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Guiding principles for the optimal use of data analytics by physicians at the point of care

https://policybase.cma.ca/en/permalink/policy11812
Last Reviewed
2020-02-29
Date
2016-02-27
Topics
Health information and e-health
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2016-02-27
Topics
Health information and e-health
Text
Electronic tools are now being used more widely in medicine than ever before. A majority of physicians in Canada have adopted electronic medical records (EMRs)-75% of physicians use EMRs to enter or retrieve clinical patient notes, and 80% use electronic tools to access laboratory/diagnostic test results. The increased use of point-of-care tools and information repositories has resulted in the mass digitization and storage of clinical information, which provides opportunities for the use of big data analytics. Big data analytics may come to be understood as the process of examining clinical data in EMRs cross-referenced with other administrative, demographic and behavioural data sources to reveal determinants of patient health and patterns in clinical practice. Its increased use may provide opportunities to develop and enhance clinical practice tools and to improve health outcomes at both point-of-care and population levels. However, given the nature of EMR use in Canada, these opportunities may be restricted to primary care practice at this time. Physicians play a central role in finding the right balance between leveraging the advantages of big data analytics and protecting patient privacy. Guiding Principles for the Optimal Use of Data Analytics by Physicians at the Point of Care outlines basic considerations for the use of big data analytics services and highlights key considerations when responding to requests for access to EMR data, including the following: * Why will data analytics be used? Will the safety and effectiveness of patient care be enhanced? Will the results be used to inform public health measures? * What are the responsibilities of physicians to respect and protect patient and physician information, provide appropriate information during consent conversations, and review data sharing agreements and consult with EMR vendors to understand how data will be used? As physicians will encounter big data analytics in a number of ways, this document also outlines the characteristics one should be looking for when assessing the safety and effectiveness of big data analytics services: * protection of privacy * clear and detailed data sharing agreement * physician-owned and -led data collaboratives * endorsement by a professional or recognized association, medical society or health care organization * scope of services and functionality/appropriateness of data While this guidance is not a standalone document-it should be used as a supplemental reference to provincial privacy legislation-it is hoped that it can aid physicians to identify suitable big data analytics services and derive benefits from them. Introduction This document outlines basic considerations for the use of big data analytics services at the point of care or for research approved by a research ethics board. This includes considerations when responding to requests for access to data in electronic medical records (EMRs). These guiding principles build on the policies of the Canadian Medical Association (CMA) on Data Sharing Agreements: Principles for Electronic Medical Records/Electronic Health Records,1 Principles Concerning Physician Information2 and Principles for the Protection of Patients' Personal Health Information,3 the 2011 clinical vignettes Disclosing Personal Health Information to Third Parties4 and Need to Know and Circle of Care,5 and the Canadian Medical Protective Association's The Impact of Big Data on Healthcare and Medical Practice.6 These guiding principles are for information and reference only and should not be construed as legal or financial advice, nor is this document a substitute for legal or other professional advice. Physicians must always comply with all legislation that applies to big data analytics, including privacy legislation. Big data analytics in the clinical context involves the collection, use and potential disclosure of patient and physician information, both of which could be considered sensitive personal information under privacy legislation. Big data analytics has the potential to improve health outcomes, both at the point of care and at a population level. Doctors have a key role to play in finding the right balance between leveraging the advantages of big data (enhanced care, service delivery and resource management) and protecting patient privacy.7 Background A majority of physicians in Canada have adopted EMRs in their practice. The percentage of physicians using EMRs to enter or retrieve clinical patient notes increased from 26% in 2007 to 75% in 2014. Eighty percent of physicians used electronic tools to access laboratory/diagnostic test results in 2014, up from 38% in 2010.8 The increasingly broad collection of information by physicians at the point of care, combined with the growth of information repositories developed by various governmental and intergovernmental bodies, has resulted in the mass digitization and storage of clinical information. Big data is the term for data sets so large and complex that it is difficult to process them using traditional relational database management systems, desktop statistics and visualization software. What is considered "big" depends on the infrastructure and capabilities of the organization managing the data.9 Analytics is the discovery and communication of meaningful patterns in data. Analytics relies on the simultaneous application of statistics, computer programming and operations research. Analytics often favours data visualization to communicate insight, and insights from data are used to guide decision-making.10 For physicians, big data analytics may come to be understood as the process of examining the clinical data in EMRs cross-referenced with other administrative, demographic and behavioural data sources to reveal determinants of patient health and patterns in clinical practice. This information can be used to assist clinical decision-making or for research approved by a research ethics board. There are four types of big data analytics physicians may encounter in the provision of patient care. They are generally performed in the following sequence, in a continuous cycle11,12,13,14: 1. Population health analytics: Health trends are identified in the aggregate within a community, a region or a national population. The data can be derived from biomedical and/or administrative data. 2. Risk-based cost analysis: Populations are segmented into groups according to the level of risk to the patient's health and/or cost to the health system. 3. Care management: Clinicians are enabled to manage patient care according to defined care pathways and clinical protocols informed by population health analytics and risk-based cost analysis. Care management includes the following: o Clinical decision support: Outcomes are predicted and/or alternative treatments are recommended to clinicians and patients at the point of care. o Personalized/precision care: Personalized data sets, such as genomic DNA sequences for at-risk patients, are leveraged to highlight best practice treatments for patients and practitioners. These solutions may offer early detection and diagnosis before a patient develops disease symptoms. o Clinical operations: Workflow management is performed, such as wait-times management, mining historical and unstructured data for patterns to predict events that may affect care. o Continuing education and professional development: Longitudinal performance data are combined across institutions, classes, cohorts or programs with correlating patient outcomes to assess models of education and/or develop new programs. 4. Performance analytics: Metrics for quality and efficiency of patient care are cross-referenced with clinical decision-making and performance data to assess clinical performance. This cycle is also sometimes understood as a component of "meaningful" or "enhanced" use of EMRs. How might physicians encounter big data analytics? Many EMRs run analytics both visibly (e.g., as a function that can be activated at appropriate junctures in the care pathway) and invisibly (e.g., as tools that run seamlessly in the background of an EMR). Physicians may or may not be aware when data are being collected, analyzed, tailored or presented by big data analytics services. However, many jurisdictions are strengthening their laws and standards, and best practices are gradually emerging.15 Physicians may have entered into a data sharing agreement with their EMR vendor when they procured an EMR for their practice. Such agreements may include provisions to share de-identified (i.e., anonymized) and/or aggregate data with the EMR vendor for specified or unspecified purposes. Physicians may also receive requests from third parties to share their EMR data. These requests may come from various sources: * provincial governments * intergovernmental agencies * national and provincial associations, including medical associations * non-profit organizations * independent researchers * EMR vendors, service providers and other private corporations National Physician Survey results indicate that in 2014, 10% of physicians had shared data from their EMRs for the purposes of research, 10% for chronic disease surveillance and 8% for care improvement. Family physicians were more likely than other specialists to share with public health agencies (22% v. 11%) and electronic record vendors (13% v. 2%). Specialists were more likely than family physicians to share with researchers (59% v. 37%), hospital departments (47% v. 20%) and university departments (28% v. 15%). There is significant variability across the provinces with regard to what proportion of physicians are sharing information from their EMRs, which is affected by the presence of research initiatives, research objectives defined by the approval of a research ethics board, the adoption rates of EMRs among physicians in the province and the functionality of those EMRs.16 For example, there are family practitioners across Canada who provide data to the Canadian Primary Care Sentinel Surveillance Network (CPCSSN). The CPCSSN is a multi-disease EMR surveillance and research system that allows family physicians, epidemiologists and researchers to understand and manage chronic care conditions for patients. Health information is collected from EMRs in the offices of participating family physicians, specifically information about Canadians suffering from chronic and mental health conditions and three neurologic conditions, including Alzheimer's and related dementias.17 In another example, the Canadian Partnership Against Cancer's Surgical Synoptic Reporting Initiative captures standardized information about surgery at the point of care and transmits the surgical report to other health care personnel. Surgeons can use the captured information, which gives them the ability to assess adherence to the clinical evidence and safety procedures embedded in the reporting templates, to track their own practices and those of their community.18 The concept of synoptic reporting-whereby a physician provides anonymized data about their practice in return for an aggregate report summarizing the practice of others -can be expanded to any area in which an appropriate number of physicians are willing to participate. Guiding principles for the use of big data analytics These guiding principles are designed to give physicians a starting point as they consider the use of big data analytics in their practices: * The objective of using big data analytics must be to enhance the safety and/or effectiveness of patient care or for the purpose of health promotion. * Should a physician use big data analytics, it is the responsibility of the physician to do so in a way that adheres to their legislative, regulatory and/or professional obligations. * Physicians are responsible for the privacy of their individual patients. Physicians may wish to refer to the CMA's policy on Principles for the Protection of Patients' Personal Health Information.19 * Physicians are responsible for respecting and protecting the privacy of other physicians' information. Physicians may wish to refer to the CMA's policy on Principles Concerning Physician Information.20 * When physicians enter into and document a broad consent discussion with their patient, which can include the electronic management of health information, this agreement should convey information to cover the elements common to big data analytics services. * Physicians may also wish to consider the potential for big data analytics to inform public health measures and enhance health system efficiency and take this into account when responding to requests for access to data in an EMR. * Many EMR vendors provide cloud-based storage to their clients, so information entered into an EMR may be available to the EMR vendor in a de-identified and/or aggregate state. Physicians should carefully read their data sharing agreement with their EMR vendor to understand how and why the data that is entered into an EMR is used, and/or they should refer to the CMA's policy on the matter, Data Sharing Agreements: Principles for Electronic Medical Records/Electronic Health Records.21 * Given the dynamic nature of this emerging tool, physicians are encouraged to share information about their experiences with big data analytics and its applications with colleagues. Characteristics of safe and effective big data analytics services 1. Protection of privacy Privacy and security concerns present a challenge in linking big data in EMRs. As data are linked, it becomes increasingly difficult to de-identify individual patients.22 As care is increasingly provided in interconnected, digital environments, physicians are having to take on the role of data stewardship. To that end, physicians may wish to employ conservative risk assessment practices-"should we" as opposed to "can we" when linking data sources-and obtain express patient consent, employing a "permission-based" approach to the collection and stewardship of data. 2. A clear and detailed data sharing agreement Physicians entering into a contract with an EMR vendor or other third party for provision of services should understand how and when they are contributing to the collection of data for the purposes of big data analytics services. There are template data sharing agreements available, which include the basic components of safe and effective data sharing, such as the model provided by the Information and Privacy Commissioner of Ontario.23 Data sharing agreements may include general use and project-specific use, both of which physicians should assess before entering into the agreement. When EMR access is being provided to a ministry of health and/or regional health authority, the data sharing agreement should distinguish between access to administrative data and access to clinical data. Physicians may wish to refer to the CMA's policy on Data Sharing Agreements: Principles for Electronic Medical Records/Electronic Health Records.24 3. Physician-owned and -led data collaboratives In some provinces there may exist opportunities to share clinical data in physician-owned and -led networks to reflect on and improve patient care. One example is the Physicians Data Collaborative in British Columbia, a not-for-profit organization open to divisions of family practice.25 Collaboratives such as this one are governed by physicians and driven by a desire to protect the privacy and safety of patients while producing meaningful results for physicians in daily practice. Participation in physician-owned data collaboratives may ensure that patient data continue to be managed by physicians, which may lead to an appropriate prioritization of physicians' obligations to balance patient-centred care and patient privacy. 4. Endorsement by a professional or other recognized association or medical society or health care organization When considering use of big data analytics services, it is best to select services created or endorsed by a professional or other recognized association or medical society. Some health care organizations, such as hospitals, may also develop or endorse services for use in their clinical environments. Without such endorsement, physicians are advised to proceed with additional caution. 5. Scope of services and functionality/appropriateness of data Physicians may wish to seek out information from EMR vendors and service providers about how big data analytics services complement the process of diagnosis and about the range of data sources from which these services draw. While big data analytics promises insight into population health and practice trends, if it is not drawing from an appropriate level of cross-referenced sources it may present a skewed picture of both.26 Ultimately, the physician must decide if the sources are appropriately diverse. Physicians should expect EMR vendors and service providers to make clear how and why they draw the information they do in the provision of analytics services. Ideally, analytics services should integrate population health analytics, risk-based cost analysis, care management services (such as point-of-care decision support tools) and performance analytics. Physicians should expect EMR vendors to allocate sufficient health informatics resources to information management, technical infrastructure, data protection and response to breaches in privacy, and data extraction and analysis.27,28 Physicians may also wish to consider the appropriateness of data analytics services in the context of their practices. Not all data will be useful for some medical specialties, such as those treating conditions that are relatively rare in the overall population. The potential for new or enhanced clinical practice tools informed by big data analytics may be restricted to primary care practice at this time.29 Finally, predictive analytics often make treatment recommendations that are designed to improve the health outcomes in a population, and these recommendations may conflict with physicians' ethical obligations to act in the best interests of individual patients and respect patients' autonomous decision-making).30 References 1 Canadian Medical Association. Data sharing agreements: principles for electronic medical records/electronic health records [CMA policy]. Ottawa: The Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD09-01.pdf 2 Canadian Medical Association. Principles concerning physician information [CMA policy]. CMAJ 2002 167(4):393-4. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD02-09.pdf 3 Canadian Medical Association. Principles for the protection of patients' personal health information [CMA policy]. Ottawa: The Association; 2010. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-03.pdf 4 Canadian Medical Association. Disclosing personal health information to third parties. Ottawa: The Association; 2011. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/CMA_Disclosure_third_parties-e.pdf 5 Canadian Medical Association. Need to know and circle of care. Ottawa: The Association; 2011. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/CMA_Need_to_know_circle_care-e.pdf 6 Canadian Medical Protective Association. The impact of big data on healthcare and medical practice. Ottawa: The Association; no date. Available: https://oplfrpd5.cmpa-acpm.ca/documents/10179/301372750/com_14_big_data_design-e.pdf 7 Kayyali B, Knott D, Van Kuiken S. The 'big data' revolution in US health care: accelerating value and innovation. New York: McKinsey & Company; 2013. p. 1. 8 College of Family Physicians of Canada, Canadian Medical Association, Royal College of Physicians and Surgeons of Canada. National physician survey, 2014. National results by FP/GP or other specialist, sex, age and all physicians. Q7. Ottawa: The Colleges and Association; 2014. Available: http://nationalphysiciansurvey.ca/wp-content/uploads/2014/08/2014-National-EN-Q7.pdf 9 Anonymous. Data, data everywhere. The Economist 2010 Feb 27. Available: www.economist.com/node/15557443 10 Anonymous. Data, data everywhere. The Economist 2010 Feb 27. Available: www.economist.com/node/15557443 11 Canada Health Infoway. Big data analytics in health. Toronto: Canada Health Infoway; 2013. Available: www.infoway-inforoute.ca/index.php/resources/technical-documents/emerging-technology/doc_download/1419-big-data-analytics-in-health-white-paper-full-report (accessed 2014 May 16). 12 Ellaway RH, Pusic MV, Galbraith RM, Cameron T. 2014 Developing the role of big data and analytics in health professional education. Med Teach 2014;36(3):216-222. 13 Marino DJ. Using business intelligence to reduce the cost of care. Healthc Financ Manage 2014;68(3):42-44, 46. 14 Porter ME, Lee TH. The strategy that will fix health care. Harv Bus Rev 2013;91(10):50-70. 15 Baggaley C. Data protection in a world of big data: Canadian Medical Protective Association information session [presentation]. 2014 Aug 20. Available: https://oplfrpd5.cmpa-acpm.ca/documents/10179/301372750/com_2014_carmen_baggaley-e.pdf 16 College of Family Physicians of Canada, Canadian Medical Association, Royal College of Physicians and Surgeons of Canada. National physician survey, 2014. National results by FP/GP or other specialist, sex, age and all physicians. Q10. Ottawa: The Colleges and Association; 2014. Available: http://nationalphysiciansurvey.ca/wp-content/uploads/2014/08/2014-National-EN-Q10.pdf 17 Canadian Primary Care Sentinel Surveillance Network. Available: http://cpcssn.ca/ (accessed 2014 Nov 15). 18 Canadian Partnership Against Cancer. Sustaining action toward a shared vision: 2012-2017 strategic plan. Toronto: The Partnership; no date. Available: www.partnershipagainstcancer.ca/wp-content/uploads/sites/5/2015/03/Sustaining-Action-Toward-a-Shared-Vision_accessible.pdf 19 Canadian Medical Association. Principles for the protection of patients' personal health information [CMA policy]. Ottawa: The Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-03.pdf 20 Canadian Medical Association. Principles for the protection of patients' personal health information [CMA policy]. Ottawa: The Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-03.pdf 21 Canadian Medical Association. Data sharing agreements: principles for electronic medical records/electronic health records [CMA policy]. Ottawa: The Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD09-01.pdf 22 Weber G, Mandl KD, Kohane IS. Finding the missing link for big biomedical data . JAMA 2014;311(24):2479-2480. doi:10.1001/jama.2014.4228. 23 Information and Privacy Commissioner of Ontario. Model data sharing agreement. Toronto: The Commissioner; 1995. Available: www.ipc.on.ca/images/Resources/model-data-ag.pdf 24 Canadian Medical Association. Data sharing agreements: principles for electronic medical records/electronic health records [CMA policy]. Ottawa: The Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD09-01.pdf 25 Physicians Data Collaborative. Overview. Available: www.divisionsbc.ca/datacollaborative/home 26 Cohen IG, Amarasingham R, Shah A, Xie B, Lo B. The legal and ethical concerns that arise from using complex predictive analytics in health care. Health Aff 2014;33(7):1139-1147. 27 Rhoads J, Ferrara L. Transforming healthcare through better use of data. Electron Healthc 2012;11(1):e27. 28 Canadian Medical Protective Association. The impact of big data and healthcare and medical practice. Ottawa: The Association; no date. Available: https://oplfrpd5.cmpa-acpm.ca/documents/10179/301372750/com_14_big_data_design-e.pdf 29 Genta RM, Sonnenberg A. Big data in gastroenterology research. Nat Rev Gastroenterol Hepatol 2014;11(6):386-390. 30 Cohen IG, Amarasingham R, Shah A, Xie B, Lo B. The legal and ethical concerns that arise from using complex predictive analytics in health care. Health Aff 2014;33(7):1139-1147.
Documents
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The physician appointment and reappointment process 2016

https://policybase.cma.ca/en/permalink/policy13564
Date
2016-12-03
Topics
Health human resources
Physician practice/ compensation/ forms
  1 document  
Policy Type
Policy document
Date
2016-12-03
Topics
Health human resources
Physician practice/ compensation/ forms
Text
Beginning in the 1990s most jurisdictions established regional health authorities (RHAs) with consolidated medical staff structures and there has been a trend toward requiring all physicians practising in a region to hold an appointment with the RHA in order to access health resources such as diagnostic imaging and laboratory services, irrespective of whether they hold hospital privileges or not. Subsequent to the consolidation of medical staff governance there have been several developments over the past decade that have implications for where and how physicians can practise, and for their ability to advocate freely on behalf of their patients. These include: * the establishment of formal physician resource plans that link the appointment process to the ability to participate in the provincial/territorial medical insurance plan; * a greater focus on clinical governance that includes detailed attention on scope of practice and privileges; * a growing concern about the ability of physicians to advocate on behalf of their patients and the communities they serve; and * an increase in the number of physicians entering into employment or contractual arrangements. The Canadian Medical Association (CMA) puts forward the following recommendations for governments, regulatory authorities, RHAs and medical staff structures within RHAs and hospitals. Recommendations Where physician appointments are to be approved in relation to Physician Resource Plans, the CMA recommends that such plans must: * take into consideration both population need and projected physician supply; * include transparency in the provision of information about available practice opportunities and on the criteria and processes through which applications for appointments are approved; * be based on a documented methodology with results in the public domain; and * be based on a medium-term projection range, using the most current and reliable data available, and be regularly reviewed and updated. The CMA recommends that the application of standardized credential templates must take into consideration the quality of care being provided by the physician and local circumstances such as the complement of medical and hospital resources available locally and the timeliness of proximity to secondary and tertiary care. The CMA strongly supports the implementation of policy to safeguard physicians from fear of reprisal and retaliation when speaking out as advocates for their patients and communities, and the right and duty of medical officers of health to speak publicly to the citizens they serve. The CMA supports provincial/territorial amendments to public health legislation to protect the right and duty of medical officers of health to speak publicly to the citizens they serve without political interference or risk of adverse employment consequences. The CMA believes that medical staff bylaws should expressly extend to physicians under contract entitlement to the procedural protections set out in the hospital or health authority bylaws. The CMA recommends that the processes of granting appointments, reappointments and privileges and allocating resources respect the following principles: 1. All processes should be fair, equitable, documented and transparent and should protect confidentiality. 2. Criteria for reappointment should be clearly specified in medical staff bylaws and should be no more onerous than necessary to verify the ongoing provision of quality care by the medical staff. 3. A regular evaluation of appointed physicians should be conducted by the appropriate clinical chief. 4. The quality of a physician's care is the most important criterion to be considered at the time of appointment, reappointment and the granting of privileges. 5. The information required for the granting of appointments, reappointments or privileges or for the allocation of medical resources must be accurate, valid and appropriate. 6. The processes of granting appointments, reappointments and privileges and allocating resources should recognize and accommodate the changes in practice patterns that may occur over the medical career cycle. 7. Physicians with established community practices have a significant investment in their practice and the community; this investment should be considered at the time of reappointment or change in privileges. 8. A recommendation, without just cause, to withdraw an appointment, to restrict privileges or to significantly reduce resources available to a physician must include appropriate compensation based on individual circumstances. 9. The reporting of legal actions or disciplinary actions as part of the reappointment or reappointment process should be restricted to those matters in which a final determination has been rendered and in which there has been an adverse finding to the physician. Objective This policy outlines the principles that should be considered for the granting of physician appointments, reappointments, privileges and access to resources at the health care facility, district or RHA level. Key definitions Appointment: The process by which a physician joins the medical staff of a health region or health facility in order to access resources to care for patients. Credentialing: An approach to obtaining, verifying and assessing the qualifications of a health professional against consistent criteria for the purposes of licensing and/or granting privileges.1 Privileges: Permission from an authorized body to a health care provider to conduct a specific scope and content of patient care. Privileges are granted based upon an evaluation of the provider's training, experience and competence related to the service, and are specific to a defined practice setting.1 Clinical peer review: The process by which physician peers assess each other's performance. A peer is a physician with relevant clinical experience in similar health care environments who also has the competence to contribute to the review of other physicians' performance.2 Background Historically the formal appointment process applied to physicians wishing to practise in hospitals. Beginning in the 1990s most jurisdictions established RHAs with consolidated medical staff structures and there has been a trend toward requiring all physicians practising in a region to hold an appointment with the RHA in order to access health resources such as diagnostic imaging and laboratory services, irrespective of whether they hold hospital privileges or not. Since the CMA first adopted principles for the physician appointment and reappointment process in 1997 there have been several developments that are reviewed below: * the establishment of formal physician resource plans that link the appointment process to the ability to participate in the provincial/territorial medical insurance plan; * a greater focus on clinical governance that includes detailed attention on scope of practice and privileges; * a growing concern about the ability of physicians to advocate on behalf of their patients and the communities they serve; and * an increase in the number of physicians entering into employment or contractual arrangements. Physician Resource Plans (PRPs): New Brunswick was the first province to require physicians to have privileges with an RHA in order to obtain a billing number.3 More recently jurisdictions such as Nova Scotia (N.S.) have introduced medium to longer range PRPs that are to be used when approving new appointments. In 2012 N.S. released a PRP for 2012-2021, which has since been updated to 2013-2022.4 Under the terms of the Nova Scotia Health Authority Medical Staff Bylaws, the RHA CEO or their designate will assess applications for new appointments in relation to need and availability of resources. The assessment is to be completed within 60 days and there is no right of review or appeal of the CEO's decision.5 Manitoba's medical staff bylaws make a similar provision.6 While Ontario has not regionalized to the same extent as other jurisdictions, legislation has been introduced that proposes to make the 14 Local Health Integration Networks (LHINs) responsible for primary care planning and performance management.7 Moreover the Bill will amend the Health Insurance Act to authorize the health minister to delegate non-fee-for-service physician compensation to the LHIN. Recommendation Where physician appointments are to be approved in relation to PRPs, the CMA recommends that such plans must: * take into consideration both population need and projected physician supply; * include transparency in the provision of information about available practice opportunities and on the criteria and processes through which applications for appointments are approved; * be based on a documented methodology with results in the public domain; and * be based on a medium-term projection range, using the most current and reliable data available, and be regularly reviewed and updated. Other physician resource planning considerations are set out in the CMA's comprehensive policy on PRPs.8 Clinical governance: Since the late 1990s there has been a great deal of attention paid to the concept of clinical governance, which may be defined as the structures, processes and culture needed to ensure that health care organizations and all individuals within them can assure the quality of the care they provide and are continuously seeking to improve it. During the past decade several provinces have carried out inquiries related to problems with pathology and radiology. In British Columbia (B.C.) the Chair of the BC Patient Safety & Quality Council conducted a review of the medical imaging credentialing and quality assurance that reported in 2011. In his final report, Dr. Douglas Cochrane set out 35 recommendations that called for much more rigorous and uniform oversight of medical practice in B.C.9 The recommendations included a call for: * the creation of a single medical staff administration to serve all health authorities and affiliated organizations; * the development of standardized processes for medical staff appointment, and credentialing and privileging, including common definitions; and * the development of performance assessment and review process for all physicians.9 The Cochrane report has resulted in the British Columbia Medical Quality Initiative (BC MQI). BC MQI is implementing an online Provincial Practitioner Credentialing and Privileging System (CACTUS Software) that will be used by all of B.C.'s RHAs to manage these processes for physicians, midwives, dentists and nurse practitioners.10 BC MQI has developed 62 privileging dictionaries for medical directors and department heads to use with their colleagues during initial and renewal privileging processes. The dictionaries recommend the required current experience to perform a certain activity in the form of numbers where applicable and also recommend the requirements for renewal of privileges and the requirements for return to practice. These recommendations are meant to take into account the individual's own experience and the context of the local site in which they work. They are meant to begin a conversation as needed with the department head, colleagues and others. The Society of Rural Physicians of Canada (SRPC) has raised concerns about the potential impact of volume-based credentialing on rural medical practice. For example, the dictionary for Family Practice with Enhanced Surgical Skills recommends that for operative delivery, a volume of at least five caesarean section deliveries be performed per year averaged over 24 months.11The SRPC has put forward recommendations that emphasize the need for appropriate peer review and consideration of geographic diversity and the range of medical practice, and that credential revalidation should be based on the actual quality of care provided by the physician, the continuing medical education completed by the physician and should also consider the impact of changes in delivery on the health outcomes in the community.12 It seems likely that other jurisdictions will be watching the CACTUS program with interest. Recommendation The CMA recommends that the application of standardized credential templates must take into consideration the quality of care being provided by the physician and local circumstances such as the complement of medical and hospital resources available locally and the timeliness of proximity to secondary and tertiary care. Advocacy: Advocacy has been identified as one of seven core roles of every physician by the Royal College of Physicians and Surgeons of Canada13 and the College of Family Physicians of Canada.14 This role entails physicians using their expertise and influence in the interests of their individual patients and the communities and populations they serve. Over the past decade there have been several instances where physicians have either expressed concern about their ability to advocate or have had disciplinary action taken against them, likely as a result of their advocacy activities. As a result of an inquiry carried out by the Health Quality Council of Alberta, the Alberta Medical Association, Alberta Health Services and the College of Physicians and Surgeons of Alberta have adopted a joint policy statement that sets out guidelines for physician advocacy.15 Eastern Health in Newfoundland and Labrador has a privacy/confidentiality oath or affirmation for physicians that acknowledges that they may have professional standards for disclosure and advocacy regarding patient safety, but stipulates the expectation that such concerns be first addressed through Eastern Health as an initial step.16 The CMA's policy on the evolving professional relationship between physicians and the health care system sets out nine factors for physicians to consider before undertaking advocacy.17 As predominantly employees of some level of government, and with a responsibility to sound an alert on population health risks, public health physicians are at greater risk of being disciplined for advocacy. There have been two high profile cases of public health physicians who have been dismissed for advocacy-related activities since 2000. Thus far only B.C. has enacted public health legislation to protect medical officers of health from political interference and adverse employment consequences. B.C.'s Public Health Act stipulates that the provincial health officer (PHO) has a duty to advise on provincial public health issues, which includes public reporting where the PHO believes it will best serve the public interest. Similarly sub-provincial medical health officers must advise on local public health issues and publicly report on them after consultation with the PHO. B.C.'s legislation also provides health officers with immunity from legal proceedings for actions done in good faith in the performance of their duties and for reports they are required to make. In addition the legislation protects health officers from "adverse actions", defined as an action that would either affect or threaten "the personal, financial or other interests of a person, or a relative, dependent, friend or business or other close association of that person" as a result of performing their duties in good faith.18 Recommendations The CMA strongly supports the implementation of policy to safeguard physicians from fear of reprisal and retaliation when speaking out as advocates for their patients and communities, and the right and duty of medical officers of health to speak publicly to the citizens they serve. The CMA supports provincial/territorial amendments to public health legislation to protect the right and duty of medical officers of health to speak publicly to the citizens they serve without political interference or risk of adverse employment consequences. Growing employment/contractual relationships: The move to RHAs, consolidation in the hospital sector and changing delivery models have had significant implications for the relationships between physicians and hospitals. The Canadian Medical Protective Association (CMPA) has identified several areas of concern, including patient advocacy, reporting of physicians, responding to adverse events, collection and use of physician information, practice arrangements and liability provision.19 One issue that the CMPA has highlighted in particular is the increasing trend in some jurisdictions for physicians to be engaged on a contracted employee basis rather than as independent contractors appointed with privileges.20 This is seen among facility-based physicians such as hospitalists, clinical and surgical assistants and laboratory physicians. The CMPA has cautioned that physicians engaged on a contractual basis may not have the same procedural rights on termination of contracts as those engaged under the privileging model and it has issued guidance on issues to consider with individual contracts, including CMPA assistance, indemnification clauses, liability provisions, confidentiality, termination of contract, dispute resolution and governing law.21 Recommendation The CMA believes that medical staff bylaws should expressly extend to physicians under contract entitlement to the procedural protections set out in the hospital or health authority bylaws. Principles Physicians must take a leadership role and be active participants in the development of appointment, reappointment and related processes; medical communities must therefore be aware of the basic principles that should be reflected in these processes. Once a physician has obtained a licence to practice, the process of appointment approval is the next step in obtaining permission to practise medicine in a health care facility, district or region. The next step is the granting of privileges. This bestows the right to perform specific medical acts within the health care facility, district or region. The final step is the provision of the necessary resources so that the physician is able to provide appropriate medical services for patient care. A medical committee with a clear structure and mandate to deal with appointments, reappointments and privileges must be maintained in all health care facilities, districts and regions so that physician input may be given during the appointment, reappointment and related processes. Clinical peer review must be foundational to these processes. Time, training and resources must be sufficient to support consistent peer review processes. The principles proposed below apply to all of the following processes: the appointment and reappointment processes, the granting of privileges and the allocation of health care facility, district or regional resources. Principles for the processes of granting appointments, reappointments and privileges and allocating resources 1. All processes should be fair, equitable, documented and transparent and should protect confidentiality. They should be completed in a timely manner and follow the rules of natural justice. At a minimum, the rules of natural justice give the physician the right to notice and the right to be heard before, and provided with reasons by, an impartial adjudicator. Given the nature of the physician's interests in the appointment, reappointment and other related processes, the following principles should also be included: * the right to be heard, either in person and (or) by representation; * the right to full disclosure of the information being considered by the committee that makes recommendations on appointments, reappointments and privileges; * the right to present evidence; * the right to a hearing free from bias, either real or perceived; * the right to a record of the proceedings; * a decision within a reasonable period; * the right to receive written reasons for the decision; and * the right to an appeal process by an independent and impartial body other than the board of the health care facility, district or region. It is important that all processes, including any review processes, follow the principles of natural justice. These processes should be part of the medical staff bylaws that guide the operation of the health care facility, district or region and should be known to all appointed physicians. 2. Criteria for reappointment should be clearly specified in medical staff bylaws and should be no more onerous than necessary to verify the ongoing provision of quality care by the medical staff. Medical staff appointments are typically for a one-year term. Criteria for reappointment vary across Canada, ranging from the provision of evidence of renewed licensure and liability coverage with a discretionary in-depth performance evaluation to the foregoing plus a mandated in-depth performance evaluation and reporting on continuing professional development activity. 3. A regular evaluation of appointed physicians should be conducted by the appropriate clinical chief. It should consist of a fair, documented process with explicit, agreed-upon criteria for the review of the physician's qualifications and credentials and the quality of care provided. If there is demonstrated inappropriate behaviour or a quality-of-care issue, a program for remediation should be established with regular follow-up over a period deemed appropriate by the physician's peers. As in other jobs, the objective of regular performance evaluations for a physician is to improve the physician's performance and the focus should be on opportunities for learning and improvement. The appraisal should entail a standardized peer evaluation process, in addition to self-assessment. The self-assessment process should include the recognition of satisfactory existing skills and the identification of new skills to be learned. In some situations remediation may be justified, for example when there is a need to upgrade skills, when interpersonal and communication skills are unacceptable, and when there is alcohol or drug abuse. Physician evaluations conducted by RHAs should take into account requirements already asked of the physician by their certifying and/or licensing body or other speciality organization in order to avoid duplication of effort. Looking ahead, with the increasing focus on team-based collaborative care, performance of team function and its impact on overall performance to meet health service requirements and quality of care is expected to become increasingly relevant. Conflict resolution mechanisms, scopes of practice and shared roles and responsibilities will need to be considered in order to assess individual and team performance. 4. The quality of a physician's care is the most important criterion to be considered at the time of appointment, reappointment and the granting of privileges. Quality care may be defined as the provision of service that satisfies the needs of the patient and meets the standards set out by recognized bodies of the profession, such as licensing bodies, national clinical societies and others. The essential components of quality include competence, accessibility, acceptability, effectiveness, appropriateness, efficiency, affordability and safety. The cost of a physician's care should not be the primary criterion considered during appointment, reappointment and related processes. Practice patterns, resulting in differences in cost of care, will differ for numerous reasons, including severity of illness, patient mix and patient choices. If there is a local, regional or district physician resource plan, then the need for a particular physician skill base as identified in the plan is an important criterion for appointment or reappointment to institutions within the plan. Physicians must be involved in the development of such a plan, and the plan must be supported by physicians at the local, district or regional level. If a practice and remuneration plan is introduced for a facility, hospital or academic health sciences centre, then participation in such a plan should not be a criterion for reappointment. 5. The information required for the granting of appointments, reappointments or privileges or for the allocation of medical resources must be accurate, valid and appropriate. The information required for these purposes should generally be limited to that which is reasonably necessary to determine the physician's ability to provide safe care. Physician's privacy should only be violated if it is determined that a medical condition or other disability poses an unacceptable risk to patients. The physician's credentials, skills, expertise and quality of care, as judged by peer assessment, should be considered during the appointment or reappointment process. Utilization data and associated indicators are being used more frequently as criteria for appointment and reappointment. Therefore, physicians must be involved in the development of such indicators, and there must be agreement by all parties on the type and quality of data or indicators to be used. In addition, before appointment or reappointment, physicians must be made aware of the data or indicators that will be used to evaluate them and the criteria by which these indicators will be applied. 6. The processes of granting appointments, reappointments and privileges and allocating resources should recognize and accommodate the changes in practice patterns that may occur over the medical career cycle. These processes should be flexible and reasonable concerning other issues such as on-call responsibilities or time needed to fulfil research and teaching commitments. It is important to recognize that a physician's practice pattern may change during his or her medical career. These changes may reflect the desire to no longer take call, the narrowing of the physician's practice to achieve a higher level of expertise in a specific area or the desire to pursue academic interests or responsibilities. Pregnancy, parental leave and the wish to practice part-time must also be considered. The quality of a physician's personal life and other special needs should be viewed as important and should be considered by those making decisions in these areas. 7. Physicians with established community practices have a significant investment in their practice and the community; this investment should be considered at the time of reappointment or change in privileges. An established physician may face financial loss if he or she is not reappointed or if there is a recommendation to substantially change his or her privileges. This possibility should be considered at the time of reappointment or change in privileges. 8. A recommendation, without just cause, to withdraw an appointment, to restrict privileges or to significantly reduce resources available to a physician must include appropriate compensation based on individual circumstances. Appropriate compensation includes financial restitution, retraining, relocation assistance and counselling assistance as required. Sufficient notice and other elements of due process should also be components of this recommendation. Generally, physicians are not employees of a health care facility, district or regional authority. Nonetheless, there are often extensive restrictions on physician mobility and limited opportunities to practice both inside and outside a province or territory. Age may also be a factor in the ability to find placement elsewhere, particularly if the physician is nearing retirement age. For these reasons, an interruption or cessation of a physician's career caused by withdrawal of an appointment, restriction of privileges or reduction in the resources available to the physician justifies appropriate compensation and due notice; this is in keeping with good human resource practices. Appropriate notice should be provided to physicians so that there is minimal impact on patient care. What constitutes timely and appropriate notice may in some cases be several months and will differ depending on the impact of the decision. Examples of decisions that could have a significant impact on physicians include: * temporary or permanent closure of operating rooms or other facilities; * strategic redirection of the hospital that may adversely affect a particular medical service or department, such as regionalization of laboratory testing or provincial centralization of a specialized service; and * implementation of a retirement policy. 9. The reporting of legal actions or disciplinary actions as part of the reappointment or reappointment process should be restricted to those matters in which a final determination has been rendered and in which there has been an adverse finding to the physician. References 1 Accreditation Canada. Qmentum Standards. Governance. Ottawa: Accreditation Canada; 2016. 2 Australian Commission on Safety and Quality in Healthcare. Review by peers: a guide for professional, clinical and administrative processes. Sydney: Australian Commission on Safety and Quality in Health Care; July 2010. Available: http://www.safetyandquality.gov.au/wp-content/uploads/2012/01/37358-Review-by-Peers.pdf (accessed 2016 May 02). 3 New Brunswick Department of Health. Registration requirements. Fredericton: New Brunswick Department of Health; 2016. Available: http://www.gnb.ca/0394/prw/RegistrationRequirements-e.asp (accessed 2016 May 02). 4 Nova Scotia Department of Health and Wellness. Shaping our Physician Workforce. Updates. Halifax: Nova Scotia Department of Health and Wellness; 2016. Available: http://novascotia.ca/dhw/shapingPhysicianWorkforce/updates.asp (accessed 2016 May 02). 5 Province of Nova Scotia. Nova Scotia Health Authority Medical Staff Bylaws. Halifax: Province of Nova Scotia; April 2015. Available: https://www.novascotia.ca/just/regulations/regs/hamedstaff.htm (accessed 2016 May 02). 6 Winnipeg Regional Health Authority. WRHA Board By-Law No.3 Medical Staff. Winnipeg: Winnipeg Regional Health Authority; March 2014. Available: http://www.wrha.mb.ca/extranet/medicalstaff/files/MedByLaw.pdf (accessed 2016 May 02). 7 Bill 41. An Act to amend various Acts in the interests of patient-centred care. 2nd Sess, 41st Leg, Ontario; 2016. Available: http://www.ontla.on.ca/bills/bills-files/41_Parliament/Session2/b041.pdf (accessed 2016 Nov 07). 8 Canadian Medical Association. Physician resource planning. Updated 2015. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-07.pdf (accessed 2016 May 02). 9 Cochrane DD. Investigation into medical imaging, credentialing and quality assurance. Phase 2 report. Vancouver: BC Patient Safety & Quality Council; Aug 2011. Available: http://www.health.gov.bc.ca/library/publications/year/2011/cochrane-phase2-report.pdf (accessed 2016 May 02). 10 British Columbia Medical Quality Initiative. Briefing note: BC MQI - Provincial Practitioner Credentialing and Privileging System (CACTUS Software) Implementation. Vancouver: British Columbia Medical Quality Initiative; January 2016. Available: http://bcmqi.ca/wp-content/uploads/Briefing-Note_ProvincialPractitionerCPSystemImplementation.pdf (accessed 2016 May 02). 11 British Columbia Medical Quality Initiative. Family Practice with Enhanced Surgical Skills Clinical Privileges. Vancouver: British Columbia Medical Quality Initiative; March 2015. Available: http://www.srpc.ca/ess2016/summit/FamilyPracticeEnhancedSurgicalSkills.pdf (accessed 2016 Nov 06). 12 Soles H, Larsen Soles T. SRPC position statement on minimum-volume credentialing. Can J Rural Med. 2016;21(4):107-11. 13 Royal College of Physicians and Surgeons of Canada. CanMEDS 2015. Physician competency framework. Ottawa: Royal College of Physicians and Surgeons of Canada; 2015. Available: http://canmeds.royalcollege.ca/uploads/en/framework/CanMEDS%202015%20Framework_EN_Reduced.pdf (accessed 2016 May 02). 14 College of Family Physicians of Canada. CanMEDS-Family Medicine. Working Group on Curriculum Review. Mississauga: College of Family Physicians of Canada; October 2009. Available: http://www.cfpc.ca/uploadedFiles/Education/CanMeds%20FM%20Eng.pdf (accessed 2016 May 02). 15 Alberta Medical Association, Alberta Health Services, College of Physicians and Surgeons of Alberta. Advocacy Policy Statement. Edmonton: Alberta Medical Association; 2015. Available: https://www.albertadoctors.org/Advocacy/Policy_Statement.pdf (accessed 2016 May 02). 16 Eastern Health. Privacy and confidentiality. ADM-030. St. John's, NL: Eastern Health; 2015. Available: http://www.easternhealth.ca/OurServices.aspx?d=2&id=743&p=740 (accessed 2016 Jun 23). 17 Canadian Medical Association. The evolving professional relationship between Canadian physicians and our evolving health care system: where do we stand? Ottawa: The Association; 2012. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_The_evolving_professional_relationship_between_Canadian_physicians_and_our_health_care_system_PD12-04-e.pdf (accessed 2016 May 02). 18 Public Health Act. SBC 2008, Chapter 28. Available: http://www.bclaws.ca/civix/document/id/complete/statreg/08028_01 (accessed 2016 Nov 07). 19 Canadian Medical Protective Association. Changing physician-hospital relationships: Managing the medico-legal implications of change. Ottawa: The Association; 2011. Available: https://www.cmpa-acpm.ca/-/changing-physician-hospital-relationships (accessed 2016 Nov 07). 20 Canadian Medical Protective Association. The changing practice of medicine: employment contracts and medical liability. Ottawa: The Association; 2012. Available: https://www.cmpa-acpm.ca/-/the-changing-practice-of-medicine-employment-contracts-and-medical-liability (accessed 2016 Nov 07). 21 Canadian Medical Protective Association. Medical-legal issues to consider with individual contracts. Ottawa: The Association; 2016. Available: https://www.cmpa-acpm.ca/-/medico-legal-issues-to-consider-with-individual-contracts (accessed 2016 Nov 07).
Documents
Less detail

Regulation of Self-Care Products in Canada

https://policybase.cma.ca/en/permalink/policy13802
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) appreciates the opportunity to respond to the Health Canada consultations on the regulation of self-care products in Canada. The CMA is encouraged that Health Canada is proposing a framework for the regulation of self-care products that is reliant on scientific proof to support health claims. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA’s comments on the regulation of self-care products, particularly natural health products and non-prescription drugs is based on the CMA Policy on Complementary and Alternative Medicine attached as Appendix 1. Our position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Canadians deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end.1 CMA supports a regulatory approach to self-care products such as natural health products that is based on risk assessment and the development of standards. 2 1 Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf F:\E-sig\JB_Signature.jpg 2 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 3Canadian Medical Association. CMA Policy Complementary and Alternative Medicine (Update 2015). Ottawa: The Association: 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-09.pdf 4 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 5 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. 6 Canadian Medical Association. Brief BR2014-09 - Bill C-17 An Act to amend the Food and Drugs Act. Ottawa: The Association; 2014. Risk Based Approach As noted above CMA has recommended a regulatory approach that is based on risk assessment. We are troubled that the consultation document does not provide enough information on Health Canada’s risk assessment process. We are concerned that the proposal for a risk based approach could place many natural health and homeopathic products in a lower risk category based on whether or not the product makes a health claim which would require no Health Canada review or licensing of these products. As noted in the consultation document all health products have some level of risk and Health Canada’s role is to ensure that the benefits of a product outweigh any know risks. CMA does not believe that a determination of risk can be made based on historical use of a product or on the basis of a philosophical system not supported by science. The CMA has a long standing position that the same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. 3 CMA would recommend that the initial risk assessment of a self-care product should be evidence informed and based on the same standards of proof and efficacy as those for conventional medicines and pharmaceuticals. As such, we are concerned that homeopathic and natural health products are given as examples of lower risk products that would not require Health Canada review or licensing. Health Claims The consultation document redefines a health claim to only those that pertain to diagnosis, treatment, prevention, cure or mitigation of disease or serious health condition. These claims will need to be supported by scientific evidence and only these health claims will be allowed and reviewed by Health Canada. The CMA has recommended that safety and efficacy claims for natural health products, and claims for the therapeutic value of these products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications currently regulated by Health Canada. 4 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.5 Therefore the CMA supports the proposal that two products making similar claims would have to provide the same level of scientific evidence and are held to the same standard. CMA would not be in support of the proposal that products can still make claims “based on traditional systems of medicine or alternate modalities” with only “adequate supporting information” to be maintained by the company without review or licensing by Health Canada. CMA would also recommend that even those products that do not make health claims are held to the same standard as those established for pharmaceutical products. Since our position is that all self-care products from lower risk to higher risk should be reviewed for safety and quality, all products should undergo review by Health Canada. Information It is certainly problematic that, as noted in the consultation document, fewer than 2 in 5 Canadians surveyed rated themselves knowledgeable about the effectiveness of self-care products. Canadians have the right to reliable, accurate information on self-care products to help ensure that choices they make are informed. It is very important that Canadians understand the level of scrutiny a product has undergone by Health Canada. CMA can support the proposal for an authorization number on those products that have been reviewed and approved by Health Canada. Equally, a disclaimer on the product label that indicates that the product has not been reviewed or approved by Health Canada for effectiveness is very important. We must guard against an assumption by the public that if Health Canada did not need to review a product there is no risk associated with the product. The Information provided on self-care products should be user friendly and easy to access and include a list of ingredients, instructions for use, indications that the product has been proven to treat, contraindications, side effects and interactions with other medications. In an era when product claims can be spread vie social media and the internet and cannot be easily monitored it is important to ensure consistent oversight of product marketing. Health claims can only be promoted if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Additional Powers In its submission on Bill C -17 An Act to amend the Food and drugs Act – Protecting Canadians from Unsafe drugs the CMA recommended that the ministerial authorities and measures to address patient safety risks should extend to natural health products.6 We would therefore suggest that Health Canada explore the need for additional powers and tools to require a company to change labels, or order a recall of an unsafe product and institute new penalties to address patient safety issues. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's regulatory framework for self-care products to ensure that the health related products Canadians receive are safe and effective. Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism Canadian Medical Association CMA POLICY COMPLEMENTARY AND ALTERNATIVE MEDICINE (Update 2015) This statement discusses the Canadian Medical Association’s (CMA) position on complementary and alternative medicine (CAM). CAM, widely used in Canada, is increasingly being subject to regulation. The CMA’s position is based on the fundamental premise that decisions about health care interventions used in Canada should be based on sound scientific evidence as to their safety, efficacy and effectiveness - the same standard by which physicians and all other elements of the health care system should be assessed. Patients deserve the highest standard of treatment available, and physicians, other health practitioners, manufacturers, regulators and researchers should all work toward this end. All elements of the health care system should “consider first the well-being of the patient.”1 The ethical principle of non-maleficence obliges physicians to reduce their patient’s risks of harm. Physicians must constantly strive to balance the potential benefits of an intervention against its potential side effects, harms or burdens. To help physicians meet this obligation, patients should inform their physician if the patient uses CAM. 1 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. 2 Canadian Medical Association. Policy resolution GC00-196 - Clinical care to incorporate evidence-based technological advances. Ottawa (ON): The Association; 2000. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 3 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 4 Canadian Medical Association. CMA statement on emerging therapies [media release]. Ottawa (ON): The Association; 2010. Available: www.facturation.net/advocacy/emerging-therapies. CAM in Canada CAM has been defined as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.”i This definition comprises a great many different, otherwise unrelated products, therapies and devices, with varying origins and levels of supporting scientific evidence. For the purpose of this i Working definition used by the National Center for Complementary and Alternative Medicine of the U.S. National Institutes of Health. analysis, the CMA divides CAM into four general categories: . Diagnostic Tests: Provided by CAM practitioners. Unknown are the toxicity levels or the source of test material, e.g., purity. Clinical sensitivity, specificity, and predictive value should be evidence-based. . Products: Herbal and other remedies are widely available over-the-counter at pharmacies and health food stores. In Canada these are regulated at the federal level under the term Natural Health Products. . Interventions: Treatments such as spinal manipulation and electromagnetic field therapy may be offered by a variety of providers, regulated or otherwise. . Practitioners: There are a large variety of practitioners whose fields include chiropractic, naturopathy, traditional Chinese and Ayurvedic medicine, and many others. Many are unregulated or regulated only in some provinces/territories of Canada. Many Canadians have used, or are currently using, at least one CAM modality. A variety of reasons has been cited for CAM use, including: tradition; curiosity; distrust of mainstream medicine; and belief in the “holistic” concept of health which CAM practitioners and users believe they provide. For most Canadians the use is complementary (in addition to conventional medicine) rather than alternative (as a replacement). Many patients do not tell their physicians that they are using CAM. Toward Evidence-Informed Health Care Use of CAM carries risks, of which its users may be unaware. Indiscriminate use and undiscriminating acceptance of CAM could lead to misinformation, false expectations, and diversion from more appropriate care, as well as adverse health effects, some of them serious. The CMA recommends that federal, provincial and territorial governments respond to the health care needs of Canadians by ensuring the provision of clinical care that continually incorporates evidence-informed technological advances in information, prevention, and diagnostic and therapeutic services.2 Physicians take seriously their duty to advocate for quality health care and help their patients choose the most beneficial interventions. Physicians strongly support the right of patients to make informed decisions about their medical care. However, the CMA’s Code of Ethics requires physicians to recommend only those diagnostic and therapeutic procedures that they consider to be beneficial to the patient or to others.3 Until CAM interventions are supported by scientifically-valid evidence, physicians should not recommend them. Unless proven beneficial, CAM services should not be publicly funded. To help ensure that Canadians receive the highest-quality health care, the CMA recommends that CAM be subject to rigorous research on its effects, that it be strictly regulated, and that health professionals and the public have access to reliable, accurate, evidence-informed information on CAM products and therapies. Specific recommendations are provided below: a) Research: Building an Evidence Base To date, much of the public’s information on CAM has been anecdotal, or founded on exaggerated claims of benefit based on few or low-quality studies. The CMA is committed to the principle that, before any new treatment is adopted and applied by the medical profession, it must first be rigorously tested and recognized as evidence-informed.4 Increasingly, good-quality, well-controlled studies are being conducted on CAM products and therapies. The CMA supports this development. Research into promising therapies is always welcome and should be encouraged, provided that it is subject to the same standards for proof and efficacy as those for conventional medical and pharmaceutical treatments. The knowledge thus obtained should be widely disseminated to health professionals and the public. b) An Appropriate Regulatory Framework Regulatory frameworks governing CAM, like those governing any health intervention, should enshrine the concept that therapies should have a proven benefit before being represented to Canadians as effective health treatments. i) Natural Health Products. Natural health products are regulated at the federal level through the Natural Health Products Directorate of Health Canada. The CMA believes that the principle of fairness must be applied to the regulatory process so that natural health products are treated fairly in comparison with other health products.5 The same regulatory standards should apply to both natural health products and pharmaceutical health products. These standards should be applied to natural health products regardless of whether a health claim is made for the product. This framework must facilitate the entry of products onto the market that are known to be safe and effective, and impede the entry of products that are not known to be safe and effective until they are better understood. It should also ensure high manufacturing standards to assure consumers of the products’ safety, quality and purity. The CMA also recommends that a series of standards be developed for each natural health product. These standards should include: 5 Canadian Medical Association. CMA statement on emerging therapies [media release]. Available: www.facturation.net/advocacy/emerging-therapies. 6 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa (ON): The Association; 1998. 7 Canadian Medical Association. Policy resolution GC08-86 - Natural health products. Ottawa (ON): The Association; 2008. 8 Canadian Medical Association. Policy resolution GC10-100 - Foods fortified with “natural health” ingredients. Ottawa (ON): The Association; 2010. Available: 9 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 7. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 10 Canadian Medical Association. CMA code of ethics (update 2004). Ottawa: The Association; 2004. Paragraph 11. Available: http://policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm. 11 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. 12 Canadian Medical Association. Brief BR1998-02 - Regulatory framework for natural health products. Ottawa: The Association; 1998. * manufacturing processes that ensure the purity, safety and quality of the product; * labelling standards that include standards for consumer advice, cautions and claims, and explanations for the safe use of the product to the consumer.6 The CMA recommends that safety and efficacy claims for natural health products be evaluated by an arm’s length scientific panel, and claims for the therapeutic value of natural health products should be prohibited when the supportive evidence does not meet the evidentiary standard required of medications regulated by Health Canada.7 Claims of medical benefit should only be permitted when compelling scientific evidence of their safety and efficacy exists.8 The Canadian Medical Association advocates that foods fortified with “natural health” ingredients should be regulated as food products and not as natural health products The CMA recommends that the regulatory system for natural health products be applied to post-marketing surveillance as well as pre-marketing regulatory review. Health Canada’s MedEffect adverse reaction reporting system now collects safety reports on Natural Health Products. Consumers, health professionals and manufacturers are encouraged to report adverse reactions to Health Canada. ii) CAM Practitioners. Regulation of CAM practitioners is at different stages. The CMA believes that this regulation should: ensure that the services CAM practitioners offer are truly efficacious; establish quality control mechanisms and appropriate standards of practice; and work to develop an evidence-informed body of competence that develops with evolving knowledge. Just as the CMA believes that natural health products should be treated fairly in comparison with other health products, it recommends that CAM practitioners be held to the same standards as other health professionals. All CAM practitioners should develop Codes of Ethics that insure practitioners consider first the best interests of their patients. Among other things, associations representing CAM practitioners should develop and adhere to conflict of interest guidelines that require their members to: . Resist any influence or interference that could undermine their professional integrity;9 . Recognize and disclose conflicts of interest that arise in the course of their professional duties and activities, and resolve them in the best interests of patients;10 . Refrain, for the most part, from dispensing the products they prescribe. Engaging in both prescribing and dispensing , whether for financial benefit or not, constitutes a conflict of interest where the provider's own interests conflict with their duty to act in the best interests of the patient. c) Information and Promotion Canadians have the right to reliable, accurate information on CAM products and therapies to help ensure that the treatment choices they make are informed. The CMA recommends that governments, manufacturers, health care providers and other stakeholders work together to ensure that Canadians have access to this information. The CMA believes that all natural health products should be labeled so as to include a qualitative list of all ingredients. 11 Information on CAM should be user-friendly and easy to access, and should include: . Instructions for use; . Indications that the product or therapy has been convincingly proven to treat; . Contraindications, side effects and interactions with other medications; . Should advise the consumer to inform their health care provider during any encounter that they are using this product.12 This information should be provided in such a way as to minimize the impact of vested commercial interests on its content. In general, brand-specific advertising is a less than optimal way of providing information about any health product or therapy. In view of our limited knowledge of their effectiveness and the risks they may contain risks, the advertising of health claims for natural health products should be severely restricted. The CMA recommends that health claims be promoted only if they have been established with sound scientific evidence. This restriction should apply not only to advertising, but also to all statements made in product or company Web sites and communications to distributors and the public. Advertisements should be pre-cleared to ensure that they contain no deceptive messages. Sanctions against deceptive advertising must be rigidly enforced, with Health Canada devoting adequate resources to monitor and correct misleading claims. The CMA recommends that product labels include approved health claims, cautions and contraindications, instructions for the safe use of the product, and a recommendation that patients tell physicians that they are using the products. If no health claims are approved for a particular natural health product, the label should include a prominent notice that there is no evidence the product contributes to health or alleviates disease. The Role of Health Professionals Whether or not physicians and other health professionals support the use of CAM, it is important that they have access to reliable information on CAM products and therapies, so that they can discuss them with their patients. Patients should be encouraged to report use of all health products, including natural health products, to health care providers during consultations. The CMA encourages Canadians to become educated about their own health and health care, and to appraise all health information critically. The CMA will continue to advocate for evidence-informed assessment of all methods of health care in Canada, and for the provision of accurate, timely and reliable health information to Canadian health care providers and patients.
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Front-of-package labelling consultation

https://policybase.cma.ca/en/permalink/policy13800
Date
2016-10-31
Topics
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-10-31
Topics
Health care and patient safety
Text
The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices. In this regard, CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans fat and calorie content of processed foods and prepared meals; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels.1 We commend Health Canada on recent work on updating the nutrition facts table and the current revision of the Canada Food Guide and are very pleased to provide a response to the consumer questionnaire on the Health Canada proposal for front-of-package (FOP) nutrition labelling. FOP nutrition labelling approach and possible symbols Do you support Health Canada's proposal to use a symbol to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. In 2011, appearing before the House of Commons Standing Committee on Health, the CMA supported a standard "at a glance" approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices.2 There is a growing body of evidence linking the consumption of diets high in saturated fats, sugars or sodium to cardiovascular and chronic disease (hypertension, dyslipidemia, diabetes mellitus, obesity, cancer, and heart disease and stroke) - leading preventable risk factors and causes of death and disability within Canada and worldwide. Therefore, the CMA does support the proposal to use a symbol for "high in" FOP labelling of foods high in sugar, sodium or saturated fats. FOP labelling on packaged foods may help Canadians make healthier food choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. Which symbol would help you recognize foods high in sodium, sugars and/or saturated fat? Please explain. Of the proposed symbols, we believe that those that resemble a stop sign would send a strong and recognizable signal of a food to avoid. The triangle yield sign shape is too similar to the shape often used to indicate a hazard such as poison. We would recommend holding focus groups with Canadians to better understand how the proposed symbols will be understood by consumers. Foods that do not have nutrition labelling Do you think these foods should be exempt from FOP symbols even if they're high in sodium, sugars and/or saturated fat? Please explain. The CMA can support the exemption of FOP labelling for products in very small packages but we would like to see a provision to include information on "high in" sugar, salt or saturated fats on foods such as sausages, bakery products, prepared dishes from the deli produced and prepackaged by grocery stores/retailers as they are categories of foods often high in these nutrients. A "high in" sticker could be added to the retailer's packaging to be consistent with other packaged foods. Nutrient levels for a "high in" FOP label Do you think the proposed nutrient levels make sense to identify foods that are high in sodium, sugars and/or saturated fat? Please explain. The CMA supports the proposed nutrient levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring that the "high in" threshold and the 15% "a lot" daily value (DV) message are consistent delivers a clear message of concern. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we suggest that the threshold for "high in" sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Updating nutrient content claims and other nutrition-related statements Do you support not allowing a "no added sugars" claim on foods high in sugars? Please explain. Allowing a food that qualifies for a "high in" sugar FOP symbol to also display a "no added sugars" claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing "no added sugar" claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. Labelling of foods that have sweeteners Do you support that these sweeteners be declared in the list of ingredients only, rather than in the list of ingredients and the front of the package? Please explain. We do not support the elimination of the labelling requirement for artificial sweeteners on the principle display panel. For products that have high intensity sweeteners added and which bear claims such as "unsweetened" or "no sugar added," a declaration of "artificially sweetened" should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn't need to be on the principal display. For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government's Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism 1 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. 2 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca --------------- ------------------------------------------------------------ --------------- ------------------------------------------------------------
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Avoiding negative consequences to health care delivery from federal taxation policy

https://policybase.cma.ca/en/permalink/policy11957
Date
2016-08-31
Topics
Health human resources
Physician practice/ compensation/ forms
  1 document  
Policy Type
Response to consultation
Date
2016-08-31
Topics
Health human resources
Physician practice/ compensation/ forms
Text
The Canadian Medical Association (CMA) provides this submission in response to Finance Canada’s consultation on Legislative Proposals Relating to Income Tax, Sales Tax and Excise Duties (Draft Tax Legislative Proposals). The CMA is the national voice of Canadian physicians. On behalf of its more than 83,000 members and the Canadian public, the CMA’s mission is helping physicians care for patients. In fulfillment of this mission, the CMA’s role is focused on national, pan-Canadian health advocacy and policy priorities. As detailed in this brief, the CMA is gravely concerned that by capturing group medical structures in the application of Clause 13 of the Draft Tax Legislative Proposals, the federal government will inadvertently negatively affect medical research, medical training and education as well as access to care. To ensure that the unintended consequences of this federal tax policy change do not occur, the CMA is strongly recommending that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction in Clause 13 of the Draft Tax Legislative Proposals. Relevance of the Canadian Controlled Private Corporation Framework to Medical Practice Canada’s physicians are highly skilled professionals, providing an important public service and making a significant contribution to our country’s knowledge economy. Due to the design of Canada’s health care system, a large majority of physicians – more than 90% – are self-employed professionals and effectively small business owners. As self-employed small business owners, physicians typically do not have access to pensions or health benefits, although they are responsible for these benefits for their employees. Access to the Canadian-Controlled Private Corporation (CCPC) framework and the Small Business Deduction (SBD) are integral to managing a medical practice in Canada. It is imperative to recognize that physicians cannot pass on any increased costs, such as changes to CCPC framework and access to the SBD, onto patients, as other businesses would do with clients. In light of the unique business perspectives of medical practice, the CMA strongly welcomed the federal recognition in the 2016 budget of the value that health care professionals deliver to communities across Canada as small business operators. Contrary to this recognition, the 2016 budget also introduced a proposal to alter eligibility to the small business deduction that will impact physicians incorporated in group medical structures. What’s at risk: Contribution of group medical structures to health care delivery The CMA estimates that approximately 10,000 to 15,000 physicians will be affected by this federal taxation proposal. If implemented, this federal taxation measure will negatively affect group medical structures in communities across Canada. By capturing group medical structures, this proposal also introduces an inequity amongst incorporated physicians, and incentivizes solo practice, which counters provincial and territorial health delivery priorities. Group medical structures are prevalent within academic health science centres and amongst certain specialties, notably oncology, anaesthesiology, radiology, and cardiology. Specialist care has become increasingly sub-specialized. For many specialties, it is now standard practice for this care to be provided by teams composed of numerous specialists, sub-specialists and allied health care providers. Team-based care is essential for educating and training medical students and residents in teaching hospitals, and for conducting medical research. Put simply, group medical structures have not been formed for taxation or commercial purposes. Rather, group medical structures were formed to deliver provincial and territorial health priorities, primarily in the academic health setting, such as teaching, medical research as well as optimizing the delivery of patient care. Over many years, and even decades, provincial and territorial governments have been supporting and encouraging the delivery of care through team-based models. To be clear, group medical structures were formed to meet health sector priorities; they were not formed for business purposes. It is equally important to recognize that group medical structures differ in purpose and function from similar corporate or partnership structures seen in other professions. Unlike most other professionals, physicians do not form these structures for the purpose of enhancing their ability to earn profit. It is critical for Finance Canada to acknowledge that altering eligibility to the small business deduction will have more significant taxation implication than simply the 4.5% difference in the small business versus general rate at the federal level. It would be disingenuous for Finance Canada to attempt to argue that removing full access to the small business deduction for incorporated physicians in group medical structures will be a minor taxation increase. As taxation policy experts, Finance Canada is aware that this change will impact provincial/territorial taxation, as demonstrated below in Table 1. Table 1: Taxation impacts by province/territory, if the federal taxation proposal is implemented In Nova Scotia, for example, approximately 60% of specialist physicians practice in group medical structures. If the federal government applies this taxation proposal to group medical structures, these physicians will face an immediate 17.5% increase in taxation. In doing so, the federal government will establish a strong incentive for these physicians to move away from team-based practice to solo practice. If this comes to pass, the federal government may be responsible for triggering a reorganization of medical practice in Nova Scotia. Excerpts from physician communiques The CMA has received as well as been copied on a significant volume of correspondence from across our membership conveying deep concern with the federal taxation proposal. To provide an illustration of the risks of this proposal to health care, below are excerpts from some of these communiques:
“Our Partnership was formed in the 1970s…The mission of the Partnership is to achieve excellence in patient care, education and research activities….there would be a serious adverse effect on retention and recruitment if members do not have access to the full small business deduction…The changes will likely result in pressure to dissolve the partnership and revert to the era of departments services by independent contractors with competing individual financial interests.” Submitted to the CMA April 15, 2016 from a member of the Anesthesia Associates of the Ottawa Hospital General Campus
“The University of Ottawa Heart Institute is an academic health care institution dedicated to patient care, research and medical education…To support what we call our “academic mission,” cardiologists at the institute have formed an academic partnership…If these [taxation] changes go forward they will crippled the ability of groups such as ours to continue to function and will have a dramatic negative impact on medical education, innovative health care research, and the provision of high-quality patient care to our sickest patients.” Submitted to the CMA April 19, 2016 from a member of the Associates in Cardiology
“We are a general partnership consisting of 93 partners all of whom are academic anesthesiologists with appointments to the Faculty of the University of Toronto and with clinical appointments at the University Health Network, Sinai Health System or Women’s College Hospital…In contrast to traditional business partnerships, we glean no business advantage whatsoever from being in a partnership…the proposed legislation in Budget 2016 seems unfair in that it will add another financial hardship to our partners – in our view, this is a regressive tax on research, teaching and innovation.” Submitted to the CMA April 14, 2016 from members of the UHN-MSH Anesthesia Associates Recommendation The CMA recommends that the federal government exempt group medical and health care delivery from the proposed changes to s.125 of the Income Tax Act regarding multiplication of access to the small business deduction, as proposed in Clause 13 of the Draft Tax Legislative Proposals. Below is a proposed legislative amendment to ensure group medical structures are exempted from Clause 13 of the Draft Tax Legislative Proposals: Section 125 of the Act is amended by adding the following after proposed subsection 125(9): 125(10) Interpretation of designated member – [group medical partnership] – For purposes of this section, in determining whether a Canadian-controlled private corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician is a designated member of a particular partnership in a taxation year, the term "particular partnership" shall not include any partnership that is a group medical partnership. 125(11) Interpretation of specified corporate income – [group medical corporation] – For purposes of this section, in determining the specified corporate income for a taxation year of a corporation controlled directly or indirectly in any manner whatever by one or more physicians or a person that does not deal at arm's length with a physician, the term "private corporation" shall not include a group medical corporation. Subsection 125(7) of the Act is amended by adding the following in alphabetical order: "group medical partnership" means a partnership that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice; "group medical corporation" means a corporation that: (a) is controlled, directly or indirectly in any manner whatever, by one or more physicians or a person that does not deal at arm's length with a physician; and (b) earns all or substantially all of its income for the year from an active business of providing services or property to, or in relation to, a medical practice. "medical practice" means any practice and authorized acts of a physician as defined in provincial or territorial legislation or regulations and any activities in relation to, or incidental to, such practice and authorized acts; "physician" means a health care practitioner duly licensed with a provincial or territorial medical regulatory authority and actively engaged in practice;
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Legalization, regulation and restriction of access to marijuana

https://policybase.cma.ca/en/permalink/policy11954
Date
2016-08-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  2 documents  
Policy Type
Response to consultation
Date
2016-08-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to make this submission in response to the consultation led by the federal Task Force on Marijuana Legalization and Regulation, which has the objective of providing advice to the government on the design of a new framework for marijuana for non-medical, or recreational, purposes. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. The Government of Canada has made a commitment to legalize, strictly regulate and restrict access to marijuana in response to the high rates of marijuana use among Canadians, particularly youtha 1 2, despite its current illegal status. The existing approach to drugs has resulted in high rates of criminal records for non-violent drug offences each yearb 3, affecting disadvantaged groups disproportionately. Organized crime is supported by these high levels of use. This situation has resulted in considerable harm to society. a Marijuana is the most commonly used illegal substance in Canada. 43% of Canadians claim to have used marijuana at some point in their life, despite almost a century of prohibition. Canadian youth has the highest rate of marijuana use among 29 developed countries. Almost a quarter of the population aged 15 to 24 years reported past-year use. b According to a Stats Canada report, there were 73 thousand marijuana-related criminal offences (67% of all police-reported drug offences) in 2013. 1 Rotermann M, Langlois, K. Prevalence and correlates of marijuana use in Canada, 2012. Health Reports. 2015 Apr;26(4):10-5. Statistics Canada Catalogue no. 82-003-X. Available: http://www.statcan.gc.ca/pub/82-003-x/2015004/article/14158-eng.pdf (accessed August 12, 2016). 2 UNICEF Office of Research. Child Well-being in Rich Countries: A Comparative overview. Innocenti Report Card 11. Florence: UNICEF Office of Research; 2013. Available: https://www.unicef-irc.org/publications/pdf/rc11_eng.pdf (accessed August 12, 2016). 3 Cotter A, Greenland J, Karam M. Drug-Related Offences in Canada, 2013. Juristat. 2015 Jun 25;1-38. Catalogue no. 85-002-X. Available: http://www.statcan.gc.ca/pub/85-002-x/2015001/article/14201-eng.pdf (accessed 2016 Aug 11). 4 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed July 25, 2016). 5 Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: Canadian Medical Association; 2014. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2016 Aug 12). Public opinion in Canada and internationally has risen steadily in support of the removal of criminal sanctions for simple marijuana possession, as well as for the legalization and regulation of marijuana. The federal Task Force has developed a discussion paper, Toward the Legalization, Regulation and Restriction of Access to Marijuana4, which includes the following objectives for the new regime for legal access to marijuana:
Protect young Canadians by keeping marijuana out of the hands of children and youth;
Keep profits out of the hands of criminals, particularly organized crime;
Reduce the burdens on police and the justice system associated with simple possession of marijuana offences;
Prevent Canadians from entering the criminal justice system and receiving criminal records for simple marijuana possession offences;
Protect public health and safety by strengthening, where appropriate, laws and enforcement measures that deter and punish more serious marijuana offences, particularly selling and distributing to children and youth, selling outside of the regulatory framework, and operating a motor vehicle while under the influence of marijuana;
Ensure Canadians are well-informed through sustained and appropriate public health campaigns, and, for youth in particular, ensure that risks are understood;
Establish and enforce a system of strict production, distribution and sales, taking a public health approach, with regulation of quality and safety (e.g., child-proof packaging, warning labels), restriction of access, and application of taxes, with programmatic support for addiction treatment, mental health support and education programs;
Continue to provide access to quality-controlled marijuana for medical purposes consistent with federal policy and Court decisions; and
Conduct ongoing data collection, including gathering baseline data, to monitor the impact of the new framework. Context The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in its smoked form.5 6 Children and youth are especially at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. 6 Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: Canadian Medical Association; 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2016 Aug 16). 7 Volkow ND, Baler RD, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014 Jun 5;370(23):2219–2227. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827335/pdf/nihms762992.pdf (accessed 2016 Aug 15). 8 Wilkinson ST, Yarnell S, Radhakrishnan R, Ball SA, D'Souza DC. Marijuana Legalization: Impact on Physicians and Public Health. Annu Rev Med. 2016 Jan 14;67:453-466. doi: http://dx.doi.org/10.1146/annurev-med-050214-013454. (accessed 2016 Aug 12). 9 World Health Organization (WHO). Management of substance abuse: Cannabis. Geneva: World Health Organization; 2016. Available: http://www.who.int/substance_abuse/facts/cannabis/en/ (accessed 2016 Aug 16). 10 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. The Lancet, 2009 Oct 23;374(9698):1383-91. doi: http://dx.doi.org/10.1016/S0140-6736(09)61037-0. (accessed 2016 Aug 12). 11 Statistics Canada. Canadian Community Health Survey – Mental Health, 2012. The Daily. Ottawa: Statistics Canada; 2013 Sep 18. Component of Statistics Canada catalogue no. 11-001-X. p. 1-2. Available: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2016 Aug 12). 12 Shenfeld A. Growing Their Own Revenue: The Fiscal Impacts of Cannabis Legalization. Economic Insights. Toronto: CIBC World Markets Inc.; 2016 Jan 28. p. 7-8. Available: http://research.cibcwm.com/economic_public/download/eijan16.pdf (accessed 2016 Aug 11). 13 Canadian Centre on Substance Abuse (CCSA). Cannabis Regulation: Lessons Learned In Colorado and Washington State. Ottawa: Canadian Centre on Substance Abuse, 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2016 Aug 15). 14 Canadian Centre on Substance Abuse (CCSA). Marijuana for Non-Therapeutic Purposes: Policy Considerations. Ottawa: Canadian Centre on Substance Abuse, 2014. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Non-Therapeutic-Marijuana-Policy-Brief-2014-en.pdf (accessed 2016 Aug 15). 15 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16). 16 Blue Ribbon Commission on Marijuana Policy. Pathways Report: Policy Options for Regulating Marijuana in California. Denver (CO): Blue Ribbon Commission on Marijuana Policy; 2015. Available: https://www.safeandsmartpolicy.org/wp-content/uploads/2015/07/BRCPathwaysReport.pdf (accessed 2016 Aug 15). 17 Walsh J, Ramsey G. Uruguay’s Drug Policy: Major Innovations, Major Challenges. Washington (DC): Brookings Institution, Washington Office on Latin America; 2015. Available: https://www.brookings.edu/wp-content/uploads/2016/07/Walsh-Uruguay-final.pdf (accessed 2016 Aug 15). 18 Centre for Addiction and Mental Health (CAMH). Cannabis Policy Framework. Toronto: Centre for Addiction and Mental Health; 2014. Available: http://www.camh.ca/en/hospital/about_camh/influencing_public_policy/documents/camhcannabispolicyframework.pdf (accessed 2016 Aug 10). Our understanding of the health effects of marijuana continues to evolve. c 7 8 9 Marijuana use is linked to several adverse health outcomes, including addiction, cardiovascular and pulmonary effects (e.g., chronic bronchitis), mental illness, and other problems, including cognitive impairment and reduced educational attainment. There seems to be an increased risk of chronic psychosis disorders, including schizophrenia, in persons with a predisposition to such disorders. The use of high potency products, higher frequency of use and early initiation are predictors of worse health outcomes. c Unlike pharmaceuticals, marijuana is a complex combination of more than 100 different chemicals. The main psychoactive component is delta-9-tetrahydrocannabinol (THC), but other components, such as cannabidiol (CBD), also act on the central nervous system and may modify the effects of THC. The concentration of these compounds can vary substantially, making it difficult to characterize the specific positive or negative health effects of marijuana, especially in uncontrolled and epidemiological studies. As well, the average content of THC in marijuana has increased substantially in the last 30 years. For these and other reasons, research and attribution of harm and benefit are challenging. d Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. e Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. f Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. The lifetime risk of dependence to marijuana is estimated at about 9%d, increasing to almost 17% in those who initiate use in adolescence.10 In 2012, about 1.3% of people aged 15 and over met the criteria for marijuana abusee or dependencef – double that of any other drugs – due to the high prevalence of marijuana use. 11 Another area of great concern is that of impairment and the operation of vehicles, as well as the performing of work in an unsafe manner. There is an increased risk of motor vehicle collisions up to 6 hours after use, depending on method of use, dose and tolerance. As well, experience in the U.S. and even in Canada has shown that there can be an increased risk of unintentional overdoses in children due to marijuana edibles. The CMA’s overarching recommendation to the federal government is that the government must take a broad public health policy approach to address the legalization and regulation of marijuana for non-medical use. A public health approach would place an increased focus on: preventing drug abuse and dependence; the availability of assessment, counselling and treatment services for those who wish to stop using; and harm reduction to increase the safety for those who are using. This approach seeks to ensure that the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. Monitoring, surveillance and research of marijuana use are essential to better understand the short and long term harms as well as to develop policy options to address prevention, treatment, harm reduction and enforcement. There are huge economic pressures at play that need to be considered in a new regime and it is essential that public health objectives be central to the process of legalization and regulation. A recent report12 estimates that it could create a $10 billion a year industry in Canada, including production and distribution. As well, legalizing marijuana will bring in considerable tax revenue, and governments could collect as much as 50% or more of that if the rate of taxation is high, as in the ‘sin’ tax on the sale of alcohol and tobacco. As well, legalization could also lead to substantial savings in enforcement and incarceration. Given these pressures by private corporations, governments and other lobby groups, it is essential that the federal and provincial/territorial governments be held accountable to public health objectives of decreasing harms of marijuana use, particularly in children and youth. The CMA’s submission does not address the question of whether marijuana should be legal; the current federal government has already made it clear that this is their intent. Instead, this submission focuses on specific recommendations from physicians as they apply to the regulatory framework, with the objective of protecting individual and public health. It is based on input from CMA’s members, discussions with key stakeholders and experts from specialty societies, a review of reports on the experience in jurisdictions that have legalized marijuana for non-medical use, such as Colorado, Washington and Uruguay13 14 15 16 17, as well as expert literature18 19. 19 George T, Vaccarino F. (eds.). Substance abuse in Canada: The effects of cannabis use during adolescence. Ottawa: Canadian Centre on Substance Abuse; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Effects-of-Cannabis-Use-during-Adolescence-Report-2015-en.pdf (accessed 2016 Aug 16). 20 Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System (BRFSS) Survey. Atlanta (GA): Centers for Disease Control and Prevention; 2016. Available: http://www.cdc.gov/brfss/ (accessed 2016 Aug 10). 21 Rocky Mountain High Intensity Drug Trafficking Area (RMHIDTA). Legalization of Marijuana in Colorado. The Impact. 2014 Aug;2:1-166. Available: http://www.rmhidta.org/html/august%202014%20legalization%20of%20mj%20in%20colorado%20the%20impact.pdf (accessed 2016 Aug 15). 22 Monte AA, Zane RD, Heard KJ. The implications of marijuana legalization in Colorado. JAMA. 2015;313(3):241-42. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/pdf/nihms679104.pdf (accessed 2016 Aug 15). 23 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16). 24 Cunningham JA, Blomqvist J, Koski-Jannes A, Raitasalo K. Societal Images of Cannabis use: Comparing Three Countries. Harm Reduct J. 2012 Jun 18;9:21. Available: http://www.biomedcentral.com/content/pdf/1477-7517-9 -21.pdf (accessed 2016 Aug 15). 25 Porath-Waller A, Brown J, Frigon A, Clark H. What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf (accessed 2016 Aug 12). 26 Health Canada. Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Health Canada; 2006. Available: http://publications.gc.ca/site/eng/349980/publication.html (accessed 2016 Aug 15). 27 Fischer B, Jeffries V, Hall W, Room R, Goldner E, Rehm J. Lower Risk Cannabis Use Guidelines for Canada (LRCUG): A Narrative Review of Evidence and Recommendations. Can J Public Health. 2011 Sep-Oct;102(5):324-27. Available: http://journal.cpha.ca/index.php/cjph/article/view/2758 (accessed 2016 Aug 16). 28 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Ottawa: Health Canada; 2013. Available: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php (accessed 2016 Aug 12). 29 Young MM, Student Drug Use Surveys Working Group (SDUS). Cross-Canada report on student alcohol and drug use: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2011. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16). 30 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16). The Task Force’s discussion paper presents the potential elements of a new system, which were grouped into five themes: 1) minimizing harms of use; 2) establishing a safe and responsible production system; 3) designing an appropriate distribution system; 4) enforcing public safety and protection; and 5) accessing marijuana for medical purposes. Each theme includes questions on specific concerns for which the Task Force is seeking input. Presented below are the CMA’s recommendations to the federal government for each section of the discussion paper. A summary of all recommendations is listed at the end of the brief. RECOMMENDATION: The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives. 1. MINIMIZING HARMS OF USE 1.1. Do you believe that these measures are appropriate to achieve the overarching objectives to minimize harms, and in particular to protect children and youth? Are there other actions which the government should consider enacting alongside these measures? Legalization and strict regulation of marijuana for recreational use seeks to reduce health and social harms, particularly in higher risk groups; however, with the increased access, there could be an inverse effect, with the potential that harms could be intensified. There is also the considerable risk that the degree of “normalization” of use that already exists could increase. Colorado has seen an increase in marijuana-related traffic deaths and an increase in the use of health care due to intoxication, burns and cyclic vomiting syndrome, as well as overdoses in children due to marijuana in edibles.20 21 22 Many of the regulatory interventions used in reducing tobacco normalization and rates, as well as controlling the harms of alcohol at a population level, are proposed in the Task Force’s discussion paper as part of a framework for marijuana legalization and regulation. These include: 1) Minimum age for legal purchase with the objective of protecting children and youth, particularly since the risks of marijuana use are higher in ages where the brain is still in development. 2) Advertising and marketing restrictions to minimize the profile and attractiveness of products, seeking to prevent or at least reduce the “normalization” of use in society, particularly among children and youth. 3) Taxation and pricing to discourage use and provide the government with revenues to offset related costs (such as substance abuse services, law enforcement and regulatory oversight). 4) Restrictions on marijuana products, particularly with regards to the THC component, given higher concentration products have added risks and unknown long term impacts, with most impact on children and youth. Restrictions would include maximum THC limits and prohibition of high-potency products. 5) Restrictions on types of marijuana products, particularly edibles, to prevent accidental or unintentional ingestion, particularly by children. Limits would be placed on dosing and potency. 6) Limitations on quantities for personal possession, with the objective of helping to reduce demand and to minimize opportunities for resale of legally purchased marijuana on the illicit market (particularly to children and youth). 7) Limitation on where marijuana can be sold in order to minimize harms. Despite the merit of each of the proposed measures, collectively these may not adequately protect children and youth. A pathway to better implementation would require: . Taking the time to adequately prepare for the implementation, including developing the capacity to meet demand, administer the system, enforce regulations and deal with adverse effects. A phased-in approach or pilots in certain jurisdictions should be considered before going nationwide. . Learning from the lessons gained in jurisdictions that have made changes in drug policy, including the U.S. states of Colorado and Washington, Uruguay, the Netherlands and Portugal. . Learning from successes and failures in the regulation of tobacco and alcohol, with respect to the objectives of reducing or eliminating use for all Canadians (tobacco) and promoting responsible use among adults, while prohibiting use in youth (alcohol). . Developing the capacity to carry out a rigorous national-level evaluation of the impact of legalization of marijuana on the health and safety of Canadians. Data collection and analysis cannot be conducted if national surveillance systems do not exist. Important data to be monitored include marijuana-related emergency room visits and hospitalizations, rates of drug-impaired driving, recreational injuries, unintentional poisonings, product contamination, overconsumption and food-borne illness from edible products.23 . Support for a research agenda to better understand harms of marijuana, particularly among vulnerable groups such as children and youth, pregnant women, people with mental illness and chronic diseases. Research should also support policy interventions, including those to address second hand smoke, harm reduction measures, treatments and effective education strategies. The CMA is supportive of the regulatory interventions proposed by the government to reduce the harms, regarding: Marketing and advertising: The CMA recommends that the marketing and advertising of marijuana be prohibited, as is currently the case for tobacco and cigarettes. Measures such as plain packaging, prohibition of appealing flavours and shapes, adequate content and potency labelling, as well as health warnings, should be incorporated to discourage experimentation. A package insert should outline health risks and supporting references, the need for securing the product in the home, preventing access by youth and children, and recommendations not to drive or work with hazardous chemicals or equipment. The insert should include information detailing the health and social consequences, including legal penalties for providing marijuana to those under a designated minimum age for purchasing. Taxation and pricing: Taxation and pricing levers should be used to discourage use, with revenues clearly earmarked for covering the health and social costs of legalization. In Colorado, for example, revenue is used in substance abuse programs, regulation of marijuana and for public school construction. However, as with tobacco, final pricing must be such as to discourage the illegal production and trafficking of marijuana. Most of future tax revenues should be redistributed to the provinces and territories. This is because they will feel the impact of legalization directly as they have jurisdiction over health care, education, social and other services, as well as responsibility for enforcement. Restrictions on the potency of marijuana products: Experience in jurisdictions where marijuana has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies. Prohibition of high potency products is important. However, there is a risk that the prohibition could lead to an illicit market of more potent marijuana preparations. Restrictions on types of marijuana products: It is essential that restrictions be placed on the dosing of products, particularly of edibles, given the incidence of accidental overdoses of children. Content in a package should not be sufficient to cause an overdose. Because of these incidents, child proof packaging should also be required. Limitations on quantities for personal possession: Placing maximum limits on quantities that can be purchased would help to reduce the opportunities for illegal distribution and sale, especially to those below the established minimum age limit. The proposed measures related to minimum age for legal purchase and limitation on where marijuana can be sold are discussed in Sections 1.2 and 3, respectively, below. In addition to the regulatory interventions proposed in the “Minimizing Harms of Use” section of the discussion paper, others are equally fundamental, including: A clear process for identifying, testing and charging individuals who are driving under the influence of marijuana should be in place prior to legalization (see further discussion under Section 4). Public education: The use of public education tools to inform youth and families of the risks and harms of marijuana use is necessary. Awareness of Canadians of the harms of marijuana is generally low.24 25 26 Youth tend to emphasize the drug’s ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There are also many dangerous myths, such as that marijuana can counter the harmful effects of smoking tobacco by preventing cancer or that marijuana makes people better drivers. There is also a perception amongst some that marijuana is not an addictive substance because it is “natural”. However, traditional public campaigns and educational programs for youth have been shown to be minimally effective. There is a need for more effective programs, including those that incorporate skills-based training that teaches youth how to handle situations that involve drugs and/or alcohol. Harm reduction measures, such as those outlined in the Lower Risk Cannabis Use Guidelines for Canadag 27 should be discussed, particularly with teens, in an effort to minimize harm, even if they choose to continue to use. g These include delaying use until early adulthood; avoiding frequent use; preferring smokeless delivery systems; using less potent products; not driving after use; and abstaining from use when at higher risk of cannabis-related problems (people with a personal or family history of psychosis, cardiovascular problems and pregnant women). It is important that these education programs be designed by governments and health professionals, and not marijuana producers or distributers. However, costs of such programs could come from the profits of such industries. Expanded access and immediate availability of substance use, mental health and social stabilization services is another very important measure to minimize harm. These services are currently difficult to access in the community and have long wait times; in many parts of Canada they are simply unavailable. A plan to expand training programs in addiction medicine and access to treatment should be in place prior to legalization. Enforcement of regulations: Licensed producers and retail outlets should be held accountable in their compliance with policies, guidance and good practices to prevent contaminants that may cause additional health issues if consumed, particularly by minors (See also Section 3). 1.2. What are your views on the minimum age for purchasing and possessing marijuana? Should the minimum age be consistent across Canada, or is it acceptable that there be variation amongst provinces and territories? In order to achieve the first objective of legalization, i.e., to protect young Canadians by keeping marijuana out of the hands of children and youth, a minimum age for its purchase and possession must be adopted. This has been an important measure in tobacco and alcohol regulations. Existing evidence on marijuana points to the importance of protecting the brain during its development. Since that development is only finalized by about 25 years of age, this would be an ideal minimum age based on currently accepted scientific evidence, although knowledge on brain development is still evolving. However, marijuana use among youth (ages 15 to 24) is still double that of the general population, at 20%, even though there has been a slight decrease in use in recent years.28 A 2011 report on student alcohol and drug use in Canada showed that of those youth who had used marijuana in the past 3 months, 25% had used it daily. The average age of initiation was 16.1 years. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.29 A minimum age lower than 25 years should be considered in order to deter youth from seeking marijuana from organized crime groups, where they are exposed to other more dangerous drugs, sometimes even laced into marijuana. In jurisdictions where marijuana has been legalized, the minimum age has been set at the same minimum age for purchase of alcohol, i.e., 21 years. In Canada, the age limits for acquiring alcohol and tobacco are either 18 or 19 years of age, depending on the province or territory. In a survey carried out with a sample of the CMA membership, 25.4% recommended age 21, 20.3% age 25, 19.7% age 18, and 14.2% age 19. The CMA recommends that the minimum age should be set at 21, and that quantities and the potency of marijuana be more restricted to those under age 25 to discourage use and sharing with underage friends. The CMA recommends that the minimum age be established at the national level, and federally regulated, to avoid differences at the provincial/territorial level. This would reduce problems with enforcement in areas near provincial/territorial borders. SECTION 1 RECOMMENDATIONS: The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana: a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out; b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach; c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and, d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation. e) Support for a research agenda. The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes. The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services. The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies. The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles. The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased. The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage. The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana. As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine. The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25. The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions. 2. ESTABLISHING A SAFE AND RESPONSIBLE PRODUCTION SYSTEM 2.1. What are your views on the most appropriate production model? Which production model would best meet consumer demand while ensuring that public health and safety objectives are achievable? What level and type of regulation is needed for producers? There will be no perfect production model, with each one having its risks and benefits. The CMA would support a tightly regulated competitive model. A set number of licenses should be granted to producers, who are part of a competitive system, and there should be a reasonable cost associated to offset regulatory expenses. Producers would have to comply with policies and guidelines set by Health Canada, and be subject to inspections. It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls. 2.2. To what extent, if any, should home cultivation be allowed in a legalized system? What, if any, government oversight should be put in place? The CMA does not recommend home cultivation in a legalized system for non-medical purposes, as it presents many challenges to municipal, enforcement and public health authorities, particularly given the potentially high number of homes that could seek to cultivate marijuana. There are many health and safety hazards in cultivation, such as high humidity and temperatures, risk of fire, as well as the use of hazardous chemicals, including pesticides used for the control of fungi, bacteria and insects. There is little quality control regarding contamination and potency of the product. As well, home cultivation has an enhanced risk of abuse, if individuals use the production for sale rather than exclusively for personal use. Access to marijuana by children and youth is also a serious concern with home cultivation. In the present marijuana for medical purposes system, where some users have been allowed to continue to grow for personal use, there is great difficulty in monitoring and inspecting these properties. However, this has been allowed given the Allard v Canada court decision, to not hinder access for medical purposes. Washington has not permitted home cultivation, but Colorado has allowed the growth of a small number of plants for personal use (up to 6 plants, with a maximum 3 mature ones, in an enclosed, locked space). 2.3. Should a system of licensing or other fees be introduced? Should limited home cultivation for non-medical purposes be an option, a system of registration and licensing would have to be set up to allow for tracking and inspections of home production. It would also allow penalties for non-registered producers as well as larger scale operations. This would be a system that would require intense government regulation, oversight and tremendous resources to be effective. 2.4. The MMPR set out rigorous requirements over the production, packaging, storage and distribution of marijuana. Are these types of requirements appropriate for the new system? Are there features that you would add or remove? The requirements for production, packaging, storage and distribution of marijuana set out by the MMPR are appropriate for the new system. However, a rigorous review of the MMPR should be conducted to determine if there are weaknesses that need to be corrected before expanding to a non-medical market. Ongoing evaluation will be warranted as well. Distribution would have to expand beyond the mail service. 2.5. What role, if any, should existing licensed producers under the MMPR have in the new system (either in the interim or the long-term)? The CMA’s policy position does not extend to whether the existing licensed producers should be suppliers to the recreational market. The experience in Colorado, however, showed that having the industry set up for medical purposes first allowed a smoother transition, in contrast with Washington, which did not have an industry. SECTION 2 RECOMMENDATIONS: The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight. The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use. The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use. 3. DESIGNING AN APPROPRIATE DISTRIBUTION SYSTEM 3.1. Which distribution model makes the most sense and why? There is the need to continue mail availability for patients accessing marijuana for medical purposes to ensure nationwide access, however, a distribution system based exclusively on mail service would probably not meet the objectives of a recreational system. When a sample of our membership was asked about distribution models, first preference was given to existing non-health care structures, such as liquor stores. In some provinces, they would have the additional benefit of having a tightly regulated government monopoly by control board entities with a social responsibility mandate. Restrictions could be placed to limit the acquisition of both alcohol and marijuana. As stated earlier, marketing should be prohibited. Staff in these stores receives training and hours can be limited. A close second preference was given to legal storefronts, similar to the independent dispensaries. Several municipalities have been in varied degrees of discussion on the regulation of the presently illegal dispensaries, and those regulations could be looked at as models in a legalized environment. When asked about health care settings, such as pharmacies, respondents to the survey did not support this model. Almost 60% disagreed or strongly disagreed. A reason for this lack of support could be that placing marijuana in pharmacies could lend it credibility as a pharmaceutical medication, whereas placing it in liquor stores would send the message that it needs strict and formal controls. As per previous discussion, the creation of private industries for production and distribution would have to be very tightly controlled to avoid commercialization. As we have learned from the alcohol and tobacco industries, private companies have an interest in recruiting customers and encouraging high levels of ongoing consumption. It is important that the regulatory framework be protected from these commercial and fiscal interests. Regardless of the actual point of sale, storefront densities should be federally set and restrictive. There is good evidence from the regulation of alcohol that the less restrictive retail outlet density is, the more harms associated with alcohol use occur. Restrictions would also be placed on distances from schools, parks, playgrounds, colleges and universities, as well as on hours of sale. Regulations would lay out standards, including for the control of product sources, proof of minimum age required for purchase and restrictions on quantities sold. 3.2. To what extent is variation across provinces and territories in terms of distribution models acceptable? In the CMA’s survey of our members, there was not a consensus among respondents as to whether provincial and territorial governments should decide on their own distribution mechanisms. Many comments stated that a federal standard is warranted due to the need for initial close oversight and the ability to make effective changes more quickly. The CMA position is that there is an important role for the federal government to play in ensuring consistency across the country and avoiding provincial/territorial variation. 3.3. Are there other models worthy of consideration? The CMA recommends a phased in approach to the roll out of the system of distribution. Several pilot locations could be considered before going nationwide. Given the novelty and impact of this new legislation, particular caution is absolutely necessary from a regulatory and public health perspective. SECTION 3 RECOMMENDATIONS: The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive. The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions. The CMA recommends a phased implementation approach prior to national availability. 4. ENFORCING PUBLIC SAFETY AND PROTECTION 4.1. How should governments approach designing laws that will reduce, eliminate and punish those who operate outside the boundaries of the new legal system for marijuana? The severity of punishment for simple possession and personal use of marijuana should be eliminated with the removal of criminal sanctions. The CMA recommends that resources currently devoted to combating simple marijuana possession through the criminal law be diverted to public health and education strategies, particularly for youth. Having a criminal record limits employment prospects, and the impact on health status is profound, disproportionately among marginalized populations. Laws should include such things as the facilitation of access by individuals to services to address substance use, mental health and social stabilization. Laws should be drafted in a clear fashion to minimize ambiguity and provide as much guidance and direction to users, health care providers, enforcement authorities, producers, distributors and others. 4.2. What specific tools, training and guidelines will be most effective in supporting enforcement measures to protect public health and safety, particularly for impaired driving? The use of marijuana is associated with an increased risk of impairment, and is incompatible with the operation of vehicles and work in safety sensitive positions due to risk of injury to oneself, coworkers or the general public. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Report on Student Alcohol and Drug Use30 states that 14–21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Often, marijuana is associated with alcohol use, having an additive effect. A clear and reliable process for identifying, testing and imposing consequences on individuals who use marijuana and drive absolutely needs to be in place nationally prior to legalization. This will be complicated by the fact that a roadside test for marijuana use is not in widespread use; blood and urine testing also pose challenges. Another issue is the fact that recent use does not necessarily equate to impairment and no scientific standard for impairment exists in the literature. All individuals charged with impaired driving should have a specialist assessment to determine whether a substance use disorder is present. Individuals with substance use disorders should have immediate access to addiction treatment, mental health services and social stabilization. There is also a need for the development of guidelines for employers for the assessment and management of risk. 4.3. Should consumption of marijuana be allowed in any publicly-accessible spaces outside the home? Under what conditions and circumstances? No public smoking should be permitted, due to the risk of second hand smoke. Second hand marijuana smoke contains many of the same toxins, including carcinogens, found in directly inhaled marijuana smoke, in similar amounts, if not more. There is special concern for harmful health effects, especially among children. The CMA does not recommend the exposure of children to second hand smoke in public areas or in the home. The success in the reduction of tobacco use rates is significantly related to banning of smoking in public places. In the CMA’s survey of a sample of its members, 51.7% disagreed with consumption in designated public places, such as the Dutch model of coffee shops. SECTION 4 RECOMMENDATIONS: The CMA recommends that the federal government reallocate resources currently dedicated to the enforcement of marijuana infractions, to public health, education and treatment programs. The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana. The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places. 5. ACCESSING MARIJUANA FOR MEDICAL PURPOSES 5.1. What factors should the government consider in determining if appropriate access to medically authorized persons is provided once a system for legal access to marijuana is in place? The CMA recognizes that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with marijuana used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency (levels of THC, CBD), interactions with medications and adverse effects. Health Canada does not approve of marijuana as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. The present system poses a serious challenge for physicians in providing the best care to patients. The CMA has long called for more research to better understand potential therapeutic indications, as well as its risks. It is important that there be support for research of marijuana in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol®), nabilone (Cesamet®) and THC/CBD (Sativex®). The present marijuana for medical purposes regime operates as an exception to a criminal prohibition for production, possession and trafficking of marijuana. It was developed in reaction to court challenges regarding the right to legal access of individuals to marijuana for medical purposes. With the new legal system for marijuana for non-medical use, the requirement to maintain a separate regulatory framework would not be necessary, given court-mandated access will be provided. As well, the experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the dual standards (including different minimum ages, purchase quantities and taxation). Provisions would have to exist within the new system to attend to legitimate medical needs of individuals who are under the minimum age for purchase of marijuana, or for those with a requirement for a more potent product than that which is legally available. Consideration might also be given to affordable access for those with low incomes. As stated previously, the option of distribution through mail would have to continue, to facilitate access in remote areas. As well, patients or their families would be able to access marijuana through the distributors of marijuana for non-medical purposes, such as storefronts or liquor store-like entities, which would have employees trained to support patients and their needs. The use of marijuana products for medical indications, through this system, should preferably be done under research protocols. This framework would contribute to the provision of more robust scientific data. SECTION 5 RECOMMENDATION: The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available. 6. Summary of Recommendations The CMA appreciates the opportunity to provide feedback on this important matter to physicians and the public. Legalization of marijuana for non-medical purposes is a fundamental shift in the approach to drugs. The CMA’s position is that it is essential that the government consult with experts, key stakeholders and the general public not only at this phase in preparation for legislation on this matter, but throughout the process of the development of regulations and implementation. Recommendations: 1) The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives. Section 1 2) The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana: a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out; b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach; c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and, d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation. e) Support for a research agenda. 3) The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes. 4) The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services. 5) The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies. 6) The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles. 7) The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased. 8) The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage. 9) The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana. 10) As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine. 11) The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25. 12) The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions. Section 2 13) The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight. 14) The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use. 15) The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use. Section 3 16) The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive. 17) The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions. 18) The CMA recommends a phased implementation approach prior to national availability. Section 4 19) The CMA recommends that the federal government reallocate resources to the enforcement of marijuana infractions to public health, education and treatment programs. 20) The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana. 21) The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places. Section 5 22) The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available. CMA Statement - Legalization of Marijuana Ottawa, September 9, 2016 - The CMA's submission to the Task Force on Marijuana Legalization and Regulation is framed by the fundamental position that the legalization of marijuana is a societal prerogative; the CMA is not weighing in on this decision as it has already been made. Keeping with our mandate as the national voice for the highest standards of health and health care, the CMA is squarely focused on minimizing the negative impact on individuals and public health. The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in smoked form. Children and youth are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. As such, the CMA's submission is framed by the overarching recommendation that the government must take a broad public health policy approach in developing the legalization framework. Focusing on the legalization issue alone is inadequate to deal with the complexity of the situation. The CMA recommendations build on Canada's experience regulating alcohol and tobacco. The legalization framework must include:
Marketing and packaging restrictions
Restrictions on the types of products and their potency
Prohibiting home cultivation
Expanding access to support services such as mental health and substance use services
Expanding access to training programs in addiction medicine, and
Making extensive educational resources on the risks of harm to the user and others available We must recognize that the legalization of marijuana is a complex matter. Overall the CMA has submitted to the Task Force 22 evidence-based recommendations for a broad public health approach. For interviews: mediainquiries@cma.ca 613-806-1865
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Health Canada’s Consultation on “Plain and Standardized Packaging”

https://policybase.cma.ca/en/permalink/policy13817
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation, May 2016. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” Over the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The current Health Canada proposal will help realize that goal and the CMA supports the measures outlined in the consultation paper. There are two elements that the CMA recommend be addressed in this consultation. The CMA recommends that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. In a similar vein, the CMA recommends a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” While the CMA supports these measures, they must be part of the overall goal of further reducing and eliminating smoking. These measures will be an essential element of a sustained, well-funded and comprehensive program to reduce tobacco use, combining policy interventions with educational and social-marketing interventions including mass media campaigns. These programs should reflect current best practices, and be evaluated regularly for effectiveness and impact. To that end, the CMA calls on the federal government to renew the Tobacco Strategy before it expires in March 2017. At the same time, the CMA also recommends that the government allocate adequate funding to ensure implementation of the strategy. Finally, the consultation paper closes with some potential challenges to the implementation of these proposals. With respect to the problem of counterfeit cigarettes, all levels of government should take the strongest possible measures to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. The problem of retailers having difficulty implementing the regulations, resulting in service delays to their customers, is not really an issue related to these proposals. It is very doubtful that the retailers will experience such problems for very long and will find ways of resolving such difficulties. As for the problem of the manufacturers continuing to innovate in order to circumvent these measures, there should be sufficient enforcement tools within the regulations that will enable Health Canada to deal with such infractions. The Canadian Medical Association remains committed to working with governments and stakeholders to address this issue. We reiterate our long-standing support for plain and standardized packaging for tobacco products. In summary, the CMA recommends that: 1) only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed; 2) a single allowable length of cigarette and that a minimum diameter or width be established; 3) the federal government renew the Tobacco Strategy before it expires in March 2017 and that that the government allocate adequate funding to ensure implementation of the strategy. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism
Vice-président, Professionnalisme médicale Canadian Medical Association
Association médicale canadienne
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Joint Canadian Medical Association & Canadian Psychiatric Association Policy - Access to mental health care

https://policybase.cma.ca/en/permalink/policy11890
Date
2016-05-20
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Policy document
Date
2016-05-20
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
One in five Canadians suffer from a mental health problem or illness in any given year. Mental illness costs Canada over $50 billion annually in health care costs, lost productivity and reductions in health-related quality of life. The social costs of poor mental health are high; a person with serious mental illness is at high risk of experiencing poverty, homelessness and unemployment. Despite the widespread prevalence of mental health disorders, it is estimated that fewer than one-third of people affected by them will seek treatment. This is due in large part to the stigma society attaches to mental illness, which can lead to discriminatory treatment in the workplace or the health care system. In recent years, awareness of mental health issues has risen considerably in Canada. However, much still needs to be done to ensure that Canadians who require mental health care have timely access to the treatment and support they need. The Canadian Medical Association (CMA) and Canadian Psychiatric Association (CPA) recommend that all stakeholders, and governments at all levels, work together toward developing a mental health care system that incorporates the following elements:
Comprehensive, patient-centred care and evidence-based treatment for mental health disorders. This includes enhancing collaboration and teamwork among health professionals, patients and their families; providing education and resources for health professionals; and supporting ongoing research to identify and disseminate best clinical practices.
Timely access to mental health services. The health care system should ensure an appropriate supply, distribution and mix of accredited mental health professionals, ensure equitable coverage of essential mental health care and treatment, and provide appropriate services for populations with unique needs, such as children and older Canadians.
Adequate supports in the community, for example in schools and workplaces, to promote mental health, identify mental health issues in a timely manner and support people with mental illness as they seek to function optimally.
Reduction of stigma and discrimination faced by Canadians with mental health disorders, in the health care system and in society. Summary of recommendations Comprehensive, patient-centred care and evidence-based treatment Governments and health care systems 1. Develop and support a continuum of evidence-based, patient-centred services for the promotion of mental health and treatment of mental illness, in the community and in hospitals, with smooth transitions and linkages between each level. 2. Develop and implement models of collaborative mental health care in the community, with input from key stakeholders including the public, patients and their families, evaluate their effectiveness and encourage the adoption of those that demonstrate success. 3. Develop and implement a national caregiver strategy and expand the financial and emotional support programs currently offered to informal caregivers. 4. Continue to develop, implement and monitor mental health indicators that reflect both health system performance and population health, regularly report the results to the public and use them to improve the delivery of mental health services in Canada. 5. Increase funding for mental health research so that it is proportionate to the burden of mental illness on Canada’s health care system. Medical faculties, professional associations and the health care systems 6. Continue to develop evidence-based guidelines and professional development programs on mental health treatment and management, for all health care providers. 7. Continue to conduct research into best practices in mental health care and treatment and communicate the results of this research promptly to health care providers and the public. Appropriate provision and funding of mental health services Governments and health care systems Address current gaps in access to mental health services in the following ways: 8. Ensure that mental health services are appropriately funded to effectively meet the needs of Canadians. 9. Make mental health a priority with all levels of government and ensure stable and appropriate funding. 10. Establish standards for access to mental health services, including appropriate maximum wait times, and measure and report them on an ongoing basis. 11. Fund and support primary health care delivery models that include mental health promotion and mental illness treatment among the services they provide and identify and address the barriers to their implementation. 12. Increase funding for access to evidence-based psychotherapies and counselling services for mental disorders. 13. Establish a program of comprehensive prescription drug coverage to ensure that all Canadians have access to medically necessary drug therapies. 14. Continue to develop linkages between remote communities and larger health centres, including telehealth and e-health services, to ensure adequate access to mental health services by people in smaller communities. Health professional associations 15. Work with governments and other stakeholders to develop a mental health human resources plan that optimizes the scope of practice of every health professional, is culturally appropriate and takes into account Canada’s diverse geography. 16. Undertake a national study of ways to optimize the supply, mix and distribution of psychiatrists in Canada and present its findings/recommendations to governments. Adequate community supports outside the health sector Governments 17. Ensure the availability of school-based mental health promotion and mental illness prevention programs, and programs that address school-related problems, such as bullying, that are associated with mental distress. 18. Work with employers and other stakeholders to support mental health programs for workplaces. 19. Provide programs and services to improve the interface between people with mental illnesses and the criminal justice system. 20. Expand programs that provide housing for people with mental illness. Reduction of stigma and discrimination Governments and the health care system 21. Incorporate identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. 22. Implement and evaluate national public awareness and education strategies to counteract the stigma associated with mental illness. 23. Enforce legislation and regulations to guard against discrimination against people with mental illness. Professional education 24. Incorporate effective anti-stigma education into the entire medical education continuum (medical school, residency and continuing professional development) for all physicians and other health professionals. 25. Incorporate effective anti-stigma education into professional development programs at hospitals and other health care facilities. Introduction Mental health disorders impose a heavy burden on Canadians and their health care system. In any given year, one in five Canadians will suffer from a mental health problem or illness. It is estimated that 10% to 20% of Canadian youth are affected by a mental health disorder. By age 40, 50% of Canadians will have had a mental illness. Mental illness can shorten life expectancy; for example, people with schizophrenia die as much as 20 years earlier than the population average. This is due both to higher rates of suicide and substance abuse and to a poorer prognosis for conditions such as heart disease, diabetes and cancer. Suicide is the second leading cause of death (after injuries) for Canadians aged 15 to 34. For people with mental health disorders, the effect on their lives goes beyond their interaction with the health care system; a person with serious mental illness is at high risk of experiencing poverty, homelessness and unemployment. Mental health disorders are costly to Canada’s health care system and to its economy. A third of hospital stays in Canada and 25% of emergency department visits are due to mental health disorders. It is estimated that mental illness costs Canada over $50 billion per year, including health care costs, lost productivity and reductions in health-related quality of life. Despite the widespread prevalence of mental health disorders, it is estimated that only one- quarter to one-third of people affected by them will seek treatment. This could be due in part to the stigma society attaches to mental illness, which deters many people from seeking needed treatment because they fear ostracism by their friends or discriminatory treatment in the workplace or the health care system. Those who do seek treatment may have a difficult time finding it. According to Statistics Canada, in 2012 almost a third of Canadians who sought mental health care reported that their needs were not met or only partially met. Lack of access to family physicians, psychiatrists and other health care providers contributes to this deficit. Though mental illnesses constitute more than 15% of the disease burden in Canada, the country spends only about seven cents of every public health care dollar on mental illness (7%), below the 10% to 11% of spending devoted to mental illness in countries such as New Zealand and the United Kingdom.4 Since 2000, however, Canadians’ awareness of mental health issues has risen considerably. The seminal 2006 report entitled Out of the Shadows at Last by the Standing Senate Committee on Social Affairs, Science and Technology, chaired by Senator Michael Kirby, made a number of recommendations aimed at increasing awareness, improving access to mental health services and reducing the stigma of mental illness. As a result of this report, in 2007 the federal government established the Mental Health Commission of Canada (MHCC) to be a catalyst for improving the mental health system and changing the attitudes and behaviours of Canadians around mental health issues. In 2012, the MHCC released Canada’s first mental health strategy, “Changing Directions, Changing Lives.” As part of her mandate from the prime minister following the 2015 federal election, Canada’s health minister has been asked to “engage provinces and territories in the development of a new multi-year Health Accord [that will] make high quality mental health services more available to Canadians who need them.” Nearly all provincial governments have also developed mental health strategies for their own jurisdictions. Much still needs to be done to translate heightened awareness into improvements in service provision to give Canadians who require mental health care timely access to the evidence-based, patient-centred treatment and support they need. The Canadian Medical Association (CMA) and Canadian Psychiatric Association (CPA) agree it is time to make mental health a high priority in Canada. The CMA and CPA recommend that all stakeholders, and governments at all levels, work together toward developing a mental health care system that is driven by needs-based plans with clear performance measures and that receives an appropriate share of health care funding. This position statement discusses and makes recommendations on issues relating to access to mental health care, with a focus on:
comprehensive, patient-centred care and evidence-based treatment for mental health disorders;
appropriately funded primary, specialty and community mental health treatment and support services;
adequate community supports for people with mental health disorders; and
reduction of the stigma and discrimination faced by Canadians with mental health disorders. Comprehensive, patient-centred care and evidence-based treatment The goal of mental health care in Canada should be to allow patients’ needs to be met in the most appropriate, timely and cost-effective manner possible. Current best practice suggests that care for patients with mental health disorders should be provided using models that incorporate the following principles. Patient-centred care One of the fundamental principles of health care is that it be patient centred. CMA defines patient-centred care as “seamless access to the continuum of care in a timely manner … that takes into consideration the individual needs and preferences of the patient and his/her family and treats the patient with respect and dignity.” For treatment of mental health disorders, it is essential that patients be core members of the health care team, working with health care providers to address their individual needs, preferences and aspirations and to seek their personal paths to well-being. Physicians and other health professionals can help patients make choices about their treatment and can provide information and support to patients and their families as they seek to cope with the effects of their illnesses and live functional lives. A continuum of mental health services Mental health disorders can be complex and can vary in severity. A patient may have short-term coping difficulties that can be resolved with counselling or a severe psychotic illness that requires frequent hospital care and intensive, lifelong support. This range of needs requires that the health care system provide different levels of care, including:
community-based programs to promote and maintain mental health and to facilitate early identification of problems requiring intervention;
community-based primary health care, including collaborative care teams, which focus on providing mental health maintenance programs and on treating high-prevalence conditions such as anxiety disorders, mood disorders and addictions;
specialized services in the community for patients with greater needs, which can be delivered through a variety of means, including community-based psychiatrists, interdisciplinary family health teams that incorporate psychiatric services and specialized interdisciplinary teams such as assertive community treatment (ACT) teams ;
acute-care mental health services including community crisis teams and beds, psychiatric emergency services and inpatient beds in community hospitals, and specialized psychiatric hospitals;
a continuum of residential care services including long-term care facilities;
seamless, integrated transitions from one level of care to another, and across age groups (e.g., from youth to adult to senior mental health services);
appropriate services for special populations, including children and adolescents, and adults with dementia;
specialized psychiatric services for patients with complex mental illnesses such as eating disorders, post-traumatic stress disorder and personality disorders; and
community-based programs that provide housing, vocational support and other services to optimize community integration of people with mental illness. Mental health care should ideally be provided in the context of caring for the patient’s overall health, taking into account any physical conditions for which the patient is receiving or may receive treatment. Collaborative and team-based mental health care Within this continuum, a variety of health care professionals with different skills and education provide mental health services in Canada. They include:
primary care physicians (family physicians and general practitioners);
psychiatrists (hospital and community based);
other specialist physicians (including emergency physicians, paediatricians, geriatricians);
other health professionals (psychologists, nurses, pharmacists, occupational therapists, social workers); and
case managers, peer support workers and system navigators. Collaborative models enable a variety of mental health care providers to work with patients and their families to provide effective, coordinated care according to a mutually agreed plan. Collaborative partnerships in mental health care have demonstrated benefits including symptom and functional improvement, reduced disability days and improved adherence to medication. Elements of a successful collaborative partnership include:
effective linkages among psychiatrists, primary care providers and other mental health professionals, including a seamless process for consultation and referral;
effective communication and information flow;
use of technology, such as electronic health records and telemedicine, to facilitate collaboration among providers in all health care settings;
coordination of care plans and clinical activities to ensure the most effective care and efficient use of resources; and
integration of mental health and primary care providers within a single service or team (in some cases, providers may work in the same practice setting).13 Education and resources for health professionals Since mental health disorders are pervasive and are often associated with other chronic conditions such as heart disease, health care providers of all disciplines and specialties often encounter them while caring for their patients. The Mental Health Core Competencies for Physicians report, prepared collaboratively by the Royal College of Physicians and Surgeons of Canada, the MHCC, the College of Family Physicians of Canada, CMA and CPA, proposes goals, principles and core mental health competencies to provide guidance to physicians of all specialties. The intent is to improve access to mental health services; improve the experience of care, including reducing stigma; recognize and address the interaction between physical and mental health; and provide practice support for physicians. To support physicians and other health care providers in treating mental health disorders, clinical and practice resources should be available to them, including:
early education in medical school and residency on mental health promotion, diagnosis and treatment of mental health conditions, and liaison with other community resources, for all specialties;
clinical practice tools including practice guidelines, clinical pathways and online decision support including prescribing guidelines for the appropriate use of psychiatric drugs;
online continuing professional development (CPD) programs ;
enhanced interprofessional education for all providers (psychiatrists, family physicians, nurses, social workers, occupational therapists, peer support workers, patients, their family members and others as relevant) ; and
evidence-based, user-friendly education and support tools for patients, which physicians can recommend to help them manage their conditions. Support for informal caregivers Often the burden of caring for a person with mental illness falls heavily on family or friends, and the role of the informal caregiver can be demanding financially, physically and/or emotionally. Though governments have instituted tax credits and other forms of support for caregivers, more help is required. A national caregiver strategy, developed by governments and other key stakeholders, could define a national standard of support for informal caregivers and expand the financial and emotional support programs that are currently offered. Research and evaluation Thanks to ongoing research, our knowledge of how to treat and manage mental health disorders is constantly growing and developing. However, there are still gaps in this knowledge, and research needs in the area remain substantial. CMA and CPA encourage a continued commitment to research into best practices in early identification, care and treatment of mental health disorders and to funding this research so that it is proportionate to the burden of mental illness on Canada’s health care system. Results of this research should be communicated to health professionals and the public as quickly and widely as possible, so that it can be rapidly incorporated into clinical practice. Mental health care interventions should also be routinely evaluated for their effectiveness in improving patient care, enhancing the sustainability of the health care system and increasing the overall health and well-being of Canadians. The MHCC has developed a set of 63 mental health indicators that focus on 13 specific areas, including access and treatment, the economy and workplace, and special populations such as seniors, children and youth. Other projects are underway to develop indicators to monitor and report more specifically on mental health system performance, such as use of emergency departments for mental health care, and physician follow-up after hospital treatment. Such indicators should be used on an ongoing basis to monitor the performance of the mental health care system and provide mental health professionals, planners and governments with reliable information that they can use to better meet the needs of Canadians. Recommendations Governments and health care systems 1. Develop and support a continuum of evidence-based, patient-centred services for the promotion of mental health and treatment of mental illness, in the community and in hospitals, with smooth transitions and linkages between each level. 2. Develop and implement models of collaborative mental health care in the community, with input from key stakeholders including the public, patients and their families, evaluate their effectiveness and encourage the adoption of those that demonstrate success. 3. Develop and implement a national caregiver strategy and expand the financial and emotional support programs currently offered to informal caregivers. 4. Continue to develop, implement and monitor mental health indicators that reflect both health system performance and population health, regularly report the results to the public and use them to improve the delivery of mental health services in Canada. 5. Increase funding for mental health research so that it is proportionate to the burden of mental illness on Canada’s health care system. Medical faculties, professional associations and health care systems 6. Continue to develop evidence-based guidelines and professional development programs on mental health treatment and management, for all health care providers. 7. Continue to conduct research into best practices in mental health care and treatment and communicate the results of this research promptly to health care providers and the public. Appropriate provision and funding of mental health services Appropriate provision of mental health services requires that people be able to access the right care in the right place at the right time, in both hospital and community settings. Unfortunately, because of the underfunding of the mental health care system, limited resources are available to accommodate all of those who need such services. The exact extent of lack of access to hospital and community mental health services is not well documented; for instance, provinces do not report wait times for psychiatric services. According to the 2015 Wait Time Alliance Report Card, no jurisdiction is measuring what proportion of patients is being seen within the benchmark time periods. In December 2015 the CPA expressed disappointment that “no visible progress has been made in measuring how well the health system meets the psychiatric needs of Canadians.” In the absence of community-based services, patients may have their discharge from hospital delayed. Once they are back in the community, they may be unable to find appropriate assistance, or assistance may be available but beyond their financial means. They may abandon treatment or rely on emergency departments for episodic crisis care.4 Canada should work to remedy the current deficiencies in access to mental health services so that people with mental health disorders have timely access to seamless, comprehensive care in the most appropriate setting. This includes ensuring an appropriate supply, distribution and mix of accredited mental health professionals, ensuring equitable coverage of essential health services and making appropriate services and supports available to populations with unique needs. Access to physician services Primary care For the majority of patients who seek treatment for a mental health problem, the first (often the only) point of contact is their primary care physician. As part of the comprehensive care they provide to patients, family physicians and general practitioners can provide mental health promotion and wellness counselling, detect and treat mental health disorders in their early stages and monitor the patient’s progress in the context of his or her overall health and well-being, referring to psychiatrists and other mental health professionals as needed.13 CMA has long recommended that every Canadian have an established professional relationship with a family physician who is familiar with his or her condition, needs and preferences. However, some Canadians may have difficulty finding primary medical care, since the proportion of family physicians and general practitioners to the population is not consistent across Canada. All stakeholders should continue working to ensure that every Canadian has access to comprehensive first-point-of-contact medical care. Psychiatric services Psychiatrists are physicians who complete five to seven years of specialty and subspecialty training to diagnose, treat and provide ongoing care for mental illnesses, particularly to people with complex illnesses that cannot be managed within a primary care setting alone. In addition to providing specialty treatment, psychiatrists are also active in the areas of education, research and advocacy about the importance of mental health promotion and mental illness prevention. They provide care across the lifespan, in both hospital and community settings. Patient access to psychiatrists is often limited by long wait times. It has been suggested that this is due to a shortage of psychiatrists, which is more severe in some parts of Canada than others. Recent surveys report that a number of specialists, including psychiatrists, are in the latter half of their careers, and there are concerns that the number of psychiatrists per Canadian population is declining. Though the Royal College notes that the number of psychiatric residency positions has increased in recent years, it is unclear if this is sufficient to meet current and future population needs. The CPA recommends the development of strategies to attract, train and retain practitioners in clinical psychiatry. Access to services not funded by provincial and territorial health systems Though Canada’s public health care system covers many mental health services and treatments, including physician consultations and hospital care, it does not cover all aspects of optimal treatment and care, and access to some therapies may be limited by the patient’s ability to pay. Psychiatric drugs, especially those that must be taken over many years, can pose a heavy financial burden for patients who do not have drug coverage through employer-provided benefit programs or provincial or territorial drug plans. Psychotherapies delivered by non-physician health care practitioners are generally not covered by government health plans and must, therefore, in most cases be paid for out of pocket or through private insurance plans, to which many Canadians do not have access. Federal, provincial and territorial governments should work to increase access to accredited psychological and counselling services that are evidence based and to provide comprehensive coverage of medically necessary prescription drugs for all Canadians. Some primary health care practices, such as family health teams in Ontario, have funding envelopes that they can use to contract with skilled mental health professionals to provide psychotherapy, stress management programs and other services that are not ordinarily funded through provincial health budgets. Models such as these help to make publicly funded mental health care available to patients who might otherwise have been unable to afford it. Access to mental health services for special populations For some populations, access to mental health services may be particularly problematic. For example, stakeholders should consider the needs of the following populations:
Children and youth: As up to 70% of mental health conditions first appear in adolescence or young adulthood, it is important that young people have access to mental health promotion and to appropriate assessment and treatment of mental health disorders. At present only one out of four children who need mental health services receives them.1,3 CMA and CPA particularly recommend increased supports for children in high-risk situations, such as those in foster care. The transition from the youth to the adult mental health service sectors should be smooth and well organized.
Remote areas: People in the North and other remote parts of Canada may have to travel many miles to access mental health and other health care services. This gap should be remedied by using technologies such as telehealth and e-mental health services and by strengthening communication and coordination between small communities and the larger health centres to which their residents travel for care.
Immigrants and refugees: New arrivals to Canada may have problems understanding our language and culture and may also face mental health problems as a result of traumatic experiences in their countries of origin or the stress of relocation.
Indigenous Peoples. Rates of mental health disorders, addictions and suicide are high among Canada’s First Nations, Inuit and Métis. Much of this is linked to past experience of forcible separation from their traditional languages and culture. Health service providers should work with Indigenous communities to address their distinct mental health needs appropriately.
Seniors: An estimated 10% to 15% of seniors report depression, and the rate is higher among those with concomitant physical illness and those living in long-term care facilities. Depression among older people may be under-recognized and under-treated or dismissed as a normal consequence of aging. Poor mental health is often associated with social isolation, a common problem among seniors. The majority of older adults in long-term care settings have dementia or another mental health condition. Recommendations Governments and health care systems Address current gaps in access to mental health services in the following ways: 8. Ensure that mental health services are appropriately funded to effectively meet the needs of Canadians. 9. Make mental health a priority with all levels of government and ensure stable and appropriate funding. 10. Establish standards for access to mental health services, including appropriate maximum wait times, and measure and report them on an ongoing basis. 11. Fund and support primary health care delivery models that include mental health promotion and mental illness treatment among the services they provide and identify and address the barriers to their implementation. 12. Increase funding for access to evidence-based psychotherapies and counselling services for mental disorders. 13. Establish a program of comprehensive prescription drug coverage to ensure that all Canadians have access to medically necessary drug therapies. 14. Continue to develop linkages between remote communities and larger health centres, including telehealth and e-health services, to ensure adequate access to mental health services by people in smaller communities. Health professional associations 15. Work with governments and other stakeholders to develop a mental health human resources plan that optimizes the scope of practice of every health professional, is culturally appropriate and takes into account Canada’s diverse geography. 16. Undertake a national study of ways to optimize the supply, mix and distribution of psychiatrists in Canada and present its findings/recommendations to governments. Adequate community supports outside the health sector People with mental health disorders often require not only treatment and care from the health sector but also support from the community at large to function optimally. Ideally, the community should provide an environment that supports patients as they work toward recovery and well-being. In addition, schools, workplaces and other community agencies can play an important role in promoting mental health and identifying problems that require attention. Schools Education and information should be made available to parents, teachers and health professionals to help them identify signs of mental illness or distress in children and adolescents, so they can intervene early and appropriately. School health education programs should include the promotion of mental health and incorporate self-management techniques such as mindfulness training to help young people develop resilience. Schools should also ensure that they minimize possible threats to children’s mental health, such as bullying, that may occur on their premises. Workplaces Unlike many other chronic conditions, mental illness frequently affects younger people and those in their most productive years, so the burden it imposes on Canada’s economy is high. Mental health disorders account for 30% of short-term workplace disability claims,1 and the Conference Board of Canada has estimated that six common mental health disorders cost the country’s economy more than $21 billion a year and predicts that this cost will increase to $30 billion by 2030. However, often employees do not disclose mental health problems to their employers for fear of losing their jobs, being ostracized by colleagues, or other negative consequences. Workplaces can support the mental health of their employees by:
offering mental health promotion assistance through stress management seminars, employee assistance and other programs;
training managers to identify potential mental health issues in their staff and to intervene early and appropriately;
eliminating stigma and discrimination and providing an environment in which employees feel safe disclosing their mental health issues; and
offering adequate benefits, including supplementary health insurance and supportive leave-of-absence programs. The MHCC’s Standard for Psychological Health and Safety in the Workplace, released in 2013, provides guidance to employers on how to promote the mental health of their staff and intervene in cases of mental distress. Correctional services People with mental illnesses are overrepresented in the criminal justice system. Estimates suggest that rates of serious mental illness among federal offenders upon admission have increased by 60% to 70% cent since 1997.4 This places a heavy burden on corrections and law enforcement staff, who are often inadequately trained to deal with mental illness. Programs and services are needed to ensure that people with mental health disorders who run afoul of the law are identified early, given appropriate treatment throughout their incarceration and followed up on release. These could include:
training for police and other frontline criminal justice and corrections workers in how to interact with people with mental illnesses;
diversion programs, such as mental health courts, to redirect people with mental illnesses who are about to enter the criminal justice system;
comprehensive psychiatric screening, assessment and treatment for incarcerated patients with mental illnesses and common co-occurring conditions such as addiction; and
Careful handover of clinical care at the point of release from custody with engagement by mental health services in the community. Housing Mental illness increases a patient’s risk for poverty and homelessness. It is estimated that two- thirds of Canada’s homeless population have a serious mental illness. Homelessness and poverty can exacerbate existing mental health and addiction problems, hinder access to treatment and reduce life expectancy. Programs such as the MHCC’s Housing First research demonstration project can improve the social and economic circumstances of people with mental illness. The MHCC project provided no-strings-attached supportive housing for people with chronic mental health problems, giving them a secure base from which they could pursue their treatment and recovery goals. Evaluation showed that this approach reduced the rate of homelessness, improved access to treatment and support services and led to cost savings, particularly for the program participants who had the highest service-use costs. Recommendations Governments 17. Ensure the availability of school-based mental health promotion and mental illness prevention programs, and programs that address school-related problems, such as bullying, that are associated with mental distress. 18. Work with employers and other stakeholders to support mental health programs for workplaces. 19. Provide programs and services to improve the interface between people with mental illnesses and the criminal justice system. 20. Expand programs that provide housing for people with mental illness. Reduction of stigma and discrimination Many believe that the primary reason for the underfunding of the mental health care system and for the reluctance of people with mental health disorders to seek treatment is the stigma attached to their conditions. Mental illness is the most stigmatized disease state in Canada, and discriminatory behaviour toward people with mental health disorders is widespread. This can include ostracism and lack of support from peers, discrimination in the workplace and distorted public perceptions, such as the tendency to equate mental illness with violent behaviour. Discriminatory behaviour can also occur in the health care system. Experts acknowledge that stigma affects health care providers’ attitude toward patients with mental health problems.29 Though many health care providers are unaware that their language or actions can be harmful, their attitude may have negative effects on the treatment their patients receive. For example, if a patient who has been treated for a psychiatric condition reports physical symptoms, these symptoms might be attributed to the mental illness rather than to a physical condition, and as a result the patient may not receive necessary treatment. This is known as diagnostic overshadowing. , CMA and CPA recommend comprehensive efforts to change the culture of stigmatization of mental illness, in the health care system and in society. A number of interventions are underway to help reduce stigma and discrimination related to mental illness. These include public awareness programs such as the Bell Let’s Talk campaign, Mental Illness Awareness Week, sponsored by the Canadian Alliance on Mental Illness and Mental Health, and the Opening Minds program of the MHCC, which focuses on specific populations including youth and health care providers. The current consensus among experts is that the most effective interventions are those that:
are aimed at changing behaviour rather than modifying attitudes;
are ongoing rather than time limited;
are targeted to specific groups rather than to the general population; and
involve direct contact with people with mental illness. Within the health care system, professional education is a potentially important means of addressing stigma and discrimination. It has been recommended that anti-stigma education be incorporated into the medical education continuum at all levels (including residency and CPD) and for all specialties and that this education incorporate direct contact with people with mental illness, to share their stories of recovery.27 All health professionals and their associations should be encouraged to address the elimination of stigma in their educational programs. CMA and CPA have worked with partners to provide education to physicians, through workshops, online materials and other means. Recommendations Governments and the health care system 21. Incorporate identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. 22. Implement and evaluate national public awareness and education strategies to counteract the stigma associated with mental illness. 23. Enforce legislation and regulations to guard against discrimination against people with mental illness. Professional education 24. Incorporate effective anti-stigma education into the entire medical education continuum (medical school, residency and CPD) for all physicians and other health professionals. 25. Incorporate effective anti-stigma education into professional development programs at hospitals and other health care facilities. Conclusion Despite increased public awareness about mental illness, ensuring access to effective mental health services and supports remains a challenge in Canada, and the stigma and discrimination associated with mental illness remain high. CMA and CPA believe that change is possible. In an ideal future, all Canadians would feel safe acknowledging their mental health problems and seeking help for them, a range of effective, evidence-based treatments would be available for every Canadian who needs them, and communities would support Canadians as they work to promote and maintain their mental health or to recover from mental illness. It is our hope that health care providers, governments, communities, patients and their families will work together toward realizing this future. References Mental Health Commission of Canada. The Facts. Calgary (AB): The Commission; 2012. Available: http://strategy.mentalhealthcommission.ca/the-facts/ (accessed 2015 May 05). Mental Health Commission of Canada. Making the case for investing in mental health in Canada. Calgary (AB): The Commission; 2013. Chesney E, Goodwin GM, Fazel S. Risks of all-cause and suicide mortality in mental disorders: a meta-review. World Psychiatry 2014; 13 (2):53–60. Mental Health Commission of Canada. Changing directions, changing lives: the Mental Health Strategy for Canada. Calgary (AB): The Commission; 2012. Available: https://strategy.mentalhealthcommission.ca/download (accessed 2014 Sep 07). Centre for Addiction and Mental Health. Mental illnesses and addictions: facts and statistics. Toronto (ON): The Centre; 2016. Available: www.camh.ca/en/hospital/about_camh/newsroom/for_reporters/Pages/addictionmentalhealthstatistics.aspx (accessed 2016 Mar 9). Mental Health Commission of Canada. Opening minds. Ottawa (ON): The Commission; 2016. Available: http://www.mentalhealthcommission.ca/English/initiatives/11874/opening-minds (accessed 2016 Mar 9). Statistics Canada. Canadian Community Health Survey: mental health, 2012 [media release]. Ottawa (ON): Statistics Canada; 2013 Sep 18. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm?HPA (accessed 2015 Sep 08). Mental Health Commission of Canada. About MHCC. Ottawa (ON): The Commission; 2016. Available: www.mentalhealthcommission.ca/English/who-we-are (accessed 2016 Mar 10). 9 Prime Minister of Canada. Minister of Health Mandate letter to the Hon. Jane Philpott, Minister of Health, November 2015. Ottawa (ON): Office of the Prime Minister of Canada; 2015. Available: http://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2016 Apr 14). Canadian Medical Association. Health care transformation in Canada: change that works. Care that lasts. Ottawa (ON): The Association; 2010. Available: http://policybase.cma.ca/dbtw-wpd/PolicyPDF/PD10-05.PDF (accessed 2015 Sep 14). Neilson G, Chaimowitz G. Informed consent to treatment in psychiatry. A position paper of the Canadian Psychiatric Association. Can J Psychiatry. 60 (4):1-12. Available: http://publications.cpa-apc.org/media.php?mid=1889 (accessed 2016 Mar 9). Ontario ACT Association. ACT model: the team approach. [Place unknown]: The Association; 2015. Available: http://ontarioacttassociation.com/act-model/ (accessed 2015 Mar 25). Kates N, Mazowita G, Lemire F, et al. The evolution of collaborative mental health care in Canada: a shared vision for the future. A position paper developed by the Canadian Psychiatric Association and the College of Family Physicians of Canada. Can J Psychiatry. 2011; 56(5): 1-10. Available: http://www.cfpc.ca/uploadedFiles/Directories/Committees_List/Collaborative%20mental%20health%20care-2011-49-web-FIN-EN.pdf (accessed 2014 Oct 16). Whiteman H. Mental illness linked to increased risk of heart disease, stroke. Medical News Today. 2014, Oct 27. Available: www.medicalnewstoday.com/articles/284461.php (accessed 2015 Mar 25). Mental Health Core Competencies Steering Committee. Mental health core competencies for physicians. Ottawa (ON): Royal College of Physicians and Surgeons of Canada, Mental Health Commission of Canada, College of Family Physicians of Canada, Canadian Psychiatric Association and Canadian Medical Association; 2014. Available: www.royalcollege.ca/portal/page/portal/rc/common/documents/policy/mhcc_june2014_e.pdf (accessed 2016 Mar 9). Canadian Collaborative Mental Health Initiative. Toolkits. Mississauga (ON): The Initiative; n.d.. Available: www.shared-care.ca/page.aspx?menu=69&app=266&cat1=745&tp=2&lk=no (accessed 2014 Oct 16) Curran V, Ungar T, Pauzé E. Strengthening collaboration through interprofessional education: a resource for collaborative mental health care educators. Mississauga (ON): Canadian Collaborative Mental Health Initiative; 2006 Feb. Available: www.shared-care.ca/files/EN_Strengtheningcollaborationthroughinterprofessionaleducation.pdf (accessed 2016 Mar 9). Canadian Medical Association. Health and health care for an aging population: policy summary of the Canadian Medical Association. Ottawa (ON): The Association; 2013 Feb. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-03.pdf (accessed 2014 Sep 14). Mental Health Commission of Canada. Informing the future: mental health indicators for Canada. Ottawa (ON): The Commission; 2015 Jan. Available: www.mentalhealthcommission.ca/English/document/68796/informing-future-mental-health-indicators-canada (accessed 2016 Mar 09). Wait Time Alliance. Time to close the gap: report card on wait times in Canada. Ottawa (ON): The Alliance; 2014 June. Available: www.waittimealliance.ca/wta-reports/2014-wta-report-card/ Canadian Psychiatric Association. Tracking access to psychiatric care needed to chart a way forward say psychiatrists [media release]. Ottawa (ON): The Association; 2015 Dec 8. Available: www.cpa-apc.org/media.php?mid=2385 (accessed 2016 Mar 09). CMA Physician Data Centre. Canadian physician statistics: general practitioners/family physicians per 100,000 population by province/territory, 1986-2014. Ottawa (ON): Canadian Medical Association; 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/14-FP_per_pop.pdf (accessed 2016 Mar 09). Canadian Collaborative Centre for Physician Resources. Psychiatry: a recent profile of the profession [bulletin]. Ottawa (ON): Canadian Medical Association; 2012 Apr. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/25-Psychiatry.pdf#search=psychiatry%20a%20recent%20profile (accessed 2016 Mar 09). Sargeant JK, Adey T, McGregor F, et al. Psychiatric human resources planning in Canada: a position paper of the Canadian Psychiatric Association. Can J Psychiatry 2010; 55 (9): 1-20. Available: http://publications.cpa-apc.org/media.php?mid=1015 (accessed 2015 Sep 14). Conference Board of Canada. Mental health issues in the labour force: reducing the economic impact on Canada. Ottawa (ON): The Board; 2012 Jul. Mental Health Commission of Canada, Canadian Standards Association. CAN/CSA-Z1003-13/BNQ 9700-803/2013 - Psychological health and safety in the workplace — prevention, promotion, and guidance to staged implementation. Toronto (ON): CSA Group; 2013. Available: http://shop.csa.ca/en/canada/occupational-health-and-safety-management/cancsa-z1003-13bnq-9700-8032013/invt/z10032013 (accessed 2014 Oct 10). Mental Health Commission of Canada. Turning the key: Assessing housing and related supports for persons living with mental health problems and illnesses. Ottawa (ON): The Commission; 2012. Available: www.mentalhealthcommission.ca/English/media/3055 (accessed 2014 Oct 10). Mental Health Commission of Canada. National final report: Cross-Site At Home/Chez Soi Project. Ottawa (ON): The Commission; 2014. Available: www.mentalhealthcommission.ca/English/document/24376/national-homechez-soi-final-report (accessed 2015 May 15). Hawthorne D; Major S; Jaworski M; et al. Combatting stigma for physicians and other health professionals. Ottawa (ON): MDcme.ca; 2011. Available https://www.mdcme.ca/courseinfo.asp?id=143 (accessed 2015 May 15). Abbey SE, Charbonneau M, Tranulis C, et al. Stigma and discrimination. Can J Psychiatry 2011; 56(10): 1-9. Available: http://publications.cpa-apc.org/media.php?mid=1221 (accessed 2015 Aug 4). Pietrus M. Opening Minds interim report. Calgary (AB): Mental Health Commission of Canada; 2013. Available: www.mentalhealthcommission.ca/English/document/17491/opening-minds-interim-report (accessed 2015 Aug 4). Mental Health Commission of Canada. Together against stigma: changing how we see mental illness: a report on the 5th International Stigma Conference, Ottawa (ON), 2012 Jun 4–6. Ottawa (ON): The Commission; 2013. Available: www.mentalhealthcommission.ca/English/media/3347 (accessed 2014 Oct 14).
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Consultation on the prescription drug list: Naloxone

https://policybase.cma.ca/en/permalink/policy11847
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide comment on the proposal by Health Canada1 to revise the listing for naloxone on the Prescription Drug List (PDL) to allow the non-prescription use of naloxone, "when indicated for emergency use for opioid overdose outside hospital settings". The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The harms associated with opioids, which include prescription medicines such as oxycodone, hydromorphone and fentanyl, as well as illegal drugs such as heroin, is a significant public health and patient safety issue. Harms include addiction, diversion, overdose and death. According to 2013 estimates2, Canada has one of the highest per capita consumptions of prescription opioids in the world. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.3 Data on the harms caused by opioids are not collected systematically in Canada; however, practitioners have seen the significant impact of these drugs on their patients and to whole communities, including indigenous peoples. Opioid addiction rates from 43% to 85% have been reported in some indigenous communities.4 5 In Ontario, according to the Office of the Chief Coroner, opioid-related deaths nearly tripled from 2002 to 2010.6 Canada's physicians believe that Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs, whether illegal or prescription-based.7 One component of this strategy is the prevention of overdose deaths and complications with appropriate medication and prompt emergency response. For over four decades, naloxone (or Narcan(r)) has been used as a prescription drug for the complete or partial reversal of opioid overdoses. Naloxone counteracts the life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. The World Health Organization placed naloxone on its list of essential medications in 1983. Physicians have been encouraged to identify patients who could benefit from the co-prescription of naloxone, along with opioids, when these are necessary. Increased risk for opioid overdose includes previous episodes of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use.8 9 More recently, with the increase in opioid overdoses, different provinces have created programs to increase access to naloxone outside of health care settings, such as "take-home naloxone programs". The experience in Canada and in other countries has been shown to have various benefits, including reducing overdose deaths.10 11 In Canada, naloxone has been administered through intramuscular or subcutaneous injection in these community-based programs, but in other countries it has also been available in a nasal spray form or in a pre-filled auto-injector format. Those that receive the naloxone kit are trained in the recognition of signs and symptoms of opioid overdose, in the administration of naloxone and first aid and in the need to call for medical follow-up. In its 2015 policy on Harms associated with Opioids and other Psychoactive Prescription Drugs, the CMA supports the improvement of access to naloxone, particularly by individuals who are at a high risk of overdose as well as third parties who can assist a person experiencing an opiate-related overdose. The CMA also encourages the creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. This would include training for health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.12 Also in 2015, the CMA approved a resolution supporting "the development and implementation of a national strategy on the use of naloxone".13 A report issued by the United Nations Office on Drugs and Crime and the World Health Organization supports making naloxone available to first responders as well as to people dependent on opioids, their peers and family members who are likely to be present when an overdose occurs.14 Many other organizations, such as the Canadian Pharmacists Association, the American Medical Association and the American Public Health Association, are also supportive of enhanced access to naloxone in the community.15 16 17 The prescription status has been one of the barriers to increased access to naloxone. It is more likely that a family member, partner or friend would need to administer the naloxone in an overdose than the person who is prescribed the drug. Community-based programs have had to work with standing orders from prescribers. First responders, such as police officers and firefighters, should be able to carry and administer the drug, given they are often the first professionals to arrive at a scene where someone has overdosed. According to Health Canada, the provinces and territories have collectively asked that the prescription status be re-evaluated. Health Canada has undertaken a Benefit-Harm-Uncertainty assessment of naloxone, and come to the following conclusions: This assessment recommended that naloxone could safely be administered without the direct supervision of a physician if the person administering the drug has appropriate training. The main risks associated with the unsupervised use of the drug are: * the administrator may have difficulty filling the syringe and administering the drug under pressure in an emergency situation; * the administrator may not seek professional care for follow-up of the patient after injection; * chance of the patient relapsing since the effects of naloxone may only last for up to one hour depending on amount and type of opioid causing the overdose; * that the patient may become very agitated and aggressive after coming out of the opioid depression (Acute Opioid Withdrawal Syndrome). These risks can be mitigated with appropriate training of the potential administrator before naloxone is distributed. The benefit of quickly responding to an overdose far outweighed these risks. Evidence from provincial take-home programs indicates that naloxone can be administered (intramuscularly or subcutaneously) by a layperson and its effects monitored successfully without practitioner supervision. Although an opioid overdose might be mistakenly diagnosed by a layperson, the injection of naloxone in a person not overdosing on an opioid will cause no serious harm.18 Various jurisdictions have delisted or are studying special conditions for the status of naloxone as a prescription drug, including Italy and some U.S. States.19 The CMA appreciates the opportunity to provide feedback on this important matter to physicians, and congratulates Health Canada in taking the initiative to make naloxone more accessible in the community; thereby helping to address the concerning levels of opioid overdoses in Canada. CMA Recommendations: That Health Canada proceed with the revisions to the listing for naloxone on the Prescription Drug List, to allow the non-prescription use of naloxone when indicated for emergency use for opioid overdose outside hospital settings. As outlined in Health Canada's assessment, the potential risks can be mitigated by well-designed community-based programs. That Health Canada assess the option of licensing naloxone products that don't require training for intramuscular or subcutaneous injection, such as nasal sprays or automated handheld injectors (similar to epinephrine auto-injectors for use in serious allergic reactions), in order to further increase accessibility. References 1 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17). 2 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013. Available: https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2012/NDR_2012_Annex_2_EFS.pdf (accessed 2016 March 17). 3 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. 4 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf (accessed 2016 March 17). 5 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf (accessed 2016 March 17). 6 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. 7 Canadian Medical Association. Policy Document PD15-06 - Harms associated with opioids and other psychoactive prescriptions drugs. Ottawa: The Author; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed 2016-March 17). 8 National Opioid Use Guideline Group. Canadian guideline for safe and effective use of opioids for chronic non-cancer pain. Hamilton, ON: McMaster University; 2010. Available: http://nationalpaincentre.mcmaster.ca/opioid/ (accessed 2016 March 17). 9 Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain-United States, 2016. MMWR Recomm Rep. 2016;65(RR-1):1-49. Available: http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1er.htm?s_cid=rr6501e1er_w (accessed 2016 March 17). 10 Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: Interrupted time series analysis. BMJ. 2013;346:f174. Available: http://www.bmj.com/content/bmj/346/bmj.f174.full.pdf (accessed 2016 March 17). 11 Banjo, O, Tzemis, D, Al-Outub, D, et al. A quantitative and qualitative evaluation of the British Columbia Take Home Naloxone program. CMAJ Open, August 21, 2014;2(3) E153-E161. Available: http://cmajopen.ca/content/2/3/E153.full (accessed 2016 March 17). 12 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/ (accessed 2016 March 17). 13 Canadian Medical Association. Policy Resolution GC15-18 - National strategy on the use of naloxone. Ottawa: The Author; 2015. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 March 17). 14 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17). 15 American Medical Association. AMA adopts new policies at annual meeting. Press Release. New York, NY: Reuters; June 19, 2012. Available: http://www.reuters.com/article/idUS182652+19-Jun-2012+GNW20120619 (accessed 2016 March 17). 16 Drug Policy Alliance. American Public Health Association Policy Statement on Preventing Overdose Through Education and Naloxone Distribution. New York, NY: Drug Policy Alliance; October 30, 2012. Available: http://www.drugpolicy.org/resource/american-public-health-association-policy-statement-preventing-overdose-through-education-a (accessed 2016 March 17). 17 Canadian Pharmacists Association. CPhA Welcomes Health Canada Move to Change Prescription Status of Naloxone. News Release. January 14, 2016. Available: https://www.pharmacists.ca/news-events/news/cpha-welcomes-health-canada-move-to-change-prescription-status-of-naloxone/ (accessed 2016 March 17). 18 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17). 19 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17).
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Regulatory framework for the mandatory reporting of adverse drug reactions and medical device incidents by provincial and territorial healthcare institutions.

https://policybase.cma.ca/en/permalink/policy11814
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Response to consultation
Date
2016-01-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation document Questions related to Mandatory Reporting of Adverse Drug Reactions and Medical Device Incidents by Provincial and Territorial Healthcare Institutions. Prescription medication has an important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient’s capacity to function productively in the community. In consideration of this important role, the CMA has developed a substantial body of policy on pharmaceutical issues which includes policy on Canada’s post-approval surveillance system for prescription medication. It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA welcomes Health Canada’s consultation on the new legislative authority established by Vanessa’s Law to implement mandatory reporting of adverse drug reactions (ADR) and medical device incidents by provincial and territorial healthcare institutions. The CMA appreciates all opportunities to work with governments, health care professionals and the public in strengthening Canada’s post-approval surveillance system and ensuring that the prescription drugs Canadians receive are safe and effective. The CMA’s submission is organized in three main sections. In the first section, the CMA’s concerns with the current ADR reporting system are identified as critical context for this regulatory development process. The second section provides an overview of the CMA’s recommendations on necessary improvements to this system. Finally, the CMA’s responses to the questions outlined in Health Canada’s discussion document are presented in the third section. Part 1: Context of CMA’s Recommendevices with which they have a concern, and also for research purposes.
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