With the advent of technology allowing for the extension of life, and as a result of the increasing importance of personal autonomy, decisional capacity, and informed consent and the growing awareness of issues related to quality of life and dying, Canadians have become increasingly interested in expressing their wishes regarding their health care and having more input into decisions about their care should they become incapable. Advance care planning (ACP) can help patients to achieve these goals.
The CMA supports development of a strategy for ACP1 in all provinces and territories. ACP leads to better concordance between patients' wishes and treatments provided,2,3 decreased anxiety for families,4 decreased moral distress for health care providers,5 decreased hospitalization rates of nursing home residents3 and fewer unnecessary medical treatments.3,6,7
ACP is at the intersection of the provision of health care, ethical values and legal rights and duties. In particular, it involves the acknowledgement of essential aspects of autonomy, informed consent, and respect of patients' care wishes now and in the future, and their intentions if they become incapable.8,9
The balancing of the need to obtain informed consent for a treatment option in the present with the need to respect health care preferences that were stated in the past has been addressed using various clinical, legal and institutional approaches across Canadian jurisdictions."
Physicians10 can play a significant role in ACP throughout the course of the patient-physician relationship, including in the pediatric setting. At any time, outcomes of the planning process can be documented and/or the patient can appoint a substitute decision-maker in writing. These documents can be identified as advance directives, personal directives or powers of attorney for personal care11 (hereinafter all will be referred to as advance directives). An advance directive does not remove the need for a physician to obtain consent before providing a treatment to a patient, except in an emergency. As stated in the Canadian Medical Protective Association's consent guide: "[U]nder medical emergency situations, treatments should be limited to those necessary to prevent prolonged suffering or to deal with imminent threats to life, limb or health. Even when unable to communicate in medical emergency situations, the known wishes of the patient must be respected."12
While much of the focus of ACP is on making care decisions and nominating proxy decision-makers in case the patient becomes incapable of making decisions in the future, ACP has much more utility. ACP conversations13 can assist patients in determining treatment trajectories and making decisions about the intensity level of interventions in their current care. Providers can have discussions with patients and their families about proposed treatments in the context of the patient's communicated goals and wishes. The process of ACP also helps patients and their families to become familiar with the language and processes used to make cooperative health care decisions.
SCOPE OF POLICY
This policy aims to provide guidance on key considerations pertinent to ACP in a way that is consistent with a physician's ethical, professional and legal obligations. This is a complex subject: physicians should be aware of the legislation in the jurisdiction in which they practise, the standards and expectations specified by their respective regulatory authority, as well as the policies and procedures of the setting(s) in which they practise (e.g., regional health authority, hospital).
1. ACP is a process of (a) respecting patients' wishes through reflection and communication, (b) planning for when the patient cannot make health care decisions and (c) discussion with friends, family and professionals; (d) it may result in a written document.5 It informs the substitute decision-maker and provides information for the clinician to consider in the provision of care within the bounds of the law.
2. Although often associated with the end of life, ACP represents the expression of a patient's wishes for any future health care when the patient is incapable. It expresses the patient's values and beliefs regarding current care decisions and provides information that can inform any decisions that must be made during an emergency when the patient's consent cannot be obtained. For these reasons, ACP should occur throughout a person's lifetime.
3. Respect for patients' dignity and autonomy is a cornerstone of the therapeutic physician-patient relationship. Patients' right to autonomous decision-making has become embedded in ethical frameworks, consent legislation and case law.14 Respect for the wishes of an incapable patient constitutes a preservation of autonomy and promotes trust between the physician and patient.15
4. The way in which the act of obtaining consent is weighed against the patient's stated wishes as outlined during the ACP process varies according to the jurisdiction in which the patient and physician are located.
1. Given the practical, ethical and legal complexities of ACP, physicians, medical learners should be supported in becoming familiar with ACP and comfortable in engaging in the process with their patients. To this end, CMA supports the development of training in ACP and efforts to make it available to all physicians and medical learners.16 For practising physicians and residents, many resources are available, for example:
a. Advance Care Planning in Canada: A National Framework
b. Facilitating Advance Care Planning: An Interprofessional Educational Program
c. Information from the Health Law Institute of Dalhousie University on the regulatory policies and legislation of individual provinces and territories
d. A comprehensive collection of Canadian resources compiled by the Speak Up campaign of the Advance Care Planning in Canada initiative
e. Pallium Canada's Learning Essential Approaches to Palliative Care module on ACP
In the case of medical students, the CMA supports the position of the Canadian Federation of Medical Students that end-of-life training is an essential facet of undergraduate medical education.
2. The issue of the supervision of medical learners practising ACP should be clarified, as considerable ambiguity currently exists.17 Medical learners would benefit from unified national guidelines concerning the nature of their participation in ACP, especially regarding end-of-life care. In the case of medical students, the CMA agrees with the recommendation of the Canadian Federation of Medical Students that supervision be mandatory during conversations about end-of-life care.
3. The CMA calls for more research on the outcomes associated with the provision of ACP training to physicians and medical learners.
4. The CMA recommends that governments and institutions promote information and education on ACP to patients and their substitute decision-makers.
PROFESSIONAL AND LEGAL RESPONSIBILITY
1. While respecting patients' values, all physicians are expected to encourage their patients to engage in ACP with them. ACP is not a one-time event. The nature of the conversation between the physician and the patient and the regularity with which they discuss the subject will depend on the patient's health status. Family physicians and physicians have ongoing care relationships with chronically ill patients are particularly well placed to have regular discussions with their patients about their beliefs, values and wishes. An effective exchange of information between family physicians (and other physicians who work in the community with outpatients) and acute or tertiary care physicians would assist in ensuring patient's wishes are considered.
2. ACP, in particular advance directives, are at the intersection of medicine and the law. Physicians should recognize this and ask patients whether they have an advance directive or have done any ACP.
3. There is wide variation across jurisdictions in terms of the requirements and procedures for ACP; therefore, physicians should inform themselves about any relevant legislation and the scope of the requirement to obtain consent within that jurisdiction when carrying out ACP.
1. The CMA supports institutional processes that recognize and support ACP. Support for ACP includes developing a consistent process for the exchange of information about patients' wishes and advance directives among health care providers, as patients traverse sectors and locations of care. Patients with a written advance directive must be identified and the advance directive integrated fully within the patient's records18 so that it is available across the institution (and ideally the health care system). The CMA advocates for the inclusion of advance care directive functionality as a conformance and usability requirement for electronic medical record vendors.19 Provinces and territories should be encouraged to establish robust organizational processes and resources for patients in all locations of care and strong province- or territory-wide policy, such as in Alberta.20
2. Institutions and other organizations should encourage health care providers to ask patients to bring their advance directive to appointments at the same time they ask them to bring a list of their medications or other medical information.
3. The CMA supports institutional/organizational audits of structures, processes and outcomes related to ACP as an important step in improving the quality and frequency of ACP activities.
ROLE FOR GOVERNMENTS
1. The CMA supports infrastructures enabling ACP, including funding that will support ACP and other end-of-life discussions.
2. The CMA promotes the incorporation of ACP into future federal and provincial/territorial senior strategies and dementia and/or frailty strategies.
3. The CMA supports the development of ACP metrics and their future inclusion in Accreditation Canada standards.
Advance care planning (ACP)
Advance care planning is a term used to describe a process of reflection, communication, conversation and planning by a capable individual with family, friends and professionals about their beliefs, values and wishes for a time when they no longer have the mental capacity to make decisions about their health care. ACP can also involve the naming of a substitute decision-maker.8
The legislated term "advance directive" has different names, definitions and legal authority across the country. For example, in British Columbia an advance directive is a written legal document that provides a mechanism for capable patients to give directions about their future health care once they are no longer capable. 21 As such, in BC an advance directive may, under certain circumstances, be considered "equivalent to consent to treatment and may be acted upon directly by a health care provider without consultation with an SDM [substitute decision-maker]." 8 In Alberta it is called a personal directive. In Ontario, "advance directive" is a generic non-legal term and refers to communications that may be oral, written or in other forms.8
In Quebec, advance care directives are legally binding, as set out in the Act respecting end-of-life care, which recognizes "the primacy of freely and clearly expressed wishes with respect to care. . ."22
Current legislation does not allow for medical assistance in dying to be requested by an advance directive.23 The CMA acknowledges that considerable public, expert and legal debate exists around the issue.
To obtain informed consent, physicians must provide adequate information to the patient or capable decision-maker about the proposed procedure or treatment; the anticipated outcome; the potential risks, benefits and complications; and reasonable available alternatives, including not having the treatment; and they must answer questions posed by the patient. Consent is only informed if there is disclosure of matters that a reasonable person in the same circumstances would want to know.24 Consent must be given voluntarily, must not be obtained through misrepresentation or fraud, must relate to the treatment and must be informed.
Substitute decision-maker (SDM or agent or proxy)
A substitute decision-maker is a capable person who will make health care decisions on behalf of an incapable individual. In all jurisdictions the health care provider must take reasonable steps to become aware of whether or not there is a substitute decision-maker before providing health treatment to an incapable patient. Legally there are implementation differences across the country. For example, in BC a substitute decision-maker is appointed through a representation agreement, in Alberta through a personal directive and in Ontario through a power of attorney for personal care.
Approved by the CMA Board of Directors May 2017
1 Canadian Medical Association. Policy resolution GC14-25 - strategy for advance care planning, palliative and end-of-life care. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 Oct 17)
2 Houben CHM, Spruit MA, Groenen MTJ, et al. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc 2014;15:477-89.
3 Martin RS, Hayes B, Gregorevic K, et al. The effects of advance care planning interventions on nursing home residents: a systematic review. J Am Med Dir Assoc 2016;7:284-93.
4 Mack JW, Weeks JC, Wright AA, et al. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol 2010;28(7):1203-8.
5 Canadian Hospice Palliative Care Association. Advance care planning in Canada: national framework. Ottawa; The Association; 2010.
6 Teo WSK, Raj AG, Tan WS, et al. Economic impact analysis of an end-of-life programme for nursing home residents. Palliat Med 2014;28(5):430-7.
7 Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end-of-life conversations. Arch Intern Med 2009;169(5):480-8.
8 Wahl J, Dykeman MJ, Gray B. Health care consent and advance care planning in Ontario. Toronto (ON): Law Commission of Ontario; 2014.
9 Canadian Medical Association. CMA Code of Ethics (update 2004). Ottawa: The Association; 2004.
10 Physician involvement is not mandatory in the process. However, it is important for physicians to engage with their patients in ACP as this can facilitate change in patients' ACP behaviour and understanding.
11 Wahl JA, Dykeman MJ, Walton T. Health care consent, advance care planning, and goals of care practice tools: the challenge to get it right. Improving the last stages of life. Toronto (ON): Law Commission of Ontario; 2016.
13 Frank C, Puxty J. Facilitating effective end-of-life communication - helping people decide. CJS Journal of CME 2016;6(2). Available: http://canadiangeriatrics.ca/wp-content/uploads/2017/02/Facilitating-Effective-End-of-Life-Communication---Helping-People-Decide.pdf (accessed 2017 April 25).
14 Fleming v Reid (1991) 82 DLR (4th) 298 (CA ON); Cuthbertson v Rasouli, 2013 SCC 53; Malette v Shulman (1990), 72 OR (2d) 417; Starson v Swayze (2003) 1 SCR 722.
15 Harmon SHE. Consent and conflict in medico-legal decision-making at the end of life: a critical issue in the Canadian context. University of New Brunswick Law Journal 2010;60(1):208-29.
16 Canadian Medical Association. Policy resolution GC13-69 - training in advance care planning. Ottawa (ON): The Association; 2013. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
17 Touchie C, De Champlain A, Pugh D, et al. Supervising incoming first-year residents: faculty expectations versus residents' experiences. Med Educ 2014;48(9):921-9.
18 Canadian Medical Association. Policy resolution GC14-19 - advance care plans. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
19 Canadian Medical Association. BD14-05-163 Advance care directive functionality. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
20 Conversations matter. Edmonton (AB): Alberta Health Services. Available: http://goals.conversationsmatter.ca.s3-website-us-east-1.amazonaws.com/ (accessed 2017 May 19).
21 Health Care (Consent) and Care Facility (Admission) Act, RSBC 1996, c 181, s.3
22 Act respecting end-of-life care, S-32.0001. Government of Quebec. Available : http://legisquebec.gouv.qc.ca/en/ShowDoc/cs/S-32.0001
23 An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) S.C. 2016, c.3. Ottawa: Government of Canada; 2016. Available: http://canlii.ca/t/52rs0 (accessed 2016 Oct 17)
24 Riebl v Hughes,  2 SCR 880; Hopp v Lepp,  2 SCR 192.
What is it?
The CMA Charter of Shared Values aims to identify shared values and commitments to each other and to the profession to which physicians and learners can commit to promote trust and respect within the profession and for each other, and identify opportunities for engagement and leadership to promote civility and confront incivility within the profession.
Why does it matter?
The Charter is intended to further strengthen professional responsibilities in support of a unified and aligned profession. We achieve the highest degree of both individual and collective success when we work together, commit together and believe together; when we share a clearly articulated set of common values, virtues and principles; and when we subscribe to the same explicit and implicit understandings.
Commitments to Each Other:
Our most important shared values
As a physician, I will strive to be respectful; I will recognize that everyone has inherent worth, is worthy of dignity, and has the right to be valued and respected, and to be treated ethically; I will respect others and their personal and professional dignity; and I will aim to promote and model respect through collaborative training and practice.
As a physician, I will strive to act with integrity; I will act in an honest and truthful manner, with consistency of intentions and actions; and I will act with moral concern to promote and model effective leadership and to achieve a good outcome for patients.
As a physician, I will strive to cultivate reciprocal relationships; I will be kind with my physician colleagues, and expect them to respond similarly; I will share and exchange my knowledge and experience with them; and I will be generous with them in spirit and in time.
As a physician, I will strive to be civil; I will respect myself and others, regardless of their role, even those with whom I may not agree; I will enter into communication with my physician colleagues with an attitude of active and open listening, whether it be in person, in writing, or virtually; and I will accept personal accountability.
Commitments to the Profession
1. Commitment to promoting a culture of respect and collegiality
As a physician, I will strive to build a culture based on mutual respect and collegiality where physicians treat each other as people in a shared endeavor, and promote civility. I will strive to:
Cultivate respectful, open, and transparent dialogue and relationships
Take responsibility for promoting civility and confronting incivility within the profession
Recognize the relative value among family medicine and specialties and across the educational spectrum, and of the profession’s shared contributions within health systems
Model healthy and supportive training and practice environments
2. Commitment to promoting a culture of self-care and support
As a physician, I will strive to build a culture of self-care and support where physicians are empowered to ask for help and are supported to care for their own physical, mental, and social well-being. I will strive to:
Value physician health and wellness and promote a professional culture that recognizes, supports, and responds effectively to your needs and colleagues in-need
Cultivate an environment of physical and psychological safety, conducive to challenging the status quo, as well as encouraging help-seeking behaviours, without fear of negative reprisal
Recognize that both individual and system-level barriers contribute to health and wellness-related issues and advocate for cultural and systemic change to remove barriers
3. Commitment to promoting a culture of leadership and mentorship
As a physician, I will strive to foster a culture of leadership and mentorship across the career life cycle. I will strive to:
Encourage and enable opportunities and participation in leadership roles across all levels of training, practice, and health system delivery
Promote and enable formal and informal mentorship opportunities and leadership training across all levels of training and practice
Value the exchange of knowledge and experience and encourage reflective relationships (bi-directional) across all levels of training and practice
4. Commitment to promoting a culture of inquiry and reflection
As a physician, I will strive to foster a culture of inquiry and reflection that values and enables reflective practice, individually and collectively. I will strive to:
Value and enable collective inquiry and self-reflection to effect meaningful change
Foster curiosity and exploration to identify strengths and capabilities of teams and health systems to generate new possibilities for action
Cultivate strong connections and relationships between, and meaningful interactions with, colleagues
5. Commitment to promoting a culture of quality
As a physician, I will strive to foster a culture of quality and quality improvement. I will strive to:
Foster intra- and inter-professional collaborations and promote collaborative models of care
Provide high quality patient care and have a view to continuous improvement at the practice and system level, and commit to developing and applying the skills and techniques of quality improvement
Understand that quality improvement is a critical and life-long part of education and practice; participate in maintaining professional standards in myself and my colleagues
Engage patients, families, and caregivers in the process of improvement
6. Commitment to valuing a culture of diversity
As a physician, I will strive to foster a community of practitioners that reflects the diversity of the communities they serve. I will strive to:
Promote diversity within the profession to be receptive and responsive to the evolving (physical, emotional, cultural, socioeconomic) needs of our patient populations
Foster a training and practice environment where diverse and unique perspectives, across generations, cultures and abilities, are heard and appreciated
Foster diversity in leadership across the full spectrum of leadership roles within the profession and health systems
Value the importance of these perspectives within the medical profession, even when they may not be my own patients, families, and caregivers in the process of improvement
Industrialization and manufacturing have had enormous positive benefits for humankind, but the consequences of hazardous by-products (chemical contamination) to human health and the environment are less well recognized. A major incident such as Bhopal is an unequivocal example of catastrophic poisoning caused by industry. However, more subtle human health impacts can result from low levels of exposure to chemical and industrial by-products from agriculture, consumer products, manufacturing, and even medical sources. Chemicals from industrial sources have been found in the soil, water, air, food and human tissue. Due to improving technology, even minuscule amounts of potentially noxious substances can be detected.
Some exposures warrant remedial action, but in others the health impact may be negligible: the toxin, dose, route and duration of exposure must be considered. Of course, there are potentially toxic substances that have been found to pose little or no harm to human health, but there are many more for which the health effects are unknown. A substantial knowledge gap exists in that the effects of many chemical agents have not been fully studied. As a result, rigorous surveillance and assessment to ensure potential health impacts are reduced or avoided is necessary. Chemicals like dichlorodiphenyltrichloroethane (DDT) can persist in the environment or in living beings long after the product was pulled from the market, making it essential that full and rigorous testing of new and existing chemicals is undertaken. Finally, research is needed to determine whether emerging issues, such as the presence of pharmaceuticals in drinking water, pose a legitimate threat to human health.
Chemicals, properly managed, can and will continue to provide enormous benefits to society, but caution is warranted because of the potential health consequences. Provided below is a discussion of certain classes of chemicals that need to be regulated, monitored and properly researched.
Agriculture represents the largest component of the global economy. Rising pressures to meet the needs of a growing population have resulted in the mechanization of farming, and the widespread use of fertilizers and pesticides.1 Fertilizer and pesticide run-off has been found in soil, water and the human food supply.2 Approximately 40 chemicals classified by the International Agency for Research on Cancer (IARC) as known, probable, or possible human carcinogens, are EPA registered pesticides available on the open market.3 Long-term low dose pesticide exposure has been linked to various cancers, immune suppression, hormonal disruption, reproductive abnormalities, birth defects, and developmental and behavioural problems.4 Certain pesticides are also known to be persistent in the human body.5 While many individual pesticides can be safely used, there is a lack of research on the effect of certain pesticides when used in combination.
Modern technologies have led to advances with a positive impact on the quality of human life. While newer consumer products have benefits over earlier materials, their use is not without side effects. Both the chemicals used to make these products and those that form key components of the products themselves may be harmful. Bisphenol A (BPA) is an industrial chemical added to many hard plastic bottles and to metal based food and beverage cans since the 1960s.6 In August 2010, Statistics Canada reported that measurable levels of BPA were found in the urine of 91 per cent of Canadians aged six to 79.7 Concerns have been raised about effects on the brain, behaviour, and prostate gland from exposure to this chemical, particularly in fetuses, infants, and children.8 In 2008, Canada banned BPA in infant bottles.9 In October 2010, Canada went a step further by becoming the first jurisdiction in the world to declare BPA toxic.10
With the growing demand for consumer products, there has been a corresponding growth in manufacturing. Manufacturing is one of the biggest contributors to outdoor air pollution, and contributes to soil and water pollution.11 In 2004, US industry released 1.8 billion pounds of potentially toxic chemicals. Exposure to some of these chemicals has been linked to severe health effects, including cancer. 12 One of the released chemicals, dioxin, can be harmful at very low levels. Dioxins accumulate in fats and break down slowly. This leads to contamination of the food supply, and human exposure through the consumption of meat, dairy, fish and shellfish.13 Even in the far north, animals have been found to contain dioxins.14 The EPA estimates that the cancer risk from dioxins already present in the general public is 1-per-1,000.15 In most cases the emissions pose minimal risk to human health. However, chemicals, and chemical combinations which remain unstudied should be properly assessed.16
Advancements in medical science and the use of pharmaceuticals, diagnostic equipment and other medical treatments have prolonged life expectancy. However, these interventions can also contribute to environmental contamination. In 2008, the Associated Press reported pharmaceuticals in the water of 24 major metropolitan areas in the United States, serving 41 million people.17 There is a concern that these pharmaceuticals could negatively impact male fertility, lead to birth defects, cause breast and testicular cancer in humans, and lead to antibiotic resistance.18 For many pharmaceuticals found in water sources, no concerted environmental impact surveys have been carried out.19
Mercury is used in fever thermometers, sphygmomanometers, gastrointestinal tubes, and oesophageal dilators20. Reports indicate that medical waste incinerators are among the largest sources of anthropogenic mercury emissions in both the United States and Canada.21 Medical waste, while not the principle source of mercury poisoning, contributes to the mercury levels present in the environment. In fetuses, infants and children, low-dose exposure to mercury can cause severe and lifelong behavioural and cognitive problems.22 At higher exposure levels, mercury may adversely affect the kidneys, the immune, neurological, respiratory, cardiovascular, gastrointestinal, and haematological systems of adults.23 It has also been linked to cancer.24
These examples highlight the major categories of human exposure to chemicals. As the review suggests, some of these chemicals have been linked to harmful human health impacts. What is important to keep in mind, however, is that the harm is conditional on the level and lengths of exposure. For most people, these chemicals pose no harm because the exposure is so low. In some cases, such as BPA, it has been determined that the potential harm is not worth the risk: the Canadian government has decided to declare BPA toxic and regulate it accordingly. In other cases, such as pharmaceuticals, the evidence simply warrants further study and surveillance. Given the potential harm to human health, surveillance and research are vitally important in all categories. The more information that is available to policy makers and health care professionals, the better the chance of limiting human health impacts.
What has been done?
Concerns regarding chemical contamination and human health have led to numerous interventions from the international community. These include the International Programme on Chemical Safety (1980), the Inter-Organization Programme for the Sound Management of Chemicals (1995), the Globally Harmonized System of Classification and Labelling (2002), and the Strategic Approach to International Chemicals Management, which was adopted by governments and stakeholders at the first International Conference on Chemicals held in Dubai in 2006. 25
Various conventions have also been passed, including the Stockholm Convention (2004) on persistent organic pollutants such as DDT, and the Rotterdam Convention (2004) which applies to pesticides and industrial chemicals.26 There is some concern about the continued effectiveness of the Rotterdam convention. In 2006, the Canadian government was instrumental in preventing the listing of asbestos as a toxic chemical. Given the persuasive evidence of the harm caused by asbestos, this action undermines the legitimacy of voluntary international conventions.27
In addition to being a signatory to all international agreements listed above, the Canadian government has programs for chemical management domestically. The main tool is the Canadian Environmental Protection Act (CEPA) 1999. Jointly administered by Environment Canada and Health Canada, it is intended to prevent pollution and address the potentially dangerous chemical substances to which Canadians are exposed.28 The plan calls for increased surveillance of certain chemicals to monitor exposure and health effects, and will increase focus on the management of the health and environmental risks of pharmaceuticals, personal care products, and chemical contamination in food.29
There were 23,000 chemical substances on the Domestic Substances List (DSL) in Canada in 1999. To date, only about 1,000 of these chemicals have been fully assessed. Of the remaining 22,000, 85% have been categorized as not requiring any additional action.30The most recent Canadian Chemicals Management Plan states that full assessments will be done on 550 substances identified as potentially harmful. Even with these additional assessments, more than 3,000 chemicals will not have been assessed.
Canadian Medical Association
In 2009, the Canadian Medical Association and the Canadian Nurses Association released a joint position statement on environmentally responsible activity for the health-care sector. Recommendations included the proper handling and disposal of toxic chemicals and the reduction of products using these substances. An adapted version of this position statement was then endorsed by a coalition of 12 national healthcare organizations and the David Suzuki Foundation.
In October 2010, the World Medical Association, of which CMA is a member, adopted a policy statement on environmental degradation and the management of chemicals. The statement calls for mercury-free health care, support for international efforts to restrict chemical pollution and to monitor harmful chemicals in humans and the environment, and mitigation of the health effects of toxic exposure to chemicals.
What needs to be done?
Research and Surveillance
Research on chemicals produced through man-made activities remains insufficient. While some of the more toxic chemicals have been reviewed and are now more closely regulated, thousands remain that have had neither health nor environmental assessments. The Domestic Substances List in Canada has 3,300 chemicals of concern that have not been assessed. There is limited research on the effect of these chemicals in combination or in different mediums. Finally, work must be done to ensure environmental and human surveillance of potential chemical exposure threats.
1. Urges the government to complete the health and environmental assessment of the chemicals on the Domestic Substances List.
2. Encourages research on the health impacts of chemical substances, as well as the combinations of these substances in different products (e.g. pesticides), and in different mediums (e.g. pharmaceuticals in drinking water). Long-term research programs are required to determine health impacts from prolonged low-dose exposures.
3. Encourages ongoing surveillance of chemicals in the environment.
4. Encourages ongoing research on the impact of regulations and monitoring of chemicals on human health and the environment.
Regulations have been developed both internationally and domestically to undertake chemical management. However, gaps remain, largely due to the voluntary nature of the frameworks. Canada can play a lead role by respecting its commitments, seeking continued adherence to these agreements and providing leadership in developing effective domestic programs and legislation.
5. Urges the government to continue to support international efforts to manage chemical pollution. In particular CMA urges the government to fully support the principles of the Rotterdam Convention and support the listing of Asbestos as an Annex III toxic chemical.
6. Supports government legislation and regulation which reduces dangerous chemical pollution, detects and monitors harmful chemicals in both humans and the environment, mitigates the health effects of toxic exposures, and requires an environmental and health impact assessment prior to the introduction of a new chemical. Regulatory frameworks should be favoured over voluntary frameworks in order to ensure a level playing field for all manufacturers and to secure rapid and equitable health protection for all Canadians. CMA encourages the government to advocate for similar legislation internationally.
Physicians can participate in the monitoring of patients for potential health effects from chemical exposure. Additionally, physicians can be leaders in encouraging greener health care practices. Finally, physicians can support national medical organizations in developing clinical tools to assess patient risk to chemical exposure.
7. Supports the phase out of mercury and other persistent, bio-accumulating and toxic chemicals in health care devices and products.
8. Supports the development of effective and safe systems to collect and dispose of pharmaceuticals that are not consumed.
9. Supports the development of clinical tools for physicians to help assess their patients' risk from chemical exposures.
Education and Professional Development
Physicians have a role to play in educating their patients, the public, and current and future colleagues about the potential human health consequences of chemical contamination. Medical education and continuing professional development in this area could have a significant impact on human health.
10. Should assist in building professional and public awareness of the impact of the environment and global chemical pollutants on personal health.
11. Supports the development of locally appropriate continuing medical education on the clinical signs, diagnosis and treatment of diseases that are introduced into communities as a result of chemical pollution.
12. Encourages physicians to inform patients about the importance of safe disposal of pharmaceuticals that are not consumed.
National and International initiatives have substantially reduced the incidence of harmful chemical contamination, but more work is needed. Evidence of health effects (or lack thereof) may be strong for certain chemicals, but for others it remains incomplete. Given the dangers of chemicals such as dioxin, which can cause severe effects with small doses, more comprehensive research is warranted. To ensure human health consequences are identified and risks are minimized, improved surveillance is essential.
Further policies and regulations are needed to ensure that chemicals utilized are as safe as possible. The Canadian BPA ban demonstrates the use of the precautionary principle in the presence of convincing if not complete evidence. While there are clear benefits associated with the use of chemicals, it is necessary to ensure that potential harmful effects are considered.'
Finally, public and health care provider information is sorely lacking. Physicians can play a role in correcting some of these deficiencies through their actions to support research and surveillance, advocacy, leadership, education, and professional development.
1 Ongley, Edwin D. (1996) Control of water pollution from agriculture- FAO irrigation and drainage paper 55.Chapter 1: Introduction to agricultural water pollution Food and Agriculture Organization of the United Nations. Available at: http://www.fao.org/docrep/w2598e/w2598e00.HTM
2 Peters, Ruud J.B. (2006) Man-Made Chemicals in Food Products. TNO Built Environment and Geosciences. Available at: http://assets.panda.org/downloads/tno_report.pdf
3 Reuben, Suzanne H. (2010) Reducing Environmental Cancer Risk: What We Can Do Now: 2008-2009 Annual Report. President's Cancer Panel. Available at: http://deainfo.nci.nih.gov/advisory/pcp/annualReports/pcp08-09rpt/PCP_Report_08-09_508.pdf
4 Reuben, Suzanne H. (2010) Reducing Environmental Cancer Risk...; Shah, Binod P. & Bhupendra Devkota (2009) "Obsolete Pesticides: Their Environmental and Human Health Hazards." The Journal of Agriculture and Environment. Vol:10 June 2009. Available at: http://www.nepjol.info/index.php/AEJ/article/view/2130/1961 ; Kjellstrom, Tord et.al. (2006) Chapter 43: Air and Water Pollution: Burden and Strategies for Control in Disease Control Priorities in Developing Countries. Disease Control Priorities Project. Available at: http://files.dcp2.org/pdf/DCP/DCP43.pdf
5 California Environmental Protection Agency (2002) Environmental Protection Indicators for California: Chapter 3: Environmental Exposure Impacts Upon Human Health. Available at: http://oehha.ca.gov/multimedia/epic/2002reptpdf/Chapter3-7of8-HumanHealth.pdf
6 United States Food and Drug Administration (2010) Update on Bisphenol A for Use in Food Contact Applications. Available at: http://www.fda.gov/newsevents/publichealthfocus/ucm064437.htm
7 CBC News (October 13, 2010) BPA declared toxic by Canada. Available at: http://www.cbc.ca/health/story/2010/10/13/bpa-toxic.html
8 States Food and Drug Administration (2010) Update on Bisphenol A...
9 Health Canada (2008) Government of Canada Protects Families with Bisphenol A Regulations Available at: http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2008/2008_167-eng.php
10 CBC News (October 13, 2010) BPA declared toxic by Canada...
11 Kjellstrom, Tord et.al. (2006) Chapter 43: Air and Water Pollution...
12 Cassady, Alison & Alex Fidis (2007) Toxic Pollution and Health: An Analysis of Toxic Chemicals Released in Communities across the United States. U.S. PIRG Education Fund. Available at: http://cdn.publicinterestnetwork.org/assets/KTfes5EXnCLOgG9eWTKU6g/ToxicPollutionandHealth2007.pdf
13 World Health Organization (2010) Dioxins and their effects on human health. Available at: http://www.who.int/mediacentre/factsheets/fs225/en/index.html
14 Woolford, Julian & Noemi Cano Ed. (2006) Killing them softly...
15 Cassady, Alison & Alex Fidis (2007) Toxic Pollution and Health...
17 Natural Resources Defense Council (2010) Dosed Without Prescription: Preventing Pharmaceutical Contamination of Our Nation's Drinking Water. Available at: http://www.nrdc.org/health/files/dosed4pgr.pdf
18 Wright-Walters, Maxine & Conrad Volz (2009) Municipal Wastewater Concentrations of Pharmaceutical and Xeno-Estrogens: Wildlife and Human Health Implications. Available at: http://www.chec.pitt.edu/Exposure_concentration_of_Xenoestrogen_in_pharmaceutical_and_Municipal_Wastewater__Final8-28-07%5B1%5D.pdf; Daughton, Christian G. (N.D.) Pharmaceuticals and the Environment. Available at: www.epa.gov/osp/regions/emerpoll/daughton.ppt; Nikolaou, Anastasia; Meric, Sureyya & Despo Fatta (2007) "Occurrence patterns of pharmaceuticals in water and wastewater environments." Analytical and Bioanalytical Chemistry. 387: 1225-1234; Natural Resources Defense Council (2010) Dosed Without Prescription...
19 Daughton, Christian G. (N.D.) Pharmaceuticals and the Environment...
20 Environment Canada. (N.D.)Mercury and the Environment. Available at: http://www.ec.gc.ca/MERCURY/SM/EN/sm-mcp.cfm#MD
21 Health Care Without Harm (2007) The Global Movement for Mercury Free Health Care. Available at: http://www.noharm.org/lib/downloads/mercury/Global_Mvmt_Mercury-Free.pdf; World Health Organization (2005) Mercury in Health Care: Policy Paper. Available at: http://www.who.int/water_sanitation_health/medicalwaste/mercurypolpaper.pdf
22 Environmental Working Group (N.D.) Chemical Pollution: The Toll on America's Health. Available at: http://www.ewg.org/files/EWG-kid-safe-toll-on-health.pdf
23 California Environmental Protection Agency (2002) Environmental Protection Indicators...
24 Reuben, Suzanne H. (2010) Reducing Environmental Cancer Risk...
25 World Health Organization (N.D.) International Programme on Chemical Safety: About us. Available at: http://www.who.int/ipcs/en/; World Health Organization (N.D.) Inter-Organization Programme for the Sound Management of Chemicals. Available at: http://www.who.int/iomc/brochure/brochure_english.pdf; United Nations Economic Commission for Europe (N.D.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS). Available at: http://www.unece.org/trans/danger/publi/ghs/ghs_welcome_e.html; Weinberg, Jack (2008) An NGO Guide to SAICM: The Strategic Approach to International Chemicals Management. Available at: http://www.ipen.org/ipenweb/documents/book/saicm%20introduction%20english.pdf
26 Eskenazi, Brenda et.al. (2009) "The Pine River Statement: Human Health Consequences of DDT Use." Environmental Health Perspectives. 117:1359-1367 Available at: http://www.eoearth.org/article/Human_Health_Consequences_of_DDT_Use#gen4; World Health Organization (N.D.) Rotterdam Convention: Share Responsibility. Available at: http://www.pic.int/home.php?type=t&id=5&sid=16
27 Kazan-Allen, Laurie (2007) Rotterdam Treaty Killed by Chrysotile Asbestos! International Ban Asbestos Secretariat. Available at: http://www.ibasecretariat.org/lka_rott_meet_geneva_oct_06.php
28 Government of Canada (2007) The Canadian Environmental Protection Act, 1999 (CEPA 1999). Available at: http://www.chemicalsubstanceschimiques.gc.ca/about-apropos/cepa-lcpe-eng.php
29 Government of Canada (2010) Chemicals Management Plan. Available at: http://www.chemicalsubstanceschimiques.gc.ca/plan/index-eng.php
While genetic testing is typically provided in a clinical setting through the referral of a health care professional (HCP) or a regulated research project, a number of private companies now offer genetic testing services directly to consumers over the Internet. Direct-to-consumer (DTC) genetic testing is distinguished from clinical genetic testing ordered by a HCP in several ways:
1. DTC genetic tests are not regulated in Canada. The clinical validity and reliability of these tests varies widely, but DTC genetic testing companies make them available to consumers without distinguishing between those that may be useful to the management of one's health, those that have some limited health value, and those that are meant purely for recreational use.
2. Many of the tests advertised and sold via the Internet have not undergone clinical evaluation.
3. Marketing materials for these tests often imply that they have health value, but the terms of reference of some of the companies that offer them state that the tests are to be used for recreational purposes and many vendors do not guarantee the validity or reliability of their results.
4. Resale of personal health information and/or DNA samples is often an important part of the business model of companies that offer DTC genetic testing, raising concerns about patient privacy and insufficient or unclear disclosure of privacy terms.
5. Unlike genetic tests ordered and administered by HCPs, DTC genetic tests are ordered directly by the consumer, who most often has not consulted with a HCP as part of a clinical assessment, and the testing may not be clinically indicated. Some companies only agree to do testing if it has been ordered by a physician, but they will provide a phone conversation with one of their physicians (not based in Canada) if a consumer does not have access to a physician. When the testing is ordered by a physician, it will sometimes be ordered by the patient's personal physician. In such cases, this does not truly represent DTC genetic testing.
6. Without appropriate pre- and post-testing counselling by a HCP, consumers are left to interpret and act upon their results on their own. They might suffer psychological consequences if they overestimate their disease risk as a result of DTC.
7. As access to DTC genetic testing increases, Canadian HCPs (specifically primary care physicians) are faced with the challenge of appropriately counselling patients when they receive their test results. However, few physicians feel they have the necessary
training and knowledge in genomics to provide adequate care in this area. Furthermore, these tests may have no clinical indication, produce uncertain results with ambiguous clinical applicability and have tenuous legal status, but they can potentially influence a patient's sense of well-being.
1. The CMA is concerned with understanding, raising awareness of, and mitigating potential patient and societal harms that may arise from DTC genetic testing.
2. The CMA emphasizes the importance of the principle of protection of patient privacy and supports the right of Canadians to understand how their health information is being used by third parties, including insurance and DTC genetic testing companies.
3. The CMA believes that patients have the right to be fully informed about what a DTC genetic test can and cannot say about their health and that the scientific evidence on which a test is based should be clearly stated and easy to understand.
4. The CMA recommends regulation of both DTC genetic tests and the marketing of these tests through the development of a national framework that would include a combination of government and industry regulation with input from medical experts.
5. The CMA believes that unnecessary genetic testing should be avoided to ensure more appropriate use of health care resources. Even if a consumer pays directly for testing, any test result, even an incidental finding from a DTC genetic testing laboratory without clinical certification, may trigger a cascade of clinical investigations and lead to further unnecessary testing and inappropriate use of resources.
6. The CMA supports educational initiatives on DTC genetic testing for physicians practising in all specialties so that they can respond to patient queries about these tests and, when necessary, their results.
PROTECTION OF PRIVACY
* Privacy and confidentiality of patients' personal health information must be maintained.
* Before a patient submits a sample to a DTC genetic testing company, the company should obtain express informed consent from the patient concerning the way in which their data will be collected and used, who will have access to the data and the interpreted results, what safeguards are in place to protect it, and how it will be disposed of in the event of a company/laboratory closure.
* Patients have the right to a clear understanding of who owns the sample and the generated data, in particular whether their data will be sold or shared with third parties. If resale of personal health information and/or DNA samples is an important part of the business model of DTC-GC companies, this should be stated explicitly in terms understandable by the consumer.
* DTC-GC companies that solicit Canadian consumers should be subject to the Personal Information Protection and Electronic Documents Act (PIPEDA).
* The CMA encourages physicians to become familiar with privacy legislation affecting the use of DTC genetic tests by insurance companies and employers.
ROLE OF PHYSICIAN
* Physicians should generally avoid using DTC genetic tests unless they have been clinically and empirically validated.
* Physicians who are presented with a patient's DTC genetic test results should take the following actions:
o They should explain to their patient the limits of the specific test the patient used. If a physician does not know this information he/she should discuss with the patient the fact that DTC genetic test results are not necessarily obtained from an accredited laboratory or interpreted in a standardized way; therefore, the validity and clinical utility of the results may be highly variable for certain tests.
o They should disclose their level of comfort in providing an accurate interpretation of the results.
o They should assess whether the test results are clinically significant in the context of that patient's symptoms, signs, medical history and family history before deciding whether it is appropriate to formally consult a specialty provider such as a medical geneticist.
o If a physician wishes to use the results of a test in their clinical assessment, they should ensure that the laboratory performing the test guarantees analytical reliability and validity.
* Physicians should adhere to the following principles related to medically indicated genetic testing:
o Physicians should generally avoid recommending and/or ordering DTC genetic tests if they do not have a clear understanding of the validity and limitations of the tests they select.
o Physicians should follow best practice guidelines and make use of clinically valid tests, accredited laboratories and specialist referral(s), when appropriate.
o Physicians must obtain informed consent from the patient before ordering any genetic test, assist the patient in interpreting the results, support the individual with respect to psychological and biological implications of the results, and refer the patient to appropriate resources.
o Many genetic tests require pre- and post-test counselling, particularly (but not limited to) tests involving children, tests establishing carrier status or tests considered to be predictive. If a provider decides to order such testing, they also accept the responsibility for facilitating access to pre- and post-test counselling.
ROLE OF GOVERNMENT
* The CMA calls on the government to enact regulations based on Bill S-201 (An Act to prohibit and prevent genetic discrimination) that establish clear boundaries for the marketing, distribution, accreditation and third-party use of DTC genetic tests.
* The CMA believes that it is the government's responsibility to ensure that Canadians are only offered reliable, accurate and medically relevant genetic testing services.
* The CMA encourages the development of national standards for the reliability and validity of DTC genetic tests by relevant federal government agencies, in conjunction with interested stakeholders (e.g., geneticists and laboratory scientists, genetic counsellors, physicians, private and public laboratories, industry, and patient groups).
* The CMA encourages the government to enact standards that can keep pace with the rapid development of technological innovation in genetic testing and genetics more generally.
* The CMA encourages the government to enact standards that hold companies accountable for being transparent about their uses of data/DNA and the potential resale of such material.
* The CMA encourages the government to enact standards that mandate that the type of testing (e.g., single-nucleotide polymorphism [SNP] analysis, targeted mutation testing, sequencing) be clearly labelled and that a clear explanation be provided of the type of information that can (or cannot) be obtained from such testing.
* Genetic testing and the interpretation of the results of such testing are highly technical and complex processes. For this reason, the CMA believes that clinical testing laboratories that are used by DTC genetic testing companies must be accredited if the companies are to claim that their testing is valid.
* The CMA believes that scientific evidence describing the validity and utility of a DTC genetic test should be clearly stated in language that is easy to understand. This information should include a clear statement of what a test can or cannot diagnose or infer, and statements about the validity of a specific test should be supported with references. A company that does not guarantee the reliability or validity of its test should not be allowed to make any (implicit or explicit) claims about the potential medical utility of its test and/or its potential to improve health.
EDUCATION AND PUBLIC ENGAGEMENT
* The CMA supports public education initiatives to increase patient awareness of the potential implications and limitations of DTC genetic testing for health purposes.
The CMA supports increased genetics training for physicians to help them to further appreciate the complex issues involved and keep pace with the rapid changes in molecular genetics. Such training would support physicians to counsel patients who seek follow-up for their DTC genetic test results.
Approved by the CMA Board of Directors May 2017
See also Background to CMA Policy on Direct-to-Consumer Genetic Testing
BACKGROUND TO CMA POLICY
DIRECT-TO-CONSUMER GENETIC TESTING
See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing
Some direct-to-consumer (DTC) genetic tests, such as "compatibility testing" for online dating, are purely recreational. Other tests, however, are marketed both as being for recreational use and as producing results that are useful to the management of one's health. This document concerns this second category of tests. The characteristics of these tests differ widely, and some of the companies that offer them clearly state that they do not guarantee the validity and reliability of their tests. As of January 2016, 246 companies offered some form of DNA test online.1 Many DTC genetic tests have started to penetrate the Canadian market, especially after the U.S. Food and Drug Administration issued a warning letter instructing some companies in the U.S. to cease providing unreliable health information that could potentially lead consumers to make misinformed decisions about their health, which caused some of these companies to seek out alternative markets.2
The increasing availability of DTC genetic tests in Canada presents several challenges, as the predictive value of most of the DTC genetic tests currently on the market is very low. Moreover, there is no standard model for the delivery and interpretation of the results of these tests. Greater regulatory guidance and protection is needed to ensure that individuals who choose to submit samples to DTC genetic testing companies are not adversely affected by information that is not necessarily predictive or even accurate.
Survey research indicates that the general public is overwhelmingly interested in genetic testing technologies.3 Researchers predict that an increasing number of individuals will use DTC genetic testing as testing technologies continue to become more affordable and efficient.3 Since genetic issues tend to cross medical specialties, it often falls on primary care physicians to understand the role of genetics in clinical care.4 In fact, genetic testing companies often direct patients to discuss their results with their primary care physician.5 Patients not only seek out their primary care providers to discuss their genetic test results and obtain appropriate follow-up but also expect them to be able to answer questions about personal genome test results.6 Despite these expectations, health professionals' awareness and knowledge of DTC genetic tests remains low.7
Although DTC genetic tests are marketed under similar names, the genetic tests available in Canada have very different characteristics. Three types of tests are offered: (1) single-nucleotide polymorphism (SNPs) analysis, which assesses an individual's risk for common multifactorial diseases (e.g., diabetes, myocardial infarction), (2) targeted mutation analysis and (3) sequencing. Some are ordered directly by the consumer while others are pre-ordered by the consumer and the order is co-signed by a physician (the patient's physician or a physician who has never met the patient and whose services are provided by the company). SNP testing assesses for a number of genetic variants that are common in the general population and that have been identified in association studies to modify (increase or decrease) the risk of a given disease.
Some DTC genetic testing companies explicitly state in their terms of service that they do not guarantee the accuracy or reliability of the test. This is due in part to deficiencies in the science underlying the tests and their interpretation. For example, the interpretation of SNPs analysis for common multifactorial diseases can only be as good as the science behind it. The scientific community has a long way to go before it will have identified all of the significant genetic risk factors and protective factors for these diseases. Because of this, a given consumer could receive greatly divergent risk interpretations.3 In the case of targeted mutation analysis and sequencing, the specific panels offered by DTC genetic testing companies may not include all of the clinically relevant genes and mutations. This could result in a consumer receiving harmful false reassurance. Test results may include information on genetic changes that are only weakly associated with disease, leading to undue anxiety. As such, the clinical and health value of DTC genetic testing continues to be debated despite consumer uptake of, and enthusiasm for, DTC genetic testing offered online.
Currently, most DTC genetic testing services exist in regulatory limbo, benefiting from laws that tend to lag behind technological innovation. Questions about access to the information yielded by these tests have emerged as a particular concern. For some companies, an important part of the business model is to sell consumers' DNA along with the clinical information that the consumers provide via their interactive websites. Most Canadians are unaware of this: they pay for a test and do not expect that their data will later be sold.
ISSUES ARISING IN CLINICAL CONTEXTS
Studies have shown that physicians see a number of benefits with DTC genetic testing, but they also have concerns. The benefits physicians have identified include convenience, promotion of preventive medicine and the provision of personalized services.5 They are concerned about the reliability of test results, the provision of adequate information/counselling, patient anxiety if the results are misunderstood, inappropriateness of advertising, discrimination with respect to employment and insurance, the possible spread of beliefs such as genetic determinism, and the inappropriate disclosure of patients' genetic information.5
The following sections will address primary concerns identified by research and in practice.
1. Patient privacy
Privacy is one of the top concerns of the general public about genetic testing.8 According to a 2010 report commissioned by the Office of the Privacy Commissioner of Canada, approximately 60% of patients indicated that privacy and discrimination fears would influence their decision to undergo genetic testing.9 The average Canadian consumer is not adequately informed that an important part of the business model of many DTC genetic testing companies is to build and sell their database of phenotypic information and DNA accumulated from their clients to third parties, such as biobanks or pharmaceutical companies.
1.1 Informed consent
The increasing quantity, complexity and diversity of DTC genetic testing services pose challenges for informed consent because both specific and generic models do not meet ethical standards when applied to this type of service.10 Many companies bind their consumers to contracts that are activated once the website is viewed, a practice that challenges the adequacy of consent, as it is common for people to view a website without reading or even seeing its terms of reference.1 Consumers who present to genetic clinics tend not to question the validity of the results they have received from DTC genetic testing,11 which can be interpreted as an indication that consumers give their consent without reading or understanding the disclaimers made by the companies.11 Physicians are concerned that this lack of informed consent could compromise the confidentiality of personal health information, encourage requests for unnecessary medical tests and potentially cause distress to patients.
The insurance industry is of particular concern in the context of privacy and DTC genetic tests. A study of patients' perceptions of DTC genetic tests found that participants were concerned that genetic results could affect their health insurance premiums or lead to denial of coverage.12 Private insurance is fundamentally rooted in the practice of discriminating between clients on the basis of risk. While insurers have generally been entitled to request genetic information in the form of family history, to access medical files and to conduct medical tests,13 consumers have expressed the view that the rules governing access to genetic information should be stricter than for access to other forms of personal information.3
While there are studies that report cases of genetic discrimination, it is often unclear whether such treatment is perceived or actual.14. Thus, the consequences of genetic testing remain uncertain. Of particular concern is the potential for discrimination on the basis of results that may not be accurate and/or reliable. Although there is presently no evidence of widespread use of genetic testing by insurance companies,14experts agree that in the next 10 years public acceptance of the use of information from genetic testing will increase and it will become possible to more accurately interpret data from genetic tests (K. Boycott, J. Davies and K. Morin, CIHR Café Scientifique, unpublished remarks), threatening to alter the currently limited role that genetic testing plays in insurance company decision-making. Before policy-makers tackle the potential issues related to the use of DTC genetic testing, it is imperative that they start at ground level and explore options to regulate insurance companies' access to such tests.
2. Patient response
2.1 Interpretation of results and changes in behaviour
Proponents of DTC genetic testing point to the potential for patients to make positive changes to their health as a result of learning about their genetic susceptibility to certain diseases. Findings of studies in this area, however, are inconsistent to date. While some studies have reported that there are some behaviour changes, it is important to keep in mind that early adopters of these services are likely to also be among those most motivated to make health-related changes.15 Recent evidence suggests the opposite response: the general population has a tendency to decrease healthy practices upon learning about a lower health risk, and they do not increase healthy practices when they learn that they have an increased health risk.15 Indeed, patients may make poorer health decisions if they are under the impression that they are not at risk for developing a certain disease; for example, they may avoid routine screening for breast or prostate cancer, or they may not follow exercise and diet advice. 16
These variations in behaviour can be largely attributed to the fact that there is an overarching risk that patients will misinterpret the data they receive from the testing companies. The problem with susceptibility tests in the context of DTC genetic testing is not only that the test results may cause psychological or physical harm but also that there is a possibility that patients will over-interpret their disease risk.10 Without expert guidance, the patient may not be able to evaluate their test results accurately enough to make informed health decisions.14 There is very little evidence to suggest that receipt of a DTC genetic test result produces sustained behavioural change.17 In fact, studies on psychological theories related to motivation do not consider disease risk information a useful tool for motivating patients to change their behaviour.15 Therefore, while receipt of DTC genetic test results may encourage patients to see their family physician and possibly undergo further consultation, the health care resources invested in interpreting results with limited clinical validity may not produce sustained behavioural changes, good or bad.
3. Resource allocation
One of the stated goals of personalized medicine is to save health care systems money by facilitating the use of fewer but more effective treatments.18 However, greater demand for genetic testing, whether public or private, could produce the opposite effect: consumption of health care resources may increase as patients consult with their regular physician about results they obtained through a DTC company.16 Furthermore, physicians who are presented with DTC genetic test results by their patients have a legal and ethical obligation to do their due diligence and carry out a complete, clinically valid investigation, which may ultimately negate the cost savings that personalized medicine is expected to produce.16
Patients who participate in DTC genetic testing are likely to drive up the utilization of health care providers, as they seek out their primary care provider to discuss their results and they obtain follow-up care from a genetic counsellor.19,5 At least one study has suggested that there is an expectation that physicians will help patients to interpret their DTC genetic test results, and DTC genetic testing companies frequently direct patients to discuss their results with their physicians before acting upon their testing information.5 Consequently, the responsibility falls on primary care providers to discuss this technology with their patients.5
Primary care providers, however, believe that genetic specialists are the most appropriate providers of counselling for DTC genetic tests.14 While they acknowledge the benefits of DTC genetic tests, including the potential for test results to encourage patients to be more involved in their care and take responsibility for their health, they also agree that test results may encourage patients to seek unnecessary and potentially expensive follow-up tests.14 As a result, additional health care resources may be required to cope with the increased demand for medical follow-up.20
4. Physician education
Although DTC genetic testing companies have been around since the early 2000s, levels of awareness among health care professionals vary, and knowledge and understanding of the services generally remain low.21 Research suggests that few physicians feel they have the necessary training and knowledge in genomics to provide adequate care in this area.17 A perceived lack of clinical utility appears to be a barrier to learning more about DTC genetic testing.6 Increased genetics training and awareness may allow physicians to better appreciate the complex issues involved and help them to better counsel patients who seek follow-up for their DTC genetic test results.
4.1 Topics that physicians want to learn about
Most physicians are concerned about the privacy implications of DTC genetic testing, specifically health insurance and employment discrimination, which may affect their patients who present with a DTC genetic test.5 Therefore, important discussion points to include in a physician education program would be information on the risks of insurance and employment discrimination, legislation currently in place to protect against genetic discrimination, and guidelines for managing risk.6 Given the ease with which patients can access DTC genetic testing, it is essential to provide health professionals with appropriate education on the potential benefits and risks of DTC genetic testing and help them develop an approach to interpreting the results of such testing, so that they can protect their patients from harm and arrange follow-up appropriately.19
5. Legislative landscape in Canada
Before May 2017, Canada did not have a law to specifically protect against genetic discrimination. Existing human rights and privacy law could only be ambiguously and tenuously applied to DTC genetic testing issues, including genetic discrimination and information collection, use and disclosure.14 The laws that regulate medical devices, such as the Food and Drugs Act, did not clearly apply in the context of DTC genetic tests either,2 because consumers are not purchasing genetic testing kits but rather they are purchasing testing services, which fall outside the scope of that legislation.22 As a result, there was limited evidence to form the regulations necessary to ensure the validity and utility of these tests.
Fortunately, on May 4, 2017, Bill S-201 (hereinafter termed S-201), An Act to prohibit and prevent genetic discrimination,23 received Royal Assent and will soon become law. S-201 provides a basis for the creation of regulations concerning the validity and utility of DTC genetic tests. The bill prohibits the requirement that an individual submit to genetic testing or disclose the results of genetic tests in order to receive goods or services or in order to enter into or continue a contract or agreement, and it prohibits submission to genetic testing or disclosure of test results from being used as the basis of any specific conditions in a contract or agreement. S-201 amends the Canada Labour Code to protect employees from being required to undergo or disclose the results of genetic testing and amends the Canadian Human Rights Act to prohibit discrimination on the grounds of genetic characteristics.21 Legislation at a provincial level, however, may still be required. Private Member's Bill 127, An Act to amend the Human Rights Code with respect to genetic characteristics,24 was presented to the Legislative Assembly of the Province of Ontario in 2013 but did not move past the first reading.
Federal and provincial privacy legislation (such as the federal Personal Information Protection and Electronic Documents Act, or PIPEDA) also plays a role in protecting against genetic discrimination by requiring an individual to consent to the collection, use or disclosure of personal information.25 Currently, the Office of the Privacy Commissioner of Canada does not support amending the Privacy Act or PIPEDA, on the grounds that these laws sufficiently apply to genetic information.23 While this legislative framework might provide some protection against genetic discrimination, there is a lack of clarity as to whether it strikes the appropriate balance between consumers' rights to privacy and the interests of insurers. Furthermore, the courts have yet to provide an opinion regarding the constitutionality of S-201 or to assist in the interpretation of privacy legislation in the context of DTC testing, because of the novelty of the service.
It is uncertain if and how Bill S-201 will inform future regulations placed upon employers and insurers. Significant gaps in the legislative framework remain; in particular, privacy protection in Canada has yet to counterbalance the lack of consumer protection in Canadian insurance laws.22 While existing legislation may offer some protection, the absence of legal precedents creates uncertainty and leaves consumers to engage in DTC testing services at their own risk.
See also CMA Policy PD17-05 Direct-to-Consumer Genetic Testing
1 Phillips AM. Only a click away - DTC genetics for ancestry, health, love ... and more: a view of the business and regulatory landscape. Appl Transl Genom 2016;8:16-22.
2 US Food and Drug Administration. Warning letter. Silver Spring (MD): The Administration; 22 Nov 2013. Available: www.fda.gov/iceci/enforcementactions/warningletters/2013/ucm376296.htm (accessed 2017 May 19).
3 Caulfield T. Direct-to-consumer testing: if consumers are not anxious, why are policy makers? Hum Genet 2011;130:23-5.
4 Delaney SK, Christman MF. Direct-to-consumer genetic testing: perspectives on its value in healthcare. Clin Pharmacol Ther 2016; 99(2):146-8.
5 Powell KP, Cogswell WA, Christianson CA, et al. Primary care physicians' awareness, experience and opinions of direct-to-consumer genetic testing. J Genet Couns 2012;21(1):113-26.
6 Powell KP, Christianson CA, Cogswell WA, et al. Educational needs of primary care physicians regarding direct-to-consumer genetic testing. J Genet Couns 2012;21(3):469-78.
7 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3): 341-8.
8 Caulfield T, McGuire AL. Direct-to-consumer genetic testing: perception, problems, and policy responses. Annu Rev Med 2012; 63:23-33.
9 Office of the Privacy Commissioner of Canada. Analysis of privacy policies and practices of direct-to-consumer genetic testing companies: private sector databanks and privacy protection norms. Ottawa: The Office; March 2010. p. 6.
10 Bunnik EM, Janssens AC, Schermer MH. Informed consent in direct-to-consumer personal genome testing: the outline of a model between specific and generic consent. Bioethics 2014;28(7):343-51.
11 Brett GR, Metcalfe SA, Amor DJ, et al. An exploration of genetic health professionals' experience with direct-to-consumer genetic testing in their clinical practice. Eur J Hum Genet 2012;20(8):825-30.
12 Wasson K, Sanders TN, Hogan NS, Cherny S, Helzlsouer KJ. Primary care patients' views and decisions about, experience of and reactions to direct-to-consumer genetic testing: a longitudinal study. J Community Genet. 2013;4:495-505
13 Lemmens T, Pullman D, Rodal R. Revisiting genetic discrimination issues in 2010: policy options for Canada [PowerPoint presentation]. Ottawa: Genome Canada; 15 June 2010. Available: www.genomecanada.ca/sites/default/files/pdf/en/gps_speakers_presentation/trudo-lemmens-daryl-pullman.pdf
14 Zinatelli F. Industry Code: Genetic testing information for insurance underwriting [Internet]. Toronto, ON: CLHIA; 2017 Jan 11. Available from https://www.clhia.ca/domino/html/clhia/CLHIA_LP4W_LND_Webstation.nsf/page/E79687482615DFA485257D5D00682400/$file/Industry%20Code%20Genetic%20Testing%20-%20Updated.pdf
15 Adams SD, Evans JP, Aylsworth AS. Direct-to-consumer genomic testing offers little clinical utility but appears to cause minimal harm. N C Med J 2013;74(6): 494-8.
16 Ram S, Russell B, Gubb M, et al. General practitioner attitudes to direct-to-consumer genetic testing in New Zealand. N Z Med J 2012;125(1364):14-26.
17 Caulfield T. Obesity genes, personalized medicine and public health policy. Curr Obes Rep 2015;4(3):319-23.
18 Caulfield T, Zarzeczny A. Defining 'medical necessity' in an age of personalised medicine: a view from Canada. Bioessays 2014;36(9):813-7.
19 Bloss CS, Schork NJ, Topol EJ. Direct-to-consumer pharmacogenomic testing is associated with increased physician utilisation. J Med Genet 2014;51(2):83-9.
20 Daly AK. Direct-to-consumer pharmacogenomic testing assessed in a US-based study. J R Coll Physicans Edinb 2014;44:212-3.
21 Jackson L, Goldsmith L, Skirton H. Guidance for patients considering direct-to-consumer genetic testing and health professionals involved in their care: development of a practical decision tool. Fam Pract 2014;31(3):341-8.
22 Mykitiuk R. Caveat emptor: direct-to-consumer supply and advertising of genetic testing. Clin Invest Med 2004;27(1):23-32.
23Parliament of Canada. Legislative summary of Bill S-201: An Act to prohibit and prevent genetic discrimination. Ottawa: Parliament of Canada; 2016
24 Parliament of Canada. Bill 127: An Act to amend the Human Rights Code with respect to genetic characteristics, 2nd Sess, 40th Leg, Ontario, 2013.
25 Personal Information Protection and Electronic Document Act (PIPEDA), S.C. 2000, C.5, para 5(3).
The Canadian Medical Association and the Canadian Nurses Association put forward the following principles to guide the transformation of the health care system in Canada toward one that is sustainable and adequately resourced, and provides universal access to quality, patient-centred care delivered along the full continuum of care in a timely and cost-effective manner. Such a system promotes health, effectively manages illness and focuses on outcomes, thereby contributing to a country's social and economic development and well-being.1
Canada's health care system is in need of transformation to better meet the health needs of Canadians. First, while it is recognized that elements of transformation are already taking place across the country, it is important that regional or jurisdictional change be guided by a common framework. Second, health care transformation must build on the five principles of the Canada Health Act (universality, accessibility, portability, comprehensiveness and public administration) that currently apply only to hospital and physician services. Moving beyond these services, a common set of principles is required to guide a national transformation toward a more effective and comprehensive medicare system. A transformed Canadian health care system demands national standards for service quality and outcomes, for which both federal and provincial/territorial governments share responsibility.
The principles below have been organized according to the Institute for Healthcare Improvement's (IHI) Triple Aim Framework, which describes the three goals of "better care for individuals, better health for populations and lower per capita costs."2 It has been IHI's experience that all three must be addressed; where organizations address only one or two, results may be achieved to the detriment of the other(s).
ENHANCE THE HEALTH CARE EXPERIENCE
The patient must be at the centre of health care. Patient-centred care is seamless access to the continuum of care in a timely manner, based on need and not the ability to pay, that takes into consideration the individual needs and preferences of the patient and his/her family, and treats the patient with respect and dignity.3 Improving the patient experience and the health of Canadians must be at the heart of any reforms.
A strong primary health care foundation as well as collaboration and communication within and between health professional disciplines along the continuum are essential to achieving patient-centred care.
Canadians deserve quality services that are appropriate for patient needs, respect individual choice and are delivered in a manner that is timely, safe, effective and according to the most currently available scientific knowledge. Services should also be provided in a manner that ensures continuity of care. Quality must encompass both the processes and the outcomes of care. More attention needs to be given to ensuring a system-wide approach to quality.
IMPROVE POPULATION HEALTH
HEALTH PROMOTION AND ILLNESS PREVENTION
The health system must support Canadians in the prevention of illness and the enhancement of their well-being. The broader social determinants of health (e.g., income, education level, housing, employment status) affect the ability of individuals to assume personal responsibility for adopting and maintaining healthy lifestyles and minimizing exposure to avoidable health risks. Coordinated investments in health promotion and disease 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. This is a responsibility that must be shared among health care providers, governments and patients, who must be actively engaged in optimizing their health and be involved in decisions that affect their overall health.
The health care system has a duty to Canadians to provide and advocate for equitable access to quality care and multi-sectoral policies to address the social determinants of health.4 In all societies, good health is directly related to the socio-economic gradient - the lower a person's social position, the worse his or her health. The relationship is so strong that it is measurable within any single socio-economic group, even the most privileged.
It is due to the sum of all parts of inequity in society - material circumstances, the social environment, behaviour, biology and psychosocial factors, all of which are shaped by the social determinants of health.5
Some health inequities are preventable; failure to address them will result in poorer health and higher health care costs than necessary. Improved health literacy (defined as the ability to access, understand and act on information for health) would help to mitigate these inequalities.
IMPROVE VALUE FOR MONEY
Sustainable health care requires universal access to quality health services that are adequately resourced and delivered along the full continuum in a timely and cost-effective manner. Canada's health care system must be sustainable in the following areas:
* Resourcing: Health services must be properly resourced based upon population needs, with appropriate consideration for the principles of interprovincial and intergenerational equity and pan-Canadian comparability of coverage for and access to appropriate health services.
- Financing: The health care system needs predictability, certainty and transparency of funding within the multi-year fiscal realities of taxpayers and governments, and funding options that promote risk-pooling, inter-provincial and inter-generational equity and administrative simplicity.
- Health human resources: Health care will be delivered within collaborative practice models; pan-Canadian standards/licensure will support inter-provincial portability of all health care providers; health human resource planning will adjust for local needs and conditions.
- Infrastructure: Health care in the 21st century demands a fully functional health care information technology system as well as buildings and capital equipment.
* Research: Health research in Canada will inform adjustments to health service delivery and to the resourcing of health services.
* Measuring and reporting: Outcome data are linked to cost data; comparable and meaningful performance measures are developed and publicly reported; outcomes are benchmarked to high-performing, comparable jurisdictions.
* Public support: The health care system must earn the support and confidence of the users and citizens of Canada, who ultimately pay for the system.
All stakeholders - the public/patients/families, providers and funders - have a responsibility for ensuring the system is effective and accountable. This includes:
* Good governance: Clear roles, lines of authority and responsibilities are necessary for the funding, regulation and delivery of health care services, even where these may be shared between levels of government and among health care providers. Patients, families and providers must be partners in the governance of the system.
* Responsible use: Services should be funded, offered and used responsibly.
* Strong public reporting: Timely, transparent reporting at the system level on both processes and outcomes that can be used and understood by stakeholders and the public are necessary.
* Enforceability and redress: Mechanisms are in place to enforce accountability and provide redress when the system does not fulfill its obligations.
* Leadership/stewardship: Long-term strategic planning and monitoring is necessary to ensure the system will be sustainable.
* Responsive/innovative: The system is able to adapt based on reporting results.
APPLICATION OF PRINCIPLES AND NEXT STEPS
Over the next several months, a number of health care initiatives will be considered at both the provincial/territorial and federal levels. This will include discussions aimed at signing a new health care accord between the federal government and the provinces/territories. Any such agreements or initiatives must be consistent with the principles set out in this document.
Approved by the CMA and CNA Boards of Directors, June 2011
1 World Health Organization. Regional Office for Europe. The Tallinn Charter: Health systems for health and wealth. Copenhagen, Denmark, 2008. http://www.euro.who.int/__data/assets/pdf_file/0008/88613/E91438.pdf.
2 See http://www.ihi.org/IHI/Programs/StrategicInitiatives/IHITripleAim.htm.
3 Canadian Medical Association. Health care transformation in Canada: Change that works. Care that lasts. Ottawa, 2010. http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Advocacy/HCT/HCT-2010report_en.pdf.
4 Canadian Nurses Association. Social justice: A means to an end; an end in itself. Ottawa, 2010.
5 The Marmot Review. Fair Society, Healthy Lives, February, 2010. http://www.marmotreview.org/AssetLibrary/pdfs/Reports/FairSocietyHealthyLives.pdf.
The Role of Health Professionals in Tobacco Cessation - Joint position statement
This statement was developed cooperatively by the Canadian Association of Occupational Therapists, Canadian Counselling and Psychotherapy Association, Canadain Dental Hygienists Association, Canadian Medical Association, Canadian Nurses Association, and Canadian Physiotherapy Association.
There is a role for every Canadian health professional in tobacco-use cessation.1 Tobacco use2 inflicts a heavy burden on Canadians' health and on the Canadian health-care system, and health professionals can advocate effectively for tobacco-use cessation at the clinical and public health levels.
As providers of client and patient-centered services, health professionals are involved in tobacco cessation by:
* assessing and documenting all forms of tobacco use, willingness to quit and risk of exposure to second-hand smoke;
* discussing with clients and patients the negative health effects of tobacco use and exposure to second-hand smoke, and the health and other benefits (e.g., financial) of becoming tobacco free;
* offering to help, and helping, tobacco users to quit;
* offering a variety of tobacco-cessation strategies (e.g., counselling, behavioural therapy, self-help materials, pharmacotherapy) as appropriate to their knowledge, skills and tools;
* providing strategies for non-smokers to help them reduce their exposure to second-hand smoke;
* being knowledgeable about and providing referrals to community-based initiatives and resources;
* recognizing that relapse occurs frequently, and conducting follow-up assessment and intervention;
* tailoring interventions to the needs of specific populations (e.g., age, gender, ethnicity, diagnosis, socio-economic status); and
* using a collaborative, multidisciplinary approach.
As educators and researchers, health professionals are involved in tobacco cessation by:
* including education on tobacco-cessation strategies and strategies for resisting tobacco use in basic education programs for health professionals;
* providing professional development programs for health professionals on tobacco cessation;
* conducting research to encourage and improve health professionals' knowledge and provision of tobacco cessation; and
* communicating research evidence about tobacco-cessation strategies.
As administrators of health-care organizations, health professionals are involved in tobacco cessation by:
* offering training on tobacco cessation as part of employee orientation;
* providing access to professional education on tobacco cessation for employees;
* enforcing applicable bans on tobacco wherever health professionals are employed (e.g., health-care facilities, private homes); and
* ensuring that tobacco-cessation programs and tobacco-free workplaces are included in accreditation standards.
As public health advocates, health professionals are involved in tobacco cessation by:
* increasing public awareness that health professionals can help people remain tobacco free or stop using tobacco; and
* advocating for federal, provincial and territorial governments' investment in comprehensive tobacco control that includes programs, legislation and policies to prevent the uptake of tobacco and reduce tobacco use (e.g., bans on tobacco advertising). Programs must focus on health promotion and include community-based initiatives.
Tobacco is an addictive and harmful product, and its use is the leading cause of preventable death in Canada.3 Each year in Canada, more than 37,000 people die prematurely due to tobacco use.4 Approximately 17 per cent of the population 15 years of age and older (about 4.8 million Canadians) smoke.5 Strong evidence has revealed that smoking is associated with more than two dozen diseases and conditions.6 The economic costs of tobacco use are estimated at $17 billion annually ($4.4 billion in direct health-care costs and $12.5 billion in indirect costs such as lost productivity).7
Second-hand smoke is also harmful. Each year, more than 1,000 non-smoking Canadians die due to second-hand smoke.8 Exposure to second-hand smoke is the number two cause of lung cancer (smoking is the number one cause).9 Second-hand smoke can also aggravate allergies, bring about asthma attacks and increase the risk of bronchitis and pneumonia.10 Research also suggests that there may be a link between second-hand smoke and the risk of breast cancer.11
Tobacco use is the result of the complex interaction of individual and social factors, such as socio-economic status, having family members who smoke and exposure to marketing tactics of the tobacco industry. Reduction and elimination of tobacco use requires comprehensive, multi-faceted strategies addressing both physical dependence and social context. Such strategies will include:
* prevention - helping to keep non-users from starting to use tobacco;
* cessation - helping current smokers to quit, and helping prevent relapse; and
* protection - protecting all Canadians from the harmful effects of tobacco use and from the influences of tobacco industry marketing.
Prevention is the most important strategy of the three; being tobacco-free is a vital element of a healthy active life. Thus, for current tobacco users, quitting is the single most effective action they can take to enhance the quality and length of their lives.
Most tobacco users would like to improve their health, and in a Canadian survey 30 per cent of all smokers stated that they intended to quit as means of doing so.12 Indeed, in studies in Canada, the U.K. and Germany, smokers rated health concerns and current health problems as the primary reason for wanting to quit;13 other reasons why smokers quit include the cost of cigarettes14 and persistent advice to quit from family15 and health professionals.16 However, the relapse rate is very high because of the addictive nature of tobacco.17 Most smokers attempt to quit several times before they finally succeed.
Smoking cessation counselling is widely recognized as an effective clinical strategy. Even a brief intervention by a health professional significantly increases the cessation rate.18 Furthermore, counselling programs that initiate follow-up calls to smokers as a "proactive" measure have been found to increase smoking-cessation rates by 50 per cent.19 The majority of Canadians consult a health professional at least once a year,20 creating several "teachable moments" when they may be more motivated than usual to change unhealthy behaviours.21 A smoker's likelihood of quitting increases when he or she hears the message from a number of health-care providers from a variety of disciplines.22
However, health professionals encounter barriers that require solutions, notably:
- the need for better education for health professionals (e.g., how to identify smokers quickly and easily, which treatments are most effective, how such treatments can be delivered);
- the need to allow for sufficient time to provide counselling;
- the need to focus on preventive care by
* increasing funding for preventive care (e.g., providing reimbursement for smoking cessation interventions, follow-up or support); and
* encouraging health-care settings to facilitate preventive care (e.g., access to quick reference guides or tools to identify people with specific risk factors);
- the need to increase public awareness of the smoking cessation services a health professional can provide; and
- the need to recognize the frustration associated with the high rate of relapse. Because of the powerful nature of tobacco dependence, smokers often go through a long period of reaching readiness before they finally quit.
Bao Y., Duan N., & Fox S. A. (2006). Is some provider advice on smoking cessation better than no advice? An instrument variable analysis of the 2001 National Health Interview Survey. Health Services Research, 41(6), 2114-2135
Breitling, L. P., Rothenbacher, D., Stegmaier, C., Raum, E., & Brenner, H. (2009). Older smokers' motivation and attempts to quit smoking. Deutsches Arzteblatt International, 106(27), 451-455.
Canadian Action Network for the Advancement, Dissemination and Adoption of Practice-informed Tobacco Treatment. (2008). Dynamic guidelines for tobacco control in Canada Version 1.0 [Wiki clinical practice guidelines]. Toronto: Author.
Canadian Cancer Society. (2010). Second-hand smoke is dangerous. Toronto: Author. Retrieved May 19, 2010, from http://www.cancer.ca/canada-wide/prevention/quit%20smoking/second-hand%20smoke.aspx
Canadian Centre on Substance Abuse, (2006). The costs of substance abuse in Canada in 2002. Ottawa: Author.
Canadian Lung Association. (2006). Smoking and tobacco: Second-hand smoke. Retrieved June 14, 2010, from http://www.lung.ca/protect-protegez/tobacco-tabagisme/second-secondaire/hurts-nuit_e.php
Canadian Dental Hygienists Association. (2004). Tobacco use cessation services and the role of the dental hygienist - a CDHA position paper. Canadian Journal of Dental Hygiene, 38(6), 260-279.
Canadian Medical Association. (2008). Tobacco control [Policy statement]. Ottawa: Author.
Fiore, M. C., Jaen, C. R., Baker, T. B., Bailey, W. C., Benowitz, N. L., & Curry, S. J. (2008). Treating tobacco use and dependence: 2008 update [Clinical practice guideline]. Rockville, MD: U.S. Department of Health and Human Services, Public Health Service.
Health Canada. (2009). Smoking and your body: Health effects of smoking. Ottawa: Author. Retrieved June 17, 2010, from http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/body-corps/index-eng.php
Health Canada. (2007). Overview of health risks of smoking. Ottawa: Author. Retrieved June 17, 2010, from http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/res/news-nouvelles/risks-risques-eng.php
Nabalamba, A, & Millar, W. J. (2007). Going to the doctor [Statistics Canada, catalogue 82-003]. Health Reports, 18(1), 23-35. Retrieved January 26, 2011, from http://www.statcan.gc.ca/pub/82-003-x/2006002/article/doctor-medecin/9569-eng.pdf
Physicians for a Smoke-Free Canada. (2005). Smoking in Canada: A statistical snapshot of Canadian smokers. Ottawa: Author. Retrieved May 14, 2010, from http://www.smoke-free.ca/pdf_1/SmokinginCanada-2005.pdf
Registered Nurses' Association of Ontario. (2007). Integrating smoking cessation into daily nursing practice [Nursing best practice guideline]. Toronto: Author.
Ross, H., Blecher, E., Yan, L., & Hyland, A. (2010) Do cigarette prices motivate smokers to quit? New evidence from the ITC survey. Addiction, November 2010.
Shields, M. (2004). A step forward, a step back: Smoking cessation and relapse. National Population Health Survey, Vol. 1, No. 1. Ottawa: Statistics Canada.
Statistics Canada. (2009). Canadian tobacco use monitoring survey (CTUMS): CTUMS 2009 wave 1 survey results. Ottawa: Author. Retrieved January 25, 2011, from http://www.hc-sc.gc.ca/hc-ps/tobac-tabac/research-recherche/stat/_ctums-esutc_2009/w-p-1_sum-som-eng.php
Stead, L. F., Lancaster, T., & Perera, R. (2006). Telephone counselling for smoking cessation (review). Cochrane Database of Systematic Reviews, Issue 3.
Vangeli, E., & West, R. (2008). Sociodemographic differences in triggers to quit smoking: findings from a national survey. Tobacco Control, 17(6), 410-415.
Young, R.P., Hopkins, R.J., Smith, M., & Hogarth, D.K. (2010). Smoking cessation: The potential role of risk assessment tools as motivational triggers. Post Graduate Medical Journal, 86(1011), 26-33.
Tobacco: The role of health professionals in smoking cessation [Joint position statement]. (2001)
1 For detailed recommendations and guidelines for tobacco treatment related to health professionals, see Canadian Action Network for the Advancement, Dissemination and Adoption of Practice-informed Tobacco Treatment, (2008); Registered Nurses' Association of Ontario, (2007); and Canadian Dental Hygienists Association, (2004).
2 For the purpose of this position statement, tobacco includes products that can be inhaled, sniffed, sucked or chewed (e.g., flavoured cigarillos, kreteks, chewing tobacco, moist snuff, betel or qat, hookah or shisha, bidis, cigars and pipes).
3 (Health Canada, 2009)
4 (Health Canada, 2007)
5 (Statistics Canada, 2009)
6 (Health Canada, 2007)
7 (Canadian Centre on Substance Abuse, 2006)
8 (Canadian Cancer Society, 2010)
9 (Canadian Lung Association, 2006)
10 (Canadian Cancer Society, 2010)
11 (Canadian Cancer Society, 2010)
12 (Physicians for a Smoke-Free Canada, 2005)
13 (Vangeli & West, 2008; Ontario Tobacco Research Unit - Tobacco Informatics Monitoring System (TIMS), 2008; Breitling, Rothenbacher, Stegmaier, Raum & Brenner, 2009)
14 (Ross, Blecher, Yan & Hyland, 2010)
15 (Young, Hopkins, Smith & Hogarth, 2010)
16 (Bao, Duan & Fox, 2006)
17 (Fiore et al., 2008; Shields, 2004)
18 (Fiore et al., 2008)
19 (Stead, Lancaster & Perera, 2006)
20 (Nabalamba & Millar, 2007)
21 (Canadian Medical Association, 2008)
22 (Fiore et al., 2008)
The legalization of medical assistance in dying (MAiD) raises a host of complex ethical and practical challenges that have implications for both policy and practice. The CMA supports maintaining the balance between three equally legitimate considerations: respecting decisional autonomy for those eligible Canadians who are seeking access, protecting vulnerable persons through careful attention to safeguards, and creating an environment in which practitioners are able to adhere to their moral commitments.
Recognizing the educational, legislative, regulatory and practice changes that will result, the CMA recommends that legislative and regulatory processes be coordinated at the federal and provincial/territorial levels to consistently guide health systems, practitioners and patients. To that end, the CMA calls for rigorous information gathering at all levels and for experience with and research on the impacts of this new practice to be reported as it unfolds. The CMA encourages medical schools to incorporate reflective training opportunities at the undergraduate and postgraduate levels that address all aspects of medical practice that might be affected by this new intervention. Further, CMA recognizes the opportunity that exists for all health systems and practitioners to facilitate effective patient access to information about all end-of-life care options.
The CMA acknowledges the importance of understanding that other acts within the realm of end-of-life care are distinct from the practice of medical assistance in dying. Further, the provision of specific assessments for eligibility to access medical assistance in dying is a distinct service unrelated to consultations for general palliative end-of-life care.
It is important that physicians be aware of this distinction and the relationship between legal, medical and ethical norms with respect to medical assistance in dying. The judicial and legislative branches of government have made changes to Canadian law in this area. Society has placed assistance in dying within the realm of regulated medical practitioners. Physicians' ethical norms and duties, arising from long-standing traditions that entail moral commitments to preserve and protect life, have not changed. The CMA supports the right of all physicians to follow their conscience when deciding whether to provide or otherwise participate in assistance in dying as per the legislation governing medical assistance in dying. The CMA equally supports conscientious participation in and conscientious objection to assistance in dying by physicians.
SCOPE OF POLICY
This policy aims to provide guidance on key considerations in a way that is consistent with a physician's ethical, professional and legal obligations. Physicians should be aware of the federal and provincial laws in the jurisdiction in which they practise, the standards and expectations outlined by their respective regulatory authority, advice from the Canadian Medical Protective Association as well as the policies and procedures of the setting(s) in which they practise (e.g., regional health authority or hospital).
RELEVANT FOUNDATIONAL CONSIDERATIONS
The following considerations underpin the CMA's position on what ought to constitute the basis of any evolving legislation, regulation or guideline on the implementation of medical assistance in dying. These considerations are not ranked according to priority or importance. As with any foundational considerations, they provide a starting point for ethical reflection, and their application requires further thought and interpretation when conflicts arise.
1. Respect for autonomy: The CMA upholds the importance of respect for decisional autonomy by competent patients - such persons are free to make informed choices and autonomous decisions about their bodily integrity, their personal aims and their care that are consistent with their personal values and beliefs. CMA also asserts that persons have inherent dignity regardless of their circumstances. Services ought to be delivered, and processes and treatments ought to be applied, in ways that strive to preserve and enhance dignity. End-of-life care strives to maintain the integrity of personhood even as bodily functions deteriorate in advance of death.
2. Respect for vulnerability: In consideration of the importance of a patient's decision regarding medical assistance in dying, and the permanence of death if medical assistance in dying is chosen by a patient, the CMA believes that careful and non-judgmental exploration with patients of the reasons they are seeking assistance in dying is always warranted. Care in this regard assists physicians to fulfill the duty to ensure that conditions of vulnerability have been identified and addressed satisfactorily. Physicians should maintain diligent attention to identifying undue coercive influences on the patient. Legislation and regulations, through a carefully designed and monitored system of safeguards, should aim to minimize harm to all patients and should also address issues of vulnerability and potential coercion.
3. Respect for freedom of conscience: The CMA believes that physicians must be able to follow their conscience without discrimination when deciding whether or not to provide or participate in assistance in dying. The CMA supports physicians who, for reasons of moral commitments to patients and for any other reasons of conscience, will not participate in decisional guidance about, eligibility assessments for, or provision of medical assistance in dying. To enable physicians to adhere to such moral commitments without causing undue delay for patients pursuing this intervention, health systems will need to implement an easily accessible mechanism to which patients can have direct access. Further, the CMA believes that physicians' general employment or contract opportunities should not be influenced by their decisions to participate in, or not participate in, any or all aspects of medical assistance in dying with patients. The right of patients to seek medical assistance in dying does not compel individual physicians to provide it. Learners should be equally free to follow their conscience without risk to their evaluations and training advancement.
4. Accountability: Physicians providing or otherwise participating in assistance in dying must ensure they have the requisite training and the appropriate competencies, and the ability to assess a patient's decisional capacity or the ability to consult with a colleague to assess capacity in more complex situations. Physicians are expected to use appropriate medical judgment to make a determination of eligibility by (1) assessing the capacity of an adult to consent to the termination of life and (2) determining whether the patient has explored their options (and the putative impacts of any of the options). If the patient wishes to continue seeking medical assistance in dying, physicians are expected to use appropriate medical judgment to determine whether s/he meets the eligibility criteria as per the legislation governing medical assistance in dying. This ought to be a shared decision, and it should be made as part of a deliberative process in the context of the patient-physician relationship. The CMA encourages physicians to participate in accountability processes within their jurisdictions that ensure equitable access to all end-of-life options, including palliative and end-of-life care provided by skilled practitioners, in service of their patients' needs and values. To that end, the CMA believes that a federal oversight body and reporting regime should be established to ensure that all processes are followed.
ADDITIONAL CONSIDERATIONS: PHYSICIAN DUTIES
5. Duty of non-abandonment: Physicians have an obligation to respond to a request for assistance in dying, regardless of how their moral commitment is expressed. Patients should never be abandoned and must always be supported by their physician and other members of their care team. The patient's physician ought to explore the reasons motivating the request and be sensitive to issues of culture and background throughout the dying process, regardless of the decisions the patient makes with respect to assistance in dying. There should be no undue delay in providing access to assistance in dying and all other end-of-life options, either from a clinical, system or facility perspective. For those who choose to provide assistance in dying, the duty of non-abandonment means that physicians have a duty to be available to patients during the act of ending their life. Physicians should be present or immediately available to manage any unexpected complications during the medical procedure, whether the chemical administration is done by the patient or by a regulated practitioner.
6. Duty to support interdisciplinary teams: The CMA advocates that physicians work within, and support other members of, interdisciplinary teams, pay close attention to the impacts of participation and non-participation in medical assistance in dying on their non-physician colleagues, and demonstrate solidarity with their team members as they navigate new legal and ethical territory together.
7. Duty to learners: The CMA recognizes the importance of unique moral considerations within learning environments. Learners are encouraged to reflect on their moral understanding of and views about assistance in dying and to seek a wide range of views and experiences from their patients and from their teachers and colleagues.
ADDRESSING ADHERENCE TO MORAL COMMITMENTS
CMA's position on conscientious participation and conscientious objection aims to harmonize two legitimate considerations: (1) effective patient access to a legally permissible medical service and (2) protection of physicians' freedom of conscience (or moral integrity) in a way that respects differences of conscience.
a. The CMA believes that physicians are not obligated to fulfill a patient's request for assistance in dying but that all physicians are obligated to respond to a patient's request. This means that physicians who choose not to provide or otherwise participate in assistance in dying are:
i. not required to provide it, or to otherwise participate in it, or to refer the patient to a physician or a medical administrator who will provide assistance in dying to the patient; but
ii. are still required to fulfill their duty of non-abandonment by responding to a patient's request for assistance in dying.
There should be no discrimination against a physician who chooses not to provide or otherwise participate in assistance in dying.
b. The CMA believes that physicians are obligated to respond to a patient's request for assistance in dying in a timely fashion. This means that physicians are obligated to, regardless of their beliefs:
i. provide the patient with complete information on all options available, including assistance in dying;
ii. advise the patient on how to access any separate central information, counselling and referral service; and
iii. transfer care of the patient to another physician or another institution, if the patient requests it, for the assessment and treatment of the patient's medical condition and exploration of relevant options. If relevant, such options may include palliative care, mental health care and, if the patient meets the eligibility criteria, provision of assistance in dying. The duty of non-abandonment still applies in all other aspects of the patient's care.
c. Physicians are expected to make available relevant medical records (i.e., diagnosis, pathology, treatment and consults) to the physician accepting care of the patient when authorized by the patient to do so.
d. Physicians are expected to act in good faith. They are expected to never abandon or discriminate against a patient requesting assistance in dying and to not impede or block access to a request for assistance in dying. Physicians should inform their patients of the fact and implications of their conscientious objection. No physician may require a patient to make a commitment not to seek assistance in dying as a condition of acceptance or retention of the patient.
WHAT MEDICAL ASSISTANCE IN DYING (MAID) ENCOMPASSES
1. Medical assistance in dying encompasses the assessment of a patient for eligibility for assistance in dying, deliberation with the patient, accompaniment of the patient through the process of deciding and, if so chosen by the patient, the provision of assistance in dying, which refers to:
a. The administering by a medical practitioner or nurse of a substance to a person, at their request, that causes their death; or
b. The prescribing or providing by a medical practitioner or nurse practitioner of a substance to a person, at their request, so that they may self-administer the substance and in doing so cause their death.
2. The Supreme Court of Canada in Carter used the terms physician-assisted dying and physician-assisted death.
These terms refer to both of the following:
a. Voluntary euthanasia, or physician-administered assistance in dying:
The physician takes the final act that will end the individual's life via, usually, the intravenous administration of a lethal substance, at the request and with the consent of a patient
b. Assisted suicide, or physician-prescribed, self-administered assistance in dying:
An individual performs the final act to end their life by, usually, ingesting a lethal substance prescribed or provided by the physician, at the request and with the consent of the patient.
3. Other commonly used terms are hastened death, physician-administered hastened death and physician-prescribed, patient-administered hastened death.
a. These terms are proposed to make a clear distinction between palliative care and other practices that hasten or bring about death, such as through the legitimate removal of life-sustaining interventions or via the provision or administration of chemicals.
4. Medical aid in dying has a distinct technical and legal meaning within Quebec, described in Bill 52, and is limited to physicians administering the lethal substance at the request of the individual.
WHAT IT DOES NOT ENCOMPASS
1. Palliative care is an integrated approach that aims to relieve suffering and improve the quality of life of those facing life-limiting acute or chronic conditions by means of early identification, assessment and treatment of pain and other symptoms.
2. Continuous palliative sedation therapy1 refers to complete sedation, with the intent of rendering the patient unable to experience the environment, sensation or thoughts, until the patient dies naturally from the underlying illness.
3. Withdrawing or withholding treatment or treatment cessation refers to withdrawing or withholding life-prolonging treatment where it is no longer indicated or desired.
4. Voluntary refusal of hydration and nutrition is the conscious and active choice to refuse and to discontinue food and fluid, orally or parenterally, with the intention of hastening death.
Approved by the CMA Board of Directors May 2017
1 Consensus statement on continuous palliative sedation therapy: www.chpca.net/media/343120/final_cpst_framework.pdf.
Older Canadians represent the fastest-growing segment of our population and are the largest users of prescription drugs. Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. According to the Canadian Institute for Health Information, in 2012, nearly two-thirds of seniors had claims for 5 or more drug classes, and more than one-quarter of seniors had claims for 10 or more drug classes. The number of drugs used by seniors increased with age.
The use of multiple medications, or polypharmacy, is of concern in the senior population. The risk of drug interactions and adverse drug reactions is several-fold higher for seniors than for younger people. This phenomenon is associated with pharmacokinetic and pharmacodynamics factors in seniors, including changes in renal and hepatic function, increased sensitivity to drugs and, potentially, multiple medical problems. In older persons, adverse drug reactions are often complex and may be the direct cause of hospital admissions for acute care. Cognitive and affective disorders, for example, may be due to adverse reactions to sedatives or hypnotic drugs. Chronic pain is a common issue, and it is important to carry out research into and education for health care providers concerning the unique challenges of managing pain in older adults.
The CMA supports the development of a coordinated national approach to reduce polypharmacy and prevent adverse drug reactions. Prescribers must be vigilant to optimize pharmacotherapy and in reconciling medications, taking into consideration physiological changes as a person ages. Deprescribing should be considered, reducing or stopping medications that may be harmful or no longer be of benefit, seeking to improve quality of life.
There has been considerable interest in determining which factors affect prescribing behavior and how best to influence these factors. Strategies that improve prescribing practices include evidence-based drug information provided through academic detailing; objective continuing medical education; accessible, user-friendly decision support tools available at point of care; and electronic prescribing systems that allow physicians access to their patient's treatment and medication profiles.
The following principles define the basic steps to appropriate prescribing for seniors.
Know the patient.
Know the diagnosis.
Know the drug history. Keep a medication list for each patient and review, update, reconcile and evaluate adherence at each visit. Instruct the patient to bring all prescription and over-the-counter medications, including medications prescribed by other physicians, and natural health products, to each appointment. In some provinces, pharmacists conduct medication use reviews for patients on public drug benefit programs.
Know the history of use of other substances such as alcohol, tobacco, cannabis, opioids and caffeine.
Consider non-pharmacologic therapy, including diet, exercise, psychotherapy or community resources. Continuing medical education in specific non-pharmacologic therapies is valuable. For example, evaluation and management of behavioural and psychological symptoms of dementia should be considered before anti-psychotic therapy. As well, Canadian standardized non-pharmacologic order sets should be developed for the treatment of delirium.
Know the drugs. Critically evaluate all sources of drug information and use multiple sources such as clinical practice guidelines, medical journals and databases, continuing medical education and regional drug information centres. Monitor patients continually for adverse drug reactions. Appropriate drug dosage depends on factors such as age, sex, body size, general health, concurrent illnesses and medications, and hepatic, renal and cognitive function (for example, older people are particularly sensitive to drugs that affect the central nervous system).
Keep drug regimens simple. Avoid mixed-frequency schedules when possible. Try to keep the number of drugs used for long-term therapy under five to minimize the chance of drug interactions and improve adherence.
Establish treatment goals. Determine how the achievement of goals will be assessed. Regularly re-evaluate goals, adequacy of response and justification for continuing therapy. Time to benefit of prescribed medications should be a key consideration when providing care to seniors at end of life.
Encourage patients to be responsible medication users. Verify that the patient and, if necessary, the caregiver, understands the methods and need for medication. Recommend the use of daily or weekly medication containers, calendars, diaries or other reminders, as appropriate, and monitor regularly for compliance. Encourage the use of one dispensary.
The Institute for Safe Medication Practices Canada has developed a program, Knowledge is the best medicine (https://www.knowledgeisthebestmedicine.org), that can be helpful to seniors and their healthcare team manage medicines safely and appropriately.
Approved by the Board on May 28, 2011
Update approved by the Board on March 02, 2019
This policy statement provides operational principles for the measurement and management of wait list systems that support timely access to necessary care for patients. This statement is based on the understanding that in order for wait list systems to be effective in improving timely access to medically necessary care for patients, physicians and other providers must be centrally involved and appropriately supported to assist in their development, measurement and management.
Since the late 1990s, Canadians have become increasingly concerned over lengthening wait times to access medically necessary care. As a result, a major focus of the 2004 Health Care Accord (10-Year Agreement to Strengthen Health Care) was to improve timely access to necessary medical care. Since then, provinces and territories have taken steps to measure, monitor and manage patient wait times. However, most efforts thus far to improve wait times have been focused on the wait between the specialist consultation and the scheduled date for treatment. Patients may also experience waits in accessing a family physician (many Canadians do not have a family physician) and waiting to see a specialist following a referral by a family physician.
Canadians deserve timely access to medically necessary care. Governments must ensure that patients are treated within established wait-time benchmarks for all major diagnostic, therapeutic, and surgical services. Physicians recognize that it is desirable to minimize waits and to properly prioritize and manage patients' wait for care by accurately capturing and utilizing wait-time data.
However, there remain serious concerns over the quality of wait-time data and who has the primary responsibility for capturing the data. Physicians and other providers are increasingly being requested to input wait-time data (e.g., length of wait for consultation or for start of treatment). Yet, in many instances, they are expected to do so without the necessary resources and supports.
Outlined below are Operational Principles for the Measurement and Management of Wait Lists developed originally through CMA's Access to Quality Health Care Project(1) with input from public opinion research as well as stakeholder groups, including CMA Core Committees, Provincial-Territorial Medical Associations and CMA Affiliates.
1. To maintain or enhance patients' quality of life and health status through effective development, measurement and management of wait lists.
2. To ensure that the development, measurement and management of wait lists are based on the best available evidence of clinical appropriateness, clinical effectiveness, rational use of resources, clinical need and patient quality of life.
A. Stakeholder Involvement
1. Physicians in clinical practice must have a leadership role:
- in identifying clinically relevant data elements through consensus;
- in developing standard definitions and measures for prioritization for wait lists; and
- in developing wait-time benchmarks.
2. Health care providers and other stakeholders should be involved in the development, measurement, maintenance, monitoring, management and evaluation of wait list systems, and should be appropriately compensated for their time and effort.
B. Database Development and Management Systems
1. Systems for developing and managing wait lists must require and provide reliable, current, useful and valid data and information.
2. Database development and wait list management requires involvement of multidisciplinary panels.
3. Systems for managing wait lists should:
- provide accurate, reliable, timely, publicly accessible and real-time information in a cost-effective manner. Deadlines for inputting data should be reasonable and implemented without the use of threats or penalties;
- collect and assess data on need, quality of life and health outcomes; be flexible and dynamic so that they can adapt over time with the development of new technologies and approaches to treatment; and
- require policies and procedures on confidentiality, so that patients' and providers' privacy are protected.
1. Systems for managing wait lists require initial and sustained investment in dedicated human resources, sophisticated information systems and information technology infrastructure at all levels (e.g., medical offices, hospitals, health regions).
1. The parties involved in managing wait lists must accept their responsibilities and obligations to each other and to the public.
2. Privacy and confidentiality of patient and provider information must be respected.
3. The systems, processes and results for managing wait lists should be widely communicated to obtain stakeholder involvement and support.
1. Systems for managing wait lists must:
- be continually monitored and evaluated to identify opportunities for improvement; and
- regularly undergo independent data audits and evaluations of process and outcome.
1. An independent, stakeholder-based, non-governmental organization with an advisory committee should be responsible for overseeing and administering systems for managing wait lists.
(1) Canadian Medical Association, Access to Quality Health Care Project, January 1998. Ottawa.