Acquired immunodeficiency syndrome (UPDATE 2000)
The Canadian Medical Association has developed the following general principles to serve as guidelines for various bodies, health care professionals and the general public. Specific aspects of infection with human immunodeficiency virus (HIV) and acquired immunodeficency syndrome (AIDS) that relate to physicians' ethical responsibilities as well as society's moral obligations are discussed. Such matters include: the need for education, research and treatment resources; the patient's right to investigation and treatment and to refuse either; the need to obtain the patient's informed consent; the right to privacy and confidentiality; the importance of infection control; and the right to financial compensation in the case of occupational exposure to HIV.
Physicians should keep their knowledge of AIDS and HIV infection up to date.
Physicians should educate patients and the general public in the prevention of AIDS by informing them of means available to protect against the risk of HIV infection and to avoid further transmission of the virus.
Health authorities should maintain an active public education program on AIDS that includes the school population and such initiatives as public service announcements by the media.
All levels of government should provide resources for adequate information and education of health care professionals and the public on HIV-related diseases; research into the prevention and treatment of HIV infection and AIDS; and the availability and accessibility of proper diagnosis and care for all patients with HIV infection.
HIV antibody testing
Physicians have an ethical responsibility to recommend appropriate testing for HIV antibody and to care for their patients with AIDS or refer them to where treatment is available.
Physicians should provide counselling to patients before and after HIV antibody testing.
Because of the potential psychologic, social and economic consequences attached to a positive HIV test result, informed consent must, with rare exceptions, be obtained from a patient before testing. However, the CMA endorses informed mandatory testing for HIV infection in cases involving the donation of blood, body fluids or organs.
The CMA recognizes that people who have doubts about their serologic status may avoid being tested for fear of indiscretion and therefore supports voluntary non-nominal testing of potential HIV carriers on request.
The CMA supports the Canadian Blood Service and Hema-Québec in their programs of testing and screening blood donations and blood products.
Confidentiality in reporting and contact tracing
The CMA supports the position that cases of HIV infection should be reported non-nominally with enough information to be epidemiologically useful. In addition, each confirmed case of AIDS should be reported non-nominally to a designated authority for epidemiologic purposes.
The CMA encourages attending physicians to assist public health authorities to trace and counsel confidentially all contacts of patients with HIV infection. Contact tracing should be carried out with the cooperation and participation of the patient to provide maximum flexibility and effectiveness in alerting and counselling as many potentially infected people as possible.
In some jurisdictions physicians may be compelled to provide detailed information to public health authorities. In such circumstances, the CMA urges those involved to maintain confidentiality to the greatest extent possible and to take all reasonable steps to inform the patient that their information is being disclosed.
The CMA Code of Ethics (article 22) advises physicians that disclosure of a patient’s HIV status to a spouse or current sexual partner may not be unethical and, indeed, may be indicated when physicians are confronted with an HIV-infected patient who is unwilling to inform the person at risk. Such disclosure may be justified when all of the following conditions are met: the partner is at risk of infection with HIV and has no other reasonable means of knowing of the risk; the patient has refused to inform his or her sexual partner; the patient has refused an offer of assistance by the physician to do so on the patient's behalf; and the physician has informed the patient of his or her intention to disclose the information to the partner.
The CMA stresses the need to respect the confidentiality of patients with HIV infection and consequently recommends that legal and regulatory safeguards to protect such confidentiality be established and maintained.
Health care institutions and professionals should ensure that adequate infection-control measures in the handling of blood and body fluids are in place and that the rights of professionals directly involved in patient care to be informed of and protected from the risks of HIV infection are safeguarded.
The CMA does not recommend routine testing of hospitalized patients.
The CMA urges appropriate funding agencies to assess the explicit and implicit costs of infection control measures and to ensure that additional funds are provided to cover these extraordinary costs.
Occupational exposure and the health care professional
Health care workers should receive adequate financial compensation in the case of HIV infection acquired as a result of accidental occupational exposure.
Physicians and other health care providers with HIV infection have the same rights as others to be protected from wrongful discrimination in the workplace and to be eligible for financial compensation for work-related infection.
Physicians with HIV infection should consult appropriate colleagues to determine the nature and extent of the risk related to their continued involvement in the care of patients.
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,
APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY
A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION
This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy.
Goal of This Joint Statement
The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider.
Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy.
This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements.
This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices.
Goal of Drug Therapy
The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research.
Working Together for Optimal Drug Therapy
Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient-physician-pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others.
For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects.
Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other.
Strategies for Collaborating to Optimize Drug Therapy
Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following.
- Respecting and supporting patients' rights to make informed decisions regarding their drug therapy.
- Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all.
- Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers.
- Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy.
- Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care.
- Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients.
- Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care.
- Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues.
- Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians.
- Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education.
- Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy).
- Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy.
- Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making.
The Physician's Responsibilities
Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role.
- Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate.
- Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate.
- Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate.
- Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities.
- Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy.
- Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public.
- Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate.
- Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist.
- Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development.
Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures.
The Pharmacist's Responsibilities
Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably.
- Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber.
- Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations).
- Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate.
- Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician.
- Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments.
- Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department.
- Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities.
- Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient.
- Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public.
- Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate.
- Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development.
Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures.
Appropriateness in Health Care
This paper discusses the concept of appropriateness in health care and advances the following definition:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
Building on that definition it makes the following policy recommendations:
* Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
* Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
* Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
As health systems struggle with the issue of sustainability and evidence that the quality of care is often sub-optimal, increasing attention is focused on the concept of appropriateness. A World Health Organization study published in 2000 described appropriateness as "a complex, fuzzy issue"1. Yet if the term is to be applied with benefit to health care systems, it demands definitional clarity. This policy document presents the Canadian Medical Association definition of appropriateness which addresses both quality and value. The roots of the definition are anchored in the evolution of Canadian health care over the last two decades. The document then considers the many issues confronting the operationalization of the term. It concludes that appropriateness can play a central role in positive health system transformation.
At the Canadian Medical Association General Council in 2013 the following resolution was adopted:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
This definition has five key components:
* right care is based on evidence for effectiveness and efficacy in the clinical literature and covers not only use but failure to use;
* right provider is based on ensuring the provider's scope of practice adequately meets but does not far exceed the skills and knowledge to deliver the care;
* right patient acknowledges that care choices must be matched to individual patient characteristics and preferences and must recognize the potential challenge of reconciling patient and practitioner perceptions;
* right venue emphasizes that some settings are better suited in terms of safety and efficiency to delivering a specific type of care than others;
* right time indicates care is delivered in a timely manner consistent with agreed upon bench marks.
It is essential to appreciate that the "right cost" is a consequence of providing the right care, that it is an outcome rather than an input. In other words, if all five components above are present, high quality care will have been delivered with the appropriate use of resources, that is, at the right cost. Equally, however, it should be cautioned that right cost may not necessarily be the affordable cost. For example, a new drug or imaging technology may offer small but demonstrable advantages over older practices, but at an enormous increase in cost. Some might argue that right care includes the use of the newer drug or technology, while others would contend the excessive opportunity costs must be taken into consideration such that the older practices remain the right care.
An Evolving Canadian Perspective from 1996 to 2013
In a pioneering paper from 1996 Lavis and Anderson wrote:
...there are two distinct types of appropriateness: appropriateness of a service and appropriateness of the setting in which care is provided. The differences between the two parallel the differences between two other concepts in health care: effectiveness and cost-containment...An appropriate service is one that is expected to do more good than harm for a patient with a given indication...The appropriateness of the setting in which care is provided is related to cost effectiveness2.
This very serviceable definition moved beyond a narrow clinical conception based solely on the therapeutic impact of an intervention on a patient, to broader contextual consideration focused on venue. Thus, for example, the care provided appropriately in a home-care setting might not be at all appropriate if given in a tertiary care hospital. Significantly, the authors added this important observation: "Setting is a proxy measure of the resources used to provide care"2. This sentence is an invitation to expand the original Lavis and Anderson definition to encompass other resources and inputs identified over the ensuing decades. Three elements are especially important.
Timeliness became an issue in Canadian health care just as the Lavis and Anderson paper appeared. In 1997 almost two-thirds of polled Canadians felt surgical wait times were excessive, up from just over half of respondents a year earlier3. By 2004 concern with wait times was sufficiently pervasive that when the federal government and the provinces concluded the First Ministers' Agreement, it included obligations to provide timely access to cancer care, cardiac care, diagnostic imaging, joint replacement and sight restoration4. These rapid developments indicate that timeliness was now considered an essential element in determining the appropriateness of care.
A second theme that became prominent in health care over the last two decades was the concept of patient-centredness. When the Canadian Medical Association released its widely endorsed Health Care Transformation in Canada in 2010, the first principle for reform was building a culture of patient-centred care. Succinctly put, this meant that "health care services are provided in a manner that works best for patients"5. To begin the process of operationalizing this concept CMA proposed a Charter for Patient-centred Care. Organized across seven domains, it included the importance of: allowing patients to participate fully in decisions about their care; respecting confidentiality of health records; and ensuring care provided is safe and appropriate. This sweeping vision underscores the fact that care which is not matched to the individual patient cannot be considered appropriate care.
A third significant development over the last two decades was heightened awareness of the importance of scopes of practice. This awareness arose in part from the emphasis placed on a team approach in newer models of primary care6, but also from the emergence of new professions such as physician assistants, and the expansion of scopes of practice for other professionals such as pharmacists7. As the same health care activity could increasingly be done by a wider range of health professionals, ensuring the best match between competence required and the service provided became an essential element to consider when defining appropriateness. Under-qualified practitioners could not deliver quality care, while overly-qualified providers were a poor use of scarce resources.
To summarize, as a recent scoping review suggested, for a complete conceptualization of appropriateness in 2013 it is necessary to add the right time, right patient and right provider to the previously articulated right care and right setting8.
Why Appropriateness Matters
The most frequent argument used to justify policy attention to appropriateness is health system cost. There is a wealth of evidence that inappropriate care - avoidable hospitalizations, for example, or alternative level of care patients in acute care beds - is wide spread in Canada9; eliminating this waste is critical to system sustainability. In Saskatchewan, for example, Regina and Saskatoon contracted in 2011 with private clinics to provide a list of 34 surgical procedures. Not only were wait times reduced, but costs were 26% lower in the surgical clinics than in hospitals for doing the same procedures10.
There is, however, an equally important issue pointing to the importance of ensuring appropriate care: sub-optimal health care quality. In the United States, for example, a study evaluated performance on 439 quality indicators for 30 acute and chronic conditions. Patients received 54.9% of recommended care, ranging from a high of 78.7% for senile cataracts to 10.5% for alcohol dependence11. A more recent Australian study used 522 quality indicators to assess care for 22 common conditions. Patients received clinically appropriate care in 57% of encounters, with a range from 90% for coronary artery disease to 13% for alcohol dependence12. While no comparable comprehensive data exist for Canada, it is unlikely the practices in our system depart significantly from peer nations. Focusing on appropriateness of care, then, is justified by both fiscal and quality concerns.
Methodology: the Challenge of Identifying Appropriateness
While there is a clear need to address appropriateness - in all its dimensions - the methods by which to assess the appropriateness of care are limited and, to date, have largely focused on the clinical aspect.
The most frequently used approach is the Rand/University of California Los Angeles (Rand) method. It provides panels of experts with relevant literature about a particular practice and facilitates iterative discussion and ranking of the possible indications for using the practice. Practices are labeled appropriate, equivocal or inappropriate13. A systematic review in 2012 found that for use on surgical procedures the method had good test-retest reliability, interpanel reliability and construct validity14. However, the method has been criticized for other short-comings: panels in different countries may reach different conclusions when reviewing the same evidence; validity can only be tested against instruments such as clinical practice guidelines that themselves may have a large expert opinion component2; Rand appropriateness ratings apply to an "average" patient, which cannot account for differences across individuals; and, finally, Rand ratings focus on appropriateness when a service is provided but does not encompass underuse, that is, failure to provide a service that would have been appropriate9.
The Rand method, while not perfect, is the most rigorous approach to determining clinical appropriateness yet devised. It has recently been suggested that a method based on extensive literature review can identify potentially ineffective or harmful practices; when applied to almost 6000 items in the Australian Medical Benefits Schedule, 156 were identified that may be inappropriate15. This method also presents challenges. For example, the authors of a study using Cochrane reviews to identify low-value practices note that the low-value label resulted mainly from a lack of randomized evidence for effectiveness16.
Assessing the appropriateness of care setting has focused almost exclusively on hospitals. Some diagnoses are known to be manageable in a community setting by primary care or specialty clinics. The rate of admissions for these ambulatory care sensitive conditions (ACSCs) - which fell from 459 per 100,000 population in 2001-02 to 320 per 100,00 in 2008-09 - is one way of gauging the appropriateness of the hospital as a care venue9. A second measure is the number of hospital patients who do not require either initial or prolonged treatment in an acute care setting. Proprietorial instruments such as the Appropriateness Evaluation Protocol (AEP)17or the InterQual Intensity of Service, Severity of Illness and Discharge Screen for Acute Care (ISD-AC)18 have been used to assess the appropriateness of hospital care for individual patients. While these instruments have been applied to Canadian hospital data19,20, there is a lack of consensus in the literature as to the reliability and utility of such tools21-23.
Benchmarks exist for appropriate wait times for some types of care in Canada through the work of the Wait Time Alliance4. These include: chronic pain, cancer care, cardiac care, digestive health care, emergency rooms, joint replacement, nuclear medicine, radiology, obstetrics and gynecology, pediatric surgery, plastic surgery, psychiatric illness, and sight restoration. The recommendations are based on evidence-informed expert opinion.
The other two domains of appropriateness - right patient, right provider - as yet have no objective tools by which to assess appropriateness.
Determining appropriateness demands a complex and time-consuming approach, and its operationalization faces a number of barriers.
The availability of some health care services may be subject to political influence which will over-ride appropriateness criteria. For example, recommendations to close smaller hospitals deemed to be redundant or inefficient may not be implemented for political reasons.
Patient expectations can challenge evidence-based appropriateness criteria. In a primary care setting, for instance, it may be difficult to persuade a patient with an ankle sprain that an x-ray is unlikely to be helpful. The insistence by the patient is compounded by an awareness of potential legal liability in the event that clinical judgment subsequently proves incorrect. Choosing Wisely Canada recommends physicians and patients become comfortable with evidence-informed conversations about potentially necessary care24.
Traditional clinical roles are difficult to revise in order to ensure that care is provided by the most appropriate health professional. This is especially true if existing funding silos are not realigned to reflect the desired change in practice patterns.
Finally, and perhaps most importantly, even if agreed upon appropriateness criteria are developed, holding practitioners accountable for their application in clinical practice is extremely difficult due to data issues25. Chart audits could be conducted to determine whether appropriateness criteria were met when specific practices were deployed, but this is not feasible on a large scale. Rates of use of some practices could be compared among peers from administrative data; however, variation in practice population might legitimately sustain practice variation. For diagnostic procedures it has been suggested that the percentage of negative results is an indicator of inappropriate use; however, most administrative claim databases would not include positive or negative test result data26. This data deficit must be addressed with health departments and regional health authorities.
There are several additional constraints on the use of the concept by health system managers.
First, the vast majority of practices have never been subject to the Rand or any other appropriateness assessment. Even for surgical procedures clinical appropriateness criteria exist for only 10 of the top 25 most common inpatient procedures and for 6 of the top 15 ambulatory procedures in the United States. Most studies are more than 5 years old27.
Second, while the notion is perhaps appealing to policy makers, it is incorrect to assume that high use of a practice equates with misuse: when high-use areas are compared to low use areas, the proportion of inappropriate use has consistently been shown to be no greater in the high-use regions28,29.
Finally, it is uncertain how large a saving can be realized from eliminating problematic clinical care. For example, a US study modeling the implementation of recommendations for primary care found that while a switch to preferentially prescribing generic drugs would save considerable resources, most of the other items on the list of questionable activities "are not major contributors to health care costs"30. What is important to emphasize is that even if dollars are not saved, by reducing inappropriate care better value will be realized for each dollar spent.
These methodological and other challenges31 notwithstanding, the Canadian Medical Association puts forward the following recommendations for operationalizing the concept of appropriateness and of clinical practice.
1. Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
Jurisdictions should develop a framework32 for identifying potentially inappropriate care, including under-use. This involves selecting criteria by which to identify and prioritize candidates for assessment; developing and applying a robust assessment methodology; and creating mechanisms to disseminate and apply the results. Frameworks must also include meaningful consideration of care venue, timeliness, patient preferences and provider scope of practice. International examples exist for some aspects of this exercise and should be adapted to jurisdictional circumstances. Necessarily, a framework will demand the collection of supporting data in a manner consistent with the following 2013 General Council resolution:
The Canadian Medical Association supports the development of data on health care delivery and patient outcomes to help the medical profession develop an appropriateness framework and associated accountability standards provided that patient and physician confidentiality is maintained.
2. Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
Both trainees and practicing physicians should have access to education and guidance on the topic of appropriateness and on practices that are misused, under-used, or over-used. Appropriately designed continuing education has been shown to alter physician practice. Point of care guidance via the electronic medical record offers a further opportunity to alert clinicians to practices that should or should not be done in the course of a patient encounter33.
An initiative co-led by the Canadian Medical Association that is designed to educate the profession about the inappropriate over use of diagnostic and therapeutic interventions is Choosing Wisely Canada. The goal is to enhance quality of care and only secondarily to reduce unnecessary expenditures. It is an initiative consistent with the intent of two resolutions from the 2013 General Council:
The Canadian Medical Association will form a collaborative working group to develop specialty-specific lists of clinical tests/interventions and procedures for which benefits have generally not been shown to exceed the risks.
The Canadian Medical Association believes that fiscal benefits and cost savings of exercises in accountability and appropriateness in clinical care are a by-product rather than the primary focus of these exercises.
3. Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
Practitioners should be provided with incentives to eliminate inappropriate care. These incentives may be financial - delisting marginal activities or providing bonuses for achieving utilization targets for appropriate but under-used care. Any notional savings could also be flagged for reinvestment in the health system, for example, to enhance access. Giving physicians the capacity to participate in audit and feedback on their use of marginal practices in comparison to peers generally creates a personal incentive to avoid outlier status. Public reporting by group or institution may also move practice towards the mean30. In any such undertakings to address quality or costs through changes in practice behaviour it is essential that the medical profession play a key role. This critical point was captured in a 2013 General Council resolution:
The Canadian Medical Association will advocate for adequate physician input in the selection of evidence used to address costs and quality related to clinical practice variation.
When appropriateness is defined solely in terms of assessing the clinical benefit of care activities it can provide a plausible rational for "disinvestment in" or "delisting of" individual diagnostic or therapeutic interventions. However, such a narrow conceptualization of appropriateness cannot ensure that high quality care is provided with the optimal use of resources. To be truly useful in promoting quality and value appropriateness must be understood to mean the right care, provided by the right provider, to the right patient, in the right venue, at the right time.
Achieving these five components of health care will not be without significant challenges, beginning with definitions and moving on to complex discussions on methods of measurement. Indeed, it may prove an aspirational goal rather than a completely attainable reality. But if every encounter in the health system - a hospitalization, a visit to a primary care provider, an admission to home care - attempted to meet or approximate each of the five criteria for appropriateness, a major step towards optimal care and value will have been achieved across the continuum. Viewed in this way, appropriateness has the capacity to become an extraordinarily useful organizing concept for positive health care transformation in Canada.
Approved by CMA Board on December 06, 2014
1. World Health Organization. Appropriateness in Health Care Services, Report on a WHO Workshop. Copenhagen: WHO; 2000.
2. Lavis JN, Anderson GM. Appropriateness in health care delivery: definitions, measurement and policy implications. CMAJ. 1996;154(3):321-8.
3. Sanmartin C, Shortt SE, Barer ML, Sheps S, Lewis S, McDonald PW. Waiting for medical services in Canada: lots of heat, but little light. CMAJ. 2000;162(9):1305-10.
4. Wait Time Alliance. Working to Improve Wait Times Across Canada. Toronto: Wait Time Alliance; 2014. Available: http://www.waittimealliance.ca. (accessed April 18, 2013)
5. Canadian Medical Association. Health Care Transformation in Canada. Ottawa: Canadian Medical Association; 2010.
6. Canadian Medical Association. CMA Policy: Achieving Patient-centred Collaborative Care. Ottawa: Canadian Medical Association; 2008.
7. Maxwell-Alleyne A, Farber A. Pharmacists' expanded scope of practice: Professional obligations for physicians and pharmacists working collaboratively. Ont Med Rev. 2013;80(4):17-9.
8. Sanmartin C, Murphy K, Choptain N, et al. Appropriateness of healthcare interventions: concepts and scoping of the published literature. Int J Technol Assess Health Care. 2008;24(3)342-9.
9. Canadian Institute for Health Information. Health Care in Canada 2010. Ottawa: CIHI; 2010.
10. MacKinnon J. Health Care Reform from the Cradle of Medicare. Ottawa: Macdonald-Laurier Institute; 2013.
11. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. NEJM. 2003;348(26):2635-45.
12. Runciman WB, Hunt TD, Hannaford NA, et al. CareTrack: assessing the appropriateness of health care delivery in Australia. Med J Aust. 2012;197(2):100-5.
13. Brook RH, Chassin MR, Fink A, Solomon DH, Kosecoff J, Park RE. A method for the detailed assessment of the appropriateness of medical technologies. Int J Technol Assess Health Care. 1986;2(1):53-63.
14. Lawson EH, Gibbons MM, Ko CY, Shekelle PG. The appropriateness method has acceptable reliability and validity for assessing overuse and underuse of surgical procedures. J Clin Epidemiol. 2012;65(11):1133-43.
15. Elshaug AG, Watt AM, Mundy L, Willis CD. Over 150 potentially low-value health care practices: an Australian study. Med J Aust. 2012;197(10):556-60.
16. Garner S, Docherty M, Somner J, et al. Reducing ineffective practice: challenges in identifying low-value health care using Cochrane systematic reviews. J Health Serv Res Policy. 2013;18(1):6-12.
17. Gertman PM, Restuccia JD. The appropriateness evaluation protocol: a technique for assessing unnecessary days of hospital care. Med Care. 1981;19(8):855-71.
18. Mitus AJ. The birth of InterQual: evidence-based decision support criteria that helped change healthcare. Prof Case Manag. 2008;13(4):228-33.
19. DeCoster C, Roos NP, Carriere KC, Peterson S. Inappropriate hospital use by patients receiving care for medical conditions: targeting utilization review. CMAJ. 1997;157(7):889-96.
20. Flintoft VF, Williams JI, Williams RC, Basinski AS, Blackstien-Hirsch P, Naylor CD. The need for acute, subacute and nonacute care at 105 general hospital sites in Ontario. Joint Policy and Planning Committee Non-Acute Hospitalization Project Working Group. CMAJ . 1998;158(10):1289-96.
21. Kalant N, Berlinguet M, Diodati JG, Dragatakis L, Marcotte F. How valid are utilization review tools in assessing appropriate use of acute care beds? CMAJ. 2000;162(13):1809-13.
22. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A systematic review of methods and results. Health policy. 2000;53(3):157-84.
23. Vetter N. Inappropriately delayed discharge from hospital: what do we know? BMJ. 2003;326(7395):927-8.
24. Choosing Wisely Canada. Recent News. Ottawa: Choosing Wisely Canada; 2015. Available: www.choosingwiselycanada.org. (accessed Dec 2014)
25. Garner S, Littlejohns P. Disinvestment from low value clinical interventions: NICEly done? BMJ. 2011;343:d4519.
26. Baker DW, Qaseem A, Reynolds PP, Gardner LA, Schneider EC. Design and use of performance measures to decrease low-value services and achieve cost-conscious care. Ann Intern Med. 2013;158(1):55-9.
27. Lawson EH, Gibbons MM, Ingraham AM, Shekelle PG, Ko CY. Appropriateness criteria to assess variations in surgical procedure use in the United States. Arch Surg. 2011;146(12):1433-40.
28. Chassin MR, Kosecoff J, Park RE, et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA. 1987;258(18):2533-7.
29. Keyhani S, Falk R, Bishop T, Howell E, Korenstein D. The relationship between geographic variations and overuse of healthcare services: a systematic review. Med care. 2012;50(3):257-61.
30. Kale MS, Bishop TF, Federman AD, Keyhani S. "Top 5" lists top $5 billion. Arch Intern Med. 2011;171(20):1856-8.
31. Elshaug AG, Hiller JE, Tunis SR, Moss JR. Challenges in Australian policy processes for disinvestment from existing, ineffective health care practices. Aust New Zealand Health Policy. 2007;4:23.
32. Elshaug AG, Moss JR, Littlejohns P, Karnon J, Merlin TL, Hiller JE. Identifying existing health care services that do not provide value for money. Med J Aust. 2009;190(5):269-73.
33. Shortt S GM, Gorbet S. Making medical practice safer: the role of public policy. Int J Risk Saf Med. 2010;22(3):159-68.
Authorizing Cannabis for Medical Purposes
The legalization of cannabis for recreational purposes came into effect with the Cannabis Act in October 2018, and patients continue to have access to cannabis for therapeutic purposes. The Cannabis Regulations have replaced the Access to Cannabis for Medical Purposes Regulations. Patients can obtain cannabis for medical purposes when a physician or nurse practitioner provides a “medical document” , authorizing its use, and determining the daily dried cannabis dose in grams.
With the authorization, patients have the choice whether to (a) buy directly from a federally licensed producer; (b) register with Health Canada to produce a limited amount for personal consumption; (c) designate someone to produce it for them; or (d) buy cannabis at provincial or territorial authorized retail outlets or online sales platforms, if above the legal age limit.
While acknowledging the unique requirements of patients suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief, physicians remain concerned about the serious lack of clinical research, guidance and regulatory oversight for cannabis as a medical treatment. There is insufficient clinical information on safety and efficacy for most therapeutic claims. There is little information around therapeutic and toxic dosages and knowledge on interactions with medications. Besides the need for appropriate research, health practitioners would benefit from unbiased, accredited educational modules and decision support tools based on the best available evidence.
The Canadian Medical Association has consistently expressed concern with the role of gatekeeper that physicians have been asked to take as a result of court decisions. Physicians should not feel obligated to authorize cannabis for medical purposes.
Physicians who choose to authorize cannabis for their patients must comply with their provincial or territorial regulatory College's relevant guideline or policy. They should also be familiar with regulations and guidance, particularly:
Health Canada’s Information for Health Care Practitioners – Medical Use of Cannabis (monograph, summary and daily dose fact sheet),
the Canadian Medical Protective Association’s guidance;
the College of Family Physicians of Canada’s preliminary guidance Authorizing Dried Cannabis for Chronic Pain or Anxiety; and
the Simplified guideline for prescribing medical cannabinoids in primary care, published in the Canadian Family Physician.
The CMA recommends that physicians should:
Ensure that there is no conflict of interest, such as direct or indirect economic interest in a licensed cannabis producer or be involved in dispensing cannabis;
Treat the authorization as an insured service, similar to a prescription, and not charge patients or the licensed producer for this service;
Until such time as there is compelling evidence of its efficacy and safety for specific indications, consider authorizing cannabis only after conventional therapies are proven ineffective in treating patients’ conditions;
Have the necessary clinical knowledge to authorize cannabis for medical purposes;
Only authorize in the context of an established patient-physician relationship;
Assess the patient’s medical history, conduct a physical examination and assess for the risk of addiction and diversion, using available clinical support tools and tests;
Engage in a consent discussion with patients which includes information about the known benefits and adverse health effects of cannabis in its various forms (e.g., edibles), including the risk of impairment to activities such as driving and work;
Advise the patient regarding harm reduction strategies and the prevention of accidental exposure for children and other people;
Document all consent discussions in patients' medical records;
Reassess the patient on a regular basis for its effectiveness to address the medical condition for which cannabis was authorized, as well as for addiction and diversion, to support maintenance, adjustment or discontinuation of treatment; and
Record the authorization of cannabis for medical purposes similar to when prescribing a controlled medication.
The Cannabis Regulations provide some consistency with many established provincial and territorial prescription monitoring programs for controlled substances. Licensed producers of cannabis for medical purposes are required to provide information to provincial and territorial medical licensing bodies upon request, including healthcare practitioner information, daily quantity of dried cannabis supported, period of use, date of document and basic patient information. The Minister of Health can also report physicians to their College should there be reasonable grounds that there has been a contravention of the Narcotic Control Regulations or the Cannabis Regulations.
Approved by CMA Board February 2015
Latest update approved by CMA Board in February 2020
The Canadian Medical Association (CMA) has always recognized the unique requirements of those individuals suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief.
However, there are a number of concerns, primarily related to the limited evidence to support many of the therapeutic claims made regarding cannabis for medical purposes, and the need to support health practitioners in their practice.1,2,3,4
While the indications for using cannabis to treat some conditions have been well studied, less
information is available about many potential medical uses.
Physicians who wish to authorize the use of cannabis for patients in their practices should consult relevant CMPA policy5 and guidelines developed by the provincial and territorial medical regulatory authorities to ensure appropriate medico-legal protection. The CMA’s policy Authorizing Marijuana for Medical Purposes6, as well as the CMA’s Guidelines For Physicians In Interactions With Industry7 should also be consulted.
The CMA makes the following recommendations:
1. Increase support for the advancement of scientific knowledge about the medical use of cannabis. The CMA encourages the government to support rigorous scientific research into the efficacy for therapeutic claims, safety, dose-response relationships, potential interactions and the most effective routes of delivery, and in various populations.
2. Apply the same regulatory oversight and evidence standards to cannabis as to pharmaceutical products under the Food and Drug Act, designed to protect the public by the assessment for safety and efficacy.
3. Increase support for physicians on the use of cannabis for medical purposes in their practice settings. As such, CMA calls on the government to work with the CMA, The College of Family Physicians of Canada, the Royal College of Physicians and Surgeons,
and other relevant stakeholders, to develop unbiased, accredited education options and licensing programs for physicians who authorize the use of cannabis for their patients based on the best available evidence.
In 2001, Health Canada enacted the Marihuana Medical Access Regulations (MMAR). These were in response to an Ontario Court of Appeal finding that banning cannabis for medicinal purposes violated the Charter of Rights and Freedoms.8 The MMAR, as enacted, was designed to establish a framework to allow legal access to cannabis, then an illegal drug, for the relief of pain, nausea and other symptoms by people suffering from serious illness where conventional treatments had failed.
While recognizing the needs of those suffering from terminal illness or chronic disease, CMA raised strong objections to the proposed regulations. There were concerns about the lack of evidence on the risks and benefits associated with the use of cannabis. This made it difficult for physicians to advise their patients appropriately and manage doses or potential side effects. The CMA believes that physicians should not be put in the untenable position of gatekeepers for a proposed medical intervention that has not undergone established regulatory review processes as required for all prescription medicines.
Additionally, there were concerns about medico-legal liability, and the Canadian Medical Protective Association (CMPA), encouraged those physicians that were uncomfortable with the regulations to refrain from authorizing cannabis to patients.
Various revisions were made to the MMAR, and then these were substituted by the Marihuana for Medical Purposes Regulations (MMPR) in 2013/ 2014 and subsequently by the Access to Cannabis for Medical Purposes Regulations (ACMPR) in 2016 and now as part of the Cannabis Act (Section 14)9. Healthcare practitioners that wish to authorize cannabis for their patients are required to sign a medical document, indicating the daily quantity of dried cannabis, expressed in grams.
For the most part, these revisions have been in response to decisions from various court decisions across the country.10,11,12 Courts have consistently sided with patients’ rights to relieve symptoms of terminal disease or certain chronic conditions, despite the limited data on the effectiveness of cannabis. Courts have not addressed the ethical position in which physicians are placed as a result of becoming the gate keeper for access to a medication without adequate evidence.
The CMA participated in many Health Canada consultations with stakeholders as well as scientific advisory committees and continued to express the concerns of the physician community. As previously noted, the Federal government has been constrained by the decisions of Canadian courts.
The current state of evidence regarding harms of cannabis use is also limited but points to some serious concerns. Ongoing research has shown that regular cannabis use during brain development (up to approximately 25 years old) is linked to an increased risk of mental health disorders including depression, anxiety, and schizophrenia, especially if there is a personal or family history of mental illness. Long term use has also been associated with issues of attention, impulse control and emotional regulation. Smoking of cannabis also has pulmonary consequences such as chronic bronchitis. It is also linked to poorer pregnancy outcomes. Physicians are also concerned with dependence, which occurs in up to 10% of regular users. From a public and personal safety standpoint, cannabis can impact judgement and increases the risk of accidents (e.g. motor vehicle incidents). For many individuals, cannabis use is not without adverse consequences.3,13,14
Pharmaceutically prepared alternative options, often administered orally, are also available and regulated in Canada.15 These drugs mimic the action of delta-9-tetra-hydrocannabional (THC) and other cannabinoids and have undergone clinical trials to demonstrate safety and effectiveness and have been approved for use through the Food and Drug Act. Of note is that in this format, the toxic by-products of smoked marijuana are avoided.16 However, the need for more research is evident.
Approved by the CMA Board in December 2010.
Last reviewed and approved by the CMA Board in March 2019.
1 Allan GM, Ramji J, Perry D, et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician, 2018;64(2):111-120. Available: http://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Jan 8).
2 College of Family Physicians of Canada (CFPC). Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance. Mississauga: CFPC; 2014. Available: https://www.cfpc.ca/uploadedFiles/Resources/_PDFs/Authorizing%20Dried%20Cannabis%20for%20Chronic%20Pain%20or%20Anxiety.pdf (accessed 2019 Jan 8).
3 The National Academies of Sciences, Engineering and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: National Academies Press; 2017. 4 Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015;313(24):2456-73.
5 Canadian Medical Protective Association (CMPA). Medical marijuana: considerations for Canadian doctors. Ottawa: CMPA; 2018. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2014/medical-marijuana-new-regulations-new-college-guidance-for-canadian-doctors (accessed 2019 Jan 8).
6 Canadian Medical Association (CMA). Authorizing marijuana for medical purposes. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11514 http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-04.pdf (accessed 2019 Jan 8).
7 Canadian Medical Association. (CMA) Guidelines for Physicians In Interactions With Industry. Ottawa: CMA; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf. (accessed 2019 Jan22).
8 R. v. Parker, 2000 CanLII 5762 (ON CA). Available: http://canlii.ca/t/1fb95 (accessed 2019 Jan 8).
9 Cannabis Act. Access to Cannabis for Medical Purposes. Section 14. 2018. Available: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-144/page-28.html#h-81 (accessed 2019 Jan 8).
10 Hitzig v. Canada, 2003 CanLII 3451 (ON SC). Available: http://canlii.ca/t/1c9jd (accessed 2019 Jan 8).
11 Allard v. Canada,  3 FCR 303, 2016 FC 236 (CanLII), Available: http://canlii.ca/t/gngc5 (accessed 2019 Jan 8).
12 R. v. Smith, 2014 ONCJ 133 (CanLII). Available: http://canlii.ca/t/g68gk (accessed 2019 Jan 8). 13 Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227.
14 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: https://www.who.int/substance_abuse/publications/msbcannabis.pdf (accessed 2019 Jan 8).
15 Ware MA. Is there a role for marijuana in medical practice? Can Fam Physician 2006;52(12):1531-1533. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1952544/pdf/0530022a.pdf (accessed 2019 Jan 8).
16 Engels FK, de Jong FA, Mathijssen RHJ, et.al. Medicinal cannabis in oncology. Eur J Cancer. 2007;43(18):2638-2644. Available: https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804907007368.pdf?locale=en_US (accessed 2019 Jan 8).
CMA PATIENT SAFETY POLICY FRAMEWORK (Update 2010)
The CMA’s mission is to promote the highest standard of health and health care for Canadians. This means, among other things, ensuring that the health care system is safe for patients and providers and effective in achieving good health outcomes for individuals and society. Unfortunately, studies published in recent years have raised concern that health care is not as safe as it could be; data collected by researchers in various countries has shown that there are unacceptably high levels of preventable adverse events, as high as 16% in one study of adverse events associated with hospital admissions. A study conducted by G. R. Baker, P.G. Norton et al, “The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada” showed an adverse event rate of 7.5 per 100 hospital admissions. (1) This suggests that of the nearly 2.5 million hospital admissions yearly in Canada, approximately 185,000 are associated with an adverse event and 70,000 of those possibly preventable.
These studies have focused attention on health care error and adverse events, but patient safety requires that participants in the health care system are constantly aware of the risks present in the system, and that risks are addressed proactively - preferably before an adverse event occurs. If a preventable adverse event does occur, it provides an opportunity to learn about and correct sources of error.
The CMA considers that a national patient safety strategy, aimed at building a culture of safety, is a priority. This Policy Framework has been developed to provide a clear statement of the CMA’s views on the principles that should underpin a patient safety strategy and to ensure clear support and direction for CMA members and staff involved in patient safety initiatives.
The Health Care System
Errors and adverse events are inevitable in any complex system and more complex systems are more prone to errors. Nevertheless, studies have demonstrated an unacceptably high level of preventable adverse events associated with management of health care.
1. Patient safety initiatives should aim to improve health outcomes for patients by minimizing the rate of preventable adverse events and improving the management of events when they occur.
2. Patient safety is one aspect of quality health care; activities relating to patient safety should result in a net increase in the quality of health care.
3. Patient safety initiatives should recognize that error and adverse events occur because of qualities of the system within which individuals operate. A primary concern of initiatives should be to prevent future errors by addressing the system rather than blaming and punishing individuals.
The Canadian public has a reasonable expectation that health care will not result in avoidable injury.
4. Patient safety initiatives should support the accountability of the health sector, including providers, funders and regulators, to patients and the wider public for the safety of health care.
Participants in Health Care
Patients as partners
5. Patient safety initiatives should promote the role of patients as partners in the provision of safe care, including the prevention and management of adverse events.
6. Patient safety initiatives should encourage and anticipate the full and appropriate disclosure to patients of relevant information that is material to their health and healthcare, including information about adverse events or effects.
Professional responsibility and support
With a very few exceptions, health care is delivered by competent, caring professionals who are striving to achieve a good outcome for patients.
7. Patient safety initiatives should recognize the responsibility of professionals for achieving and maintaining the standard of their own practice.
8. Patient safety initiatives, while responding appropriately to adverse events, should be sensitive to the professional role and personal well being of individual physicians and other health care providers.
Learning and Collaboration
9. Patient safety initiatives should promote and reflect teamwork, communication and collaboration at all levels.
10. Patient safety initiatives should support learning from one’s own experience and the sharing of knowledge so that it is possible to learn from the experience of others.
Legal and Regulatory Environment
11. Patient Safety initiatives should promote a legal and regulatory environment that supports open communication and effective management of adverse events.
12. The protection afforded to the opinions expressed within quality assurance committees must be upheld
Evidence Base and Evaluation
Patient safety initiatives should be based on sound evidence.
Patient safety initiatives should contain provision for appropriate evaluation.
Patient safety initiatives should contain provision for broad dissemination of findings.
PATIENT SAFETY INITIATIVE AREAS
Building a culture of safety in Canadian health care will require the collaboration of many different groups and organizations. The CMA can play a leadership role within this larger group and within its own constituency of over 70,000 physicians. In some instances, it will be the CMA’s role to advocate for initiatives that can be delivered only by another provider or through a consortium; in other instances, CMA can assume sole responsibility for taking action. The CMA has identified that, as priorities, it will support:
Advocacy for changes to legislation and regulation that would remove disincentives for health care providers to share information about adverse events.
Raising awareness of patient safety and changing attitudes towards risk, error and adverse events within the health care community.
Developing and providing resources such as clinical practice guidelines and information technology systems that have been shown to standardize practice and reduce adverse events.
Reporting systems that collect and aggregate data on risks so that good practices can be developed and shared.
Education and training for health care professionals and managers to provide them with the conceptual and practical tools to introduce change into their practice and organizations.
Advocacy for, and development of, an agenda for patient safety research in Canada.
The involvement of government at all levels in supporting and committing resources to initiatives for improved patient safety.
Adverse event – any unintended injury or complication that is caused by health care management rather than the patient’s disease and that leads to prolonged hospital stay, morbidity or mortality. Adverse events do not necessarily result from error, for example a toxic reaction to a drug in a patient without apparent risk factors for the reaction.
Error – the failure of a planned action to be completed as intended (“error of execution”) or the use of a wrong plan to achieve an aim (“error of planning”). An error may not result in an adverse event if the error does not result in harm or is intercepted.
Risk – the chance of injury or loss as defined as a measure of the probability and severity of an adverse effect to health, property, the environment or other things of value.
(1) G. Ross Baker, Peter G. Norton, Virginia Flintoft, Régis Blais, Adalsteinn Brown, Jafna Cox, Ed Etchells, William A. Ghali, Philip Hébert, Sumit R. Majumdar, Maeve O'Beirne, Luz Palacios-Derflingher, Robert J. Reid, Sam Sheps, and Robyn Tamblyn. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada Can. Med. Assoc. J., May 2004; 170: 1678 - 1686.
CMA Statement on Emerging Therapies
The CMA is keenly aware of the heart-rending suffering experienced by MS patients and the devastating impact it has on families and we recognize how desperately they are seeking treatments to alleviate their symptoms. Physicians and researchers dedicate their lives to finding new treatments to prevent and ease the suffering of patients while supporting those battling disease. Along with the physician's care and compassion, clinical research is a key weapon in the battle to manage and treat disease. The CMA believes that all medical decisions must be based upon scientific evidence. That is at the heart of our commitment to patient-centred care.
The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-based. This principle is highly relevant in the case of the Canadian Institutes of Health Research (CIHR) recent recommendations. The CMA concurs with the CIHR's position on the need for an evidence-based approach to the development of clinical trials of the recently proposed condition called "chronic cerebrospinal venous insufficiency" (CCSVI). We would hope that the findings of the seven diagnostic studies that are underway will be shared and analyzed as soon as they become available, and that clinical intervention trials would be supported as indicated by the evidence and if researchers come forward with scientifically sound ethical protocols. If additional Canadian funding bodies initiate clinical research in the area, we would encourage CIHR to provide advice if requested.
Racism is a structural determinant of health and drives health and social inequities. The recent incidents of anti-Black violence, racism and discrimination in the US and Canada also shed light on the structural inequities and racism that exist within the medical profession and the health system.
The profession of medicine is grounded in respect for all people. This commitment recognizes that everyone has equal and inherent worth, the right to be valued and respected, and the right to be treated with dignity.
It’s critical that our medical culture – and society more broadly – upholds these values. But today, we’re reminded that there’s much more to do as a profession, and as a global community, to get us there.
Earlier this year, we launched our first-ever policy on equity and diversity in medicine Opens in a new window to help break down the many broad and systemic barriers that remain, to reduce discrimination and bias within our profession, and to create physically and psychologically safe environments for ourselves, our colleagues and our patients.
Alongside this policy comes a commitment to holding ourselves accountable to recognizing and challenging behaviours, practices and conditions that hinder equity and diversity, including racism.
Instances of racism, intolerance, exclusion, violence and discrimination have no place in medicine, and no place in our society. The Canadian Medical Association condemns racism in all its forms. Today, we stand alongside all those who have been affected by these appalling and inexcusable actions and beliefs.
Dr. Sandy Buchman
President, Canadian Medical Association
COMPLEMENTARY AND ALTERNATIVE MEDICINE
This statement discusses the Canadian Medical Association's (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA's position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should "consider first the well-being of the patient."1 The ethical principle of non-maleficence obliges physicians to reduce their patient's risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM.
CAM in Canada
CAM has been defined as "a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine."i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this analysis, the CMA divides CAM into four general categories:
* Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based.
* Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products.
* Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise.
* Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada.
Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the "holistic" concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM.
Toward Evidence-Informed Health Care
Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious.
The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA's Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below:
a) Research: Building an Evidence Base
To date, much of the public's information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public.
b) An Appropriate Regulatory Framework
Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments.
i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada.
The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products' safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include:
* manufacturing processes that ensure the purity, safety and quality of the product;
* labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6
The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm's length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8
The Canadian Medical Association advocates that foods fortified with "natural health" ingredients should be regulated as food products and not as natural health products
The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada's MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada.
ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge.
Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients.
Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to:
* Resist any influence or interference that could undermine their professional integrity;9
* Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10
* Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient.
c) Information and Promotion
Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include:
* Instructions for use;
* Indications that the product or therapy has been convincingly proven to treat;
* Contraindications, side effects and interactions with other medications;
* Should advise the consumer to inform their health care provider during any encounter that they are using this product.12
This information should be provided in such a way as to minimize the impact of vested commercial interests on its content.
In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims.
The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease.
The Role of Health Professionals
Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients.
Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically.
The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health.
1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004.
2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies.
5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies.
6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998.
7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008.
8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with "natural health" ingredients. Ottawa (ON): The Association; 2010. Available:
9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm.
11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.
12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998.