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.
Joint Statement on Scopes of Practice (February 2003)
Canada's physicians, nurses, pharmacists and other health professionals recognize that a sustainable health workforce is a key challenge facing our health care system. In this regard, scopes of practice is an important issue that needs to be addressed.
The Canadian Medical Association (CMA), the Canadian Nurses Association (CNA) and the Canadian Pharmacists Association (CPhA) have approved the following principles and criteria for the determination of scopes of practice. The primary purposes of such determinations are to meet the health care needs of Canadians, and to serve the interests of patients and the public safely, efficiently and competently.
The CPhA, CNA and CMA believe that policy decisions taken in this area must put patients first. Secondly, they should be grounded in principles that reflect our commitment to professionalism, lifelong learning and patient safety. Thirdly, that there be recognition of the need for legislative and regulatory changes to support evolving scopes of practice. Moreover, we believe that health professionals must be involved in decision-making processes in this area.
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, nurses and pharmacists 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.
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 judgement, 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.
This document is based on a January 2002 policy developed by the Canadian Medical Association whicb has been endorsed by the Canadian Nurses Association and the Canadian Pharmacists Association. We welcome the support of other health care providers for these principles and criteria regarding scopes of practice.