as cost-saving.
Many interventions have the potential to increase health
equity, if available and accessible in a local context. Many stakeholders highlighted opportunities to increase knowledge of the
initial steps and advocate on a systematic level to increase availability of services.
Suggested performance measures
We developed a set of performance measures to accompany this
guidleline for consideration by providers and policy-makers:
The proportion of adults who are assessed for homelessness
or vulnerable housing over 1 year.
The proportion of eligible adults who are considered for
income assistance over 1 year.
The proportion of eligible adults using opioids who are
offered opioid agonist therapy over 1 year.
The Homeless Health Research Network will be responsible for
updating this guideline every 5 years.
This guideline complements other published guidelines. This
current guideline aims to support the upcoming Indigenousspecific guidelines that recognize the importance of Indigenous
leadership and methodology that will recognize distinct underlying causes of Indigenous homelessness (Jesse Thistle, York University, Toronto, Ont.: personal communication, 2020).
The World Health Organization has developed guidelines to
promote healthy housing standards to save lives, prevent disease
and increase quality of life.196 Other guidelines specific to opioid
use disorder exist,197,198 including 1 for “treatment-refractory”
patients.199 In the United Kingdom, the National Institute for
Health Care and Excellence has published guidelines for outpatient treatment of schizophrenia and has published multimorbidity guidelines (www.nice.org.uk/guidance). The National
Health Care for the Homeless Council in the US has adapted best
practices to support front-line workers caring for homeless
How is this guideline different?
This guideline distills initial steps and evidence-based
approaches, to both homeless and vulnerably housed people,
with the assistance of patients and other stakeholders. It also
introduces a new clinical lens with upstream interventions that
provide a social and health foundation for community integration. Its initial steps support the vision of the Centre for Homelessness Impact in the UK, which envisions a society where the
experience of homelessness, in instances where it cannot be prevented, is only ever rare, brief and nonrecurrent.201 Finally, we
hope that our stakeholder engagement inspires and equips
future students, health providers and the public health community to implement the initial step recommendations.
Gaps in knowledge
Evidence-based policy initiatives will need to address the accelerating health and economic disparities between homeless and general
housed populations. As primary care expands its medical home
models,27 there will be a research opportunity for more traumainformed care202 to support the evidence-based interventions in
this guideline. Indeed, clinical research can refine how providers
use the initial steps protocol: housing, income, case management
and addiction. With improved living conditions, care coordination
and continuity of care, research and practice can shift to treatable
conditions, such as HIV and HCV infection, substance use disorder,
mental illness and tuberculosis.203
Medical educators will also need to develop new training
tools to support the delivery of interventions. Curricula and training that support the delivery of interventions, such as traumainformed and patient-centred care, will also be needed.12 Many
of the recommended interventions in this guideline rely on collaboration of community providers, housing coordinators and
case management. Interdisciplinary primary care research and
maintenance of linkages to primary care will benefit from new
homeless health clinic networks. Monitoring transitions in care
and housing availability will be an important research goal for
Canada’s National Housing Strategy and the associated Reaching
Homelessness has become a health emergency. Initial steps in
addressing this crisis proposed in this guideline include strongly
recommending PSH as an urgent intervention. The guideline also
recognizes the trauma, disability, mental illness and stigma
facing people with lived homelessness experience and thus recommends initial steps of income assistance, intensive case management for mental illness, and harm-reduction and addictiontreatment interventions, including access to opioid agonist
therapy and supervised consumption facilities.
The successful implementation of this guideline will depend
on a focus on the initial recommendations, trust, patient safety
and an ongoing collaboration between primary health care,
mental health providers, public health, people with lived experience and broader community organizations, including those
beyond the health care field.
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Competing interests: Gary Bloch is a founding member, former board
member and currently a clinician with Inner City Health Associates
(ICHA), a group of physicians working with individuals experiencing
homelessness in Toronto, which provided funding for the development
of this guideline. He did not receive payment for work on the guideline
and did not participate in any ICHA board decision-making relevant to
this project. Ritika Goel, Michaela Beder and Stephen Hwang also receive payment for clinical services from ICHA, and did not receive
payment for any aspect of the submitted work. No other competing interests were declared.
This article has been peer reviewed.
Affiliations: C.T. Lamont Primary Health Care Research Centre (Pottie,
d Wendy Muckle led
the Homeless Health Summit. Esther Shoemaker led the Delphi consensus. Olivia Magwood led the reviews on lived experiences and substance
use, Tim Aubry led the review on housing, Gary Bloch and Vanessa Brcic
led the review on income, David Ponka and Eric Agbata led the review
on case management, Jean Zhuo Jing Wang and Sebastian Mott led the
homeless youth review, Harneel Kaur led the homeless migrant review,
Christine Mathew and Anne Andermann led the homeless women
review, Syeda Shanza Hashmi and Ammar Saad led medical student
engagement and competency review, Thomas Piggott co-led the GRADE
Assessment with Olivia Magwood and Kevin Pottie, Michaela Beder and
Nicole Kozloff contributed substantially to the substance use review,
and Neil Arya and Stephen Hwang provided critical policy information.
All of the named authors engaged in the writing and review, gave final
approval of the version of the guideline to be published, and agreed to
be accountable for all aspects of the work.
Funding: This guideline was supported by a peer-reviewed grant from
the Inner City Health Associates, and supplemental project grants from
the Public Health Agency of Canada, Employment Social Development
Canada, Canadian Medical Association and Champlain Local Integrated
Health Network. Personnel from collaborating agencies provided nonbinding feedback during the preparation of systematic reviews and the
guideline. The funders had no role in the design or conduct of the study;
collection, analysis and interpretation of the data; or preparation,
review or final approval of the guideline. Final decisions regarding the
protocol and issues that arose during the guideline-development process were solely the responsibility of the guideline steering committee.
Acknowledgements: The authors thank everyone who participated in
the development of this guideline, including community scholars, technical team leads, guideline panel members and working group members.
Endorsements: Canadian Medical Association, Canadian Public Health
Association, Canadian Federation of Medical Students, The College of
Family Physicians of Canada, Public Health Physicians of Canada, Canadian Association of Emergency Physicians, The Canadian Alliance to
End Homelessness, Canadian Nurses Association
Disclaimer: The views expressed herein do not necessarily represent
the views of the funding agencies.
Correspondence to: Kevin Pottie, firstname.lastname@example.org
To Whom It May Concern:
The Canadian Medical Association (CMA) is pleased to provide its comments with respect to Health Canada’s Patented Medicines Regulations Consultations. The CMA is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations.
As the second-largest share of total health expenditures in Canada, forecast to be 16% in 2016, the cost of drugs is of significant concern to physicians.1 In 2014, 42.6% of prescribed drug spending ($12.5 billion) came from the public sector.2 Pharmaceuticals play an important role in overcoming disease and maintaining health but access to these drugs can be problematic outside of hospital care due to their cost. This is why the CMA has called for a pan-Canadian system of catastrophic coverage for prescription drugs.3 We viewed this as a step toward the development of comprehensive, universal coverage for prescription medicines in Canada.4
1 CIHI. National Health Expenditure Trends 1975-2016, December 15, 2016
3 Canadian Medical Association (CMA). A New Vision for Health Care in Canada: Addressing the Needs of an Aging Population. 2016 Pre-budget Submission to the Minister of Finance. Ottawa: The Association; 2016 Feb 12
In its brief to the Commission of Inquiry on the Pharmaceutical Industry in August, 1984, the CMA stated that we “fully support the objective of providing prescription drugs to patients at the lowest possible cost that is consistent with wise health care delivery.”5 This remains our objective. This submission will address the proposed improvements to the regulations raised in the consultation document from a broad perspective.
5 Canadian Medical Association (CMA). Brief to the Commission of Inquiry on the Pharmaceutical Industry August 15, 1984
6 Gray C. Patented drugs: Is the price right? CMAJ 1998 158:1645
7 Silversides A. Monitoring the price of new drugs CMAJ 2006 174(11):1548-1549
8 The Commission of Inquiry on the Pharmaceutical Industry. The Report of the Commission of Inquiry on the Pharmaceutical Industry H.C. Eastman, Commissioner. Ottawa Minister of Supply and Services 1985 p. 347
9 Industry Canada. Pharmaceutical industry profile. https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html (Accessed 2017 June 20)
10 Morgan SG, Leopold C, Wagner AK. Drivers of expenditures on primary care prescription drugs in 10 high-income countries with universal health coverage. CMAJ 2017;189:E794-9
The ability of the PMPRB to monitor drug prices has long been the subject of review and concern.6,7 The CMA is pleased that the Government of Canada is undertaking this review to provide the Patented Medicines Prices review Board (PMPRB) with a new regulatory framework to protect Canadians from excessive prices and improving the regulatory process. The board needs to use every economic measure and tool at its disposal to ensure Canadians pay fair and equitable prescription drug prices.
As the Eastman Commission pointed out in its 1985 report, “Canadian consumption is a small proportion of world consumption so that Canadian patent policy has little effect on the world-wide profitability of the pharmaceutical industry.”8 Indeed, Canadian pharmaceutical sales represent 2% of the global market which makes us the tenth largest world market.9 Yet our small size with respect to the global market has not shielded us from high prices. For example, a recent study found that although the volume of therapies purchased in Canada across six classes of “primary care medicines” was similar, we paid an estimated $2.3 billion more for them in 2015 than if these treatments had the “same average cost per day in Canada as in the nine comparator countries combined.”10
Prescription medication spending is an issue for many Canadians, especially when it has an impact on compliance with prescription regimes, an unintended consequence of the manner in which the board’s regulatory framework has been applied. On the
Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.11 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.12
11 Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15.
12 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23.
13 Vebeeten D, Astiles P, Prada, G. Understanding Health and Social Services for seniors in Canada. Ottawa: The Conference Board of Canada, 2015.
16 Morgan SG, Lee A. Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries BMJ Open 2017;7: e014287. doi:10.1136/bmjopen-2016-014287 (access 2017 Jun 16)
17 Zhang R., Martin D., Naylor CD., Regulator or regulatory shield? The case for reforming Canada’s Patented Medicines Prices review Board. CMAJ 2017 April 10;189:E515-6. doi: 10.1503/cmaj.161355
The CMA is especially worried about the impact high drug costs have on seniors in the absence of universal drug coverage. They have access to some level of drug coverage in all provinces and territories but it is not even.13 Eight provinces have an income-test that determines the deductibles they will pay while in two they pay a small portion of the cost with the province or a third-party insurer covering the rest.14 All three territories have plans for those who qualify but the provisions may be limited.15 A recent study found that older Canadian adults (55 and older) had the second-highest prevalence (8.3%) of cost-related non-adherence (CRNA) for prescribed medications.16 CRNA was higher among those with lower incomes and lower among those over 65.
Finally, the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures the government undertakes to strengthen and improve the PMPRB do not exacerbate drug shortages.
The PMPRB’s current benchmark “that Canadian prices for patented drugs should be less than the median of prices in selected comparison countries” places us at a distinct disadvantage.17 As the authors note, “it puts Canada well above the OECD average by
aligning Canada with countries that spend more from the outset.”18 The PMBRB should expand its range of comparator countries beyond those identified originally (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States) to include those OECD countries with middle to low patent drug pricing.19
Furthermore, to ensure that the process is clear and transparent for Canadians, the PMPRB should “set prices closer to what comparator countries actually pay for their drugs as opposed to the “sticker” prices that most commonly represent the starting point for confidential negotiations.”20 Canadians deserve that much after years of paying such high prices for their patented medicines.
The CMA is very concerned about the cost of medications. In the absence of universal drug coverage and, at a minimum, a pan-Canadian system of catastrophic coverage of prescription drug costs, a strengthened and robust regulatory framework for the pricing of patented medicines in Canada is crucial. The CMA calls on the federal government to revise the PMPRB regulations such that it provides Canadians with transparency and clarity around the setting of patented medicines prices while achieving the lowest costs possible and ensuring we continue to have access to a wide array of pharmaceutical products.
Granger R. Avery, MB BS, FRRMS
The Canadian Medical Association (CMA) is pleased to provide its response to Health Canada's public consultation on the Guide to New Authorities (power to require & disclose information, power to order a label change and power to order a recall), in reference to the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), which came into force on November 6, 2014.
The CMA supports a robust legislative framework toward an unbiased, evidence-based system for the oversight of pharmaceutical products, which spans both the pre- and post-approval of these products, with the ultimate goal of patient safety. Prescription medication plays a critical role as part of a high-quality, patient-centred and cost-effective health care system. It is a priority to physicians that all Canadians have access to affordable, safe and effective prescription medications.
Stemming from this perspective, the CMA strongly welcomed the new ministerial authorities established by Vanessa's Law as an important contribution to patient safety and the effectiveness of Health Canada's oversight of prescription pharmaceuticals. With these new authorities now in effect, it is critical that implementation is comprehensive, effective and transparent. As such, CMA's response to this public consultation on the new Guide will focus on the need for:
* increased clarity on the thresholds that underpin the use of these new authorities,
* guidance on the notification of public, physicians and other health care practitioners, and
* a commitment to ongoing oversight and revision process of this guidance.
ISSUE 1: PROVIDE INCREASED CLARITY ON THE THRESHOLDS
In CMA's brief1 to the House of Commons Standing Committee on Health as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, key recommendations included clarification of both ministerial authority and responsibility in support of patient safety. The CMA supported the intent of the expansion of these powers, but expressed concern with the lack of clarity on the threshold required to be met to enable the use of these new authorities.
In order to ensure the consistent and effective implementation of these new ministerial authorities, the CMA considers it essential that the Guide provide more clarity on the threshold that enables the use of the new authorities, including the determination of serious risk.
To determine this threshold, Health Canada relies on experts to analyze scientific information and make a recommendation to the Minister.
The CMA recommends that guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
As the definition of "serious risk of injury to human health" is not provided in Vanessa's Law, it is critical that it be addressed in the Guide. Annex A of the Guide states that "the determination of whether a therapeutic product presents a serious risk is complex and is conducted on a case-by-case basis when new information becomes available", and puts forward a "non-exhaustive" list of elements to be considered. It also states that different weights would be attributed to different elements and suggests further contextual elements. The CMA is concerned that without a clear process for the determination of what constitutes a serious risk that subjectivity may have an undue role in this determination and there is the potential for a lack of consistency from case to case. Further, a detailed process is required to ensure that this threshold does not constrain ministerial authority when action is needed.
The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
ISSUE 2: INCLUDE GUIDANCE NOTIFICATION TO PUBLIC, PHYSICIANS AND OTHER HEALTH CARE PRACTITIONERS
The CMA is supportive of the guiding principles that should govern all decisions made by Health Canada acting as a regulatory decision-maker, i.e., that power is exercised in a process that is free from bias, based on evidence and in a transparent manner.
In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies2 and by Health Canada, when these new authorities are exercised.
Access to accurate, unbiased information is essential for people to make decisions about their own health.. A clear elaboration and articulation of the process and timelines for how and when public notification is issued in relation to the exercise of the new ministerial authorities is critical to ensure their comprehensive, effective and transparent implementation.
Also, when new information is discovered about a prescription medication, it is important that health professionals be informed as quickly and efficiently as possible.
As part of Health Canada's commitment to transparency, the CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
The U.S. Food and Drug Administration (U.S. FDA), for example, provides guidance and instructions on their public notification expectations in a situation where a product may pose a significant health hazard.3 In addition, there are different mechanisms of public notification, including 'mobile web' and alerts.
Finally, also consistent with the guidance of the U.S. FDA, the CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
ISSUE 3: SPECIFY THE OVERSIGHT AND REVISION OF THE GUIDANCE
As part of its public consultation outreach with stakeholders on this new guidance, Health Canada officials have described the Guide as an evergreen document that will be continually updated. The CMA is supportive of Health Canada's efforts to engage stakeholders and the public in the development and revision of this guidance.
To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
The CMA welcomed this opportunity to submit recommendations on how Health Canada may improve the Guide to New Authorities, which is critical to the comprehensive, effective and transparent implementation of the new authorities established by Vanessa's Law. The CMA looks forward to continued and ongoing collaboration with Health Canada on its implementation of these important new powers.
Overview of Recommendations
1. The CMA recommends that the guidance be expanded to specify a mechanism for experts, external to Health Canada, to submit recommendations for action and the process by which these recommendations would be considered.
2. The CMA recommends that the elements and process for the determination of "serious risk" be further defined, in order to bring clarity to the determination of a threshold for serious risk, and support reasoned decisions which stand up to legal challenges.
3. In order to support transparency, the CMA recommends that the guidance be expanded to include the notification of the public, both by companies and by Health Canada when these new authorities are exercised.
4. The CMA recommends that the guidance should be expanded to include public disclosure of Health Canada's usage of the guidance: how the thresholds are applied on a case by case basis and the outcomes of decisions, even when the process results in no action being taken.
5. The CMA recommends that the guidance be expanded to require evaluation by companies and Health Canada of the use of the power for collection of information, label change or recall and public reporting on the effectiveness of the action taken.
6. To ensure clarity on how or when the revision process will be undertaken, the CMA recommends that the guidance include a timeline for revision, a mechanism for stakeholders to identify issues with the guidance, and the circumstances that would trigger an early review, possibly leading to a revision.
1 Canadian Medical Association (2014) Bill C-17 An Act to amend the Food and Drugs Act - Protecting Canadians from Unsafe Drugs. Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2014-09.pdf
2 Note: Throughout this submission, "companies" refers to whom the new ministerial powers apply outside of the regulator - as explained in the consultation document, in the case of s. 21.1 it is a "person" (can include an individual, a research institution, a corporation or an authorization holder), in the case of 21.2 it is the therapeutic product authorization holder, and in the case of s.21.3 it is a "person".
3 U.S. Food and Drug Administration (2015) Guidance for Industry: Product Recalls, Including Removals and Corrections. Retrieved from: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm
The Canadian Medical Association (CMA) is pleased to participate in the Government of Canada's consultation on ensuring the ongoing strength of Canada's retirement income system. Ensuring sufficient income in retirement is a concern for CMA's more than 72,000 physician members and the patients they serve. With the aging of the Canadian population and the decline in the number of Canadians participating in employer-sponsored pension plans, now is the time to explore strengthening the third pillar of Canada's government-supported retirement income system: tax-assisted savings opportunities. Two areas in need of government attention are tax-assisted savings vehicles for high-earning and self-employed Canadians, and vehicles available to help Canadians save to meet future continuing care needs.
Like the Canadian population at large, physicians represent an aging demographic - 38% of Canada's physicians are 55 or older - for whom retirement planning is an important concern. In addition, the vast majority of CMA members are self-employed physicians and, as such, they are unable to participate in workplace registered pension plans (RPPs). This makes physicians more reliant on Registered Retirement Savings Plans (RRSPs) relative to other retirement savings vehicles. As we saw during the recent economic downturn, the volatility of global financial markets can have an enormous impact on the value of RRSPs over the short- and medium-term. This variability is felt most acutely when RRSPs reach maturity during a time of declining market returns and RRSP holders are forced to 'sell low'.
The possibility that higher-earning Canadians, such as physicians, may not be saving enough for retirement was raised by Jack Mintz, Research Director for the Research Working Group on Retirement Income Adequacy of Federal-Provincial-Territorial Ministers of Finance. In his Summary Report on Retirement Income Adequacy Research, Mr. Mintz reported that income replacement rates in retirement fall below 60% of after-tax income for about 35% of Canadians in the top income quintile. This is due to the effect of the maximum RPP/RRSP dollar limits, which is why the government should consider raising these limits.
The CMA supports exploring ways to expand tax-assisted options available for retirement saving, particularly measures that would allow organizations to sponsor RPPs and Supplementary Employee Retirement Plans (SERPs) on behalf of the self-employed.
Such changes could allow the growing ranks of self-employed Canadians to benefit from the security and peace of mind already available to Canadians with workplace pensions. CMA members favour a voluntary approach, both for employers/plan sponsors in deciding whether to sponsor such plans and for potential plan participants in choosing whether or not to participate.
Just as the government should explore ways to modernize the rules governing registered pension plans to account for today's demographics and employment structures, so too should it explore ways to help Canadians save for their continuing care - including home care and long-term care - needs. When universal, first-dollar coverage of hospital and physician services-commonly known as 'medicare' - was implemented in Canada in the late-1950s and 1960s, health care within an institutional setting was the norm and life expectancy was almost a decade shorter than it is today. With Canadians living longer and continuing care falling outside the boundaries of Canada Health Act first-dollar coverage, there is a growing need to help Canadians save for their home care and long-term care needs.
The attached backgrounder highlights the pressing need for greater support for home and long-term care in Canada, as well as some principles and options for governments to help Canadians pay for these services. It should be noted that the introduction of Tax-free Savings Accounts (TFSAs) in the 2008 federal budget created a new savings vehicle to support Canadians' continuing care needs. The CMA was pleased to see its introduction.
Government action on these two related issues would benefit all Canadians. Expanding retirement-saving options for physicians would provide a strong incentive for physicians to stay in Canada. Similarly, by helping Canadians save for their own continuing care needs, governments could contribute to the health of elderly citizens and ease the demand on unpaid caregivers and government-funded continuing care.
Ensuring that Canadians have the tools at their disposal to save for their continuing care needs and that Canada's physicians have the right tools to save for retirement are important issues for the CMA. Canada's physicians have long been active on these issues and government action on these files would benefit all Canadians. We are pleased to take part in Finance Canada's consultations and would welcome any further opportunities to participate.
Anne Doig, MD, CCFP, FCFP
Dear Mr. Rodrigue:
The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2
1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018
2 Ibid pg.1
3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide.
The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling.
The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol
must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important.
Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message.
As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion.
Foods to be exempted from front-of-package nutrition labelling
There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium.
Nutrient thresholds for sodium, sugar & saturated fat
CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans-fat and calorie content of processed foods and prepared meals.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern.
4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca.
While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend that the threshold for “high in”
sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education.
Nutrient content claims, in relation to Front-of-Packaging Labelling symbol
Allowing a food that qualifies for a “high in” sugar FOP symbol to also display a “no added sugars” claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing “no added sugar” claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion.
High-intensity sweetener labelling
Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal display panel. For products that have high intensity sweeteners added and which bear claims such as “unsweetened” or “no sugar added,” a declaration of “artificially sweetened” should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn’t need to be on the principal display.
Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine.
For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government’s Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
The Canadian Medical Association (CMA) is pleased to provide comment on the proposal by Health Canada1 to revise the listing for naloxone on the Prescription Drug List (PDL) to allow the non-prescription use of naloxone, "when indicated for emergency use for opioid overdose outside hospital settings".
The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care.
The harms associated with opioids, which include prescription medicines such as oxycodone, hydromorphone and fentanyl, as well as illegal drugs such as heroin, is a significant public health and patient safety issue. Harms include addiction, diversion, overdose and death.
According to 2013 estimates2, Canada has one of the highest per capita consumptions of prescription opioids in the world. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.3
Data on the harms caused by opioids are not collected systematically in Canada; however, practitioners have seen the significant impact of these drugs on their patients and to whole communities, including indigenous peoples. Opioid addiction rates from 43% to 85% have been reported in some indigenous communities.4 5 In Ontario, according to the Office of the Chief Coroner, opioid-related deaths nearly tripled from 2002 to 2010.6
Canada's physicians believe that Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs, whether illegal or prescription-based.7 One component of this strategy is the prevention of overdose deaths and complications with appropriate medication and prompt emergency response.
For over four decades, naloxone (or Narcan(r)) has been used as a prescription drug for the complete or partial reversal of opioid overdoses. Naloxone counteracts the life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. The World Health Organization placed naloxone on its list of essential medications in 1983.
Physicians have been encouraged to identify patients who could benefit from the co-prescription of naloxone, along with opioids, when these are necessary. Increased risk for opioid overdose includes previous episodes of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use.8 9
More recently, with the increase in opioid overdoses, different provinces have created programs to increase access to naloxone outside of health care settings, such as "take-home naloxone programs". The experience in Canada and in other countries has been shown to have various benefits, including reducing overdose deaths.10 11 In Canada, naloxone has been administered through intramuscular or subcutaneous injection in these community-based programs, but in other countries it has also been available in a nasal spray form or in a pre-filled auto-injector format. Those that receive the naloxone kit are trained in the recognition of signs and symptoms of opioid overdose, in the administration of naloxone and first aid and in the need to call for medical follow-up.
In its 2015 policy on Harms associated with Opioids and other Psychoactive Prescription Drugs, the CMA supports the improvement of access to naloxone, particularly by individuals who are at a high risk of overdose as well as third parties who can assist a person experiencing an opiate-related overdose. The CMA also encourages the creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. This would include training for health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.12 Also in 2015, the CMA approved a resolution supporting "the development and implementation of a national strategy on the use of naloxone".13
A report issued by the United Nations Office on Drugs and Crime and the World Health Organization supports making naloxone available to first responders as well as to people dependent on opioids, their peers and family members who are likely to be present when an overdose occurs.14 Many other organizations, such as the Canadian Pharmacists Association, the American Medical Association and the American Public Health Association, are also supportive of enhanced access to naloxone in the community.15 16 17
The prescription status has been one of the barriers to increased access to naloxone. It is more likely that a family member, partner or friend would need to administer the naloxone in an overdose than the person who is prescribed the drug. Community-based programs have had to work with standing orders from prescribers. First responders, such as police officers and firefighters, should be able to carry and administer the drug, given they are often the first professionals to arrive at a scene where someone has overdosed.
According to Health Canada, the provinces and territories have collectively asked that the prescription status be re-evaluated. Health Canada has undertaken a Benefit-Harm-Uncertainty assessment of naloxone, and come to the following conclusions:
This assessment recommended that naloxone could safely be administered without the direct supervision of a physician if the person administering the drug has appropriate training.
The main risks associated with the unsupervised use of the drug are:
* the administrator may have difficulty filling the syringe and administering the drug under pressure in an emergency situation;
* the administrator may not seek professional care for follow-up of the patient after injection;
* chance of the patient relapsing since the effects of naloxone may only last for up to one hour depending on amount and type of opioid causing the overdose;
* that the patient may become very agitated and aggressive after coming out of the opioid depression (Acute Opioid Withdrawal Syndrome).
These risks can be mitigated with appropriate training of the potential administrator before naloxone is distributed. The benefit of quickly responding to an overdose far outweighed these risks. Evidence from provincial take-home programs indicates that naloxone can be administered (intramuscularly or subcutaneously) by a layperson and its effects monitored successfully without practitioner supervision. Although an opioid overdose might be mistakenly diagnosed by a layperson, the injection of naloxone in a person not overdosing on an opioid will cause no serious harm.18
Various jurisdictions have delisted or are studying special conditions for the status of naloxone as a prescription drug, including Italy and some U.S. States.19
The CMA appreciates the opportunity to provide feedback on this important matter to physicians, and congratulates Health Canada in taking the initiative to make naloxone more accessible in the community; thereby helping to address the concerning levels of opioid overdoses in Canada.
That Health Canada proceed with the revisions to the listing for naloxone on the Prescription Drug List, to allow the non-prescription use of naloxone when indicated for emergency use for opioid overdose outside hospital settings. As outlined in Health Canada's assessment, the potential risks can be mitigated by well-designed community-based programs.
That Health Canada assess the option of licensing naloxone products that don't require training for intramuscular or subcutaneous injection, such as nasal sprays or automated handheld injectors (similar to epinephrine auto-injectors for use in serious allergic reactions), in order to further increase accessibility.
1 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17).
2 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013. Available: https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2012/NDR_2012_Annex_2_EFS.pdf (accessed 2016 March 17).
3 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
4 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf (accessed 2016 March 17).
5 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf (accessed 2016 March 17).
6 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013.
7 Canadian Medical Association. Policy Document PD15-06 - Harms associated with opioids and other psychoactive prescriptions drugs. Ottawa: The Author; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed 2016-March 17).
8 National Opioid Use Guideline Group. Canadian guideline for safe and effective use of opioids for chronic non-cancer pain. Hamilton, ON: McMaster University; 2010. Available: http://nationalpaincentre.mcmaster.ca/opioid/ (accessed 2016 March 17).
9 Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain-United States, 2016. MMWR Recomm Rep. 2016;65(RR-1):1-49. Available: http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1er.htm?s_cid=rr6501e1er_w (accessed 2016 March 17).
10 Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: Interrupted time series analysis. BMJ. 2013;346:f174. Available: http://www.bmj.com/content/bmj/346/bmj.f174.full.pdf (accessed 2016 March 17).
11 Banjo, O, Tzemis, D, Al-Outub, D, et al. A quantitative and qualitative evaluation of the British Columbia Take Home Naloxone program. CMAJ Open, August 21, 2014;2(3) E153-E161. Available: http://cmajopen.ca/content/2/3/E153.full (accessed 2016 March 17).
12 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/ (accessed 2016 March 17).
13 Canadian Medical Association. Policy Resolution GC15-18 - National strategy on the use of naloxone. Ottawa: The Author; 2015. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 March 17).
14 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17).
15 American Medical Association. AMA adopts new policies at annual meeting. Press Release. New York, NY: Reuters; June 19, 2012. Available: http://www.reuters.com/article/idUS182652+19-Jun-2012+GNW20120619 (accessed 2016 March 17).
16 Drug Policy Alliance. American Public Health Association Policy Statement on Preventing Overdose Through Education and Naloxone Distribution. New York, NY: Drug Policy Alliance; October 30, 2012. Available: http://www.drugpolicy.org/resource/american-public-health-association-policy-statement-preventing-overdose-through-education-a (accessed 2016 March 17).
17 Canadian Pharmacists Association. CPhA Welcomes Health Canada Move to Change Prescription Status of Naloxone. News Release. January 14, 2016. Available: https://www.pharmacists.ca/news-events/news/cpha-welcomes-health-canada-move-to-change-prescription-status-of-naloxone/ (accessed 2016 March 17).
18 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17).
19 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17).
On behalf of the Canadian Medical Association (CMA), I am responding to your request for consultation on renewal of the Federal Tobacco Control Strategy (FTCS) and on the consultation document: “Seizing the Opportunity: The Future of Tobacco Control in Canada.” We are pleased that Health Canada is renewing the FTCS.
The most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014. The decrease is welcome news but much more needs to be done to ensure the decline continues.
We support the Endgame Summit’s goal of less than 5% tobacco use by 2035. It must be recognized that specific sub-populations, such as Indigenous populations, will require different targets along with prevalence reduction goals that recognize their unique circumstances and needs. Tobacco has ceremonial significance among Indigenous peoples; the harm associated with tobacco arises not from its ceremonial use but from its daily, repeated abuse.
As the Summit suggests a renewed strategy must go beyond the traditional approaches of incremental stricter measures by focussing on the activities of the tobacco industry while offering more assistance to those affected by tobacco products. The whole-of-government approach recommended by the Summit and the framework it proposes are essential for the success of the strategy in the long-term.
The CMA believes that despite the reduction in smoking rates, tobacco control remains a priority and should continue to be supported by a sustained, well-funded federal strategy and strong leadership and support from Health Canada, including a coordinated, comprehensive
national cessation strategy. We recommend that the next version of the FTCS make the following initiatives a priority:
. Pricing There is abundant evidence that high prices are crucial to discouraging tobacco use, especially among young people who are particularly sensitive to price increases. The Summit’s recommendation of a joint pricing strategy developed by Health Canada and Finance Canada that combines substantial excise tax increases and other measures will be key in that regard. As in reducing prevalence, pricing strategies that recognize the unique circumstances and needs of specific sub-populations will need to be developed.
. Plain and Standardized Tobacco Packaging The CMA recommends only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA also supports a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.”
. Retailing The CMA recommends tightening the licensing system to limit the number of outlets where tobacco products can be purchased. The more restricted is tobacco availability, the easier it is to regulate.
. Age of sale The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco, preventing them from starting to use tobacco and encouraging them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. The CMA supports raising the minimum age of sale to 21 years.
. Promotion Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to young people. The CMA supports educational and public relations initiatives aimed at countering these messages. For example, movie classification systems should restrict access by children and youth to films that portray tobacco use and tobacco product placement. The CMA also supports a total ban on promotion, including tobacco-branded tobacco accessories and non-tobacco products.
. Industry interference The CMA supports the Endgame Summit’s recommendations with respect to preventing the tobacco industry’s interference with health policy (i.e., Article 5.3 Guidelines to the Framework Convention on Tobacco Control).
It is the CMA’s position that the federal government has a vital role to play in smoking cessation. A fully funded and resourced tobacco control strategy that meets the challenges of the 21st century will help accomplish that goal.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
The Canadian Medical Association (CMA) is pleased to provide its comments with respect to the Government of Canada's consultation on the Proposed Excise Duty Framework for Cannabis Products published November 10.1
In the move towards the legalization and regulation of cannabis, there are many economic interests at play; private corporations and different levels of government stand to benefit greatly with sales and considerable tax revenue.2 It is essential that the federal and provincial/territorial governments be held accountable to the public health and safety objectives set out for the new regime for legal access to cannabis, particularly that of protecting children and youth.3 It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls.
Final pricing must be such as to discourage the illegal production and trafficking of cannabis. However, a balance must be found with the use of taxation and pricing levers to discourage use. Revenues need to be clearly earmarked to cover the health and social costs of legalization. In some U.S. jurisdictions, for example, some of the revenue is directed to recovering the costs of regulatory programs as well as in substance use treatment programs, and for social programs.
Most of the future tax revenues should be redistributed to the provinces and territories. This is because they have jurisdiction over services that will likely feel the impact with legalization, such as health care, education, social and other services, as well as enforcement of legislation and regulations. A public health approach to legalization will emphasize prevention, education and treatment initiatives which require adequate and reliable funding. It will also require strong surveillance and monitoring activities to adjust measures should unintended harms be detected. Resources need to be promptly available to address potential negative impacts.
CMA recommends that the revenue resulting from the taxation of cannabis production and sales be earmarked to address health and social harms of cannabis use and its commercialization, in line with a public health approach to the legalization of cannabis.
The proposal states that "Any cannabis products sold under the proposed Cannabis Act for medical purposes will be subject to the duty rates and conditions of the excise duty framework, which will become applicable as per the transitional rules (...) Cannabis products that are produced by an individual (or a designated person) for the individual's own medical purposes in accordance with the proposed Cannabis Act will not be subject to the excise duty. Seeds and seedlings used in this production will be subject to duty."1
The CMA is supportive of similar taxation treatment of cannabis products, regardless of whether they are used for medical or non-medical purposes.
The CMA has long called for more research to better understand potential therapeutic indications of cannabis, as well as its risks.4 5 Physicians recognize that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with cannabis used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency, interactions with medications and adverse effects. Health Canada does not approve of cannabis as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. It is important that there be support for cannabis research in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol(r)), nabilone (Cesamet(r)) and THC/CBD (Sativex(r)).
The experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the different standards.6 A lower tax rate on cannabis for medical use could potentially provide an incentive for people to seek a medical authorization, and that was observed initially in Colorado.7
The CMA recommends that the same tax rates be applied to the production and sales of both the medical and the non-medical use of cannabis products.
The move towards the legalization and regulation of cannabis will require a balanced approach to discourage the illegal production and trafficking of cannabis while also using taxation and pricing levers to discourage use. Much of the revenues raised should be redistributed to the provinces and territories to enable them to cover the health and social costs of legalization.
A public health approach to legalization will emphasize prevention, education, treatment and surveillance initiatives which requires adequate and reliable funding.
1 Department of Finance Canada. Proposed excise duty framework for cannabis products. Ottawa: Department of Finance Canada; 2017. Available: http://www.fin.gc.ca/n17/data/17-114_1-eng.asp (accessed 2017 Dec 05).
2 Sen A, Wyonch R. Don't (over) tax that joint, my friend. Intelligence MEMOS. Ottawa: CD Howe Institute; 2017 Jul 19. Available: https://www.cdhowe.org/sites/default/files/blog_Anindya%20and%20Rosalie_0719.pdf (accessed 2017 Dec 06).
3 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed 2017 Dec 05).
4 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/cannabis.pdf (accessed 2017 Dec 05).
5 Canadian Medical Association (CMA). Medical Marijuana. CMA Policy. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD11-02-e.pdf (accessed 2017 Dec 05).
6 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2017 Dec 05).
7 Office of the Parliamentary Budget Officer. Legalized cannabis: Fiscal considerations. Ottawa: Office of the Parliamentary Budget Officer; 2016. Available: http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2016/Legalized%20Cannabis/Legalized%20Canabis%20Fiscal%20Considerations_EN.pdf (accessed 2017 Dec 05).
1. Protection and disclosure of the information
This is a foundational component of any regulatory framework for both practitioners and patients/requestors. The CMA recommends placing greater emphasis on the protection of privacy by
a. conducting a privacy impact assessment, with input from the Federal Privacy Commissioner (if that hasn't already been done).
b. requiring, as part of the regulations, privacy/data sharing agreements in instances when
o data is shared to meet the objectives outlined (p. 2); and
o information collected under the framework will be made available to designated provincial and territorial government bodies for their use (p. 3). This is particularly important given that this involves the collection of identifiable (private) information about practitioners and patients/requestors.
c. using aggregate data where applicable.
d. providing greater detail on how the "Rigorous protection of all personal information (patient and practitioner) will be a paramount feature of the monitoring regime" - such detail is essential even in the preliminary stages of developing a monitoring and reporting system.
2. Further specification of what constitutes a request
As is currently stated, what constitutes a request is not sufficiently defined, i.e., what constitutes a "written request"? Is any written request a request? What about for those who can't (or who can no longer) write? Further specifying what constitutes a request is especially important since the practitioner has to document the circumstances of the request in every instance, including where follow-up is required and a report has to be filed as part of a follow-up.
A timeframe of 10 days to file a report is alarmingly short. It is commonly known that physicians already feel burdened by paperwork and it is highly likely that they would find it nearly impossible to meet this requirement. This could conceivably deter physicians from choosing to provide assistance in dying or participate in an assessment under threat of criminal sanction, potentially significantly impacting patient access.
Information required for this category includes "results of the eligibility assessment". It should be required to explicitly include reasons why the patient/requestor was deemed ineligible.
5. MAiD self-administered
a. The application of safeguards should be a specific category requiring reporting (and not simply used an example).
b. To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to require stating whether the practitioner was present during the self-administration.
6. Coroners and medical examiners
When the monitoring regime (periodically) requests information from Chief Coroners or Medical Examiners:
To assess (in)consistency of emerging practices and the variability of provincial legislative or regulatory requirements, it would be worthwhile to gather data on who completes the death certificate and the information included on the death certificate.
The Canadian Medical Association (CMA) is pleased to provide input on the proposed regulations of the federal monitoring of Medical Assistance in Dying in Canada.
The CMA fully supports the proposed intent of the regulations, in particular, public accountability and transparency and safeguards for vulnerable patient populations. Tracking trends and carrying out research is very important to monitor the implementation and implications of medical assistance in dying.
The CMA further supports the intent to provide electronic reporting and guidance documents, and to leverage any synergies between the federal and provincial/territorial governments, especially to prevent duplication and to promote consistency in reporting across the country.
The CMA would like to raise the following critical areas for your consideration:
1. Definitions/parameters of terms
There continues to be a need to more clearly define several terms to ensure consistency of reporting. For example:
a. Who constitutes a “practitioner”? One can argue that there is a broad scope of who is “a medical practitioner or nurse practitioner”. Is it the practitioner who provides MAiD? Or he practitioner who first reads a patient’s request for MAiD? Or is the first practitioner? Or second practitioner who assesses the patient?
b. What constitutes a therapeutic relationship (as one of the eight proposed items to be collected about the practitioner)? A therapeutic relationship is not required to access MAiD. This criterion should be removed and if not, given the differences in opinion in the health professions as to what constitutes a therapeutic relationship includes, it should be clearly defined.
c. What constitutes a request, a written request, the receipt of a request? If reporting obligations are “triggered” by a patient’s “written request”, at what point is that request actually triggered? The very first practitioner who receives the patient’s written request? Or the practitioner who conducts the eligibility assessment upon receipt of the written request? Or the practitioner who provides the prescription or carries out the procedure?
d. On a related point, without clear definitions, any future comparative analysis of research or trends will be difficult as there will be no common starting point.
e. There continues to be confusion on how to count or when to start counting the required 10 clear days. There are many reasons why this requires more clarity.
2. Collection and protection of data
We applaud Health Canada for further reducing and revising data requirements. We submit, however, that further reductions are required for several reasons, including adherence to privacy best practices that require the collection of the least amount of data necessary to achieve reasonable purposes. In particular:
a. In view of the quantity and highly personal and sensitive data that will be collected about patients and practitioners, data sharing agreements should be required; for example, agreements between the federal government and provincial/territorial governments or between researchers and others requesting use of the data to facilitate the appropriate sharing of data.
b. Collection of personal information should be limited to what is relevant to the purpose of monitoring medical assistance in dying. Personal information, such as the patient’s full postal code, marital status, or principal occupation is beyond the scope of the eligibility criteria outlined in the legislation and thus beyond the scope of the purpose of monitoring the impact of the legislation.
c. Any “characteristics” of the patient should refer only to the eligibility criteria. If other data will be collected beyond that scope, the justification for doing so, and the characteristics themselves, should be clearly outlined.
d. The scope of the information collected about the practitioner could be narrowed. As is, it is very broad – a list of eight items – while the Quebec regulations, as a comparator, have only three-four items that must be collected in relation to the physician who administers MAiD.
3. Additional requirements
Schedule 4 [section 2(i)] of the proposed regulations requires that the practitioner opine as to whether the patient met, or did not meet, all of the eligibility criteria outlined in the legislation – with two significantly expanded requirements; the requirements that the practitioner: 1) provide an estimate as to the amount of time MAiD shortened the patient’s life; and 2) indicate the anticipated likely cause of natural death of the patient.
These additional requirements are beyond the letter and spirit of the legislation and, in many ways, are in direct contradiction to the legislation. The Legislature was not unaware when it drafted the Act that it did not follow other jurisdictions’ criteria requiring either a terminal illness or a prognosis of time within which the practitioner believed the patient would die, e.g., “within the next 6 months”.
It is specifically the lack of a timeframe that makes the legislation unique and provides flexibility for both patients and practitioners. By adding these two additional criteria for reporting, in effect, they become additional criteria for eligibility which is, as stated above, beyond the scope, and in contradiction to, the legislation.
4. Lack of clarity of reasons for ineligibility
There is a potential for misunderstanding as to whether reasons are required when the patient does not meet the criteria under Schedule 4, section 2(a) – (h). The introduction to section 2 speaks to the practitioner giving an indication as to (a) whether the patient met or (b) did not meet the criteria. However, in the itemized criteria [2(a)-(h)] it only speaks to the practitioner having to provide reasons when the patient meets the criteria (and not when the patient has not met the criteria). It would be helpful to specify that reasons should be required when the patient does and does not meet the criteria. This is also crucial for the publication of the Minister of Health’s annual report requiring that the reasons, and which eligibility criteria were not met, be addressed.
The CMA recognizes the importance of regulations to capture the provision, collection, use, and disposal of information for the purpose of monitoring MAiD. The CMA cautions against introducing reporting requirements that are beyond the scope of the legislation.
As noted in the legislation, practitioners who fail to provide information under the regulations may be found guilty under the Criminal Code and subject to possible imprisonment. It is thus imperative that the federal government drafts clear regulations that respect the legislation, privacy, research ethics, and a de minimus approach.
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices. In this regard, CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans fat and calorie content of processed foods and prepared meals; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels.1 We commend Health Canada on recent work on updating the nutrition facts table and the current revision of the Canada Food Guide and are very pleased to provide a response to the consumer questionnaire on the Health Canada proposal for front-of-package (FOP) nutrition labelling.
FOP nutrition labelling approach and possible symbols
Do you support Health Canada's proposal to use a symbol to identify foods that are high in sodium, sugars and/or saturated fat? Please explain.
In 2011, appearing before the House of Commons Standing Committee on Health, the CMA supported a standard "at a glance" approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices.2
There is a growing body of evidence linking the consumption of diets high in saturated fats, sugars or sodium to cardiovascular and chronic disease (hypertension, dyslipidemia, diabetes mellitus, obesity, cancer, and heart disease and stroke) - leading preventable risk factors and causes of death and disability within Canada and worldwide. Therefore, the CMA does support the proposal to use a symbol for "high in" FOP labelling of foods high in sugar, sodium or saturated fats. FOP labelling on packaged foods may help Canadians make healthier food choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling.
Which symbol would help you recognize foods high in sodium, sugars and/or saturated fat? Please explain.
Of the proposed symbols, we believe that those that resemble a stop sign would send a strong and recognizable signal of a food to avoid. The triangle yield sign shape is too similar to the shape often used to indicate a hazard such as poison. We would recommend holding focus groups with Canadians to better understand how the proposed symbols will be understood by consumers.
Foods that do not have nutrition labelling
Do you think these foods should be exempt from FOP symbols even if they're high in sodium, sugars and/or saturated fat? Please explain.
The CMA can support the exemption of FOP labelling for products in very small packages but we would like to see a provision to include information on "high in" sugar, salt or saturated fats on foods such as sausages, bakery products, prepared dishes from the deli produced and prepackaged by grocery stores/retailers as they are categories of foods often high in these nutrients. A "high in" sticker could be added to the retailer's packaging to be consistent with other packaged foods.
Nutrient levels for a "high in" FOP label
Do you think the proposed nutrient levels make sense to identify foods that are high in sodium, sugars and/or saturated fat? Please explain.
The CMA supports the proposed nutrient levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring that the "high in" threshold and the 15% "a lot" daily value (DV) message are consistent delivers a clear message of concern.
While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we suggest that the threshold for "high in" sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education.
Updating nutrient content claims and other nutrition-related statements
Do you support not allowing a "no added sugars" claim on foods high in sugars? Please explain.
Allowing a food that qualifies for a "high in" sugar FOP symbol to also display a "no added sugars" claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing "no added sugar" claims on these foods.
The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion.
Labelling of foods that have sweeteners
Do you support that these sweeteners be declared in the list of ingredients only, rather than in the list of ingredients and the front of the package? Please explain.
We do not support the elimination of the labelling requirement for artificial sweeteners on the principle display panel. For products that have high intensity sweeteners added and which bear claims such as "unsweetened" or "no sugar added," a declaration of "artificially sweetened" should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn't need to be on the principal display.
For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government's Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice.
Jeff Blackmer, MD, MHSc, FRCPC
Vice-president, Medical Professionalism
1 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca.
2 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation on new and innovative ideas on how to further strengthen the federal government’s health-focussed approach to substance use issues through the Canadian Drugs and Substances Strategy (CDSS)
What sorts of circumstances do you see within your networks, communities or in society that you think contribute to problematic substance use?
There are multiple factors that contribute to problematic substance use. It is a serious, chronic and relapsing medical condition for which there are effective treatments. However, using the social determinants as a framework, most health promotion and prevention efforts will take place outside of the traditional health and medical care services. .
Many Canadians face barriers in their physical, social and economic environments which can contribute to problematic substance use, and certain populations are at higher risk given these circumstances. For example, early childhood is a critical time in the social, emotional, cognitive and physical development of a person. Experiences in early life can ‘get under the skin’, changing the ways that genes are expressed. Negative experiences such as poverty or family or parental violence can have significant impacts on this important period of development.
What is necessary is a coordinated effort across government sectors to ensure that all policy decisions serve to increase opportunities for health. Improving population health and reducing inequities should be an overall objective for all governments in Canada.
Have you seen or experienced programs, practices or models at the local or regional level that could be expanded, or implemented more broadly, to improve circumstances or social determinants of health that influence substance use?
Income is critical to individual health and is closely linked to many of the other social determinants of health. These include but are not limited to: education, employment, early childhood development, housing, social exclusion, and physical environment. Adequate consideration must be given to the social and economic determinants of health, factors such as income and housing that have a major impact on health outcomes. Minimizing poverty should be a top priority.
In 2015, the CMA passed a resolution endorsing the concept of a basic income guarantee, which is a cash transfer from government to citizens not tied to labour market participation. It ensures sufficient income to meet basic needs and live with dignity, regardless of employment status. A basic income guarantee has the potential to alleviate or even eliminate poverty. It has the potential to reduce the substantial, long-term social consequences of poverty, including higher crime rates and fewer students achieving success in the educational system.
Drug use must not be treated with a criminal justice approach, which does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. More investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system. Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential.
What needs to change to make sure that opioid medications are being provided and used appropriately, based on the needs of each patient?
Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. Doctors support patients in the management of acute and chronic pain, as well as problematic substance use, and as such have long been concerned about the harms associated with opioid use.
Treatment options and services for both problematic substance use as well as pain management are woefully under-resourced in Canada. Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals; non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies; appropriate pharmaceutical prescription options, covered by provincial formularies; and a focus on patient participation and empowerment.12 Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services.
It is also important to support clinicians in their practice. The 2017 Opioid Prescribing Guidelines need to be kept current through ongoing funding. Physicians require tools, including those that facilitate monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; and, tapering of problematic or ineffective doses.
How can we make sure that those who require prescription opioids to manage their pain have access to them, without judgement or discrimination?
Governments need to incorporate the identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. They also need to implement and evaluate national public awareness and education strategies to counteract the stigma associated with substance use issues as well as enforcing legislation and regulations to guard against discrimination against people with mental and substance use issues.
Health professionals need to have access to education on pain management and treatment of problematic substance use, recognizing both issues as serious medical conditions for which there are effective treatments.
Which kinds of messages would work best to help Canadians understand the serious harms that can result from stigma around substance use?
A recent report from the Canadian Centre on Substance Use and Addiction (CCSA) and Public Safety Canada cited stigma as “an enormous barrier to individuals seeking and maintaining treatment.” Even though there is broad recognition that we are in a public health crisis, until very recently the focus of the federal National Anti-Drug Strategy was heavily skewed towards a criminal justice approach rather than a public health approach with an emphasis on enforcement, as opposed to prevention, treatment and harm reduction.8 This has serious implications in how society views people who use drugs. As noted in the CCSA-Public Safety report, “Language matters. Speak about people first, with compassion and respect.”13
A stigma reduction strategy must be core to the activities of the federal government. Stigma involves thoughts, emotions and behaviours; thus, a comprehensive approach includes interventions to target each of these dimensions at both the individual and population level. The strategy should include aspects of:
* Public awareness and education to facilitate understanding about the importance of early diagnosis, treatment, recovery and prevention;
* Enhanced provider/student education and support;
* Policy analysis and modification of discriminatory legislation;
* Support for a strong voluntary sector to voice the concerns of patients and their families;
* Exposure to positive spokespeople (e.g. prominent Canadians) who have mental illness and/or addiction in order to highlight success stories;
* Researching stigma.
How can we best act to reduce stigma across the country?
Engagement with people who use drugs to help them share their stories and experiences with stigma with the public
What would you recommend to improve substance use treatment services in Canada?
This challenge requires a complex and multifaceted solution; and to further this aim, Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the other two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant. One of the fundamental principles of health care is that it be patient centred.11 CMA defines patient-centred care as “seamless access to the continuum of care in a timely manner … that takes into consideration the individual needs and preferences of the patient and his/her family and treats the patient with respect and dignity.”
It is essential that patients be core members of the health care team, working with health care providers to address their individual needs, preferences and aspirations and to seek their personal paths to well-being. Physicians and other health professionals can help patients make choices about their treatment and can provide information and support to patients and their families as they seek to cope with the effects of problematic use and live functional lives. The health care provider community needs tools to assist in the reduction of stigma, access to resources and supportive environments.
What obstacles or barriers do people face when they want to access treatment in Canada?
Obstacles to treatment include the lack of publicly-funded treatment centres, access to locations for remote areas, limited number of beds available, the cost of private treatment (lack of insurance), and stigma. The CMA supports the enhancement of access to options for treatment that address different needs.12 Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that treatment programs be culturally relevant for Indigenous communities.
In addition to current harm reduction initiatives – such as supervised consumption sites, needle exchange programs – what other harm reduction services should governments consider implementing in Canada?
There is a dire need to address harm reduction in prisons. Even back in 2005, the CMA recommended to the Correctional Service of Canada that it develop, implement and evaluate a pilot needle exchange program in prison(s) under its jurisdiction. These services are not widespread and accessible to prison populations. In Canada, people in prison face far greater risk of HIV and hepatitis C infection because they are denied access to sterile injection equipment as a harm reduction strategy.
Hospitals need to incorporate harm reduction strategies as well, allowing people who use drugs to access much needed health services.
How can we better bring public health and law enforcement together to explore ways to reduce the cycle of involvement for people who use substances with the criminal justice system?
Training for police and other frontline criminal justice and corrections workers in how to interact with people with substance use issues is essential. The CMA believes that the government must take a broad public health policy approach. Changes to the criminal law affecting cannabis must not promote normalization of its use and must be tied to a national drug strategy that promotes awareness and prevention and provides for comprehensive treatment.13
The CMA recognized that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach. The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug's physiological harm.
What further steps can the federal government take to better address current regulation and enforcement priorities, such as addressing organized drug crime and the dangerous illegal drugs like fentanyl being brought into Canada?
The federal government must continue to work closely with the RCMP, local and provincial law enforcement agencies, Canada Post, the Canadian Border Services Agency, Crown attorneys, the Canadian military, and international health officials and law enforcement agencies to address this issue. This topic was covered in the recent CCSA/Public Safety Canada report.10
Recognizing Indigenous rights and self-determination, how can all governments work together to address the high rates of problematic substance use faced by some Indigenous communities?
Difficulties in access are particularly acute for Canada's Indigenous peoples. Many live in communities with limited access to health care services, sometimes having to travel hundreds of miles to access care. Additionally, there are jurisdictional challenges; many fall through the cracks between the provincial and federal health systems.
While geography is a significant barrier for Indigenous peoples, it is not the only one. Indigenous peoples living in Canada's urban centres also face difficulties. Poverty, social exclusion and discrimination can be barriers to needed health care. Of all federal spending on indigenous programs and services only 10% is allocated to urban Aboriginals. This means that Aboriginals living in urban areas are unable to access programs such as Aboriginal head start, or alcohol and drug services, which would be available if they were living on reserve. Further, even when care is available it may not be culturally appropriate.
Canada's indigenous peoples tend to be over-represented in populations most at risk and with the greatest need for care, making the lack of access a much greater issue for their health status. It is important that problematic substance use programs be culturally relevant for Indigenous communities.
It is clear that the First Nations and Inuit peoples of Canada experience mental illness, problematic substance use and poor mental health at rates exceeding that of other Canadians.11 Individual, community and population level factors contribute to this including socioeconomic status, social environment, child development, nutrition, maternal health, culture and access to health services. The urgent need to work with these communities and identify the structures and interventions to reduce the burden of mental illness and substance use is critical to the health and wellness and future of First Nations and Inuit peoples.
Enhanced federal capacity should be created through First Nations and Inuit Health that will provide increased funding and support for First Nations and Inuit community health strategies. The establishment of a working groups comprised of First Nations and Inuit health experts and accountable to First Nations and Inuit leadership is essential for the success of this initiative. Both expert and resource supports are integral elements to facilitate and encourage culturally appropriate strategies and programming in these communities.
What can we learn from Indigenous approaches to problematic substance use, such as using holistic approaches, that may help inform activities under the CDSS?
The federal government must consult First Nations, Inuit, and Métis representatives to develop programs that are culturally relevant and appropriate for Indigenous communities.
How can governments, and the health, social, and law enforcement sectors design more effective substance use policies and programs for at-risk populations?
The government must identify and consult those communities and populations most at risk. This includes First Nations, Inuit, and Métis representatives, community advocates, municipalities, and provincial and local public health officers. Data that describes rates of use and issues specific to each at risk group is important to be able to better understand and address needs.
What are effective policies and programs to help improve access to prevention, treatment, and harm reduction services for at-risk populations?
There are innovative approaches to address the needs of high-volume users as well as at-risk populations. As many of these involve greater integration between health and the community sector and attention to issues not traditionally funded through health care payment systems, there is a need to provide access to funds to enable these innovations to continue and be spread across the country.
A targeted, integrated approach to identify communities in need is required and this must be based on reliable community data (i.e., meaningful use of patient data) which can be used to integrate resources to improve health status. For example, the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) is Canada's first multi-disease electronic medical records (EMR) surveillance and research system that allows family physicians, epidemiologists and researchers from across the country to better understand and manage chronic care conditions for their patients. Health information is collected from EMRs in the offices of participating primary care providers (e.g. family physicians) for the purposes of improving the quality of care for Canadians suffering from chronic and mental health conditions and three neurologic conditions including Alzheimer's and related dementias. CPCSSN makes it possible to securely collect and report on vital information from Canadians' health records to improve the way these chronic diseases and neurologic conditions are managed (http://cpcssn.ca/).
What urgent gaps related to substance use (in terms of data, surveillance, and/or research) need to be addressed in Canada?
Improvements are being made in the collection of data in Canada. This is crucial to be able to assess the harms and track the trends and impact of the introduction of policy changes.12 As well, the government must continue to improve the ability of the Public Health Agency of Canada, the Canadian Institute of Health Information, the chief coroners of Canada and related agencies to collect, analyze and report data.
One such program is the surveillance system in the United States called RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance system) that is “a surveillance system that collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs.” It surveys data involving opioids including poison control centres, treatment programs, on the “illicit acquisition or distribution of prescription opioids, stimulants, and other prescription drugs of interest from entities investigating drug diversion cases,” among other opioid-related issues.
The CMA has recommended that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring.
Prescription Monitoring Programs (PMP) should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary. Further, PMPs are a valuable component in addressing the gaps related to substance use.
How can we use research tools to better identify emerging substance use issues as early as possible?
See above response to question 18 - “RADARS”
Government of Canada. Consultation on strengthening Canada’s approach to substance use issues. Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-strengthening-canada-approach-substance-use-issues.html (accessed 2018 Sep 5).
Canadian Medical Association (CMA). Health in all policies. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-10.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Early childhood development. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Canadian Medical Association Submission on Motion 315 (Income Inequality). Ottawa: The Association; 2013. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2013-07.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). CMA’s recommendations for effective poverty reduction strategies. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-04.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Bill C-2 An Act to amend the Controlled Drugs and Substances Act. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-11.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed: 2018 Nov 26).
Canadian Medical Association (CMA). Non-prescription availability of low-dose codeine products. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-04.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Health Canada consultation on restriction of marketing and advertising of opioids. Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-13.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Joint Canadian Medical Association & Canadian Psychiatric Association Policy - Access to mental health care. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf (accessed 2018 Nov 26).
Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed 2018 Nov 26).
Public Safety Canada, Canadian Centre on Substance Use and Addiction. 2018 Law Enforcement Roundtable on the Opioid Crisis. Meeting Summary. Ottawa; 2018. Available: https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/lw-nfrcmnt-rndtbl-pd-crss-2018/index-en.aspx?utm_source=stakeholders&utm_medium=email&utm_campaign=opioidcrisis (accessed 2018 Nov 29).
Canadian Medical Association (CMA). Study on Mental Health, Mental Illness and Addiction in Canada: Supplementary Submission to the Senate Standing Committee on Social Affairs, Science and Technology. Ottawa: The Association; 2006. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2006-01.pdf (accessed 2018 Nov 29).
Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 2018).
Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Nov 28).
Canadian Medical Association (CMA). Ensuring equitable access to health care: Strategies for governments, health system planners, and the medical profession. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-04.pdf (accessed 2018 23 Nov).
Canadian Medical Association (CMA). Submission to Advisory Panel on Healthcare Innovation. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-06.pdf (accessed 2018 Nov 29).
Radars System. 2018. Available: https://www.radars.org/. (accessed: 2018 Nov 29).
Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Dec 4).
Sproule B. Prescription Monitoring Programs in Canada: Best Practice and Program Review. Ottawa, ON, 2015 Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Prescription-Monitoring-Programs-in-Canada-Report-2015-en.pdf (accessed 2018 Dec 4).
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).
Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of
Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Feb 01).
Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Feb 04).
Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana.
CMA Submission to the House of Commons Standing Committee on Health. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11138 (accessed 2019 Feb 14).
Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs.
CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://policybase.cma.ca/en/permalink/policy1968 (accessed 2019 Feb 14).
Monte A, Zane R, Heard K. The Implications of Marijuana Legalization in Colorado JAMA. 2015 January 20; 313(3): 241–242 Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ (accessed 2019 Feb 15).
Peters E, Bae D, Barrington-Trimis J, et al. Prevalence and Sociodemographic Correlates of Adolescent Use and Polyuse of Combustible, Vaporized, and Edible Cannabis Products JAMA Network Open. 2018;1(5): e182765. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703946 (accessed 2019 Feb 15).
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Vandrey R, Raber JC, Raber ME, et al. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. Research Letter JAMA 2015 Jun 23-30;313(24):2491-3. Available: https://jamanetwork.com/journals/jama/fullarticle/2338239 (accessed 2019 Feb 06).
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Gobbi G, Atkin T, Zytynski T, et al. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood. A Systematic Review and Meta-analysis JAMA Psychiatry. 2019 Feb 13. doi: 10.1001/jamapsychiatry.2018.4500. Available: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2723657 (accessed 2019 Feb 15).
Saunders A, Stevenson RS. Marijuana Lollipop-Induced Myocardial Infarction. Can J Cardiol. 2019 Feb;35(2):229. Available: https://www.onlinecjc.ca/article/S0828-282X(18)31324-2/fulltext (accessed: 2019 Feb 11).
Grant CN, Bélanger RE.Cannabis and Canada’s children and youth. Paediatr Child Health. 2017 May;22(2):98-102. Available: https://www.cps.ca/en/documents/position/cannabis-children-and-youth (accessed 2019 Feb 06).
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Paradis C, April N, Cyr C, et al. The Canadian alcopop tragedy should trigger evidence-informed revisions of federal alcohol regulations. Drug Alcohol Rev. 2019 Feb 4. Available: https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.12896 (accessed 2019 Feb 14).
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Standardized Appearance). Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Feb 05).
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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).
Since 1867, the Canadian Medical Association has been the national voice of Canada’s medical profession. We work with physicians, residents and medical students on issues that matter to the profession and the health of Canadians. We advocate for policy and programs that drive meaningful change for physicians and their patients
The Canadian Medical Association (CMA) appreciates this opportunity to respond to the notice as
published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health
Canada’s proposed Vaping Products Promotion Regulations “that would (1) prohibit the promotion of vaping products and vaping product-related brand elements by means of advertising that is done in a manner that can be seen or heard by young persons, including the display of vaping products at points of sale where they can be seen by young persons; and (2) require that all vaping advertising convey a health warning about the health hazards of vaping product use.”
Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have
been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public
warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest
possible measures to control its use.
The CMA has always, and will continue to support, strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on governments in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence.
It is imperative that the regulations concerning the promotion of vaping products be tightened sooner rather than later. While the CMA views Health Canada’s proposed regulations as a step in the right direction, they should only be considered as the start of extensive regulatory, policy and public health work required to effectively address the harms associated with vaping.
Vaping is not without risks. Evidence continues to grow about the hazards associated with the use of e-cigarettes, especially for youth and young adults. The emergence of e-cigarette, or vaping, product use-associated lung injury (EVALI) in the United States and to a lesser extent in Canada, illustrates the danger these products can pose. The Centers for Disease Control and Prevention (CDC) reported that as of January 7, 2020 that there were 2,602 cases of hospitalized EVALI or deaths (57 so far) reported by all 50 states, the District of Columbia, and 2 U.S. territories (Puerto Rico, and the U.S. Virgin Islands). In an update published in the CDC’s Morbidity and Mortality Weekly Report, “younger age was significantly associated with acquiring THC-containing and nicotine-containing products through informal sources.” The report concludes with this warning: “Irrespective of the ongoing investigation, e-cigarette, or
vaping, products should never be used by youths, young adults, or pregnant women.”3 In Canada, as of January 7, 2020, 15 cases of severe pulmonary illness associated with vaping have been reported to the Public Health Agency of Canada.
A recent public opinion survey conducted by the Angus Reid Institute (ARI) indicates that Canadians are growing more concerned about the safety of vaping as more information on the potential harms becomes available. The survey found that the number of people saying that vaping does more harm than good rose from 35% in 2018 to 62% in 2019.5 Further, 17% of parents with children under 19 said their child either vaped or had tried it; 92% of those parents considered vaping harmful.5 Significant to this discussion is the fact that 90% of respondents support “banning advertisements of vaping products in areas frequented by young people. This includes areas such as bus shelters or parks, and digital spaces like social media.”5 As public unease continues to rise, the need for further tightening of regulations becomes vital.
Unfortunately, the federal government is still behind the curve when it comes to the proliferation of vaping and the vaping industry. Health Canada will have to step up surveillance and enforcement if tightening of the regulations is to be effective.
This brief will address the planned regulations as well as discuss important issues not covered such as nicotine levels and flavours. We have expressed concerns about these topics in previous consultations and will be reiterating them here.
Promotion of Vaping Products
The CMA appreciates Health Canada’s intent to tighten the regulations but this proposal is not sufficient, and we must reiterate our long-held position that the restrictions on the promotion of all vaping products and devices be the same as those for tobacco products. , The proposed regulations provides the vaping industry with too much latitude in their promotion activities to ensure youth are protected. As we noted in our response to Health Canada’s consultation on The Impact of Vaping Products Advertising on Youth and Nonusers of Tobacco Products, the advertisements that have been permitted to this point seem to have managed to find their way to youth, even if they are not directed at them, as has been asserted.7, We recommended vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions. The CMA stands by that recommendation.7
The methods used by the vaping industry in the past succeeded in attracting more and more youth and young adults and it will no doubt continue efforts to find novel approaches for promoting their products, including the use of popular social media channels. , , , Indeed, “JUUL’s™ advertising imagery in its first 6 months on the market was patently youth oriented. For the next 2 ½ years it was more muted, but the company’s advertising was widely distributed on social media channels frequented by youth, was amplified by hashtag extensions, and catalyzed by compensated influencers and affiliates.”10
The vaping industry’s efforts to circumvent marketing restrictions in other jurisdictions are evident in view of some recent developments. A US study outlines an e-cigarette marketing technique that involves the promotion of scholarships for students. The study found 21 entities (manufacturers, e-cigarette review websites, distributors) offering 40 scholarships, ranging in value from $300 to $5000 (US).13 Most of the scholarships required “an essay submission, with most listing prompts related to e-cigarettes or eliciting information about the benefits of vaping.”13 The authors suggest “that prohibitions on e-cigarette scholarships to youth are also needed, as many of these scholarships require youth under the age of 18 years (for whom use of e-cigarettes are illegal) to write positive essays about vaping.”13
The CMA reiterates, yet again, its position that all health warnings for vaping products and devices should be similar to those presently required for tobacco packages in Canada.6, The need for such cautions is important in that we still do not understand fully the effects vaping can have on the human body.
More research is needed into the potential harms of using electronic cigarettes to understand the long-term effects users may face. , , The proposed health warnings are not strong enough in light of the research and knowledge that has emerged to date about the harms caused by e-cigarettes. For example, a recent US study highlighted the potential link between e-cigarette use and depression. It found “a significant cross-sectional association between e-cigarette use and depression, which highlights the need for prospective studies analyzing the longitudinal risk of depression with e-cigarette use.”18 As the authors note, “the potential mental health consequences may have regulatory implications for novel tobacco products.”18
Further, with respect to respiratory issues, a US study found that “use of e-cigarettes appears to be an independent risk factor for respiratory disease in addition to all combustible tobacco smoking.” The authors also don’t recommend the use of e-cigarettes as a smoking cessation tool because “for most smokers, using an e-cigarette is associated with lower odds of successfully quitting smoking.”19
Nicotine levels and flavours are not addressed in this consultation. However, the CMA considers these issues to be vital in the effort to protect youth and young adults from the harms associated with e-cigarettes and will therefore provide comment in effort to speed movement toward resolving these problems.
The CMA remains very concerned about the rising levels of nicotine available through the vaping process. They supply “high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences.”
Hammond et al noted in their 2019 study that “JUUL® uses benzoic acid and nicotine salt technology to
deliver higher concentrations of nicotine than conventional e-cigarettes; indeed, the nicotine concentration in the standard version of JUUL® is more than 50 mg/mL, compared with typical levels of 3-24 mg/mL for other e-cigarettes.”9 The salts and flavours available to be used with these devices reduce the harshness and bitterness of the taste of the e-liquids with some of the competition delivering even higher levels of nicotine.
The CMA called on Health Canada to restrict the level of nicotine in vaping products to avoid youth (and adults) from developing a dependence.20 Health Canada set the maximum level at 66 mg/ml while a European Union (EU) directive of 2014 indicates the level should not exceed 20 mg/ml. , Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment. , Utilizing the EU level as an interim measure until more scientific research is available to determine an optimal level is acceptable.
On December 5, 2019, the Government of Nova Scotia became the first province or territory to announce it would institute a ban on sale of flavoured e-cigarettes and juices, as of April 1, 2020. The CMA recommends that flavours banned to reduce the attractiveness of vaping to youth as much as possible; others share this sentiment.6,7, Flavours are strong factors in attracting youth, especially when coupled with assertions of lower harm. Their success in doing so is evidenced by the rise in the rates of vaping among youth.9, A recent US study found that “perceiving flavored e-cigarettes as easier to use than unflavored e-cigarettes may lead to e-cigarette use progression among youth never tobacco users. Determining the factors (including e-cigarette marketing and specific e-cigarette flavors) that lead to perceived ease of using flavored e-cigarettes would inform efforts to prevent and curb youth e-cigarette use.” The CMA recommends that flavours be banned to reduce the attractiveness of vaping to youth as much as possible.
1. The CMA recommends that vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions.
2. The CMA reiterates its position that all health warnings for vaping products and devices should be similar to those for tobacco packages.
3. The CMA believes that the European Union 2014 directive indicating the nicotine concentration not exceed 20 mg/ml should be adopted as an interim measure until more scientific research is available to determine an optimum level.
4. CMA recommends flavours be banned to reduce the attractiveness of vaping to youth as much as possible.
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).
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