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Health Care Coverage for Migrants: An Open Letter to the Canadian Federal Government

https://policybase.cma.ca/en/permalink/policy13940
Date
2018-12-15
Topics
Population health/ health equity/ public health
Health systems, system funding and performance
Ethics and medical professionalism
  1 document  
Policy Type
Policy endorsement
Date
2018-12-15
Topics
Population health/ health equity/ public health
Health systems, system funding and performance
Ethics and medical professionalism
Text
Dear Prime Minister Trudeau & Ministers Taylor and Hussen, We are writing to you today as members of the health community to urge your action on a crucial matter pertaining to health and human rights. You will no doubt be aware that the United Nations Human Rights Committee (UNHRC) recently issued a landmark decision condemning Canada for denying access to essential health care on the basis of immigration status based on the case of Nell Toussaint. Nell is a 49-year-old woman from Grenada who has been living in Canada since 1999, and who suffered significant negative health consequences as a result of being denied access to essential health care services. The UNHRC’s decision condemns Canada’s existing discriminatory policies, and finds Canada to be in violation of both the right to life, as well as the right to equality and freedom from discrimination. Based on its review of the International Covenant on Civil and Political Rights, the UNHRC has declared that Canada must provide Nell with adequate compensation for the significant harm she suffered. As well, they have called on Canada to report on its review of national legislation within a 180-day period, in order “to ensure that irregular migrants have access to essential health care to prevent a reasonably foreseeable risk that can result in loss of life”. The United Nations Special Rapporteur has pushed for the same, calling on the government “to protect health-related rights to life, security of the person, and equality of individuals and groups in situations of vulnerability”. Nell is one of an estimated half million people in Ontario alone who are denied access to health coverage and care on the basis of their immigration status, putting their health at risk. As members of Canada’s health community, we are appalled by the details of this case as well as its broad implications, and call on the government to: 1. Comply with the UNHRC’s order to review existing laws and policies regarding health care coverage for irregular migrants. 2. Ensure appropriate resource allocation, so that all people in Canada are provided universal and equitable access to health care services, regardless of immigration status. 3. Provide Nell Toussaint with adequate compensation for the significant harm she has suffered as a result of not receiving essential health care services. For more information on this issue, please see our backgrounder here: https://goo.gl/V9vPyo. Sincerely, Arnav Agarwal, MD, Internal Medicine Resident, University of Toronto, Toronto ON Nisha Kansal, BHSc, MD Candidate, McMaster University, Hamilton ON Michaela Beder, MD, Psychiatrist, Toronto ON Ritika Goel, MD, Family Physician, Toronto ON This open letter is signed by the following organizations and individuals: Bathurst United Church TOPS 1. Arnav Agarwal, MD, Internal Medicine Resident, University of Toronto, Toronto ON 2. Nisha Kansal, BHSc, MD Candidate, McMaster University, Hamilton ON 3. Michaela Beder, MD FRCPC, Psychiatrist, Toronto ON 4. Ritika Goel, MD, Family Physician, Toronto ON 5. Gordon Guyatt, MD FRCPC, Internal Medicine Specialist, McMaster University, Hamilton ON 6. Melanie Spence, RN, Nursing, South Riverdale Community Health Centre, Toronto ON 7. Yipeng Ge, BHSc, Medical Student, University of Ottawa, Ottawa ON 8. Stephen Hwang, MD, Professor of Medicine, University of Toronto, Toronto ON 9. Gigi Osler, BScMed, MD, FRCSC, Otolaryngology-Head and Neck Surgery, Canadian Medical Association, Ottawa ON 10. Anjum Sultana, MPH, Public Policy Professional, Toronto ON 11. Danyaal Raza, MD, MPH, CCFP, Family Medicine, Toronto ON 12. P.J. Devereaux, MD, PhD, Cardiologist, McMaster University, Brantford ON 13. Mathura Karunanithy, MA, Public Policy Researcher, Toronto ON 14. Philip Berger, MD, Family Physician, Toronto ON 15. Nanky Rai, MD MPH, Primary Care Physician, Toronto ON 16. Michaela Hynie, Prof, Researcher, York University, Toronto ON 17. Meb Rashid, MD CCFP FCFP, Family Physician, Toronto ON 18. Sally Lin, MPH, Public Health, Victoria BC 19. Jonathon Herriot, BSc, MD, CCFP, Family Physician, Toronto ON 20. Carolina Jimenez, RN, MPH, Nurse, Toronto ON 21. Rushil Chaudhary, BHSc, Medical Student, Toronto ON 22. Nisha Toomey, MA (Ed), PhD Student, University of Toronto, Toronto ON 23. Matei Stoian, BSc, BA, Medical Student, McMaster University, Hamilton ON 24. Ruth Chiu, MD, Family Medicine Resident, Kingston ON 25. Priya Gupta, Medical Student, Hamilton ON 26. The Neighbourhood Organization (TNO), Toronto, ON 27. Mohammad Asadi-Lari, MD/PhD Candidate, University of Toronto, Toronto ON 28. Kathleen Hughes, MD Candidate, McMaster University, Hamilton ON 29. Nancy Vu, MPA, Medical Student, McMaster University, Hamilton ON 30. Ananthavalli Kumarappah, MD, Family Medicine Resident, University of Calgary, Calgary AB 31. Renee Sharma, MSc, Medical Student, University of Toronto, Toronto ON 32. Daniel Voloshin, Medical Student , McMaster Medical School , Hamilton ON 33. Sureka Pavalagantharajah, Medical Student, McMaster University, Hamilton ON 34. Alice Cavanagh , MD/PhD Student, McMaster University, Hamilton ON 35. Krish Bilimoria, MD(c), Medical Student, University of Toronto, North York ON 36. Bilal Bagha, HBSc, Medical Student, St. Catharines ON 37. Rana Kamhawy, Medical Student, Hamilton ON 38. Annie Yu, Medical Student, Toronto ON 39. Samantha Rossi, MA, Medical Student, University of Toronto, Toronto ON 40. Carlos Chan, MD Candidate, Medical Student, McMaster University, St Catharines ON 41. Jacqueline Vincent, MA, Medical Student, McMaster, Kitchener ON 42. Eliza Pope, BHSc, Medical Student, University of Toronto, Toronto ON 43. Cara Elliott, MD, Medical Student, Toronto ON 44. Antu Hossain, MPH, Public Health Professional, East York ON 45. Lyubov Lytvyn, MSc, PhD Student in Health Research, McMaster University, Burlington ON 46. Michelle Cohen, MD, CCFP, Family Physician, Brighton ON 47. Serena Arora, Medical Student, Hamilton ON 48. Saadia Sediqzadah, MD, Psychiatrist, Toronto ON 49. Maxwell Tran, Medical Student, University of Toronto, Toronto ON 50. Asia van Buuren, BSc, Medical Student, Toronto ON 51. Darby Little, Medical Student, University of Toronto, Toronto ON 52. Ximena Avila Monroy, MD MSc, Psychiatry Resident, Sherbrooke QC 53. Abeer Majeed, MD, CCFP, Family Physician, Toronto ON 54. Oluwatobi Olaiya, RN, Medical Student, Hamilton ON 55. Ashley Warnock, MSc, HBSc, HBA, Medical Student, McMaster University, Hamilton ON 56. Nikhita Singhal, Medical Student, Hamilton ON 57. Nikki Shah, MD Candidate, Medical Student, Hamilton ON 58. Karishma Ramjee, MD Family Medicine Resident , Scarborough ON 59. Yan Zhang, MSc, Global Health Professional, Toronto ON 60. Megan Saunders, MD, Family Physician, Toronto ON 61. Pooja Gandhi, MSc, Speech Pathologist, Mississauga ON 62. Julianna Deutscher, MD, Resident, Toronto ON 63. Diana Da Silva, MSW, Social Worker, Toronto ON Health Care Coverage for Migrants: An Open Letter to the Canadian Federal Government Sign here - https://goo.gl/forms/wAXTJE6YiqUFSo8x1 The Right Honourable Justin Trudeau, Prime Minister of Canada The Honourable Ginette P. Taylor, Minister of Health The Honourable Ahmed D. Hussen, Minister of Immigration, Refugees and Citizenship CC: Mr. Dainius Puras, United Nations Special Rapporteur on the right of everyone to the enjoyment of the highest attainable standard of health Dear Prime Minister Trudeau & Ministers Taylor and Hussen, We are writing to you today as members of the health community to urge your action on a crucial matter pertaining to health and human rights. You will no doubt be aware that the United Nations Human Rights Committee (UNHRC) recently issued a landmark decision condemning Canada for denying access to essential health care on the basis of immigration status based on the case of Nell Toussaint. Nell is a 49-year-old woman from Grenada who has been living in Canada since 1999, and who suffered significant negative health consequences as a result of being denied access to essential health care services. The UNHRC’s decision condemns Canada’s existing discriminatory policies, and finds Canada to be in violation of both the right to life, as well as the right to equality and freedom from discrimination. Based on its review of the International Covenant on Civil and Political Rights, the UNHRC has declared that Canada must provide Nell with adequate compensation for the significant harm she suffered. As well, they have called on Canada to report on its review of national legislation within a 180-day period, in order “to ensure that irregular migrants have access to essential health care to prevent a reasonably foreseeable risk that can result in loss of life”. The United Nations Special Rapporteur has pushed for the same, calling on the government “to protect health-related rights to life, security of the person, and equality of individuals and groups in situations of vulnerability”. Nell is one of an estimated half million people in Ontario alone who are denied access to health coverage and care on the basis of their immigration status, putting their health at risk. As members of Canada’s health community, we are appalled by the details of this case as well as its broad implications, and call on the government to: 1. Comply with the UNHRC’s order to review existing laws and policies regarding health care coverage for irregular migrants. 2. Ensure appropriate resource allocation, so that all people in Canada are provided universal and equitable access to health care services, regardless of immigration status. 3. Provide Nell Toussaint with adequate compensation for the significant harm she has suffered as a result of not receiving essential health care services. For more information on this issue, please see our backgrounder here: https://goo.gl/V9vPyo. Sincerely, Arnav Agarwal, MD, Internal Medicine Resident, University of Toronto, Toronto ON Nisha Kansal, BHSc, MD Candidate, McMaster University, Hamilton ON Michaela Beder, MD, Psychiatrist, Toronto ON Ritika Goel, MD, Family Physician, Toronto ON
Documents
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CMA Code of Ethics and Professionalism

https://policybase.cma.ca/en/permalink/policy13937
Date
2018-12-08
Topics
Population health/ health equity/ public health
  3 documents  
Policy Type
Policy document
Date
2018-12-08
Replaces
Code of ethics of the Canadian Medical Association (Update 2004)
Topics
Population health/ health equity/ public health
Text
CMA CODE OF ETHICS AND PROFESSIONALISM Compassion A compassionate physician recognizes suffering and vulnerability, seeks to understand the unique circumstances of each patient and to alleviate the patient’s suffering, and accompanies the suffering and vulnerable patient. Honesty An honest physician is forthright, respects the truth, and does their best to seek, preserve, and communicate that truth sensitively and respectfully. Humility A humble physician acknowledges and is cautious not to overstep the limits of their knowledge and skills or the limits of medicine, seeks advice and support from colleagues in challenging circumstances, and recognizes the patient’s knowledge of their own circumstances. Integrity A physician who acts with integrity demonstrates consistency in their intentions and actions and acts in a truthful manner in accordance with professional expectations, even in the face of adversity. Prudence A prudent physician uses clinical and moral reasoning and judgement, considers all relevant knowledge and circumstances, and makes decisions carefully, in good conscience, and with due regard for principles of exemplary medical care. The CMA Code of Ethics and Professionalism articulates the ethical and professional commitments and responsibilities of the medical profession. The Code provides standards of ethical practice to guide physicians in fulfilling their obligation to provide the highest standard of care and to foster patient and public trust in physicians and the profession. The Code is founded on and affirms the core values and commitments of the profession and outlines responsibilities related to contemporary medical practice. In this Code, ethical practice is understood as a process of active inquiry, reflection, and decision-making concerning what a physician’s actions should be and the reasons for these actions. The Code informs ethical decision-making, especially in situations where existing guidelines are insufficient or where values and principles are in tension. The Code is not exhaustive; it is intended to provide standards of ethical practice that can be interpreted and applied in particular situations. The Code and other CMA policies constitute guidelines that provide a common ethical framework for physicians in Canada. In this Code, medical ethics concerns the virtues, values, and principles that should guide the medical profession, while professionalism is the embodiment or enactment of responsibilities arising from those norms through standards, competencies, and behaviours. Together, the virtues and commitments outlined in the Code are fundamental to the ethical practice of medicine. Physicians should aspire to uphold the virtues and commitments in the Code, and they are expected to enact the professional responsibilities outlined in it. Physicians should be aware of the legal and regulatory requirements that govern medical practice in their jurisdictions. Trust is the cornerstone of the patient–physician relationship and of medical professionalism. Trust is therefore central to providing the highest standard of care and to the ethical practice of medicine. Physicians enhance trustworthiness in the profession by striving to uphold the following interdependent virtues: A. VIRTUES EXEMPLIFIED BY THE ETHICAL PHYSICIAN 2 B. FUNDAMENTAL COMMITMENTS OF THE MEDICAL PROFESSION Consider first the well-being of the patient; always act to benefit the patient and promote the good of the patient. Provide appropriate care and management across the care continuum. Take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm has occurred. Recognize the balance of potential benefits and harms associated with any medical act; act to bring about a positive balance of benefits over harms. Commitment to the well-being of the patient Promote the well-being of communities and populations by striving to improve health outcomes and access to care, reduce health inequities and disparities in care, and promote social accountability. Commitment to justice Practise medicine competently, safely, and with integrity; avoid any influence that could undermine your professional integrity. Develop and advance your professional knowledge, skills, and competencies through lifelong learning. Commitment to professional integrity and competence Always treat the patient with dignity and respect the equal and intrinsic worth of all persons. Always respect the autonomy of the patient. Never exploit the patient for personal advantage. Never participate in or support practices that violate basic human rights. Commitment to respect for persons Contribute to the development and innovation in medicine through clinical practice, research, teaching, mentorship, leadership, quality improvement, administration, or advocacy on behalf of the profession or the public. Participate in establishing and maintaining professional standards and engage in processes that support the institutions involved in the regulation of the profession. Cultivate collaborative and respectful relationships with physicians and learners in all areas of medicine and with other colleagues and partners in health care. Commitment to professional excellence Value personal health and wellness and strive to model self-care; take steps to optimize meaningful co-existence of professional and personal life. Value and promote a training and practice culture that supports and responds effectively to colleagues in need and empowers them to seek help to improve their physical, mental, and social well-being. Recognize and act on the understanding that physician health and wellness needs to be addressed at individual and systemic levels, in a model of shared responsibility. Commitment to self-care and peer support Value and foster individual and collective inquiry and reflection to further medical science and to facilitate ethical decision-making. Foster curiosity and exploration to further your personal and professional development and insight; be open to new knowledge, technologies, ways of practising, and learning from others. Commitment to inquiry and reflection 3 C. PROFESSIONAL RESPONSIBILITIES The patient–physician relationship is at the heart of the practice of medicine. It is a relationship of trust that recognizes the inherent vulnerability of the patient even as the patient is an active participant in their own care. The physician owes a duty of loyalty to protect and further the patient’s best interests and goals of care by using the physician’s expertise, knowledge, and prudent clinical judgment. In the context of the patient–physician relationship: 1. Accept the patient without discrimination (such as on the basis of age, disability, gender identity or expression, genetic characteristics, language, marital and family status, medical condition, national or ethnic origin, political affiliation, race, religion, sex, sexual orientation, or socioeconomic status). This does not abrogate the right of the physician to refuse to accept a patient for legitimate reasons. 2. Having accepted professional responsibility for the patient, continue to provide services until these services are no longer required or wanted, or until another suitable physician has assumed responsibility for the patient, or until after the patient has been given reasonable notice that you intend to terminate the relationship. 3. Act according to your conscience and respect differences of conscience among your colleagues; however, meet your duty of non-abandonment to the patient by always acknowledging and responding to the patient’s medical concerns and requests whatever your moral commitments may be. 4. Inform the patient when your moral commitments may influence your recommendation concerning provision of, or practice of any medical procedure or intervention as it pertains to the patient’s needs or requests. 5. Communicate information accurately and honestly with the patient in a manner that the patient understands and can apply, and confirm the patient’s understanding. 6. Recommend evidence-informed treatment options; recognize that inappropriate use or overuse of treatments or resources can lead to ineffective, and at times harmful, patient care and seek to avoid or mitigate this. 7. Limit treatment of yourself, your immediate family, or anyone with whom you have a similarly close relationship to minor or emergency interventions and only when another physician is not readily available; there should be no fee for such treatment. 8. Provide whatever appropriate assistance you can to any person who needs emergency medical care. 9. Ensure that any research to which you contribute is evaluated both scientifically and ethically and is approved by a research ethics board that adheres to current standards of practice. When involved in research, obtain the informed consent of the research participant and advise prospective participants that they have the right to decline to participate or withdraw from the study at any time, without negatively affecting their ongoing care. 10. Never participate in or condone the practice of torture or any form of cruel, inhuman, or degrading procedure. Physicians and patients Patient-physician relationship 4 11. Empower the patient to make informed decisions regarding their health by communicating with and helping the patient (or, where appropriate, their substitute decision-maker) navigate reasonable therapeutic options to determine the best course of action consistent with their goals of care; communicate with and help the patient assess material risks and benefits before consenting to any treatment or intervention. 12. Respect the decisions of the competent patient to accept or reject any recommended assessment, treatment, or plan of care. 13. Recognize the need to balance the developing competency of minors and the role of families and caregivers in medical decision-making for minors, while respecting a mature minor’s right to consent to treatment and manage their personal health information. 14. Accommodate a patient with cognitive impairments to participate, as much as possible, in decisions that affect them; in such cases, acknowledge and support the positive roles of families and caregivers in medical decision-making and collaborate with them, where authorized by the patient’s substitute decision-maker, in discerning and making decisions about the patient’s goals of care and best interests. 15. Respect the values and intentions of a patient deemed incompetent as they were expressed previously through advance care planning discussions when competent, or via a substitute decision-maker. 16. When the specific intentions of an incompetent patient are unknown and in the absence of a formal mechanism for making treatment decisions, act consistently with the patient’s discernable values and goals of care or, if these are unknown, act in the patient’s best interests. 17. Respect the patient’s reasonable request for a second opinion from a recognized medical expert. Physicians and the practice of medicine Patient privacy and the duty of confidentiality 18. Fulfill your duty of confidentiality to the patient by keeping identifiable patient information confidential; collecting, using, and disclosing only as much health information as necessary to benefit the patient; and sharing information only to benefit the patient and within the patient’s circle of care. Exceptions include situations where the informed consent of the patient has been obtained for disclosure or as provided for by law. 19. Provide the patient or a third party with a copy of their medical record upon the patient’s request, unless there is a compelling reason to believe that information contained in the record will result in substantial harm to the patient or others. 20. Recognize and manage privacy requirements within training and practice environments and quality improvement initiatives, in the context of secondary uses of data for health system management, and when using new technologies in clinical settings. 21. Avoid health care discussions, including in personal, public, or virtual conversations, that could reasonably be seen as revealing confidential or identifying information or as being disrespectful to patients, their families, or caregivers. Medical decision-making is ideally a deliberative process that engages the patient in shared decision-making and is informed by the patient’s experience and values and the physician’s clinical judgment. This deliberation involves discussion with the patient and, with consent, others central to the patient’s care (families, caregivers, other health professionals) to support patient-centred care. In the process of shared decision-making: Decision-making 5 22. Recognize that conflicts of interest may arise as a result of competing roles (such as financial, clinical, research, organizational, administrative, or leadership). 23. Enter into associations, contracts, and agreements that maintain your professional integrity, consistent with evidenceinformed decision-making, and safeguard the interests of the patient or public. 24. Avoid, minimize, or manage and always disclose conflicts of interest that arise, or are perceived to arise, as a result of any professional relationships or transactions in practice, education, and research; avoid using your role as a physician to promote services (except your own) or products to the patient or public for commercial gain outside of your treatment role. 25. Take reasonable steps to ensure that the patient understands the nature and extent of your responsibility to a third party when acting on behalf of a third party. 26. Discuss professional fees for non-insured services with the patient and consider their ability to pay in determining fees. 27. When conducting research, inform potential research participants about anything that may give rise to a conflict of interest, especially the source of funding and any compensation or benefits. 28. Be aware of and promote health and wellness services, and other resources, available to you and colleagues in need. 29. Seek help from colleagues and appropriate medical care from qualified professionals for personal and professional problems that might adversely affect your health and your services to patients. 30. Cultivate training and practice environments that provide physical and psychological safety and encourage help-seeking behaviours. 31. Treat your colleagues with dignity and as persons worthy of respect. Colleagues include all learners, health care partners, and members of the health care team. 32. Engage in respectful communications in all media. 33. Take responsibility for promoting civility, and confronting incivility, within and beyond the profession. Avoid impugning the reputation of colleagues for personal motives; however, report to the appropriate authority any unprofessional conduct by colleagues. 34. Assume responsibility for your personal actions and behaviours and espouse behaviours that contribute to a positive training and practice culture. 35. Promote and enable formal and informal mentorship and leadership opportunities across all levels of training, practice, and health system delivery. 36. Support interdisciplinary team-based practices; foster team collaboration and a shared accountability for patient care. Physicians and self Physicians and colleagues Managing and minimizing conflicts of interest 6 38. Recognize that social determinants of health, the environment, and other fundamental considerations that extend beyond medical practice and health systems are important factors that affect the health of the patient and of populations. 39. Support the profession’s responsibility to act in matters relating to public and population health, health education, environmental determinants of health, legislation affecting public and population health, and judicial testimony. 40. Support the profession’s responsibility to promote equitable access to health care resources and to promote resource stewardship. 41. Provide opinions consistent with the current and widely accepted views of the profession when interpreting scientific knowledge to the public; clearly indicate when you present an opinion that is contrary to the accepted views of the profession. 42. Contribute, where appropriate, to the development of a more cohesive and integrated health system through interprofessional collaboration and, when possible, collaborative models of care. 43. Commit to collaborative and respectful relationships with Indigenous patients and communities through efforts to understand and implement the recommendations relevant to health care made in the report of the Truth and Reconciliation Commission of Canada. 44. Contribute, individually and in collaboration with others, to improving health care services and delivery to address systemic issues that affect the health of the patient and of populations, with particular attention to disadvantaged, vulnerable, or underserved communities. Approved by the CMA Board of Directors Dec 2018 37. Commit to ensuring the quality of medical services offered to patients and society through the establishment and maintenance of professional standards. Physicians and society
Documents
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Health Canada consultation on restriction of marketing and advertising of opioids

https://policybase.cma.ca/en/permalink/policy13921
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
/Policypdf/PD08-01.pdf (accessed 2018 Jul 17). 25 Canadian Medical Association. CMA Code of Ethics (Update
  1 document  
Policy Type
Response to consultation
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to Health Canada in response to the publication of the Notice of Intent to restrict the marketing and advertising of opioids.1 The CMA is very concerned with the high rates of overdose deaths due to opioids2 and supports a comprehensive, multi-pronged approach to address this public health crisis.3 As part of the Government of Canada's strategy, the Minister of Health's 2017 mandate letter committed to "consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies."4 Health Canada is proposing to further restrict drug manufacturers' advertising of opioids and is consulting on the scope and intent of the restrictions. The Food and Drugs Act defines advertisement as "any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device".5 Opioids are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. These medications have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.3 Any measures to address advertising must not restrict appropriate access. Limiting access without appropriate alternatives and careful tapering can lead to undue suffering and seeking of drugs, potentially tainted, on the illegal market. However, of great concern, opioid dispensing levels have been shown to be strongly correlated with increased mortality, morbidity and treatment admissions for substance use.6,7 Many patients were prescribed these medications and developed dependence.8 Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.9,10 However, there is evidence for pain relief in the short term but insufficient evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.11,12,13 There was also a concerted effort by industry to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer pain. While stating that the risk of addiction was less than one percent, many studies have shown that the risk varies from 0 to 50% depending on the criteria used and sub population studied.14 Marketing significantly influences the type and amount of opioids consumed.15 Substantial tension exists between the competitive pressures that manufacturers face to expand product sales and support for limited, evidence-based use of most cost-effective available alternatives.16 Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage.17 Important contributing factors for the increase in opioid prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with patients. Prescriptions also increased due to the availability of new, highly potent opioid drugs.18,19 Addressing advertising is only one component of the issue, and significant efforts need to be made to address issues such as access to alternatives for pain management and treatment of addiction. Presently, advertising of opioids is prohibited to the public, and only permitted to health care professionals if the claims are consistent with the terms of market authorization by Health Canada. Pharmaceutical industry's marketing practices to health care practitioners "can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts."1 As well, industry has sponsored advocacy organizations dedicated to the treatment of pain and key opinion leaders.15,20 Studies have shown that marketing influences prescribing patterns.21 Initiatives to regulate advertising and the promotion of prescription drugs have come from industry, nongovernmental organizations and government. The pharmaceutical industry itself is voluntarily self-regulated in Canada through the Pharmaceutical Advertising Advisory Board (PAAB), pre-clearing marketing initiatives based on a Code of Advertising.22 The CMA recommends that marketing initiatives could be vetted for accuracy and truthfulness through a pre-clearance mechanism such as PAAB. Faced with multiple legal challenges in the U.S., some opioid manufacturers have limited marketing, however, such measures had not been taken in Canada. The federal government has a complaints-based system and hasn't been proactive in the regulation and monitoring of advertising and marketing of opioids. In recently published regulations amending the Food and Drug Regulations,23 the Minister of Health can require companies to develop and implement risk management plans, which include the preclearance of opioid-related materials to be provided to health care professionals. Product information prepared by manufacturers, summarizing scientific evidence on effects and setting out conditions for use, as well as promotional activities are subject to regulatory approval. The authority conferred to the Minister has the objective of allowing Health Canada to "appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use" of opioids. CMA supports such actions. As Van Zee has noted in the case of the United States, "modifications of the promotion and marketing of controlled drugs by the pharmaceutical industry and an enhanced capacity of the Food and Drug Administration to regulate and monitor such promotion can have a positive impact on public health".14 This approach would confer a similar benefit for Canada in that, if effective, could contribute to unbiased, evidence-based prescribing. There are important guidelines and standards in place, developed by physicians, to guide relationships with the pharmaceutical industry. CMA's "Guidelines for Physicians in Interactions with Industry"24 were developed as a resource tool both for physicians, medical students and residents, as well as medical organizations, to support decisions as to appropriate relationships with industry, in conjunction with CMA's Code of Ethics.25 In summary, physicians have a responsibility to ensure that their interaction with the pharmaceutical industry is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible, appropriately managing these situations when necessary. These guidelines include principles for continuing medical education and continuing professional development (CME/CPD) and are the basis for the National Standard for Support of Accredited CPD Activities, developed by the Royal College of Physicians and Surgeons of Canada (RCPSC), the College of Family Physicians of Canada (CFPC) and the Collège des médecins du Québec. According to the Standard, "the interests of organizations that provide financial and in-kind support for the development of accredited CPD activities cannot be assumed to always be congruent with the goal of addressing the educational needs of the medical profession. Therefore, it is essential that the medical profession define and assume their responsibility for setting standards that will guide the development, delivery, and evaluation of accredited CPD activities."26 Physicians must complete CPD credits to maintain their professional license, and the accreditation bodies (such as CFPC, RCPSC) have processes in place to assure that these courses are evidence-based and free from industry bias. In recognition of the importance of opioid prescribing, and the key role that physicians play in this field, the CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids. This funding could include unconditional contribution from the opioid manufacturers, to ensure independence. The CMA appreciates the role that Health Canada has had in funding evidence-based guidelines.27 This has been a key initiative, which sought to provide physicians with unbiased information. Ongoing funding to maintain their currency would be warranted. The CMA supports long overdue actions related to the restriction of the marketing of opioids and looks forward to collaboration between Health Canada and the physician community. Recommendations The CMA supports Health Canada's efforts to place significant restrictions on the ability of drug manufacturers to advertise opioids to health care practitioners. Marketing initiatives should be vetted for accuracy and truthfulness through a pre-clearance mechanism. The CMA recommends that the measures chosen to constrain advertising do not unduly restrict access to opioids for appropriate use. The CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids, and consider unconditional funding from opioid manufacturers. The CMA recommends that the government support keeping the 2017 Opioid Prescribing Guidelines current through ongoing funding. The CMA recognizes that restricting advertising is only one, overdue, measure to address the opioid crisis, and recommends that issues such as access to alternatives for pain management and addiction treatment urgently be addressed. 1 Government of Canada. Notice of intent to restrict the marketing and advertising of opioids. Ottawa: Government of Canada; 2018. Available: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/restrict-advertising-opioids.html (accessed 2018 Jul 17). 2 Public Health Agency of Canada. National report: apparent opioid-related deaths in Canada (released June 2018). Ottawa: Public Health Agency of Canada; 2018. Available: https://www.canada.ca/en/public-health/services/publications/healthy-living/national-report-apparent-opioid-related-deaths-released-june-2018.html (accessed 2018 Jul 17). 3 Canadian Medical Association. Harms associated with opioids and other psychoactive prescription drugs. Ottawa: Canadian Medical Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Jul 17). 4 Trudeau J. Minister of Health mandate letter. Ottawa: Office of the Prime Minister; 2017 Oct 4. Available: https://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2018 Jul 17). 5 Government of Canada. Food and Drugs Act. Ottawa: Government of Canada; 1985. Available: http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html (accessed 2018 Jul 17). 6 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf 2013;22(4):438-42. 7 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q 2011;14(1):22-4. 8 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend 2004;73(2):199-207. 9 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician 2014;17(1):E1-10. 10 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ 2011;343:d5142 DOI: 10.1136/bmj.d5142. 11 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology 2014;83:1277-84. 12 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147-59. 13 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010;(1):CD006605. 14 Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-27. 15 Hamunen K, Paakkari P, Kalso E. Trends in opioid consumption in the Nordic countries 2002-2006. Eur J Pain 2009;13:954-962. 16 Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2018:1-26. 17 Canadian Medical Association. Optimal prescribing. Ottawa: Canadian Medical Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf (accessed 2018 Jul 17). 18 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health 2008;99(3):182-4. 19 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction 2013;109:177-81. 20 Dyer O. OxyContin maker stops marketing opioids, as report details payments to advocacy groups. BMJ 2018;360:k791. 21 Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioethics 2003;3(3):39-46. 22 Pharmaceutical Advertising Advisory Board. PAAB Code. Ottawa: PAAB; 2018. Available: http://code.paab.ca/ (accessed 2018 Jul 17). 23 Regulations Amending the Food and Drug Regulations (Opioids), SOR/2018-77. Canada Gazette, Part II 2018 May 2;152(9). Available: http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html (accessed 2018 Jul 17). 24 Canadian Medical Association. Guidelines for physicians in interactions with industry. Ottawa: Canadian Medical Association; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf (accessed 2018 Jul 17). 25 Canadian Medical Association. CMA Code of Ethics (Update 2004). Ottawa: Canadian Medical Association; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Code_of_ethics_of_the_Canadian_Medical_Association_Update_2004_PD04-06-e.pdf (accessed 2018 Jul 17). 26 Royal College of Physicians and Surgeons of Canada. National standard for support of accredited CPD activities. Ottawa: Royal College of Physicians and Surgeons of Canada; 2017. Available: http://www.royalcollege.ca/rcsite/cpd/providers/tools-resources-accredited-cpd-providers/national-standard-accredited-cpd-activities-e (accessed 2018 Jul 17). 27 Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ 2017;189:E659-66.
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Best practices for smartphone and smart-device clinical photo taking and sharing

https://policybase.cma.ca/en/permalink/policy13860
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
-principles-for-the-protection-of-patient-privacy-pd18-02-e.pdf © 2018 Canadian Medical Association
  1 document  
Policy Type
Policy document
Date
2018-03-03
Topics
Health information and e-health
Ethics and medical professionalism
Text
Clinical photography is a valuable tool for physicians. Smartphones, as well as other devices supporting network connectivity, offer a convenient, efficient method to take and share images. However, due to the private nature of the information contained in clinical photographs there are concerns as to the appropriate storage, dissemination, and documentation of clinical images. Confidentiality of image data must be considered and the dissemination of these images onto servers must respect the privacy and rights of the patient. Importantly, patient information should be considered as any information deriving from a patient, and the concepts outlined therefore apply to any media that can be collected on, or transmitted with, a smart-device. Clinical photography can aid in documenting form and function, in tracking conditions and wound healing, in planning surgical operations, and in clinical decision-making. Additionally, clinical photographs can provide physicians with a valuable tool for patient communication and education. Due to the convenience of this type of technology it is not appropriate to expect physicians to forego their use in providing their patients with the best care available. The technology and software required for secure transfer, communication, and storage of clinical media is presently available, but many devices have non-secure storage/dissemination options enabled and lack user-control for permanently deleting digital files. In addition, data uploaded onto server systems commonly cross legal jurisdictions. Many physicians are not comfortable with the practice, citing security, privacy, and confidentiality concerns as well as uncertainty in regards to regional regulations governing this practice.1 Due to concern for patient privacy and confidentiality it is therefore incredibly important to limit the unsecure or undocumented acquisition or dissemination of clinical photographs. To assess the current state of this topic, Heyns et al. have reviewed the accessibility and completeness of provincial and territorial medical regulatory college guidelines.2 Categories identified as vital and explored in this review included: Consent; Storage; Retention; Audit; Transmission; and Breach. While each regulatory body has addressed limited aspects of the overall issue, the authors found a general lack of available information and call for a unified document outlining pertinent instructions for conducting clinical photography using a smartphone and the electronic transmission of patient information.2 The discussion of this topic will need to be ongoing and it is important that physicians are aware of applicable regulations, both at the federal and provincial levels, and how these regulations may impact the use of personal devices. The best practices supported here aim to provide physicians and healthcare providers with an understanding of the scope and gravity of the current environment, as well as the information needed to ensure patient privacy and confidentiality is assessed and protected while physicians utilize accessible clinical photography to advance patient care. Importantly, this document only focusses on medical use (clinical, academic, and educational) of clinical photography and, while discussing many core concepts of patient privacy and confidentiality of information, should not be perceived as a complete or binding framework. Additionally, it is recommended that physicians understand the core competencies of clinical photography, which are not described here. The Canadian Medical Association (CMA) suggests that the following recommendations be implemented, as thoroughly as possible, to best align with the CMA policy on the Principles for the Protection of Patient Privacy (CMA Policy PD2018-02). These key recommendations represent a non-exhaustive set of best practices - physicians should seek additional information as needed to gain a thorough understanding and to stay current in this rapidly changing field. KEY RECOMMENDATIONS 1. CONSENT * Informed consent must be obtained, preferably prior, to photography with a mobile device. This applies for each and any such encounter and the purpose made clear (i.e. clinical, research, education, publication, etc.). Patients should also be made aware that they may request a copy of a picture or for a picture to be deleted. * A patient's consent to use electronic transmission does not relieve a physician of their duty to protect the confidentiality of patient information. Also, a patient's consent cannot override other jurisdictionally mandated security requirements. * All patient consents (including verbal) should be documented. The acquisition and recording of patient consent for medical photography/dissemination may be held to a high standard of accountability due to the patient privacy and confidentiality issues inherent in the use of this technology. Written and signed consent is encouraged. * Consent should be considered as necessary for any and all photography involving a patient, whether or not that patient can be directly recognized, due to the possibility of linked information and the potential for breach of privacy. The definition of non-identifiable photos must be carefully considered. Current technologies such as face recognition and pattern matching (e.g. skin markers, physical structure, etc.), especially in combination with identifying information, have the potential to create a privacy breach. * Unsecure text and email messaging requires explicit patient consent and should not be used unless the current gold standards of security are not accessible. For a patient-initiated unsecure transmission, consent should be clarified and not assumed. 2. TRANSMISSION * Transmission of photos and patient information should be encrypted as per current-day gold standards (presently, end-to-end encryption (E2EE)) and use only secure servers that are subject to Canadian laws. Explicit, informed consent is required otherwise due to privacy concerns or standards for servers in other jurisdictions. Generally, free internet-based communication services and public internet access are unsecure technologies and often operate on servers outside of Canadian jurisdiction. * Efforts should be made to use the most secure transmission method possible. For data security purposes, identifying information should never be included in the image, any frame of a video, the file name, or linked messages. * The sender should always ensure that each recipient is intended and appropriate and, if possible, receipt of transmission should be confirmed by the recipient. 3. STORAGE * Storing images and data on a smart-device should be limited as much as possible for data protection purposes. * Clinical photos, as well as messages or other patient-related information, should be completely segregated from the device's personal storage. This can be accomplished by using an app that creates a secure, password-protected folder on the device. * All information stored (on internal memory or cloud) must be strongly encrypted and password protected. The security measures must be more substantial than the general password unlock feature on mobile devices. * Efforts should be made to dissociate identifying information from images when images are exported from a secure server. Media should not be uploaded to platforms without an option for securely deleting information without consent from the patient, and only if there are no better options. Automatic back-up of photos to unsecure cloud servers should be deactivated. Further, other back-up or syncing options that could lead to unsecure server involvement should be ascertained and the risks mitigated. 4. Cloud storage should be on a Canadian and SOCII certified server. Explicit, informed consent is required otherwise due to privacy concerns for servers in other jurisdictions. 5. AUDIT & RETENTION * It is important to create an audit trail for the purposes of transparency and medical best practice. Key information includes patient and health information, consent type and details, pertinent information regarding the photography (date, circumstance, photographer), and any other important facts such as access granted/deletion requests. * Access to the stored information must be by the authorized physician or health care provider and for the intended purpose, as per the consent given. Records should be stored such that it is possible to print/transfer as necessary. * Original photos should be retained and not overwritten. * All photos and associated messages may be considered part of the patient's clinical records and should be maintained for at least 10 years or 10 years after the age of majority, whichever is longer. When possible, patient information (including photos and message histories between health professionals) should be retained and amalgamated with a patient's medical record. Provincial regulations regarding retention of clinical records may vary and other regulations may apply to other entities - e.g. 90 years from date of birth applies to records at the federal level. * It may not be allowable to erase a picture if it is integral to a clinical decision or provincial, federal, or other applicable regulations require their retention. 6. BREACH * Any breach should be taken seriously and should be reviewed. All reasonable efforts must be made to prevent a breach before one occurs. A breach occurs when personal information, communication, or photos of patients are stolen, lost, or mistakenly disclosed. This includes loss or theft of one's mobile device, texting to the wrong number or emailing/messaging to the wrong person(s), or accidentally showing a clinical photo that exists in the phone's personal photo album. * It should be noted that non-identifying information, when combined with other available information (e.g. a text message with identifiers or another image with identifiers), can lead to highly accurate re-identification. * At present, apps downloaded to a smart-device for personal use may be capable of collecting and sharing information - the rapidly changing nature of this technology and the inherent privacy concerns requires regular attention. Use of specialized apps designed for health-information sharing that help safeguard patient information in this context is worth careful consideration. * Having remote wipe (i.e. device reformatting) capabilities is an asset and can help contain a breach. However, inappropriate access may take place before reformatting occurs. * If a smartphone is strongly encrypted and has no clinical photos stored locally then its loss may not be considered a breach. * In the event of a breach any patient potentially involved must be notified as soon as possible. The CMPA, the organization/hospital, and the Provincial licensing College should also be contacted immediately. Provincial regulations regarding notification of breach may vary. Approved by the CMA Board of Directors March 2018 References i Heyns M†, Steve A‡, Dumestre DO‡, Fraulin FO‡, Yeung JK‡ † University of Calgary, Canada ‡ Section of Plastic Surgery, Department of Surgery, University of Calgary, Canada 1 Chan N, Charette J, Dumestre DO, Fraulin FO. Should 'smart phones' be used for patient photography? Plast Surg (Oakv). 2016;24(1):32-4. 2 Unpublished - Heyns M, Steve A, Dumestre DO, Fraulin FO, Yeung J. Canadian Guidelines on Smartphone Clinical Photography.
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Federal monitoring of medical assistance in dying regulations

https://policybase.cma.ca/en/permalink/policy13856
Date
2018-02-13
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Response to consultation
Date
2018-02-13
Topics
Ethics and medical professionalism
Text
The Canadian Medical Association (CMA) is pleased to provide input on the proposed regulations of the federal monitoring of Medical Assistance in Dying in Canada. The CMA fully supports the proposed intent of the regulations, in particular, public accountability and transparency and safeguards for vulnerable patient populations. Tracking trends and carrying out research is very important to monitor the implementation and implications of medical assistance in dying. The CMA further supports the intent to provide electronic reporting and guidance documents, and to leverage any synergies between the federal and provincial/territorial governments, especially to prevent duplication and to promote consistency in reporting across the country. The CMA would like to raise the following critical areas for your consideration: 1. Definitions/parameters of terms There continues to be a need to more clearly define several terms to ensure consistency of reporting. For example: a. Who constitutes a “practitioner”? One can argue that there is a broad scope of who is “a medical practitioner or nurse practitioner”. Is it the practitioner who provides MAiD? Or he practitioner who first reads a patient’s request for MAiD? Or is the first practitioner? Or second practitioner who assesses the patient? b. What constitutes a therapeutic relationship (as one of the eight proposed items to be collected about the practitioner)? A therapeutic relationship is not required to access MAiD. This criterion should be removed and if not, given the differences in opinion in the health professions as to what constitutes a therapeutic relationship includes, it should be clearly defined. c. What constitutes a request, a written request, the receipt of a request? If reporting obligations are “triggered” by a patient’s “written request”, at what point is that request actually triggered? The very first practitioner who receives the patient’s written request? Or the practitioner who conducts the eligibility assessment upon receipt of the written request? Or the practitioner who provides the prescription or carries out the procedure? d. On a related point, without clear definitions, any future comparative analysis of research or trends will be difficult as there will be no common starting point. e. There continues to be confusion on how to count or when to start counting the required 10 clear days. There are many reasons why this requires more clarity. 2. Collection and protection of data We applaud Health Canada for further reducing and revising data requirements. We submit, however, that further reductions are required for several reasons, including adherence to privacy best practices that require the collection of the least amount of data necessary to achieve reasonable purposes. In particular: a. In view of the quantity and highly personal and sensitive data that will be collected about patients and practitioners, data sharing agreements should be required; for example, agreements between the federal government and provincial/territorial governments or between researchers and others requesting use of the data to facilitate the appropriate sharing of data. b. Collection of personal information should be limited to what is relevant to the purpose of monitoring medical assistance in dying. Personal information, such as the patient’s full postal code, marital status, or principal occupation is beyond the scope of the eligibility criteria outlined in the legislation and thus beyond the scope of the purpose of monitoring the impact of the legislation. c. Any “characteristics” of the patient should refer only to the eligibility criteria. If other data will be collected beyond that scope, the justification for doing so, and the characteristics themselves, should be clearly outlined. d. The scope of the information collected about the practitioner could be narrowed. As is, it is very broad – a list of eight items – while the Quebec regulations, as a comparator, have only three-four items that must be collected in relation to the physician who administers MAiD. 3. Additional requirements Schedule 4 [section 2(i)] of the proposed regulations requires that the practitioner opine as to whether the patient met, or did not meet, all of the eligibility criteria outlined in the legislation – with two significantly expanded requirements; the requirements that the practitioner: 1) provide an estimate as to the amount of time MAiD shortened the patient’s life; and 2) indicate the anticipated likely cause of natural death of the patient. These additional requirements are beyond the letter and spirit of the legislation and, in many ways, are in direct contradiction to the legislation. The Legislature was not unaware when it drafted the Act that it did not follow other jurisdictions’ criteria requiring either a terminal illness or a prognosis of time within which the practitioner believed the patient would die, e.g., “within the next 6 months”. It is specifically the lack of a timeframe that makes the legislation unique and provides flexibility for both patients and practitioners. By adding these two additional criteria for reporting, in effect, they become additional criteria for eligibility which is, as stated above, beyond the scope, and in contradiction to, the legislation. 4. Lack of clarity of reasons for ineligibility There is a potential for misunderstanding as to whether reasons are required when the patient does not meet the criteria under Schedule 4, section 2(a) – (h). The introduction to section 2 speaks to the practitioner giving an indication as to (a) whether the patient met or (b) did not meet the criteria. However, in the itemized criteria [2(a)-(h)] it only speaks to the practitioner having to provide reasons when the patient meets the criteria (and not when the patient has not met the criteria). It would be helpful to specify that reasons should be required when the patient does and does not meet the criteria. This is also crucial for the publication of the Minister of Health’s annual report requiring that the reasons, and which eligibility criteria were not met, be addressed. Conclusion The CMA recognizes the importance of regulations to capture the provision, collection, use, and disposal of information for the purpose of monitoring MAiD. The CMA cautions against introducing reporting requirements that are beyond the scope of the legislation. As noted in the legislation, practitioners who fail to provide information under the regulations may be found guilty under the Criminal Code and subject to possible imprisonment. It is thus imperative that the federal government drafts clear regulations that respect the legislation, privacy, research ethics, and a de minimus approach. .
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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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6 records – page 1 of 1.