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 OF ABORIGINAL PEOPLES 2002
A CMA Policy Statement
That the federal government adopt a comprehensive strategy for improving the health of Aboriginal peoples that involves a partnership among governments, non-governmental organizations, universities and the Aboriginal communities.
2) The Need to Address Health Determinants
The health status of Canada’s Aboriginal peoples is a result of a broad range of factors: social, biological, economic, political, educational and environmental. The complexity and interdependence of these health determinants suggest that the health status of Aboriginal peoples is unlikely to be improved significantly by increasing the quantity of health services. Instead, inequities within a wide range of social and economic factors should be addressed; for example:
interactions with the justice system
racism and social marginalization
water supply and waste disposal
housing quality and infrastructure
cultural identity, (for example, long-term effects of the residential school legacy.)
That all stakeholders work to improve provision for the essential needs of Aboriginal peoples and communities that affect their health (e.g. housing, employment, education, water supply).
3) The Importance of Self-Determination
One characteristic of successful Aboriginal communities is a high degree of self-efficacy and control over their own circumstances. This empowerment can take many forms, from developing community-driven health initiatives to determining how to use lands.
It is increasingly recognized that self-determination in cultural, social, political and economic life improves the health of Aboriginal peoples and their communities, and that Aboriginal peoples can best determine their requirements and the solutions to their problems. Therefore, the CMA encourages and supports the Aboriginal peoples in their move toward increasing self-determination and community control. A just and timely settlement of land claims is one means by which Aboriginal communities can achieve this self-determination and self-sufficiency.
That governments and other stakeholders:
Settle land claims and land use issues expeditiously;
Work toward resolving issues of self-determination for Aboriginal peoples and their communities in areas of cultural, social, political and economic life.
4) Community Control of Health Services
Control by Aboriginal peoples of health and social services is increasing across Canada as part of a broader transfer of control of political power, resources and lands. This transfer has not progressed at the same pace across all Aboriginal communities; the needs of Urban Aboriginal peoples, for example, are only beginning to be addressed.
CMA supports the development of community-driven models for delivery of health care and health promotion, responsive to the culture and needs of individual communities. Successful community-driven models of health care delivery generally recognize that the Aboriginal concept of health is holistic in nature, incorporating mental, emotional and spiritual as well as physical components. Translating this concept into practice may involve:
Development of primary care models that are grounded within Aboriginal culture at a local level;
Integration of disease treatment services with health promotion and health education programs, and with traditional healing practices;
Integration of health and social services;
Interprofessional collaboration within a multi-disciplinary team.
CMA also supports programs to increase the involvement of Aboriginal peoples in professional and other decision-making roles affecting the health of their community – for example, increased representation in health-care management positions, and on health facility boards where there is a significant Aboriginal population.
That all stakeholders actively encourage the development of integrated, holistic primary care service delivery relevant to the needs and culture of Aboriginal communities and under community control.
5) Cultural Responsiveness in the Patient/Physician Relationship
As mentioned above, the concept of “health” in Aboriginal culture is holistic and incorporates many components. The concepts of continuity, wholeness and balance within and among people are important to Aboriginal culture, as is a close affinity with the natural environment – both in practical and spiritual senses , which emphasises the importance of stewardship of the land as a component of individual and community health maintenance for present and future generations.
Physicians should work in collaboration with Aboriginal peoples and groups to promote a greater understanding and acceptance of their respective philosophies and approaches. This could include:
an openness and respect for traditional medicine and traditional healing practices (e.g. sweat lodges, herbal medicines, healing circles). This should be balanced with a recognition that not all Aboriginal people, whether First Nation, Métis or Inuit, adhere to or understand their traditional ceremonial practices.
improved cross-cultural awareness in physicians, which could be facilitated by greater contact with their local Aboriginal communities, better understanding of local Aboriginal cultures, history and current setting,
development of cross-cultural patient-physician communication skills.
a) That educational initiatives in cross-cultural awareness of Aboriginal health issues be developed for the Canadian population, and in particular for health care providers,
b) that practice tools and resources be developed to support physicians (Aboriginal and non-Aboriginal) and other health care professionals practicing in Aboriginal communities.
6) Access to Health Services
Canada is often considered to have one of the best health care systems in the world and is typically described as providing “universal access”. However, our system does not provide equal access to services for all people living in Canada – the most underserviced being those in northern Canada, which contains many Aboriginal communities.
Several kinds of access problems exist in Aboriginal communities:
Lack of access to employment, adequate housing, nutritious food, clean water and other social or economic determinants of health.
Factors that impede access to health care services, particularly in remote locations; for example, language and cultural differences, and the difficulty of transporting patients to tertiary centres.
Lack of specific services (for example, mental health services) for Aboriginal peoples in many regions of Canada. Specific groups, such as women and the elderly, have unique and distinct needs that should be addressed.
Program delivery that involves multiple federal, provincial and municipal funding agencies. Physicians and patients alike have trouble obtaining information about and entry into existing programs and funding for new programs because of jurisdictional confusion.
CMA has previously recommended that the Canadian health system develop and apply agreed-upon standards for timely access to care. This includes the need to increase timely and appropriate access by Aboriginal peoples to health care and health promotion services, geared to different segments of the population according to their needs.
a) That governments and other stakeholders simplify and clarify jurisdictional responsibilities with respect to Aboriginal health at the federal, provincial and municipal level, with a goal of simplifying access to service delivery.
b) That strategies be explored to increase access to health services by remote communities; for example, through the use of technology (e.g. Web sites, telemedicine) to connect them with academic medical centres.
7) Health Human Resources
There is an urgent need to increase the training, recruitment and retention of Aboriginal health care providers. The 1996 Royal Commission on Aboriginal Peoples recommended that a cadre of 10,000 Aboriginal health care and social service workers be trained to meet the needs of a complex and diverse community. While progress has been made in recent years, an intensive focus on recruitment, training and retention is required in order to achieve this goal.
A comprehensive health human resource strategy should be developed, to increase the recruitment, training and retention of Aboriginal students in medicine and other health disciplines. Such a strategy could include:
Outreach programs to interest Aboriginal young people in the health sciences.
Access and support programs for Aboriginal medical students.
Residency positions for recently graduated Aboriginal physicians or physicians wishing to practice in Aboriginal populations, including re-entry positions for physicians currently in practice.
Mentoring and leadership-development programs for Aboriginal medical students, residents and physicians.
Programs to counter racism and discrimination in the health-care system.
Initiatives to recruit and train Community Health Representatives/ Workers, birth attendants and other para-professionals within Aboriginal communities.
a) That CMA and others work to develop a health human resource strategy aimed at improving the recruitment, training, retention of Aboriginal physicians and other health-care workers;
b) That medical and other health faculties increase access and support programs to encourage enrollment of Aboriginal students.
8) Health Information
Information about the health status and health care experience of Aboriginal peoples, is essential for future planning and advocacy. For Aboriginal peoples to effectively develop self-determination in health care delivery, they should have access to data that can be converted into useful information on their population. The “OCAP” principle (ownership, control, access to and possession of health data) is seen as integral to First Nation community empowerment, but may prove acceptable to other Aboriginal groups as well.
A considerable amount of data currently exists, though there are gaps in coverage, particularly regarding Métis, Inuit and urban and rural off-reserve First Nations populations. This data can come from a variety of federal and provincial/territorial sources, including periodic surveys, federal censuses, Aboriginal Peoples Survey data holdings, and also regional physician and hospital utilization statistics. However, jurisdictional and ownership issues have hindered Aboriginal people from accessing and making use of this data.
CMA supports the development and maintenance of mechanisms to systematically collect and analyze longitudinal health information for Aboriginal people, and the removal of barriers that prevent Aboriginal organizations from fully accessing information in government databases. Aboriginal health information should be subject to guarantees of privacy and confidentiality. The CMA urges relevant government departments to ensure that revisions to the Indian Act do not infringe on the privacy of health information of Aboriginal peoples in Canada.
That the Government of Canada support the First Nations and Inuit Regional Longitudinal Health Survey Process, and the First Nations and Inuit Health Information System, and parallel interests for the Métis and Inuit. These programs should be operated under the control of their respective Aboriginal communities
The CMA supports culturally relevant research into the determinants of Aboriginal health and effective treatment and health-promotion strategies to address them. Specifically, the CMA supports the efforts of the Institute of Aboriginal Peoples’ Health at the Canadian Institute for Health Research, in addressing the needs of Canada’s Aboriginal peoples.
Aboriginal peoples should be involved in research design, data collection and analysis; research should support the communities as they build capacity and develop initiatives to address their health needs. Ideally, research should address not only determinants of ill health but also the reasons for positive health outcomes.
The CMA also acknowledges the need to communicate research results to Aboriginal communities to help them develop and evaluate health programs. In particular there is an urgent need among Aboriginal communities for the sharing of successes.
That government and other stakeholders
Support Aboriginal peoples and communities in the development of Aboriginal research and the means of interpreting its findings.
Make public communication of health research results a priority in order to facilitate its use by Aboriginal communities.
CMA’S CONTINUED COMMITMENT
The Canadian Medical Association, consistent with its mandate to advocate for the highest standards of health and health care in Canada, will continue to work with the Aboriginal community and other stakeholders on activities addressing the following issue areas:
Research and Practice Enhancement:.
Public and Community Health Programming:.
Advocacy for healthy public policy.
November 15, 2002
Principles concerning physician information (CMA policy – approved June 2002)
In an environment in which the capacity to capture, link and transmit information is growing and the need for fuller accountability is being created, the demand for physician information, and the number of people and organizations seeking to collect it, is increasing.
Physician information, that is, information that includes personal health information about and information that relates or may relate to the professional activity of an identifiable physician or group of physicians, is valuable for a variety of purposes. The legitimacy and importance of these purposes varies a great deal, and therefore the rationale and rules related to the collection, use, access and disclosure of physician information also varies. The Canadian Medical Association (CMA) developed this policy to provide guiding principles to those who collect, use, have access to or disclose physician information. Such people are termed “custodians,” and they should be held publicly accountable. These principles complement and act in concert with the CMA Health Information Privacy Code (1), which holds patient health information sacrosanct.
Physicians have legitimate interests in what information about them is collected, on what authority, by whom and for what purposes it is collected, and what safeguards and controls are in place. These interests include privacy and the right to exercise some control over the information; protection from the possibility that information will cause unwarranted harm, either at the individual or the group level; and assurance that interpretation of the information is accurate and unbiased. These legitimate interests extend to information about physicians that has been rendered in non-identifiable or aggregate format (e.g., to protect against the possibility of individual physicians being identified or of physician groups being unjustly stigmatized). Information in these formats, however, may be less sensitive than information from which an individual physician can be readily identified and, therefore, may warrant less protection.
The purposes for the use of physician information may be more or less compelling. One compelling use is related to the fact that physicians, as members of a self-regulating profession, are professionally accountable to their patients, their profession and society. Physicians support this professional accountability purpose through the legislated mandate of their regulatory colleges. Physicians also recognize the importance of peer review in the context of professional development and maintenance of competence.
The CMA supports the collection, use, access and disclosure of physician information subject to the conditions outlined below.
Purpose(s): The purpose(s) for the collection of physician information, and any other purpose(s) for which physician information may be subsequently used, accessed or disclosed, should be precisely specified at or before the collection. There should be a reasonable expectation that the information will achieve the stated purpose(s). The policy does not prevent the use of information for purposes that were not intended and not reasonably anticipated if principles 3 and 4 of this policy are met.
Consent: As a rule, information should be collected directly from the physician. Subject to principle 4, consent should be sought from the physician for the collection, use, access or disclosure of physician information. The physician should be informed about all intended and anticipated uses, accesses or disclosures of the information.
Conditions for collection, use, access and disclosure: The information should:
be limited to the minimum necessary to carry out the stated purpose(s),
be in the least intrusive format required for the stated purpose(s), and its collection, use, access and disclosure should not infringe on the physician’s duty of confidentiality with respect to that information.
Use of information without consent: There may be justification for the collection, use, access or disclosure of physician information without the physician’s consent if, in addition to the conditions in principle 3 being met, the custodian publicly demonstrates with respect to the purpose(s), generically construed, that:
the stated purpose(s) could not be met or would be seriously compromised if consent were required,
the stated purpose(s) is(are) of sufficient importance that the public interest outweighs to a substantial degree the physician’s right to privacy and right of consent in a free and democratic society, and
that the collection, use, access or disclosure of physician information with respect to the stated purpose(s) always ensures justice and fairness to the physician by being consistent with principle 6 of this policy.
Physician’s access to his or her own information: Physicians have a right to view and ensure, in a timely manner, the accuracy of the information collected about them. This principle does not apply if there is reason to believe that the disclosure to the physician will cause substantial adverse effect to others. The onus is on the custodian to justify a denial of access.
6. Information quality and interpretation: Custodians must take reasonable steps to ensure that the information they collect, use, gain access to or disclose is accurate, complete and correct. Custodians must use valid and reliable collection methods and, as appropriate, involve physicians to interpret the information; these physicians must have practice characteristics and credentials similar to those of the physician whose information is being interpreted.
7. Security: Physical and human safeguards must exist to ensure the integrity and reliability of physician information and to protect against unauthorized collection, use, access or disclosure of physician information.
8. Retention and destruction: Physician information should be retained only for the length of time necessary to fulfill the specified purpose(s), after which time it should be destroyed.
9. Inquiries and complaints: Custodians must have in place a process whereby inquiries and complaints can be received, processed and adjudicated in a fair and timely way. The complaint process, including how to initiate a complaint, must be made known to physicians.
10. Openness and transparency: Custodians must have transparent and explicit record-keeping or database management policies, practices and systems that are open to public scrutiny, including the purpose(s) for the collection, use, access and disclosure of physician information. The existence of any physician information record-keeping systems or database systems must be made known and available upon request to physicians.
11. Accountability: Custodians of physician information must ensure that they have proper authority and mandate to collect, use, gain access to or disclose physician information. Custodians must have policies and procedures in place that give effect to the principles in this document. Custodians must have a designated person who is responsible for monitoring practices and ensuring compliance with the policies and procedures.
(1) Canadian Medical Association. Health Information Privacy Code. CMAJ 1998;159(8):997-1016.
Principles For Providing Information About Prescription Drugs To Consumers
Approved by the CMA Board of Directors, March 2003
Since the late 1990's expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada1, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public.
Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information.
The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the "biological revolution", e.g. gene therapies.
The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 2
Principle #1: The Goal is Good Health
The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care.
Principle #2: Ready Access
Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator.
Principle #3: Patient Involvement
Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically.
Principle #4: Evidence-Based Content
Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available.
Principle #5: Appropriate Information
Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following:
* indications for use of the drug
* side effects
* relative cost.
In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies).
Principle #6: Objectivity of Information Sources
Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information.
Principle #7: Endorsement/ Accreditation
Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board.
Principle #8: Monitoring and Revision
Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate.
Principle #9: Physicians as Partners
Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory.
Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient's condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public.
Principle #10: Research and Evaluation
Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes.
1 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, "information-seeking" advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media.
2 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general.
SCOPES OF PRACTICE
This policy outlines the principles and criteria that are important for physicians to consider when they are involved in the determination of the scopes of practice of physicians and other health care providers, whether regulated or unregulated, in all settings.
The primary purposes of scopes of practice determinations are to meet the health care needs and to serve the interests of patients and the public safely, efficiently, and competently.
There are many factors impacting the scopes of practice of health providers: broadening definition of health, emerging use of alternative therapies, increasing patient consumerism, advances in technology and in treatment and diagnostic modalities, information technology, legislation, changing demographics, increasing health care costs, and the shortage of physicians, nurses and other providers. Scopes of practice must reflect these changes in societal needs (including the need of the public for access to services), societal expectations, and preferences of patients and the public for certain types of health care providers to fulfill particular roles and functions, while at the same time reflecting economic realities. These factors and related issues (e.g., access, availability and cost) are influencing
governments and other stakeholders to consider new roles and expanded scopes of practice for health care providers.
There is a need to define principles and criteria for understanding and articulating scopes of practice that ensure public safety and appropriate utilization of provider skills.
Principles for determining scopes of practice
Focus: Scopes of practice statements should promote safe, ethical, high-quality care that responds to the needs of patients and the public in a timely manner, is affordable and is provided by competent health care providers.
Flexibility: A flexible approach is required that enables providers to practise to the extent of their education, training, skills, knowledge, experience, competence and judgment while being responsive to the needs of patients and the public.
Collaboration and cooperation: In order to support interdisciplinary approaches to patient care and good health outcomes, physicians engage in collaborative and cooperative practice with other health care providers who are qualified and appropriately trained and who use, wherever possible, an evidence-based approach. Good communication is essential to collaboration and cooperation.
Coordination: A qualified health care provider should coordinate individual patient care.
Patient choice: Scopes of practice should take into account patients' choice of health care provider.
Criteria for determining scopes of practice
Accountability: Scopes of practice should reflect the degree of accountability, responsibility and authority that the health care provider assumes for the outcome of his or her practice.
Education: Scopes of practice should reflect the breadth, depth and relevance of the training and education of the health care provider. This includes consideration of the extent of the accredited or approved educational program(s), certification of the provider and maintenance of competency.
Competencies and practice standards: Scopes of practice should reflect the degree of knowledge, values, attitudes and skills (i.e., clinical expertise and judgment, critical thinking, analysis, problem solving, decision making, leadership) of the provider group.
Quality assurance and improvement: Scopes of practice should reflect measures of quality assurance and improvement that have been implemented for the protection of patients and the public.
Risk assessment: Scopes of practice should take into consideration risk to patients.
Evidence-based practices: Scopes of practice should reflect the degree to which the provider group practices are based on valid scientific evidence where available.
Setting and culture: Scopes of practice should be sensitive to the place, context and culture in which the practice occurs.
Legal liability and insurance: Scopes of practice should reflect case law and the legal liability assumed by the health care provider including mutual professional malpractice protection or liability insurance coverage.
Regulation: Scopes of practice should reflect the legislative and regulatory authority, where applicable, of the health care provider.
Principles and criteria to ensure safe, competent and ethical patient care should guide the development of scopes of practice of health care providers. To this end, the CMA has developed these principles and criteria to assist physicians and medical organizations when they are involved in the determination of scopes of practice.
The CMA welcomes opportunities to dialogue with others on how scopes of practice can be improved for the benefit of patients and society in general.