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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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CMA Patient Safety Policy Framework (Update 2010)

https://policybase.cma.ca/en/permalink/policy9747
Last Reviewed
2018-03-03
Date
2010-02-27
Topics
Health care and patient safety
  1 document  
Policy Type
Policy document
Last Reviewed
2018-03-03
Date
2010-02-27
Replaces
CMA Patient Safety Policy Framework (2001)
Topics
Health care and patient safety
Text
CMA PATIENT SAFETY POLICY FRAMEWORK (Update 2010) BACKGROUND The CMA’s mission is to promote the highest standard of health and health care for Canadians. This means, among other things, ensuring that the health care system is safe for patients and providers and effective in achieving good health outcomes for individuals and society. Unfortunately, studies published in recent years have raised concern that health care is not as safe as it could be; data collected by researchers in various countries has shown that there are unacceptably high levels of preventable adverse events, as high as 16% in one study of adverse events associated with hospital admissions. A study conducted by G. R. Baker, P.G. Norton et al, “The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada” showed an adverse event rate of 7.5 per 100 hospital admissions. (1) This suggests that of the nearly 2.5 million hospital admissions yearly in Canada, approximately 185,000 are associated with an adverse event and 70,000 of those possibly preventable. These studies have focused attention on health care error and adverse events, but patient safety requires that participants in the health care system are constantly aware of the risks present in the system, and that risks are addressed proactively - preferably before an adverse event occurs. If a preventable adverse event does occur, it provides an opportunity to learn about and correct sources of error. The CMA considers that a national patient safety strategy, aimed at building a culture of safety, is a priority. This Policy Framework has been developed to provide a clear statement of the CMA’s views on the principles that should underpin a patient safety strategy and to ensure clear support and direction for CMA members and staff involved in patient safety initiatives. PRINCIPLES The Health Care System Outcomes Errors and adverse events are inevitable in any complex system and more complex systems are more prone to errors. Nevertheless, studies have demonstrated an unacceptably high level of preventable adverse events associated with management of health care. 1. Patient safety initiatives should aim to improve health outcomes for patients by minimizing the rate of preventable adverse events and improving the management of events when they occur. Quality 2. Patient safety is one aspect of quality health care; activities relating to patient safety should result in a net increase in the quality of health care. Systemic factors 3. Patient safety initiatives should recognize that error and adverse events occur because of qualities of the system within which individuals operate. A primary concern of initiatives should be to prevent future errors by addressing the system rather than blaming and punishing individuals. Accountability The Canadian public has a reasonable expectation that health care will not result in avoidable injury. 4. Patient safety initiatives should support the accountability of the health sector, including providers, funders and regulators, to patients and the wider public for the safety of health care. Participants in Health Care Patients as partners 5. Patient safety initiatives should promote the role of patients as partners in the provision of safe care, including the prevention and management of adverse events. 6. Patient safety initiatives should encourage and anticipate the full and appropriate disclosure to patients of relevant information that is material to their health and healthcare, including information about adverse events or effects. Professional responsibility and support With a very few exceptions, health care is delivered by competent, caring professionals who are striving to achieve a good outcome for patients. 7. Patient safety initiatives should recognize the responsibility of professionals for achieving and maintaining the standard of their own practice. 8. Patient safety initiatives, while responding appropriately to adverse events, should be sensitive to the professional role and personal well being of individual physicians and other health care providers. Learning and Collaboration 9. Patient safety initiatives should promote and reflect teamwork, communication and collaboration at all levels. 10. Patient safety initiatives should support learning from one’s own experience and the sharing of knowledge so that it is possible to learn from the experience of others. Legal and Regulatory Environment 11. Patient Safety initiatives should promote a legal and regulatory environment that supports open communication and effective management of adverse events. 12. The protection afforded to the opinions expressed within quality assurance committees must be upheld Evidence Base and Evaluation Patient safety initiatives should be based on sound evidence. Patient safety initiatives should contain provision for appropriate evaluation. Patient safety initiatives should contain provision for broad dissemination of findings. PATIENT SAFETY INITIATIVE AREAS Building a culture of safety in Canadian health care will require the collaboration of many different groups and organizations. The CMA can play a leadership role within this larger group and within its own constituency of over 70,000 physicians. In some instances, it will be the CMA’s role to advocate for initiatives that can be delivered only by another provider or through a consortium; in other instances, CMA can assume sole responsibility for taking action. The CMA has identified that, as priorities, it will support: Advocacy for changes to legislation and regulation that would remove disincentives for health care providers to share information about adverse events. Raising awareness of patient safety and changing attitudes towards risk, error and adverse events within the health care community. Developing and providing resources such as clinical practice guidelines and information technology systems that have been shown to standardize practice and reduce adverse events. Reporting systems that collect and aggregate data on risks so that good practices can be developed and shared. Education and training for health care professionals and managers to provide them with the conceptual and practical tools to introduce change into their practice and organizations. Advocacy for, and development of, an agenda for patient safety research in Canada. The involvement of government at all levels in supporting and committing resources to initiatives for improved patient safety. GLOSSARY Adverse event – any unintended injury or complication that is caused by health care management rather than the patient’s disease and that leads to prolonged hospital stay, morbidity or mortality. Adverse events do not necessarily result from error, for example a toxic reaction to a drug in a patient without apparent risk factors for the reaction. Error – the failure of a planned action to be completed as intended (“error of execution”) or the use of a wrong plan to achieve an aim (“error of planning”). An error may not result in an adverse event if the error does not result in harm or is intercepted. Risk – the chance of injury or loss as defined as a measure of the probability and severity of an adverse effect to health, property, the environment or other things of value. (1) G. Ross Baker, Peter G. Norton, Virginia Flintoft, Régis Blais, Adalsteinn Brown, Jafna Cox, Ed Etchells, William A. Ghali, Philip Hébert, Sumit R. Majumdar, Maeve O'Beirne, Luz Palacios-Derflingher, Robert J. Reid, Sam Sheps, and Robyn Tamblyn. The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada Can. Med. Assoc. J., May 2004; 170: 1678 - 1686.
Documents
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CMA statement on emerging therapies

https://policybase.cma.ca/en/permalink/policy10352
Last Reviewed
2018-03-03
Date
26-08-2010
Topics
Health care and patient safety
  1 document  
Policy Type
Policy document
Last Reviewed
2018-03-03
Date
26-08-2010
Topics
Health care and patient safety
Text
CMA Statement on Emerging Therapies The CMA is keenly aware of the heart-rending suffering experienced by MS patients and the devastating impact it has on families and we recognize how desperately they are seeking treatments to alleviate their symptoms. Physicians and researchers dedicate their lives to finding new treatments to prevent and ease the suffering of patients while supporting those battling disease. Along with the physician's care and compassion, clinical research is a key weapon in the battle to manage and treat disease. The CMA believes that all medical decisions must be based upon scientific evidence. That is at the heart of our commitment to patient-centred care. 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-based. This principle is highly relevant in the case of the Canadian Institutes of Health Research (CIHR) recent recommendations. The CMA concurs with the CIHR's position on the need for an evidence-based approach to the development of clinical trials of the recently proposed condition called "chronic cerebrospinal venous insufficiency" (CCSVI). We would hope that the findings of the seven diagnostic studies that are underway will be shared and analyzed as soon as they become available, and that clinical intervention trials would be supported as indicated by the evidence and if researchers come forward with scientifically sound ethical protocols. If additional Canadian funding bodies initiate clinical research in the area, we would encourage CIHR to provide advice if requested.
Documents
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Health risks associated with tanning facilities

https://policybase.cma.ca/en/permalink/policy9880
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-82
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, will call on governments to strengthen labelling requirements on tanning equipment and require signage in tanning facilities that outlines the carcinogenic potential and overall health risks associated with tanning facilities.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-82
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, will call on governments to strengthen labelling requirements on tanning equipment and require signage in tanning facilities that outlines the carcinogenic potential and overall health risks associated with tanning facilities.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, will call on governments to strengthen labelling requirements on tanning equipment and require signage in tanning facilities that outlines the carcinogenic potential and overall health risks associated with tanning facilities.
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Regulating the artificial tanning industry

https://policybase.cma.ca/en/permalink/policy9881
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-83
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, affiliate and associate organizations and other stakeholders, will call on all levels of government to regulate the artificial tanning industry, with a focus on banning access to children and youth under 18 years of age.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-83
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, affiliate and associate organizations and other stakeholders, will call on all levels of government to regulate the artificial tanning industry, with a focus on banning access to children and youth under 18 years of age.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, affiliate and associate organizations and other stakeholders, will call on all levels of government to regulate the artificial tanning industry, with a focus on banning access to children and youth under 18 years of age.
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Comprehensive pregnancy care

https://policybase.cma.ca/en/permalink/policy9882
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Population health/ health equity/ public health
Health care and patient safety
Resolution
GC10-84
The Canadian Medical Association will work with provincial/territorial medical associations, affiliate and associate organizations, and other stakeholders to further develop educational materials for primary care providers and women on the importance of pre-pregnancy and early-pregnancy health, and early access to comprehensive pregnancy care.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Population health/ health equity/ public health
Health care and patient safety
Resolution
GC10-84
The Canadian Medical Association will work with provincial/territorial medical associations, affiliate and associate organizations, and other stakeholders to further develop educational materials for primary care providers and women on the importance of pre-pregnancy and early-pregnancy health, and early access to comprehensive pregnancy care.
Text
The Canadian Medical Association will work with provincial/territorial medical associations, affiliate and associate organizations, and other stakeholders to further develop educational materials for primary care providers and women on the importance of pre-pregnancy and early-pregnancy health, and early access to comprehensive pregnancy care.
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Installation of automatic external defibrillators in public facilities

https://policybase.cma.ca/en/permalink/policy9884
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-87
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, supports where feasible and cost-effective the installation of automatic external defibrillators in public facilities and high traffic areas such as sports arenas.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-87
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, supports where feasible and cost-effective the installation of automatic external defibrillators in public facilities and high traffic areas such as sports arenas.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, supports where feasible and cost-effective the installation of automatic external defibrillators in public facilities and high traffic areas such as sports arenas.
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Prenatal screening tests

https://policybase.cma.ca/en/permalink/policy9885
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Health systems, system funding and performance
Resolution
GC10-86
The Canadian Medical Association, in collaboration with provincial/territorial medical associations and other stakeholders, calls on governments to offer, promote and fund prenatal screening tests for the most common chromosomal abnormalities.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Health systems, system funding and performance
Resolution
GC10-86
The Canadian Medical Association, in collaboration with provincial/territorial medical associations and other stakeholders, calls on governments to offer, promote and fund prenatal screening tests for the most common chromosomal abnormalities.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations and other stakeholders, calls on governments to offer, promote and fund prenatal screening tests for the most common chromosomal abnormalities.
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Online continuing medical education

https://policybase.cma.ca/en/permalink/policy9892
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Population health/ health equity/ public health
Ethics and medical professionalism
Health information and e-health
Resolution
GC10-69
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, calls on governments to ensure that the necessary technology is in place to guarantee that physicians in rural and remote locations have access to accredited online continuing medical education/continuing professional development.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Population health/ health equity/ public health
Ethics and medical professionalism
Health information and e-health
Resolution
GC10-69
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, calls on governments to ensure that the necessary technology is in place to guarantee that physicians in rural and remote locations have access to accredited online continuing medical education/continuing professional development.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, calls on governments to ensure that the necessary technology is in place to guarantee that physicians in rural and remote locations have access to accredited online continuing medical education/continuing professional development.
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Pre-mixed alcoholic energy drinks

https://policybase.cma.ca/en/permalink/policy9901
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-78
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, urges governments to ensure that liquor boards and other relevant bodies comply with existing Health Canada regulations for the sale of pre-mixed alcoholic energy drinks.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health care and patient safety
Resolution
GC10-78
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, urges governments to ensure that liquor boards and other relevant bodies comply with existing Health Canada regulations for the sale of pre-mixed alcoholic energy drinks.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, urges governments to ensure that liquor boards and other relevant bodies comply with existing Health Canada regulations for the sale of pre-mixed alcoholic energy drinks.
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Antibiotic resistant organisms in humans

https://policybase.cma.ca/en/permalink/policy9902
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Population health/ health equity/ public health
Ethics and medical professionalism
Health care and patient safety
Resolution
GC10-79
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, will work with Health Canada and the Public Health Agency of Canada to investigate the agriculture-related release of antibiotic resistant organisms and residual antibiotics into earth and water ecosystems, as well as the role they play in the emergence of antibiotic resistant organisms in humans.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Population health/ health equity/ public health
Ethics and medical professionalism
Health care and patient safety
Resolution
GC10-79
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, will work with Health Canada and the Public Health Agency of Canada to investigate the agriculture-related release of antibiotic resistant organisms and residual antibiotics into earth and water ecosystems, as well as the role they play in the emergence of antibiotic resistant organisms in humans.
Text
The Canadian Medical Association, in collaboration with provincial/territorial medical associations, will work with Health Canada and the Public Health Agency of Canada to investigate the agriculture-related release of antibiotic resistant organisms and residual antibiotics into earth and water ecosystems, as well as the role they play in the emergence of antibiotic resistant organisms in humans.
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Antibiotics in animals

https://policybase.cma.ca/en/permalink/policy9904
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC10-81
The Canadian Medical Association calls on the federal government to investigate animal husbandry techniques that decrease the need for antibiotics in animals and to support techniques proven to be effective.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC10-81
The Canadian Medical Association calls on the federal government to investigate animal husbandry techniques that decrease the need for antibiotics in animals and to support techniques proven to be effective.
Text
The Canadian Medical Association calls on the federal government to investigate animal husbandry techniques that decrease the need for antibiotics in animals and to support techniques proven to be effective.
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Mixed Martial Arts

https://policybase.cma.ca/en/permalink/policy9906
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC10-88
The Canadian Medical Association advocates for a ban on Mixed Martial Arts prize fighting matches in Canada.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
GC10-88
The Canadian Medical Association advocates for a ban on Mixed Martial Arts prize fighting matches in Canada.
Text
The Canadian Medical Association advocates for a ban on Mixed Martial Arts prize fighting matches in Canada.
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E-health strategies

https://policybase.cma.ca/en/permalink/policy9908
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health information and e-health
Health systems, system funding and performance
Resolution
GC10-90
The Canadian Medical Association will work with provincial/territorial medical associations to ensure investments made by the Canada Health Infoway are aligned with, and respect e-health strategies that are currently being implemented or developed within various jurisdictions.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health information and e-health
Health systems, system funding and performance
Resolution
GC10-90
The Canadian Medical Association will work with provincial/territorial medical associations to ensure investments made by the Canada Health Infoway are aligned with, and respect e-health strategies that are currently being implemented or developed within various jurisdictions.
Text
The Canadian Medical Association will work with provincial/territorial medical associations to ensure investments made by the Canada Health Infoway are aligned with, and respect e-health strategies that are currently being implemented or developed within various jurisdictions.
Less detail
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health information and e-health
Population health/ health equity/ public health
Physician practice/ compensation/ forms
Resolution
GC10-93
The Canadian Medical Association supports and will expedite research into the expansion of telemedicine and the utilization of emerging technologies, to directly link health care providers and patients.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health information and e-health
Population health/ health equity/ public health
Physician practice/ compensation/ forms
Resolution
GC10-93
The Canadian Medical Association supports and will expedite research into the expansion of telemedicine and the utilization of emerging technologies, to directly link health care providers and patients.
Text
The Canadian Medical Association supports and will expedite research into the expansion of telemedicine and the utilization of emerging technologies, to directly link health care providers and patients.
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Medical records

https://policybase.cma.ca/en/permalink/policy9923
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Health care and patient safety
Health information and e-health
Resolution
GC10-106
The Canadian Medical Association will work with provincial/territorial medical associations and other stakeholders including patients to develop a national strategy for the long-term retention, retrieval and disposal of medical records.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Ethics and medical professionalism
Health care and patient safety
Health information and e-health
Resolution
GC10-106
The Canadian Medical Association will work with provincial/territorial medical associations and other stakeholders including patients to develop a national strategy for the long-term retention, retrieval and disposal of medical records.
Text
The Canadian Medical Association will work with provincial/territorial medical associations and other stakeholders including patients to develop a national strategy for the long-term retention, retrieval and disposal of medical records.
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Random breath tests

https://policybase.cma.ca/en/permalink/policy9976
Last Reviewed
2017-03-04
Date
2010-06-01
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
BD10-05-194
The Canadian Medical Association (CMA) supports the use of random breath tests in existing police spot check programs as part of a comprehensive plan to reduce drunk-driving related mortality and morbidity in Canada. Any such programs should be consistent with the protections established in the Canadian Charter of Rights and Freedoms.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-06-01
Topics
Ethics and medical professionalism
Health care and patient safety
Resolution
BD10-05-194
The Canadian Medical Association (CMA) supports the use of random breath tests in existing police spot check programs as part of a comprehensive plan to reduce drunk-driving related mortality and morbidity in Canada. Any such programs should be consistent with the protections established in the Canadian Charter of Rights and Freedoms.
Text
The Canadian Medical Association (CMA) supports the use of random breath tests in existing police spot check programs as part of a comprehensive plan to reduce drunk-driving related mortality and morbidity in Canada. Any such programs should be consistent with the protections established in the Canadian Charter of Rights and Freedoms.
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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 --------------- ------------------------------------------------------------ --------------- ------------------------------------------------------------
Documents
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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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Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada

https://policybase.cma.ca/en/permalink/policy13936
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
Text
Thank you Mr. Chair. I am Dr. Jeff Blackmer, the Vice-President of Medical Professionalism for the Canadian Medical Association. On behalf of the CMA, let me first commend the committee for initiating an emergency study on this public health crisis in Canada. As the national organization representing over 83,000 Canadian physicians, the CMA has an instrumental role in collaborating with other health stakeholders, governments and patient organizations in addressing the opioid crisis in Canada. On behalf of Canada’s doctors, the CMA is deeply concerned with the escalating public health crisis related to problematic opioid and fentanyl use. Physicians are on the front lines in many respects. Doctors are responsible for supporting patients with the management of acute and chronic pain. Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. The CMA has long been concerned with the harms associated with opioid use. In fact, we appeared before this committee as part of its 2013 study on the government’s role in addressing prescription drug abuse. At that time, we made a number of recommendations on the government’s role – some of which I will reiterate today. Since then, the CMA has taken numerous actions to contribute to Canada’s response to the opioid crisis. These actions have included advancing the physician perspective in all active government consultations. In addition to the 2013 study by the health committee, we have also participated in the 2014 ministerial roundtable and recent regulatory consultations led by Health Canada — specifically, on tamper resistant technology for drugs and delisting of naloxone for the prevention of overdose deaths in the community. 3 Our other actions have included: · Undertaking physician polling to better understand physician experiences with prescribing opioids; · Developing and disseminating new policy on addressing the harms associated with opioids; · Supporting the development of continuing medical education resources and tools for physicians; · Supporting the national prescription drug drop off days; and, · Hosting a physician education session as part of our annual meeting in 2015. Further, I’m pleased to report that the CMA has recently joined the Executive Council of the First Do No Harm strategy, coordinated by the Canadian Centre on Substance Abuse. In addition, we have joined 7 leading stakeholders as part of a consortium formed this year to collaborate on addressing the issue from a medical standpoint. I will now turn to the CMA’s recommendations for the committee’s consideration. These are grouped in four major theme areas. 1) Harm Reduction The first of them is harm reduction. Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. Despite the fact that there is broad recognition that we are in a public health crisis, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach rather than a public health approach. In its current form, this strategy does not significantly address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. The CMA strongly recommends that the federal government review the National Anti-Drug Strategy to reinstate harm reduction as a core pillar. Supervised consumption sites are an important part of a harm reduction program that must be considered in an overall strategy to address harms from opioids. The availability of supervised consumption sites is still highly limited in Canada. The CMA maintains its concerns that the new criteria established by the Respect for Communities Act are overly burdensome and deter the establishment of new sites. 4 As such, the CMA continues to recommend that the act be repealed or at the least, significantly amended. 2) Expanding Pain Management and Addiction Treatment The second theme area I will raise is the need to expand treatment options and services. Treatment options and services for both addiction as well as pain management are woefully under-resourced in Canada. This includes substitution treatments such as buprenorphine-naloxone as well as services that help patients taper off opioids or counsel them with cognitive behavioural therapy. Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. The CMA recommends that the federal government deliver additional funding on an emergency basis to significantly expand the availability and access to addiction treatment and pain management services. 3) Investing in Prescriber and Patient Education The third theme I will raise for the committee’s consideration is the need for greater investment in both prescriber as well as patient education resources. For prescribers, this includes continuing education modules as well as training curricula. We need to ensure the availability of unbiased and evidenced-based educational programs in opioid prescribing, pain management and in the management of addictions. Further, support for the development of educational tools and resources based on the new clinical guidelines to be released in early 2017 will have an important role. Finally, patient and public education on the harms associated with opioid usage is critical. As such, the CMA recommends that the federal government deliver new funding to support the availability and provision of education and training resources for prescribers, patients and the public. 4) Establishing a Real-time Prescription Monitoring Program Finally, to support optimal prescribing, it is critical that prescribers be provided with access to a real-time prescription monitoring program. 5 Such a program would allow physicians to review a patient’s prescription history from multiple health services prior to prescribing. Real-time prescription monitoring is currently only available in two jurisdictions in Canada. Before closing, I must emphasize that the negative impacts associated with prescription opioids represent a complex issue that will require a multi-faceted, multi-stakeholder response. A key challenge for public policy makers and prescribers is to mitigate the harms associated with prescription opioid use, without negatively affecting patient access to the appropriate treatment for their clinical conditions. To quote a past CMA president: “the unfortunate reality is that there is no silver bullet solution and no one group or government can address this issue alone”. The CMA is committed to being part of the solution. Thank you.
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