Like all scientific and medical procedures, assisted human reproduction has the potential for both benefit and harm. It is in the interests of individual Canadians and Canadian society in general that these practices be regulated so as to maximize their benefits and minimize their harms. To help achieve this goal, the Canadian Medical Association (CMA) has developed this policy on regulating these practices. It replaces previous CMA policy on assisted reproduction.
The objectives of any Canadian regulatory regime for assisted reproduction should include the following:
(a) to protect the health and safety of Canadians in the use of human reproductive materials for assisted reproduction, other medical procedures and medical research;
(b) to ensure the appropriate treatment of human reproductive materials outside the body in recognition of their potential to form human life; and
(c) to protect the dignity of all persons, in particular children and women, in relation to uses of human reproductive materials.
When a Canadian regulatory regime for assisted reproduction is developed, it should incorporate the following principles:
For the regulation of assisted reproduction, existing organizations such as medical licensing authorities, accreditation bodies and specialist societies should be involved to the greatest extent possible.
If the legislation establishing the regulatory regime is to include prohibitions as well as regulation, the prohibition of specific medical and scientific acts must be justified on explicit scientific and/or ethical grounds.
If criminal sanctions are to be invoked, they should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
Whatever regulatory agency is created should include significant membership of scientists and clinicians working in the area of assisted reproduction.
Elements of a Regulatory Regime
The regulation of assisted reproduction in Canada should include the following elements:
Legislation to create a national regulatory body with appropriate responsibilities and accountability for coordinating the activities of organizations that are working in the area of assisted reproduction and for carrying out functions that other organizations cannot perform.
The development and monitoring of national standards for research related to human subjects including genetics and reproduction. The regulatory body would work closely with the Canadian Institutes of Health Research, other federal and provincial research granting councils, the National Council on Ethics in Human Research and other such organizations.
The development and monitoring of national standards for training and certifying physicians in those reproductive technologies deemed acceptable. As is the case for all post-graduate medical training in Canada, this is appropriately done through bodies such as the Royal College of Physicians and Surgeons of Canada and the College of Family Physicians of Canada.
The licensing and monitoring of individual physicians. This task is the responsibility of the provincial and territorial medical licensing authorities which could regulate physician behaviour in respect to the reproductive technologies, just as they do for other areas of medical practice.
The development of guidelines for medical procedures. This should be done by medical specialty societies such as the Society of Obstetricians and Gynaecologists of Canada (SOGC) and the Canadian Fertility and Andrology Society (CFAS).
The accreditation of facilities where assisted reproduction is practised. There is already in Canada a well functioning accreditation system, run by the Canadian Council on Health Services Accreditation, which may be suitable for assisted reproduction facitilies.
Whatever regulatory body is established to deal with assisted reproduction should utilize, not duplicate, the work of these organizations. In order to maximize the effectiveness of these organizations, the regulatory body could provide them with additional resources and delegated powers.
The CMA is opposed to the criminalization of scientific and medical procedures. Criminalization represents an unjustified intrusion of government into the patient-physician relationship. Previous attempts to criminalize medical procedures (for example, abortion) were ultimately self-defeating. If the federal government wishes to use its criminal law power to regulate assisted reproduction, criminal sanctions should apply only in cases of deliberate contravention of the directives of the regulatory agency and not to specific medical and scientific acts.
The CMA recommends to the appropriate government authorities that all boxing be banned in Canada. Until such time, strategies to prevent injury should be pursued.
The CMA considers boxing a dangerous sport. While most sports involve risk of injury, boxing is distinct in that the basic intent of the boxer is to harm and incapacitate his or her opponent.
Boxers are at significant risk of injuries resulting in brain damage. Boxers are susceptible not only to acute life-threatening brain trauma, but also to the chronic and debilitating effects of gradual cerebral atrophy. Studies demonstrate a correlation between the number of bouts fought and the presence of cerebral abnormalities in boxers. There is also a risk of eye injury including long-term damage such as retinal tears and detachments.
- CMA supports a ban on professional and amateur boxing in Canada.
- Until boxing is banned in this country, the following preventive strategies should be pursued to reduce brain and eye injuries in boxers:
- Head blows should be prohibited. CMA encourages universal use of protective garb such as headgear and thumbless, impact-absorbing gloves
- The World Boxing Council, World Boxing Association and other regulatory bodies should develop and enforce objective brain injury risk assessment tools to exclude individual boxers from sparring or fighting.
- The World Boxing Council, World Boxing Association and other regulatory bodies should develop and enforce standard criteria for referees, ringside officials and ringside physicians to halt sparring or boxing bouts when a boxer has experienced blows that place him or her at imminent risk of serious injury.
- The World Boxing Council, World Boxing Association and other regulatory bodies should encourage implementation of measures advocated by the World Medical Boxing Congress to reduce the incidence of brain and eye injuries.
- CMA believes that the professional responsibility of the physician who serves in a medical capacity in a boxing contest is to protect the health and safety of the contestants. The desire of spectators, promoters of the event, or even injured athletes that they not be removed from the contest should not influence the physician’s medical judgment.
- Further long term outcome data should be obtained from boxers in order to more accurately establish successful preventive interventions. CMA encourages ongoing research into the causes and treatments of boxing-related injuries, and into the effects of preventive strategies.
The Canadian Medical Association (CMA) has always recognized the unique requirements of those individuals suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief.
However, there are a number of concerns, primarily related to the limited evidence to support many of the therapeutic claims made regarding cannabis for medical purposes, and the need to support health practitioners in their practice.1,2,3,4
While the indications for using cannabis to treat some conditions have been well studied, less
information is available about many potential medical uses.
Physicians who wish to authorize the use of cannabis for patients in their practices should consult relevant CMPA policy5 and guidelines developed by the provincial and territorial medical regulatory authorities to ensure appropriate medico-legal protection. The CMA’s policy Authorizing Marijuana for Medical Purposes6, as well as the CMA’s Guidelines For Physicians In Interactions With Industry7 should also be consulted.
The CMA makes the following recommendations:
1. Increase support for the advancement of scientific knowledge about the medical use of cannabis. The CMA encourages the government to support rigorous scientific research into the efficacy for therapeutic claims, safety, dose-response relationships, potential interactions and the most effective routes of delivery, and in various populations.
2. Apply the same regulatory oversight and evidence standards to cannabis as to pharmaceutical products under the Food and Drug Act, designed to protect the public by the assessment for safety and efficacy.
3. Increase support for physicians on the use of cannabis for medical purposes in their practice settings. As such, CMA calls on the government to work with the CMA, The College of Family Physicians of Canada, the Royal College of Physicians and Surgeons,
and other relevant stakeholders, to develop unbiased, accredited education options and licensing programs for physicians who authorize the use of cannabis for their patients based on the best available evidence.
In 2001, Health Canada enacted the Marihuana Medical Access Regulations (MMAR). These were in response to an Ontario Court of Appeal finding that banning cannabis for medicinal purposes violated the Charter of Rights and Freedoms.8 The MMAR, as enacted, was designed to establish a framework to allow legal access to cannabis, then an illegal drug, for the relief of pain, nausea and other symptoms by people suffering from serious illness where conventional treatments had failed.
While recognizing the needs of those suffering from terminal illness or chronic disease, CMA raised strong objections to the proposed regulations. There were concerns about the lack of evidence on the risks and benefits associated with the use of cannabis. This made it difficult for physicians to advise their patients appropriately and manage doses or potential side effects. The CMA believes that physicians should not be put in the untenable position of gatekeepers for a proposed medical intervention that has not undergone established regulatory review processes as required for all prescription medicines.
Additionally, there were concerns about medico-legal liability, and the Canadian Medical Protective Association (CMPA), encouraged those physicians that were uncomfortable with the regulations to refrain from authorizing cannabis to patients.
Various revisions were made to the MMAR, and then these were substituted by the Marihuana for Medical Purposes Regulations (MMPR) in 2013/ 2014 and subsequently by the Access to Cannabis for Medical Purposes Regulations (ACMPR) in 2016 and now as part of the Cannabis Act (Section 14)9. Healthcare practitioners that wish to authorize cannabis for their patients are required to sign a medical document, indicating the daily quantity of dried cannabis, expressed in grams.
For the most part, these revisions have been in response to decisions from various court decisions across the country.10,11,12 Courts have consistently sided with patients’ rights to relieve symptoms of terminal disease or certain chronic conditions, despite the limited data on the effectiveness of cannabis. Courts have not addressed the ethical position in which physicians are placed as a result of becoming the gate keeper for access to a medication without adequate evidence.
The CMA participated in many Health Canada consultations with stakeholders as well as scientific advisory committees and continued to express the concerns of the physician community. As previously noted, the Federal government has been constrained by the decisions of Canadian courts.
The current state of evidence regarding harms of cannabis use is also limited but points to some serious concerns. Ongoing research has shown that regular cannabis use during brain development (up to approximately 25 years old) is linked to an increased risk of mental health disorders including depression, anxiety, and schizophrenia, especially if there is a personal or family history of mental illness. Long term use has also been associated with issues of attention, impulse control and emotional regulation. Smoking of cannabis also has pulmonary consequences such as chronic bronchitis. It is also linked to poorer pregnancy outcomes. Physicians are also concerned with dependence, which occurs in up to 10% of regular users. From a public and personal safety standpoint, cannabis can impact judgement and increases the risk of accidents (e.g. motor vehicle incidents). For many individuals, cannabis use is not without adverse consequences.3,13,14
Pharmaceutically prepared alternative options, often administered orally, are also available and regulated in Canada.15 These drugs mimic the action of delta-9-tetra-hydrocannabional (THC) and other cannabinoids and have undergone clinical trials to demonstrate safety and effectiveness and have been approved for use through the Food and Drug Act. Of note is that in this format, the toxic by-products of smoked marijuana are avoided.16 However, the need for more research is evident.
Approved by the CMA Board in December 2010.
Last reviewed and approved by the CMA Board in March 2019.
1 Allan GM, Ramji J, Perry D, et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician, 2018;64(2):111-120. Available: http://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Jan 8).
2 College of Family Physicians of Canada (CFPC). Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance. Mississauga: CFPC; 2014. Available: https://www.cfpc.ca/uploadedFiles/Resources/_PDFs/Authorizing%20Dried%20Cannabis%20for%20Chronic%20Pain%20or%20Anxiety.pdf (accessed 2019 Jan 8).
3 The National Academies of Sciences, Engineering and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: National Academies Press; 2017. 4 Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015;313(24):2456-73.
5 Canadian Medical Protective Association (CMPA). Medical marijuana: considerations for Canadian doctors. Ottawa: CMPA; 2018. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2014/medical-marijuana-new-regulations-new-college-guidance-for-canadian-doctors (accessed 2019 Jan 8).
6 Canadian Medical Association (CMA). Authorizing marijuana for medical purposes. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11514 http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-04.pdf (accessed 2019 Jan 8).
7 Canadian Medical Association. (CMA) Guidelines for Physicians In Interactions With Industry. Ottawa: CMA; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf. (accessed 2019 Jan22).
8 R. v. Parker, 2000 CanLII 5762 (ON CA). Available: http://canlii.ca/t/1fb95 (accessed 2019 Jan 8).
9 Cannabis Act. Access to Cannabis for Medical Purposes. Section 14. 2018. Available: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-144/page-28.html#h-81 (accessed 2019 Jan 8).
10 Hitzig v. Canada, 2003 CanLII 3451 (ON SC). Available: http://canlii.ca/t/1c9jd (accessed 2019 Jan 8).
11 Allard v. Canada,  3 FCR 303, 2016 FC 236 (CanLII), Available: http://canlii.ca/t/gngc5 (accessed 2019 Jan 8).
12 R. v. Smith, 2014 ONCJ 133 (CanLII). Available: http://canlii.ca/t/g68gk (accessed 2019 Jan 8). 13 Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227.
14 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: https://www.who.int/substance_abuse/publications/msbcannabis.pdf (accessed 2019 Jan 8).
15 Ware MA. Is there a role for marijuana in medical practice? Can Fam Physician 2006;52(12):1531-1533. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1952544/pdf/0530022a.pdf (accessed 2019 Jan 8).
16 Engels FK, de Jong FA, Mathijssen RHJ, et.al. Medicinal cannabis in oncology. Eur J Cancer. 2007;43(18):2638-2644. Available: https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804907007368.pdf?locale=en_US (accessed 2019 Jan 8).
Climate Change and Human Health
Climate change is increasingly recognized as a significant threat facing society and has the potential to be one of the greatest threats to human health in the 21st Century1. While the damage is being done now, many of the health effects may arise only decades in the future2.
Possible impacts could include some or all of the following:
* Increased mortality, disease and injuries from heat waves and other extreme weather events;
* Continued change in the range of some infectious disease vectors (i.e. 260-320 million more cases of malaria predicted by 2080, with six billion more at risk for dengue fever);
* Effects on food yields- increased malnutrition;
* Increased flooding in some areas and increased droughts in others, along with other impacts on freshwater supply;
* Increases in foodborne and waterborne illnesses;
* Warming and rising sea levels adding to displacement and also impacting water supply through salination;
* Impaired functioning of ecosystems;
* Negative effects on air quality associated with ground level ozone, including increases in cardio-respiratory morbidity and mortality, asthma, and allergens;
* Displacement of vulnerable populations (especially in coastal areas)1; and
* Loss of livelihoods3.
Most of the impacts of climate change will result from amplifying the existing health hazards found in populations4. How susceptible a population is to the effects of climate change is dependent on their existing vulnerabilities (i.e. disease burden, resources etc.) as well as their adaptive capacity5. The World Health Organization has projected that countries that have, and will likely continue to suffer the greatest effects, are those who have contributed the smallest amount to the causes of climate change.6
While the vast majority of climate change deaths will occur in developing countries with systemic vulnerabilities, a recent Health Canada report has noted that Canada is likely to experience higher rates of warming in this century than most other countries in the world. Climate change scenarios predict an increased risk of extreme weather and other climate events for all regions of Canada, with the exception of extreme cold7. Canadians most vulnerable to climate change include seniors, children and infants, socially disadvantaged individuals, and those with pre-existing medical conditions such as cardiovascular disease8. Those living in cities could be especially vulnerable due to the impact of the heat island effect. However, given their greater access to emergency, health, social, and financial resources, they might also have the greatest adaptive capacity9.
The health consequences of climate change have the potential to be more severe in far northern regions. Populations in Canada's north including aboriginals have already begun to see differences in their hunting practices as a result of changing ice patterns10, and the melting of permanent snowpacks11. Changes in ice patterns have also led to increased injuries12. In some places in the North, climate changes have led to greater risks from avalanches, landslides and other hazards13. Further problems are related to the infrastructure in Northern Canada, with some communities already noticing degradation of structures due to the thawing of the permafrost14. Given that much of the Northern infrastructure is already in disrepair, this represents a considerable problem. Geographic isolation, and a lack of resources may further exacerbate the situation15.
What CMA has done?
Physicians have a critical role to play in advancing public understanding of the potential impact of climate change on health and promoting health protecting responses.
The CMA has been working on the issue of climate change and human health for a number of years. CMA was supportive of Canada's ratification of the Kyoto Protocol, and urged the Government of Canada to commit to choosing a climate change strategy that satisfied Canada's international commitments while also maximizing the clean air co-benefits and smog-reduction potential of any greenhouse gas reduction initiatives.
In 2007, a number of resolutions were passed at General Council calling on government to properly plan for the health impacts of climate change and put in place measures to mitigate the impact of climate change on vulnerable populations in Canada's north. In that same year, CMA and the Canadian Nurses Association updated a joint position statement first entered into in 1994 calling for environmentally responsible activity in the health-care sector.
Most recently, the CMA has been an integral part of the drafting of the World Medical Association (WMA) policies on health and climate change. The WMA Declaration of Delhi on Health and Climate Change was adopted at its annual General Assembly in New Delhi, India in October 2009, The declaration calls for action in five main areas; advocacy to combat global warming; leadership-help people be healthy enough to adapt to climate change; education and capacity building; surveillance and research; and collaboration to prepare for climate emergencies. This policy is written to complement the WMA declaration.
What needs to be done?
Climate change may lead to significant impacts on human health. While it is unlikely that these outcomes can be avoided, there are some strategies that can be employed to help limit the negative consequences.
Education and Capacity Building
There is a need for greater public and health professional awareness and education about climate change in order to gain understanding of the health consequences and support for strategies to reduce green house gases and mitigate climate change effects.
1. A national public awareness program on the importance of the environment and global climate change to personal health;
2. Encouraging health sciences schools to enhance their provision of educational programs on environmental health; and fostering the development of continuing education modules on environmental health and environmental health practices.
Surveillance and Research
There are important gaps in our knowledge on the health impacts of climate change as well as the effectiveness of various mitigation and adaptation strategies. Surveillance and reporting functions need to be strengthened to allow for greater accuracy in modeling of future impacts.
3. That the federal government must address the gaps in research regarding climate change and health by undertaking studies to
- quantify and model the burden of disease that will be caused by global climate change
- identify the most vulnerable populations, the particular health impacts of climate change on vulnerable populations, and possible new protections for such populations;
- increase the collection and accuracy of health data, particularly for vulnerable and underserved populations;
- report diseases that emerge in conjunction with global climate change, and participate in field investigations, as with outbreaks of infectious diseases; and
- develop and expand surveillance systems to include diseases caused by global climate change.
Reducing the Burden of Disease to Mitigate Climate Change Impacts
How susceptible a population is to the effects of climate change is dependent on their existing vulnerabilities. Therefore, work needs to be done to reduce the burden of diseases and improve upon the social determinants of health for vulnerable populations in Canada and globally.
4. That the federal and provincial/territorial governments work together to improve the ability of the public to adapt to climate change and catastrophic weather events by
- Encouraging behaviours that improve overall health,
- Creating targeted programs designed to address specific exposures,
- Providing health promotion information and education on self-management of the symptoms of climate-associated illness,
- Ensuring physical infrastructure that allows for adaptation;
5. That the federal government develop concrete actions to reduce the health impact of climate-related emissions, in particular those initiatives which will also improve the general health of the population;
6. That the federal government support the Millennium Development Goals and support the principles outlined in the WHO Commission on the Social Determinants of Health report; and
Preparing for Climate Emergencies
To deal with the future burden of climate change related health issues there is a need to ensure adequate health capacity and infrastructure. Rebuilding of public health capacity globally is seen as the most important, cost-effective, and urgently needed response to climate change16. Domestically, there is a need to ensure adequate surge capacity within the health care system to be prepared for an increase in illness related to climate change effects. There is also a need to strengthen not only the health systems, but the infrastructure (i.e. housing) for vulnerable populations including Aboriginals and those in the North.
CMA recommends that the federal and provincial /territorial governments work together to:
7. Strengthen the public health system both domestically and internationally in order to improve the capacity of communities to adapt to climate change;
8. Ensure adequate surge capacity within Canada's health system to handle the increase in climate change related illness;
9. Ensure the health of vulnerable populations is adequate to handle climate change related situations;
10. Develop knowledge about the best ways to adapt to and mitigate the health effects of climate change;
11. Integrate health professionals into the emergency preparedness plans of government and public health authorities so that front-line providers are adequately informed and prepared to properly manage any health emergencies.
Advocacy to Combat Climate Change
Finally, there is a need to take action to reduce the damaging effects of climate change. The global community needs to come together to reduce the levels of green house gases being released in the atmosphere, and focus on safer more environmentally friendly energy sources. Investments in cuts to greenhouse gas emissions would greatly outweigh their costs, and could help to reduce the future burden of climate change related illness17.
12. That the government of Canada become a global leader in promoting equitable, carbon neutral economic, industrial, and social policies, and practices that fight global warming and adopt specific green house gas reduction targets as determined by the evolving science of climate change.
13. That health care professionals act within their professional settings to reduce the environmental impact of medical activities and to develop environmentally sustainable professional settings;
14. That all Canadians act to minimize individual impacts on the environment, and encourage others to do so, as well.
The CMA believes that Canada must prepare now for the potential health threat that climate change poses to its population. While many of these effects will take decades to materialize, certain populations, such as those in Canada's north, or those in low lying coastal areas, are already starting to experience the impact of climate change.
A focus on education and health promotion, as well as advocacy for improved public policy and primary health care resources will be a good start in dealing with this issue. Additionally, further research and data collection is necessary to improve our understanding of climate change and the effectiveness of adaptation and mitigation strategies.
Finally, the global community needs to act together to address the health and environmental impacts of climate change. By working together, in an international response, strategies can be implemented to mitigate any negative health effects of climate change.
Canada's physicians believe that: What is good for the environment is also good for human health. It is past time for those of us in the health sector in Canada to engage fully in the debate and discussions within our own house, as well as in the broader body politic to ensure that protecting human health is the bottom line of environmental and climate change strategies.
1 Currently a third of the world's population lives within 60 miles of the shoreline and 13 of 20 biggest world cities located on the coast- more than a billion people could be displaced (Costello et.al., 2009)
1 Costello, Anthony et.al. "Managing the health effects of climate change.' The Lancet Volume 373 May 16, 2009. pp.1693-1733.
2 World Health Organization, World Meteorological Organization & United Nations Environment Programme (2003) Climate Change and Human Health- Risks and Responses, Summary. Available at: http://www.who.int/globalchange/climate/en/ccSCREEN.pdf
3 Confalonieri et.al., (2007) Human Health. Climate Change 2007: Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Available at: http://www1.ipcc.ch/pdf/assessment-report/ar4/wg2/ar4-wg2-chapter8.pdf ; Epstein, Paul R. "Climate Change and Human Health." The New England Journal of Medicine 353 (14) October 6, 2005.; Friel, Sharon; Marmot, Michael; McMichael, Anthony J.; Kjellstrom, Tord & Denny Vagero. "Global health equity and climate stabilization: a common agenda." The Lancet Volume 372 November 8, 2008. pp.1677-1683.
4Confalonieri et.al., (2007) Human Health. Climate Change 2007: Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Available at: http://www1.ipcc.ch/pdf/assessment-report/ar4/wg2/ar4-wg2-chapter8.pdf; World Health Organization (2009) Protecting Health From Climate Change: Global research priorities. Available at: http://whqlibdoc.who.int/publications/2009/9789241598187_eng.pdf
5 Health Canada (2001) Climate Change and Health & Well-being: A Policy Primer Available at: http://www.hc-sc.gc.ca/ewh-semt/pubs/climat/policy_primer-abecedaire_en_matiere/index-eng.php
6 Campbell-Lendrum, Diarmid; Corvalan, Carlos & Maria Neira "Global climate change: implications for international public health policy." Bulletin of the World Health Organization. March 2007, 85 (3) pp.235-237
7 Seguin, Jacinthe & Peter Berry (2008) "Human Health in a Changing Climate: A Canadian Assessment of Vulnerabilities and Adaptive Capacity, Synthesis Report." Health Canada Available at: http://www.nbhub.org/hubfiles/pdf/HealthinChangingClimate_Synthesis_english_low.pdf
8 Health Canada (2002) Climate Change And Health & Well-Being: A Policy Primer for Canada's North. Available at: http://dsp-psd.pwgsc.gc.ca/Collection/H46-2-02-290E.pdf
9 Seguin, Jacinthe & Peter Berry (2008) "Human Health in a Changing Climate: A Canadian Assessment of Vulnerabilities and Adaptive Capacity, Synthesis Report." Health Canada Available at: http://www.nbhub.org/hubfiles/pdf/HealthinChangingClimate_Synthesis_english_low.pdf
11 Health Canada (2002) Climate Change And Health & Well-Being: A Policy Primer for Canada's North. Available at: http://dsp-psd.pwgsc.gc.ca/Collection/H46-2-02-290E.pdf
12 Epstein, Paul R. "Climate Change and Human Health." The New England Journal of Medicine 353 (14) October 6, 2005.
13 Seguin, Jacinthe & Peter Berry (2008) "Human Health in a Changing Climate: A Canadian Assessment of Vulnerabilities and Adaptive Capacity, Synthesis Report." Health Canada Available at: http://www.nbhub.org/hubfiles/pdf/HealthinChangingClimate_Synthesis_english_low.pdf
14 Field, Christopher B. et.al. (2007) North America. Climate Change 2007: Impacts, Adaptation and Vulnerability. Contribution of Working Group II to the Fourth Assessment Report of the Intergovernmental Panel on Climate Change. Available at: http://www1.ipcc.ch/pdf/assessment-report/ar4/wg2/ar4-wg2-chapter14.pdf
15 Health Canada (2002) Climate Change And Health & Well-Being: A Policy Primer for Canada's North. Available at: http://dsp-psd.pwgsc.gc.ca/Collection/H46-2-02-290E.pdf
16 World Health Organization, World Meteorological Organization & United Nations Environment Programme (2003) Climate Change and Human Health- Risks and Responses, Summary. Available at: http://www.who.int/globalchange/climate/en/ccSCREEN.pdf
17 Campbell-Lendrum, Diarmid; Corvalan, Carlos & Maria Neira "Global climate change: implications for international public health policy." Bulletin of the World Health Organization. March 2007, 85 (3) pp.235-237
CMA PATIENT SAFETY POLICY FRAMEWORK (Update 2010)
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.
The Health Care System
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.
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.
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.
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.
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.
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.
Health and safety in the workplace continue to be areas of concern to the CMA. The CMA recommends that educational programs on the risks of drug-related impairment to health and safety in the workplace be directed toward labour, management and the public in general. Occupations for which impairment resulting from drug use may constitute a serious hazard should be identified and designated as such. The association recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds to suspect impairment of the worker. Workers holding safety-sensitive jobs should be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) being taken to the occupational health physician or, in the absence of such, to the physician of the worker's choice. The CMA is opposed to routine pre-employment drug testing. It recommends that random drug testing among employees be restricted to safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable. Drug testing should always be conducted in such a way as to protect confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
The idea of drug testing among workers has developed from society's concern over the relation between drug use and impairment, with resultant risks to the worker, fellow workers and the public.
Education: Since prevention is the principal and ultimate objective the association recommends that educational programs on the risks of impairment to health and safety in the workplace be directed toward labour, management and the public in general.
Illicit drugs are not the only ones that may cause impairment. Certain prescription drugs and even some over-the-counter medications may affect a person's ability to carry out professional functions safely; such effects may vary considerably from one person to another.
Alcohol is by far the most common impairing drug implicated in accidents; in addition, the scientific literature contains a growing body of information on impairment and dangers resulting from the use and misuse of various therapeutic medications. Far less is documented or known about the role of illicit drugs in work-related accidents.
Safety-sensitive occupations: In most workplaces there are occupations for which impairment may constitute a serious hazard. Such occupations should be identified and designated as such. Workers who hold such safety-sensitive jobs must accept the fact that other workers and the public need to be protected from the hazards of impairment, whether from physical or psychologic ill health or from the use of drugs (over-the-counter, prescription or illicit).
Performance assessment of safety-sensitive occupations: The CMA recommends that supervisors be trained to refer a worker in a safety-sensitive job for a health assessment if the supervisor has reasonable grounds (e.g., unsatisfactory performance or observed unusual behaviour) to suspect impairment of the worker. The examining physician may recommend that some tests (including tests for the presence of certain drugs) be carried out under pre-agreed protocols. Workers holding safety-sensitive jobs must be educated to report any departure from their usual state of health as well as any drugs (prescribed or otherwise) they may be taking to the occupational health physician or, in the absence of such, to the physician of the worker's choice.
Testing: Any discussion of drug testing must take the following into account:
If a quantitative test is to be used to determine impairment a limit must be established beyond which a person is deemed to be impaired. However, since the threshold of impairment varies from one person to another this variation should be taken into account when a worker is being assessed.
The tests must be valid and reliable. They must be performed only in laboratories accredited for drug testing.
The tests must provide results rapidly enough to be useful in deciding whether the person should continue to work.
If different testing procedures are available and the differences between the validity and reliability are not significant the least intrusive alternative should be chosen.
The test should be conducted in such a way as to ensure confidentiality and should be undertaken with the subject's informed consent (except when otherwise required by law).
Pre-employment testing: The CMA opposes routine pre-employment drug testing for the following reasons:
Routine pre-employment drug screening may not objectively identify those people who constitute a risk to society.
The mass, low-cost screening tests may not be reliable or valid.
The circumstances may not justify possible human rights violations.
Random testing: The CMA believes that random drug testing among employees has a limited role, if any, in the workplace. Such testing should be restricted to employees in safety-sensitive positions and undertaken only when measures of performance and effective peer or supervisory observation are unavailable.
Role of occupational health services: Occupational health physicians must not be involved in a policing or disciplinary role with respect to employee testing.
CMA recommends that employers provide a safe environment for all workers. With the help of experts such as those from national and provincial agencies dedicated to dealing with substance abuse occupational health departments should develop lists of drugs known to cause short-term or long-term impairment, including alcohol. These lists should be posted prominently in the workplace, and workers should be advised that in the event of obvious impairment those involved in safety-sensitive occupations will be asked to undergo medical assessment. If testing for drugs is indicated refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
Alcohol impairment should not be tolerated, and legislation should be considered that would set a legal blood alcohol level for safety-sensitive occupations. Breathalyzers or other detection methods could be used if alcohol impairment is suspected in a person holding safety-sensitive occupation. As stated previously, refusal to submit to testing may result in a presumption of noncompliance with the health requirements of the job.
These measures should be discussed with labour and management. Labour should be expected to recognize drug-related impairment as a serious health and safety issue, and management should demonstrate its concern by ensuring access to treatment, prevention and educational programs such as employee assistance programs.
FIREARMS CONTROL (UPDATE 2001)
Firearms are a major cause of death and injury in Canada and account for nearly 1,400 deaths annually. The CMA has made several recommendations to governments and other bodies undertaking legislative review and public policy change. These recommendations relate to the regulation of firearms, education for the safe handling of firearms, broad-based violence prevention programs, and research and information provision. In addition, the CMA has produced guidelines to assist physicians in identifying and counselling patients at risk of violent behaviour and in reporting patients at risk.
Firearms are a major cause of death and injury in Canada.. The cost to society of firearm-related injury, particularly spinal cord and head injuries, is considerable.
Over the short term, policy should focus on firearms and the user. Applying stringent controls on firearms, however, may have little effect on the rates of death and injury if the underlying problems of violence in society are not addressed.
In an effort to accommodate both short-term and long-term solutions the CMA recommends the following to governments and bodies undertaking legislative review and public policy change.
The object of regulation should be to deter people at risk for violent or self-destructive behaviour from having easy access to firearms. A regulatory policy should address (a) the acquisition of firearms (e.g., licensing of firearms and/or users, processes to screen would-be purchasers who are at risk), b) secure firearm and ammunition storage methods and modifications to firearms that would render them less accessible to children or those acting on violent impulses and (c) severe penalties for offenses such as the use of a firearm in the commission of a crime or an act of violence, including family violence.
Training in safe handling of firearms is strongly recommended, particularly for all first-time firearm users. Broader-based education programs aimed at the prevention of violence (e.g., in schools) may also be efficacious and should be evaluated for their impact in reducing violence.
Research and information provision
CMA encourages research in a number of areas, including the following.
Firearm surveillance: the types of firearms or classes of ammunition disproportionately involved in intentional deaths and injuries, the circumstances surrounding a firearm incident (e.g., argument between friends, alcohol involvement) and data on injuries and deaths.
Determination of behavioural or environmental risk factors for violent behaviour: the relative risk or benefit of keeping a firearm at home for protection i.e.. the scientific assessment of the deterrence effect):
The effects of factors such as alcohol, drug use and family history of violence on the risk of violent death; and how accurately experts can identify people at risk.
Case-control and cohort studies on gun control, crime and the antecedents of violent behaviour.
Evaluation of education programs that discourage firearm-related violence or promote safe handling of firearms.
Role of physicians
The CMA recommends that physicians consider the following guidelines.
Management of patients at risk
It is not always possible to identify people at risk of violent or self-destructive behaviour; however, the CMA recommends that physicians be alert to warning signs that a patient may be at risk and manage that patient accordingly. For example, always ask depressed patients about suicidal and homicidal thoughts and plans (asking will not plant ideas); admit suicidal patients to hospital, even against their will, particularly if they do not have supportive families who can monitor them at home; have the family remove all firearms from the home of a patient at risk; and monitor the patient frequently, writing small prescriptions if medication is required.
Good clinical judgement and close follow-up are perhaps the most effective ways of managing a self-destructive or violent patient.
Reporting of patients at risk
No specific guidelines exist for the reporting of patients at risk of violent behaviour. The physician should consider whether the risk of harm to society (or a third party) posed by a patient outweighs that patient's right to confidentiality.
Counselling and public advocacy
A physician may be asked for a reference for an applicant of a firearms acquisition certificate. Before providing the reference the physician should consider the applicant carefully for risk factors, recommend appropriate firearms training and caution against the concomitant use of firearms, alcohol and other drugs.
A physician should become an advocate for nonviolent conflict resolution. As research accumulates about the most effective interventions for nonviolent conflict resolution the health sector may be able to draw on this research to work to reduce violence in society.
Like motor vehicle and bicycle safety, firearm safety is a public health issue. The CMA holds that physicians, as advocates for the health of Canadians, can help reduce firearm-related damage and address the concomitant underlying problem of violence in society.
Guidelines for CMA’s Activities and Relationships with Other Parties
As the national voice of medicine in Canada, the CMA provides leadership for physicians, promotes the highest standards of health and health care for Canadians and acts as advocate for all Canadian physicians. In the furtherance of its purpose, the CMA conducts a variety of activities and has a variety of relationships with other parties. The CMA’s activities range from policy development to the delivery of products and services to physicians and the public. Its relationships with other parties range from the purchase of goods and services that support operations to partnerships that further or are consistent with its advocacy strategies.
The CMA actively seeks out relationships with others in recognition of the benefits these bring in the attainment of the CMA’s purposes. Such benefits may include:
- unifying the profession through relations with physician groups, including the divisions and affiliates
- enabling a stronger advocacy voice in association with others
- enhancing the CMA’s credibility with other parties
- providing financial and human resources to support CMA activities
- providing skills and capabilities that CMA may not possess
- providing additional membership services.
Activities or relationships with other parties and products and services produced through the activity or relationship (“activities or relationships”) that undermine the CMA’s reputation of professionalism, independence and quality are to be avoided, not only for their own sake but also because a diminishment of the CMA’s reputation impedes its ability to achieve its purposes.
The following principles have been developed to help guide decisions about the kinds of activities CMA undertakes and about its relations with other parties, with the objective of ensuring the integrity and good reputation of the CMA. A process or processes will be developed to implement the principles, which will include the preparation of subdocuments on applying the principles to specific areas; for example, sponsorship, endorsement and coalitions.
The CMA should rigorously and actively pursue its laudable ends and seek out relationships with others to attain them with the caveat that activities or relationships that would tarnish the integrity or reputation of CMA or the medical profession or that would diminish the trust placed in them should be avoided.
Conformity with CMA’s purpose
The activity or relationship should further or support the CMA’s purposes as elaborated in its objects, vision and mission.
The CMA’s purposes have been explicitly and widely agreed upon.
The CMA holds itself to be, and encourages reliance that it is, an organization that pursues its specified purposes.
Activities and relationships that do not further or support the CMA’s purposes have the potential to thwart these purposes in a number of ways, including inadequate accountability, inappropriate use of resources, unconstrained exercise of merely private judgement or inappropriate self-interest.
2. Medical professionalism and ethics
The activity or relationship should be consistent with medical professionalism and with CMA’s Code of Ethics.
The CMA is an association of physicians.
When the CMA acts, it represents the medical profession.
The CMA’s actions reflect upon the medical profession.
The CMA’s stature and reputation are inextricably linked to the medical profession’s work, the professional stature of its member physicians and the trust Canadians place in their physicians.
Engaging in activities or relationships that are inconsistent with medical professionalism and CMA’s Code of Ethics would erode trust in the CMA.
The activity or relationship should not undermine the CMA’s independence.
To be a credible voice and influence and to be worthy of the trust and confidence of physicians and of the public, the CMA should be, and be seen to be, free of undue influence and in control of the decisions it makes.
Undue influence occurs when one is induced to do or not do something that is contrary to what one would otherwise do if left to act freely. Undue influence deprives one of free agency and destroys free will such that it is rendered more the will of another than of one’s own.
Activities and relationships that may undermine independence include:
activities or relationships that provide revenue or benefit to the CMA such that ongoing dependency on the revenue or benefit impedes independence
activities and relationships that create a product or service that is seen to be associated with the CMA but over which the CMA does not have final control or veto or the capacity to extricate itself
Consistency with policy
The activity or relationship should be consistent with CMA policy.
The CMA develops policy in pursuance of its purposes; these should be referred to when making decisions in connection with activities or relationships.
Conflicting goals and activities
Relationships with parties whose goals or activities directly conflict with the CMA’s objects, mission or vision should be avoided.
This does not preclude discussion with others or participation in events for the purposes of obtaining information, monitoring or lobbying.
The terms and conditions of the activity or relationship should be transparent.
Transparency promotes an openness to scrutiny and serves to enhance accountability and to discourage relationships or activities that could be considered problematic.
The principle is generally applicable except in connection to matters related to competitive advantage, trade secret or a reasonable agreement of confidentiality.
Compliance and accountability
Processes must be in place to ensure that proposed and ongoing activities or relationships are appropriately reviewed for compliance with and clear accountability for these principles.
These include the activities of the secretariat and the corporate subsidiaries.
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.
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
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
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
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