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
Inherent in all health care professional Codes of Ethics is the duty to provide care to patients and to relieve suffering whenever possible. However, this duty does not exist in a vacuum, and depends on the provision of goods and services referred to as reciprocal obligations, which must be provided by governments, health care institutions and other relevant bodies and agencies. The obligation of government and society to physicians can be seen as comparable to the obligations of physicians to their patients.
The recent experience of Canadian physicians during the SARS epidemic in Toronto has heightened the sensitivities of the medical profession to several issues that arose during the course of dealing with that illness. Many of the lessons learned (and the unanswered questions that arose) also apply to the looming threat of an avian flu (or other) pandemic. Canadian physicians may be in a relatively unique position to consider these issues given their experience and insight.
The intent of this working paper is to highlight the ethical issues of greatest concern to practicing Canadian physicians which must be considered during a pandemic. In order to address these issues before they arise, the CMA presents this paper for consideration by individual physicians, physician organizations, governments, policy makers and interested bodies and stakeholders. Although many of the principles and concepts could readily be applied to other health care workers, the focus of this paper will be on physicians.
Policies regarding physicians in training, including medical students and residents, should be clarified in advance by the relevant bodies involved in their oversight and training. Issues of concern would include the responsibilities of trainees to provide care during a pandemic and the potential effect of such an outbreak on their education and training.
A. Physician obligations during a pandemic
The professional obligations of physicians are well spelled out in the CMA Code of Ethics and other documents and publications and are not the main focus of this paper. However, they will be reviewed and discussed as follows.
Several important principles of medical ethics will be of particular relevance in considering this issue. Physicians have an obligation to be beneficent to their patients and to consider what is in the patient's best interest. According to the first paragraph of the CMA Code of Ethics (2004), "Consider first the well-being of the patient".
Traditionally, physicians have also respected the principle of altruism, whereby they set aside concern for their own health and well-being in order to serve their patients. While this has often manifested itself primarily as long hours away from home and family, and a benign neglect of personal health issues, at times more drastic sacrifices have been required. During previous pandemics, many physicians have served selflessly in the public interest, often at great risk to their own well-being.
The principle of justice requires physicians to consider what is owed to whom and why, including what resources are needed, and how these resources would best be employed during a pandemic. These resources might include physician services but could also include access to vaccines and medications, as well as access to equipment such as ventilators or to a bed in the intensive care unit. According to paragraph 43 of the CMA Code of Ethics, physicians have an obligation to "Recognize the responsibility of physicians to promote equitable access to health care resources".
In addition, physicians can reasonably be expected to participate in the process of planning for a pandemic or other medical disaster. According to paragraph 42 of the CMA Code of Ethics, physicians should "Recognize the profession's responsibility to society in matters relating to public health, health education, environmental protection, legislation affecting the health and well-being of the community and the need for testimony at judicial proceedings". This responsibility could reasonably be seen to apply both to individual physicians as well as the various bodies and organizations that represent them.
Physicians also have an ethical obligation to recognize their limitations and the extent of the services they are able to provide. During a pandemic, physicians may be asked to assume roles or responsibilities with which they are not comfortable, nor prepared. Paragraph 15 of the CMA Code of Ethics reminds physicians to "Recognize your limitations and, when indicated, recommend or seek additional opinions or services".
However, physicians have moral rights as well as obligations. The concept of personal autonomy allows physicians some discretion in determining where, how and when they will practice medicine. They also have an obligation to safeguard their own health. As stated in paragraph 10 of the CMA Code of Ethics, physicians should "Promote and maintain your own health and well-being".
The SARS epidemic has served to reopen the ethical debate. Health care practitioners have been forced to reconsider their obligations during a pandemic, including whether they must provide care to all those in need regardless of the level of personal risk. As well, they have been re-examining the obligation of governments and others to provide reciprocal services to physicians, and the relationship between these obligations.
B. Reciprocal obligations towards physicians
While there has been much debate historically (and especially more recently) about the ethical obligations of physicians towards their patients and society in general, the consideration of reciprocal obligations towards physicians is a relatively recent phenomenon.
During the SARS epidemic, a large number of Canadian physicians unselfishly volunteered to assist their colleagues in trying to bring the epidemic under control. They did so, in many cases, in spite of significant personal risk, and with very little information about the nature of the illness, particularly early in the course of the outbreak. Retrospective analysis has cast significant doubt and concern on the amount of support and assistance provided to physicians during the crisis. Communication and infrastructure support was poor at best. Equipment was often lacking and not always up to standard when it was available. Psychological support and counselling was not readily available at the point of care, nor was financial compensation for those who missed work due to illness or quarantine. Although the Ontario government did provide retrospective compensation for many physicians whose practices were affected by the outbreak, the issue was addressed late, and not at all in some cases.
It is clear that Canadian physicians have learned greatly from this experience. The likelihood of individuals again volunteering "blindly" has been reduced to the point where it may never happen again. There are expectations that certain conditions and obligations will be met in order to optimize patient care and outcomes and to protect health care workers and their families.
Because physicians and other health care providers will be expected to put themselves directly in harm's way, and to bear a disproportionate burden of the personal hardships associated with a pandemic, the argument has been made that society has a reciprocal obligation to support and compensate these individuals.
According to the University of Toronto Joint Centre for Bioethics report We stand on guard for thee, "(The substantive value of) reciprocity requires that society support those who face a disproportionate burden in protecting the public good, and take steps to minimize burdens as much as possible. Measures to protect the public good are likely to impose a disproportionate burden on health care workers, patients and their families."
Therefore, in order to provide adequate care for patients, the reciprocal obligation to physicians requires providing some or all of the following:
Prior to a pandemic
- Physicians and the organizations that represent them should be more involved in planning and decision making at the local, national and international levels. In turn, physicians and the organizations that represent them have an obligation to participate as well.
- Physicians should be made aware of a clear plan for resource utilization, including:
- how physicians will be relieved of duties after a certain time;
- clearly defined roles and expectations, especially for those practicing outside of their area of expertise;
- vaccination/treatment plans - will physicians (and their families) have preferential access based on the need to keep caregivers healthy and on the job;
- triage plans, including how the triage model might be altered and plans to inform the public of such.
- Physicians should have access to the best equipment needed and should be able to undergo extra training in its use if required.
- Politicians and leaders should provide reassurances that satisfy physicians that they will not be "conscripted" by legislation.
During a pandemic
- Physicians should have access to up-to-date, real time information.
- Physicians should be kept informed about developments in Canada and globally.
- Communication channels should be opened with other countries (e.g. Canada should participate in WHO initiatives to identify the threats before they arrive on our doorstep).
- Resources should be provided for backup and relief of physicians and health care workers.
- Arrangements should be made for timely provision of necessary equipment in an ongoing fashion.
- Physicians should be compensated for lost clinical earnings and to cover expenses such as lost wages, lost group earnings, overhead, medical care, medications, rehabilitative therapy and other relevant expenses in case of quarantine, clinic cancellations or illness (recognizing that determining exactly when or where an infection was acquired may be difficult).
- Families should receive financial compensation in the case of a physician family member who dies as a result of providing care during a pandemic.
- In the event that physicians may be called upon in a pandemic to practice outside of their area of expertise or outside their jurisdiction, they should to contact their professional liability protection provider for information on their eligibility for protection in these circumstances.
- Interprovincial or national licensing programs should be developed to provide physicians with back-up and relief and ensure experts can move from place to place in a timely fashion without undue burden.
- Psychological and emotional counselling and support should be provided in a timely fashion for physicians, their staff and family members.
- Accommodation (i.e. a place to stay) should be provided for physicians who have to travel to another locale to provide care; or who don't want to go home and put their family at risk, when this is applicable, i.e. the epidemiology of the infectious disease causing the pandemic indicates substantially greater risk of acquiring infection in the health care setting than in the community.
- Billing and compensation arrangements should ensure physicians are properly compensated for the services they are providing, including those who may not have an active billing number in the province where the services are being provided.
After a pandemic
- Physicians should receive assistance in restarting their practice (replacing staff, restocking overhead, communicating with patients, and any other costs related to restarting the practice).
- Physicians should receive ongoing psychological support and counselling as required.
C. How are physician obligations and reciprocal obligations related?
Beyond a simple statement of the various obligations, it is clear that there must be some link between these different obligations. This is particularly important since there is now some time to plan for the next pandemic and to ensure that reciprocal obligations can be met prior to its onset. Physicians have always provided care in emergency situations without questioning what they are owed. According to paragraph 18 of the CMA Code of Ethics, physicians should "Provide whatever appropriate assistance you can to any person with an urgent need for medical care".
However, in situations where obligations can be anticipated and met in advance, it is reasonable to expect that they will be addressed. Whereas a physician who encounters an emergency situation at the site of a car crash will act without concern for personal gain or motivation, a physician caring for the same patient in an emergency department will rightly expect the availability of proper equipment and personnel.
In order to ensure proper patient care and physician safety, and to ensure physicians are able to meet their professional obligations and standards, the reciprocal obligations outlined above should be addressed by the appropriate body or organization.
If patient and physician well-being is not optimized by clarifying the obligations of physicians and society prior to the next pandemic, in spite of available time and resources necessary to do so, there are many who would call into question the ethical duty of physicians to provide care. However, the CMA believes that, in the very best and most honourable traditions of the medical profession, its members will provide care and compassion to those in need. We call on governments and society to assist us in optimizing this care for all Canadians.
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.
CORE AND COMPREHENSIVE HEALTH CARE SERVICES
CMA believes that physicians must be actively involved in the decision-making process on core and comprehensive services. It developed a framework for this purpose after review and analysis of national and international decision-making frameworks, and after consideration of the political, policy and legal context of Canadian health care decision making. In addition to the framework, key terms associated with core and comprehensive health care services are operationally defined. Quality of care and ethical and economic factors are considered in a balanced and flexible manner, recognizing that the relative importance of any one factor may vary depending on the health care service being considered.
CMA first prepared this policy in 1994 to help physicians participate in making choices concerning core and comprehensive health care services. Over a decade later, the issue of defining these services remains a central issue for patients, providers and funders of Canada's health care system. Looking ahead, this will become even more pertinent as regional authorities assume greater authority in planning and allocating health funding across a broad range of programs.
Constructive leadership from the medical profession is essential to ensure a high quality Canadian health care system. Specifically, physicians must be actively involved in the decision-making process on core and comprehensive health care services.
CMA reviewed and analyzed several national and international decision-making frameworks and subsequently developed a framework for making decisions about core and comprehensive health care services (Core and Comprehensive Health Care Services: a Framework for Decision Making, CMA, 1994). It also considered the current political, policy and legal context in which decisions on health care are made in Canada. Key terms associated with core and comprehensive health care services were operationally defined.
CMA encourages the use of its framework for making decisions about these services. Quality of care and ethical and economic factors are considered in a balanced and flexible manner, recognizing that the relative importance of any one factor may vary depending on the health care service being considered. Each factor affects decision making at the patient-physician (micro) level, the hospital and regional (meso) level and the provincial, territorial and national (macro) level.
This policy summary addresses the requirement for governments to fund core medical services but not the availability or desirability of private or alternative funding for these services.
Uniform use and interpretation of the terms used in this area are particularly important in policy development, negotiations and communications. The 1984 Canada Health Act stipulates that all "medically necessary" services be insured; however, the act does not define "medically necessary." This lack of a clear operational definition gives the provinces/territories some flexibility in the breadth of coverage provided by their insurance plans. However, it may also cause ambiguity and difficulty in selecting core health care services.
CMA defines medically necessary services as those "that a qualified physician determines are required to assess, prevent, treat, rehabilitate or palliate a given health concern or problem as supported by available scientific evidence and/or professional experience." (Adapted from Core and Comprehensive Health Care Services, page 96.)
Health care services are "not only services provided by or under the supervision of a physician, but also a wide range of services performed by many other health care professionals." (Adapted from Core and Comprehensive Health Care Services, page 92.) Medical services is "a category of health care services provided by or under the supervision of a physician." (Core and Comprehensive Health Care Services, page 96.)
Comprehensive health care and medical services are distinguished from core health care and medical services. Comprehensive health care and medical services are "a broad range of services that covers most, if not all, health care needs. These services may or may not be funded/insured by a government plan." (Core and Comprehensive Health Care Services, page 86.) Core health care and medical services are those that "are available to everyone as funded/insured by a government plan. [Alternative] funding sources for these services are not necessarily excluded." (Core and Comprehensive Health Care Services, page 86.)
Framework for decision making
CMA advocates a systematic and transparent decision-making framework for determining which services are considered core and comprehensive health care services. The framework was originally intended for medical services; however, it can also be applied to health care services. It is flexible so that users may adapt it to their own specific circumstances and needs. It is not a formula or set process that yields a quantifiable result for any given service, nor does it prescribe which services to insure or not insure. CMA has put forth the following principle concerning the framework.
When decisions about core and comprehensive health care services are made, the various levels at which decisions can be made must be considered. These include the patient- physician (micro) level, the hospital and regional (meso) level and the provincial, territorial and national (macro) level.
CMA recognizes that decisions are made at several levels: (1) the micro level, which involves individual decisions about service delivery made by patients, physicians and other providers, (2) the meso level, which involves regional health authorities and health care institutions such as hospitals, community groups and professional staff, and (3) the macro level, which involves system wide decisions made by governments, the electorate and professions as a whole.
It is important to take into account the likely effect of any decision on each level: a decision that is acceptable at the macro level may be impossible to deliver at the meso level and inappropriate for patients or practitioners at the micro level. Coordination is essential to make consistent decisions among levels and incorporate the concerns of patients, providers and payers.
CMA upholds a second principle concerning the decision making framework.
Quality of care and ethical and economic factors must be considered when decisions about core and comprehensive health care services are made.
Quality of care
Effectiveness, efficiency, appropriateness and patient acceptance are elements of quality of care. To be considered a core medical service, a medical service must be of high quality (i.e., it addresses effectively a health concern or condition through improved health outcomes and is delivered efficiently, appropriately and in a manner acceptable to patients) as well as fulfilling ethical and economic criteria. A medical service that is shown to be of little effectiveness cannot be delivered efficiently or poses many problems for patient safety or acceptance is less "medically necessary" than services that meet the quality of care criteria. Such a service is therefore unlikely to become or remain a core medical service.
The adoption of evidence-based medicine such as through the use of clinical practice guidelines (CPGs) is a key component of quality improvement. CPGs are based on a systematic review of experience and research, and they help physicians to make decisions about necessary care. CPGs that are well developed and appropriately evaluated may also help to define core health care services. CPGs are also tools for the pursuit of quality, to maximize effective care and to reduce waste and ineffective activity in a given service, resulting in savings.
Clinical research is a key aspect of improvement in quality of care. Such research focuses on the effectiveness and impact of health care services on health outcomes. Procedures that demonstrate better outcomes than others should be included in a core health care package, whereas those that demonstrate inferior outcomes may be limited or excluded in some instances. When applying the concept of core health care services, provision must be made for ongoing evaluation of the quality of current services and appropriate assessment of new ones.
While it is important that the decision-making framework be evidence-based to the greatest extent possible, it should not be evidence-bound - that is, decisions may still need to be made from limited evidence.
Balancing finite fiscal resources and high quality medical and other health care services requires explicit societal choices about which services will be publicly funded (and for whom), which can be purchased and which will not be available at all in the Canadian system. These issues are ethical ones because they involve rights, responsibilities and societal values.
Whether decisions about resource allocation are made at the macro, meso or micro level, they must be fair. This means that those likely to be affected by a decision, whether they are patients, providers or payers, must have adequate opportunity for input into the decision-making process and must be informed about the reasons for the decisions.
When the availability of a health care service is inadequate to meet the demand, the criteria for allocating it should be fair and explicit. One such criterion is medical need: even if not all needed services can be publicly funded, services that are clearly unnecessary should not be funded in this way. Funding decisions should be nondiscriminatory; decisions about which health care services should or should not be publicly funded should not be based on age, sex, race, lifestyle and other personal and social characteristics of the potential recipients of a service.
Economic factors (Cost-effectiveness)
The level of public funding for health care services is ultimately a societal decision, as discussed in the section on ethical factors. Once such a societal decision has been made, economic factors are useful in determining the allocation of resources among health care services, especially in times of fiscal restraint.
There are various economic methods for evaluating funding decisions, the most common of which is cost effectiveness analysis. This approach suggests that decisions to insure a particular service should take into account cost in relation to outcome, e.g., cost per quality-adjusted life-year. Services that have a low cost for a significant gain in effectiveness may be more acceptable for public funding than others. This approach cannot be used in isolation; quality of care and ethical considerations must be taken into account before a final determination of the source of funding for core or comprehensive health care services is made.
Determination of which health care services are to be included in or excluded from a publicly financed health insurance plan should also incorporate an economic analysis of the primary and secondary effects on both the patient and provider populations. Some of the factors that should be included in such an analysis are: availability of substitutes, discretionary income, availability of private insurance, direct and indirect costs of service provision, barriers to entry and the existence of fixed global budgets. Economic analyses also include measurement of the opportunity costs, in terms of foregone services, associated with public financing of health care services. When possible, the public's needs should be distinguished from its wants for the purposes of public policy and funding.
From a clinical perspective, providers have always addressed patient needs on a case-by-case basis. However, fiscal restraint and the rationalization of health care services often result in the onus being placed on the provider to make micro resource allocation decisions. Local decisions (i.e., at the hospital and community level) about the rationalization of health care resources can restrict providers' ability to deliver services and patients' ability to receive them. Therefore, it is critical that the patient and provider perspectives be included in any economic analysis undertaken to define core health care services.
As enunciated in its policy statement, Federal Health Financing, the CMA will urge the federal government to ensure that full funding be available to support provincial and territorial provision of core medical services.
Nevertheless, there remain concerns regarding how the comprehensiveness principle is being interpreted. First, the array of core services varies considerably among the provinces/territories (e.g., prescription drug coverage). Second, the basket of core health services needs to be modernized to reflect Canadians' emerging health needs and how health care is now being delivered (e.g,. more out-patient care).
While a degree of latitude is required to accommodate differing regional needs, core services should be available to all Canadians on uniform terms and conditions and should not be limited to physician and hospital services. There should be ongoing periodic monitoring and reporting of the comparability of Canadians' access to a full range of medically necessary health services across the country.
Furthermore, there is a need for a federal/provincial/territorial process that is transparent, accountable, evidence-based and inclusive to regularly update the basket of core services. CMA will work with provincial/territorial medical associations and other stakeholders to develop a process for defining a national list of core medical services.
Greater transparency is required when de-insuring services, including the need for consultation and providing an adequate notice period for patients, providers and funders.
A new framework is also required to govern the funding of a basket of core health services that allows at least some core services to be cost-shared under uniform terms and conditions in all provinces and territories.
Direct-to-Consumer Advertising (DTCA) Policy Statement
Canadians have a right to information about prescription drugs and other therapeutic interventions, to enable them to make informed decisions about their own health. This information must be evidence based and provide details about side effects and health risks as well as benefits.
Brand-specific direct-to-consumer advertisements, such as those permitted in the United States, do not provide optimal information on prescription drugs. We are concerned that DTCA:
* is not information but marketing, and sends the message that a prescription drug is a “consumer good” rather than a health care benefit.
* may not provide enough information to allow the consumer to make appropriate drug choices. For example, it generally does not provide information about other products or therapies that could be used to treat the same condition. In addition, it may stimulate demand by exaggerating the risks of a disease and generating unnecessary fear.
* may strain the relationship between patients and providers, for example if a patient’s request for an advertised prescription drug is refused.
* drives up the cost of health care, and undermines the efforts of physicians, pharmacists and others to promote optimal drug therapy.
Patient groups, health care providers, governments and pharmaceutical manufacturers should be supported in activities to develop objective, reliable plain-language information about prescription drugs to ensure that Canadians are able to make informed health care decisions.
* Support the provision of objective, evidence-based, reliable plain-language information for the public about prescription drugs.
* Oppose direct-to-consumer prescription drug advertising in Canada.
Federal Health Financing (Update 2008)
The Canadian Medical Association believes that financial support from the federal government for health care should provide the following:
* The maintenance and improvement of standards of health care service across Canada.
* The financial stability necessary to effectively plan health care delivery and flexibility in spending across Canada to respond to local circumstances, emerging health needs, and new patient-care modalities.
* The indexing of federal health cash payments to provinces and territories to reflect changes in population growth, ageing, epidemiology, current knowledge, new technology and economic growth.
* Greater accountability, visibility and improved linkages of services to users.
* Greater equity across the provinces and territories in the ability to finance necessary health care programs.
* The joint policy discussions necessary to address health issues of national importance.
The CMA is committed to preserving the right of reasonable access to high-quality health care regardless of ability to pay. It is also committed to achieving national health care standards (accessibility, universality, portability, comprehensiveness and public administration) and to developing health goals to ensure that all Canadians receive the best possible care when required. The CMA supports the goal of maintaining the national integrity of the health care system. It encourages the federal government to be sensitive to the concerns of equity, and to ensure that provinces and territories that have not attained a level of health care services and facilities equivalent to those of other provinces and territories, because of fiscal incapacities, have access to additional funding requirements to reduce the gap. The CMA recognizes that flexibility in spending across Canada is important to respond to changing health care needs and changes in the delivery of health care, as is the necessity of joint policy discussions to address health issues of national importance. Stability in funding is viewed as the mechanism to achieving effective health care planning.
Over 50 years of federal financing
In 1957 and 1966, the federal government introduced the Hospital Insurance and Diagnostic Services Act and Medicare Act. These programs reflected the federal government's desire to implement 50-50 basis with the provinces for the funding of hospital and physician services. The federal support was program specific, with contributions determined to be about half the national average of per-capita expenditures on health care. This provided greater assistance to provinces with lower per-capita costs.
In 1977, the funding arrangement was replaced by the negotiated Established Programs Financing (EPF) arrangements. The new "block-funding" agreement established a predetermined level of financial contributions by the federal government that was linked to the rate of change of gross national product (GNP) and changes in the provincial/territorial populations. It is important to note that federal transfers are comprised of cash and tax points.
The objectives of the EPF arrangements as set out by the Prime Minister in June 1976, were (a) to maintain across Canada the standards of service to the public under these major programs, and to facilitate their improvement; (b) to put the programs on a more stable footing, so that both levels of government are better able to plan their expenditures; (c) to give the provinces the flexibility of in the use of their own funds which they have been spending in these fields; (d) to bring about greater equity among the provinces with regard to the amount of federal funds that they receive under the program; and (e) to provide for continuing joint policy discussions relating to the health and post-secondary education fields.
The need for funding predictability
Over the course of their existence, the EPF arrangements were amended four times - 1982 (Bill C-97), 1984 (Bill C-96), 1989 (Bill C-33) and 1991(Bill C-69). These changes resulted in freezes in the growth of federal health transfers and created a period of funding uncertainty for provinces and territories.
On April 1, 1996, the federal government introduced the Canada Health and Social Transfer (CHST) which combined two transfer programs, EPF and the Canada Assistance Plan into one transfer program for insured health services, post secondary education and social assistance programs. Cash payments under the CHST were subject to the five program criteria of the Canada Health Act (1984) - accessibility, portability, comprehensiveness, and public administration as well as the single condition that the province/territory must provide social assistance to applicants without a minimum residency requirement.
In combining these programs the federal government used the opportunity to cut cash entitlements to the provinces/territories from $18.5 billion per year 1995-1996 to a low of $11.1 billion per year in 1999-2000. However, due to improving economic conditions and a rapidly impending balanced budget, the federal government announced in its September 1997 Throne Speech that it would be increasing the cash floor to $12.5 billion per year in 1998-1999 to 2002-2003. This measure was announced in the 1998-1999 budget; however, rather than an increase in funding, it was merely a partial reversal in cash reductions to the provinces/territories.
Targeted federal financing
Since 2000, the federal government has increased the use of targeted investments and in the health arena.
On Sept. 11, 2000, First Ministers issued a Communiqué on Health announcing a series of investments, over five years, which focused on health and other social programs. The CHST cash floor was "increased" by $2.5 billion effective April 1, 2001.
The February 2003 Budget in support of that year's First Ministers' Accord on Health Care Renewal confirmed: (1) a two-year extension to 2007-2008 of the five-year legislative framework put in place in September 2000, with an additional $1.8 billion; (2) a $2.5 billion CHST supplement, giving provinces the flexibility to draw down funds as they require up to the end of 2005-2006; and (3) the restructuring of the CHST to create a separate Canada Health Transfer and a Canada Social Transfer effective April 1, 2004, in order to increase transparency and accountability.
In September 2004, First Ministers signed an agreement on health care that included commitments to reduce wait times, address gaps in health human resources, expand home care, continue efforts in primary care reform, implement a national pharmaceutical strategy, and develop national public health goals.
To support the new agreement, the federal government committed to increase health funding by a total of $18 billion over 6 years or $41 billion over 10 years. This includes:
* $3 billion to close the "short-term Romanow gap;"
* $500 million for home care and catastrophic coverage;
* $4.5 billion for a Wait Time Reduction Fund;
* $1 billion for health human resources (to be transferred in last four years of agreement);
* $500 million for medical equipment; and
* a 6% escalator for the Canada Health Transfer.
The 2007 budget provided over one billion additional dollars for the health care system mainly through a $612 million investment to accelerate the implementation of patient wait-time guarantees, $400 million for Canada Health Infoway to support the further development of health information systems and electronic records, and $300 million for a vaccine program to protect women and girls against cancer of the cervix.
Clarifying responsibilities and accountability
The 2007 budget made reference to the federal government's constitutional responsibilities for health care and stressed an increased concern of accounting for federal health transfers to the provinces/territories.
The Oct. 16, 2007 Speech from the Throne, to open the second session of the 39th Parliament of the Government of Canada, included a commitment to introduce legislation that would place formal limits on the use of the federal spending power for new cost-shared programs in areas of provincial/territorial jurisdiction, and would also provide an opt-out option with compensation for provinces and territories if they offer compatible programs.
The main foundation for this proposal is set out in the Feb. 4, 1999 Social Union Framework Agreement (SUFA), in which the federal government gave several undertakings with regard to new "Canada-wide initiatives" in areas of provincial jurisdiction:
* collaboration with provincial/territorial governments to identify priorities and objectives;
* not to introduce new initiatives without agreement of a majority of provincial governments;
* provincial/territorial governments to determine detailed program design and mix;
* provincial/territorial governments can reinvest any funds not needed to deliver objectives;
* federal/provincial/territorial governments to agree on accountability framework; and
* funding to be contingent on meeting or committing to objectives specified in accountability framework.
The most notable application of SUFA principles in respect of new programs to date has been the Sept. 15, 2004 Asymmetrical Federalism that Respects Quebec's Jurisdiction Agreement in which Quebec agreed to develop and implement its own plan to attain the objectives of the First Ministers' 10-Year Plan to Strengthen Health Care, and to report progress to Quebecers using comparable indicators, mutually agreed to with other governments.
The accountability framework set out in SUFA would appear to be the linchpin of assuring the national character of any future health programs. Its implementation has thus far been a failure. While governments did agree to common indicators in 2000 and 2003, and did produce them in 2002 and 2004, they have been resistant to any attempts at comparability/benchmarking between jurisdictions and they failed to produce them at all in 2006. The Health Council of Canada lamented this lack of cooperation in its 2007 annual report.
Ensuring federal health financing is responsive to Canadians' health needs
The CMA believes that the federal government has a special responsibility for financing health care. The development of the health care financing system on a cooperative federal/provincial/territorial basis has many merits. It has resulted in the clear perception that the federal government has an obligation to ensure that reasonably comparable, high quality health care services are available, on a reasonably comparable basis, to all Canadians.
Through its financial contributions in support of the 2000, 2003 and 2004 health accords, the federal government has effectively restored the cuts made to federal health transfers during the early 1990s. However, health care which is now at 40 per cent of total provincial/territorial program spending continues to grow. The CMA must remain vigilant to ensure that the federal government continues to provide stable, predictable and adequate funding necessary to maintain and improve the standards of health care service across Canada. This federal funding should provide for a system that is effective, efficient and responsible.
With respect to the broader continuum of care, the future of Medicare is uncertain. While the federal government's role in funding health care remains tied to the Canada Health Act, Medicare must be modernized to reflect the current and future reality of the delivery of care. In 1975, just after Medicare was fully adopted, hospital and physician expenditures represented 60% of total health expenditures; as of 2006, this share has dropped by almost one-third to 43%. Over the past two decades, prescription drugs, as a proportion of total health spending, have doubled from 7% in 1986 to an estimated 14.2% in 2006. While a majority of Canadians have prescription drug coverage from either private or public plans, it is estimated that some 3.5 million are either uninsured or underinsured for prescription drug costs.
However, there is a clear consensus on the need for catastrophic prescription drug coverage and a growing concern about how to address the issue of very costly "orphan" drugs for rare diseases, and expensive treatments for common diseases such as breast cancer. In 2003, First Ministers committed to having catastrophic drug coverage in place by the end of 2005-2006, and while this is one of the elements of the National Pharmaceuticals Strategy, little collective action has taken place beyond further study. Similarly a 2003 commitment by First Ministers to first-dollar coverage for a basket of short-term acute home care, community mental health and end-of-life care services remains unmet.
The issue of long-term care of the elderly also looms on the horizon as the first cohort of the baby boom generation turns 65 in 2011. Indeed hospitals are already feeling the pinch of a lack of alternative level of care beds. International experience suggests that long-term care cannot nor should not be financed on the same pay-as-you-go basis as medical/hospital insurance.
Innovative approaches will be required to provide funding for the broader continuum of care (see CMA Policy Statement, It's Still About Access: Medicare Plus). We can expect to continue to see a mix of public and private plans and out-of-pocket payments (e.g., co-payments) and greater use of tax policy. This is the experience of most European and other industrialized countries. In Canada and internationally, the prospects for additional health programs funded on a first-dollar basis out of general taxation revenues are slim. In its 2007 budget, the federal government introduced a Registered Disability Savings Plan to help parents of children with a severe disability to ensure their children's future financial security by investing after-tax income on which the investment income will accumulate tax-free. Consideration should be given to implementing a similar contributions-based program for long-term care as is found in some other countries.
Another possibility would see the creation of a Canada Extended Health Services Financing Act that would provide a mechanism for sustainable federal funding to support provinces and territories providing necessary health services in the home and community setting. Such legislation would be based on a series of principles supported by Canadians to meet their health care needs.
GUIDING PRINCIPLES FOR PHYSICIAN ELECTRONIC MEDICAL RECORDS (EMR) ADOPTION IN AMBULATORY CLINICAL PRACTICE
The following principles outline what is important to physicians and why as they make the decision to adopt electronic medical record systems (EMRs) in ambulatory clinical practice.
Physician adoption of the EMR has the potential to transform patient care and the quality of health statistics and health research in Canada, as long as the right conditions are met and the guiding principles outlined here are adhered to. Adoption of EMRs in clinical ambulatory practices will lead to significant improvements in data comprehensiveness, clinical relevance and quality — and this, in turn, will lead to improved clinical decision support, core data sets and health statistics that meet the primary goal of enhancing health care delivery, treatment and outcomes.
Privacy. A physician’s ethical and legal responsibility as data steward of the patient’s medical information must be protected and enhanced.1
Choice. There must be appropriate independence of choice that respects physicians’ professional and business autonomy. Physicians must be free to choose the EMR product that best meets the needs of their practice model, type and size.
Voluntary. Physician adoption of EMRs must be voluntary, not mandated or coerced.
Non-discriminatory. Programs designed to offset physicians’ costs or encourage them to adopt EMRs must be non-discriminatory (i.e., not tied to a single EMR product or health care practice model). While such restrictions may be attractive to some payors and administrators, they discriminate against physicians who do not meet their criteria and risk creating two “classes” of physicians and patients.
Outcome-related incentives. Incentives for EMR adoption should be tied to clinical benefits and outcomes, not driven by cost containment. Financial incentives or bonuses that are tied to clinical outcomes may encourage EMR utilization and optimize the use of these systems in ambulatory clinical practices.
1 For more detail on the physician’s ethical responsibilities as data steward of patient information please refer to the CMA Code of Ethics and Professionalism, Guiding Principles for the Optimal Use of Data Analytics by Physicians at the Point of Care, and Guiding Principles for Physicians Recommending Mobile Health Applications to Patients.
Unrestricted. Funding for EMRs in physician offices must be equally available to all physicians, and not restricted to a single EMR product or physician practice model.
Funding. Cost analyses have determined that the majority of the benefits from EMRs accrue to the health care system (i.e., payors and patients) and not to individual physicians. It is only reasonable that those who benefit most should assume the costs.
Comprehensive. The cost of implementing an EMR system goes beyond acquisition of hardware and software. Funding for physician adoption of EMRs must be comprehensive and include costs associated with the initial purchase, as well as implementation, change management, ongoing operation, and evergreening of the system.
Save harmless. Early adoptors who need to update or replace their existing systems, as well as physicians whose EMR vendor goes out of business, must not be disadvantaged. These physicians must not be penalized or excluded from funding programs, and should be provided with the necessary transition support.
Vendor sustainability. Vendor stability is critical to EMR adoption by physicians. This can be achieved through vendor compliance with technical and business requirements that address fiscal sustainability as well as EMR product quality, technical standards and capabilities.
Due diligence. Because physician practices vary in type, size and needs, there is no “one-size-fits-all” EMR solution. Physicians must assess the needs of their individual practice to determine the best product.
Workflow re-engineering. Implementation of EMRs in ambulatory clinical practice may require workflow adjustment or re-engineering. Assessments of workflow and practice needs must be part of EMR change management programs.
HR impact. Adoption of EMRs in ambulatory clinical practices will have an impact on human resources. Provision should be made for physician and office staff retraining, retention and turnover.
Support and service agreements. Physician use of EMRs in ambulatory clinical practice requires appropriate support and service agreements not only to provide the necessary infrastructure and connectivity, but also to guarantee ongoing, accessible and reliable technical support. Physicians must be able to access patient records in their EMR system at all times, regardless of where the records are physically stored (e.g., off-site with an alternate service provider, or onsite in a local client server).
Risk management strategies (liability and insurance) tied to EMR adoption must address the privacy, security, business continuity and professional liability requirements of physician practice in an electronic environment.
Change management and transition
Critical to success. To fully realize the benefits from EMR adoption, the move from paper to electronic records requires change management support and services geared specifically to physician EMR adoption.
Ongoing. Change management is a key success factor in driving both uptake and optimal utilization of EMRs in ambulatory clinical practice. To realize the full benefits of EMR adoption on health care outcomes, physician change management programs must be ongoing, not one-time.
Comprehensive. Comprehensive change management for physicians who adopt EMRs must include the tools and services to assist with system needs assessment, EMR selection, implementation, workflow adjustment, and training for physicians and staff, as well as suggestions to maximize use of the EMR.
Physician driven and designed. Change management must meet the real and individual needs of physicians as they move to an EMR-based practice. This requires flexibility (not one-size-fits-all), “just in time” capacity and delivery, and a mechanism for evaluating the program.
Payor funded and delivered. Delivery and costs of these programs should be borne by payors as part of any physician EMR funding programs or agreements.
Usability and human factors
User interface and usability. User interface and usability of EMR systems are critical success factors for physician acceptance and optimal utilization of EMRs in clinical practice.
Workflow. EMR adoption requires changes to physician workflow, such as history-taking and charting. Done properly, workflow changes related to EMRs should result in administrative efficiencies and improved clinical outcomes.
Core principles of practice must be respected. The EMR must allow the physician to practice comprehensive care, efficiently manage patients with multiple problems and respect the doctor-patient relationship where the patient’s values, wishes, advance directives and physical and social function are integral to medical care.
Training and education. Training in the use, benefits, shortcomings and opportunities of an EMR must become part of the medical education curricula in all stages of physician practice: undergraduate, postgraduate and continuing medical education.
Standardized data. Large data sets that record every observation are unworkable in practice. The EMR must allow the physician to record and access data in a standardized way.
Data quality. Data quality is critical to patient care. Physicians require access to accurate, clinically relevant data. Inaccurately recorded and unfiltered data does not benefit patient care.
Clinical patient care
Management of patient records. EMR systems allow physicians to quickly access and manage patient data in an organized fashion (e.g., search, sort and retrieve data, spot trends, or flag charts). This leads to more efficient practices and enhances care delivery.
Referrals and patient summaries. The ability to transmit referral requests and reports electronically using an EMR greatly facilitates the consultation process. Core clinical data sets generated from the EMR can be used to share or hand off patient care among providers, facilitating both continuity of care and emergency access to relevant data.
Drugs and lab reports. Physician use of an EMR permits drug and lab data to be recorded and shared more accurately and efficiently. Benefits to patient care include automated prescription renewals, quick identification of patients affected by drug alerts, and collation of lab data to show trends.
Decision support. EMR adoption in ambulatory clinical practice makes clinical decision support (i.e., access to timely, appropriate, evidence-based information) possible at the point of care. This has the potential to enhance patient safety, care delivery and health outcomes.
Patient values and autonomy. Patient values and autonomy cannot become secondary to the "data management" requirements of the EMR. An EMR must provide the same (or better) standards of patient confidentiality as traditional paper-based records.
Accessibility. Patient data must always be collected and stored in an EMR with the primary goal of improving individual patient care. Data accessibility for clinical care is more important than compiling a large common data set.
Standardized data. Primary care is driven by symptoms, not diagnoses, and both must be recorded in the EMR in a standardized way.
Clinical coding. Primary care disorders are low-prevalence and will require a high degree of precision when data are coded.
Evidence-based care models. The episode-of-care data model demonstrates how symptoms and symptom clusters evolve over time. It is possible to derive the sensitivity and specificity of symptoms and symptom clusters to improve pre-test likelihood and avoid unproductive testing.
Core and aggregate data. Standardized data means that core data sets can be combined, and their aggregation allows identification and analysis of rarer conditions.
GUIDING PRINCIPLES FOR PHYSICIANS RECOMMENDING MOBILE HEALTH APPLICATIONS TO PATIENTS
This document is designed to provide basic information for physicians about how to assess a mobile health application for recommendation to a patient in the management of that patient's health, health care, and health care information.
These guiding principles build on the Canadian Medical Association's (CMA) Physician Guidelines for Online Communication with Patients.1
* Mobile health applications, distinct from regulated medical devices, may be defined as an application on a mobile device that is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease. The functions of these applications may include:
o The ability to store and track information about an individual or group's health or the social determinants thereof;
o Periodic educational information, reminders, or motivational guidance;
o GPS location information to direct or alert patients;
o Standardized checklists or questionnaires.2
* Mobile health applications can enhance health outcomes while mitigating health care costs because of their potential to improve a patient's access to information and care providers.3
* Mobile health applications are most commonly used on a smart phone and/or tablet. Some may also interface with medical devices.
* The use of mobile health applications reflects an emerging trend towards personalized medicine and patient involvement in the management of their health information. By 2016, 142 million health apps will have been downloaded.4 According to some industry estimates, by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users worldwide will have downloaded at least one mobile health application.5
* While mobile health application downloads are increasing, there is little information about usage and adherence by patients. It is believed that many patients cease to use a mobile health application soon after downloading it.
* Distributers of mobile health applications do not currently assess content provided by mobile health applications for accuracy, comprehensiveness, reliability, timeliness, or conformity to clinical practice guidelines.6 However, mobile applications may be subjected to certain standards to ensure critical technical requirements such as accessibility, reachability, adaptability, operational reliability, and universality.
* Increasingly there are independent websites providing reviews of medical apps and checklists for health care professionals. However, the quality criteria used by these sites, potential conflicts of interest, and the scope and number of mobile apps assessed are not always declared by these groups.
To date, randomized controlled trials are not usually employed to assess the effectiveness of mobile health applications. Some believe that the rigorousness of this type of assessment may impede the timeliness of a mobile health application's availability.7
* Some examples of the uses of mobile health applications include tracking fitness activities to supplement a healthy lifestyle; supported self-management of health and health information; post-procedure follow up; viewing of test results; and the virtualization of interaction between patients and providers, such as remote patient monitoring for chronic disease management. Some mobile health applications may be linked to a patient profile or patient portal associated with a professional or recognized association or medical society or health care organization.
* Some mobile health applications may be an extension of an electronic medical records (EMR) platform.
* The objective of recommending a mobile health application to a patient must be to enhance the safety and/or effectiveness of patient care or otherwise for the purpose of health promotion.
* A mobile health application is one approach in health service delivery. Mobile health applications should complement, rather than replace, the relationship between a physician and patient.
* No one mobile health application is appropriate for every patient. Physicians may wish to understand a patient's abilities, comfort level, access to technology, and the context of the application of care before recommending a mobile health application.
* Should a physician recommend a mobile health application to a patient, it is the responsibility of the physician to do so in a way that adheres to legislation and regulation (if existing) and/or professional obligations.
* If the mobile health application will be used to monitor the patient's condition in an ongoing manner, the physician may wish to discuss with the patient what they should watch for and the steps they should take in response to information provided.
* Physicians are encouraged to share information about applications they have found effective with colleagues.
* Physicians who require additional information about the competencies associated with eHealth and the use of health information technologies may wish to consult The Royal College of Physicians and Surgeons of Canada's (RCPSC) framework of medical competencies, CanMEDS.8
* Physicians may wish to enter into and document a consent discussion with their patient, which can include the electronic management of health information or information printed out from electronic management platforms like mobile health applications. This agreement may include a one-time conveyance of information and recommendations to cover the elements common to many mobile health applications, such as the general risk to privacy associated with storing health information on a mobile device.
Characteristics of a safe and effective mobile health application
A mobile health application does not need to have all of the following characteristics to be safe and effective. However, the more of the following characteristics a mobile health application has, the likelier it will be appropriate for recommendation to a patient:
1. Endorsement by a professional or recognized association or medical society or health care organization
As recommended by the Canadian Medical Protective Association (CMPA), it is best to select mobile health applications that have been created or endorsed by a professional or recognized association or medical society.9 Some health care organizations, such as hospitals, may also develop or endorse applications for use in their clinical environments. There may also be mobile health applications associated with an EMR platform used by an organization or practice. Finally, some mobile health applications may have been subject to a peer review process distinct from endorsement by an association or organization.
There are a number of usability factors than can complicate the use of mobile applications, including interface and design deficiencies, technological restrictions, and device and infrastructure malfunction.
Many developers will release periodic updates and software patches to enhance the stability and usability of their applications. Therefore, it would be prudent for the physician recommending the mobile health application to also recommend to the patient that they determine if the application has been updated within the last year.
Physicians considering recommending a mobile health application to a patient may wish to ask about the patient's level of comfort with mobile health technologies, their degree of computer literacy, whether or not the patient owns a mobile device capable of running the application, and whether or not the patient is able to bear potential one-time or ongoing costs associated with use of the application.
Physicians may consider testing the application themselves beforehand to understand whether its functionality and interface make it easy to use.
3. Reliability of information
Physicians considering recommending a mobile health application may wish to understand how the patient intends to use the information, and/or review the information with the patient to understand whether it is current and appropriate.
Information presented by the mobile health application should be appropriately referenced and time-stamped with the last update by the application developer.
4. Privacy and security
In 2014, the Officer of the Information and Privacy Commissioner of Alberta assessed approximately 1200 mobile applications and found nearly one-third of them required access to personal information beyond what should be required relative to their functionality and purpose, and that basic privacy information was not always made available.10
Physicians entering into and documenting a consent discussion with their patients may wish to include the electronic management of health information in the scope of these discussions, and make a notation of the discussion in the patient's health record.
Some mobile health applications may feature additional levels of authentication for use, such as an additional password or encryption protocols. If all other factors between applications are equal, physicians may wish to recommend that patients use mobile health applications adhering to this higher standard of security.
5. Avoids conflict-of-interest
Physicians may wish to recommend that patients learn more about the company or organization responsible for the development of the application and their mandate. There is a risk of secondary gains by mobile health application developers and providers where information about patients and/or usage is gathered and sold to third parties.
A standardized conflict of interest statement may be made available through the mobile health application or on the developer's website. If so, physicians may wish to refer the patient to this resource.
Physicians who develop mobile applications for commercial gain or have a stake in those who develop applications for commercial gain may risk a complaint being made to the College on the basis that the physician engaged in unprofessional conduct if they recommend mobile health applications to their patients in the course of patient care.
6. Does not contribute to fragmentation of health information
Some mobile health applications may link directly to an EMR, patient portal, or government data repository. These data resources may be standardized, linked, and cross-referenced.
However, health information entered into an application may also be stored on a mobile device and/or the patient's home computer, or developers of mobile health applications may store information collected by their application separately. While there may be short-term benefits to using a particular mobile health application, the range of applications and developers may contribute to the overall fragmentation of health information.
If all other factors between applications are considered equal, physicians may wish to recommend mobile health applications which contribute to robust existing data repositories, especially an existing EMR.
7. Demonstrates its impact on patient health outcomes
While not all mobile health applications will have an appropriate scale of use and not all developers will have the capacity to collect and analyze data, physicians may wish to recommend mobile health applications that have undergone validation testing to demonstrate impact of use on patient health outcomes. If mobile health applications are claiming a direct therapeutic impact on patient populations, physicians may wish to recommend that their patients seek out or request resources to validate this claim.
1 Canadian Medical Association. Physician guidelines for online communication with patients. Ottawa: The Association; 2005. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD05-03.pdf?_ga=1.32127742.1313872127.1393248073
2 US Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research. Mobile medical applications: guidance for industry and Food and Drug Administration staff. Rockville (MD): The Administration; 2015. Available:
3 Canada Health Infoway. Mobile health computing between clinicians and patients. White paper. Toronto: The Infoway; 2014 Apr. Available: www.infoway-inforoute.ca/index.php/resources/video-gallery/doc_download/2081-mobile-health-computing-between-clinicians-and-patients-white-paper-full-report
4 iHealthBeat. 44M mobile health apps will be downloaded in 2012, report predicts. Available: www.ihealthbeat.org/articles/2011/12/1/44m-mobile-health-apps-will-be-downloaded-in-2012-report-predicts
5 Jahns R-G. 500m people will be using healthcare mobile applications in 2015. Research2guidance. Available: www.research2guidance.com/500m-people-will -be-using-healthcare-mobile-applications-in-2015/
6 Lyver, M. Standards: a call to action. Future Practice. 2013 Nov. Available: www.cma.ca/Assets/assets-library/document/en/about-us/FP-November2013-e.pdf
7 Rich P. Medical apps: current status. Future Practice 2013 Nov. Available: www.cma.ca/Assets/assets-library/document/en/about-us/FP-November2013-e.pdf
8 Royal College of Physicians and Surgeons of Canada. The CanMEDS 2015 eHealth Expert Working Group report. Ottawa: The College; 2014. Available: www.royalcollege.ca/portal/page/portal/rc/common/documents/canmeds/framework/ehealth_ewg_report_e.pdf
9 Canadian Medical Protective Association. Managing information to delivery safer care. Ottawa: The Association; 2013. Available: https://oplfrpd5.cmpa-acpm.ca/en/duties-and-responsibilities/-/asset_publisher/bFaUiyQG069N/content/managing-information-to-deliver-safer-care
10 Office of the Information and Privacy Commissioner of Alberta. Global privacy sweep rasies concerns about mobile apps [news release]. Available: www.oipc.ab.ca/downloads/documentloader.ashx?id=3482
The harms associated with psychoactive prescription medicinesi including sedatives and tranquilizers1, stimulants2, and analgesics, particularly opioids3, such as oxycodone, hydromorphone and fentanyl, are a significant public health and patient safety issue.
Canada has one of the highest per capita consumption of prescription opioids in the world.4 Dispensing of medications has substantially increased in Canada, although patterns vary considerably between provinces.5 In 2011, while opioid consumption for medical purposes in morphine equivalence (ME)ii was 62mg per person globally, Canada's ME was 812mg per person.6 When comparing to other developed countries, Australia's ME was 427 and Denmark's 483. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.7
Psychoactive medications pose significant health and safety risks. The harms include overdoses, suicides, motor vehicle accidents, relationship and employment problems, workplace accidents and exposure to blood borne pathogens and other infections when used by injection, besides addiction.
Data are not collected systematically in Canada, making it difficult to assess the harms and track the trends and impact of the introduction of policy changes. However, practitioners have seen the significant impact of these prescription drugs on their patients and to public health. Studies in Ontario show that the number of people enrolled in methadone maintenance treatment rose from about 7,800 in 2001 to over 35,000 in 2011, where opioids have surpassed heroin as the drug used.8 Opioid-related deaths nearly tripled from 2002 to 2010, according to the Office of the Chief Coroner of Ontario.9 Another study showed that other non-opioid depressants (sedatives), such as benzodiazepines, were involved in 92% of the opioid-related deaths.10
The impact is felt particularly among vulnerable populations, such as youth, seniors, First Nations and those living in poverty. In 2013, opioids were reported as the third most common drug used by students in Ontario (after alcohol and marijuana).11 Opioid addiction rates anywhere from 43% to 85% have been reported in some Indigenous communities.12 13 While accurate data on the harms of prescription medication among seniors is lacking, it is well known that the prevalence of pain is higher among older adults and that they account for a significant proportion of prescriptions.
The "high" they produce also leads to these medications being sought after for recreational purposes and, as they are legal products, they are often more easily accessible than street drugs. Surveys with youth have shown that as much as 70% of opioids have been obtained from legitimate prescriptions to family and friends (55% were shared at no cost).14 As well, because opioids have high abuse liability and addiction potential, people have resorted to illegal behaviour to obtain them, such as doctor-shopping, forging prescribers' signatures, or buying from street dealers.
Of great concern, opioid dispensing levels are strongly correlated with increased mortality, morbidity and treatment admissions for substance use.15 16 Studies in Ontario and British Columbia have replicated similar findings in the US. Many patients were prescribed these medications and developed dependence.17
Psychoactive medications are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. Medications, such as opioids, have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.
Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.18 19 However, there is evidence for significant pain relief in the short term but a need for more evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.20 21 22
Important contributing factors for the increase in prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with the patient. In addition, there are new highly potent opioid drugs available.23 24
Canada's physicians are deeply concerned about the harms of opioids and other psychoactive prescription medications. As prescribers, they have a fundamental role in helping to ensure safe and effective use of these drugs, and the deterrence of abuse. 25 26 27 Physicians assess patients and consider whether a prescription is clinically indicated according to best practices, as well as consider whether the benefits outweigh the risks, while screening for risk factors for substance dependence and diversion. This area can be a source of tension with patients who might seek to obtain drugs through fraudulent means.28 It is also an area which causes concern to many physicians, and this could be affecting access to adequate pain management where it is needed.29
The challenge for physicians and public policymakers is how to mitigate the harms of psychoactive prescription drug use, while ensuring that patients have access to the appropriate treatment for their clinical conditions.
Comprehensive National Strategy
Canada's physicians believe that this challenge requires a complex and multifaceted solution; and to further such a solution, the CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant.
The federal government has created the National Advisory Council on Prescription Drug Misuse, co-chaired by the Canadian Centre on Substance Abuse, the Coalition on Prescription Drug Misuse (Alberta) and the Nova Scotia Department of Health and Wellness, in partnership with Health Canada's First Nations and Inuit Health Branch's Prescription Drug Abuse Coordinating Committee. In its 2013 report First Do No Harm: Responding to Canada's Prescription Drug Crisis30, there are nearly 60 recommendations toward the development of a strategy to combat the harms associated with psychoactive prescription medications. However, there is much still to be done.
The CMA supports collaborative efforts by the federal and provincial/territorial governments, and by health professionals and other stakeholders, to develop and implement a comprehensive national strategy. Such a strategy should include the following:
1. Improvement of Drug Safety
Health Canada, as the agency that approves prescription drugs for use and monitors their safety once on the market, has several levers by which it can control Canadians' access to drugs. One of these is the Controlled Drugs and Substances Act (CDSA) and its regulations, which govern access to illegal products and recently has included psychoactive prescription drugs.
Because of their health and safety risks, it is important that Health Canada ensures that the CDSA subjects psychoactive substances to high levels of regulatory scrutiny during both the approval process and post-approval surveillance. The Act should require manufacturers to:
* Meet stringent pre-approval requirements. For example, Health Canada could require intensive review of pre-approval clinical trial results and of product monographs by an expert impartial review committee (including addiction, pain and public health expertise); or require that the manufacturer fulfill special conditions, such as formal post-market studies, as a condition of the drugs' approval; or even require larger sample sizes or longer study periods to assess harms;
* Adhere to restrictions on the marketing of controlled medications to health professionals and the general public. The adequacy of regulations needs to be assessed in this regard.
* Develop and cover tamper-resistant formulations of psychoactive drugs of concern. Although not a standalone solution, tamper-resistant formulations can reduce the potential for manipulation to be able to use through snorting, chewing or intravenously.
2. Enhancement of Optimal Prescribing through Evidence-Based Guidance, Education and Support for Prescribers
CMA recommends that appropriate prescribing of psychoactive medications should be addressed through evidence-based guidance and education. A strategy to support optimal therapy might include:
* Support for models of care that allow a physician to spend time with complex patients.
* Ongoing development and dissemination of clinical guidance. The Canadian Guideline for Use of Opioids to Treat Chronic Non-Cancer Pain was published in the CMAJ in 2010. CMA has co-sponsored an online CME module based on this guideline. There is interest in similar guidelines for sedatives and stimulants.
* Evaluative research to support the critical review of guidelines periodically. It is essential to review data on chronic conditions for which risks might outweigh benefits.
* Relevant, unbiased and easily accessible information for prescribers, which can readily be incorporated into everyday practice. This should include clinical decision-support tools for use at the point of care, inclusive of dosing guidelines and guidance on when to seek consultation with experts. Physicians also require tools, including those that facilitate: monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; tapering of problematic or ineffective doses; among others.
* Educational programs in optimal prescribing, pain management and in the management of addictions, as part of the curriculum in medical school, and residency training as well as in continuing education. Particular support is needed for those in primary care.
* Guidance for prescribers about how to deal with conflict in their practice. This would include guidance for patient-centred educational discussions on safe opiate prescribing and use and management of addictions.
* Access to expert advice if required through such means as:
o Policies or standards of practice developed by provincial regulatory colleges of physicians, which can include limitations on prescription volume, treatment period and indications.
o Communities of practice, knowledge hubs and clinical support networks that link practitioners with experts in the field, facilitating triage and supporting front line generalists. Experts can not only provide clinical information, but can provide mentorship and personal advice about best practices.
o Feedback to practitioners about their prescribing practices, particularly if potentially concerning patterns are identified. This initiative should be facilitated by collaborative work between health care professionals and their respective provincial regulatory colleges.
o Academic detailing programs, which use personalized, one-on-one techniques to deliver impartial prescribing information to practitioners.
3. Enhancement of Optimal Prescribing through Physician Regulation and Prescription Monitoring Programs
Medicine is a regulated profession, and the provincial colleges of physicians have ultimate authority and responsibility for the oversight of physician practice. The colleges have taken a leading role in educating their members about appropriate prescribing, in monitoring prescribing practices to ensure their appropriateness and taking disciplinary action when required, and through collaborating with law enforcement agencies to detect and halt criminal diversion.
The CMA recommends that federal and provincial regulations regarding controlled substances recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and the purpose for which the data are collected. Standardization of monitoring systems across Canada according to best practices can contribute to addressing the harms associated with psychoactive prescription medication by:
* Allowing health care practitioners to identify previous or concomitant prescriptions of controlled medications with more than one practitioner at the time the prescription is requested or filled;
* Deterring interprovincial or jurisdictional fraud, by allowing health care practitioners to identify other prescriptions at the time the prescription is requested or filled; and
* Improving professional regulatory bodies' capacity for oversight and intervention by establishing a mechanism for real-time monitoring.
The CMA recommends that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring.
PMPs should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary.
CMA also recommends that Health Canada ensure that its legislative framework be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can help individual physicians or pharmacists identify potential diversion and double prescriptions, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, and could minimize the potential administrative burden.
PMPs should conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. The CMA strongly recommends that Health Canada undertake a privacy impact assessment of the regulatory framework for controlled prescription drugs, and share the results with stakeholders.
4. Increase in Access to Treatment for Pain
Chronic pain affects many aspects of a person's life including their ability to work, their emotional, mental and physical health, and their quality of life. Pain costs Canada an estimated $60 Billion dollars per year; more than the cost of heart disease, cancer and diabetes.31 CMA has endorsed a national strategy for pain, developed and proposed by the Canadian Pain Coalition and Canadian Pain Society,32 which addresses four target areas: awareness and education; access; research; and ongoing monitoring.
Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include:
* Care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals;
* Recommendation of non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies;
* Appropriate pharmaceutical prescription options, covered by provincial formularies; and
* A focus on patient participation and empowerment.
However, specialized pain treatment programs are in short supply. Wait times are greater than one year at more than one third of publicly funded inter-professional treatment programs.33 In many parts of Canada, particularly rural and remote areas, such programs are not available. In addition, while physician visits are covered by the public health care system, services provided by other health professionals are more likely to be either covered by private health benefits or paid out of pocket, and are therefore beyond the means of many Canadians. These factors may result in heavier reliance on prescription medication as treatment for chronic pain.
The CMA recommends that all partners work to improve and promote access to specialized treatment programs for pain management, and that investments be made in research about options for treatment.
5. Increase in Access to Treatment for Addiction
Access to addiction treatment is very limited and, when available, is primarily comprised of detox or the substitution treatments with methadone or Suboxone(r) (buprenorphine and naloxone). As addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry by definition, which manifests along biological, psychological, social and spiritual dimensions, treatment must address all those areas rather than just one or another.34
The CMA supports the enhancement of access to options for addiction treatment that address different needs. Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that addiction programs be culturally relevant for Indigenous communities.
Treatment programs must also be integrated within the health care system and be adequately funded to meet evidence based, best-practice guidelines.
CMA also supports the development and dissemination of practice tools and guidelines to help physicians assess the addiction potential of a patient receiving psychoactive medications, and to assist in managing patients who have addiction and related problems and complications.
6. Increase in Information through Epidemiological Surveillance
One of the challenges in dealing with prescription drug abuse, which can reflect hazardous (episodic) use, harmful (regular) use or addiction, is the incompleteness of our knowledge of the extent of the problem. Countries, such as the US and France, are able to monitor psychoactive drug use, while in Canada we still rely on unsystematically collected or locally limited data. The creation of a national surveillance system that supports the collection of systematic, standardized information would:
* Permit the thorough assessment of the problem, with the development and monitoring of indicators;
* Support the early detection of diversion or inappropriate prescribing behaviour;
* Support the establishment of best practices to address crucial issues;
* Identify research priorities; and
* Evaluate the impact of the implementation of strategies.
Sources of information should include PMPs, coroner's investigations, emergency room admissions, and poison control data, among others.
7. Prevention of Deaths due to Overdose
Overdose deaths have increased dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. Opioid death and complications overdoses can be prevented with appropriate medication and prompt emergency response. The CMA recommends the:
* Creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. Training should be made available to health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.35
* Improvement of access to naloxone to reverse opioid overdoses. This should include the prescription of naloxone to high risk individuals and third parties who can assist a victim experiencing an opiate-related overdose.
* Enactment of Good Samaritan laws by all levels of government in order to protect callers from criminal charges if they call emergency services to report an overdose. 36 37
8. Provision of Information for Patients and the Public
Awareness programs that provide accurate information to patients and the general public are important, and could include:
* Information on the benefits and harms of psychoactive prescription medication use, and signs of dependence and overdose. This should include the risk of dependence and addiction associated with the use of opiates for the treatment of acute and chronic pain.
* Messages aimed at the prevention of problematic drug use among young people and other populations at risk.
* Information regarding safe medication storage and disposal, and reducing access to medications from family and friends. CMA supports national prescription drug "drop off" days, and recommends that patients be educated about the importance of routinely returning unused prescription drugs to the pharmacy.
The CMA recommends that Canada have a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based. This strategy should include:
* That Health Canada require that manufacturers meet stringent pre-approval requirements, adhere to restrictions on the marketing of controlled medications to health professionals and the general public, and develop formulations of psychoactive drugs of concern that are tamper-resistant.
* Support for optimal prescribing through evidence-based guidance, education and supports, such as clinical guidance, clinical decision-support tools, educational programs, expert advice, and supportive models of care.
* The enhancement of optimal prescribing through physician regulation and the development of a pan-Canadian system of real-time prescription monitoring programs, compatible with electronic medical and pharmacy record systems, based on national standards.
* Increased access to specialized pain management and treatment, according to best practices, with investments in research.
* The enhancement of access to options for addiction treatment that address different needs, and the support for the development and dissemination of practice tools and guidelines.
* The creation of a national surveillance system that supports the collection of systematic, standardized information to better inform and track policy changes.
* The creation and scaling up of community-based programs that
* Offer access to opioid overdose prevention tools and services, including the improvement of access to medication to reverse opioid overdoses (naloxone) and the enactment of Good Samaritan laws by all levels of government.
* The provision of accurate information to patients and the general public, including safe medication storage and disposal.
i Psychoactive drugs are substances that, when taken, have the ability to change an individual's consciousness, mood or thinking processes (WHO, 2004). Psychoactive prescription drugs include sedatives (such as benzodiazepines and barbiturates), stimulants (such as amphetamines), and opioids (such as oxycodone, hydromorphone, morphine and fentanyl). [World Health Organization (2004) Neuroscience of psychoactive substance use and dependence. Available at: http://www.who.int/substance_abuse/publications/en/Neuroscience.pdf]
ii Comprises six main opioids: fentanyl, hydromorphone, methadone, morphine, oxycodone and pethidine.
1 Canadian Centre on Substance Abuse. Prescription sedatives and tranquilizers. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Sedatives-and-Tranquilizers-2013-en.pdf
2 Canadian Centre on Substance Abuse. Prescription stimulants. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Prescription-Stimulants-2013-en.pdf
3 Canadian Centre on Substance Abuse. Prescription opioids. Canadian drug summary. Ottawa: The Centre; 2013. Available: http://ccsa.ca/Resource%20Library/CCSA-Canadian-Drug-Summary-Prescription-Opioids-2013-en.pdf
4 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013.
5 Fischer B, Jones W, Murray K, et al. Differences and over-time changes in levels of prescription opioid analgesic dispensing from retail pharmacies in Canada, 2005-2010. Pharmacoepidemiol Drug Saf. 2011;20:1269-77.
6 United Nations Office on Drugs and Crime. World drug report 2014. New York: The Office; 2014. Available: www.unodc.org/documents/wdr2014/World_Drug_Report_2014_web.pdf
7 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
8 Fischer B, Argento E. Prescription opioid related misuse, harms, diversion and interventions in Canada: a review. Pain Physician. 2012;15:ES191-ES203.
9 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013.
10 Dhalla IA, Mamdani MM, Sivilotti MLA, et al. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone CMAJ. 2009;181(12): 891-6.
11 Centre for Addiction and Mental Health. Drug use among Ontario students, 1977-2013: results of the Ontario Student Drug Use and Health Survey. Toronto: The Centre; 2013. Available: www.camh.ca/en/research/news_and_publications/ontario-student-drug-use-and-health-survey/Documents/2013%20OSDUHS%20Docs/2013OSDUHS_Highlights_DrugUseReport.pdf
12 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf
13 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf
14 US Department of Health and Human Services Results from the 2010 National Survey on Drug Use and Health: Summary of National Findings. Rockville (MD): The Department; 2011. p. 25. Available: www.oas.samhsa.gov/NSDUH/2k10NSDUH/2k10Results.pdf
15 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q. 2011;14(1):22-4.
16 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf. 2013;22(4):438-42.
17 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend. 2004;73(2):199-207.
18 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142 DOI: 10.1136/bmj.d5142.
19 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician. 2014;17(1):E1-10.
20 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology. 2014;83:1277-84. Available: www.neurology.org/content/83/14/1277.full.pdf+html
21 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009;10:147-59.
22 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev. 2010;(1):CD006605.
23 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health. 2008;99(3): 182-4.
24 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81.
25 Silversides A. Opioid prescribing challenges doctors. CMAJ. 2009;181(8):E143-E144.
26 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ. 2011;343:d5142.
27 Kirschner N, Ginsburg J, Sulmasy LS. Prescription drug abuse: a policy position paper from the American College of Physicians. Ann Intern Med. 2014;160:198-213.
28 Saveland C, Hawker L, Miedema B, et al. Abuse of family physicians by patients seeking controlled substances. Can Fam Physician. 2014;60:e131-6.
29 Wenghofer EF, Wilson L, Kahan M, et al. Survey of Ontario primary care physicians' experiences with opioid prescribing. Can Fam Physician. 2011;57(3):324-32.
30 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse-report-en.pdf
31 Canadian Pain Strategy Initiative. Rise up against pain: the Canadian Pain Strategy. Available: http://canadianpainstrategy.ca/en/home.aspx
32 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf
33 Canadian Pain Coalition, Canadian Pain Society. Call to action: the need for a national pain strategy for Canada. 2011. Available: http://canadianpainstrategy.ca/media/11445/final%20nat%20pain%20strategy%20for%20can%20121511%20eng.pdf
34 American Society of Addiction Medicine. Public policy statement: definition of addiction. 2011. Available: www.asam.org/for-the-public/definition-of-addiction
35 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/
36 Follett KM, Piscitelli A, Parkinson M, et al. Barriers to calling 9-1-1 during overdose emergencies in a Canadian context. Crit Social Work. 2014;15(1):18-28. Available: http://www1.uwindsor.ca/criticalsocialwork/system/files/Follett_Piscitelli_Parkinson_Munger_2014.pdf
37 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/
HEALTH IN ALL POLICIES
Despite significant investments in health and improvements in medical treatment and technologies, health outcomes in Canada have not been moving in the right direction. Chronic diseases such as diabetes and the corresponding risk factors, among them obesity, continue to rise. This negative health status can undermine not only individual health but the productivity and prosperity of the country as well.1 As noted in the Adelaide Statement on Health in All Policies, "Good health enhances quality of life, improves workforce productivity, increases the capacity for learning, strengthens families and communities, supports sustainable habitats and environments, and contributes to security, poverty reduction and social inclusion."2
Research suggests that 15% of population health is determined by biology and genetics, 10% by physical environments, 25% by the actions of the health care system, with 50% being determined by our social and economic environment.3 Many studies show that people low on the socio-economic scale are likely to carry a higher burden of just about any disease.4 Poverty accounts for 24% of person years of life lost in Canada (second only to 30% for neoplasms).5 These numbers demonstrate a need to rethink the way we work to improve the health of the Canadian population. While a strong health care system is vital, changes to our health system alone will not be sufficient to improve health outcomes or reduce the disparities that currently exist in disease burden and health risks.
Using health determinants as a focus means that most health promotion and prevention efforts will take place outside of the health and medical care service.6 Canadians must be supported to make the choices that keep them healthy and reduce their risks of injury and disease. However, many face barriers in their physical, social and economic environments which make these healthy choices difficult. What is necessary is a coordinated effort across government sectors to ensure that all policy decisions serve to increase opportunities for health. As noted by the former Minister of Health and Welfare, Jake Epp, "it is not an overstatement to say that public policy has the power to provide people with the opportunities for health, as well as to deny them such opportunities... All policies having a direct bearing on health need to be coordinated."7
Improving population health and reducing inequities should be an overall objective for all governments in Canada. Not only will it help to reduce costs to the health system, it will also increase economic growth as healthier people lose fewer days of work and contribute to overall economic productivity.8 As laid out in the principles to Guide Health Care Transformation, "Coordinated investments in health promotion and disease and injury prevention, including attention to the role of the social determinants of health, are critical to the future health and wellness of Canadians and to the viability of the health care system.9"
The utilization of such an approach is not new. Governments from England to Finland to New Zealand have increasingly recognized the importance of the social determinants of health and have developed national strategies accordingly. These strategies, often referred to as 'health in all policies,' call for a whole of government approach where cross-departmental collaboration is established at the highest government level to increase the health of the population and reduce inequalities.10 The World Health Organization defines health in all policies as follows:
Health in all Policies (HiAP) is an approach to public policies across sectors that systematically takes into account the health and health systems implications of decisions, seeks synergies, and avoids harmful health impacts, in order to improve population health and health equity. A HiAP approach is founded on health-related rights and obligations. It emphasizes the consequences of public policies on health determinants, and aims to improve the accountability of policy-makers for health impacts at all levels of policy-making.11
This approach looks at all policies that have a health impact not just those in the health sector. Policies are reviewed for their potential impact on population health and health system utilization.12
There are many ways that a HiAP approach can be implemented. Examples include:
inter-ministerial and inter-departmental committees; community consultations and Citizens' Juries; cross-sector action teams; partnership platforms; integrated budgets and accounting; Health Lens Analyses; cross-cutting information and evaluation systems; impact assessments; joined-up workforce development; and legislative frameworks.13
A Plan for Canada
Role of the Federal Government:
While the provinces and territories have constitutional authority for the majority of health system delivery, the federal government has a significant role in health: through system oversight, Canada Health Act; delivery to certain populations, Canada's Aboriginal peoples; as well as accountability and pan-Canadian initiatives for the various health systems. Additionally, the federal government has significant control over areas such as taxation, food security and agriculture, justice, transportation safety and income security (eg child tax benefits, Old- Age Security). All of these can have a marked impact on both individual and population health.
As a result of these responsibilities the Canadian government needs to adopt a clear mandate to focus on the health of the population. Actions must be taken to provide Canadians with the ability to make healthy choices. All legislation must be subject to a health lens to determine potential health implications so as to minimize or mitigate any negative consequences and maximize opportunities for health benefits. Given the central coordinating function of Cabinet in policy setting and delivery, this would be an ideal place to incorporate a HiAP approach.
1. CMA recommends that the federal government acknowledge the relationship of the social determinants of health on the health of the population as well as the demands of the health care system and that it implement a Health in All Policies approach for all cabinet decision-making.
While Cabinet should serve as the central decision-making body for a HiAP approach, there must be formal and sustainable structures that allow timely analysis of the health consequences of policy decisions, which appropriately engage stakeholders, and which ensure that health impacts are actually considered in policy decision-making.14
Such an approach will require some form of enabling legislation as well as benefits for departments that conduct HiAP analysis. In Quebec, for example, all policies are required to undergo a review of health impacts under Section 54 of the 2002 Quebec Public Health Act.15
In addition, it is likely that a lead agency will need to be appointed to facilitate the necessary data collection/analysis to review policies. In the Netherlands health impact assessments are the responsibility of the Department of Intersectoral Policy at the Netherlands School of Public Health.16 Since 2000, the Swedish National Public Health Institute (SNIPH) has been tasked with developing methodology in strategically important areas and with supporting the application of health assessments on the central, regional and local level.17 In England, the Public Health Observatories play a key role in providing data and analysis for health impact assessments.18
A significant barriers to HiAP in Canada is the existing data infrastructure. Hundreds of major and minor publications speak to the volume of analyses undertaken on health and health systems every year in Canada. Despite this effort, Canadian policy makers and the public do not fully understand how health system vs. non-health factors contribute to the health outcomes observed or the picture of overall health. The available data tends to focus on the health care system, sickness and the measurement of sickness related risks. What is missing is a way of organizing the data which provides greater insight for planners and greater accountability for all Canadians. This capacity will need to be developed in order to properly implement a HiAP approach.
2. CMA recommends that the federal government provide the necessary enabling environment to allow for the application of a health in all policies approach in all new policy development.
As the experiences from other countries demonstrate there is some value in selecting a few Ministries to begin the process. Once selected the Ministries should be responsible for starting the process and screening any new policies. If there is a potential health impact they would then contact the centralized resource to conduct the analysis and produce a report with potential impacts and recommendations for change. This report would go back to the originating Ministry for review and modification of the policy as necessary. Changes should be highlighted and the revised policy should be sent with the health analysis report to Cabinet for final decision-making. This will help to improve the policy and will create greater awareness among all Cabinet members of the potential health implications of various policies.
3. CMA recommends that the Federal Minister of Health work with Cabinet to select appropriate Ministries to begin the implementation of the health in all policies approach.
Role of Health Care Sector:
Government is not the only group with a role in HiAP. The health sector, including Canada's physicians can work to ensure that the policy environment promotes health. By working with governments at all levels, physicians can uses their vast knowledge and expertise to provide evidence regarding potential health implications, and promote the development of evidence-informed decision making. In addition, they can work with partners both within and outside of the health sector to advocate as necessary for policy improvements.19
4. CMA recommends that physicians and other health care providers use their knowledge and expertise to support governments in the development of evidence-informed policy which promotes the health of the population.
Investments in the health system will only go so far in improving the health of the population. Population health approaches must tackle the wider social determinants of health. To do so the government must consider health in all the policies that it develops.
1 Reeves, Richard A Liberal Dose? Health and Wellbeing - the Role of the State: An Independent Report. 2010. Available: www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/@ps/documents/digitalasset/dh_111695.pdf
2 World Health Organizatio. Adelaide Statement on Health in All Policies: moving toward a shared governance for health and well-being. Geneva:The Organization; 2010. Available: www.who.int/social_determinants/hiap_statement_who_sa_final.pdf (accessed 2015 Apr 16).
3 Keon, WJ, Pépin L. (2008) Population Health Policy: Issues and Options. Ottawa: The Senate of Canada; 2008. Available at: www.parl.gc.ca/Content/SEN/Committee/392/soci/rep/rep10apr08-e.pdf
4 Dunn JR. The Health Determinants Partnership Making Connections Project: Are Widening Income Inequalities Making Canada Less Healthy? Toronto :The Health Determinants Partnership; 2002 Available: http://en.healthnexus.ca/sites/en.healthnexus.ca/files/resources/widening_income_equalities.pdf (accessed 2015 Apr 16)
5 Wilkins R, Berthelot J-M, Ng E. Trends in mortality by neighbourhood income in urban Canada from 1971 to 1996. Statistics Canada.Health Rep. 2002:13(Supplement): 10.
6 Knutsson I, Linell A Health impact assessment developments in Sweden. Scand J Public Health. 2010;38:115-120.
7 Epp, J. Achieving health for all: a framework for health promotion. Ottawa: Health and Welfare Canada; 1986. Available: www.hc-sc.gc.ca/hcs-sss/pubs/system-regime/1986-frame-plan-promotion/index-eng.php
8 Munro, D Healthy People, Healthy Performance, Healthy Profits: The Case for Business Action on the Socio-Economic Determinants of Health. Ottawa: Conference Board of Canada; 2008.Available: www.conferenceboard.ca/Libraries/NETWORK_PUBLIC/dec2008_report_healthypeople.sflb
9 Canadian Medical Association, Canadian Nursese Association. Principles for Health Care Transformation in Canada. Ottawa: The Associations; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-13.pdf
10 St-Pierre L. Governance Tools And Framework For Health In All Policies. Available: www.rvz.net/uploads/docs/Achtergrondstudie_-_Governance_tools_and_framework1.pdf
11 World Health Organization, Government of South Australia. Adapted from WHO Working Definition prepared for the 8Th Global Conference on Health Promotion, Helsinki, 10-14 June 2013.
12 Ollila E, Baum F, Pe ña S. Introduction to health in all policies and the analytical framework of the book. In Leppo K, Ollila E, Pera S, et al., editors. Health in all policies: seizing opportunities, implementing policies. Chap. 1. Finland: Ministry of Social Affairs and Health; 2013. Available: www.euro.who.int/__data/assets/pdf_file/0007/188809/Health-in-All-Policies-final.pdf.
13 World Health Organization, Government of South Australia. Adelaide Statement on Health in All Policies: moving towards a shared governance for health and well-being. Geneva: The Organization; 2010. Available: www.who.int/social_determinants/hiap_statement_who_sa_final.pdf (accessed October 18, 2014)
14 Rudolph, L, Caplan J, Mitchell C, et al. Health in All Policies: Improving Health Through Intersectoral Collaboration. Washington(DC): Institute of Medicine. Available: www.phi.org/uploads/application/files/q79jnmxq5krx9qiu5j6gzdnl6g9s41l65co2ir1kz0lvmx67to.pdf (accessed October 21, 2014).
15 National Collaborating Centre for Healthy Public Policy. Implementation of Sectin 54 of Quebec's Public Health Act. Quebec: The Centre; 2012. Available at: www.ncchpp.ca/docs/Section54English042008.pdf
16 Wright, J, Parry J, Scully EInstitutionalizing policy-level health impact assessment in Europe: Is coupling health impact assessment with strategic environmental assessment the next step forward? Bull World Health Orga. 2005;83(6):472-7
17 Knutsson I, Linell A Health impact assessment developments in Sweden. Scand J Public Health. 2010;38(2):115-20
18 St-Pierre L. Governance Tools And Framework for health in all policies. Available: www.rvz.net/uploads/docs/Achtergrondstudie_-_Governance_tools_and_framework1.pdf
19 Leppo K, Tangcharoensathien V. The health sector's role in HiAP. In Leppo K, Ollila E, Pera S, et al., editors. Health in all policies: seizing opportunities, implementing policies. Chap. 14. Finland: Ministry of Social Affairs and Health; 2013.
Available: www.euro.who.int/__data/assets/pdf_file/0007/188809/Health-in-All-Policies-final.pdf. (accessed October 18, 2014)