With the advent of technology allowing for the extension of life, and as a result of the increasing importance of personal autonomy, decisional capacity, and informed consent and the growing awareness of issues related to quality of life and dying, Canadians have become increasingly interested in expressing their wishes regarding their health care and having more input into decisions about their care should they become incapable. Advance care planning (ACP) can help patients to achieve these goals.
The CMA supports development of a strategy for ACP1 in all provinces and territories. ACP leads to better concordance between patients' wishes and treatments provided,2,3 decreased anxiety for families,4 decreased moral distress for health care providers,5 decreased hospitalization rates of nursing home residents3 and fewer unnecessary medical treatments.3,6,7
ACP is at the intersection of the provision of health care, ethical values and legal rights and duties. In particular, it involves the acknowledgement of essential aspects of autonomy, informed consent, and respect of patients' care wishes now and in the future, and their intentions if they become incapable.8,9
The balancing of the need to obtain informed consent for a treatment option in the present with the need to respect health care preferences that were stated in the past has been addressed using various clinical, legal and institutional approaches across Canadian jurisdictions."
Physicians10 can play a significant role in ACP throughout the course of the patient-physician relationship, including in the pediatric setting. At any time, outcomes of the planning process can be documented and/or the patient can appoint a substitute decision-maker in writing. These documents can be identified as advance directives, personal directives or powers of attorney for personal care11 (hereinafter all will be referred to as advance directives). An advance directive does not remove the need for a physician to obtain consent before providing a treatment to a patient, except in an emergency. As stated in the Canadian Medical Protective Association's consent guide: "[U]nder medical emergency situations, treatments should be limited to those necessary to prevent prolonged suffering or to deal with imminent threats to life, limb or health. Even when unable to communicate in medical emergency situations, the known wishes of the patient must be respected."12
While much of the focus of ACP is on making care decisions and nominating proxy decision-makers in case the patient becomes incapable of making decisions in the future, ACP has much more utility. ACP conversations13 can assist patients in determining treatment trajectories and making decisions about the intensity level of interventions in their current care. Providers can have discussions with patients and their families about proposed treatments in the context of the patient's communicated goals and wishes. The process of ACP also helps patients and their families to become familiar with the language and processes used to make cooperative health care decisions.
SCOPE OF POLICY
This policy aims to provide guidance on key considerations pertinent to ACP in a way that is consistent with a physician's ethical, professional and legal obligations. This is a complex subject: physicians should be aware of the legislation in the jurisdiction in which they practise, the standards and expectations specified by their respective regulatory authority, as well as the policies and procedures of the setting(s) in which they practise (e.g., regional health authority, hospital).
1. ACP is a process of (a) respecting patients' wishes through reflection and communication, (b) planning for when the patient cannot make health care decisions and (c) discussion with friends, family and professionals; (d) it may result in a written document.5 It informs the substitute decision-maker and provides information for the clinician to consider in the provision of care within the bounds of the law.
2. Although often associated with the end of life, ACP represents the expression of a patient's wishes for any future health care when the patient is incapable. It expresses the patient's values and beliefs regarding current care decisions and provides information that can inform any decisions that must be made during an emergency when the patient's consent cannot be obtained. For these reasons, ACP should occur throughout a person's lifetime.
3. Respect for patients' dignity and autonomy is a cornerstone of the therapeutic physician-patient relationship. Patients' right to autonomous decision-making has become embedded in ethical frameworks, consent legislation and case law.14 Respect for the wishes of an incapable patient constitutes a preservation of autonomy and promotes trust between the physician and patient.15
4. The way in which the act of obtaining consent is weighed against the patient's stated wishes as outlined during the ACP process varies according to the jurisdiction in which the patient and physician are located.
1. Given the practical, ethical and legal complexities of ACP, physicians, medical learners should be supported in becoming familiar with ACP and comfortable in engaging in the process with their patients. To this end, CMA supports the development of training in ACP and efforts to make it available to all physicians and medical learners.16 For practising physicians and residents, many resources are available, for example:
a. Advance Care Planning in Canada: A National Framework
b. Facilitating Advance Care Planning: An Interprofessional Educational Program
c. Information from the Health Law Institute of Dalhousie University on the regulatory policies and legislation of individual provinces and territories
d. A comprehensive collection of Canadian resources compiled by the Speak Up campaign of the Advance Care Planning in Canada initiative
e. Pallium Canada's Learning Essential Approaches to Palliative Care module on ACP
In the case of medical students, the CMA supports the position of the Canadian Federation of Medical Students that end-of-life training is an essential facet of undergraduate medical education.
2. The issue of the supervision of medical learners practising ACP should be clarified, as considerable ambiguity currently exists.17 Medical learners would benefit from unified national guidelines concerning the nature of their participation in ACP, especially regarding end-of-life care. In the case of medical students, the CMA agrees with the recommendation of the Canadian Federation of Medical Students that supervision be mandatory during conversations about end-of-life care.
3. The CMA calls for more research on the outcomes associated with the provision of ACP training to physicians and medical learners.
4. The CMA recommends that governments and institutions promote information and education on ACP to patients and their substitute decision-makers.
PROFESSIONAL AND LEGAL RESPONSIBILITY
1. While respecting patients' values, all physicians are expected to encourage their patients to engage in ACP with them. ACP is not a one-time event. The nature of the conversation between the physician and the patient and the regularity with which they discuss the subject will depend on the patient's health status. Family physicians and physicians have ongoing care relationships with chronically ill patients are particularly well placed to have regular discussions with their patients about their beliefs, values and wishes. An effective exchange of information between family physicians (and other physicians who work in the community with outpatients) and acute or tertiary care physicians would assist in ensuring patient's wishes are considered.
2. ACP, in particular advance directives, are at the intersection of medicine and the law. Physicians should recognize this and ask patients whether they have an advance directive or have done any ACP.
3. There is wide variation across jurisdictions in terms of the requirements and procedures for ACP; therefore, physicians should inform themselves about any relevant legislation and the scope of the requirement to obtain consent within that jurisdiction when carrying out ACP.
1. The CMA supports institutional processes that recognize and support ACP. Support for ACP includes developing a consistent process for the exchange of information about patients' wishes and advance directives among health care providers, as patients traverse sectors and locations of care. Patients with a written advance directive must be identified and the advance directive integrated fully within the patient's records18 so that it is available across the institution (and ideally the health care system). The CMA advocates for the inclusion of advance care directive functionality as a conformance and usability requirement for electronic medical record vendors.19 Provinces and territories should be encouraged to establish robust organizational processes and resources for patients in all locations of care and strong province- or territory-wide policy, such as in Alberta.20
2. Institutions and other organizations should encourage health care providers to ask patients to bring their advance directive to appointments at the same time they ask them to bring a list of their medications or other medical information.
3. The CMA supports institutional/organizational audits of structures, processes and outcomes related to ACP as an important step in improving the quality and frequency of ACP activities.
ROLE FOR GOVERNMENTS
1. The CMA supports infrastructures enabling ACP, including funding that will support ACP and other end-of-life discussions.
2. The CMA promotes the incorporation of ACP into future federal and provincial/territorial senior strategies and dementia and/or frailty strategies.
3. The CMA supports the development of ACP metrics and their future inclusion in Accreditation Canada standards.
Advance care planning (ACP)
Advance care planning is a term used to describe a process of reflection, communication, conversation and planning by a capable individual with family, friends and professionals about their beliefs, values and wishes for a time when they no longer have the mental capacity to make decisions about their health care. ACP can also involve the naming of a substitute decision-maker.8
The legislated term "advance directive" has different names, definitions and legal authority across the country. For example, in British Columbia an advance directive is a written legal document that provides a mechanism for capable patients to give directions about their future health care once they are no longer capable. 21 As such, in BC an advance directive may, under certain circumstances, be considered "equivalent to consent to treatment and may be acted upon directly by a health care provider without consultation with an SDM [substitute decision-maker]." 8 In Alberta it is called a personal directive. In Ontario, "advance directive" is a generic non-legal term and refers to communications that may be oral, written or in other forms.8
In Quebec, advance care directives are legally binding, as set out in the Act respecting end-of-life care, which recognizes "the primacy of freely and clearly expressed wishes with respect to care. . ."22
Current legislation does not allow for medical assistance in dying to be requested by an advance directive.23 The CMA acknowledges that considerable public, expert and legal debate exists around the issue.
To obtain informed consent, physicians must provide adequate information to the patient or capable decision-maker about the proposed procedure or treatment; the anticipated outcome; the potential risks, benefits and complications; and reasonable available alternatives, including not having the treatment; and they must answer questions posed by the patient. Consent is only informed if there is disclosure of matters that a reasonable person in the same circumstances would want to know.24 Consent must be given voluntarily, must not be obtained through misrepresentation or fraud, must relate to the treatment and must be informed.
Substitute decision-maker (SDM or agent or proxy)
A substitute decision-maker is a capable person who will make health care decisions on behalf of an incapable individual. In all jurisdictions the health care provider must take reasonable steps to become aware of whether or not there is a substitute decision-maker before providing health treatment to an incapable patient. Legally there are implementation differences across the country. For example, in BC a substitute decision-maker is appointed through a representation agreement, in Alberta through a personal directive and in Ontario through a power of attorney for personal care.
Approved by the CMA Board of Directors May 2017
1 Canadian Medical Association. Policy resolution GC14-25 - strategy for advance care planning, palliative and end-of-life care. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 Oct 17)
2 Houben CHM, Spruit MA, Groenen MTJ, et al. Efficacy of advance care planning: a systematic review and meta-analysis. J Am Med Dir Assoc 2014;15:477-89.
3 Martin RS, Hayes B, Gregorevic K, et al. The effects of advance care planning interventions on nursing home residents: a systematic review. J Am Med Dir Assoc 2016;7:284-93.
4 Mack JW, Weeks JC, Wright AA, et al. End-of-life discussions, goal attainment, and distress at the end of life: predictors and outcomes of receipt of care consistent with preferences. J Clin Oncol 2010;28(7):1203-8.
5 Canadian Hospice Palliative Care Association. Advance care planning in Canada: national framework. Ottawa; The Association; 2010.
6 Teo WSK, Raj AG, Tan WS, et al. Economic impact analysis of an end-of-life programme for nursing home residents. Palliat Med 2014;28(5):430-7.
7 Zhang B, Wright AA, Huskamp HA, et al. Health care costs in the last week of life: associations with end-of-life conversations. Arch Intern Med 2009;169(5):480-8.
8 Wahl J, Dykeman MJ, Gray B. Health care consent and advance care planning in Ontario. Toronto (ON): Law Commission of Ontario; 2014.
9 Canadian Medical Association. CMA Code of Ethics (update 2004). Ottawa: The Association; 2004.
10 Physician involvement is not mandatory in the process. However, it is important for physicians to engage with their patients in ACP as this can facilitate change in patients' ACP behaviour and understanding.
11 Wahl JA, Dykeman MJ, Walton T. Health care consent, advance care planning, and goals of care practice tools: the challenge to get it right. Improving the last stages of life. Toronto (ON): Law Commission of Ontario; 2016.
13 Frank C, Puxty J. Facilitating effective end-of-life communication - helping people decide. CJS Journal of CME 2016;6(2). Available: http://canadiangeriatrics.ca/wp-content/uploads/2017/02/Facilitating-Effective-End-of-Life-Communication---Helping-People-Decide.pdf (accessed 2017 April 25).
14 Fleming v Reid (1991) 82 DLR (4th) 298 (CA ON); Cuthbertson v Rasouli, 2013 SCC 53; Malette v Shulman (1990), 72 OR (2d) 417; Starson v Swayze (2003) 1 SCR 722.
15 Harmon SHE. Consent and conflict in medico-legal decision-making at the end of life: a critical issue in the Canadian context. University of New Brunswick Law Journal 2010;60(1):208-29.
16 Canadian Medical Association. Policy resolution GC13-69 - training in advance care planning. Ottawa (ON): The Association; 2013. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
17 Touchie C, De Champlain A, Pugh D, et al. Supervising incoming first-year residents: faculty expectations versus residents' experiences. Med Educ 2014;48(9):921-9.
18 Canadian Medical Association. Policy resolution GC14-19 - advance care plans. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
19 Canadian Medical Association. BD14-05-163 Advance care directive functionality. Ottawa (ON): The Association; 2014. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 May 26).
20 Conversations matter. Edmonton (AB): Alberta Health Services. Available: http://goals.conversationsmatter.ca.s3-website-us-east-1.amazonaws.com/ (accessed 2017 May 19).
21 Health Care (Consent) and Care Facility (Admission) Act, RSBC 1996, c 181, s.3
22 Act respecting end-of-life care, S-32.0001. Government of Quebec. Available : http://legisquebec.gouv.qc.ca/en/ShowDoc/cs/S-32.0001
23 An Act to amend the Criminal Code and to make related amendments to other Acts (medical assistance in dying) S.C. 2016, c.3. Ottawa: Government of Canada; 2016. Available: http://canlii.ca/t/52rs0 (accessed 2016 Oct 17)
24 Riebl v Hughes,  2 SCR 880; Hopp v Lepp,  2 SCR 192.
Canadians are living longer, healthier lives than ever before. The number of seniors expected to need help or care in the next 30 years will double, placing an unprecedented challenge on Canada’s health care system. That we face this challenge speaks to the immense success story that is modern medicine, but it doesn’t in any way minimize the task ahead.
Publicly funded health care was created about 50 years ago when Canada’s population was just over 20 million and the average life expectancy was 71. Today, our population is over 36 million and the average life expectancy is 10 years longer. People 85 and older make up the fastest growing age group in our country, and the growth in the number of centenarians is also expected to continue.
The Canadian Medical Association is pleased that the House of Commons Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities is studying ways Canada can respond to these challenges. Here, for your consideration, we present 15 comprehensive recommendations that would help our seniors remain active, contributing citizens of their communities while improving the quality of their lives. These range from increasing capital investment in residential care infrastructure, to enhancing assistance for caregivers, to improving the senior-friendliness of our neighbourhoods.
The task faced by this committee, indeed the task faced by all of Canada, is daunting. That said, it is manageable and great advances can be made on behalf of seniors. By doing so, we will ultimately deliver both health and financial benefits to all Canadians.
Dr. Laurent Marcoux, CMA President
The Canadian Medical Association (CMA) is pleased to submit this brief to the Standing Committee on Human Resources, Skills and Social Development and the Status of Persons with Disabilities as part of its study regarding how the Government can support vulnerable seniors today while preparing for the diverse and growing seniors population of tomorrow. This brief directly addresses the three themes considered by this Committee:
How the Government can improve access to housing for seniors including aging in place and affordable and accessible housing;
How the Government can improve income security for vulnerable seniors; and
How the Government can improve the overall quality of life and well-being for seniors including community programming, social inclusivity, and social determinants of health.
Improving access to housing for seniors
As part of a new National Housing Strategy, the federal government announced in the 2017 Budget that it will invest more than $11.2 billion in a range of initiatives designed to build, renew, and repair Canada’s stock of affordable housing and help to ensure that Canadians have adequate and affordable housing that meets their needs. While a welcome step, physicians continue to see the problems facing seniors in relation to a lack of housing options and supports — problems that cascade across the entire health care system.
A major hindrance to social equity in health care delivery and a serious cause of wait times is the inappropriate placement of patients, particularly seniors, in hospitals. Alternate level of care (ALC) beds are often used in acute care hospitals to accommodate patients — most of whom are medically stable seniors — waiting for appropriate levels of home care or access to a residential care home/facility. High rates of ALC patients in hospitals affect all patients by contributing to hospital overcrowding, lengthy waits in emergency departments, delayed hospital admissions, cancelled elective surgeries, and sidelined ambulance services waiting to offload new arrivals (often referred to as code gridlock).1 Moreover, unnecessarily long hospital stays can leave patients vulnerable to hospital-acquired illnesses and disabilities such as delirium, deconditioning, and falls.
Daily costs - Ontario
$842: acute care hospital, per patient
$126: long-term care residence, per patient
$42: home care, per patient
# of acute care hospital beds = 18,571 14% waiting for placement = 2,600 beds
Providing more cost-effective and appropriate solutions will optimize the use of health care resources. It has been estimated that it costs $842 per day for a hospital bed versus $126 per day for a long-term care bed and $42 per day for care at home.2 An investment in appropriate home or residential care, which can take many forms, will alleviate inappropriate hospital admissions and facilitate timely discharges.
The residential care sector is facing significant challenges because of the rising numbers of older seniors with increasingly complex care needs. The demand for residential care will increase significantly over the next several years because of the growing number of frail elderly seniors requiring this service. New facilities will need to be constructed and existing facilities will need to be upgraded to comply with enhanced regulatory requirements and respond to residents’ higher care needs.
The Conference Board of Canada has produced a residential care bed forecast tied to population growth of age cohorts. It is estimated that Canada will require an average of 10,500 new beds per year over the next 19 years, for a total of 199,000 new beds by 2035. This forecast does not include the investments needed to renovate and retrofit existing long-term care homes.3 A recent report by the Canadian Institute for Health Information indicated that residential care capacity must double over the next 20 years (assuming no change in how care is currently provided), necessitating a transformation in how seniors care is provided across the continuum of care.4 These findings provide a sense of the immense challenges Canada faces in addressing the residential care needs of older seniors.
Investments in residential care infrastructure and continuing care will improve care for seniors while significantly reducing wait times in hospitals and across the system, benefiting all patients. Efforts to de-hospitalize the system and address the housing and residential care options for Canada’s aging population are key. The federal government can provide significant pan-Canadian assistance by investing in residential care infrastructure.
The CMA recommends that the federal government include capital investment in residential care infrastructure, including retrofit and renovation, as part of its commitment to invest in social infrastructure.
Improving income security for vulnerable seniors
Income is a key factor impacting the health of individuals and communities. Higher income and social status are linked to better health.5
Adequate Income: Poverty among seniors in Canada dropped sharply in the 1970s and 1980s but it has been rising in recent years. In 2012, the incidence of low income among people aged 65 years and over was 12.1%. This rate was considerably higher for single seniors at 28.5%.6
Incidence of low income (2012)
Seniors overall: 12.1%
Single seniors: 28.5%
Most older Canadians rely on Old Age Security (OAS), the Canada Pension Plan (CPP), and their personal pensions or investments to maintain their basic standard of living in retirement. Some seniors are also eligible for a Guaranteed Income Supplement (GIS) to improve their financial security. The CMA recognizes the federal government’s actions to strengthen these programs and initiatives to ensure their viability and to provide sustainable tax relief. These measures must continue and evolve to support aging Canadians so they can afford to live at home or in age-friendly communities as they get older. The government’s actions to ensure adequate income support will also assist aging Canadians to take care of their health, maintain independence, and continue living safely without the need for institutional care.
On the topic of seniors’ income security, the financial abuse of seniors cannot be overlooked. Elder abuse can take many forms: financial, physical, psychological, sexual, and neglect. Often the abuser is a family member, friend, or other person in a position of trust. Researchers estimate that 4 to 10% of Canadian seniors experience abuse or neglect, but that only a small portion of this is reported. The CMA supports public awareness initiatives that bring attention to elder abuse, as well as programs to intervene with seniors who are abused and with their abusers.
The CMA recommends that the federal government take steps to provide adequate income support for older Canadians, as well as education and protection from financial abuse.
Improving the overall quality of life and well-being for seniors
Improving how we support and care for Canada’s growing seniors population has been a priority for CMA over the past several years. For the first time in Canada’s history, persons aged 65 years and older outnumber those under the age of 15 years.7 Seniors are projected to represent over 20% of the population by 2024 and up to 25% of the population by 2036.8 People aged 85 years and over make up the fastest growing age group in Canada — this portion of the population grew by 127% between 1993 and 2013.9 Statistics Canada projects, on the basis of a medium-growth scenario, that there will be over 11,100 Canadians aged 100 years and older by 2021, 14,800 by 2026 and 20,300 by 2036.7
Though age does not automatically mean ill health or disability, the risk of both increases with age. Approximately 75 to 80% of Canadian seniors report having one or more chronic conditions.10 Because of increasing rates of disability and chronic disease, the demand for health services is expected to increase as Canada’s population ages. The Conference Board of Canada has estimated 2.4 million Canadians 65 years and older will need continuing care, both paid and unpaid, by 2026 — a 71% increase since 2011.11
When publicly funded health care was created about 50 years ago, Canada’s population was just over 20 million and the average life expectancy was 71. Today, our population is over 36 million and the average life expectancy is 10 years longer. The aging of our population is both a success story and a pressing health policy issue.
National seniors strategy
Canada needs a new approach to ensure that both our aging population and the rest of Canadians can get the care they need, when and where they need it. The CMA believes that the federal government should invest in seniors care now, guided by a pan-Canadian seniors strategy. In doing so, it can help aging Canadians be as productive as possible — at work, in their communities, and in their homes.
The CMA is pleased with the June 2017 Report of the Standing Senate Committee on National Finance that called for the federal government to develop, in collaboration with the provinces and territories and Indigenous partners, a national seniors strategy in order to control spending growth while ensuring appropriate and accessible care.12 The CMA is also pleased that MP Marc Serré (Nickel Belt) secured support for his private members’ motion calling for the development of a national seniors strategy. Over 50,000 Canadians have already lent their support to this cause (see www.DemandaPlan.ca).
The CMA recommends that the federal government provide targeted funding to support the development of a pan-Canadian seniors strategy to address the needs of the aging population.
Improving assistance for home care and Canada’s caregivers
Many of the services required by seniors, in particular home care and long-term care, are not covered by the Canada Health Act. Funding for these services varies widely from province to province. The disparity among the provinces in terms of their fiscal capacity in the current economic climate will mean improvements in seniors care will advance at an uneven pace. The funding and delivery of accessible home care services will help more aging Canadians to recover from illness, live at home longer, and contribute to their families and communities. Multi-year funding arrangements to reinforce commitment to and financial investment in home care should be carefully considered.13 The development of innovative partnerships and models to help ensure services and resources for seniors’ seamless transition across the continuum of care are also important.
The CMA recommends governments work with the health and social services sectors, and with private insurers, to develop a framework for the funding and delivery of accessible and sustainable home care and long-term care services.
Family and friend caregivers are an extremely important part of the health care system. A 2012 Statistics Canada study found that 5.4 million Canadians provided care to a senior family member or friend, and 62% of caregivers helping seniors said that the care receiver lived in a private residence separate from their own.14 According to a report by Carers Canada, the Canadian Home Care Association, and the Canadian Cancer Action Network, caregivers provide an array of services including personal and medical care, housekeeping, advocacy, financial management, and social/emotional support. The report also indicated that caregivers contribute $25 billion in unpaid labour to our health system.15 Given their enormous contributions, Canada’s caregivers need support in the form of financial assistance, education, peer support, and respite care. A pan-Canadian caregiver strategy is needed to ensure caregivers are provided with the support they require.15
Personal and Medical Care
worth $25 billion in
Social-emo ional Suppor
The CMA recommends that the federal government and other stakeholders work together to develop and implement a pan-Canadian caregiver strategy, and expand the support programs currently offered to informal caregivers.
Canadians want governments to do more to help seniors and their family caregivers.16 The federal government’s new combined Canada Caregiver Credit
(CCC) is a non-refundable credit to individuals caring for dependent relatives with infirmities (including persons with disabilities). The CCC will be more accessible and will extend tax relief to more caregivers by including dependent relatives who do not live with their caregivers and by increasing the income threshold. Making the new CCC a refundable tax credit for caregivers whose tax owing is less than the total credit would result in a refund payment to provide further financial support for low-income families.
The CMA recommends that the federal government improve awareness of the new Canada Caregiver Credit and amend it to make it a refundable tax credit for caregivers.
The federal government’s recent commitment to provide $6 billion over 10 years to the provinces and territories for home care, including support for caregivers, is a welcome step toward improving opportunities for seniors to remain in their homes. As with previous bilateral funding agreements, it is important to establish clear operating principles between the parties to oversee the funding implementation and for the development of clear metrics to measure performance.
The CMA recommends that the federal government develop explicit operating principles for the home care funding that has been negotiated with the provinces and territories to recognize funding for caregivers and respite care as eligible areas of investment.
The federal government’s recent funding investments in home care and mental health recognize the importance of these aspects of the health care system. They also signal that Canada has under-invested in home and community-based care to date. Other countries have more supportive systems and programs in place — systems and programs that Canada should consider.
The CMA recommends the federal government convene an all-party parliamentary international study that includes stakeholders to examine the approaches taken to mitigate the inappropriate use of acute care for elderly persons and provide support for caregivers.
Programs and supports to promote healthy aging
The CMA believes that governments at all levels should invest in programs and supports to promote healthy aging, a comprehensive continuum of health services to provide optimal care and support to older Canadians, and an environment and society that is “age friendly”.17
The Public Health Agency of Canada (PHAC) defines healthy aging as “the process of optimizing opportunities for physical, social and mental health to enable seniors to take an active part in society without discrimination and to enjoy independence and quality of life.”18 It is believed that initiatives to promote healthy aging and enable older Canadians to maintain their health will help lower health care costs by reducing the overall burden of disability and chronic disease. Such initiatives should focus on physical activity, good nutrition, injury (e.g. falls) prevention, and seniors’ mental health (including depression).
The CMA recommends that governments at all levels support programs to promote physical activity, nutrition, injury prevention, and mental health among older Canadians.
For seniors who have multiple chronic diseases or disabilities, care needs can be complex, and they may vary greatly from one person to another and involve many health care providers. Complex care needs demand a flexible and responsive health system. The CMA believes that quality health care for older Canadians should be delivered on a continuum from community-based health care (e.g. primary health care, chronic disease management programs), to home care
(e.g. visiting health care workers to give baths and foot care), to long-term care and palliative care. Ideally, this continuum should be managed so that the senior can remain at home and out of emergency departments, hospitals, and long-term care unless appropriate; easily access necessary care; and make a smooth transition from one level of care to another when necessary.
The CMA recommends governments and other stakeholders work together to develop and implement models of integrated, interdisciplinary health service delivery for older Canadians.
Every senior should have the opportunity to have a family physician or to be part of a family practice that serves as a medical home. This provides a central hub for the timely provision and coordination of the comprehensive menu of health and medical services. A medical home should provide patients with access to medical advice and the provision of, or direction to, needed care 24 hours a day, seven days a week, 365 days a year. Research in 2014 by the Commonwealth Fund found that the percentage of Canadian seniors who have a regular family physician or place of care is very high (98%); however, their ability to get timely access based on same-day or next-day appointments was among the lowest of 11 nations.19 Compared to seniors in most other countries surveyed, Canadian seniors were also more likely to use the emergency department and experience problems with care coordination.
The CMA recommends governments continue efforts to ensure that older Canadians have access to a family physician, supported by specialized geriatric services as appropriate.
Prescription drugs represent the fastest-growing item in the health budget and the second-largest category of health expenditure. As the population of seniors grows, there will be an ongoing need for detailed information regarding seniors’ drug use and expenditure to support the overall management of public drug programs.20 Despite some level of drug coverage for seniors in all provinces and territories, some seniors still skip doses or avoid filling prescriptions due to cost, and more research into the extent of this problem is required.21 The CMA supports the development of an equitable and comprehensive pan-Canadian pharmacare program. As a step toward comprehensive, universal coverage, the CMA has repeatedly called on the federal government to implement a system of catastrophic coverage for prescription medication to reduce cost barriers of treatment and ensure Canadians do not experience undue financial hardship. Moreover, with more drugs available to treat a large number of complex and chronic health conditions, the CMA supports the development of a coordinated national approach to reduce polypharmacy among the elderly.
The CMA recommends governments and other stakeholders work together to develop and implement a pan-Canadian pharmaceutical strategy that addresses both comprehensive coverage of essential medicines for all Canadians, and programs to encourage optimal prescribing and drug therapy.
Optimal care and support for older Canadians also depends on identifying, adapting, and implementing best practices in the care of seniors. PHAC’s Best Practices Portal22 is one noteworthy initiative, and the system needs to spread and scale best practices by leveraging and enhancing pan-Canadian resources that build capacity and improve performance in home care and other sectors.13
The CMA recommends that governments and other stakeholders support ongoing research to identify best practices in the care of seniors, and monitor the impact of various interventions on health outcomes and costs.
An environment and society that is “age friendly”
One of the primary goals of seniors policy in Canada is to promote the independence of older Canadians, avoiding costly institutionalization for as long as feasible. To help older Canadians successfully maintain their independence, governments and society must keep the social determinants of health in mind when developing and implementing policy that affects seniors. It is also important to eliminate discrimination against seniors and promote positive messaging around aging. An age-friendly society respects the experience, knowledge, and capabilities of its older members and accords them the same worth and dignity as it does other citizens.
Employment is also important for seniors who need or desire it. Many seniors are choosing to remain active in the workplace for a variety of reasons, such as adding to their financial resources or staying connected to a social network.23 The CMA recognizes the federal government’s support for seniors who opt to continue working. And, while many employers encourage older workers and accommodate their needs, employment may be difficult to find in workplaces that are unwilling to hire older workers.
The CMA recommends that governments at all levels and other partners give older Canadians access to opportunities for meaningful employment if they desire.
The physical environment, including the built environment, can help to promote seniors’ independence and successful, healthy aging. The World Health Organization defines an “age-friendly environment” as one that fosters health and well-being and the participation of people as they age.24 Age-friendly environments are accessible, equitable, inclusive, safe and secure, and supportive. They promote health and prevent or delay the onset of disease and functional decline. They provide people-centered services and support to enable recovery or to compensate for the loss of function so that people can continue to do the things that are important to them.24 These factors should be taken into consideration by those who design and build communities. For example, buildings should be designed with entrance ramps and elevators; sidewalks could have sloping curbs for walkers and wheelchairs; and frequent, accessible public transportation should be provided in neighbourhoods with large concentrations of seniors.
The CMA recommends that governments and communities take the needs of older Canadians into account when designing buildings, walkways, transportation systems, and other aspects of the built environment.
The CMA recognizes the federal government’s commitment to support vulnerable seniors today while preparing for the diverse and growing seniors’ population of tomorrow. The CMA’s recommendations in this submission can assist the government as it seeks to improve access to housing for seniors, enhance income security for vulnerable seniors, and improve the overall quality of life for seniors in ways that will help to advance inclusion, well-being, and the health of Canada’s aging population.
To maximize the health and well-being of older Canadians, and ensure their active engagement and independence for as long as possible, the CMA believes that the health care system, governments, and society should work with older Canadians to promote healthy aging, provide quality patient-centred health care and support services, and build communities that value Canadians of all ages.
1 Simpson C. Code Gridlock: Why Canada needs a national seniors strategy. Address to the Canadian Club of Ottawa by Dr. Christopher Simpson, President, Canadian Medical Association; 2014 Nov. 18; Ottawa, Ontario. Available: https://www.cma.ca/En/Lists/Medias/Code_Gridlock_final. pdf#search=code%20gridlock (accessed 2016 Sep 22).
2 North East Local Health Integration Network. HOME First shifts care of seniors to HOME. LHINfo Minute, Northeastern Ontario Health Care Update. Sudbury: The Network; 2011. Cited by Home Care Ontario. Facts & figures - publicly funded home care. Hamilton: Home Care Ontario; 2017 Jun. Available: http://www.homecareontario.ca/home-care-services/facts-figures/publiclyfundedhomecare (accessed 2016 Sep 22).
3 Conference Board of Canada. A cost-benefit analysis of meeting the demand for long-term care beds. Ottawa: Conference Board of Canada; Manuscript submitted for publication.
4 Canadian Institute for Health Information (CIHI). Seniors in transition: exploring pathways across the care continuum. Ottawa: The Institute; 2017. Available: https://www.cihi.ca/sites/default/files/document/seniors-in-transition-report-2017-en.pdf (accessed 2017 Jun 30).
5 World Health Organization. Health Impact Assessment (HIA). The determinants of health. Available: http://www.who.int/hia/evidence/doh/en/ (accessed 2017 Oct 23).
6 Statistics Canada. Persons in low income (after-tax low income measure), 2012. The Daily. Ottawa: Statistics Canada; 2014 Dec 10. Available: http://www.statcan.gc.ca/daily-quotidien/141210/t141210a003-eng.htm (accessed 2017 Oct 17).
7 Statistics Canada. Population projections: Canada, the provinces and territories, 2013 to 2063. The Daily. Ottawa: Statistics Canada; 2014 Sep 17. Available: http://www.statcan.gc.ca/daily-quotidien/140917/dq140917a-eng.pdf (accessed 2016 Sep 19).
8 Statistics Canada. Canada Year Book 2012, seniors. Ottawa: Statistics Canada; 2012. Available: https://www.statcan.gc.ca/pub/11
402-x/2012000/chap/seniors-aines/seniors-aines-eng.htm (accessed 2017 Oct 18).
9 Public Health Agency of Canada. The Chief Public Health Officer’s report on the state of public health in Canada, 2014: public health in the future. Ottawa: Public Health Agency of Canada; 2014. Available: https://www.canada.ca/content/dam/phac-aspc/migration/phac-aspc/ cphorsphc-respcacsp/2014/assets/pdf/2014-eng.pdf (accessed 2016 Sep 19).
10 Canadian Institute for Health Information (CIHI). Health Care in Canada, 2011: A Focus on Seniors and Aging. Ottawa: The Institute; 2014 Nov. Available: https://secure.cihi.ca/free_products/HCIC_2011_seniors_report_en.pdf (accessed 2016 Sept 19).
11 Stonebridge C, Hermus G, Edenhoffer K. Future care for Canadian seniors: a status quo forecast. Ottawa: Conference Board of Canada; 2015. Available: http://www.conferenceboard.ca/e-library/abstract.aspx?did=7374 (accessed 2016 Sep 20).
12 Report of the Standing Senate Committee on National Finance. Getting ready: For a new generation of active seniors. Ottawa: The Committee; 2017 Jun. Available: https://sencanada.ca/content/sen/committee/421/NFFN/Reports/NFFN_Final19th_Aging_e.pdf (accessed 2017 Oct 18).
13 Canadian Home Care Association, The College of Family Physicians of Canada, Canadian Nurses Association. Better Home Care in Canada: A National Action Plan. 2016. Ottawa: Canadian Home Care Association, The College of Family Physicians of Canada, Canadian Nurses Association; 2016. Available: http://www.thehomecareplan.ca/wp-content/uploads/2016/10/Better-Home-Care-Report-Oct-web.pdf (accessed 2017 Oct 23).
14 Turcotte M, Sawaya C. Senior care: differences by type of housing. Insights on Canadian society. Cat. No. 75-006-X. Ottawa: Statistics Canada; 2015 Feb 25. Available: http://www.statcan.gc.ca/pub/75-006-x/2015001/article/14142-eng.pdf (accessed 2016 Sep 22).
15 Carers Canada, Canadian Home Care Association, Canadian Cancer Action Network. Advancing Collective Priorities: A Canadian Carer Strategy. 2017. Mississauga: Canadian Home Care Association, Canadian Cancer Action Network; 2017. Available: http://www.cdnhomecare.ca/media. php?mid=4918 (accessed 2017 Oct 23).
16 Ipsos Public Affairs, HealthCareCAN, Canadian College of Health Leaders. National Health Leadership Conference report. Toronto: Ipsos Public Affairs; 2016 Jun 6. Available: http://www.nhlc-cnls.ca/assets/2016%20Ottawa/NHLCIpsosReportJune1.pdf (accessed 2016 Jun 06).
17 Canadian Medical Association. Health and Health Care for an Aging Population. Ottawa: The Association; December 2013. Available: https:// www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Health_and_Health_Care_for_an_Aging-Population_ PD14-03-e.pdf (accessed 2017 Oct 20).
18 Government of Canada. The Chief Public Health Officer’s Report on the State of Public Health in Canada 2010 – Canada’s experience in setting the stage for healthy aging. Ottawa: Government of Canada; 2014. Available: https://www.canada.ca/en/public-health/corporate/publications/ chief-public-health-officer-reports-state-public-health-canada/annual-report-on-state-public-health-canada-2010/chapter-2.html (accessed 2017 Oct 23).
19 Commonwealth Fund. 2014 International Health Policy Survey of Older Adults in Eleven Countries. 2014. New York: Commonweath Fund; 2014. Available: http://www.commonwealthfund.org/~/media/files/publications/in-the-literature/2014/nov/pdf_1787_commonwealth_fund_2014_intl_ survey_chartpack.pdf (accessed 2017 Oct 23).
20 Canadian Institute for Health Information. Drug Use among Seniors on Public Drug Programs in Canada, 2002 to 2008. (2010). Ottawa: The Institute; 2010. Available: https://secure.cihi.ca/free_products/drug_use_in_seniors_2002-2008_e.pdf (accessed 2017 Oct 23).
21 Law MR, Cheng L, Dhalla IA, Heard D, Morgan SG. The effect of cost on adherence to prescription medications in Canada. CMAJ. 2012 Feb21;184(3):297-302. Available: http://www.cmaj.ca/content/184/3/297.short. (accessed 2017 Oct 23).
22 Public Health Agency of Canada. Canadian Best Practices Portal. Ottawa: Public Health Agency of Canada; 2016. Available: http://cbpp-pcpe. phac-aspc.gc.ca/public-health-topics/seniors/ (accessed 2017 Oct 23).
23 Government of Canada. Action for Seniors report. 2014. Ottawa: Government of Canada; 2014. Available: https://www.canada.ca/en/ employment-social-development/programs/seniors-action-report.html (accessed 2017 Oct 23).
24 World Health Organization (WHO). Age-friendly environments. Geneva: WHO; 2017. Available: http://www.who.int/ageing/projects/age
friendly-environments/en/ (accessed 2017 Oct 23).
The Canadian Medical Association (CMA) is pleased to make submissions on Bill S-4. CMA has followed the history of PIPEDA and participated in the studies of various Standing Committees, most notably and recently in 2007 to the House of Commons Standing Committee on Access to Information, Privacy and Ethics. CMA is pleased that amendments to PIPEDA are once again being considered.
The Canadian Medical Association represents over 80,000 physicians in Canada. Privacy is an important value to physicians and the patients to whom they serve. This is reflected in our Code of Ethics and policies, in particular, Principles for the Protection of Patients' Personal Health Information and Statement of Principles: The Sale and Use of Data on Individual Physicians' Prescribing. Physicians are also required to abide by privacy and confidentiality standards of practice. Thus, the CMA has a strong interest and valuable insights into the topic of personal information and privacy with respect to health information.
We thank the Standing Committee for the opportunity to comment on the proposed amendments to PIPEDA. Our key comments are outlined below:
CMA supports the existing legislative framework on the collection, use and disclosure of personal information produced by an individual in the course of their employment, business or profession ("work product") and suggests further amendments focus on strengthening it further.
CMA supports the current standing of work products, that work products are considered to be personal information. That is, we support the framework defining personal information as information about an identifiable individual and that there is no carved out definition or exemption for "work product".
CMA supports the position of the Office of Privacy Commissioner's following its 2007 investigation on work products, that they should not be exempted for two main reasons:
* The exemption is not needed, and it would be inconsistent with the balanced approach in the current definition of personal information. The current definition of personal information and the approach to deciding issues based on that definition have worked well. They have promoted a level of privacy protection that balances the right of privacy in personal information with the needs of organizations for the reasonable and appropriate collection, use and disclosure of personal information. ...Because the concept of "work product" is ambiguous, excluding it from the definition of personal information could have unpredictable consequences that would diminish privacy unnecessarily.
It is the CMA's position that work products should be considered personal information and given the section 7 amendments, work products should only be collected, used or disclosed without consent only if it is consistent with the purposes for which the information was produced.
In the case of physicians, a prime example of a physician's work product is prescribing information. Prescribing information is a synthesis of assessing patients - by probing into their health, familial, social and sometimes financial background - infused with medical knowledge, skill and competencies resulting in a diagnosis and treatment plan, which often includes prescribing a medication or test. Not only is the physician's prescribing information a product of physicians' work but would not exist but for a trusting physician-patient relationship wherein the patient's private and personal information are shared under circumstances of vulnerability and trust. The outcome is that this is personal information. Prescribing information is about an individual: it includes the name of the patient, the name of the prescribing physician, and the drug name, dosage, amount and frequency; giving major clues as to what the patient's health issue(s) are.
For further clarity, however, CMA recommends that physician information, and physician work products, should be specifically recognized within the legislation as personal information. To this end, we would propose that the following addition be made to the definition section under personal health information:
Section 2.(1) "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual;
CMA supports the amendments to subsections 7(1)-(3) of the Act that any subsequent collection, use and disclosure of work products without consent must be related to the original purpose (of collection, use and disclosure). This relationship reflects the government's understanding and faithfulness to privacy principles. This is particularly critical when dealing with health information, and is even more critical in today's world given the ease of linking information through advancements in technology. In the absence of a causal relationship, personal information should not be used for system performance, commercial enterprise, data brokering, research, assessment or other purposes.
CMA recommends that the legislation should go further and allow persons who believe that protection cannot be afforded under the legislation that they have the authority to refuse to communicate the information. This is the conceptual approach taken in Quebec's Act Respecting the Protection of Personal Information in the Private Sector wherein persons have an opportunity to refuse that professional information (as defined therein) be used for commercial purposes. Physicians are constantly writing prescriptions and such information should only be used for other purposes in the interests of patients and the health care system, and not to serve commercial interests or marketing strategies. If physicians do not feel that such protection is afforded patients, then they should be permitted to refuse that such information be collected, used or disclosed. Patient privacy should be primary.
And finally, addressing work products in legislation clears up past differences of interpretation by Privacy Commissioners thus, providing certainty and clarity to the public.
That Section 2. (1) "personal health information", be amended to read as follows: "personal health information", with respect to an individual, whether living or deceased, means .....(d) information that is collected or is the outcome of collecting information in the course of providing health services to the individual;
CMA is pleased to see a section on breaches of security safeguards and recommends greater specificity.
As noted above, physicians have responsibilities as data stewards and custodians of health information. As such, CMA supports breach notification measures that would enhance and protect patient privacy. In principle, we support the proposed amendments of breach disclosures to the Privacy Commissioner, to individuals and to organizations.
However, CMA is concerned that meeting the requirements may be confusing. For example, in the health care context, it is easy to surmise that all health information is "sensitive". A far more difficult matter is determining whether the risk reaches the threshold of "significant harm" and the "probability" that the information "will be misused". The result being that incidental disclosures will be reported causing unnecessary concern and confusion in the patient population. Further specificity is recommended and we suggest something akin to Ontario's Personal Health Information Protection Act, 2004 (PHIPA).
The PHIPA is an act specifically dealing with personal health information. One of its purposes is "to establish rules for the collection, use and disclosure of personal health information about individuals that protect the confidentiality of that information and the privacy of individuals with respect to that information, while facilitating the effective provision of health care" (section 1a ). The PHIPA notification provision states that the individual shall be notified "...at the first reasonable opportunity if the information is stolen, lost or accessed by unauthorized persons", [section 12(2)]. CMA is unaware of any concerns with this approach.
The language of PIPIEDA is one of reasonable belief of real risk of significant harm to an individual. The issue is the test for required notification of patients for incidental inadvertent breaches and decreasing "notification fatigue". To illustrate the issue, if physicians were told today that patient data could be retrieved from the drums of discarded photocopiers and printers, it would be inappropriate for legislation to suggest that the entire patient population during the life of the photocopier or printer be notified. To this end, we recommend that there be acknowledgement that in some circumstances notification may not be required. The probability of misuse under PIPEDA is more ambiguous than the PHIPA test. Under PHIPA, the approach is more objective in that the data must be stolen, lost or accessed by unauthorized persons. To our knowledge, the Ontario model has been in place for almost a decade with no significant issues and thus we submit is one that works.
In other jurisdictions (eg., Newfoundland and Labrador, Nova Scotia, New Brunswick) with health privacy legislation, there is acknowledgement of trying to balance notification and those breaches unlikely to result in harm by directly indicating when notification is not required.
CMA recommends that the statute move towards a more objective test and acknowledge that there are situations when notice is not required.
CMA supports disclosure without consent under limited circumstances, but finds the current list of disclosures overly inclusive.
Health information is considered highly sensitive information and is initially collected for the purpose of individual patient health care. It should only be disclosed with consent and in only some exceptions without consent. The PIPEDA amendments for disclosure without consent have been broadened.
Privacy, confidentiality and trust are the foundations of the patient-physician relationship. Without these fundamental values in play, open and honest communications cannot occur and patients would not receive the care they require. Both the patient and the physician have significant investment in the relationship. CMA respects the requirements to disclose information without consent under certain premises, such as required by court order or statute. However, any kind of activity requiring physicians to disclose patient's information without consent for the purposes of advancing a government or institution's goal could jeopardize the relationship.
Both the patient's consent and the physician's consent should be required if there is potential to disturb this relationship. The physician is fiduciary of the relationship and is appropriately situated to assess and determine whether disclosure will disturb the relationship.
While CMA acknowledges that certain situations may require that disclosure occur without consent (eg. purposes of investigating fraud, national security, abuse or as legally required), disclosure for less malicious activities (e.g., breaches of an agreement, insurance claims) ought to require a court order or warrant. For example, under the proposed section 7(3)(d.1) if a physician were in default of a contract with a technology company supplying electronic medical record software or app to his/her clinic, the company could disclose health information without consent for the "purposes of investigating a breach of an agreement". While we appreciate that there is a caveat that disclosure without advising the patient can only occur if there is a reasonable expectation that the disclosure would compromise the investigation, we submit that leaving the determination of what is "reasonable" to an interested party to the breach is unfair to all. Another example, if a physician is a witness to a dispute between an employer and union representing an employee for denial of long term disability by an insurance company, and has filed a witness statement which includes a medical report he/she wrote to the employer's insurance company, under the proposed section 7(3)(e.1) disclosure of health information without consent is permitted in order to assess, process or settle an insurance claim.
CMA is concerned that the disclosure amendments are overly broad and do not differentiate sufficiently between highly time sensitive or grossly malicious situations, and those where it is merely expedient or an administrative encumbrance to seek consent.
In addition, the disclosure requirements are framed in permissive (ie., may) and not mandatory language (ie., shall). This is very problematic when the "organization" is a physicians' clinic unless the physician's own consent is made as a pre-condition. CMA believes this suggestion is a progressive one in keeping with the broadened disclosure amendments. Physicians are in a relationship of trust and take seriously the protection of patient privacy and confidentiality, for which they are trained and are ethically and legally required to protect.
To place physicians in a position which might entail breaching this trust may impact the confidence of the physician and the patient in the patient-physician relationship which is required to properly formulate appropriate treatment plans; thus, negatively impacting the health of Canadians.
That disclosures of health information without consent require a warrant or subpoena or court order. Furthermore, disclosures of health information require the physician's consent that in his/her opinion the disclosure does not harm the patient-physician relationship. And, finally any broadened disclosure situations be restricted to criminal activity or that impacting national security.
Once again, CMA appreciates the opportunity to provide comment as part of the committee's study of Bill S-4. CMA is prepared to work with Parliament, governments, health professionals and the public in ensuring legislative frameworks for the collection, usage and disclosure of personal information for legitimate and reasonable purposes.
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
Appropriateness in Health Care
This paper discusses the concept of appropriateness in health care and advances the following definition:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
Building on that definition it makes the following policy recommendations:
* Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
* Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
* Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
As health systems struggle with the issue of sustainability and evidence that the quality of care is often sub-optimal, increasing attention is focused on the concept of appropriateness. A World Health Organization study published in 2000 described appropriateness as "a complex, fuzzy issue"1. Yet if the term is to be applied with benefit to health care systems, it demands definitional clarity. This policy document presents the Canadian Medical Association definition of appropriateness which addresses both quality and value. The roots of the definition are anchored in the evolution of Canadian health care over the last two decades. The document then considers the many issues confronting the operationalization of the term. It concludes that appropriateness can play a central role in positive health system transformation.
At the Canadian Medical Association General Council in 2013 the following resolution was adopted:
The Canadian Medical Association adopts the following definition for appropriateness in health care: It is the right care, provided by the right providers, to the right patient, in the right place, at the right time, resulting in optimal quality care.
This definition has five key components:
* right care is based on evidence for effectiveness and efficacy in the clinical literature and covers not only use but failure to use;
* right provider is based on ensuring the provider's scope of practice adequately meets but does not far exceed the skills and knowledge to deliver the care;
* right patient acknowledges that care choices must be matched to individual patient characteristics and preferences and must recognize the potential challenge of reconciling patient and practitioner perceptions;
* right venue emphasizes that some settings are better suited in terms of safety and efficiency to delivering a specific type of care than others;
* right time indicates care is delivered in a timely manner consistent with agreed upon bench marks.
It is essential to appreciate that the "right cost" is a consequence of providing the right care, that it is an outcome rather than an input. In other words, if all five components above are present, high quality care will have been delivered with the appropriate use of resources, that is, at the right cost. Equally, however, it should be cautioned that right cost may not necessarily be the affordable cost. For example, a new drug or imaging technology may offer small but demonstrable advantages over older practices, but at an enormous increase in cost. Some might argue that right care includes the use of the newer drug or technology, while others would contend the excessive opportunity costs must be taken into consideration such that the older practices remain the right care.
An Evolving Canadian Perspective from 1996 to 2013
In a pioneering paper from 1996 Lavis and Anderson wrote:
...there are two distinct types of appropriateness: appropriateness of a service and appropriateness of the setting in which care is provided. The differences between the two parallel the differences between two other concepts in health care: effectiveness and cost-containment...An appropriate service is one that is expected to do more good than harm for a patient with a given indication...The appropriateness of the setting in which care is provided is related to cost effectiveness2.
This very serviceable definition moved beyond a narrow clinical conception based solely on the therapeutic impact of an intervention on a patient, to broader contextual consideration focused on venue. Thus, for example, the care provided appropriately in a home-care setting might not be at all appropriate if given in a tertiary care hospital. Significantly, the authors added this important observation: "Setting is a proxy measure of the resources used to provide care"2. This sentence is an invitation to expand the original Lavis and Anderson definition to encompass other resources and inputs identified over the ensuing decades. Three elements are especially important.
Timeliness became an issue in Canadian health care just as the Lavis and Anderson paper appeared. In 1997 almost two-thirds of polled Canadians felt surgical wait times were excessive, up from just over half of respondents a year earlier3. By 2004 concern with wait times was sufficiently pervasive that when the federal government and the provinces concluded the First Ministers' Agreement, it included obligations to provide timely access to cancer care, cardiac care, diagnostic imaging, joint replacement and sight restoration4. These rapid developments indicate that timeliness was now considered an essential element in determining the appropriateness of care.
A second theme that became prominent in health care over the last two decades was the concept of patient-centredness. When the Canadian Medical Association released its widely endorsed Health Care Transformation in Canada in 2010, the first principle for reform was building a culture of patient-centred care. Succinctly put, this meant that "health care services are provided in a manner that works best for patients"5. To begin the process of operationalizing this concept CMA proposed a Charter for Patient-centred Care. Organized across seven domains, it included the importance of: allowing patients to participate fully in decisions about their care; respecting confidentiality of health records; and ensuring care provided is safe and appropriate. This sweeping vision underscores the fact that care which is not matched to the individual patient cannot be considered appropriate care.
A third significant development over the last two decades was heightened awareness of the importance of scopes of practice. This awareness arose in part from the emphasis placed on a team approach in newer models of primary care6, but also from the emergence of new professions such as physician assistants, and the expansion of scopes of practice for other professionals such as pharmacists7. As the same health care activity could increasingly be done by a wider range of health professionals, ensuring the best match between competence required and the service provided became an essential element to consider when defining appropriateness. Under-qualified practitioners could not deliver quality care, while overly-qualified providers were a poor use of scarce resources.
To summarize, as a recent scoping review suggested, for a complete conceptualization of appropriateness in 2013 it is necessary to add the right time, right patient and right provider to the previously articulated right care and right setting8.
Why Appropriateness Matters
The most frequent argument used to justify policy attention to appropriateness is health system cost. There is a wealth of evidence that inappropriate care - avoidable hospitalizations, for example, or alternative level of care patients in acute care beds - is wide spread in Canada9; eliminating this waste is critical to system sustainability. In Saskatchewan, for example, Regina and Saskatoon contracted in 2011 with private clinics to provide a list of 34 surgical procedures. Not only were wait times reduced, but costs were 26% lower in the surgical clinics than in hospitals for doing the same procedures10.
There is, however, an equally important issue pointing to the importance of ensuring appropriate care: sub-optimal health care quality. In the United States, for example, a study evaluated performance on 439 quality indicators for 30 acute and chronic conditions. Patients received 54.9% of recommended care, ranging from a high of 78.7% for senile cataracts to 10.5% for alcohol dependence11. A more recent Australian study used 522 quality indicators to assess care for 22 common conditions. Patients received clinically appropriate care in 57% of encounters, with a range from 90% for coronary artery disease to 13% for alcohol dependence12. While no comparable comprehensive data exist for Canada, it is unlikely the practices in our system depart significantly from peer nations. Focusing on appropriateness of care, then, is justified by both fiscal and quality concerns.
Methodology: the Challenge of Identifying Appropriateness
While there is a clear need to address appropriateness - in all its dimensions - the methods by which to assess the appropriateness of care are limited and, to date, have largely focused on the clinical aspect.
The most frequently used approach is the Rand/University of California Los Angeles (Rand) method. It provides panels of experts with relevant literature about a particular practice and facilitates iterative discussion and ranking of the possible indications for using the practice. Practices are labeled appropriate, equivocal or inappropriate13. A systematic review in 2012 found that for use on surgical procedures the method had good test-retest reliability, interpanel reliability and construct validity14. However, the method has been criticized for other short-comings: panels in different countries may reach different conclusions when reviewing the same evidence; validity can only be tested against instruments such as clinical practice guidelines that themselves may have a large expert opinion component2; Rand appropriateness ratings apply to an "average" patient, which cannot account for differences across individuals; and, finally, Rand ratings focus on appropriateness when a service is provided but does not encompass underuse, that is, failure to provide a service that would have been appropriate9.
The Rand method, while not perfect, is the most rigorous approach to determining clinical appropriateness yet devised. It has recently been suggested that a method based on extensive literature review can identify potentially ineffective or harmful practices; when applied to almost 6000 items in the Australian Medical Benefits Schedule, 156 were identified that may be inappropriate15. This method also presents challenges. For example, the authors of a study using Cochrane reviews to identify low-value practices note that the low-value label resulted mainly from a lack of randomized evidence for effectiveness16.
Assessing the appropriateness of care setting has focused almost exclusively on hospitals. Some diagnoses are known to be manageable in a community setting by primary care or specialty clinics. The rate of admissions for these ambulatory care sensitive conditions (ACSCs) - which fell from 459 per 100,000 population in 2001-02 to 320 per 100,00 in 2008-09 - is one way of gauging the appropriateness of the hospital as a care venue9. A second measure is the number of hospital patients who do not require either initial or prolonged treatment in an acute care setting. Proprietorial instruments such as the Appropriateness Evaluation Protocol (AEP)17or the InterQual Intensity of Service, Severity of Illness and Discharge Screen for Acute Care (ISD-AC)18 have been used to assess the appropriateness of hospital care for individual patients. While these instruments have been applied to Canadian hospital data19,20, there is a lack of consensus in the literature as to the reliability and utility of such tools21-23.
Benchmarks exist for appropriate wait times for some types of care in Canada through the work of the Wait Time Alliance4. These include: chronic pain, cancer care, cardiac care, digestive health care, emergency rooms, joint replacement, nuclear medicine, radiology, obstetrics and gynecology, pediatric surgery, plastic surgery, psychiatric illness, and sight restoration. The recommendations are based on evidence-informed expert opinion.
The other two domains of appropriateness - right patient, right provider - as yet have no objective tools by which to assess appropriateness.
Determining appropriateness demands a complex and time-consuming approach, and its operationalization faces a number of barriers.
The availability of some health care services may be subject to political influence which will over-ride appropriateness criteria. For example, recommendations to close smaller hospitals deemed to be redundant or inefficient may not be implemented for political reasons.
Patient expectations can challenge evidence-based appropriateness criteria. In a primary care setting, for instance, it may be difficult to persuade a patient with an ankle sprain that an x-ray is unlikely to be helpful. The insistence by the patient is compounded by an awareness of potential legal liability in the event that clinical judgment subsequently proves incorrect. Choosing Wisely Canada recommends physicians and patients become comfortable with evidence-informed conversations about potentially necessary care24.
Traditional clinical roles are difficult to revise in order to ensure that care is provided by the most appropriate health professional. This is especially true if existing funding silos are not realigned to reflect the desired change in practice patterns.
Finally, and perhaps most importantly, even if agreed upon appropriateness criteria are developed, holding practitioners accountable for their application in clinical practice is extremely difficult due to data issues25. Chart audits could be conducted to determine whether appropriateness criteria were met when specific practices were deployed, but this is not feasible on a large scale. Rates of use of some practices could be compared among peers from administrative data; however, variation in practice population might legitimately sustain practice variation. For diagnostic procedures it has been suggested that the percentage of negative results is an indicator of inappropriate use; however, most administrative claim databases would not include positive or negative test result data26. This data deficit must be addressed with health departments and regional health authorities.
There are several additional constraints on the use of the concept by health system managers.
First, the vast majority of practices have never been subject to the Rand or any other appropriateness assessment. Even for surgical procedures clinical appropriateness criteria exist for only 10 of the top 25 most common inpatient procedures and for 6 of the top 15 ambulatory procedures in the United States. Most studies are more than 5 years old27.
Second, while the notion is perhaps appealing to policy makers, it is incorrect to assume that high use of a practice equates with misuse: when high-use areas are compared to low use areas, the proportion of inappropriate use has consistently been shown to be no greater in the high-use regions28,29.
Finally, it is uncertain how large a saving can be realized from eliminating problematic clinical care. For example, a US study modeling the implementation of recommendations for primary care found that while a switch to preferentially prescribing generic drugs would save considerable resources, most of the other items on the list of questionable activities "are not major contributors to health care costs"30. What is important to emphasize is that even if dollars are not saved, by reducing inappropriate care better value will be realized for each dollar spent.
These methodological and other challenges31 notwithstanding, the Canadian Medical Association puts forward the following recommendations for operationalizing the concept of appropriateness and of clinical practice.
1. Provinces and territories should work with providers to develop a comprehensive framework by which to assess the appropriateness of health care.
Jurisdictions should develop a framework32 for identifying potentially inappropriate care, including under-use. This involves selecting criteria by which to identify and prioritize candidates for assessment; developing and applying a robust assessment methodology; and creating mechanisms to disseminate and apply the results. Frameworks must also include meaningful consideration of care venue, timeliness, patient preferences and provider scope of practice. International examples exist for some aspects of this exercise and should be adapted to jurisdictional circumstances. Necessarily, a framework will demand the collection of supporting data in a manner consistent with the following 2013 General Council resolution:
The Canadian Medical Association supports the development of data on health care delivery and patient outcomes to help the medical profession develop an appropriateness framework and associated accountability standards provided that patient and physician confidentiality is maintained.
2. Provinces and territories should work with providers to develop robust educational products on appropriateness in health care and to disseminate evidence-informed strategies for necessary changes in care processes.
Both trainees and practicing physicians should have access to education and guidance on the topic of appropriateness and on practices that are misused, under-used, or over-used. Appropriately designed continuing education has been shown to alter physician practice. Point of care guidance via the electronic medical record offers a further opportunity to alert clinicians to practices that should or should not be done in the course of a patient encounter33.
An initiative co-led by the Canadian Medical Association that is designed to educate the profession about the inappropriate over use of diagnostic and therapeutic interventions is Choosing Wisely Canada. The goal is to enhance quality of care and only secondarily to reduce unnecessary expenditures. It is an initiative consistent with the intent of two resolutions from the 2013 General Council:
The Canadian Medical Association will form a collaborative working group to develop specialty-specific lists of clinical tests/interventions and procedures for which benefits have generally not been shown to exceed the risks.
The Canadian Medical Association believes that fiscal benefits and cost savings of exercises in accountability and appropriateness in clinical care are a by-product rather than the primary focus of these exercises.
3. Provinces and territories should work with providers to put in place incentives to decrease the provision of marginally useful or unnecessary care.
Practitioners should be provided with incentives to eliminate inappropriate care. These incentives may be financial - delisting marginal activities or providing bonuses for achieving utilization targets for appropriate but under-used care. Any notional savings could also be flagged for reinvestment in the health system, for example, to enhance access. Giving physicians the capacity to participate in audit and feedback on their use of marginal practices in comparison to peers generally creates a personal incentive to avoid outlier status. Public reporting by group or institution may also move practice towards the mean30. In any such undertakings to address quality or costs through changes in practice behaviour it is essential that the medical profession play a key role. This critical point was captured in a 2013 General Council resolution:
The Canadian Medical Association will advocate for adequate physician input in the selection of evidence used to address costs and quality related to clinical practice variation.
When appropriateness is defined solely in terms of assessing the clinical benefit of care activities it can provide a plausible rational for "disinvestment in" or "delisting of" individual diagnostic or therapeutic interventions. However, such a narrow conceptualization of appropriateness cannot ensure that high quality care is provided with the optimal use of resources. To be truly useful in promoting quality and value appropriateness must be understood to mean the right care, provided by the right provider, to the right patient, in the right venue, at the right time.
Achieving these five components of health care will not be without significant challenges, beginning with definitions and moving on to complex discussions on methods of measurement. Indeed, it may prove an aspirational goal rather than a completely attainable reality. But if every encounter in the health system - a hospitalization, a visit to a primary care provider, an admission to home care - attempted to meet or approximate each of the five criteria for appropriateness, a major step towards optimal care and value will have been achieved across the continuum. Viewed in this way, appropriateness has the capacity to become an extraordinarily useful organizing concept for positive health care transformation in Canada.
Approved by CMA Board on December 06, 2014
1. World Health Organization. Appropriateness in Health Care Services, Report on a WHO Workshop. Copenhagen: WHO; 2000.
2. Lavis JN, Anderson GM. Appropriateness in health care delivery: definitions, measurement and policy implications. CMAJ. 1996;154(3):321-8.
3. Sanmartin C, Shortt SE, Barer ML, Sheps S, Lewis S, McDonald PW. Waiting for medical services in Canada: lots of heat, but little light. CMAJ. 2000;162(9):1305-10.
4. Wait Time Alliance. Working to Improve Wait Times Across Canada. Toronto: Wait Time Alliance; 2014. Available: http://www.waittimealliance.ca. (accessed April 18, 2013)
5. Canadian Medical Association. Health Care Transformation in Canada. Ottawa: Canadian Medical Association; 2010.
6. Canadian Medical Association. CMA Policy: Achieving Patient-centred Collaborative Care. Ottawa: Canadian Medical Association; 2008.
7. Maxwell-Alleyne A, Farber A. Pharmacists' expanded scope of practice: Professional obligations for physicians and pharmacists working collaboratively. Ont Med Rev. 2013;80(4):17-9.
8. Sanmartin C, Murphy K, Choptain N, et al. Appropriateness of healthcare interventions: concepts and scoping of the published literature. Int J Technol Assess Health Care. 2008;24(3)342-9.
9. Canadian Institute for Health Information. Health Care in Canada 2010. Ottawa: CIHI; 2010.
10. MacKinnon J. Health Care Reform from the Cradle of Medicare. Ottawa: Macdonald-Laurier Institute; 2013.
11. McGlynn EA, Asch SM, Adams J, et al. The quality of health care delivered to adults in the United States. NEJM. 2003;348(26):2635-45.
12. Runciman WB, Hunt TD, Hannaford NA, et al. CareTrack: assessing the appropriateness of health care delivery in Australia. Med J Aust. 2012;197(2):100-5.
13. Brook RH, Chassin MR, Fink A, Solomon DH, Kosecoff J, Park RE. A method for the detailed assessment of the appropriateness of medical technologies. Int J Technol Assess Health Care. 1986;2(1):53-63.
14. Lawson EH, Gibbons MM, Ko CY, Shekelle PG. The appropriateness method has acceptable reliability and validity for assessing overuse and underuse of surgical procedures. J Clin Epidemiol. 2012;65(11):1133-43.
15. Elshaug AG, Watt AM, Mundy L, Willis CD. Over 150 potentially low-value health care practices: an Australian study. Med J Aust. 2012;197(10):556-60.
16. Garner S, Docherty M, Somner J, et al. Reducing ineffective practice: challenges in identifying low-value health care using Cochrane systematic reviews. J Health Serv Res Policy. 2013;18(1):6-12.
17. Gertman PM, Restuccia JD. The appropriateness evaluation protocol: a technique for assessing unnecessary days of hospital care. Med Care. 1981;19(8):855-71.
18. Mitus AJ. The birth of InterQual: evidence-based decision support criteria that helped change healthcare. Prof Case Manag. 2008;13(4):228-33.
19. DeCoster C, Roos NP, Carriere KC, Peterson S. Inappropriate hospital use by patients receiving care for medical conditions: targeting utilization review. CMAJ. 1997;157(7):889-96.
20. Flintoft VF, Williams JI, Williams RC, Basinski AS, Blackstien-Hirsch P, Naylor CD. The need for acute, subacute and nonacute care at 105 general hospital sites in Ontario. Joint Policy and Planning Committee Non-Acute Hospitalization Project Working Group. CMAJ . 1998;158(10):1289-96.
21. Kalant N, Berlinguet M, Diodati JG, Dragatakis L, Marcotte F. How valid are utilization review tools in assessing appropriate use of acute care beds? CMAJ. 2000;162(13):1809-13.
22. McDonagh MS, Smith DH, Goddard M. Measuring appropriate use of acute beds. A systematic review of methods and results. Health policy. 2000;53(3):157-84.
23. Vetter N. Inappropriately delayed discharge from hospital: what do we know? BMJ. 2003;326(7395):927-8.
24. Choosing Wisely Canada. Recent News. Ottawa: Choosing Wisely Canada; 2015. Available: www.choosingwiselycanada.org. (accessed Dec 2014)
25. Garner S, Littlejohns P. Disinvestment from low value clinical interventions: NICEly done? BMJ. 2011;343:d4519.
26. Baker DW, Qaseem A, Reynolds PP, Gardner LA, Schneider EC. Design and use of performance measures to decrease low-value services and achieve cost-conscious care. Ann Intern Med. 2013;158(1):55-9.
27. Lawson EH, Gibbons MM, Ingraham AM, Shekelle PG, Ko CY. Appropriateness criteria to assess variations in surgical procedure use in the United States. Arch Surg. 2011;146(12):1433-40.
28. Chassin MR, Kosecoff J, Park RE, et al. Does inappropriate use explain geographic variations in the use of health care services? A study of three procedures. JAMA. 1987;258(18):2533-7.
29. Keyhani S, Falk R, Bishop T, Howell E, Korenstein D. The relationship between geographic variations and overuse of healthcare services: a systematic review. Med care. 2012;50(3):257-61.
30. Kale MS, Bishop TF, Federman AD, Keyhani S. "Top 5" lists top $5 billion. Arch Intern Med. 2011;171(20):1856-8.
31. Elshaug AG, Hiller JE, Tunis SR, Moss JR. Challenges in Australian policy processes for disinvestment from existing, ineffective health care practices. Aust New Zealand Health Policy. 2007;4:23.
32. Elshaug AG, Moss JR, Littlejohns P, Karnon J, Merlin TL, Hiller JE. Identifying existing health care services that do not provide value for money. Med J Aust. 2009;190(5):269-73.
33. Shortt S GM, Gorbet S. Making medical practice safer: the role of public policy. Int J Risk Saf Med. 2010;22(3):159-68.
The Canadian Medical Association will work with stakeholders in medical education to encourage awareness of the difference between non-commissioned financial/insurance advisers employed by national and provincial/territorial medical associations and commissioned financial/insurance advisers employed by banks and other corporations.
The Canadian Medical Association will work with stakeholders in medical education to encourage awareness of the difference between non-commissioned financial/insurance advisers employed by national and provincial/territorial medical associations and commissioned financial/insurance advisers employed by banks and other corporations.
The Canadian Medical Association will work with stakeholders in medical education to encourage awareness of the difference between non-commissioned financial/insurance advisers employed by national and provincial/territorial medical associations and commissioned financial/insurance advisers employed by banks and other corporations.
The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1
Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety.
Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite.
The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3
In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.*
CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult.
Public health approach to addiction
Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components.
Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program).
Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5
Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential.
Harm reduction is part of health practice
Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms.
Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs.
The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9
Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10
Supervised Consumption Sites are evidence-based
Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment.
Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12
Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services.
Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15
Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been:
* A reduction in the overall rate of needle sharing in the area;19
* A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21
* Increased access to addiction counseling and increased enrolment in detox programs;22 23
* Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24
* Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and
* No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26
* Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28
Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence.
Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety.
Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation.
The CMA has the following concerns with Bill C-2:
1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation."
2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation.
3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances".
4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need.
It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.
* "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services.
1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4
2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do
3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3
4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23
5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967
6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf
8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf
9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf
10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf
12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf
13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm
14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services
15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics
16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf
17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404.
19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18.
20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351.
21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7.
22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919.
23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence.
24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36.
25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34.
26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php
27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76.
28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36.
29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper.
30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction.
31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374.
32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136
33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20)
34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act.
The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care.
Prescription medication has a very important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan.
The CMA supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end.
1) Clarify ministerial authority and responsibility
The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety.
The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3):
* Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening.
* Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety.
In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority.
Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3.
2) Oversight of natural health products
The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting.
To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety.
Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products.
3) Comprehensive post-market surveillance and response system
The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings.
A) Increasing accountability and public transparency
Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks.
Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4
Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear.
The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data.
Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication.
Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks.
B) Improving the reporting and communication system
The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place.
Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness.
When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting.
In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes:
* Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care.
* Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line.
* Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting.
* Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis.
Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health.
In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report.
Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it.
Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes:
* Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records;
* Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and
* Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public.
Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting.
Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution".
Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective.
1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf
Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf
Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf
Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf
Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf
Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf
Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf
2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada.
http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30)
3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21)
4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2)
5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from:
The CMA is pleased to provide this submission to the House of Commons Standing Committee on Health on Bill C-45, the Cannabis Act.
The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development.
i The term cannabis is used, as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant.
ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on
1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27).
2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27).
3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27).
4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27).
5 Riley D, O’Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000.
6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1–e12.
7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27).
8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27).
9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27).
10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27).
11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016.
12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017.
13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13.
14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1–8.
The CMA’s approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4
Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research.
There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like “deep inhalation” to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6
Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation (“the Task Force”).7
According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%–30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis’ increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation
Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27).
and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results.
The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles.
Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force’s recommendations,12 the bill addresses several aspects of a legal-regulatory framework “to provide legal access to cannabis and to control and regulate its production, distribution and sale.”13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3
There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people.
Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth
From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16
15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657–64
16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1–4.
17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303–310.
18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496–506.
19 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): The National Academies Press; 2017.
20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27).
21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27)
22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383–91.
23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27).
24 Miech RA, Johnston LD, O’Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975–2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011.
25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785–7.
26 Health Canada. Strong foundation, renewed focus: an overview of Canada’s Federal Tobacco Control Strategy 2012–2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27).
27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9.
Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18
This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use.
Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades.
The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5
The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug’s physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a “ticketable” offence rather than a criminal one.
iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002).
iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003.
v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27).
Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25.
Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component
The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach.
We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians’ perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v
The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21
A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence — double the rate for any other drug — because of the high prevalence of cannabis use.23
The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis’ general risks but also on its special risks for the young and its harmful effects on them.
This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs.
The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26
vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years.
The Lower-Risk Cannabis Use Guidelines were developed as a “science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks.”6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings.
Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years
The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada’s usual pharmaceutical regulatory approval process.
The Task Force’s discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place.
Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review — specifically, a program evaluation of the medical access framework in five years.11
If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed,
especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach’s short- and long-term impact on the reduction of harms.5
vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review).
viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4).
The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process.
Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis’ production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction.
1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use.
2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis.
3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age).
3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years.
The Canadian Medical Association is pleased to present this submission to the House of Commons Standing Committee on Health regarding Bill C-422, National Lyme disease strategy.
The Canadian Medical Association (CMA) is the national organization representing over 80,000 physicians in Canada; its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care.
Lyme disease is a growing problem in Canada. According to the Public Health Agency of Canada (PHAC) there were 315 cases of Lyme disease reported in Canada in 2012 -two and one-half times more cases than the 128 reported in 2009, the year that it became a reportable disease. In the Ottawa area, cases have increased almost 8 fold from 6 in 2009 to 47 in 2013. The PHAC surveillance indicates that established populations of blacklegged ticks are spreading their geographic scope, and are increasing in number, in much of southern Canada. In 2013 the US Center for Disease Control and Prevention released new estimates of Lyme disease that was 10 times higher than the previous yearly reported number of 30,000 reported cases.1 This highlights the difficulty in establishing the true burden of illness from Lyme disease.
Why this matters to Canada's physicians
The Canadian Medical Association supports the implementation of a national strategy that can address the breath of public health and medical issues surrounding the spread of Lyme disease in Canada. As with any new infectious disease threat, Canada needs to ensure that we are prepared to address the impact of Lyme disease on Canadians.
CMA's policy on climate change and human health notes that changes in the range of some infectious disease vectors such as blacklegged ticks, are a possible consequence of climate change in Canada. Research has suggested that the tick vector of Lyme disease has been expanding into southeastern Canada which can lead to increased disease risk for those living in areas with tick populations.2
In this policy, CMA recommends that the federal government report diseases that emerge in relation to global climate change, and participate in field investigations, as with outbreaks of infectious diseases like Lyme disease, and develop and expand surveillance systems to include diseases caused by global climate change.
The World Medical Association Declaration of Delhi on Health and Climate Change urges colleges and universities to develop locally appropriate continuing medical and public health education on the clinical signs, diagnosis and treatment of new diseases that are introduced into communities as a result of climate change. Diagnosis of Lyme disease can be difficult, as signs and symptoms can be non-specific and found in other conditions. 3 If Lyme disease is not recognized during the early stages, patients may suffer seriously debilitating disease, which may be more difficult to treat.4 Given the increasing incidence of Lyme disease in Canada, continuing education for health care and public health professionals and a national standard of care would improve identification, treatment and management of Lyme disease. Greater awareness of where blacklegged ticks are endemic in Canada, as well as information on the disease and prevention measures, can help Canadians protect themselves from infection.
The CMA supports a national Lyme disease strategy which includes the federal, provincial and territorial governments and the medical and patient communities. This strategy must address concerns around research, surveillance, diagnosis, treatment and management of the disease and public health prevention measures will advance our current knowledge base, and improve the care and treatment of those suffering from Lyme disease.
Once again, CMA is pleased to provide this brief to the Standing Committee on Health as part of its study on this important issue. Canada's physicians recognize the importance of monitoring all emerging infectious diseases in Canada. In addition, Canada's physicians recognize the importance of developing strategies to treat, manage, and prevent Lyme disease in Canada.
1 CDC provides estimate of Americans diagnosed with Lyme disease each year, media release August 19, 2013 Accessed at http://www.cdc.gov/media/releases/2013/p0819-lyme-disease.html on Feb 21, 2014.
2 Ogden, N., L. Lindsay, and P. Leighton. 2013. Predicting the rate of invasion of the agent of Lyme disease Borrelia burgdorferi. Journal of Applied Ecology. April, 2013. 50(2):510-518.
3 Mayo Clinic, accessed at http://www.mayoclinic.org/diseases-conditions/lyme-disease/basics/tests-diagnosis/con-20019701 on Feb 21, 2014.
4 Wormser GP, Dattwyler RJ, Shapiro ED, et al. The clinical assessment, treatment, and prevention of Lyme disease, human granulocytic anaplasmosis, and babesiosis: clinical practice guidelines by the Infectious Diseases Society of America. Clin Infect Dis 2006;43: 1089-134.
Building a Comprehensive Post-Market Surveillance System : Canadian Medical Association Response to Health Canada’s Discussion Paper “Designing a Mandatory System for Reporting Serious Adverse Reactions”
Building a Comprehensive Post-Market Surveillance System
Canadian Medical Association Response to Health Canada’s Discussion Paper
“Designing a Mandatory System for Reporting Serious Adverse Reactions”
Submitted to Health Canada
July 28, 2005
The CMA believes that all stakeholders should work together to improve adverse drug reaction (ADR) reporting, in the interests of improving patients’ safety and health. However, we believe that activity in pursuit of this end must be based on two fundamental premises:
a) Reporting is only one part of a comprehensive post-market surveillance system. In order to effectively monitor the safety of Canada’s drug supply, this system should include:
* a simple, comprehensive and user-friendly reporting process;
* rigorous analysis of reports to identify significant threats to drug safety;
* a communications system that produces useful information, distributed to health care providers and the public in a timely, easily understood manner.
There is no point in enacting a mandatory reporting requirement until all of these elements are in place. We wonder why mandatory reporting has been singled out for discussion when a holistic approach to reforming Canada’s drug safety system is called for.
b) Health care providers should be encouraged to participate willingly and voluntarily in the reporting process. To be successful, Canada’s post-market surveillance system will depend on the active participation of physicians and other health professionals. Experience with health system quality and safety improvement efforts over the past several years has demonstrated that meaningful acceptance is most effectively obtained when those involved are willing participants.
If you build a comprehensive, efficient and effective post-market surveillance system, physicians will participate actively in it. Forcing them to participate before the system has been built will result in alienation, frustration and failure.
Comments on Discussion Paper
a) Is Mandatory Reporting Necessary?
This is a fundamental question and the discussion paper does not satisfactorily address it. There are two reasons why we question the necessity for imposing an ADR reporting requirement on health professionals.
First, as awareness of the drug-safety system’s importance has increased, the number of ADR reports has increased along with it - more than 10% in 2004, as the discussion paper notes - without a mandatory reporting requirement. Given this trend, it is highly probable that time, education, adequate resources and increasing familiarity with the surveillance system will raise reporting rates to the desired level (however defined) without mandatory reporting.
Second, as the discussion paper points out, there is no evidence that mandatory reporting has been effective in other jurisdictions where it has been implemented. The paper offers no clear explanation for this lack of success. More importantly, it does not indicate how Health Canada plans to ensure that mandatory reporting will succeed in this country when it has proven ineffective elsewhere. A primary principle of any system change is that we should not repeat the mistakes of others. Before launching a program whose success has not been proven, other viable, and possibly more effective, alternatives should be examined.
b) Addressing known barriers to reporting
The CMA acknowledges that ADRs are under-reported, in Canada and worldwide. The discussion paper identifies a number of barriers to reporting, and its list mirrors the observations and experiences of our own members. We believe most of these barriers can, and should, be overcome.
We also agree that it is necessary to raise health professionals’ awareness of the importance of, and process for, ADR reporting. But we question the curious assertion that “Mandatory reporting could raise awareness of the value of reporting simply by virtue of the public debate.” Surely there are more positive ways to raise awareness than publicly speculating about the punitive consequences of non-compliance. We suggest that instead, Health Canada work with physicians and other health professionals to address the existing barriers to reporting. Specifically, we recommend that Health Canada implement:
* a well-funded and targeted awareness-raising campaign focused on provider education and positive messaging,
* a user-friendly reporting system, including appropriate forms, efficient processes and adequate fees.
These measures are within Health Canada’s purview in the existing policy and legislative environment. We believe they would increase reporting without the need for coercive measures. At a minimum, positive system improvements should be tried first before considering a mandatory-reporting requirement.
With regard to specific questions posed in the discussion paper:
Question 1: Health professionals should be explicitly protected from any liability as a result of reporting an adverse drug reaction. This should be the case regardless of whether reporting is voluntary or mandatory.
Question 2: Professionals should be compensated for all meaningful work including the completion of forms and any follow-up required as a result of the information they have provided. We would be happy to expand further on this issue on request.
Question 3: Issues of confidentiality should be covered in legislation. The CMA has developed an extensive and authoritative body of knowledge on privacy issues in health care, which we would be pleased to share with Health Canada.
c) Improved report quality
We agree that increasing the quality and richness of ADR reports is as important as increasing their number. Perhaps it is even more important, since high-quality reports allow for high-quality analysis. Mandatory reporting will not improve the quality of ADR reports; it will simply increase their quantity. It may even compromise the system’s efficiency and effectiveness by increasing the volume of clinically insignificant reports. Experience elsewhere has taught us that true quality cannot be legislated or imposed; any attempt to do so would be pointless.
If ADR reports included the information listed in Table 4, this would improve their usefulness and the effectiveness of the overall surveillance process. However, it is unrealistic to expect all reports to contain this level of information. The treating physician may not be able to provide all of it, especially if he or she is not the patient’s regular primary care provider. Some of this information, particularly about outcomes, may not be available at the time of the reporting, and gathering it would require follow-up by Health Canada.
Health Canada should consider measures other than mandatory reporting to improve the quality of ADR reports. The CMA suggests that consideration be given to:
* Improving follow-up capacity. We agree that it should be made easier for Health Canada officials to contact reporters and request details on follow-up or outcomes. This should be considered as part of a comprehensive initiative to improve Health Canada’s capacity to analyze ADR reports.
* Establishing a sentinel system. Another option for increasing high-quality reports would be to establish a “sentinel” group of practicing physicians who would contract to report all ADRs in detail. These physicians, because of their contractual obligation, would be committed to assiduous reporting. Sentinel systems could be established concurrently with efforts to increase voluntary ADR reporting by the broader health professional community.
In addition to the current information provided, consideration should be given to including on reporting forms the option to allow Health Canada officials to act on information the physician provides; for example, in the reporting of sexually transmitted diseases physicians provide certain information and have the option to request that public health officials undertake follow-up and contact tracing.
d) Minimize administrative burden
We agree that Health Canada should give consideration to making the ADR reporting system user-friendly, non-complex and easy to integrate into the patient-care work stream. These reforms can and should be implemented regardless of whether a mandatory requirement is in place. They do not need mandatory reporting to make them work; in fact, they are more likely to encourage ADR reporting than any form of coercive legislation.
Rather than making a mandatory reporting requirement “fit” with the traditional patient-care framework, we invite Health Canada to work with us to increase health professionals’ capacity to report ADRs voluntarily.
We are already working with Health Canada to improve physicians’ access to drug safety material. Health Canada’s ADR reporting form can now be downloaded from the cma.ca web site, which also posts the latest drug alerts from Health Canada and from the Food and Drug Administration in the U.S. We have developed an on-line course in partnership with Health Canada, to teach physicians when and how to make ADR reports.
We hope to build on this collaboration, with the goal of making it possible for physicians to report ADRs online via cma.ca. This will permit them to fit reporting more conveniently into their daily workflow. (Note: the “MedEffects” Web portal now being developed at Health Canada does not fit well into the workflow and therefore will not make reporting easier for health professionals.)
In the future, we hope that ADR reporting can be built directly into the Electronic Medical Record (EMR). We think this will be a critical element in the bi-directional communicating that ADR reporting requires. It will also enable rapid integration of advisories into the EMR so that they can be available to physicians at the time they are writing a prescription. Before electronic ADR reporting can work, a standard for electronic data should be in place (at present it is not) and Health Canada should develop the capacity to accept data electronically.
Health Canada’s discussion paper makes reference to cost-benefit analysis. We recommend that you take great care not to over-emphasize cost-benefit when it comes to enhancing patient safety. Meaningful improvements in the post-market surveillance system will be costly whatever solution Health Canada eventually embraces, and it is impossible to measure financially the value of safety. What is an acceptable cost for one life saved?
e) Minimize Over-Reporting
The discussion paper acknowledges that not all adverse reactions need be reported. We strongly agree that one of the dangers of mandatory reporting is its potential to overwhelm the system with an unmanageable flood of reports. There is no reason to require reports of minor side effects that are already known to be associated with given drugs.
We agree that the reactions Health Canada most needs to know about are those which are severe and/or unexpected. If Health Canada insists on implementing a mandatory reporting system, it should be limited to these reactions (possibly with the corollary that well known serious ADRs would not need to be reported). However, the operating definitions may need clarification, and we recommend that Health Canada consult with health professionals and others on operational guidelines for defining “serious adverse reaction.”
Health Canada’s desire to encourage reports on drugs approved within the last 5 years is understandable (though some drugs may be on the market for longer than this before their true risks are known). In practice, however, many physicians do not know which drugs these are, and seeking out this information may impose a heavy administrative burden. As we move toward an EMR-based reporting system, a tag on the Drug Identification Number to tell when the drug was approved will allow physicians to identify which medications require special vigilance.
Appropriate reporting could be encouraged, and over-reporting discouraged, by clear guidelines as to what should be reported as well as appropriate compensation for reporting.
f) Match Assessment Capacities
In our opinion, this is one of the most important sections in the document. What happens once the reports have been received is crucial if we want to identify a serious drug risk as quickly as possible. Under the current system, one of the most significant barriers to physicians’ reporting is lack of confidence that anything meaningful will be done with their reports.
Enhancements to the analysis function must be made concurrently with efforts to increase ADR reporting. ADR reports are only cyber-bytes or stacks of paper unless we can learn from them.
This requires rigorous data analysis that can sort “signal from noise” – in other words, sift through thousands of reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. This requires substantial resources, including an adequate number of staff with the expertise and sensitivity required for this demanding task. Unless Health Canada has this capacity, increasing the number of reports will only add to the backlog in analysts’ in-boxes.
The CMA recommends that Health Canada allocate sufficient resources to enable it to effectively analyze and respond to ADR reports and other post-market surveillance information.
g) Respect privacy
Privacy of both patient and physician information is a significant concern. Physicians’ ethical obligation to maintain patient confidentially is central to the patient-physician relationship and must be protected.
We acknowledge that issues of privacy and confidentiality must be resolved when designing an ADR reporting system, particularly as we work toward electronic communication of drug surveillance data and its incorporation into an EMR. For example, regulations should explicitly state that ADR reports are to be used only for the purpose for which they were submitted, i.e. for post-market drug surveillance. In addition, Health Canada should ensure that any privacy provisions it develops meet the legislative test outlined in Section 3.6 of CMA’s Health Information Privacy Code (Attachment I).
Health Canada can be assured that physicians take their privacy obligations seriously. The CMA has been a strong and pro-active player in debate on this issue, and our Privacy Code lays the groundwork on which we believe any privacy policies involving ADR reporting should be based.
h) Compliance through sanctions
Physicians are motivated to report ADRs by their concern for public health and their patients’ well-being. In addition, they are guided by the CMA Code of Ethics and governed by regulatory authorities in every province.
A clear ethical and professional obligation already exists to report anything that poses a serious threat to patient safety. If physicians do not comply with this obligation, sanctions are available to the provincial regulatory authorities. In fact, the most serious threat for physicians is loss of standing with the professional regulatory authority, not the courts or any external judicial system. It would be superfluous to add a second level of regulation or scrutiny when remedies already exist.
The discussion paper presents few alternatives to the existing self-regulatory system.
As the paper itself acknowledges, it is unrealistic to impose sanctions based on failure to report an ADR, since it is not always easy to determine whether an adverse effect is attributable to a health product. But the only suggested alternatives - requiring physicians to demonstrate knowledge, or to have the required reporting forms in their office - seem intrusive, crude and unreasonable; they are also meaningless since they have no direct relation to a physician’s failure to report. If Health Canada is considering a large outlay of taxpayers’ dollars for post-market surveillance, we suggest they target those funds to education and awareness raising, and to enhancing the system’s ability to generate and communicate meaningful signal data, rather than to enforcing a mandatory reporting system based on weak compliance measures, with no evidence of its effectiveness in other jurisdictions.
Physicians who are in serious breach of their ethical and legal responsibility to report are subject to sanctions by provincial regulatory authorities. Most provincial colleges have policies or guidelines regarding timely reporting and appropriate enforcement mechanisms. Medicine’s tradition of self-regulation has served it well, and we recommend that Health Canada respect and support existing regulatory authorities as they maintain the standards for appropriate professional behaviour.
As we have said before - the preferred quality improvement tools to enhance performance and encourage compliance are education and positive reinforcement, not legislation and the threat of sanctions.
In its discussion paper Health Canada has invited stakeholders to provide their input on how best to develop a mandatory system for reporting ADRs. The Canadian Medical Association believes that the best way to do this is not to develop one at all. Instead, we believe stakeholders should concentrate on building a sustainable, robust and effective post-market surveillance system which:
* encourages and facilitates voluntary reporting, by designing a simple and efficient process that can be incorporated into a physician’s daily workflow;
* effectively uses reporting data to identify major public health risks;
* communicates drug safety information to providers and the public in a timely, meaningful and practical way.
The CMA is committed to working, in partnership with Health Canada and other stakeholders, toward the ultimate goal of a responsive, efficient and effective post-market drug surveillance system. This is part of our long-standing commitment to optimizing Canadians’ safety and health, and achieving our vision of a healthy population and a vibrant medical profession.
Canada’s Lower-Risk Cannabis Use Guidelines (LRCUG)
Cannabis use has health risks best avoided by abstaining
Delay taking up cannabis use until later in life
Identify and choose lower-risk cannabis products
Don’t use synthetic cannabinoids
Avoid smoking burnt cannabis—choose safer ways of using
If you smoke cannabis, avoid harmful smoking practices
Limit and reduce how often you use cannabis
Don’t use and drive, or operate other machinery
Avoid cannabis use altogether if you are at risk for mental health problems or are pregnant
Avoid combining these risks
Fischer, B., Russell, C., Sabioni, P., van den Brink, W., Le Foll, B., Hall,
W., Rehm, J. & Room, R. (2017). Lower-Risk Cannabis Use Guidelines (LRCUG): An evidence-based update. American Journal of Public Health, 107(8). DOI: 10.2105/AJPH.2017.303818.
The LRCUG have been endorsed by the following organizations:
Council of Chief Medical Officers of Health
The Lower-Risk Cannabis Use Guidelines (LRCUG) are an evidence-based intervention project by the Canadian Research Initiative in Substance Misuse (CRISM), funded by the Canadian Institutes of Health Research (CIHR).
A longer evidence summary of the guidelines, aimed at health professionals, is available at camh.ca.
Cannabis use is a personal choice,
but it comes with risks to your
health and well-being. Follow
these recommendations to reduce your risks.
Cannabis use is a personal choice,
but it comes with risks to your
health and well-being. Follow
these recommendations to reduce your risks.
Health risks of cannabis use
There is strong scientific evidence that cannabis use is associated with a variety of health risks. The risks depend on your constitution, which kinds of cannabis products you use and how or how often you use them. Some of the main health risks are:
problems with thinking, memory or physical co-ordination
impaired perceptions or hallucinations
fatal and non-fatal injuries, including those from motor-vehicle accidents, due to impairment