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.
Inherent in all health care professional Codes of Ethics is the duty to provide care to patients and to relieve suffering whenever possible. However, this duty does not exist in a vacuum, and depends on the provision of goods and services referred to as reciprocal obligations, which must be provided by governments, health care institutions and other relevant bodies and agencies. The obligation of government and society to physicians can be seen as comparable to the obligations of physicians to their patients.
The recent experience of Canadian physicians during the SARS epidemic in Toronto has heightened the sensitivities of the medical profession to several issues that arose during the course of dealing with that illness. Many of the lessons learned (and the unanswered questions that arose) also apply to the looming threat of an avian flu (or other) pandemic. Canadian physicians may be in a relatively unique position to consider these issues given their experience and insight.
The intent of this working paper is to highlight the ethical issues of greatest concern to practicing Canadian physicians which must be considered during a pandemic. In order to address these issues before they arise, the CMA presents this paper for consideration by individual physicians, physician organizations, governments, policy makers and interested bodies and stakeholders. Although many of the principles and concepts could readily be applied to other health care workers, the focus of this paper will be on physicians.
Policies regarding physicians in training, including medical students and residents, should be clarified in advance by the relevant bodies involved in their oversight and training. Issues of concern would include the responsibilities of trainees to provide care during a pandemic and the potential effect of such an outbreak on their education and training.
A. Physician obligations during a pandemic
The professional obligations of physicians are well spelled out in the CMA Code of Ethics and other documents and publications and are not the main focus of this paper. However, they will be reviewed and discussed as follows.
Several important principles of medical ethics will be of particular relevance in considering this issue. Physicians have an obligation to be beneficent to their patients and to consider what is in the patient's best interest. According to the first paragraph of the CMA Code of Ethics (2004), "Consider first the well-being of the patient".
Traditionally, physicians have also respected the principle of altruism, whereby they set aside concern for their own health and well-being in order to serve their patients. While this has often manifested itself primarily as long hours away from home and family, and a benign neglect of personal health issues, at times more drastic sacrifices have been required. During previous pandemics, many physicians have served selflessly in the public interest, often at great risk to their own well-being.
The principle of justice requires physicians to consider what is owed to whom and why, including what resources are needed, and how these resources would best be employed during a pandemic. These resources might include physician services but could also include access to vaccines and medications, as well as access to equipment such as ventilators or to a bed in the intensive care unit. According to paragraph 43 of the CMA Code of Ethics, physicians have an obligation to "Recognize the responsibility of physicians to promote equitable access to health care resources".
In addition, physicians can reasonably be expected to participate in the process of planning for a pandemic or other medical disaster. According to paragraph 42 of the CMA Code of Ethics, physicians should "Recognize the profession's responsibility to society in matters relating to public health, health education, environmental protection, legislation affecting the health and well-being of the community and the need for testimony at judicial proceedings". This responsibility could reasonably be seen to apply both to individual physicians as well as the various bodies and organizations that represent them.
Physicians also have an ethical obligation to recognize their limitations and the extent of the services they are able to provide. During a pandemic, physicians may be asked to assume roles or responsibilities with which they are not comfortable, nor prepared. Paragraph 15 of the CMA Code of Ethics reminds physicians to "Recognize your limitations and, when indicated, recommend or seek additional opinions or services".
However, physicians have moral rights as well as obligations. The concept of personal autonomy allows physicians some discretion in determining where, how and when they will practice medicine. They also have an obligation to safeguard their own health. As stated in paragraph 10 of the CMA Code of Ethics, physicians should "Promote and maintain your own health and well-being".
The SARS epidemic has served to reopen the ethical debate. Health care practitioners have been forced to reconsider their obligations during a pandemic, including whether they must provide care to all those in need regardless of the level of personal risk. As well, they have been re-examining the obligation of governments and others to provide reciprocal services to physicians, and the relationship between these obligations.
B. Reciprocal obligations towards physicians
While there has been much debate historically (and especially more recently) about the ethical obligations of physicians towards their patients and society in general, the consideration of reciprocal obligations towards physicians is a relatively recent phenomenon.
During the SARS epidemic, a large number of Canadian physicians unselfishly volunteered to assist their colleagues in trying to bring the epidemic under control. They did so, in many cases, in spite of significant personal risk, and with very little information about the nature of the illness, particularly early in the course of the outbreak. Retrospective analysis has cast significant doubt and concern on the amount of support and assistance provided to physicians during the crisis. Communication and infrastructure support was poor at best. Equipment was often lacking and not always up to standard when it was available. Psychological support and counselling was not readily available at the point of care, nor was financial compensation for those who missed work due to illness or quarantine. Although the Ontario government did provide retrospective compensation for many physicians whose practices were affected by the outbreak, the issue was addressed late, and not at all in some cases.
It is clear that Canadian physicians have learned greatly from this experience. The likelihood of individuals again volunteering "blindly" has been reduced to the point where it may never happen again. There are expectations that certain conditions and obligations will be met in order to optimize patient care and outcomes and to protect health care workers and their families.
Because physicians and other health care providers will be expected to put themselves directly in harm's way, and to bear a disproportionate burden of the personal hardships associated with a pandemic, the argument has been made that society has a reciprocal obligation to support and compensate these individuals.
According to the University of Toronto Joint Centre for Bioethics report We stand on guard for thee, "(The substantive value of) reciprocity requires that society support those who face a disproportionate burden in protecting the public good, and take steps to minimize burdens as much as possible. Measures to protect the public good are likely to impose a disproportionate burden on health care workers, patients and their families."
Therefore, in order to provide adequate care for patients, the reciprocal obligation to physicians requires providing some or all of the following:
Prior to a pandemic
- Physicians and the organizations that represent them should be more involved in planning and decision making at the local, national and international levels. In turn, physicians and the organizations that represent them have an obligation to participate as well.
- Physicians should be made aware of a clear plan for resource utilization, including:
- how physicians will be relieved of duties after a certain time;
- clearly defined roles and expectations, especially for those practicing outside of their area of expertise;
- vaccination/treatment plans - will physicians (and their families) have preferential access based on the need to keep caregivers healthy and on the job;
- triage plans, including how the triage model might be altered and plans to inform the public of such.
- Physicians should have access to the best equipment needed and should be able to undergo extra training in its use if required.
- Politicians and leaders should provide reassurances that satisfy physicians that they will not be "conscripted" by legislation.
During a pandemic
- Physicians should have access to up-to-date, real time information.
- Physicians should be kept informed about developments in Canada and globally.
- Communication channels should be opened with other countries (e.g. Canada should participate in WHO initiatives to identify the threats before they arrive on our doorstep).
- Resources should be provided for backup and relief of physicians and health care workers.
- Arrangements should be made for timely provision of necessary equipment in an ongoing fashion.
- Physicians should be compensated for lost clinical earnings and to cover expenses such as lost wages, lost group earnings, overhead, medical care, medications, rehabilitative therapy and other relevant expenses in case of quarantine, clinic cancellations or illness (recognizing that determining exactly when or where an infection was acquired may be difficult).
- Families should receive financial compensation in the case of a physician family member who dies as a result of providing care during a pandemic.
- In the event that physicians may be called upon in a pandemic to practice outside of their area of expertise or outside their jurisdiction, they should to contact their professional liability protection provider for information on their eligibility for protection in these circumstances.
- Interprovincial or national licensing programs should be developed to provide physicians with back-up and relief and ensure experts can move from place to place in a timely fashion without undue burden.
- Psychological and emotional counselling and support should be provided in a timely fashion for physicians, their staff and family members.
- Accommodation (i.e. a place to stay) should be provided for physicians who have to travel to another locale to provide care; or who don't want to go home and put their family at risk, when this is applicable, i.e. the epidemiology of the infectious disease causing the pandemic indicates substantially greater risk of acquiring infection in the health care setting than in the community.
- Billing and compensation arrangements should ensure physicians are properly compensated for the services they are providing, including those who may not have an active billing number in the province where the services are being provided.
After a pandemic
- Physicians should receive assistance in restarting their practice (replacing staff, restocking overhead, communicating with patients, and any other costs related to restarting the practice).
- Physicians should receive ongoing psychological support and counselling as required.
C. How are physician obligations and reciprocal obligations related?
Beyond a simple statement of the various obligations, it is clear that there must be some link between these different obligations. This is particularly important since there is now some time to plan for the next pandemic and to ensure that reciprocal obligations can be met prior to its onset. Physicians have always provided care in emergency situations without questioning what they are owed. According to paragraph 18 of the CMA Code of Ethics, physicians should "Provide whatever appropriate assistance you can to any person with an urgent need for medical care".
However, in situations where obligations can be anticipated and met in advance, it is reasonable to expect that they will be addressed. Whereas a physician who encounters an emergency situation at the site of a car crash will act without concern for personal gain or motivation, a physician caring for the same patient in an emergency department will rightly expect the availability of proper equipment and personnel.
In order to ensure proper patient care and physician safety, and to ensure physicians are able to meet their professional obligations and standards, the reciprocal obligations outlined above should be addressed by the appropriate body or organization.
If patient and physician well-being is not optimized by clarifying the obligations of physicians and society prior to the next pandemic, in spite of available time and resources necessary to do so, there are many who would call into question the ethical duty of physicians to provide care. However, the CMA believes that, in the very best and most honourable traditions of the medical profession, its members will provide care and compassion to those in need. We call on governments and society to assist us in optimizing this care for all Canadians.
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public.
Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general.
Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another.
Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents.
Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit).
Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice.
Testing: Any discussion of drug testing must take the following into account:
If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed.
The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing.
The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work.
If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen.
The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons:
Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society.
The mass, low-cost screening tests may not be reliable or valid.
The circumstances may not justify possible human rights violations.
Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable.
Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing.
CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY
The history of health care delivery in Canada has included interaction between physicians and the pharmaceutical and health supply industries; this interaction has extended to research as well as to education. Physicians understand that they have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible and appropriately manage these situations when necessary. They understand as well the need for the profession to lead by example by promoting physician-developed guidelines.
The following guidelines have been developed by the CMA to serve as a resource tool for physicians in helping them to determine what type of relationship with industry is appropriate. They are not intended to prohibit or dissuade appropriate interactions of this type, which have the potential to benefit both patients and physicians.
Although directed primarily to individual physicians, including residents, and medical students, the guidelines also apply to relationships between industry and medical organizations.
1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians.
2. Relationships between physicians and industry are guided by the CMA's
Code of Ethics and by this document.
3. The practising physician's primary obligation is to the patient. Relationships with industry are inappropriate if they negatively affect the fiduciary nature of the patient-physician relationship.
4. Physicians should resolve any conflict of interest between themselves and their patients resulting from interactions with industry in favour of their patients. In particular, they must avoid any self-interest in their prescribing and referral practices.
5. Except for physicians who are employees of industry, in relations with industry the physician should always maintain professional autonomy and independence. All physicians should remain committed to scientific methodology.
6. Those physicians with ties to industry have an obligation to disclose those ties in any situation where they could reasonably be perceived as having the potential to influence their judgment.
7. A prerequisite for physician participation in all research activities is that these activities are ethically defensible, socially responsible and scientifically valid. The physician's primary responsibility is the well-being of the patient.
8. The participation of physicians in industry sponsored research activities must always be preceded by formal approval of the project by an appropriate ethics review body. Such research must be conducted according to the appropriate current standards and procedures.
9. Patient enrolment and participation in research studies must occur only with the full, informed, competent and voluntary consent of the patient or his or her proxy, unless the research ethics board authorizes an exemption to the requirement for consent. In particular, the enrolling physician must inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of the physician's participation and must advise prospective subjects that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care.
10. The physician who enrolls a patient in a research study has an obligation to ensure the protection of the patient's privacy, in accordance with the provisions of applicable national or provincial legislation and CMA's Health Information Privacy Code. If this protection cannot be guaranteed, the physician must disclose this as part of the informed consent process.
11. Practising physicians should not participate in clinical trials unless the study will be registered prior to its commencement in a publicly accessible research registry.
12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid.
13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study and obtain informed consent for submission of patient information may be remunerated for this activity.
14. Incremental costs (additional costs that are directly related to the research study) must not be paid by health care institutions or provincial or other insurance agencies regardless of whether these costs involve diagnostic procedures or patient services. Instead, they must be assumed by the industry sponsor or its agent.
15. When submitting articles to medical journals, physicians must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure. Funding sources for the study should also be disclosed.
16. Physicians should only be included as an author of a published article reporting the results of an industry sponsored trial if they have contributed substantively to the study or the composition of the article.
17. Physicians should not enter into agreements that limit their right to publish or disclose results of the study or report adverse events which occur during the course of the study. Reasonable limitations which do not endanger patient health or safety may be permissible.
Industry-Sponsored Surveillance Studies
18. Physicians should participate only in post-marketing surveillance studies that are scientifically appropriate for drugs or devices relevant to their area of practice and where the study may contribute substantially to knowledge about the drug or device. Studies that are clearly intended for marketing or other purposes should be avoided.
19. Such studies must be reviewed and approved by an appropriate research ethics board. The National Council on Ethics in Human Research is an additional source of advice.
20. The physician still has an obligation to report adverse events to the appropriate body or authority while participating in such a study.
Continuing Medical Education / Continuing Professional Development (CME/CPD)
21. This section of the Guidelines is understood to address primarily medical education initiatives designed for practicing physicians. However, the same principles will also apply for educational events (such as noon-hour rounds and journal clubs) which are held as part of medical or residency training.
22. The primary purpose of CME/CPD activities is to address the educational needs of physicians and other health care providers in order to improve the health care of patients. Activities that are primarily promotional in nature, such as satellite symposia, should be identified as such to faculty and attendees and should not be considered as CME/CPD.
23. The ultimate decision on the organization, content and choice of CME/CPD activities for physicians shall be made by the physician-organizers.
24. CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity, objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to the participants at their CME/CPD events any financial affiliations with manufacturers of products mentioned at the event or with manufacturers of competing products. There should be a procedure available to manage conflicts once they are disclosed.
25. The ultimate decision on funding arrangements for CME/CPD activities is the responsibility of the physician-organizers. Although the CME/CPD publicity and written materials may acknowledge the financial or other aid received, they must not identify the products of the company(ies) that fund the activities.
26. All funds from a commercial source should be in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity.
27. Industry representatives should not be members of CME content planning committees. They may be involved in providing logistical support.
28. Generic names should be used in addition to trade names in the course of CME/CPD activities.
29. Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA's Code of Ethics, which prohibits endorsement of a specific product.
30. If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of this fact.
31. Negotiations for promotional displays at CME/CPD functions should not be influenced by industry sponsorship of the activity. Promotional displays should not be in the same room as the educational activity.
32. Travel and accommodation arrangements, social events and venues for industry sponsored CME/CPD activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME/CPD event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. Hospitality and other arrangements should not be subsidized by sponsors for personal guests of attendees or faculty, including spouses or family members.
33. Faculty at CME/CPD events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. All attendees at an event cannot be designated faculty. Faculty indicates a presenter who prepares and presents a substantive educational session in an area where they are a recognized expert or authority.
Electronic Continuing Professional Development (eCPD)
34. The same general principles which apply to "live, in person" CPD events, as outlined above, also apply to eCPD (or any other written curriculum-based CPD) modules. The term "eCPD" generally refers to accredited on-line or internet-based CPD content or modules. However, the following principles can also apply to any type of written curriculum based CPD.
35. Authors of eCPD modules are ultimately responsible for ensuring the content and validity of these modules and should ensure that they are both designed and delivered at arms'-length of any industry sponsors.
36. Authors of eCPD modules should be physicians with a special expertise in the relevant clinical area and must declare any relationships with the sponsors of the module or any competing companies.
37. There should be no direct links to an industry or product website on any web page which contains eCPD material.
38. Information related to any activity carried out by the eCPD participant should only be collected, used, displayed or disseminated with the express informed consent of that participant.
39. The methodologies of studies cited in the eCPD module should be available to participants to allow them to evaluate the quality of the evidence discussed. Simply presenting abstracts that preclude the participant from evaluating the quality of evidence should be avoided. When the methods of cited studies are not available in the abstracts, they should be described in the body of the eCPD module.
40. If the content of eCPD modules is changed, re-accreditation is required.
41. Physicians may be approached by industry representatives and asked to become members of advisory or consultation boards, or to serve as individual advisors or consultants. Physicians should be mindful of the potential for this relationship to influence their clinical decision making. While there is a legitimate role for physicians to play in these capacities, the following principles should be observed:
A. The exact deliverables of the arrangement should be clearly set out and put in writing in the form of a contractual agreement. The purpose of the arrangement should be exclusively for the physician to impart specialized medical knowledge that could not otherwise be acquired by the hiring company, and should not include any promotional or educational activities on the part of the company itself.
B. Remuneration of the physician should be reasonable and take into account the extent and complexity of the physician's involvement.
C. Whenever possible, meetings should be held in the geographic locale of
the physician or as part of a meeting which he/she would normally attend. When these arrangements are not feasible, basic travel and accommodation expenses may be reimbursed to the physician advisor or consultant. Meetings should not be held outside of Canada, with the exception of international boards.
Clinical Evaluation Packages (Samples)
42. The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated.
43. Physicians who accept samples or other health care products are responsible for recording the type and amount of medication or product dispensed. They are also responsible for ensuring their age-related quality and security and their proper disposal.
44. Practising physicians should not accept personal gifts of any significant monetary or other value from industry. Physicians should be aware that acceptance of gifts of any value has been shown to have the potential to influence clinical decision making.
45. These guidelines apply to relationships between physicians and all commercial organizations, including but not limited to manufacturers of medical devices, nutritional products and health care products as well as service suppliers.
46. Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party, and then only on a cost-recovery basis.
47. Physicians should not invest in industries or related undertakings if this might inappropriately affect the manner of their practice or their prescribing behaviour.
48. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately.
49. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers or distributors in exchange for seeing them in a promotional or similar capacity.
50. Practising physicians may accept patient teaching aids appropriate to their area of practice provided these aids carry at most the logo of the donor company and do not refer to specific therapeutic agents, services or other products.
Medical Students and Residents
51. The principles in these guidelines apply to physicians-in training as well as to practising physicians.
52. Medical curricula should deal explicitly with the guidelines by including educational sessions on conflict of interest and physician-industry interactions.