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Guidelines for Physicians in Interactions with Industry

https://policybase.cma.ca/en/permalink/policy9041
Last Reviewed
2019-03-03
Date
2007-12-01
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
(www.cma.ca). PD08-01 CMA POLICY GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY The history
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2007-12-01
Replaces
Physicians and the pharmaceutical industry (Update 2001)
Topics
Ethics and medical professionalism
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
GUIDELINES FOR PHYSICIANS IN INTERACTIONS WITH INDUSTRY The history of health care delivery in Canada has included interaction between physicians and the pharmaceutical and health supply industries; this interaction has extended to research as well as to education. Physicians understand that they have a responsibility to ensure that their participation in such collaborative efforts is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible and appropriately manage these situations when necessary. They understand as well the need for the profession to lead by example by promoting physician-developed guidelines. The following guidelines have been developed by the CMA to serve as a resource tool for physicians in helping them to determine what type of relationship with industry is appropriate. They are not intended to prohibit or dissuade appropriate interactions of this type, which have the potential to benefit both patients and physicians. Although directed primarily to individual physicians, including residents, and medical students, the guidelines also apply to relationships between industry and medical organizations. General Principles 1. The primary objective of professional interactions between physicians and industry should be the advancement of the health of Canadians. 2. Relationships between physicians and industry are guided by the CMA's Code of Ethics and by this document. 3. The practising physician's primary obligation is to the patient. Relationships with industry are inappropriate if they negatively affect the fiduciary nature of the patient-physician relationship. 4. Physicians should resolve any conflict of interest between themselves and their patients resulting from interactions with industry in favour of their patients. In particular, they must avoid any self-interest in their prescribing and referral practices. 5. Except for physicians who are employees of industry, in relations with industry the physician should always maintain professional autonomy and independence. All physicians should remain committed to scientific methodology. 6. Those physicians with ties to industry have an obligation to disclose those ties in any situation where they could reasonably be perceived as having the potential to influence their judgment. Industry-Sponsored Research 7. A prerequisite for physician participation in all research activities is that these activities are ethically defensible, socially responsible and scientifically valid. The physician's primary responsibility is the well-being of the patient. 8. The participation of physicians in industry sponsored research activities must always be preceded by formal approval of the project by an appropriate ethics review body. Such research must be conducted according to the appropriate current standards and procedures. 9. Patient enrolment and participation in research studies must occur only with the full, informed, competent and voluntary consent of the patient or his or her proxy, unless the research ethics board authorizes an exemption to the requirement for consent. In particular, the enrolling physician must inform the potential research subject, or proxy, about the purpose of the study, its source of funding, the nature and relative probability of harms and benefits, and the nature of the physician's participation and must advise prospective subjects that they have the right to decline to participate or to withdraw from the study at any time, without prejudice to their ongoing care. 10. The physician who enrolls a patient in a research study has an obligation to ensure the protection of the patient's privacy, in accordance with the provisions of applicable national or provincial legislation and CMA's Health Information Privacy Code. If this protection cannot be guaranteed, the physician must disclose this as part of the informed consent process. 11. Practising physicians should not participate in clinical trials unless the study will be registered prior to its commencement in a publicly accessible research registry. 12. Because of the potential to influence judgment, remuneration to physicians for participating in research studies should not constitute enticement. It may cover reasonable time and expenses and should be approved by the relevant research ethics board. Research subjects must be informed if their physician will receive a fee for their participation and by whom the fee will be paid. 13. Finder's fees, whereby the sole activity performed by the physician is to submit the names of potential research subjects, should not be paid. Submission of patient information without their consent would be a breach of confidentiality. Physicians who meet with patients, discuss the study and obtain informed consent for submission of patient information may be remunerated for this activity. 14. Incremental costs (additional costs that are directly related to the research study) must not be paid by health care institutions or provincial or other insurance agencies regardless of whether these costs involve diagnostic procedures or patient services. Instead, they must be assumed by the industry sponsor or its agent. 15. When submitting articles to medical journals, physicians must state any relationship they have to companies providing funding for the studies or that make the products that are the subject of the study whether or not the journals require such disclosure. Funding sources for the study should also be disclosed. 16. Physicians should only be included as an author of a published article reporting the results of an industry sponsored trial if they have contributed substantively to the study or the composition of the article. 17. Physicians should not enter into agreements that limit their right to publish or disclose results of the study or report adverse events which occur during the course of the study. Reasonable limitations which do not endanger patient health or safety may be permissible. Industry-Sponsored Surveillance Studies 18. Physicians should participate only in post-marketing surveillance studies that are scientifically appropriate for drugs or devices relevant to their area of practice and where the study may contribute substantially to knowledge about the drug or device. Studies that are clearly intended for marketing or other purposes should be avoided. 19. Such studies must be reviewed and approved by an appropriate research ethics board. The National Council on Ethics in Human Research is an additional source of advice. 20. The physician still has an obligation to report adverse events to the appropriate body or authority while participating in such a study. Continuing Medical Education / Continuing Professional Development (CME/CPD) 21. This section of the Guidelines is understood to address primarily medical education initiatives designed for practicing physicians. However, the same principles will also apply for educational events (such as noon-hour rounds and journal clubs) which are held as part of medical or residency training. 22. The primary purpose of CME/CPD activities is to address the educational needs of physicians and other health care providers in order to improve the health care of patients. Activities that are primarily promotional in nature, such as satellite symposia, should be identified as such to faculty and attendees and should not be considered as CME/CPD. 23. The ultimate decision on the organization, content and choice of CME/CPD activities for physicians shall be made by the physician-organizers. 24. CME/CPD organizers and individual physician presenters are responsible for ensuring the scientific validity, objectivity and completeness of CME/CPD activities. Organizers and individual presenters must disclose to the participants at their CME/CPD events any financial affiliations with manufacturers of products mentioned at the event or with manufacturers of competing products. There should be a procedure available to manage conflicts once they are disclosed. 25. The ultimate decision on funding arrangements for CME/CPD activities is the responsibility of the physician-organizers. Although the CME/CPD publicity and written materials may acknowledge the financial or other aid received, they must not identify the products of the company(ies) that fund the activities. 26. All funds from a commercial source should be in the form of an unrestricted educational grant payable to the institution or organization sponsoring the CME/CPD activity. 27. Industry representatives should not be members of CME content planning committees. They may be involved in providing logistical support. 28. Generic names should be used in addition to trade names in the course of CME/CPD activities. 29. Physicians should not engage in peer selling. Peer selling occurs when a pharmaceutical or medical device manufacturer or service provider engages a physician to conduct a seminar or similar event that focuses on its own products and is designed to enhance the sale of those products. This also applies to third party contracting on behalf of industry. This form of participation would reasonably be seen as being in contravention of the CMA's Code of Ethics, which prohibits endorsement of a specific product. 30. If specific products or services are mentioned, there should be a balanced presentation of the prevailing body of scientific information on the product or service and of reasonable, alternative treatment options. If unapproved uses of a product or service are discussed, presenters must inform the audience of this fact. 31. Negotiations for promotional displays at CME/CPD functions should not be influenced by industry sponsorship of the activity. Promotional displays should not be in the same room as the educational activity. 32. Travel and accommodation arrangements, social events and venues for industry sponsored CME/CPD activities should be in keeping with the arrangements that would normally be made without industry sponsorship. For example, the industry sponsor should not pay for travel or lodging costs or for other personal expenses of physicians attending a CME/CPD event. Subsidies for hospitality should not be accepted outside of modest meals or social events that are held as part of a conference or meeting. Hospitality and other arrangements should not be subsidized by sponsors for personal guests of attendees or faculty, including spouses or family members. 33. Faculty at CME/CPD events may accept reasonable honoraria and reimbursement for travel, lodging and meal expenses. All attendees at an event cannot be designated faculty. Faculty indicates a presenter who prepares and presents a substantive educational session in an area where they are a recognized expert or authority. Electronic Continuing Professional Development (eCPD) 34. The same general principles which apply to "live, in person" CPD events, as outlined above, also apply to eCPD (or any other written curriculum-based CPD) modules. The term "eCPD" generally refers to accredited on-line or internet-based CPD content or modules. However, the following principles can also apply to any type of written curriculum based CPD. 35. Authors of eCPD modules are ultimately responsible for ensuring the content and validity of these modules and should ensure that they are both designed and delivered at arms'-length of any industry sponsors. 36. Authors of eCPD modules should be physicians with a special expertise in the relevant clinical area and must declare any relationships with the sponsors of the module or any competing companies. 37. There should be no direct links to an industry or product website on any web page which contains eCPD material. 38. Information related to any activity carried out by the eCPD participant should only be collected, used, displayed or disseminated with the express informed consent of that participant. 39. The methodologies of studies cited in the eCPD module should be available to participants to allow them to evaluate the quality of the evidence discussed. Simply presenting abstracts that preclude the participant from evaluating the quality of evidence should be avoided. When the methods of cited studies are not available in the abstracts, they should be described in the body of the eCPD module. 40. If the content of eCPD modules is changed, re-accreditation is required. Advisory/Consultation Boards 41. Physicians may be approached by industry representatives and asked to become members of advisory or consultation boards, or to serve as individual advisors or consultants. Physicians should be mindful of the potential for this relationship to influence their clinical decision making. While there is a legitimate role for physicians to play in these capacities, the following principles should be observed: A. The exact deliverables of the arrangement should be clearly set out and put in writing in the form of a contractual agreement. The purpose of the arrangement should be exclusively for the physician to impart specialized medical knowledge that could not otherwise be acquired by the hiring company, and should not include any promotional or educational activities on the part of the company itself. B. Remuneration of the physician should be reasonable and take into account the extent and complexity of the physician's involvement. C. Whenever possible, meetings should be held in the geographic locale of the physician or as part of a meeting which he/she would normally attend. When these arrangements are not feasible, basic travel and accommodation expenses may be reimbursed to the physician advisor or consultant. Meetings should not be held outside of Canada, with the exception of international boards. Clinical Evaluation Packages (Samples) 42. The distribution of samples should not involve any form of material gain for the physician or for the practice with which he or she is associated. 43. Physicians who accept samples or other health care products are responsible for recording the type and amount of medication or product dispensed. They are also responsible for ensuring their age-related quality and security and their proper disposal. Gifts 44. Practising physicians should not accept personal gifts of any significant monetary or other value from industry. Physicians should be aware that acceptance of gifts of any value has been shown to have the potential to influence clinical decision making. Other Considerations 45. These guidelines apply to relationships between physicians and all commercial organizations, including but not limited to manufacturers of medical devices, nutritional products and health care products as well as service suppliers. 46. Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party, and then only on a cost-recovery basis. 47. Physicians should not invest in industries or related undertakings if this might inappropriately affect the manner of their practice or their prescribing behaviour. 48. Practising physicians affiliated with pharmaceutical companies should not allow their affiliation to influence their medical practice inappropriately. 49. Practising physicians should not accept a fee or equivalent consideration from pharmaceutical manufacturers or distributors in exchange for seeing them in a promotional or similar capacity. 50. Practising physicians may accept patient teaching aids appropriate to their area of practice provided these aids carry at most the logo of the donor company and do not refer to specific therapeutic agents, services or other products. Medical Students and Residents 51. The principles in these guidelines apply to physicians-in training as well as to practising physicians. 52. Medical curricula should deal explicitly with the guidelines by including educational sessions on conflict of interest and physician-industry interactions.
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Achieving Patient-Centred Collaborative Care

https://policybase.cma.ca/en/permalink/policy9060
Last Reviewed
2019-03-03
Date
2007-12-01
Topics
Health systems, system funding and performance
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2007-12-01
Topics
Health systems, system funding and performance
Text
ACHIEVING PATIENT-CENTRED COLLABORATIVE CARE (2008) The Canadian Medical Association (CMA) recognizes that collaborative care is a desired and necessary part of health care delivery in Canada and an important element of quality, patient-centred care. The CMA considers patient-centred care to be the cornerstone of good medical practice. This is reflected in the first principle of the CMA Code of Ethics, which states that physicians have a fundamental responsibility to "Consider first the well-being of the patient." As patient advocates, physicians strive to ensure that their patients receive the best possible care. The CMA supports greater collaboration among providers in the interest of better patient care. In the context of clinical practice, the CMA defines collaborative care as follows: "Collaborative care entails physicians and other providers using complementary skills, knowledge and competencies and working together to provide care to a common group of patients based on trust, respect and an understanding of each others' skills and knowledge. This involves a mutually agreed upon division of roles and responsibilities that may vary according to the nature of the practice personalities and skill sets of the individuals. The relationship must be beneficial to the patient, and acceptable to the physician and other providers. If designed appropriately, collaborative care models have the potential to: * improve access to care; * enhance the quality and safety of care; * enhance the coordination and efficiency of care; and * enhance provider morale and reduce burnout within health professions. To realize this full potential, the profession acknowledges and accepts that it has a central role to play in the evolution of a team-based approach to care. These policy principles have been prepared by the Canadian Medical Association in order to ensure that the evolution of collaborative care in Canada is built around the needs of individual patients and groups of patients. This policy is founded on the CMA's document, Putting Patients' First: Patient-Centred Collaborative Care - A Discussion Paper. Principles for Collaborative Care The medical profession supports collaborative care, both in the hospital and in the community, as one of the essential elements of health care delivery in Canada. In the interests of enhancing the evolution of patient-centred collaborative care, the CMA proposes the following "critical success factors" and principles to address meaningfully the issues and barriers identified by physicians and bring clarity to the discussions. 1. PATIENT-CENTRED CARE First and foremost, medical care delivered by physicians and health care delivered by others should be aligned around the values and needs of patients. Collaborative care teams should foster and support patients, and their families, as active participants in their health care decision-making. New models should have the potential to empower patients to enhance their role in prevention and self-care. Models of collaborative care must be designed to meet the needs of patients. Collaborative models of practice must reduce fragmentation and enhance the quality and safety of care provided to patients. It is the patient who ultimately must make informed choices about the care he or she will receive. 2. RECOGNITION OF THE PATIENT-PHYSICIAN RELATIONSHIP The mutual respect and trust derived from the patient-physician relationship is the cornerstone of medical care. This trust is founded on the ethical principles that guide the medical profession as defined in the CMA Code of Ethics. The impact of collaborative models of practice on this relationship, and hence the patient's satisfaction and experience with their care, is unknown. Models of collaborative care must support the patient-physician relationship. Entry into and exit from a formal collaborative care arrangement must be voluntary for both the patient and the physician. A common Code of Ethics should guide the practice of collaborative care teams. Every resident of Canada has the right to access a personal family physician. † 3. PHYSICIAN AS THE CLINICAL LEADER Effective teams require effective leadership. A defined clinical leader is required to ensure proper functioning of the team and to facilitate decision-making, especially in complex or emergent situations. In collaborative care the clinical leader is responsible for maximizing the expertise and input of the entire team in order to provide the patient with comprehensive and definitive care. It is important to differentiate "clinical leadership" from "team coordination." The CMA defines a clinical leader as: "The individual who, based on his or her training, competencies and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient. The clinical leader is ultimately accountable to the patient for making definitive clinical decisions." Whereas, the team coordinator is defined as: "The individual, who, based on his or her training, competencies and experience, is best able to coordinate the services provided by the team so that they are integrated to provide the best care for the patient." The concept of "most responsible physician" has been and continues to be used to identify the individual who is ultimately responsible for the care of the patient. The "most responsible physician" is responsible for collecting, synthesizing and integrating the expert opinion of physician and non physician team members to determine the clinical management of the patient. Similarly, the presence of a defined clinical leader in a collaborative care setting creates clarity for patients, their families and the health care team by making lines of communication and responsibility clear, ultimately improving the quality and safety of care. In the CMA's opinion, the physician is best equipped to provide clinical leadership. This does not necessarily imply that a physician must be the team coordinator. Many teams will exist in which the physician will have a supporting role, including those focused on population health and patient education. We believe the most effective teams are ones in which the leadership roles have been clearly defined and earned. Some physicians may be prepared to play both roles; however, other members of the team may be best suited to serve as team coordinator. Currently, patients rely on, and expect, physicians to be clinical leaders in the assessment and delivery of the medical care they receive. In a collaborative care environment this expectation of physician leadership will not change. Team members will have specific knowledge and expertise in their respective disciplines. Physicians, by virtue of their broad and diverse knowledge, training and experience, have a unique appreciation of the full spectrum of health and health care delivery in their field of practice and are therefore best qualified to evaluate and synthesize diverse professional perspectives to ensure optimal patient care. The physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume the role of clinical leader in collaborative care teams. There may be some situations in which the physician may delegate clinical leadership to another health care professional. Other health care professionals may be best suited to act as team coordinator. 4. MUTUAL RESPECT AND TRUST Trust between individuals and provider groups evolves as knowledge and understanding of competencies, skills and scopes of practice are gained. Trust is also essential to ensuring that the team functions efficiently and maximizes the contributions of all members. Funders and providers should recognize the importance of team building in contributing to team effectiveness. Collaborative care funding models should support a more formalized and integrated approach to both change management and team building. As relationships are strengthened within the team, so too are trust and respect. Physicians and all team members have an opportunity to be positive role models to motivate and inspire their colleagues. All team members ought to make a commitment to respect and trust each other with the knowledge that it will lead to enhanced care for patients and a more productive work environment for all. To serve the health care needs of patients, there must be a collaborative and respectful interaction among health care professionals, with recognition and understanding of the contributions of each provider to the team. In order to build trust and respect within the team it is essential that members understand and respect the professional responsibility, knowledge and skills that come with their scope of practice within the context of the team. 5. CLEAR COMMUNICATION In collaborative care environments, it is essential that all members of the team communicate effectively to provide safe and optimal care. Effective communication is essential to ensure safe and coordinated care as the size of the team expands to meet patient needs. It is the responsibility of all team members to ensure that the patient is receiving timely, clear and consistent messaging. Physicians can take a leadership role in modeling effective communications throughout the team. In particular, there is an opportunity to enhance the consultation and referral process, in order to provide clear and concise instructions to colleagues and optimize care. Sufficient resources, including dedicated time and support, must be available to the team to maximize these communication requirements. Effective communication within collaborative care teams is critical for the provision of high quality patient care. Planning, funding and training for collaborative care teams must include measures to support communication within these teams. Mechanisms must be in place within a collaborative team to ensure that both the patients, and their caregiver(s) where appropriate, receive timely information from the most appropriate provider. Effective and efficient communications within the collaborative care team, both with the patient and among team members, should be supported by clear documentation that identifies the author. A common, accessible patient record in collaborative care settings is desirable to ensure appropriate communication between physicians and other health care professionals, to prevent duplication, coordinate care, share information and protect the safety of patients. An integrated electronic health record is highly desirable to facilitate communication and sharing among team members. 6. CLARIFICATION OF ROLES AND SCOPES OF PRACTICE In order for the team to function safely and efficiently, it is critically important that the scope of practice, roles and responsibilities of each health care professional on the team be clearly defined and understood. In turn, the patient, as a team member, should also have a clear understanding of the roles and scopes of practice of their providers. Collaborative care must first and foremost serve the needs of patients, with the goal of enhancing patient care; collaborative care is not contingent upon altering the scope of practice of any provider group and must not be used as a means to expand the scope of practice and/or independence of a health professional group. Changes in the scope of practice of all provider groups must be done with oversight from the appropriate regulatory authority. Where non-physicians have been provided with an opportunity to undertake activities related to patient care typically unique to the practice of medicine (e.g., ordering tests), they must not do so independently but undertake these activities within the context of the team and in a manner acceptable to the clinical leader. The role and scope of practice of each member of the collaborative care team should be clearly understood and delineated in job descriptions and employment contracts. A formal process for conflict resolution should be in place so that issues can be dealt with in a timely and appropriate manner. 7. CLARIFICATION OF ACCOUNTABILITY AND RESPONSIBILITY In the context of providing optimal care, providers must be accountable and responsible for the outcome of their individual practice, while sharing responsibility for the proper functioning of the collaborative care team. This individual responsibility is required so that regardless of the number and diversity of providers involved in the team, patients can be assured that their well-being is protected and that the team is working toward a common goal. In collaborative care teams, a physician should be identified as the person most responsible for the clinical care of individual patients, and as such must be accountable for the care rendered to patients. This is consistent with the commitment made by the physician in the doctor-patient relationship, mirrors the clinical training of the physician relative to other providers, is reflective of the current state of tort law as it applies to medical practice, and is compatible with the structure of care delivery in hospitals and in the community. Clearly, this type of arrangement does not eliminate the necessity for all providers to be accountable for the care that they provide. It is essential that all providers be responsible and accountable for the care that they provide and for the well-being of the patient. As clinical leader, the physician should be responsible for the clinical oversight of an individual patient's care. 8. LIABILITY PROTECTION FOR ALL MEMBERS OF THE TEAM As discussed earlier in this paper, the resolution of the multiplicity of liability issues that result from care delivered by teams requires clearly defined roles and responsibilities in the team setting and the absolute requirement for appropriate and sufficient liability coverage for each health professional. The August 2006 statement of the Canadian Medical Protective Association, Collaborative Care: A medical liability perspective, identifies issues of concern to physicians and proposes solutions to reduce those risks. All members of a collaborative care team must have adequate professional liability protection and/or insurance coverage to accommodate their scope of practice and their respective roles and responsibilities within the collaborative care team. Physicians, in their role as clinical leaders of collaborative care teams, must be satisfied with the ongoing existence of appropriate liability protection as a condition of employment of, or affiliation with, other members on collaborative care teams. Formalized procedures should be established to ensure evidence of this liability protection. 9. SUFFICIENT HUMAN RESOURCES AND INFRASTRUCTURE Collaborative models of health care delivery hold the promise of enhancing access to care for patients at a time of serious health human resource shortages. However, effective patient-centred collaborative care depends on an adequate supply of physicians, nurses and other providers. Governments and decision-makers must continue to enhance their efforts to increase the number of physicians and nurses available to provide health care services. Collaborative care should not be seen as an opportunity for governments to substitute one care provider for another simply because one is more plentiful or less costly than the other. In addition, governments must understand that co-location of individuals in a team is not a requirement for all collaborative care. Where team co-location does not exist, appropriate resources must be dedicated to ensure communication can be timely, effective and appropriate between providers. Governments, at all levels, must address the serious shortage of physicians to ensure quality patient care for Canadians. The effective functioning of a collaborative care team depends on the contribution of a physician. Governments must enhance access to medical care by increasing the number of physicians and providers, and not by encouraging or empowering physician substitution. 10. SUFFICIENT FUNDING & PAYMENT ARRANGEMENTS Funding must be present to support all aspects of the development of collaborative care teams. At the practice level, remuneration methods for physicians, irrespective of their specialty, must be available to facilitate collaborative care arrangements and environments in which physicians practice. All care delivery models, including collaborative care teams, must have access to adequate and appropriate resources. This includes, but should not be limited to, funding for health human resources, administration/management infrastructure, liability protection, clinical and team/administrative training, team building, and information technology. Remuneration models should be established in a manner that encourages providers to participate effectively in the delivery of care and team effectiveness. Reimbursement models must be configured to remunerate the communicator, coordinator, manager, and other roles and responsibilities of providers necessary for the success of collaborative care practice. The ability of a physician to work in a collaborative care team must not be based on the physician's choice of remuneration. Similarly, patients should not be denied access to the benefits of collaborative practice as a result of the physician's choice of payment model. Collaborative care relationships between physicians and other health care providers should continue to be encouraged and enhanced through appropriate resource allocation at all levels of the health care system. Physicians should be appropriately compensated for all aspects of their clinical care and leadership activities in collaborative care teams. Physicians should not be expected to incur the cost of adopting and maintaining health information technology capabilities that facilitate their ability to participate in collaborative practice teams. Governments must fund and support in an ongoing manner, both financially and technically, the development and integration of electronic health records. 11. SUPPORTIVE EDUCATION SYSTEM Canada is renowned for a quality medical education system and for the early efforts to enhance interprofessional training. The success of collaborative care requires a commitment towards interprofessional education and is contingent upon the positive attitudes and support of educators. To facilitate a sustainable shift toward collaborative practice, these efforts must be continued and enhanced in a meaningful way. However, governments and educators must ensure that the availability and quality of medical education is not compromised for medical trainees. Interprofessional education, at the undergraduate, postgraduate and continuing education levels, is necessary to facilitate a greater understanding of the potential roles, responsibilities and capabilities of health professions, with the overall goal of building better health care teams founded on mutual respect and trust. Governments must understand the importance of interprofessional education and fund educational institutions appropriately to meet these new training needs. Educational opportunities must exist at all levels of training to acquire both clinical knowledge and team effectiveness/leadership training. Interprofessional education opportunities must not come at the expense of core medical training. High quality medical education must be available to all medical trainees as a first priority. 12. RESEARCH AND EVALUATION More research and evaluations are necessary to demonstrate the benefits of collaborative care, to foster greater adoption by providers and to attract the necessary investment by governments. Quality management systems must be built into the team to ensure efficiencies can be recorded. Measures of the quality of care, cost effectiveness and patient and provider satisfaction should be evaluated. Research into the effectiveness of collaborative care models on health outcomes, patient and provider satisfaction and health care cost effectiveness should be ongoing, transparent and supported by governments. Quality assessment measures must be incorporated into the ongoing work of collaborative care teams. † Where the term "family physician" is used, it is also meant to include general practitioners.
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CMA Response: Health Canada's Medical Marijuana Regulatory Proposal

https://policybase.cma.ca/en/permalink/policy10702
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. “Ross Rebagliati to Open medical marijuana franchise
  1 document  
Policy Type
Parliamentary submission
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association welcomes the opportunity to comment on proposed changes to Health Canada's Marihuana for Medical Purposes Regulations, published in the Canada Gazette, Part I on December 15, 2012. CMA provided comments on the proposed changes when Health Canada first announced them in June 2011. Our position on these changes, and indeed on the entire Medical Marihuana Access Program (MMAP), has been consistent since the program was initiated. We remain deeply concerned that, though the program has made a physician's authorization the key to a patient's access to medical marijuana, physicians and other health professionals have little to no evidence-based information about its use as medical therapy. As our President, Dr. Anna Reid, noted in December, the regulatory proposals are "equivalent to asking doctors to prescribe while blindfolded." Health Canada gives two reasons for its regulatory proposal: first, to address concerns about the safety of home grow-ops; and secondly, to reduce the cost of administering a program that has proven more popular than anticipated. Neither of these reasons is related to improving patient care or advancing our clinical knowledge of marijuana as a medical treatment. CMA understands that many Canadians suffer constant pain from chronic or terminal illnesses and are searching for anything that will provide relief. We know that some patients find that use of marijuana relieves their symptoms and that some health professionals also believe it has therapeutic value. However, we are concerned that these claims remain inadequately supported by scientific research. Controlled studies of medical marijuana have been published recently and some have shown benefits. However, these studies are few in number, of short duration and with small samples, and knowledgeable clinicians say that more research is required. In addition, some say that marijuana has become more potent since it became a popular recreational drug in the 1960s, though others disagree,1 and growers say they can develop strains tailored to the needs of individual medical users.2 Though these claims are part of the popular understanding of medical marijuana, there is no scientifically valid evidence that supports them. What Physicians Have Told Us In May 2012, CMA surveyed members of its "e-panel" of physicians to obtain more information about their attitudes and needs regarding medical marijuana. The survey received just over 600 responses out of more than 2,200, for a 27 per cent response rate. Among the findings: * About 70 per cent of respondents had been asked by patients to approve medical marijuana, though only four per cent said they were asked to do so "often." Of those who were asked, one-third reported that they "never" supported such requests, while 18 per cent "usually" did so. * 64 per cent of respondents were concerned that patients who request medical marijuana may actually be using it for recreational purposes; * A large majority of respondents said they would find more information on the appropriate use of marijuana for medicinal purposes, and on its therapeutic benefits and risks, useful or very useful. * About two-thirds agreed or strongly agreed that they would feel more comfortable if: o Physicians wishing to use medical marijuana in their practices were required to undergo special training and licensing; and, o Health Canada offered them protection from liability. * In open-ended questions, some respondents expressed favourable views on marijuana's medical benefits. However, a larger number expressed concern over its harmful effects, such as: psychotic symptoms, especially in younger people; potential for addiction and dependency; and the risks to lung health from smoking it or any other substance. Marijuana is Not Like Other Therapeutic Products Theoretically, marijuana, when used for medicinal purposes, is regulated under the Food and Drugs Act. However, because of its unique legal position, Health Canada has exempted it from the applications of the Act and its regulations, and it has not undergone the scrutiny of benefits and risks required of other therapeutic products approved for use in Canada, be they prescription-only or over-the-counter. According to the Food and Drugs Act (FDA), all drugs requiring a health professional's authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials, which remain the best currently available means of validating knowledge. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs in real-world use. Though the CMA has been critical of some aspects of this system,3 we acknowledge that it has added to our body of knowledge on drug safety risks. If marijuana were not an illegal product, it might have been assessed through some form of pre-approval and post-approval surveillance. By exempting marijuana from the FDA's pre-approval and post-approval requirements, Health Canada has lost an opportunity to improve our knowledge of the drug's therapeutic uses. The Views of Canadians A recent online survey conducted by Ipsos-Reid on behalf of the CMA provides insight into the views of Canadians on Health Canada's regulatory proposal.4 The survey found: * 92 per cent of Canadians think it is very or somewhat important that Health Canada not remove itself from its oversight role until guidelines are put in place for physicians; * 90 per cent believe that research on the effectiveness, safety and risks of medical marijuana is needed before Health Canada removes itself from the authorization process; * 85 per cent of Canadians believe medical marijuana should be subject to the same rigorous testing and approval standards as other medicines; * 79 per cent agree that Health Canada has a responsibility to maintain its role in the authorization process.; The Role of the Physician The CMA cannot with certainty predict the consequences of these regulatory changes for the practising physician (and, if the regulations are approved, for the nurse practitioner as well). However, we have several causes for concern: * The gatekeeper role of health professionals: The most significant change, from our point of view, is that Health Canada is removing itself from the approval process, making it a transaction between the patient, the practitioner and the licensed producer. In addition, Section 125 of the regulatory proposal would reduce the content of the authorization form, from its current two-page format to a brief document requiring little more information than is required for a standard medical prescription. We are concerned that these changes will put an even greater onus on physicians than do the current regulations. The CMA agrees with the Federation of Medical Regulatory Authorities that the lack of evidence to support the use of marijuana for medicinal purposes signifies that it is not a medical intervention. In our opinion, putting physicians in the role of gatekeeper for access to marijuana is inappropriate and may be an abdication of responsibility on Health Canada's part.5 Such a move could increase physicians' liability risk and put them at odds with their medical regulatory authorities, which have no choice but to continue to advise physicians to exercise extreme caution. The CMA believes, as does the Canadian Medical Protective Association, that a drug's approval under the Food and Drugs Act does not impose a legal obligation on physicians or nurse practitioners to authorize its use if, in their judgment, it is clinically inappropriate. The Ontario Court of Appeal reached a similar decision recently in the case of R. v. Mernagh. * Protection of Physician Privacy. Under the proposed regulations, health information and physician data - such as the patient's name and date of birth, or the provider's licence number - will be collected by licensed producers who may not be subject to the same regulatory and privacy constraints as the health care sector. The draft regulations also indicate that the licensed producer is expected to confirm that the data on the "medical document" is correct and complete - in other words, health providers who authorize medical marijuana use will receive correspondence from the producer. We are very concerned about the risks this would pose to the privacy of patient and health care provider information. We believe Health Canada should conduct a privacy impact assessment of its proposed regulations or, if it has done so, to share the results. * Physicians as Dispensers. Section 124 of the proposed regulations would allow authorized health care practitioners to "sell, provide or administer dried marijuana." This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that "Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party."6 * Other possible consequences. We are also concerned about other potential consequences of the regulatory changes. Will more people go to health professionals requesting an authorization, on the assumption that the new regulations will make it easier to get? Will entrepreneurs seize the opportunity to establish "dispensaries" whose intended clientele are not those in legitimate medical need, as recent news stories have suggested?7 Will medical marijuana advocates put increased pressure on physicians to authorize its use? Meeting the Information Needs of Physicians In one respect, Health Canada has listened to physicians' concerns regarding the lack of evidence about medical marijuana, and acknowledged the need to remedy this problem. Though it is not addressed in the draft regulations, Health Canada has established an Expert Advisory Committee (EAC) to help provide comprehensive information to health professionals. The CMA has attended meetings of this committee in an observer capacity, suggested the names of practising physicians to serve as members, and made a presentation to the committee at its meeting in November 2012. If the EAC follows the CMA's suggestions, it will consider actively supporting the following activities: * Funding of scientific research on the clinical risks and benefits of marijuana; * Knowledge translation activities to convert this research into accessible, user-friendly tools for education and practice; * Development of best practice guidelines in the therapeutic use of marijuana. Though this guideline would of necessity be based on "C" level evidence, it would be an improvement on what now exists; and * Support for a compulsory training and licensing program for physicians wanting to authorize marijuana for medicinal purposes. The CMA believes that the EAC should be given the mandate and resources to undertake these activities. Conclusion Health Canada's stated mission is to help the people of Canada maintain and improve their health. The CMA believes that if Health Canada wants its Medical Marihuana Access Program to serve this mission, it should not withdraw from administering the program, leaving it to health professionals working within a large knowledge gap. Rather, it should support solid research into the use of marijuana as medication and make a commitment to share this knowledge with the health professional community and to support best clinical practices. 1 Bonsor K: "How marijuana works". Accessed at http://science.howstuffworks.com/marijuana5.htm 2 http://medicalmarijuana.ca/learning-center/marijuana-strains 3 CMA Submission to the House of Commons Standing Committee on Health: Post-Market Surveillance of Prescription Drugs (February 28, 2008). Accessed at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf 4 Online survey of 1,000 Canadians the week of Feb. 24, 2013 conducted by Ipsos-Reid. Summary report of the poll can be accessed at www.cma.ca/advocacy/cma-media-centre. 5 Letter to Health Canada from Yves Robert, MD, President of the Federation of Medical Regulatory Authorities of Canada, November 4, 2011. 6 CMA. 2004. Guidelines for Physicians in Interactions with Industry. Guideline can be accessed online: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. "Ross Rebagliati to Open medical marijuana franchise." Vancouver Sun. January 23, 2013. Accessed at http://www.vancouversun.com/health/Ross+Rebagliati+open+medical+marijuana+franchise/7860946/story.html
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