Like all scientific and medical procedures, assisted human reproduction has the potential for both benefit and harm. It is in the interests of individual Canadians and Canadian society in general that these practices be regulated so as to maximize their benefits and minimize their harms. To help achieve this goal, the Canadian Medical Association (CMA) has developed this policy on regulating these practices. It replaces previous CMA policy on assisted reproduction.
The objectives of any Canadian regulatory regime for assisted reproduction should include the following:
(a) to protect the health and safety of Canadians in the use of human reproductive materials for assisted reproduction, other medical procedures and medical research;
(b) to ensure the appropriate treatment of human reproductive materials outside the body in recognition of their potential to form human life; and
(c) to protect the dignity of all persons, in particular children and women, in relation to uses of human reproductive materials.
When a Canadian regulatory regime for assisted reproduction is developed, it should incorporate the following principles:
For the regulation of assisted reproduction, existing organizations such as medical licensing authorities, accreditation bodies and specialist societies should be involved to the greatest extent possible.
If the legislation establishing the regulatory regime is to include prohibitions as well as regulation, the prohibition of specific medical and scientific acts must be justified on explicit scientific and/or ethical grounds.
If criminal sanctions are to be invoked, they should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
Whatever regulatory agency is created should include significant membership of scientists and clinicians working in the area of assisted reproduction.
Elements of a Regulatory Regime
The regulation of assisted reproduction in Canada should include the following elements:
Legislation to create a national regulatory body with appropriate responsibilities and accountability for coordinating the activities of organizations that are working in the area of assisted reproduction and for carrying out functions that other organizations cannot perform.
The development and monitoring of national standards for research related to human subjects including genetics and reproduction. The regulatory body would work closely with the Canadian Institutes of Health Research, other federal and provincial research granting councils, the National Council on Ethics in Human Research and other such organizations.
The development and monitoring of national standards for training and certifying physicians in those reproductive technologies deemed acceptable. As is the case for all post-graduate medical training in Canada, this is appropriately done through bodies such as the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada.
The licensing and monitoring of individual physicians. This task is the responsibility of the provincial and territorial medical licensing authorities which could regulate physician behaviour in respect to the reproductive technologies, just as they do for other areas of medical practice.
The development of guidelines for medical procedures. This should be done by medical specialty societies such as the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian Fertility and Andrology Society (CFAS).
The accreditation of facilities where assisted reproduction is practised. There is already in Canada a well functioning accreditation system, run by the Canadian Council on Health Services Accreditation, which may be suitable for assisted reproduction facitilies.
Whatever regulatory body is established to deal with assisted reproduction should utilize, not duplicate, the work of these organizations. In order to maximize the effectiveness of these organizations, the regulatory body could provide them with additional resources and delegated powers.
The CMA is opposed to the criminalization of scientific and medical procedures. Criminalization represents an unjustified intrusion of government into the patient-physician relationship. Previous attempts to criminalize medical procedures (for example, abortion) were ultimately self-defeating. If the federal government wishes to use its criminal law power to regulate assisted reproduction, criminal sanctions should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
The CMA recommends to the appropriate government authorities that all boxing be banned in Canada. Until such time, strategies to prevent injury should be pursued.
The CMA considers boxing a dangerous sport. While most sports involve risk of injury, boxing is distinct in that the basic intent of the boxer is to harm and incapacitate his or her opponent.
Boxers are at significant risk of injuries resulting in brain damage. Boxers are susceptible not only to acute life-threatening brain trauma, but also to the chronic and debilitating effects of gradual cerebral atrophy. Studies demonstrate a correlation between the number of bouts fought and the presence of cerebral abnormalities in boxers. There is also a risk of eye injury including long-term damage such as retinal tears and detachments.
- CMA supports a ban on professional and amateur boxing in Canada.
- Until boxing is banned in this country, the following preventive strategies should be pursued to reduce brain and eye injuries in boxers:
- Head blows should be prohibited. CMA encourages universal use of protective garb such as headgear and thumbless, impact-absorbing gloves
- The World Boxing Council, World Boxing Association and other regulatory bodies should develop and enforce objective brain injury risk assessment tools to exclude individual boxers from sparring or fighting.
- The World Boxing Council, World Boxing Association and other regulatory bodies should develop and enforce standard criteria for referees, ringside officials and ringside physicians to halt sparring or boxing bouts when a boxer has experienced blows that place him or her at imminent risk of serious injury.
- The World Boxing Council, World Boxing Association and other regulatory bodies should encourage implementation of measures advocated by the World Medical Boxing Congress to reduce the incidence of brain and eye injuries.
- CMA believes that the professional responsibility of the physician who serves in a medical capacity in a boxing contest is to protect the health and safety of the contestants. The desire of spectators, promoters of the event, or even injured athletes that they not be removed from the contest should not influence the physician’s medical judgment.
- Further long term outcome data should be obtained from boxers in order to more accurately establish successful preventive interventions. CMA encourages ongoing research into the causes and treatments of boxing-related injuries, and into the effects of preventive strategies.
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.
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.
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public.
Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general.
Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another.
Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents.
Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit).
Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice.
Testing: Any discussion of drug testing must take the following into account:
If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed.
The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing.
The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work.
If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen.
The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons:
Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society.
The mass, low-cost screening tests may not be reliable or valid.
The circumstances may not justify possible human rights violations.
Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable.
Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing.
CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
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.
FIREARMS CONTROL (UPDATE 2001)
Firearms are a major cause of death and injury in Canada and account for nearly 1,400 deaths annually. The CMA has made several recommendations to governments and other bodies undertaking legislative review and public policy change. These recommendations relate to the regulation of firearms, education for the safe handling of firearms, broad-based violence prevention programs, and research and information provision. In addition, the CMA has produced guidelines to assist physicians in identifying and counselling patients at risk of violent behaviour and in reporting patients at risk.
Firearms are a major cause of death and injury in Canada.. The cost to society of firearm-related injury, particularly spinal cord and head injuries, is considerable.
Over the short term, policy should focus on firearms and the user. Applying stringent controls on firearms, however, may have little effect on the rates of death and injury if the underlying problems of violence in society are not addressed.
In an effort to accommodate both short-term and long-term solutions the CMA recommends the following to governments and bodies undertaking legislative review and public policy change.
The object of regulation should be to deter people at risk for violent or self-destructive behaviour from having easy access to firearms. A regulatory policy should address (a) the acquisition of firearms (e.g., licensing of firearms and/or users, processes to screen would-be purchasers who are at risk), b) secure firearm and ammunition storage methods and modifications to firearms that would render them less accessible to children or those acting on violent impulses and (c) severe penalties for offenses such as the use of a firearm in the commission of a crime or an act of violence, including family violence.
Training in safe handling of firearms is strongly recommended, particularly for all first-time firearm users. Broader-based education programs aimed at the prevention of violence (e.g., in schools) may also be efficacious and should be evaluated for their impact in reducing violence.
Research and information provision
CMA encourages research in a number of areas, including the following.
Firearm surveillance: the types of firearms or classes of ammunition disproportionately involved in intentional deaths and injuries, the circumstances surrounding a firearm incident (e.g., argument between friends, alcohol involvement) and data on injuries and deaths.
Determination of behavioural or environmental risk factors for violent behaviour: the relative risk or benefit of keeping a firearm at home for protection i.e.. the scientific assessment of the deterrence effect):
The effects of factors such as alcohol, drug use and family history of violence on the risk of violent death; and how accurately experts can identify people at risk.
Case-control and cohort studies on gun control, crime and the antecedents of violent behaviour.
Evaluation of education programs that discourage firearm-related violence or promote safe handling of firearms.
Role of physicians
The CMA recommends that physicians consider the following guidelines.
Management of patients at risk
It is not always possible to identify people at risk of violent or self-destructive behaviour; however, the CMA recommends that physicians be alert to warning signs that a patient may be at risk and manage that patient accordingly. For example, always ask depressed patients about suicidal and homicidal thoughts and plans (asking will not plant ideas); admit suicidal patients to hospital, even against their will, particularly if they do not have supportive families who can monitor them at home; have the family remove all firearms from the home of a patient at risk; and monitor the patient frequently, writing small prescriptions if medication is required.
Good clinical judgement and close follow-up are perhaps the most effective ways of managing a self-destructive or violent patient.
Reporting of patients at risk
No specific guidelines exist for the reporting of patients at risk of violent behaviour. The physician should consider whether the risk of harm to society (or a third party) posed by a patient outweighs that patient's right to confidentiality.
Counselling and public advocacy
A physician may be asked for a reference for an applicant of a firearms acquisition certificate. Before providing the reference the physician should consider the applicant carefully for risk factors, recommend appropriate firearms training and caution against the concomitant use of firearms, alcohol and other drugs.
A physician should become an advocate for nonviolent conflict resolution. As research accumulates about the most effective interventions for nonviolent conflict resolution the health sector may be able to draw on this research to work to reduce violence in society.
Like motor vehicle and bicycle safety, firearm safety is a public health issue. The CMA holds that physicians, as advocates for the health of Canadians, can help reduce firearm-related damage and address the concomitant underlying problem of violence in society.
Guidelines for CMA’s Activities and Relationships with Other Parties
As the national voice of medicine in Canada, the CMA provides leadership for physicians, promotes the highest standards of health and health care for Canadians and acts as advocate for all Canadian physicians. In the furtherance of its purpose, the CMA conducts a variety of activities and has a variety of relationships with other parties. The CMA’s activities range from policy development to the delivery of products and services to physicians and the public. Its relationships with other parties range from the purchase of goods and services that support operations to partnerships that further or are consistent with its advocacy strategies.
The CMA actively seeks out relationships with others in recognition of the benefits these bring in the attainment of the CMA’s purposes. Such benefits may include:
- unifying the profession through relations with physician groups, including the divisions and affiliates
- enabling a stronger advocacy voice in association with others
- enhancing the CMA’s credibility with other parties
- providing financial and human resources to support CMA activities
- providing skills and capabilities that CMA may not possess
- providing additional membership services.
Activities or relationships with other parties and products and services produced through the activity or relationship (“activities or relationships”) that undermine the CMA’s reputation of professionalism, independence and quality are to be avoided, not only for their own sake but also because a diminishment of the CMA’s reputation impedes its ability to achieve its purposes.
The following principles have been developed to help guide decisions about the kinds of activities CMA undertakes and about its relations with other parties, with the objective of ensuring the integrity and good reputation of the CMA. A process or processes will be developed to implement the principles, which will include the preparation of subdocuments on applying the principles to specific areas; for example, sponsorship, endorsement and coalitions.
The CMA should rigorously and actively pursue its laudable ends and seek out relationships with others to attain them with the caveat that activities or relationships that would tarnish the integrity or reputation of CMA or the medical profession or that would diminish the trust placed in them should be avoided.
Conformity with CMA’s purpose
The activity or relationship should further or support the CMA’s purposes as elaborated in its objects, vision and mission.
The CMA’s purposes have been explicitly and widely agreed upon.
The CMA holds itself to be, and encourages reliance that it is, an organization that pursues its specified purposes.
Activities and relationships that do not further or support the CMA’s purposes have the potential to thwart these purposes in a number of ways, including inadequate accountability, inappropriate use of resources, unconstrained exercise of merely private judgement or inappropriate self-interest.
2. Medical professionalism and ethics
The activity or relationship should be consistent with medical professionalism and with CMA’s Code of Ethics.
The CMA is an association of physicians.
When the CMA acts, it represents the medical profession.
The CMA’s actions reflect upon the medical profession.
The CMA’s stature and reputation are inextricably linked to the medical profession’s work, the professional stature of its member physicians and the trust Canadians place in their physicians.
Engaging in activities or relationships that are inconsistent with medical professionalism and CMA’s Code of Ethics would erode trust in the CMA.
The activity or relationship should not undermine the CMA’s independence.
To be a credible voice and influence and to be worthy of the trust and confidence of physicians and of the public, the CMA should be, and be seen to be, free of undue influence and in control of the decisions it makes.
Undue influence occurs when one is induced to do or not do something that is contrary to what one would otherwise do if left to act freely. Undue influence deprives one of free agency and destroys free will such that it is rendered more the will of another than of one’s own.
Activities and relationships that may undermine independence include:
activities or relationships that provide revenue or benefit to the CMA such that ongoing dependency on the revenue or benefit impedes independence
activities and relationships that create a product or service that is seen to be associated with the CMA but over which the CMA does not have final control or veto or the capacity to extricate itself
Consistency with policy
The activity or relationship should be consistent with CMA policy.
The CMA develops policy in pursuance of its purposes; these should be referred to when making decisions in connection with activities or relationships.
Conflicting goals and activities
Relationships with parties whose goals or activities directly conflict with the CMA’s objects, mission or vision should be avoided.
This does not preclude discussion with others or participation in events for the purposes of obtaining information, monitoring or lobbying.
The terms and conditions of the activity or relationship should be transparent.
Transparency promotes an openness to scrutiny and serves to enhance accountability and to discourage relationships or activities that could be considered problematic.
The principle is generally applicable except in connection to matters related to competitive advantage, trade secret or a reasonable agreement of confidentiality.
Compliance and accountability
Processes must be in place to ensure that proposed and ongoing activities or relationships are appropriately reviewed for compliance with and clear accountability for these principles.
These include the activities of the secretariat and the corporate subsidiaries.
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.