ACHIEVING PATIENT-CENTRED COLLABORATIVE CARE
The Canadian Medical Association (CMA) recognizes that collaborative care is a desired and necessary part of health care delivery in Canada and an important element of quality, patient-centred care. The CMA considers patient-centred care to be the cornerstone of good medical practice. This is reflected in the first principle of the CMA Code of Ethics, which states that physicians have a fundamental responsibility to "Consider first the well-being of the patient." As patient advocates, physicians strive to ensure that their patients receive the best possible care.
The CMA supports greater collaboration among providers in the interest of better patient care. In the context of clinical practice, the CMA defines collaborative care as follows:
"Collaborative care entails physicians and other providers using complementary skills, knowledge and competencies and working together to provide care to a common group of patients based on trust, respect and an understanding of each others' skills and knowledge. This involves a mutually agreed upon division of roles and responsibilities that may vary according to the nature of the practice personalities and skill sets of the individuals. The relationship must be beneficial to the patient, and acceptable to the physician and other providers.
If designed appropriately, collaborative care models have the potential to:
* improve access to care;
* enhance the quality and safety of care;
* enhance the coordination and efficiency of care; and
* enhance provider morale and reduce burnout within health professions.
To realize this full potential, the profession acknowledges and accepts that it has a central role to play in the evolution of a team-based approach to care.
These policy principles have been prepared by the Canadian Medical Association in order to ensure that the evolution of collaborative care in Canada is built around the needs of individual patients and groups of patients. This policy is founded on the CMA's document, Putting Patients' First: Patient-Centred Collaborative Care - A Discussion Paper.
Principles for Collaborative Care
The medical profession supports collaborative care, both in the hospital and in the community, as one of the essential elements of health care delivery in Canada. In the interests of enhancing the evolution of patient-centred collaborative care, the CMA proposes the following "critical success factors" and principles to address meaningfully the issues and barriers identified by physicians and bring clarity to the discussions.
1. PATIENT-CENTRED CARE
First and foremost, medical care delivered by physicians and health care delivered by others should be aligned around the values and needs of patients.
Collaborative care teams should foster and support patients, and their families, as active participants in their health care decision-making. New models should have the potential to empower patients to enhance their role in prevention and self-care.
Models of collaborative care must be designed to meet the needs of patients.
Collaborative models of practice must reduce fragmentation and enhance the quality and safety of care provided to patients.
It is the patient who ultimately must make informed choices about the care he or she will receive.
2. RECOGNITION OF THE PATIENT-PHYSICIAN RELATIONSHIP
The mutual respect and trust derived from the patient-physician relationship is the cornerstone of medical care. This trust is founded on the ethical principles that guide the medical profession as defined in the CMA Code of Ethics. The impact of collaborative models of practice on this relationship, and hence the patient's satisfaction and experience with their care, is unknown.
Models of collaborative care must support the patient-physician relationship.
Entry into and exit from a formal collaborative care arrangement must be voluntary for both the patient and the physician.
A common Code of Ethics should guide the practice of collaborative care teams.
Every resident of Canada has the right to access a personal family physician. †
3. PHYSICIAN AS THE CLINICAL LEADER
Effective teams require effective leadership. A defined clinical leader is required to ensure proper functioning of the team and to facilitate decision-making, especially in complex or emergent situations. In collaborative care the clinical leader is responsible for maximizing the expertise and input of the entire team in order to provide the patient with comprehensive and definitive care.
It is important to differentiate "clinical leadership" from "team coordination."
The CMA defines a clinical leader as:
"The individual who, based on his or her training, competencies and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient. The clinical leader is ultimately accountable to the patient for making definitive clinical decisions."
Whereas, the team coordinator is defined as:
"The individual, who, based on his or her training, competencies and experience, is best able to coordinate the services provided by the team so that they are integrated to provide the best care for the patient."
The concept of "most responsible physician" has been and continues to be used to identify the individual who is ultimately responsible for the care of the patient. The "most responsible physician" is responsible for collecting, synthesizing and integrating the expert opinion of physician and non physician team members to determine the clinical management of the patient. Similarly, the presence of a defined clinical leader in a collaborative care setting creates clarity for patients, their families and the health care team by making lines of communication and responsibility clear, ultimately improving the quality and safety of care.
In the CMA's opinion, the physician is best equipped to provide clinical leadership. This does not necessarily imply that a physician must be the team coordinator. Many teams will exist in which the physician will have a supporting role, including those focused on population health and patient education. We believe the most effective teams are ones in which the leadership roles have been clearly defined and earned. Some physicians may be prepared to play both roles; however, other members of the team may be best suited to serve as team coordinator.
Currently, patients rely on, and expect, physicians to be clinical leaders in the assessment and delivery of the medical care they receive. In a collaborative care environment this expectation of physician leadership will not change. Team members will have specific knowledge and expertise in their respective disciplines. Physicians, by virtue of their broad and diverse knowledge, training and experience, have a unique appreciation of the full spectrum of health and health care delivery in their field of practice and are therefore best qualified to evaluate and synthesize diverse professional perspectives to ensure optimal patient care.
The physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume the role of clinical leader in collaborative care teams. There may be some situations in which the physician may delegate clinical leadership to another health care professional. Other health care professionals may be best suited to act as team coordinator.
4. MUTUAL RESPECT AND TRUST
Trust between individuals and provider groups evolves as knowledge and understanding of competencies, skills and scopes of practice are gained. Trust is also essential to ensuring that the team functions efficiently and maximizes the contributions of all members.
Funders and providers should recognize the importance of team building in contributing to team effectiveness. Collaborative care funding models should support a more formalized and integrated approach to both change management and team building.
As relationships are strengthened within the team, so too are trust and respect. Physicians and all team members have an opportunity to be positive role models to motivate and inspire their colleagues. All team members ought to make a commitment to respect and trust each other with the knowledge that it will lead to enhanced care for patients and a more productive work environment for all.
To serve the health care needs of patients, there must be a collaborative and respectful interaction among health care professionals, with recognition and understanding of the contributions of each provider to the team.
In order to build trust and respect within the team it is essential that members understand and respect the professional responsibility, knowledge and skills that come with their scope of practice within the context of the team.
5. CLEAR COMMUNICATION
In collaborative care environments, it is essential that all members of the team communicate effectively to provide safe and optimal care. Effective communication is essential to ensure safe and coordinated care as the size of the team expands to meet patient needs. It is the responsibility of all team members to ensure that the patient is receiving timely, clear and consistent messaging.
Physicians can take a leadership role in modeling effective communications throughout the team. In particular, there is an opportunity to enhance the consultation and referral process, in order to provide clear and concise instructions to colleagues and optimize care. Sufficient resources, including dedicated time and support, must be available to the team to maximize these communication requirements.
Effective communication within collaborative care teams is critical for the provision of high quality patient care. Planning, funding and training for collaborative care teams must include measures to support communication within these teams.
Mechanisms must be in place within a collaborative team to ensure that both the patients, and their caregiver(s) where appropriate, receive timely information from the most appropriate provider.
Effective and efficient communications within the collaborative care team, both with the patient and among team members, should be supported by clear documentation that identifies the author.
A common, accessible patient record in collaborative care settings is desirable to ensure appropriate communication between physicians and other health care professionals, to prevent duplication, coordinate care, share information and protect the safety of patients.
An integrated electronic health record is highly desirable to facilitate communication and sharing among team members.
6. CLARIFICATION OF ROLES AND SCOPES OF PRACTICE
In order for the team to function safely and efficiently, it is critically important that the scope of practice, roles and responsibilities of each health care professional on the team be clearly defined and understood. In turn, the patient, as a team member, should also have a clear understanding of the roles and scopes of practice of their providers.
Collaborative care must first and foremost serve the needs of patients, with the goal of enhancing patient care; collaborative care is not contingent upon altering the scope of practice of any provider group and must not be used as a means to expand the scope of practice and/or independence of a health professional group.
Changes in the scope of practice of all provider groups must be done with oversight from the appropriate regulatory authority.
Where non-physicians have been provided with an opportunity to undertake activities related to patient care typically unique to the practice of medicine (e.g., ordering tests), they must not do so independently but undertake these activities within the context of the team and in a manner acceptable to the clinical leader.
The role and scope of practice of each member of the collaborative care team should be clearly understood and delineated in job descriptions and employment contracts.
A formal process for conflict resolution should be in place so that issues can be dealt with in a timely and appropriate manner.
7. CLARIFICATION OF ACCOUNTABILITY AND RESPONSIBILITY
In the context of providing optimal care, providers must be accountable and responsible for the outcome of their individual practice, while sharing responsibility for the proper functioning of the collaborative care team. This individual responsibility is required so that regardless of the number and diversity of providers involved in the team, patients can be assured that their well-being is protected and that the team is working toward a common goal.
In collaborative care teams, a physician should be identified as the person most responsible for the clinical care of individual patients, and as such must be accountable for the care rendered to patients. This is consistent with the commitment made by the physician in the doctor-patient relationship, mirrors the clinical training of the physician relative to other providers, is reflective of the current state of tort law as it applies to medical practice, and is compatible with the structure of care delivery in hospitals and in the community. Clearly, this type of arrangement does not eliminate the necessity for all providers to be accountable for the care that they provide.
It is essential that all providers be responsible and accountable for the care that they provide and for the well-being of the patient.
As clinical leader, the physician should be responsible for the clinical oversight of an individual patient's care.
8. LIABILITY PROTECTION FOR ALL MEMBERS OF THE TEAM
As discussed earlier in this paper, the resolution of the multiplicity of liability issues that result from care delivered by teams requires clearly defined roles and responsibilities in the team setting and the absolute requirement for appropriate and sufficient liability coverage for each health professional. The August 2006 statement of the Canadian Medical Protective Association, Collaborative Care: A medical liability perspective, identifies issues of concern to physicians and proposes solutions to reduce those risks.
All members of a collaborative care team must have adequate professional liability protection and/or insurance coverage to accommodate their scope of practice and their respective roles and responsibilities within the collaborative care team.
Physicians, in their role as clinical leaders of collaborative care teams, must be satisfied with the ongoing existence of appropriate liability protection as a condition of employment of, or affiliation with, other members on collaborative care teams.
Formalized procedures should be established to ensure evidence of this liability protection.
9. SUFFICIENT HUMAN RESOURCES AND INFRASTRUCTURE
Collaborative models of health care delivery hold the promise of enhancing access to care for patients at a time of serious health human resource shortages. However, effective patient-centred collaborative care depends on an adequate supply of physicians, nurses and other providers. Governments and decision-makers must continue to enhance their efforts to increase the number of physicians and nurses available to provide health care services.
Collaborative care should not be seen as an opportunity for governments to substitute one care provider for another simply because one is more plentiful or less costly than the other.
In addition, governments must understand that co-location of individuals in a team is not a requirement for all collaborative care. Where team co-location does not exist, appropriate resources must be dedicated to ensure communication can be timely, effective and appropriate between providers.
Governments, at all levels, must address the serious shortage of physicians to ensure quality patient care for Canadians.
The effective functioning of a collaborative care team depends on the contribution of a physician.
Governments must enhance access to medical care by increasing the number of physicians and providers, and not by encouraging or empowering physician substitution.
10. SUFFICIENT FUNDING & PAYMENT ARRANGEMENTS
Funding must be present to support all aspects of the development of collaborative care teams. At the practice level, remuneration methods for physicians, irrespective of their specialty, must be available to facilitate collaborative care arrangements and environments in which physicians practice. All care delivery models, including collaborative care teams, must have access to adequate and appropriate resources. This includes, but should not be limited to, funding for health human resources, administration/management infrastructure, liability protection, clinical and team/administrative training, team building, and information technology.
Remuneration models should be established in a manner that encourages providers to participate effectively in the delivery of care and team effectiveness.
Reimbursement models must be configured to remunerate the communicator, coordinator, manager, and other roles and responsibilities of providers necessary for the success of collaborative care practice.
The ability of a physician to work in a collaborative care team must not be based on the physician's choice of remuneration. Similarly, patients should not be denied access to the benefits of collaborative practice as a result of the physician's choice of payment model.
Collaborative care relationships between physicians and other health care providers should continue to be encouraged and enhanced through appropriate resource allocation at all levels of the health care system.
Physicians should be appropriately compensated for all aspects of their clinical care and leadership activities in collaborative care teams.
Physicians should not be expected to incur the cost of adopting and maintaining health information technology capabilities that facilitate their ability to participate in collaborative practice teams. Governments must fund and support in an ongoing manner, both financially and technically, the development and integration of electronic health records.
11. SUPPORTIVE EDUCATION SYSTEM
Canada is renowned for a quality medical education system and for the early efforts to enhance interprofessional training. The success of collaborative care requires a commitment towards interprofessional education and is contingent upon the positive attitudes and support of educators. To facilitate a sustainable shift toward collaborative practice, these efforts must be continued and enhanced in a meaningful way. However, governments and educators must ensure that the availability and quality of medical education is not compromised for medical trainees.
Interprofessional education, at the undergraduate, postgraduate and continuing education levels, is necessary to facilitate a greater understanding of the potential roles, responsibilities and capabilities of health professions, with the overall goal of building better health care teams founded on mutual respect and trust.
Governments must understand the importance of interprofessional education and fund educational institutions appropriately to meet these new training needs.
Educational opportunities must exist at all levels of training to acquire both clinical knowledge and team effectiveness/leadership training.
Interprofessional education opportunities must not come at the expense of core medical training. High quality medical education must be available to all medical trainees as a first priority.
12. RESEARCH AND EVALUATION
More research and evaluations are necessary to demonstrate the benefits of collaborative care, to foster greater adoption by providers and to attract the necessary investment by governments. Quality management systems must be built into the team to ensure efficiencies can be recorded. Measures of the quality of care, cost effectiveness and patient and provider satisfaction should be evaluated.
Research into the effectiveness of collaborative care models on health outcomes, patient and provider satisfaction and health care cost effectiveness should be ongoing, transparent and supported by governments.
Quality assessment measures must be incorporated into the ongoing work of collaborative care teams.
† Where the term "family physician" is used, it is also meant to include general practitioners.
Antimicrobials (which include antibiotics) are a precious public resource and an essential tool for fighting infections in both humans and animals. Their importance to human medical, nutritional and economic security cannot be understated. Yet globally, antimicrobials are losing their effectiveness more quickly than new such drugs, treatments and therapies are being identified and introduced to market.1 Over time, this dynamic has eroded the human antimicrobial arsenal, placing the lives and futures of an unacceptable number of people at risk.
Antimicrobial resistance (AMR) occurs when microorganisms such as bacteria, viruses, fungi and parasites come into contact with antimicrobial drugs, such as antibiotics, antivirals, antifungals, antimalarials and anthelmintics, and undergo changes. The drugs are rendered ineffective and cannot eradicate infections from the body.
AMR is an international challenge that threatens to reverse over a century of progress in public health, health care and human development attributable to antimicrobial use. Indeed, the effects of AMR are already being felt across Canada’s health care system. Currently, Canada’s dedicated investment in solutions to militate against encroaching AMR in the AMR and antimicrobial stewardship (AMS) fields (both federally and provincially/territorially) can only be viewed as wholly inadequate to address the scope of the problem and the risks it poses for the health of Canadians.
Therefore, to: (1) promote awareness of AMR; (2) incentivize investment in AMR mitigation strategies; and (3) support the mobilization of an effective suite of more clinically effective management/treatment practices and policies, the following target audience recommendations are offered.a
a All the policy recommendations made in this document are not meant to be interpreted as clinical practice guidelines. Any individual who suspects they may have an infection should promptly consult a physician.
Key AMR principle — the “One Health” approach
a) The complexity of AMR underscores the need for coordinated action known as the “One Health” approach. The term implies integrated strategies that span the human, animal/agricultural and environmental sectors. Thus, cooperation across a wide variety of stakeholders is necessary to address the collective nature of AMR. These stakeholders include governments, health professionals, private and public partners, and the public at large.
b) The One Health approach will require attention and investment in the following domains: (1) surveillance of antimicrobial prescribing and usage; (2) infection prevention and control practices that mitigate the spread of resistant pathogens; (3) stewardship programs and practices that educate health professionals, the public, and the private sector and nudge each into more appropriate patterns of supply and demand; and (4) a program of innovation, research and development focused on diagnostics, vaccines and alternative treatments to reduce reliance on antimicrobials. This includes the development of novel antimicrobials that expand the currently available arsenal.
c) Given the global dimensions of AMR, a successful One Health approach will require ambitious investments in global AMR mitigation. Given that health infrastructure and resources are limited in low- to middle-income countries, the impacts of AMR will primarily be felt in those settings.
1. Physicians and allied health professionals
a) Be aware that AMR is a serious public health crisis.
b) Know that various Canadian prescribing aides/guidelines are available to assist physicians in choosing appropriate antibiotics and improving practice (e.g., Choosing Wisely Canada).
c) Know that using antibiotics appropriately can help combat AMR and that diagnosis and laboratory testing play a key role. This includes only prescribing antibiotics for conditions that are clinically infectious and of a non-viral nature. Viral infections are the greatest source of antibiotic misuse.
d) Consider delayed prescriptions and/or prioritize follow-up for patients when diagnosis is initially undifferentiated or when symptoms worsen, progress or are prolonged.
e) Know that prevention of infections through hand hygiene, vaccination and appropriate use of antibiotic prophylaxis is evidence based and effective
f) Know that durations of therapy and dosage rates for treating many infections change with time and that you should prescribe antimicrobials for the shortest effective duration (using the narrowest spectrum possible).
g) Consider the potential side effects of antibiotics (including C. difficile and allergic reactions) in prescribing and when counselling patients as to their potential side effects.
h) Engage in conversations with patients about antimicrobials regarding:
i. their appropriate use;
ii. their potential risks;
iii. when to delay, begin or end an antimicrobial prescription (e.g., delayed prescriptions); and
iv. when to seek medical reassessment if symptoms worsen or persist.
i) Ask your local hospital or specialty organization about educational initiatives related to antibiotic prescribing.
j) Collaborate where possible with colleagues in other prescribing professions to reduce unnecessary antimicrobial use.
2. Patients and the Canadian public
a) Be aware that AMR is a significant problem that is linked to the inappropriate use of antimicrobials like antibiotics. Therefore, commit to only taking antibiotics if they are prescribed and only as directed by an authorized health professional.
i. Never share, or use, the antibiotics of others as it may contribute to AMR and have serious consequences for your health.
b) Consider that your expectations about antimicrobials may unduly pressure physicians, and other prescribers, to provide you a prescription when an antimicrobial would not be appropriate or helpful.
c) Engage in a conversation with prescribers about:
i. whether an antimicrobial is necessary;
ii. the risks associated with taking an antimicrobial;
iii. whether there are simpler and safer options to pursue; and
iv. when you should take further actions if your symptoms worsen or do not improve.
d) Rather than keeping antimicrobials in your medicine cabinet, throwing them in the garbage/toilet or sharing them with family or friends, practise a One Health mindset. Dispose of all unused and expired antimicrobials at your local pharmacy. This will limit the spread of resistance and prevent antimicrobials from finding their way into the environment.
e) Help limit resistance by staying up to date with all recommended vaccinations, and practise good hand hygiene.
f) If you or a family member have had personal experiences with AMR, consider sharing them with local politicians (provincial/territorial and federal).
3. Governments (federal, provincial/territorial)
a) (Including internationally) immediately make substantial, long term, coordinated and directly dedicated financial investments in AMR and AMS. Specific areas to prioritize include:
i. AMR and AMS awareness campaigns targeted to the public;
ii. campaigns that support health professionals to incorporate AMS principles into their everyday practice;
iii. detailed, and integrated, action plans based on clear metrics of success and that address the needs of communities, primary care practitioners, patients and health care organizations (including long-term care facilities);
iv. practical surveillance of antimicrobial resistance, purchasing, prescribing and use that maximizes the opportunity to respond to changing landscapes;
v. studying in detail the links, and associated risks, between animal health and agricultural practices and human health;
vi. scaling up local AMS initiatives at the provincial/territorial and national health care delivery levels;
vii. pharmaceutical development pipelines and non-pharmacological treatment options for AMR infections;
viii. inexpensive, accurate and timely point-of-care diagnostic tests (usable in the community, at the bedside or in a clinic) to optimize prescribing; and
ix. fostering clinical research, development and innovation in the fields of AMR and AMS.
b) Scale up coordination between federal and provincial/territorial AMR and AMS activities.
c) Hold regular, high-level meetings of ministers of health, agriculture and finance (both federally and provincially/territorially) to discuss the implications of unchecked AMR and how best to mobilize public finances to address it.
d) Strongly consider an arms-length, national-level taskforce to address AMR and AMS.
e) Strengthen the roles of the chief public health officer and the provincial/territorial chief medical officers in addressing AMR and AMS.
f) Undertake a timely review of the Canadian Antimicrobial Resistance Surveillance System (CARRS) with an emphasis on:
i. scaling up the system;
ii. standardizing all AMR reporting metrics across the country; and
iii. injecting adequate resources into AMR surveillance and tracking antimicrobial usage rates.
g) Establish a permanent review body on infectious disease, including pharmacists, microbiologist and other experts, to evaluate the forthcoming Pan-Canadian Action Plan on AMR and release regular progress reports.
4. Health care institutions and organizations
a) Implement strategic AMR plans that are coordinated, cross-departmental and adopted institution wide. These should be premised on:
i. standardized and comprehensive reporting metrics for AMR and antimicrobial usage;
ii. tailored infection prevention and control programs to screen for and effectively prevent new AMR infections;
iii. improving public and professional awareness of AMR organization wide;
iv. improving conservation measures such as prescribing practices (audit and feedback, incentives programs, etc.); and
v. supporting and incentivizing appropriate prescribing of antimicrobials.
b) Evaluate whether existing policies and procedures, diagnostics and testing capacities, and multidisciplinary and organizational cultures are strategically geared toward combatting AMR.
c) Where possible, develop collaborations with other local health institutions, clinical researchers and community, public and private partners to promote AMS.
5. Accreditation and regulatory bodies
a) Regularly review and establish meaningful criteria for accreditation, ethical codes and regulatory practice standards surrounding AMR and AMS so that practitioners and health institutions can be informed, supported and kept up to date on emerging AMR trends, practices and issues.
b) Adopt profession-specific mandatory requirements for AMR and AMS (proper credentialing and training, regular updating of knowledge and competence for prescribing antimicrobials, appropriate data collection regarding antimicrobial usage, etc.) as part of credentialing.
c) Work to promote, support and enhance existing AMS practices and programs.
d) Collaborate with health institutions, professional health associations and other accreditation and regulatory bodies to implement AMS goals/plans.
6. Colleges and faculties for medicine and allied health professions
a) Promote and support more educational resources for AMS and AMR, throughout the continuum of education (undergraduate, postgraduate and continuing education).
i. Topics for these resources should include (1) awareness of AMR and AMS, (2) appropriate diagnostic testing, (3) strategies to minimize antimicrobial use and (4) personal prescribing practices.
b) Promote and support research on AMR and the implementation and dissemination of effective AMS strategies.
1 Public Health Agency of Canada. Tackling antimicrobial resistance and antimicrobial use: a pan-Canadian framework for action. Ottawa: Public Health Agency of Canada; 2017. Available: https://www.canada.ca/content/dam/hc-sc/documents/services/publications/drugs-health-products/tackling-antimicrobial-resistance-use-pan-canadian-framework-action/tackling-antimicrobial-resistance-use-pan-canadian-framework-action.pdf (accessed 2018 Aug 10).
BACKGROUND TO CMA POLICY
See also CMA Policy Antimicrobial Resistance PD19-08
The world is at the tipping point of a post-antibiotic era. “Worldwide, we are relying more heavily on antibiotics to ensure our medical, nutritional, and economic security; while simultaneously causing the decline of their usefulness with overuse and ill-advised use.” It is estimated that the world’s use of antimicrobials increased by 65% between 2000 and 2015 — mainly in low- to middle-income countries.
Dr. Margaret Chan, the former head of the World Health Organization (WHO), described antimicrobial resistance (AMR) as a slow-moving tsunami for public health. Other experts have characterized AMR as a looming “antibiotic apocalypse,” warning that all countries “will face disastrous consequences if the spread of AMR is not contained.” Others are now calling AMR the “climate change” of health care. According to the UK’s review on AMR, an estimated 10 million people globally will die annually by 2050, and AMR will surpass cancer to become the leading cause of death.
AMR occurs when “microorganisms (such as bacteria, fungi, viruses, and parasites) change when they are exposed to antimicrobial drugs (such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics). … As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others.” Microorganisms that develop antimicrobial resistance are sometimes referred to as “superbugs.” “Nightmare bacteria,” as they have been dubbed, are bacterial strains that no conventional antimicrobial can effectively treat; their incidence is on the rise.
AMR represents a unique challenge for the medical profession as it is estimated that as many as 50% of current antibiotic prescriptions are either inappropriate or unnecessary. In addition, taking an antimicrobial involves potentially considerable exposure to side effects or risk. At stake are many currently routine, and lifesaving, forms of medical treatment. Critically, these include many medications for currently treatable bacterial infections, and many forms of surgery (including cesarean delivery), radiation therapy, chemotherapy and neonatal care.4
THE UNDERLYING DYNAMICS OF AMR
AMR is driven by a complex set of interlocking factors. These include: (1) increased global travel and medical tourism; (2) inappropriate, and unnecessarily high, use of antimicrobials in the agrifood sector; (3) poor medical prescribing practices; (4) inadequate implementation of infection prevention and control measures; (5) lack of knowledge, inappropriate expectations and misuse of antimicrobials on the part of the general public; (6) availability of poor-quality antimicrobials; (7) lack of access to rapid, affordable and accurate rapid diagnostic tools and infrastructure; (8) inadequate and underused surveillance data from AMR surveillance systems; (9) international travel rates; and (10) low commercial interest in, or support for, new antimicrobial research and development.
To make progress on AMR, we need to carefully think about how to address its various drivers. Antimicrobial stewardship (AMS) is a term describing coordinated efforts, at any program level, to: (1) promote the appropriate use of antimicrobials; (2) improve patient outcomes; (3) reduce microbial resistance and preserve the effectiveness of antimicrobials; and (4) decrease the spread of infections caused by multidrug-resistant organisms. AMS efforts are based on the “One Health” approach. These include: (1) surveillance; (2) conservation of existing AM effectiveness; (3) innovation through research and development; and (4) infection prevention and control.
Fundamentally, AMR can be thought of as a collective action problem, similar in character to the problem of climate change.3, While all stakeholders have a role to play in combatting AMR, each has very different resources, abilities and perspectives on AMR. Canada and much of the developed world have the luxury of health infrastructures, finances and regulatory frameworks that can make AMR mitigation possible. But in low- to middle-income countries — places where antibiotics might be the only real health care available — the very discussion of AMS can be perceived as threatening. Simply put, this illustrates the fact that solutions to AMR need to mobilize and leverage a collective strategy that is as broad and as connected as possible. To be successful, these solutions will need to do so in a manner that acknowledges the local reality of health care delivery.
Global investment in antimicrobial research and development is underwhelming, a dynamic described as a “drying up” of the pharmaceutical pipeline.8 This is evidenced by the recent large-scale withdrawal of major pharmaceutical companies from antimicrobial research and development, reflecting the lack of profitability in this area. On the pharmaceutical side, there are clear barriers to companies investing in the development of novel antimicrobials. Underlying factors include: (1) 10-year timelines, and an estimated minimum $1 billion price tag for development; (2) high development failure rates for new antimicrobials; (3) the inevitable emergence of resistance to any newly developed antimicrobial; (4) antimicrobials being offered at relatively cheap dosage rates over shorter durations of use; and (5) the need to preserve the efficacy of any antimicrobial’s future use, which limits their economic viability.8
WHAT ARE THE CANADIAN CONTEXTS?
AMR is already a major costly public health challenge in both the US and Canada. AMR infections are clearly linked to poorer health outcomes, longer hospital stays and higher mortality rates.3 The Public Health Agency of Canada (PHAC) estimates that roughly 18,000 hospitalized Canadians contract drug-resistant infections per year. The Canadian Patient Safety Institute estimates that 8,000 Canadian patients die annually with an AMR-related infection. It is estimated that close to 23 million antibiotic prescriptions are written annually for patients in Canada, the approximate equivalent to 1.6% of the population being on an antimicrobial on any given day.
An action plan in Canada is being developed by PHAC. On the surface, the action plan appears comprehensive in that it outlines a One Health approach.10 However, despite commitments to take comprehensive, measurable action on AMS, Canadian leadership on AMR has historically lagged because of a lack of concrete coordination between PHAC and the provinces and because it has been challenging to implement local initiatives systemically.
Previous shortcomings were highlighted in the Auditor General of Canada’s 2015 report and again in a 2017 issue brief by HealthCareCAN.18 Although efforts continue and the action plan is set for release at some point in 2019, concerns remain that: (1) the scope of coordinated efforts with the provinces and territories requires an interest in cooperation that may not exist between the two levels of government; (2) relative to the scope of the problem, sufficient and dedicated resources won’t be allocated; and (3) efforts on the industrial and agricultural fronts may not be sufficiently coordinated with AMR efforts for human health.
In the spring of 2018 the House of Commons Standing Committee on Health (HESA) released a report outlining 10 recommendations for action on AMR in Canada. Although the federal government “accepted” most of the committee’s recommendations, no meaningful (and dedicated) AMR funding has been announced in advance of the action plan’s launch. Indeed, the federal government’s response to the HESA report sought to downplay the need for either urgent action or additional resources. This was done by pointing to nominal federal AMR efforts over the span of more than a decade.
It should be noted that a small number of excellent localized AMS initiatives exist and have begun yielding promising local AMS results in Canada. AMR and AMS champions such as Choosing Wisely Canada, Do Bugs Need Drugs, and the Association of Medical Microbiology and Infectious Disease Canada have long argued that with proper resourcing, localized initiatives can be scaled up to a systemic level of application within provincial health care systems.
GLOBALLY, WHERE DOES AMR STAND?
Urgent action is required at an international level to combat AMR. Although AMR remains a complex public health challenge, the benefits of AMS are clear. The preservation of these precious resources will save lives and can positively affect both quality of care and health care delivery costs.7,14 Globally, many higher income nations and, increasingly, middle-income countries have now developed AMR/AMS action plans. Like the situation in Canada, these emerging and existing global action strategies remain largely unimplemented. Initial cash infusions into the AM drug development pipeline are beginning to emerge.8
Despite this, experts warn that such investments are too short term and wholly inadequate to address the scope of the looming AMR crisis.8, This reflects the many complexities that exist in the implementation of AMR action plans, owing in large part to: (1) a general lack of resources or prioritization; (2) complacency about AMR as a pressing public health concern; (3) difficulties in generalizing local AMS efforts; (4) coordination between sectorial actors; and (5) a lack of tangible AMR metrics and evidence.
If AMS gains are to be made in low- and middle-income countries, the impact of limited resources in those settings will need to be considered.13 Realistically these countries will require various forms of monetary incentives and assistance to be able to effectively adopt AMR programs. If such support is not provided, human health rights will be affected and global AMS efforts will be undermined. Finally, there are now well-established calls for an international model, even a treaty, to be implemented on AMR/AMS.12,
Like all scientific and medical procedures, assisted human reproduction has the potential for both benefit and harm. It is in the interests of individual Canadians and Canadian society in general that these practices be regulated so as to maximize their benefits and minimize their harms. To help achieve this goal, the Canadian Medical Association (CMA) has developed this policy on regulating these practices. It replaces previous CMA policy on assisted reproduction.
The objectives of any Canadian regulatory regime for assisted reproduction should include the following:
(a) to protect the health and safety of Canadians in the use of human reproductive materials for assisted reproduction, other medical procedures and medical research;
(b) to ensure the appropriate treatment of human reproductive materials outside the body in recognition of their potential to form human life; and
(c) to protect the dignity of all persons, in particular children and women, in relation to uses of human reproductive materials.
When a Canadian regulatory regime for assisted reproduction is developed, it should incorporate the following principles:
For the regulation of assisted reproduction, existing organizations such as medical licensing authorities, accreditation bodies and specialist societies should be involved to the greatest extent possible.
If the legislation establishing the regulatory regime is to include prohibitions as well as regulation, the prohibition of specific medical and scientific acts must be justified on explicit scientific and/or ethical grounds.
If criminal sanctions are to be invoked, they should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
Whatever regulatory agency is created should include significant membership of scientists and clinicians working in the area of assisted reproduction.
Elements of a Regulatory Regime
The regulation of assisted reproduction in Canada should include the following elements:
Legislation to create a national regulatory body with appropriate responsibilities and accountability for coordinating the activities of organizations that are working in the area of assisted reproduction and for carrying out functions that other organizations cannot perform.
The development and monitoring of national standards for research related to human subjects including genetics and reproduction. The regulatory body would work closely with the Canadian Institutes of Health Research, other federal and provincial research granting councils, the National Council on Ethics in Human Research and other such organizations.
The development and monitoring of national standards for training and certifying physicians in those reproductive technologies deemed acceptable. As is the case for all post-graduate medical training in Canada, this is appropriately done through bodies such as the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada.
The licensing and monitoring of individual physicians. This task is the responsibility of the provincial and territorial medical licensing authorities which could regulate physician behaviour in respect to the reproductive technologies, just as they do for other areas of medical practice.
The development of guidelines for medical procedures. This should be done by medical specialty societies such as the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian Fertility and Andrology Society (CFAS).
The accreditation of facilities where assisted reproduction is practised. There is already in Canada a well functioning accreditation system, run by the Canadian Council on Health Services Accreditation, which may be suitable for assisted reproduction facitilies.
Whatever regulatory body is established to deal with assisted reproduction should utilize, not duplicate, the work of these organizations. In order to maximize the effectiveness of these organizations, the regulatory body could provide them with additional resources and delegated powers.
The CMA is opposed to the criminalization of scientific and medical procedures. Criminalization represents an unjustified intrusion of government into the patient-physician relationship. Previous attempts to criminalize medical procedures (for example, abortion) were ultimately self-defeating. If the federal government wishes to use its criminal law power to regulate assisted reproduction, criminal sanctions should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
The CMA recommends to the appropriate government authorities that all boxing be banned in Canada. Until such time, strategies to prevent injury should be pursued.
The CMA considers boxing a dangerous sport. While most sports involve risk of injury, boxing is distinct in that the basic intent of the boxer is to harm and incapacitate his or her opponent.
Boxers are at significant risk of injuries resulting in brain damage. Boxers are susceptible not only to acute life-threatening brain trauma, but also to the chronic and debilitating effects of gradual cerebral atrophy. Studies demonstrate a correlation between the number of bouts fought and the presence of cerebral abnormalities in boxers. There is also a risk of eye injury including long-term damage such as retinal tears and detachments.
- CMA supports a ban on professional and amateur boxing in Canada.
- Until boxing is banned in this country, the following preventive strategies should be pursued to reduce brain and eye injuries in boxers:
- Head blows should be prohibited. CMA encourages universal use of protective garb such as headgear and thumbless, impact-absorbing gloves
- The World Boxing Council, World Boxing Association and other regulatory bodies should develop and enforce objective brain injury risk assessment tools to exclude individual boxers from sparring or fighting.
- The World Boxing Council, World Boxing Association and other regulatory bodies should develop and enforce standard criteria for referees, ringside officials and ringside physicians to halt sparring or boxing bouts when a boxer has experienced blows that place him or her at imminent risk of serious injury.
- The World Boxing Council, World Boxing Association and other regulatory bodies should encourage implementation of measures advocated by the World Medical Boxing Congress to reduce the incidence of brain and eye injuries.
- CMA believes that the professional responsibility of the physician who serves in a medical capacity in a boxing contest is to protect the health and safety of the contestants. The desire of spectators, promoters of the event, or even injured athletes that they not be removed from the contest should not influence the physician’s medical judgment.
- Further long term outcome data should be obtained from boxers in order to more accurately establish successful preventive interventions. CMA encourages ongoing research into the causes and treatments of boxing-related injuries, and into the effects of preventive strategies.
Concussions and head injuries are a common occurrence in sport and leisure activities, and frequently occur in occupational settings as well. While the majority of individuals who suffer from a concussion will recover with time, others may be at risk for serious and lasting complications. These include (1) children; (2) previous history of head injury or concussion; (3) prior mental health symptoms; and (4) missed diagnosis and management.
This aim of this advocacy and policy document is to improve safety during activity by raising awareness of concussions, and by working to improve the detection and safe management of concussions when they occur. It is not a clinical practice guideline. It should not be perceived as a plea to avoid sports or leisure activities, but rather as a call for safer sporting, leisure, and occupational practices. The documented health benefits that result from establishing an active lifestyle in youth and maintaining it throughout life cannot be overstated.
Achieving balance of safe play in sport, leisure and occupational activities while promoting greater physical activity levels for Canadians would have the effect of reducing health care costs in Canada, while promoting a healthier concussion recovery culture for all Canadians.
Therefore, to promote better concussion and head trauma awareness and prevention, as well as better management/treatment practices, the following policy recommendations for key target audiences across all levels of sport, leisure, and occupational activity are made.
Key Concussion & Head Injury Principles:
a) The detection of concussions and head injury should be a shared responsibility and any stakeholder/observer to such an injury should verbally raise their concerns that a concussion may have occurred.
i. It is important to understand that individuals with a possible concussion, or head injury, may not be able to recognize that they are suffering from a concussion;
ii. It is important to recognize that engrained within popular culture are dangerous notions (e.g., to minimize, ignore, downplay, or play through the pain, etc.) that cause individuals/observers to ignore the real, often hidden, dangers of such injuries.
b) Broadly speaking, access to the latest edition of the internationally recognized Concussion Recognition Tool (CRT) should be promoted/available to help identify the signs and symptoms of a possible concussion;
c) Any individual who sustains more than a minor head injury should be immediately removed from play, activity, or occupation, and not permitted to return on the same day3 (regardless of whether a concussion is later suspected).
i. These individuals should be the subject of observation for developing/evolving concussion symptoms or emergency warning signs (especially within the first 4 hours post-injury, but also up to 48 hours when red-flag symptoms are present).
d) Following first aid principles, where an individual displays signs of a serious head or spinal injury, that individual should lie still (not moving their head or neck) until a qualified individual has performed an evaluation; to determine whether emergency evacuation for medical assessment is necessary.
e) Any individual with a suspected concussion (especially where red-flag symptoms are present), or more severe traumatic brain injury, should be promptly evaluated by a physician to:
i. Either rule-out or confirm a diagnosis via an appropriate medical assessment; and
ii. Institute the provision of an age-appropriate follow-up care plan (including progressive return to school, work, and play protocols) if such an injury is confirmed.1
f) Ideally, a physician knowledgeable in concussion management determines when, and how, a concussed individual should progressively return to both cognitive (school or work) and physical activities.
g) Following a suspected, or diagnosed concussion, an individual should not return to play, or resume any activity associated with a heightened risk of head trauma, until cleared by a physician to do so.1
a) Where possible, encourage safe play practices in sports, and where appropriate, educate patients about the risks of head injuries (associated with high-risk behavior in sports, leisure and occupational activities).
b) Gain/maintain, through relevant continuous medical education, competencies related to the assessment, diagnosis and management of concussion according to most current clinical practice recommendations (e.g., latest edition of the CRT, SCAT, Child SCAT, Acute Concussion Evaluation Tool, etc.).
c) Be aware that clinical practice guidelines and assessment tools exist to assist in assessing and treating concussed individuals (e.g., Ontario Neurotrauma Foundation, Parachute Canada, etc.).
d) When assessing a patient with a potential concussion:
i. Rule out the presence of more severe traumatic brain and musculoskeletal injury;
ii. Assess for any previous concussion history, risk factors and newly arising complications;
iii. Educate and instruct parents, athletes and any individual that sustains a concussion about what to do, and what to expect, in the post concussive phase. (This should be based on the most current age-appropriate concussion management guidelines);4
iv. Provide individualized recommendations on how to optimally apply the progressive return-to-school, work, and play strategies with consideration for the specificities of the patient’s usual activities and responsibilities;4
v. Work to provide concussed patients timely access for medical reassessment in the event of worsening or persistent symptoms (including mental health); and
vi. In the presence of persistent or worsening symptoms (including mental health), consider what external, evidence based, concussion resources may be necessary as well as referral.
2. Medical Colleges & Faculties:
a) Promote/support medical education regarding; awareness, detection/diagnosis; and the appropriate management of concussions, throughout the continuum of medical education (undergraduate, post-graduate, and continuing medical education).
b) Support research in concussion prevention, detection, and treatment or management.
3. Athletes in Contact/Collision Sports:
a) (Prior to the commencement of the sporting season) be given age-appropriate instruction2 to understand:
i. How to identify the signs and symptoms of a possible concussion using the latest edition of the internationally recognized CRT (e.g. Concussion Recognition Tool, or Concussion Awareness Training Tool (CATT));
ii. The risks associated with concussion (including long term and mental health); especially, the risks of potentially life-threatening complications associated with continued sport participation, while presenting with signs or symptoms of a possible concussion;
iii. What to do/expect if a concussion is ever suspected (including for teammates), and the expected role of the athlete and team members;
iv. Removal and progressive returns to school, work and play policies/procedures, and the expected role of the athlete in the recovery process; and
v. How to foster a healthy sporting culture (that promotes: safe play practices; fosters concussion/injury prevention and reporting; peer-to-peer support; and combat injury stigmatization).
b) Have such instruction reinforced periodically throughout the sporting season as needed.
c) Be aware of, and seek treatment for, potentially serious mental health issues that may arise post-concussive injury.
4. Parents with Minors in Contact/Collision Sports:
a) Prior to the commencement of a sporting season, request and be open to receiving instruction2 on:
i. How to identify the signs and symptoms of a possible concussion using the latest edition of the internationally recognized CRT (e.g. Concussion Recognition Tool, or Concussion Awareness Training Tool (CATT));
ii. The risks associated with concussion; especially, the risks of potentially life-threatening complications associated with continued sport participation, while presenting with signs or symptoms of a possible concussion;
iii. What to do/expect if a concussion is ever suspected for an athlete;
iv. Removal and progressive returns to school, work and play policies/procedures, and the expected role of the parent(s) in the recovery process; and
v. How to foster a healthy sporting culture that promotes: safe play practices; fosters concussion/injury prevention and reporting; peer-to-peer support; and combats injury stigmatization.
b) Have such instruction reinforced periodically throughout the sporting season as needed.
c) Be prepared to address potentially serious mental health issues that may arise post-concussive injury.
5. Individuals Who Sustain a Head Injury Outside of Organized Sports:
a) Be aware of possible signs and symptoms of a possible concussion, and immediately withdraw from activity and seek medical assessment a possible concussion is suspected.1
i. Refer to the latest addition of the internationally recognized CRT (Concussion Recognition Tool) for further guidance on signs and symptoms.3
b) Understand the risks associated with concussion; including the risks of potentially life-threatening complications associated with repeated head injury if signs or symptoms of a possible concussion are present.
c) In the event of a diagnosis of concussion, judiciously implement the medical recommendations received regarding their gradual return to cognitive and physical activity (including the need for medical reassessment in the presence of persistent symptoms).
d) Openly communicate their recovery needs and work with any group or individual who might support them in their recovery process (e.g., employers, family members, school, etc.).
e) Be aware of, and seek treatment for, potentially serious mental health issues that may arise post-concussive injury.
6. Coaches, Trainers, Referees, & First Responders:
a) Receive certified emergency first aid training.
b) Receive periodic education (ideally annually) on national standards regarding the signs and symptoms, potential long-term consequences, appropriate steps for initial intervention, and immediate management (including: athlete removal-from-play; observation; determining when medical assessment is necessary; and progressive return to school, work and play procedures).
c) Be trained in the use of the latest edition of the internationally recognized CRT (Concussion Recognition Tool) – to detect whether an injured individual is suffering from a concussion.2
d) Be knowledgeable and responsible to ensure safety and safe play practices are applied throughout the sporting season.
e) Be responsible for fostering a healthy sporting culture (promote safe play practices, foster concussion/injury prevention and reporting, peer-to-peer support and combat injury stigmatization).
f) Be prepared to address potentially serious mental health issues that may arise post-concussive injury.
7. Licensed Health Care Providers Involved as Therapists in Sport Environments:
a) Be fully licensed in their professional field and pursue continuing professional development to maintain competencies related to concussion and head injuries.
b) Promote the implementation of properly adapted concussion management protocols (that comply with the most current clinical recommendations, based on consideration for the specificities of each sport environment and available resources).
c) Work with qualified physicians to initiate/implement tailored medically supervised concussion management protocols that define:
i. Mutual and shared health professional responsibilities to optimize the quality, and safety of patient care (within one’s scope of practice); and
ii. The optimal corridors for timely access to medical (re)assessment with due consideration for available resources.
d) Be prepared to address potentially serious mental health issues that may arise post-concussive injury.
8. Educational Institutions & Sports Organizations:
a) (Especially in the cases involving minors) implement, and keep updated, prevention strategies to include:
i. Safety standards that include safe play policies; and
ii. Mandatory safety gear/equipment (tailored to individual sport settings).
b) Mandatory concussion and head injury protocols that work to:
i. Reduce the occurrence of concussions and head injury by promoting: safe play practices; fostering concussion/injury prevention and reporting; peer-to-peer support, and combatting injury stigmatization;
ii. Ensure the prompt detection, and standardized early management of concussion and head injuries, by informing all potential stakeholders (in the preseason phase) about the nature/risks of concussion and head injury, and how any such occurrence will be dealt with should they occur;
iii. Enshrine into practice removal-from-play, and post-injury observation of athletes;
iv. Progressively reintegrate students back into symptom guided educational and physical activities based on the most current recommendations;2
v. Reintegrate injured athletes back into unrestricted training activities and sport once medical clearance has been obtained; and
vi. Foster better lines of communication for injury management/recovery between: parents, athletes, coaches, school personnel, therapists and physicians.
vii. Address potentially serious mental health issues that may arise post-concussive injury.
9. Employers (Occupational Considerations)
a) Comply with workplace safety laws and implement safety standards to reduce the incidence of head injuries in the work environment.
b) Integrate considerations for concussion and head injury in health and safety protocols that work to:
i. Reduce the occurrence of concussions and head injury by promoting: safe practices; concussion/injury prevention and reporting; peer-to-peer support, and combats injury stigmatization;
ii. Ensure prompt detection and standardized early management of concussion and head injuries by informing potential stakeholders about the nature/risks of concussion and head injury, and how occurrences will be dealt with should they occur;
iii. Enshrine into practice/ workplace culture the removal-from-work, and post-injury observation of workers;
iv. Progressively reintegrate workers back into symptom guided cognitive and physical activities based on the most current recommendations;
v. Reintegrate injured workers with a confirmed diagnosis of concussion, progressively back into work activities only once medical clearance has been obtained; and
vi. Foster better lines of communication, and support for, injury management between: employees, employers, medical professionals and insurances.
vii. Address the potentially serious mental health issues that may arise post-concussive injury.
10. Governments & Professional Regulatory Bodies:
a) Implement comprehensive public health strategies for the Canadian population to:
i. Increase awareness that concussions can be sustained in accidents, sports, leisure and occupational contexts;
ii. Inform head injuries should be taken seriously; and
iii. Explain how and why concussions should be prevented and promptly assessed by a physician where they are suspected to have occurred.
b) Define appropriate scopes of practice for all health professionals involved in the field of concussion detection, management, and treatment.
c) Work with key stakeholders to develop compensation structures to support physicians to allocate the time necessary to: (1) conduct appropriate assessments to rule out concussions, (2) provide ongoing concussion management, and (3) develop detailed medical clearance plans.
d) Work with key stakeholders to develop standardized educational tools for physicians to provide to patients with concussions.
i. Ideally this would include contextualized tools for sports teams, schools, and employers.
e) Adopt legislation or regulation for educational institutions and community-based sport associations to establish clear expectations/obligations regarding concussion awareness and management for youth in sports (e.g., Ontario’s Rowan’s law).
i. To have meaningful impact, such initiatives must also be accompanied by: implementation funding to support the development and implementation of sport specific concussion management protocols; and monitoring/compliance programs.
f) Establish a national concussion and sports injury surveillance system (with standardized metrics) to collect detailed head and sport injury related information. Thus, providing the ability to research such injuries in an ongoing and timely manner.
g) Provide research opportunities/funding on concussions. Specific examples of research areas to prioritize include:
i. Effective prevention strategies for both adults and children in a range of sport, leisure, or occupational environments;
ii. The incidence and impact of concussions in children, and how to reduce their occurrence (inside and outside of sport);
iii. Address knowledge gaps for concussion identification, management, and medical clearance for physicians not specialized in concussion care;
iv. Explore all health professionals’ participation in concussion management providing for respective: competency, expertise, interdisciplinary collaboration, and appropriate roles;
v. Evaluate how emerging point of care diagnostics and biomarker testing will be incorporated into sport, leisure and work environments;
vi. Continued development of effective, user-friendly, and age appropriate management strategies/tools for physicians regarding concussion identification, management, and medical clearances; and
vii. Develop a harmonized understanding of “concussion” and “mild traumatic brain injury” (MTBI) constructs/concepts, so that adults with concussion signs or symptoms, who do not meet the more restrictive MTBI criteria, are properly managed.
McCrory P, Meeuwisse W, Dvorak J, et al. Consensus Statement on Concussion in Sport - the 5th International Conference on Concussion in Sport Held in Berlin. Br J Sports Med 2017, 51: 838-847.
Parachute Canada. Canadian Guideline on Concussion in Sport. 2017. Available: http://www.parachutecanada.org/injury-topics/item/canadian-guideline-on-concussion-in-sport (accessed 2018 Jul 31).
Concussion in Sport Group. Concussion Recognition Tool 5. Br J Sports Med 2017 51: 872. Available: https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097508CRT5.full.pdf (accessed 2018 July 31st). (accessed 2018 Jul 31).
Ontario Neurotrauma Foundation. Guidelines for Concussion/Mild Traumatic Brain Injury & Persistent Symptoms. Health Care Professional Version. 3rd Ed, Adults (18 + years of age). Toronto: Ontario Neurotrauma Foundation; 2018. Available: http://braininjuryguidelines.org/concussion/fileadmin/media/adult-concussion-guidelines-3rd-edition.pdf (accessed 2018 Jul 31).
Concussion in Sport Group. Sport Concussion Assessment Tool – 5th Ed. Br J Sports Med 2017, 0:1-8. Available: https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097508CRT5.full.pdf (accessed 2018 July 31).
Approved by the CMA Board of Directors March 2019
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.
The objective of this policy is to provide guidance to physicians and institutions by identifying a set of guiding principles and commitments to promote equity and diversity in medicine (as defined in the Guiding Principles section). We address equity and diversity in medicine to improve circumstances and opportunities for all physicians and learners as part of our efforts to create a more collaborative and respectful culture and practice of medicine. To achieve this, we must redress inequities, bias, and discrimination in learning and practice environments.
Individual protection from bias and discrimination is a fundamental right of all Canadians. By embracing the principles of equity and diversity, we can systematically address root causes and reduce structural barriers faced by those who want to enter the medical profession and those practicing medicine. In so doing, we improve their opportunities for advancement, health, and livelihood.
The principles of equity and diversity are grounded in the fundamental commitment of the medical profession to respect for persons. This commitment recognizes that everyone has equal and inherent worth, has the right to be valued and respected, and to be treated with dignity. When we address equity and diversity, we are opening the conversation to include the voices and knowledge of those who have historically been under-represented and/or marginalized. It is a process of empowerment—where a person can engage with and take action on issues they define as important. Empowerment involves a meaningful shift in experience that fosters belonging in the profession and draws on community supports.
As part of equity and diversity frameworks, inclusion is often articulated to refer to strategies used to increase an individual’s ability to contribute fully and effectively to organisational structures and processes. Inclusion strategies are specific organisational practices or programs focused on encouraging the involvement and participation of individuals from diverse backgrounds to integrate and value their perspectives in decision-making processes. Robust processes for inclusion are a vehicle to achieving equity and diversity. Thus, in this policy, the process of inclusion is understood to be positioned at the nexus of the overarching principles of equity and diversity.
Equity and diversity initiatives can be carefully structured to complement and strengthen merit-based approaches. Enhanced support and appropriate methods of evaluation that increase equity of opportunity (for example, equity in training, hiring processes, and in access to resources) provide all physicians and learners with a fair opportunity to cultivate and demonstrate their unique capabilities and strengths, and to realize their full potential.
Promoting equity and diversity fosters a just professional and learning culture that cultivates the diverse perspectives within it, reflects the communities physicians serve, and promotes professional excellence and social accountability as means to better serve patients. An increasingly diverse medical population provides opportunities for underserviced populations to receive better access to medical services and bolsters the management of clinical cases through the contribution of different points of view. Evidence indicates that when demonstrably more equity and diversity in medicine is achieved, physicians experience greater career satisfaction, health and wellness, and a sense of solidarity with the profession while patients experience improved care and a more responsive and adaptable health care system. Evidence further indicates that realizing the full potential of human capital is an essential driver of innovation and health system development.
This policy is consistent with the CMA Code of Ethics and Professionalism and the CMA Charter of Shared Values and strives to be in the spirit of the recommendations relevant to health made in the report of the Truth and Reconciliation Commission of Canada. The policy is informed by a body of evidence described in the accompanying Background document that includes a Glossary of terms.
A clear set of principles and commitments to improving equity and diversity demonstrates that we hold ourselves accountable to recognizing and challenging behaviours, practices, and conditions that hinder equity and diversity and to promoting behaviours, practices, and conditions that will achieve these goals.
Achieving equity in medicine
Equity refers to the treatment of people that recognizes and is inclusive of their differences by ensuring that every individual is provided with what they need to thrive, which may differ from the needs of others. It is a state in which all members of society have similar chances to become socially active, politically influential, and economically productive through the absence of avoidable or remediable differences among groups of people (defined socially, economically, demographically, or geographically). Equity in the medical profession is achieved when every person has the opportunity to realize their full potential to create and sustain a career without being unfairly impeded by discrimination or any other characteristic-related bias or barrier. To achieve this, physicians must 1) recognize that structural inequities that privilege some at the expense of others exist in training and practice environments and 2) commit to reducing these by putting in place measures that make recruitment, retention, and advancement opportunities more accessible, desirable, and achievable. To that end, physicians must apply evidence-based strategies and support applied research into the processes that lead to inequities in training and practice environments.
Fostering diversity in medicine
Diversity refers to observable and non-observable characteristics which are constructed—and sometimes chosen—by individuals, groups, and societies to identify themselves (e.g., age, culture, religion, indigeneity, ethnicity, language, gender, sexuality, health, ability, socio-economic and family status, geography). The barriers to diversity in medicine are broad and systemic. Individuals and groups with particular characteristics can be excluded from participation based on biases or barriers. Even when they are included, they are often not able to use the full range of their skills and competencies. As with improving equity, the benefits of a more diverse medical profession include improved health outcomes, system-level adaptation, and physician health and wellness. To achieve these benefits, the medical profession must become increasingly diverse by striving to create, foster, and retain physicians and learners who reflect the diversity of the communities they serve and it must be responsive to the evolving (physical, emotional, cultural, and socioeconomic) needs of patients.
Promoting a just professional and learning culture
Physicians value learning and understand that it reflects, and is informed by, the professional culture of medicine. A just professional and learning culture is one of shared respect, shared knowledge, shared opportunity, and the experience of learning together. An environment that is physically and psychologically safe by reducing bias, discrimination, and harassment is critical to creating and sustaining such a culture. To achieve this, the profession must strive to integrate cultural safety by fostering and adopting practices of cultural competence and cultural humility. Physicians and leaders across all levels of training, practice, and health settings, and through formal and informal mentorships, must also promote and foster environments where diverse perspectives are solicited, heard, and appreciated. In this way, diverse individuals are both represented in the professional culture of medicine and actively involved in decision-making processes in all aspects of the profession.
Fostering solidarity within the profession
Solidarity means standing alongside others by recognizing our commonality, shared vulnerabilities and goals, and interdependence. It is enacted through collective action and aims. To show solidarity within the profession means making a personal commitment to recognizing others as our equals, cultivating respectful, open, and transparent dialogue and relationships, and role modelling this behaviour. Solidarity enables each of us to support our colleagues in meeting their individual and collective responsibilities and accountabilities to their patients and to their colleagues. Being accountable to these goals and to each other means taking action to ensure the principles that guide the medical profession are followed, responding justly and decisively when they are not, and continually searching for ways to improve the profession through practice-based learning and experience.
Promoting professional excellence and social accountability
Engaged and informed research and action on equity and diversity is critical to promoting professional excellence and social accountability in medicine as means to better serve patients. Professional excellence is a fundamental commitment of the profession to contribute to the development of and innovation in medicine and society through clinical practice, research, teaching, mentorship, leadership, quality improvement, administration, and/or advocacy on behalf of the profession or the public. Social accountability is a pillar of the commitment to professional excellence by focusing those efforts on fostering competence to address the evolving health needs of the patients and communities physicians are mandated to serve. For care to be socially accountable, and to achieve professional excellence, physicians must provide leadership through advocacy and through action: advocacy about the benefits of addressing equity and diversity to achieve equitable health outcomes; and actions to be responsive to patient, community, and population health needs through high-quality evidence-based patient care.
To accomplish equity and diversity in medicine, organizational and institutional changes will be required across many facets of operation and culture including leadership, education, data gathering/analysis, and continuous improvement through feedback and evaluation of policies and programs. To achieve this, the CMA seeks to provide direction on broad action areas that require further specific actions and development measures in specific recruitment, training, and practice contexts. The CMA recommends:
All medical organizations, institutions, and physician leaders:
A. Take a leadership role in achieving greater equity and diversity by co-creating policies and processes that apply to them, and the individuals therein, in an accountable and transparent manner. This includes:
1. Identifying and reducing structural inequities, barriers, and biases that exist in training and practice environments to create fair opportunities for all physicians and learners; and providing the appropriate platforms, resources, and training necessary to do so to effect change collaboratively.
2. Practicing and promoting cultural safety, cultural competence, and cultural humility.
3. Providing training on implicit bias, allyship, cultural safety, cultural competence, and cultural humility, structural competence, and the value of diversity in improving health outcomes.
4. Ensuring a process is in place to review all workforce and educational policies, procedures, and practices toward considering their impact on equity and diversity. Areas of consideration include (but are not limited to) recruitment, promotion, pay, leave of absence, parental leave, resources and support, and working/learning conditions and accommodations.
5. Ensuring safe, appropriate, and effective avenues exist for those who may have experienced discrimination, harassment, or abuse in training and practice environments to report these events outside of their supervisory/promotional chain. Those experiencing these events should also be able to seek counselling without the fear of negative consequences.
6. Working towards creating and appropriately funding equity and diversity Chairs, Committees, or Offices with a mandate to investigate and address issues in equity and diversity.
7. Promoting and enabling formal and informal mentorship and sponsorship opportunities for historically under-represented groups.
B. Encourage the collection and use of data related to equity and diversity through research and funding, and, specifically, review their data practices to ensure:
1. Historically under-represented groups are meaningfully engaged through the co-development of data practices.
2. Data regarding the representation of under-represented groups is being systematically and appropriately collected and analyzed.
3. Information collected is used to review and inform internal policy and practice with the aim of reducing or eliminating system-level drivers of inequity.
4. Findings relating to these data are made accessible.
C. Support equity and diversity in recruitment, hiring, selection, appointment, and promotion practices by:
1. Requesting and participating in training to better understand approaches and strategies to promote equity and diversity, including implicit bias and allyship training that highlights the roles and responsibilities of all members of the community with emphasis on self-awareness, cultural safety, and sensitivity to intersectionalities.
2. Studying organizational environments and frameworks and identifying and addressing hiring procedures, especially for leadership and executive positions, that perpetuate institutional inequities and power structures that privilege or disadvantage people.
3. Adopting explicit criteria to recruit inclusive leaders and to promote qualified candidates from historically under-represented groups in selection processes.
Additional recommendations for institutions providing medical education and training:
1. Establishing programs that espouse cultural safety, cultural competence, and cultural humility.
2. Encouraging all instructors develop competencies including non-discriminatory and non-stereotyping communication, awareness of intersectionality, and cultural safety.
3. Providing training programs, at the undergraduate level onwards, that include awareness and education around stereotypes (gender and otherwise), intersectionalities, and the value of diversity in improving health outcomes.
4. Providing diversity mentorship programs that aim to support diverse candidates through education and training to graduation.
5. Promoting and funding student-led programs that create safe and positive spaces for students and principles of equity and diversity.
6. Ensuring recruitment strategies and admission frameworks in medical schools incorporate more holistic strategies that recognize barriers faced by certain populations to enable a more diverse pool of candidates to apply and be fairly evaluated.
7. Developing learning communities (such as undergraduate pipelines described in the background document) to promote careers in medicine as a viable option for individuals from historically under-represented communities.
Approved by the CMA Board of Directors December 2019
FIREARMS CONTROL (UPDATE 2001)
Firearms are a major cause of death and injury in Canada and account for nearly 1,400 deaths annually. The CMA has made several recommendations to governments and other bodies undertaking legislative review and public policy change. These recommendations relate to the regulation of firearms, education for the safe handling of firearms, broad-based violence prevention programs, and research and information provision. In addition, the CMA has produced guidelines to assist physicians in identifying and counselling patients at risk of violent behaviour and in reporting patients at risk.
Firearms are a major cause of death and injury in Canada.. The cost to society of firearm-related injury, particularly spinal cord and head injuries, is considerable.
Over the short term, policy should focus on firearms and the user. Applying stringent controls on firearms, however, may have little effect on the rates of death and injury if the underlying problems of violence in society are not addressed.
In an effort to accommodate both short-term and long-term solutions the CMA recommends the following to governments and bodies undertaking legislative review and public policy change.
The object of regulation should be to deter people at risk for violent or self-destructive behaviour from having easy access to firearms. A regulatory policy should address (a) the acquisition of firearms (e.g., licensing of firearms and/or users, processes to screen would-be purchasers who are at risk), b) secure firearm and ammunition storage methods and modifications to firearms that would render them less accessible to children or those acting on violent impulses and (c) severe penalties for offenses such as the use of a firearm in the commission of a crime or an act of violence, including family violence.
Training in safe handling of firearms is strongly recommended, particularly for all first-time firearm users. Broader-based education programs aimed at the prevention of violence (e.g., in schools) may also be efficacious and should be evaluated for their impact in reducing violence.
Research and information provision
CMA encourages research in a number of areas, including the following.
Firearm surveillance: the types of firearms or classes of ammunition disproportionately involved in intentional deaths and injuries, the circumstances surrounding a firearm incident (e.g., argument between friends, alcohol involvement) and data on injuries and deaths.
Determination of behavioural or environmental risk factors for violent behaviour: the relative risk or benefit of keeping a firearm at home for protection i.e.. the scientific assessment of the deterrence effect):
The effects of factors such as alcohol, drug use and family history of violence on the risk of violent death; and how accurately experts can identify people at risk.
Case-control and cohort studies on gun control, crime and the antecedents of violent behaviour.
Evaluation of education programs that discourage firearm-related violence or promote safe handling of firearms.
Role of physicians
The CMA recommends that physicians consider the following guidelines.
Management of patients at risk
It is not always possible to identify people at risk of violent or self-destructive behaviour; however, the CMA recommends that physicians be alert to warning signs that a patient may be at risk and manage that patient accordingly. For example, always ask depressed patients about suicidal and homicidal thoughts and plans (asking will not plant ideas); admit suicidal patients to hospital, even against their will, particularly if they do not have supportive families who can monitor them at home; have the family remove all firearms from the home of a patient at risk; and monitor the patient frequently, writing small prescriptions if medication is required.
Good clinical judgement and close follow-up are perhaps the most effective ways of managing a self-destructive or violent patient.
Reporting of patients at risk
No specific guidelines exist for the reporting of patients at risk of violent behaviour. The physician should consider whether the risk of harm to society (or a third party) posed by a patient outweighs that patient's right to confidentiality.
Counselling and public advocacy
A physician may be asked for a reference for an applicant of a firearms acquisition certificate. Before providing the reference the physician should consider the applicant carefully for risk factors, recommend appropriate firearms training and caution against the concomitant use of firearms, alcohol and other drugs.
A physician should become an advocate for nonviolent conflict resolution. As research accumulates about the most effective interventions for nonviolent conflict resolution the health sector may be able to draw on this research to work to reduce violence in society.
Like motor vehicle and bicycle safety, firearm safety is a public health issue. The CMA holds that physicians, as advocates for the health of Canadians, can help reduce firearm-related damage and address the concomitant underlying problem of violence in society.
Guidelines for CMA’s Activities and Relationships with Other Parties
As the national voice of medicine in Canada, the CMA provides leadership for physicians, promotes the highest standards of health and health care for Canadians and acts as advocate for all Canadian physicians. In the furtherance of its purpose, the CMA conducts a variety of activities and has a variety of relationships with other parties. The CMA’s activities range from policy development to the delivery of products and services to physicians and the public. Its relationships with other parties range from the purchase of goods and services that support operations to partnerships that further or are consistent with its advocacy strategies.
The CMA actively seeks out relationships with others in recognition of the benefits these bring in the attainment of the CMA’s purposes. Such benefits may include:
- unifying the profession through relations with physician groups, including the divisions and affiliates
- enabling a stronger advocacy voice in association with others
- enhancing the CMA’s credibility with other parties
- providing financial and human resources to support CMA activities
- providing skills and capabilities that CMA may not possess
- providing additional membership services.
Activities or relationships with other parties and products and services produced through the activity or relationship (“activities or relationships”) that undermine the CMA’s reputation of professionalism, independence and quality are to be avoided, not only for their own sake but also because a diminishment of the CMA’s reputation impedes its ability to achieve its purposes.
The following principles have been developed to help guide decisions about the kinds of activities CMA undertakes and about its relations with other parties, with the objective of ensuring the integrity and good reputation of the CMA. A process or processes will be developed to implement the principles, which will include the preparation of subdocuments on applying the principles to specific areas; for example, sponsorship, endorsement and coalitions.
The CMA should rigorously and actively pursue its laudable ends and seek out relationships with others to attain them with the caveat that activities or relationships that would tarnish the integrity or reputation of CMA or the medical profession or that would diminish the trust placed in them should be avoided.
Conformity with CMA’s purpose
The activity or relationship should further or support the CMA’s purposes as elaborated in its objects, vision and mission.
The CMA’s purposes have been explicitly and widely agreed upon.
The CMA holds itself to be, and encourages reliance that it is, an organization that pursues its specified purposes.
Activities and relationships that do not further or support the CMA’s purposes have the potential to thwart these purposes in a number of ways, including inadequate accountability, inappropriate use of resources, unconstrained exercise of merely private judgement or inappropriate self-interest.
2. Medical professionalism and ethics
The activity or relationship should be consistent with medical professionalism and with CMA’s Code of Ethics.
The CMA is an association of physicians.
When the CMA acts, it represents the medical profession.
The CMA’s actions reflect upon the medical profession.
The CMA’s stature and reputation are inextricably linked to the medical profession’s work, the professional stature of its member physicians and the trust Canadians place in their physicians.
Engaging in activities or relationships that are inconsistent with medical professionalism and CMA’s Code of Ethics would erode trust in the CMA.
The activity or relationship should not undermine the CMA’s independence.
To be a credible voice and influence and to be worthy of the trust and confidence of physicians and of the public, the CMA should be, and be seen to be, free of undue influence and in control of the decisions it makes.
Undue influence occurs when one is induced to do or not do something that is contrary to what one would otherwise do if left to act freely. Undue influence deprives one of free agency and destroys free will such that it is rendered more the will of another than of one’s own.
Activities and relationships that may undermine independence include:
activities or relationships that provide revenue or benefit to the CMA such that ongoing dependency on the revenue or benefit impedes independence
activities and relationships that create a product or service that is seen to be associated with the CMA but over which the CMA does not have final control or veto or the capacity to extricate itself
Consistency with policy
The activity or relationship should be consistent with CMA policy.
The CMA develops policy in pursuance of its purposes; these should be referred to when making decisions in connection with activities or relationships.
Conflicting goals and activities
Relationships with parties whose goals or activities directly conflict with the CMA’s objects, mission or vision should be avoided.
This does not preclude discussion with others or participation in events for the purposes of obtaining information, monitoring or lobbying.
The terms and conditions of the activity or relationship should be transparent.
Transparency promotes an openness to scrutiny and serves to enhance accountability and to discourage relationships or activities that could be considered problematic.
The principle is generally applicable except in connection to matters related to competitive advantage, trade secret or a reasonable agreement of confidentiality.
Compliance and accountability
Processes must be in place to ensure that proposed and ongoing activities or relationships are appropriately reviewed for compliance with and clear accountability for these principles.
These include the activities of the secretariat and the corporate subsidiaries.
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.