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Antimicrobial Resistance (AMR)

https://policybase.cma.ca/en/permalink/policy14079

Date
2019-03-02
Topics
Health care and patient safety
Population health/ health equity/ public health
  2 documents  
Policy Type
Policy document
Date
2019-03-02
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
Antimicrobials (which include antibiotics) are a precious public resource and an essential tool for fighting infections in both humans and animals. Their importance to human medical, nutritional and economic security cannot be understated. Yet globally, antimicrobials are losing their effectiveness more quickly than new such drugs, treatments and therapies are being identified and introduced to market.1 Over time, this dynamic has eroded the human antimicrobial arsenal, placing the lives and futures of an unacceptable number of people at risk. Antimicrobial resistance (AMR) occurs when microorganisms such as bacteria, viruses, fungi and parasites come into contact with antimicrobial drugs, such as antibiotics, antivirals, antifungals, antimalarials and anthelmintics, and undergo changes. The drugs are rendered ineffective and cannot eradicate infections from the body. AMR is an international challenge that threatens to reverse over a century of progress in public health, health care and human development attributable to antimicrobial use. Indeed, the effects of AMR are already being felt across Canada’s health care system. Currently, Canada’s dedicated investment in solutions to militate against encroaching AMR in the AMR and antimicrobial stewardship (AMS) fields (both federally and provincially/territorially) can only be viewed as wholly inadequate to address the scope of the problem and the risks it poses for the health of Canadians. Therefore, to: (1) promote awareness of AMR; (2) incentivize investment in AMR mitigation strategies; and (3) support the mobilization of an effective suite of more clinically effective management/treatment practices and policies, the following target audience recommendations are offered.a a All the policy recommendations made in this document are not meant to be interpreted as clinical practice guidelines. Any individual who suspects they may have an infection should promptly consult a physician. 2 Key AMR principle — the “One Health” approach a) The complexity of AMR underscores the need for coordinated action known as the “One Health” approach. The term implies integrated strategies that span the human, animal/agricultural and environmental sectors. Thus, cooperation across a wide variety of stakeholders is necessary to address the collective nature of AMR. These stakeholders include governments, health professionals, private and public partners, and the public at large. b) The One Health approach will require attention and investment in the following domains: (1) surveillance of antimicrobial prescribing and usage; (2) infection prevention and control practices that mitigate the spread of resistant pathogens; (3) stewardship programs and practices that educate health professionals, the public, and the private sector and nudge each into more appropriate patterns of supply and demand; and (4) a program of innovation, research and development focused on diagnostics, vaccines and alternative treatments to reduce reliance on antimicrobials. This includes the development of novel antimicrobials that expand the currently available arsenal. c) Given the global dimensions of AMR, a successful One Health approach will require ambitious investments in global AMR mitigation. Given that health infrastructure and resources are limited in low- to middle-income countries, the impacts of AMR will primarily be felt in those settings. Recommendations 1. Physicians and allied health professionals Should: a) Be aware that AMR is a serious public health crisis. b) Know that various Canadian prescribing aides/guidelines are available to assist physicians in choosing appropriate antibiotics and improving practice (e.g., Choosing Wisely Canada). c) Know that using antibiotics appropriately can help combat AMR and that diagnosis and laboratory testing play a key role. This includes only prescribing antibiotics for conditions that are clinically infectious and of a non-viral nature. Viral infections are the greatest source of antibiotic misuse. d) Consider delayed prescriptions and/or prioritize follow-up for patients when diagnosis is initially undifferentiated or when symptoms worsen, progress or are prolonged. e) Know that prevention of infections through hand hygiene, vaccination and appropriate use of antibiotic prophylaxis is evidence based and effective f) Know that durations of therapy and dosage rates for treating many infections change with time and that you should prescribe antimicrobials for the shortest effective duration (using the narrowest spectrum possible). 3 g) Consider the potential side effects of antibiotics (including C. difficile and allergic reactions) in prescribing and when counselling patients as to their potential side effects. h) Engage in conversations with patients about antimicrobials regarding: i. their appropriate use; ii. their potential risks; iii. when to delay, begin or end an antimicrobial prescription (e.g., delayed prescriptions); and iv. when to seek medical reassessment if symptoms worsen or persist. i) Ask your local hospital or specialty organization about educational initiatives related to antibiotic prescribing. j) Collaborate where possible with colleagues in other prescribing professions to reduce unnecessary antimicrobial use. 2. Patients and the Canadian public Should: a) Be aware that AMR is a significant problem that is linked to the inappropriate use of antimicrobials like antibiotics. Therefore, commit to only taking antibiotics if they are prescribed and only as directed by an authorized health professional. i. Never share, or use, the antibiotics of others as it may contribute to AMR and have serious consequences for your health. b) Consider that your expectations about antimicrobials may unduly pressure physicians, and other prescribers, to provide you a prescription when an antimicrobial would not be appropriate or helpful. c) Engage in a conversation with prescribers about: i. whether an antimicrobial is necessary; ii. the risks associated with taking an antimicrobial; iii. whether there are simpler and safer options to pursue; and iv. when you should take further actions if your symptoms worsen or do not improve. d) Rather than keeping antimicrobials in your medicine cabinet, throwing them in the garbage/toilet or sharing them with family or friends, practise a One Health mindset. Dispose of all unused and expired antimicrobials at your local pharmacy. This will limit the spread of resistance and prevent antimicrobials from finding their way into the environment. e) Help limit resistance by staying up to date with all recommended vaccinations, and practise good hand hygiene. f) If you or a family member have had personal experiences with AMR, consider sharing them with local politicians (provincial/territorial and federal). 3. Governments (federal, provincial/territorial) Should: 4 a) (Including internationally) immediately make substantial, long term, coordinated and directly dedicated financial investments in AMR and AMS. Specific areas to prioritize include: i. AMR and AMS awareness campaigns targeted to the public; ii. campaigns that support health professionals to incorporate AMS principles into their everyday practice; iii. detailed, and integrated, action plans based on clear metrics of success and that address the needs of communities, primary care practitioners, patients and health care organizations (including long-term care facilities); iv. practical surveillance of antimicrobial resistance, purchasing, prescribing and use that maximizes the opportunity to respond to changing landscapes; v. studying in detail the links, and associated risks, between animal health and agricultural practices and human health; vi. scaling up local AMS initiatives at the provincial/territorial and national health care delivery levels; vii. pharmaceutical development pipelines and non-pharmacological treatment options for AMR infections; viii. inexpensive, accurate and timely point-of-care diagnostic tests (usable in the community, at the bedside or in a clinic) to optimize prescribing; and ix. fostering clinical research, development and innovation in the fields of AMR and AMS. b) Scale up coordination between federal and provincial/territorial AMR and AMS activities. c) Hold regular, high-level meetings of ministers of health, agriculture and finance (both federally and provincially/territorially) to discuss the implications of unchecked AMR and how best to mobilize public finances to address it. d) Strongly consider an arms-length, national-level taskforce to address AMR and AMS. e) Strengthen the roles of the chief public health officer and the provincial/territorial chief medical officers in addressing AMR and AMS. f) Undertake a timely review of the Canadian Antimicrobial Resistance Surveillance System (CARRS) with an emphasis on: i. scaling up the system; ii. standardizing all AMR reporting metrics across the country; and iii. injecting adequate resources into AMR surveillance and tracking antimicrobial usage rates. g) Establish a permanent review body on infectious disease, including pharmacists, microbiologist and other experts, to evaluate the forthcoming Pan-Canadian Action Plan on AMR and release regular progress reports. 5 4. Health care institutions and organizations Should: a) Implement strategic AMR plans that are coordinated, cross-departmental and adopted institution wide. These should be premised on: i. standardized and comprehensive reporting metrics for AMR and antimicrobial usage; ii. tailored infection prevention and control programs to screen for and effectively prevent new AMR infections; iii. improving public and professional awareness of AMR organization wide; iv. improving conservation measures such as prescribing practices (audit and feedback, incentives programs, etc.); and v. supporting and incentivizing appropriate prescribing of antimicrobials. b) Evaluate whether existing policies and procedures, diagnostics and testing capacities, and multidisciplinary and organizational cultures are strategically geared toward combatting AMR. c) Where possible, develop collaborations with other local health institutions, clinical researchers and community, public and private partners to promote AMS. 5. Accreditation and regulatory bodies Should: a) Regularly review and establish meaningful criteria for accreditation, ethical codes and regulatory practice standards surrounding AMR and AMS so that practitioners and health institutions can be informed, supported and kept up to date on emerging AMR trends, practices and issues. b) Adopt profession-specific mandatory requirements for AMR and AMS (proper credentialing and training, regular updating of knowledge and competence for prescribing antimicrobials, appropriate data collection regarding antimicrobial usage, etc.) as part of credentialing. c) Work to promote, support and enhance existing AMS practices and programs. d) Collaborate with health institutions, professional health associations and other accreditation and regulatory bodies to implement AMS goals/plans. 6. Colleges and faculties for medicine and allied health professions Should: a) Promote and support more educational resources for AMS and AMR, throughout the continuum of education (undergraduate, postgraduate and continuing education). i. Topics for these resources should include (1) awareness of AMR and AMS, (2) appropriate diagnostic testing, (3) strategies to minimize antimicrobial use and (4) personal prescribing practices. b) Promote and support research on AMR and the implementation and dissemination of effective AMS strategies. 6 1 Public Health Agency of Canada. Tackling antimicrobial resistance and antimicrobial use: a pan-Canadian framework for action. Ottawa: Public Health Agency of Canada; 2017. Available: https://www.canada.ca/content/dam/hc-sc/documents/services/publications/drugs-health-products/tackling-antimicrobial-resistance-use-pan-canadian-framework-action/tackling-antimicrobial-resistance-use-pan-canadian-framework-action.pdf (accessed 2018 Aug 10). BACKGROUND TO CMA POLICY Antimicrobial Resistance See also CMA Policy Antimicrobial Resistance PD19-08 OVERVIEW The world is at the tipping point of a post-antibiotic era. “Worldwide, we are relying more heavily on antibiotics to ensure our medical, nutritional, and economic security; while simultaneously causing the decline of their usefulness with overuse and ill-advised use.” It is estimated that the world’s use of antimicrobials increased by 65% between 2000 and 2015 — mainly in low- to middle-income countries. Dr. Margaret Chan, the former head of the World Health Organization (WHO), described antimicrobial resistance (AMR) as a slow-moving tsunami for public health. Other experts have characterized AMR as a looming “antibiotic apocalypse,” warning that all countries “will face disastrous consequences if the spread of AMR is not contained.” Others are now calling AMR the “climate change” of health care. According to the UK’s review on AMR, an estimated 10 million people globally will die annually by 2050, and AMR will surpass cancer to become the leading cause of death. AMR occurs when “microorganisms (such as bacteria, fungi, viruses, and parasites) change when they are exposed to antimicrobial drugs (such as antibiotics, antifungals, antivirals, antimalarials, and anthelmintics). … As a result, the medicines become ineffective and infections persist in the body, increasing the risk of spread to others.” Microorganisms that develop antimicrobial resistance are sometimes referred to as “superbugs.” “Nightmare bacteria,” as they have been dubbed, are bacterial strains that no conventional antimicrobial can effectively treat; their incidence is on the rise. AMR represents a unique challenge for the medical profession as it is estimated that as many as 50% of current antibiotic prescriptions are either inappropriate or unnecessary. In addition, taking an antimicrobial involves potentially considerable exposure to side effects or risk. At stake are many currently routine, and lifesaving, forms of medical treatment. Critically, these include many medications for currently treatable bacterial infections, and many forms of surgery (including cesarean delivery), radiation therapy, chemotherapy and neonatal care.4 THE UNDERLYING DYNAMICS OF AMR AMR is driven by a complex set of interlocking factors. These include: (1) increased global travel and medical tourism; (2) inappropriate, and unnecessarily high, use of antimicrobials in the agrifood sector; (3) poor medical prescribing practices; (4) inadequate implementation of infection prevention and control measures; (5) lack of knowledge, inappropriate expectations and misuse of antimicrobials on the part of the general public; (6) availability of poor-quality antimicrobials; (7) lack of access to rapid, affordable and accurate rapid diagnostic tools and infrastructure; (8) inadequate and underused surveillance data from AMR surveillance systems; (9) international travel rates; and (10) low commercial interest in, or support for, new antimicrobial research and development. To make progress on AMR, we need to carefully think about how to address its various drivers. Antimicrobial stewardship (AMS) is a term describing coordinated efforts, at any program level, to: (1) promote the appropriate use of antimicrobials; (2) improve patient outcomes; (3) reduce microbial resistance and preserve the effectiveness of antimicrobials; and (4) decrease the spread of infections caused by multidrug-resistant organisms. AMS efforts are based on the “One Health” approach. These include: (1) surveillance; (2) conservation of existing AM effectiveness; (3) innovation through research and development; and (4) infection prevention and control. Fundamentally, AMR can be thought of as a collective action problem, similar in character to the problem of climate change.3, While all stakeholders have a role to play in combatting AMR, each has very different resources, abilities and perspectives on AMR. Canada and much of the developed world have the luxury of health infrastructures, finances and regulatory frameworks that can make AMR mitigation possible. But in low- to middle-income countries — places where antibiotics might be the only real health care available — the very discussion of AMS can be perceived as threatening. Simply put, this illustrates the fact that solutions to AMR need to mobilize and leverage a collective strategy that is as broad and as connected as possible. To be successful, these solutions will need to do so in a manner that acknowledges the local reality of health care delivery. Global investment in antimicrobial research and development is underwhelming, a dynamic described as a “drying up” of the pharmaceutical pipeline.8 This is evidenced by the recent large-scale withdrawal of major pharmaceutical companies from antimicrobial research and development, reflecting the lack of profitability in this area. On the pharmaceutical side, there are clear barriers to companies investing in the development of novel antimicrobials. Underlying factors include: (1) 10-year timelines, and an estimated minimum $1 billion price tag for development; (2) high development failure rates for new antimicrobials; (3) the inevitable emergence of resistance to any newly developed antimicrobial; (4) antimicrobials being offered at relatively cheap dosage rates over shorter durations of use; and (5) the need to preserve the efficacy of any antimicrobial’s future use, which limits their economic viability.8 WHAT ARE THE CANADIAN CONTEXTS? AMR is already a major costly public health challenge in both the US and Canada. AMR infections are clearly linked to poorer health outcomes, longer hospital stays and higher mortality rates.3 The Public Health Agency of Canada (PHAC) estimates that roughly 18,000 hospitalized Canadians contract drug-resistant infections per year. The Canadian Patient Safety Institute estimates that 8,000 Canadian patients die annually with an AMR-related infection. It is estimated that close to 23 million antibiotic prescriptions are written annually for patients in Canada, the approximate equivalent to 1.6% of the population being on an antimicrobial on any given day. An action plan in Canada is being developed by PHAC. On the surface, the action plan appears comprehensive in that it outlines a One Health approach.10 However, despite commitments to take comprehensive, measurable action on AMS, Canadian leadership on AMR has historically lagged because of a lack of concrete coordination between PHAC and the provinces and because it has been challenging to implement local initiatives systemically. Previous shortcomings were highlighted in the Auditor General of Canada’s 2015 report and again in a 2017 issue brief by HealthCareCAN.18 Although efforts continue and the action plan is set for release at some point in 2019, concerns remain that: (1) the scope of coordinated efforts with the provinces and territories requires an interest in cooperation that may not exist between the two levels of government; (2) relative to the scope of the problem, sufficient and dedicated resources won’t be allocated; and (3) efforts on the industrial and agricultural fronts may not be sufficiently coordinated with AMR efforts for human health. In the spring of 2018 the House of Commons Standing Committee on Health (HESA) released a report outlining 10 recommendations for action on AMR in Canada. Although the federal government “accepted” most of the committee’s recommendations, no meaningful (and dedicated) AMR funding has been announced in advance of the action plan’s launch. Indeed, the federal government’s response to the HESA report sought to downplay the need for either urgent action or additional resources. This was done by pointing to nominal federal AMR efforts over the span of more than a decade. It should be noted that a small number of excellent localized AMS initiatives exist and have begun yielding promising local AMS results in Canada. AMR and AMS champions such as Choosing Wisely Canada, Do Bugs Need Drugs, and the Association of Medical Microbiology and Infectious Disease Canada have long argued that with proper resourcing, localized initiatives can be scaled up to a systemic level of application within provincial health care systems. GLOBALLY, WHERE DOES AMR STAND? Urgent action is required at an international level to combat AMR. Although AMR remains a complex public health challenge, the benefits of AMS are clear. The preservation of these precious resources will save lives and can positively affect both quality of care and health care delivery costs.7,14 Globally, many higher income nations and, increasingly, middle-income countries have now developed AMR/AMS action plans. Like the situation in Canada, these emerging and existing global action strategies remain largely unimplemented. Initial cash infusions into the AM drug development pipeline are beginning to emerge.8 Despite this, experts warn that such investments are too short term and wholly inadequate to address the scope of the looming AMR crisis.8, This reflects the many complexities that exist in the implementation of AMR action plans, owing in large part to: (1) a general lack of resources or prioritization; (2) complacency about AMR as a pressing public health concern; (3) difficulties in generalizing local AMS efforts; (4) coordination between sectorial actors; and (5) a lack of tangible AMR metrics and evidence. If AMS gains are to be made in low- and middle-income countries, the impact of limited resources in those settings will need to be considered.13 Realistically these countries will require various forms of monetary incentives and assistance to be able to effectively adopt AMR programs. If such support is not provided, human health rights will be affected and global AMS efforts will be undermined. Finally, there are now well-established calls for an international model, even a treaty, to be implemented on AMR/AMS.12,

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Appropriateness in health care

https://policybase.cma.ca/en/permalink/policy11516

Last Reviewed
2020-02-29
Date
2014-12-06
Topics
Health care and patient safety
  1 document  
Policy Type
Policy document
Last Reviewed
2020-02-29
Date
2014-12-06
Topics
Health care and patient safety
Text
CMA POLICY Appropriateness in Health Care Summary 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. Introduction 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. Definition 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. Barriers 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. Important Caveats 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. Policy Recommendations 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. Conclusion 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 References 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.

Documents

Less detail

Concussion in Sport, Leisure, and Occupational Settings

https://policybase.cma.ca/en/permalink/policy14023

Date
2019-03-02
Topics
Health care and patient safety
Population health/ health equity/ public health
  2 documents  
Policy Type
Policy document
Date
2019-03-02
Replaces
Head injury and sport (2011)
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
Concussions and head injuries are a common occurrence in sport and leisure activities, and frequently occur in occupational settings as well. While the majority of individuals who suffer from a concussion will recover with time, others may be at risk for serious and lasting complications. These include (1) children; (2) previous history of head injury or concussion; (3) prior mental health symptoms; and (4) missed diagnosis and management. This aim of this advocacy and policy document is to improve safety during activity by raising awareness of concussions, and by working to improve the detection and safe management of concussions when they occur. It is not a clinical practice guideline. It should not be perceived as a plea to avoid sports or leisure activities, but rather as a call for safer sporting, leisure, and occupational practices. The documented health benefits that result from establishing an active lifestyle in youth and maintaining it throughout life cannot be overstated. Achieving balance of safe play in sport, leisure and occupational activities while promoting greater physical activity levels for Canadians would have the effect of reducing health care costs in Canada, while promoting a healthier concussion recovery culture for all Canadians. Therefore, to promote better concussion and head trauma awareness and prevention, as well as better management/treatment practices, the following policy recommendations for key target audiences across all levels of sport, leisure, and occupational activity are made. Key Concussion & Head Injury Principles: a) The detection of concussions and head injury should be a shared responsibility and any stakeholder/observer to such an injury should verbally raise their concerns that a concussion may have occurred. i. It is important to understand that individuals with a possible concussion, or head injury, may not be able to recognize that they are suffering from a concussion; ii. It is important to recognize that engrained within popular culture are dangerous notions (e.g., to minimize, ignore, downplay, or play through the pain, etc.) that cause individuals/observers to ignore the real, often hidden, dangers of such injuries. b) Broadly speaking, access to the latest edition of the internationally recognized Concussion Recognition Tool (CRT) should be promoted/available to help identify the signs and symptoms of a possible concussion; c) Any individual who sustains more than a minor head injury should be immediately removed from play, activity, or occupation, and not permitted to return on the same day3 (regardless of whether a concussion is later suspected). i. These individuals should be the subject of observation for developing/evolving concussion symptoms or emergency warning signs (especially within the first 4 hours post-injury, but also up to 48 hours when red-flag symptoms are present). d) Following first aid principles, where an individual displays signs of a serious head or spinal injury, that individual should lie still (not moving their head or neck) until a qualified individual has performed an evaluation; to determine whether emergency evacuation for medical assessment is necessary. e) Any individual with a suspected concussion (especially where red-flag symptoms are present), or more severe traumatic brain injury, should be promptly evaluated by a physician to: i. Either rule-out or confirm a diagnosis via an appropriate medical assessment; and ii. Institute the provision of an age-appropriate follow-up care plan (including progressive return to school, work, and play protocols) if such an injury is confirmed.1 f) Ideally, a physician knowledgeable in concussion management determines when, and how, a concussed individual should progressively return to both cognitive (school or work) and physical activities. g) Following a suspected, or diagnosed concussion, an individual should not return to play, or resume any activity associated with a heightened risk of head trauma, until cleared by a physician to do so.1 Recommendations For: 1. Physicians: Should: a) Where possible, encourage safe play practices in sports, and where appropriate, educate patients about the risks of head injuries (associated with high-risk behavior in sports, leisure and occupational activities). b) Gain/maintain, through relevant continuous medical education, competencies related to the assessment, diagnosis and management of concussion according to most current clinical practice recommendations (e.g., latest edition of the CRT, SCAT, Child SCAT, Acute Concussion Evaluation Tool, etc.). c) Be aware that clinical practice guidelines and assessment tools exist to assist in assessing and treating concussed individuals (e.g., Ontario Neurotrauma Foundation, Parachute Canada, etc.). d) When assessing a patient with a potential concussion: i. Rule out the presence of more severe traumatic brain and musculoskeletal injury; ii. Assess for any previous concussion history, risk factors and newly arising complications; iii. Educate and instruct parents, athletes and any individual that sustains a concussion about what to do, and what to expect, in the post concussive phase. (This should be based on the most current age-appropriate concussion management guidelines);4 iv. Provide individualized recommendations on how to optimally apply the progressive return-to-school, work, and play strategies with consideration for the specificities of the patient’s usual activities and responsibilities;4 v. Work to provide concussed patients timely access for medical reassessment in the event of worsening or persistent symptoms (including mental health); and vi. In the presence of persistent or worsening symptoms (including mental health), consider what external, evidence based, concussion resources may be necessary as well as referral. 2. Medical Colleges & Faculties: Should: a) Promote/support medical education regarding; awareness, detection/diagnosis; and the appropriate management of concussions, throughout the continuum of medical education (undergraduate, post-graduate, and continuing medical education). b) Support research in concussion prevention, detection, and treatment or management. 3. Athletes in Contact/Collision Sports: Should: a) (Prior to the commencement of the sporting season) be given age-appropriate instruction2 to understand: i. How to identify the signs and symptoms of a possible concussion using the latest edition of the internationally recognized CRT (e.g. Concussion Recognition Tool, or Concussion Awareness Training Tool (CATT)); ii. The risks associated with concussion (including long term and mental health); especially, the risks of potentially life-threatening complications associated with continued sport participation, while presenting with signs or symptoms of a possible concussion; iii. What to do/expect if a concussion is ever suspected (including for teammates), and the expected role of the athlete and team members; iv. Removal and progressive returns to school, work and play policies/procedures, and the expected role of the athlete in the recovery process; and v. How to foster a healthy sporting culture (that promotes: safe play practices; fosters concussion/injury prevention and reporting; peer-to-peer support; and combat injury stigmatization). b) Have such instruction reinforced periodically throughout the sporting season as needed. c) Be aware of, and seek treatment for, potentially serious mental health issues that may arise post-concussive injury. 4. Parents with Minors in Contact/Collision Sports: Should: a) Prior to the commencement of a sporting season, request and be open to receiving instruction2 on: i. How to identify the signs and symptoms of a possible concussion using the latest edition of the internationally recognized CRT (e.g. Concussion Recognition Tool, or Concussion Awareness Training Tool (CATT)); ii. The risks associated with concussion; especially, the risks of potentially life-threatening complications associated with continued sport participation, while presenting with signs or symptoms of a possible concussion; iii. What to do/expect if a concussion is ever suspected for an athlete; iv. Removal and progressive returns to school, work and play policies/procedures, and the expected role of the parent(s) in the recovery process; and v. How to foster a healthy sporting culture that promotes: safe play practices; fosters concussion/injury prevention and reporting; peer-to-peer support; and combats injury stigmatization. b) Have such instruction reinforced periodically throughout the sporting season as needed. c) Be prepared to address potentially serious mental health issues that may arise post-concussive injury. 5. Individuals Who Sustain a Head Injury Outside of Organized Sports: Should: a) Be aware of possible signs and symptoms of a possible concussion, and immediately withdraw from activity and seek medical assessment a possible concussion is suspected.1 i. Refer to the latest addition of the internationally recognized CRT (Concussion Recognition Tool) for further guidance on signs and symptoms.3 b) Understand the risks associated with concussion; including the risks of potentially life-threatening complications associated with repeated head injury if signs or symptoms of a possible concussion are present. c) In the event of a diagnosis of concussion, judiciously implement the medical recommendations received regarding their gradual return to cognitive and physical activity (including the need for medical reassessment in the presence of persistent symptoms). d) Openly communicate their recovery needs and work with any group or individual who might support them in their recovery process (e.g., employers, family members, school, etc.). e) Be aware of, and seek treatment for, potentially serious mental health issues that may arise post-concussive injury. 6. Coaches, Trainers, Referees, & First Responders: Should: a) Receive certified emergency first aid training. b) Receive periodic education (ideally annually) on national standards regarding the signs and symptoms, potential long-term consequences, appropriate steps for initial intervention, and immediate management (including: athlete removal-from-play; observation; determining when medical assessment is necessary; and progressive return to school, work and play procedures). c) Be trained in the use of the latest edition of the internationally recognized CRT (Concussion Recognition Tool) – to detect whether an injured individual is suffering from a concussion.2 d) Be knowledgeable and responsible to ensure safety and safe play practices are applied throughout the sporting season. e) Be responsible for fostering a healthy sporting culture (promote safe play practices, foster concussion/injury prevention and reporting, peer-to-peer support and combat injury stigmatization). f) Be prepared to address potentially serious mental health issues that may arise post-concussive injury. 7. Licensed Health Care Providers Involved as Therapists in Sport Environments: Should: a) Be fully licensed in their professional field and pursue continuing professional development to maintain competencies related to concussion and head injuries. b) Promote the implementation of properly adapted concussion management protocols (that comply with the most current clinical recommendations, based on consideration for the specificities of each sport environment and available resources). c) Work with qualified physicians to initiate/implement tailored medically supervised concussion management protocols that define: i. Mutual and shared health professional responsibilities to optimize the quality, and safety of patient care (within one’s scope of practice); and ii. The optimal corridors for timely access to medical (re)assessment with due consideration for available resources. d) Be prepared to address potentially serious mental health issues that may arise post-concussive injury. 8. Educational Institutions & Sports Organizations: Should: a) (Especially in the cases involving minors) implement, and keep updated, prevention strategies to include: i. Safety standards that include safe play policies; and ii. Mandatory safety gear/equipment (tailored to individual sport settings). b) Mandatory concussion and head injury protocols that work to: i. Reduce the occurrence of concussions and head injury by promoting: safe play practices; fostering concussion/injury prevention and reporting; peer-to-peer support, and combatting injury stigmatization; ii. Ensure the prompt detection, and standardized early management of concussion and head injuries, by informing all potential stakeholders (in the preseason phase) about the nature/risks of concussion and head injury, and how any such occurrence will be dealt with should they occur; iii. Enshrine into practice removal-from-play, and post-injury observation of athletes; iv. Progressively reintegrate students back into symptom guided educational and physical activities based on the most current recommendations;2 v. Reintegrate injured athletes back into unrestricted training activities and sport once medical clearance has been obtained; and vi. Foster better lines of communication for injury management/recovery between: parents, athletes, coaches, school personnel, therapists and physicians. vii. Address potentially serious mental health issues that may arise post-concussive injury. 9. Employers (Occupational Considerations) Should: a) Comply with workplace safety laws and implement safety standards to reduce the incidence of head injuries in the work environment. b) Integrate considerations for concussion and head injury in health and safety protocols that work to: i. Reduce the occurrence of concussions and head injury by promoting: safe practices; concussion/injury prevention and reporting; peer-to-peer support, and combats injury stigmatization; ii. Ensure prompt detection and standardized early management of concussion and head injuries by informing potential stakeholders about the nature/risks of concussion and head injury, and how occurrences will be dealt with should they occur; iii. Enshrine into practice/ workplace culture the removal-from-work, and post-injury observation of workers; iv. Progressively reintegrate workers back into symptom guided cognitive and physical activities based on the most current recommendations; v. Reintegrate injured workers with a confirmed diagnosis of concussion, progressively back into work activities only once medical clearance has been obtained; and vi. Foster better lines of communication, and support for, injury management between: employees, employers, medical professionals and insurances. vii. Address the potentially serious mental health issues that may arise post-concussive injury. 10. Governments & Professional Regulatory Bodies: Should: a) Implement comprehensive public health strategies for the Canadian population to: i. Increase awareness that concussions can be sustained in accidents, sports, leisure and occupational contexts; ii. Inform head injuries should be taken seriously; and iii. Explain how and why concussions should be prevented and promptly assessed by a physician where they are suspected to have occurred. b) Define appropriate scopes of practice for all health professionals involved in the field of concussion detection, management, and treatment. c) Work with key stakeholders to develop compensation structures to support physicians to allocate the time necessary to: (1) conduct appropriate assessments to rule out concussions, (2) provide ongoing concussion management, and (3) develop detailed medical clearance plans. d) Work with key stakeholders to develop standardized educational tools for physicians to provide to patients with concussions. i. Ideally this would include contextualized tools for sports teams, schools, and employers. e) Adopt legislation or regulation for educational institutions and community-based sport associations to establish clear expectations/obligations regarding concussion awareness and management for youth in sports (e.g., Ontario’s Rowan’s law). i. To have meaningful impact, such initiatives must also be accompanied by: implementation funding to support the development and implementation of sport specific concussion management protocols; and monitoring/compliance programs. f) Establish a national concussion and sports injury surveillance system (with standardized metrics) to collect detailed head and sport injury related information. Thus, providing the ability to research such injuries in an ongoing and timely manner. g) Provide research opportunities/funding on concussions. Specific examples of research areas to prioritize include: i. Effective prevention strategies for both adults and children in a range of sport, leisure, or occupational environments; ii. The incidence and impact of concussions in children, and how to reduce their occurrence (inside and outside of sport); iii. Address knowledge gaps for concussion identification, management, and medical clearance for physicians not specialized in concussion care; iv. Explore all health professionals’ participation in concussion management providing for respective: competency, expertise, interdisciplinary collaboration, and appropriate roles; v. Evaluate how emerging point of care diagnostics and biomarker testing will be incorporated into sport, leisure and work environments; vi. Continued development of effective, user-friendly, and age appropriate management strategies/tools for physicians regarding concussion identification, management, and medical clearances; and vii. Develop a harmonized understanding of “concussion” and “mild traumatic brain injury” (MTBI) constructs/concepts, so that adults with concussion signs or symptoms, who do not meet the more restrictive MTBI criteria, are properly managed. McCrory P, Meeuwisse W, Dvorak J, et al. Consensus Statement on Concussion in Sport - the 5th International Conference on Concussion in Sport Held in Berlin. Br J Sports Med 2017, 51: 838-847. Parachute Canada. Canadian Guideline on Concussion in Sport. 2017. Available: http://www.parachutecanada.org/injury-topics/item/canadian-guideline-on-concussion-in-sport (accessed 2018 Jul 31). Concussion in Sport Group. Concussion Recognition Tool 5. Br J Sports Med 2017 51: 872. Available: https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097508CRT5.full.pdf (accessed 2018 July 31st). (accessed 2018 Jul 31). Ontario Neurotrauma Foundation. Guidelines for Concussion/Mild Traumatic Brain Injury & Persistent Symptoms. Health Care Professional Version. 3rd Ed, Adults (18 + years of age). Toronto: Ontario Neurotrauma Foundation; 2018. Available: http://braininjuryguidelines.org/concussion/fileadmin/media/adult-concussion-guidelines-3rd-edition.pdf (accessed 2018 Jul 31). Concussion in Sport Group. Sport Concussion Assessment Tool – 5th Ed. Br J Sports Med 2017, 0:1-8. Available: https://bjsm.bmj.com/content/bjsports/early/2017/04/26/bjsports-2017-097508CRT5.full.pdf (accessed 2018 July 31). Approved by the CMA Board of Directors March 2019

Documents

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Fetal Alcohol Spectrum Disorder (Update 2009)

https://policybase.cma.ca/en/permalink/policy9489

Last Reviewed
2017-03-04
Date
2009-05-31
Topics
Health care and patient safety
  1 document  
Policy Type
Policy document
Last Reviewed
2017-03-04
Date
2009-05-31
Replaces
Fetal alcohol syndrome (Update 2000)
Topics
Health care and patient safety
Text
FETAL ALCOHOL SPECTRUM DISORDER (UPDATE 2009) Fetal Alcohol Spectrum Disorder (FASD) is a leading cause of environment-related birth defects and developmental disabilities in North America. The Canadian Medical Association (CMA) believes that the prudent choice for women who are or may become pregnant is to abstain from alcohol, and encourages their partners to support them in this endeavour. The CMA urges Canadian governments to enact legislation that requires alcoholic beverages sold in Canada to be labelled with warnings of the hazards of consuming alcohol during pregnancy. The CMA also calls upon the federal government to examine the role that advertising plays in promoting the consumption of alcoholic beverages and to review existing policies and regulations in this area. Fetal alcohol spectrum disorder (FASD) is an umbrella term used to describe the range of disabilities and diagnoses that result from drinking alcohol during pregnancy. It is estimated that more than 3,000 babies in Canada are born with FASD every year. Those who live with FASD may have mild to very severe problems with their health. They may have delays in their development, intellectual problems and problems in their social lives. Examples of these include: * skeletal abnormalities such as facial deformities * physical disabilities such as kidney and internal organ problems * depression or obsessive-compulsive disorder * difficulty understanding the consequences of their actions These disabilities are lifelong and those affected may need lifelong support. The drinking patterns of teenagers and the potential for women of reproductive age to consume alcohol mean that the health care system must actively address the prevention of FASD. Also, alcohol use may play a considerable role in unplanned pregnancy and inadequate prenatal and postnatal care. The CMA strongly supports all activities that encourage Canadians to moderate their alcohol consumption. The association encourages the public to be aware of the issues related to alcohol consumption, particularly the adverse effects on the fetus. In a continued effort to support the reduction of alcohol consumption, the CMA urges Canadian governments to enact legislation that requires alcoholic beverages sold in Canada to be labelled with warnings of the hazards of alcohol consumption during pregnancy.1 Appropriate agencies should also adopt regulations and/or policies to ensure that warnings about the adverse interaction between alcohol and both prescription and non-prescription products are prominently displayed or distributed wherever alcohol and drugs are sold or dispensed.2 The CMA also calls upon the federal government to examine the role that advertising plays in promoting the consumption of alcoholic beverages and to review existing policies and regulations in this area. The adverse effects of alcohol consumption by pregnant women are preventable. The CMA believes that the prudent choice for women who are or may become pregnant is to abstain from alcohol and encourages their partners to support them in this endeavour. Physicians should use appropriate screening methods to identify alcohol use in their patients. Physicians can play a leading role in educating and counselling women, spouses and family members about the dangers of alcohol to the fetus. The CMA also recommends that alcohol and drug addiction treatment services give high priority to the needs of pregnant women seeking help. 1 General Council resolution 89-67: That the Canadian Medical Association urge Governments in Canada to enact legislation requiring that all alcoholic beverages sold in Canada be labelled with warnings on the hazard from the consumption of alcohol during pregnancy. Note: this motion was rescinded because it was superseded by the Policy on Fetal Alcohol Syndrome (2000). 2 General Council resolution 87-31

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Health Canada consultation on potential market for cannabis health products that would not require practitioner oversight

https://policybase.cma.ca/en/permalink/policy14125

Date
2019-09-03
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-09-03
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on potential markets for cannabis health products that would not require practitioner oversight.1 The CMA’s approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counseling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines2 and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation,3 and recommendations regarding Bill C-45.4 As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45.5 We also responded to Health Canada’s recent Consultation on Edible Cannabis, Extracts & Topicals.6 Overview The CMA first expressed its concerns about the sale of natural health products containing cannabis in our response to the proposed regulatory approach to the Cannabis Act, Bill C-45.5 We recognize that, in general, health products include prescription health products, non-prescription drugs, natural health products, cosmetics and medical devices. Although all these products are regulated by Health Canada, they are subject to different levels of scrutiny for safety, efficacy and quality, and in some cases, industry does not need to provide scientific evidence to support the claims made on the label. Health Claims As with all health products, the CMA supports an approach in which higher risk products, that is, those for which health claims are made, must be subject to a more meticulous standard of review. Rigorous scientific evidence is needed to support claims of health benefits and to identify potential risks and adverse reactions. We support Health Canada’s proposal that authorized health claims for cannabis health products (CHP) would be permitted for treatment of minor ailments, on the strict condition they are substantiated via a strong evidentiary process. It is the view of the CMA that all such products making a health claim must be reviewed thoroughly for efficacy, as well as safety and quality, for the protection of Canadians.5 Recent experience in the United States supports this approach. A warning letter was sent to Curaleaf Inc. of Wakefield, Massachusetts, by the US Food and Drug Administration (FDA) “for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.”7 This is not the first time it was necessary for the FDA to take such action. The agency had sent letters on previous occasions to other businesses over claims “to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.”7 The CMA shares the FDA’s concerns that such claims “can put patients and consumers at risk by leading them to put off important medical care.”7 A study conducted by Dalhousie University found that only 35.8% of respondents were familiar with the biochemical properties of CBD when asked what cannabinoid they thought was potentially a pain killer.8 Systematic reviews and guidelines have highlighted the state of the science and the limited indications for which there is evidence.9,10,11 Both cannabis and CBD specifically have been approved for use in a few conditions, but more research is needed in this rapidly growing field. For example, medical cannabinoids have been approved in several jurisdictions for the treatment of multiple sclerosis but the evidence of how well it works is limited. As the Canadian authors note, “carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.”12 Consumers need to be reassured that health claims are being assessed thoroughly so they can make informed decisions.13 4 Packaging and Labelling Requirements The CMA has laid out its position with respect to packaging and labelling with respect to cannabis products.5,6 Strict packaging requirements are necessary as their wider availability raises several public health issues, not the least of which is ingestion by young children. Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. To reiterate:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause a poisoning Prescription Drugs Containing Cannabis The CMA addressed prescription drugs containing cannabis in a previous brief.5 The level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence to support claims of efficacy is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product. As a result, consumers presently do not have enough information to choose appropriate products. Prescription drugs are subject to Health Canada’s pharmaceutical regulatory approval process, based on each drug’s specific indication, dose, route of administration and target population. Health claims need to be substantiated via a strong evidentiary process. All potential prescription medications containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs (e.g., Marinol® and Sativex®), to protect Canadians from further misleading claims. The CMA urges caution especially around exemptions for paediatric formulations that would allow for traits that would “appeal to youth.” The CMA understands that these products, used under strict health professional supervision, should be child friendly, for example, regarding palatability, but we do not support marketing strategies that would suggest their use is recreational (e.g., producing them in candy or animal formats). Recommendations 1. The CMA recommends that all cannabis health products, including those with CBD, making a health claim must be reviewed thoroughly for efficacy, as well as safety and quality, for the protection of Canadians. 2. The CMA recommends that strict packaging requirements be put in place with respect cannabis health products as their wider availability raises several public health issues, not the least of which is ingestion by young children. 3. The CMA recommends tamper-resistant and child-proof containers need to be in place to enhance consumer safety. 4. The CMA recommends that all potential prescription medications containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs to protect Canadians from further misleading claims. 5 1Health Canada. Document: Consultation on Potential Market for Cannabis Health Products that would not Require Practitioner Oversight. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-potential-market-cannabis/document.html (accessed 2019 Aug 8). 2 Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed&. (accessed 2019 Aug 8). 3 Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Aug 8). 4 Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Aug 8). 5 Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Aug 8). 6 Canadian Medical Association (CMA). Health Canada Consultation on Edible Cannabis, Extracts & Topicals Ottawa: CMA; Available: https://policybase.cma.ca/en/permalink/policy14020 (accessed 2019 Aug 8). 7 Food and Drug Administration (FDA). FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety. Media Release. Silver Spring, MD: FDA; 2019 Jul 23. Available: https://www.fda.gov/news-events/press-announcements/fda-warns-company-marketing-unapproved-cannabidiol-products-unsubstantiated-claims-treat-cancer (accessed 2019 Aug 15). 8 Charlebois S., Music J., Sterling B. Somogyi S. Edibles and Canadian consumers’ willingness to consider recreational cannabis in food or beverage products: A second assessment. Faculty of Management: Dalhousie University; May, 2019 Available: https://cdn.dal.ca/content/dam/dalhousie/pdf/management/News/News%20%26%20Events/Edibles%20and%20Canadian%20Consumers%20English_.pdf (accessed 2019 Aug 20). 9 Allan GM. Et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician. Feb 2018;64(2):111. Available: https://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Aug 29). 10 Health Canada. Information for Health Care Professionals. Cannabis (marihuana, marijuana) and the cannabinoids) Dried or fresh plant and oil administration by ingestion or other means Psychoactive agent. Ottawa: Health Canada; October 2018. Available: https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-medication/cannabis/information-medical-practitioners/information-health-care-professionals-cannabis-cannabinoids-eng.pdf (accessed 2019 Aug 29). 11 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: Current state of evidence and recommendations for research. Washington, DC: The National Academies Press; 2017. Available: http://www.nationalacademies.org/hmd/reports/2017/health-effects-of-cannabis-and-cannabinoids.aspx (accessed 2019 Aug 29). 12 Slaven M., Levine O. Cannabinoids for Symptoms of Multiple Sclerosis JAMA Network Open. 2018;1(6):e183484. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2706491 (accessed 2019 Aug 26). 13 Food and Drug Administration (FDA). What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD Consumer Updates. Silver Spring, MD: FDA; 2019 July 17. Available: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis (accessed 2019 Aug 29).

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Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products

https://policybase.cma.ca/en/permalink/policy14022

Date
2019-03-22
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-03-22
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products under the authority of the Tobacco and Vaping Products Act (TVPA). Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes. This brief will address the two main issues outlined in the Notice of Intent: the placement of advertising and health warnings. Placement of Advertising The CMA’s approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. This would include the same approach to plain and standardized packaging regulations under consideration for tobacco products.2, The CMA is concerned that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. It is from a public health perspective that the CMA is calling for all vaping advertising to be strictly limited. The CMA supports the provisions proposed for point-of-sale information. The material offered will need to have the health warnings included in this Notice of Intent. However, the sections of the proposed regulations most problematic to the CMA are those encompassing public places, broadcast media, and the publications areas. Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.2 The advertisements permitted currently seem to have managed to find their way to youth, even if they are not directed at them, as claimed. A report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.” Social media provides an easy means of promoting vaping products and techniques, especially to youth.21 A US study found that the landscape is “being dominated by pro-vaping messages disseminated by the vaping industry and vaping proponents, whereas the uncertainty surrounding e-cigarette regulation expressed within the public health field appears not to be reflected in ongoing social media dialogues.” The authors recommended that “real-time monitoring and surveillance of how these devices are discussed, promoted, and used on social media is necessary in conjunction with evidence published in academic journals.”6 The need to address the issue of advertising around vaping is growing more urgent. Vaping is becoming more popular and more attractive to Canadian youth, especially with the arrival of more high-tech versions of electronic cigarettes such as the pod-based JUUL™. , A similar trend has been observed in the United States where a recent study indicated that “use by adolescents and young adults of newer types of e-cigarettes such as pod-based systems is increasing rapidly.” JUUL™ entered the US market in 2015 “with a novel chemistry (nicotine salts) enabling higher concentrations in a limited aerosol plume.” JUUL’s™ nicotine levels contained 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods. Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).10 The nicotine salts are “less harsh and less bitter, making e-liquids more palatable despite higher nicotine levels.”10 It has been noted by researchers that “among adolescents and young adults who use them, pod-based e-cigarettes are synonymous with the brand-name JUUL™ and use is termed “juuling,” whereas “vaping” has typically been used by youths to refer to using all other types of e-cigarettes.”9 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.10, The purpose in doing so is because “smoking is not a natural behavior, like eating or drinking, the manufacturers of these devices commonly add flavoring to the liquid from which the nicotine aerosol is generated, to make the initial exposures more pleasurable. The flavoring enhances the appeal to first-time users — especially teenagers.” The CMA and other expert groups would prefer to see flavours banned to reduce the attractiveness of vaping as much as possible.2, It is very important that the pod-based systems are cited specifically to ensure they are included under the new advertising regulations for all vaping products. Youth vaping has reached the point where the US Food and Drug Administration referred to it as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.” Durham Region Health Department, using data from the Ontario Student Drug Use and Health Survey conducted by CAMH and administered by the Institute for Social Research, York University, noted that 17% of high school students in that region had used an electronic cigarette in the past year (2016-17), numbers that are similar for the rest of Ontario. In the United States, a survey indicated that, among high school students, “current e-cigarette use increased from 1.5% (220,000 students) in 2011 to 20.8% (3.05 million students) in 2018;” between 2017 and 2018 alone it rose 78% (from 11.7% to 20.8%). Concern is growing across Canada among educators seeing a rise in the number of youths turning to vaping. , , The problem has reached the point where a school official resorted to removing the doors from the washrooms to “crack down” on vaping in the school. Youth themselves are aware of the increasing problem; many are turning to YouTube to learn “vape tricks” such as making smoke rings. Some refer to the practice of vaping as “the nic;” as a University of Ottawa student noted “They call it getting light-headed. Sometimes it's cool.” As the Canadian Paediatric Society noted in 2015, efforts to “denormalize tobacco smoking in society and historic reductions in tobacco consumption may be undermined by this new ‘gateway’ product to nicotine dependency.” , Decades of effort to reduce the incidence of smoking are in danger of being reversed. A growing body of evidence indicates that vaping can be considered the prime suspect. A Canadian study provides “strong evidence” that use of electronic cigarettes among youth is leading them to the consumption of combustible tobacco products. In a similar vein, a “large nationally representative study of US youths supports the view that e-cigarettes represent a catalyst for cigarette initiation among youths.” Granting vaping manufacturers scope to advertise will likely exacerbate this problem. Health Warnings The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages.2,3 We support the proposed warning labels being placed on all vaping products. The need for such warnings is important as there is still much that is not known about the effects vaping can have on the human body. Substances that have been identified in e-cigarette liquids and aerosols include “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.” Researchers have noted that there is a “striking diversity of the flavorings in e-cigarette liquids, (and that) the effects on health of the aerosol constituents produced by these flavorings are unknown.” A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.” Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.” , Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.” Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.”32 The need for parents to be educated on the impact of vaping on children is also very important. A study examining how smoke-free and vape-free home and car policies vary for parents who are dual users of cigarettes and e-cigarettes, who only smoke cigarettes, or who only use e-cigarettes demonstrated that these parents may perceive e-cigarette aerosol as safe for children. It noted that “dual users were less likely than cigarette-only smokers to report various child-protective measures inside homes and cars.”33 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. The CMA recommends that vaping advertisements should not be permitted in any public places, broadcast media, and in publications of any type, with no exceptions. 3. The CMA supports the provisions proposed in this Notice of Intent for point-of-sale information. This should include health warnings. 4. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products. 5. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids. Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products Ottawa: Health Canada; 2019 Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youth-non-users-tobacco-products.html (accessed 2019 Feb 27) Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-06.pdf (accessed 2019 Mar 1). Canadian Medical Association. Health Canada consultation on tobacco products regulations (plain and standardized appearance) Ottawa: CMA; 2018 Sep 6 Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2019 Mar 5) Gagnon E. IMPERIAL TOBACCO: Kids shouldn’t be vaping; our marketing is aimed at adults. Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/opinion/imperial-tobacco-kids-shouldnt-be-vaping-our-marketing-is-aimed-at-adults-289673/ (accessed 2019 Mar 8) U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA-8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. Available https://cancercontrol.cancer.gov/brp/tcrb/monographs/21/docs/m21_complete.pdf (accessed 2019 Mar 8) McCausland K, Maycock B, Leaver T, Jancey J. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review J Med Internet Res 2019;21(2):e11953 Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 Mar 14) Glauser W. New vaping products with techy allure exploding in popularity among youth. CMAJ 2019 February 11;191:E172-3. doi: 10.1503/cmaj.109-5710 Available: http://www.cmaj.ca/content/191/6/E172 (accessed 2019 Mar 1) Crowe K. Canada's 'wicked' debate over vaping CBC News February 2, 2019 Available https://www.cbc.ca/news/health/vaping-juul-vype-health-canada-cigarette-smoking-nicotine-addiction-1.5003164 (accessed 2019 Mar 8) McKelvey K et al. Adolescents’ and Young Adults’ Use and Perceptions of Pod-Based Electronic Cigarettes. JAMA Network Open. 2018;1(6):e183535. doi:10.1001/jamanetworkopen.2018.3535 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2707425 (accessed 2019 Mar 1) Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. doi:10.1136/tobaccocontrol-2018-054796 Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 Mar 12) Reichardt EM., Guichon J. Vaping is an urgent threat to public health The Conversation March 13, 2019 Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 Mar 14) Drazen JM., Morrissey S., Campion, EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680 Available: https://www.nejm.org/doi/full/10.1056/NEJMe1900484 (accessed 2019 Mar 13) Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there CBC News November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 Mar 13) Food and Drug Administration Statement. Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use Media Release February 11, 2019 Available: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631112.htm (accessed 2019 Mar 11) Durham Region Health Department Students’ use of e-cigarettes in the past year, 2016-2017 Quick Facts December 2018 Available https://www.durham.ca/en/health-and-wellness/resources/Documents/HealthInformationServices/HealthStatisticsReports/E-cigaretteAlternativeSmokingDeviceStudents-QF.pdf (accessed 2019 Mar 11) Cullen KA et al. Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018 Morbidity and Mortality Weekly Report November 16, 2018 Vol. 67 No. 45 Available: https://www.cdc.gov/mmwr/volumes/67/wr/mm6745a5.htm (accessed 2019 Mar 13) Munro N. Vaping on the rise in Nova Scotia high schools Halifax Chronicle Herald March 5, 2019 Available: https://www.thechronicleherald.ca/news/local/vaping-on-the-rise-in-nova-scotia-high-schools-289761/ (accessed 2019 Mar 11) Soloducha A. Is your child vaping? Regina Catholic Schools educating parents as trend continues to rise CBC News March 1, 2019 Available https://www.cbc.ca/news/canada/saskatchewan/regins-catholic-schools-vaping-education-1.5039717 (accessed 2019 Mar 11) Emde W. Growth of vaping labelled ‘crisis’ in Vernon. Kelowna Daily Courier Available http://www.kelownadailycourier.ca/life/article_253d6404-4168-11e9-934f-7b6df68fb0fd.html (accessed 2019 Mar 11) Lathem C. Ottawa principal's solution to student vaping: Remove the washroom doors. CTV News January 9, 2019 Available https://www.ctvnews.ca/canada/ottawa-principal-s-solution-to-student-vaping-remove-the-washroom-doors-1.4246317 (accessed 2019 Mar 11)) Calioa D. Vaping an 'epidemic,' Ottawa high school student says CBC News November 27, 2018 Available https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 Mar 11) Schnurr J. New data is showing a worrisome trend about vaping and smoking among teens CTV News January 18, 2019 Available https://ottawa.ctvnews.ca/new-data-is-showing-a-worrisome-trend-about-vaping-and-smoking-among-teens-1.4260008 (accessed 2019 Mar 11) Stanwick R. E-cigarettes: Are we renormalizing public smoking? Reversing five decades of tobacco control and revitalizing nicotine dependency in children and youth in Canada Policy Statement Canadian Paediatric Society March 6, 2015 (Reaffirmed February 28, 2018) Available: https://www.cps.ca/en/documents/position/e-cigarettes (accessed 2019 Mar 12) Fairchild AL., Bayer R., Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med 370:4 January 23, 2014 Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2019 Mar 12) Hammond d. et al. Electronic cigarette use and smoking initiation among youth: a longitudinal cohort study. CMAJ October 30, 2017 189 (43) E1328-E1336; Available: http://www.cmaj.ca/content/189/43/E1328 (accessed 2019 Mar 1) Berry KM et al. Association of Electronic Cigarette Use With Subsequent Initiation of Tobacco Cigarettes in US Youths JAMA Network Open. 2019;2(2):e187794. doi:10.1001/jamanetworkopen.2018.7794 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2723425?resultClick=3 (accessed 2019 Mar 12) National Academies of Sciences, Engineering, and Medicine. 2018. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press. doi: https://doi.org/10.17226/24952. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 Mar 13) Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med 2016;375:1372-81 Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Mar 13) Goniewicz ML. et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes JAMA Network Open. 2018;1(8):e185937 Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2718096 (accessed 2019 Mar 13) Chan LF. Et al. Pulmonary toxicity of e-cigarettes Am J Physiol Lung Cell Mol Physiol 313: L193–L206, 2017 Available: https://www.physiology.org/doi/full/10.1152/ajplung.00071.2017?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed (accessed 2019 Mar 13) Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control. 0:1-8, 2019. American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Mar 13) Drehmer JE, Nabi-Burza E, Hipple Walters B, et al. Parental Smoking and E-cigarette Use in Homes and Cars. Pediatrics. 2019;143(4):e20183249 Available: https://pediatrics.aappublications.org/content/early/2019/03/07/peds.2018-3249 (accessed 2019 Mar 13)

Documents

Less detail

Health Canada consultation on vaping products labelling and packaging regulations

https://policybase.cma.ca/en/permalink/policy14124

Date
2019-09-05
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-09-05
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to the notice as published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health Canada’s intent to establish a single set of regulations under the authorities of the Tobacco and Vaping Products Act (TVPA) and the Canada Consumer Product Safety Act (CCPSA) with respect to the labelling and packaging of vaping products.1 Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. Introduction In our most recent brief, the CMA expressed its concerns regarding vaping and youth. This included marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths.2 In April 2019, the Council of Chief Medical Officers of Health expressed alarm at the rising number of Canadian youths who are vaping, having found this trend “very troubling.”3 The CMA concurred with this assessment and supports Health Canada’s intention to further tighten the regulations.2 Identifying Vaping Substances The findings of a recent Canadian study indicate an increase in vaping among adolescents in Canada and the United States.4 The growing acceptance of this practice is of concern to the CMA because of the rapidly emerging popularity of vaping products such as JUUL® and similar devices.4 It will be very important to identify clearly on the packaging all the vaping substances contained therein, along with a list of ingredients, as not enough is known about the long-term effects users may face.5,6 Users need to know what they are consuming so they can make informed choices about the contents. Studies have found substances in e-cigarette liquids and aerosols such as “nicotine, solvent carriers (PG and glycerol), tobacco-specific nitrosamines (TSNAs), aldehydes, metals, volatile organic compounds (VOCs), phenolic compounds, polycyclic aromatic hydrocarbons (PAHs), flavorings, tobacco alkaloids, and drugs.”7 Nicotine Content As Hammond et al noted in their recent study, “JUUL® uses benzoic acid and nicotine salt technology to deliver higher concentrations of nicotine than conventional e-cigarettes; indeed, the nicotine concentration in the standard version of JUUL® is more than 50 mg/mL, compared with typical levels of 3-24 mg/mL for other e-cigarettes.”4 The salts and flavours available to be used with these devices reduce the harshness and bitterness of the taste of the e-liquids. Some of its competition deliver even higher levels of nicotine.8 The CMA has expressed its concerns about the rising levels of nicotine available through the vaping process.2 They supply “high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences.”9 The higher levels of nicotine in vaping devices is also of concern because it “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.”10,11 The CMA has called on Health Canada to restrict the level of nicotine in vaping products to avoid youth (and adults) from developing a dependence.2 4 Health Warnings The CMA reiterates, again, its position that health warnings for vaping should be similar to those for tobacco packages.12,13 We support placing warning labels on all vaping products, regardless of the size of the package. The “space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available.”13 The need for such cautions is important as there is still much that is not known about the effects vaping can have on the human body. A US study found “evidence that using combusted tobacco cigarettes alone or in combination with e-cigarettes is associated with higher concentrations of potentially harmful tobacco constituents in comparison with using e-cigarettes alone.”14 Some researchers have found that there is “significant potential for serious lung toxicity from e-cig(arette) use.”15,16 Another recent US study indicates that “adults who report puffing e-cigarettes, or vaping, are significantly more likely to have a heart attack, coronary artery disease and depression compared with those who don’t use them or any tobacco products.”17 Further, it was found that “compared with nonusers, e-cigarette users were 56 percent more likely to have a heart attack and 30 percent more likely to suffer a stroke.17 A worrisome development has emerged in the United States. The Centers for Disease Control and Prevention is working in consultation with the states of Wisconsin, Illinois, California, Indiana, and Minnesota regarding a “cluster of pulmonary illnesses linked to e-cigarette product use, or “vaping,” primarily among adolescents and young adults.”18 Additional possible cases have been identified in other states and are being investigated. Child-Resistant Containers The CMA supports the need for child-resistant containers in order to enhance consumer safety; we have adopted a similar position with respect to cannabis in all forms.19,20 The need to include warning labels should reinforce the need for packaging these vaping products such that they will be inaccessible to small children. Recommendations 1. The CMA recommends more research into the health effects of vaping as well as on the components of the vaping liquids. 2. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth and adults from developing a dependence. 3. The CMA reiterates its position that health warnings for vaping should be like those being considered for tobacco packages. We support the proposed warning labels being placed on all vaping products. 4. The CMA recommends that all the vaping substances be identified clearly on the packaging, along with a list of ingredients. 5. The CMA supports the need for child-resistant containers. 5 1 Government of Canada. Canada Gazette, Part I, Volume 153, Number 25: Vaping Products Labelling and Packaging Regulations. Ottawa: Government of Canada; 2019. Available: http://gazette.gc.ca/rp-pr/p1/2019/2019-06-22/html/reg4-eng.html (accessed 2019 Jul 10). 2 Canadian Medical Association (CMA). Health Canada Consultation on Reducing Youth Access and Appeal of Vaping Products. Ottawa: CMA; 2019 May 24. Available: https://policybase.cma.ca/en/permalink/policy14078 (accessed 2019 Jul 10). 3 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Ottawa: Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 Jul 24). 4 Hammond David, Reid Jessica L, Rynard Vicki L, et al. Prevalence of vaping and smoking among adolescents in Canada, England, and the United States: repeat national cross sectional surveys BMJ. 2019; 365:2219. Available: https://www.bmj.com/content/bmj/365/bmj.l2219.full.pdf (accessed 2019 Jul 24). 5 WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization; 2019. Available: https://apps.who.int/iris/bitstream/handle/10665/326043/9789241516204-eng.pdf?ua=1 (accessed 2019 Jul 30). 6 Dinakar, C., O’Connor GT. The Health Effects of Electronic Cigarettes. N Engl J Med. 2016;375:1372-81. Available: https://www.nejm.org/doi/full/10.1056/NEJMra1502466 (accessed 2019 Jul 30). 7 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 Jul 29). 8 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. 9 Barrington-Trimis JL, Leventhal AM. Adolescents’ Use of “Pod Mod” E-Cigarettes —Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 Jul 30). 10 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0212353 (accessed 2019 Jul 30). 11 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 Jul 30). 12 Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Jul 30). 13 Canadian Medical Association. Health Canada consultation on tobacco products regulations (plain and standardized appearance) Ottawa: CMA; 2018 Sep 6. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Jul 30). 14 Goniewicz ML. et al. Comparison of Nicotine and Toxicant Exposure in Users of Electronic Cigarettes and Combustible Cigarettes JAMA Network Open. 2018;1(8):e185937. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2718096 (accessed 2019 Jul 30). 15 Chan LF. Et al. Pulmonary toxicity of e-cigarettes Am J Physiol Lung Cell Mol Physiol. 313: L193–L206, 2017 Available: https://www.physiology.org/doi/pdf/10.1152/ajplung.00071.2017 (accessed 2019 Jul 30). 16 Li D, Sundar IK, McIntosh S, et al. Association of smoking and electronic cigarette use with wheezing and related respiratory symptoms in adults: cross-sectional results from the Population Assessment of Tobacco and Health (PATH) study, wave 2. Tob Control. 0:1-8, 2019. 17 American College of Cardiology. E-Cigarettes Linked to Heart Attacks, Coronary Artery Disease and Depression. Media Release March 7, 2019 Available: https://www.acc.org/about-acc/press-releases/2019/03/07/10/03/ecigarettes-linked-to-heart-attacks-coronary-artery-disease-and-depression (accessed 2019 Jul 30). 18 Centers for Disease Control and Prevention. CDC, states investigating severe pulmonary disease among people who use e-cigarettes. Media Statement 2019 Aug 17. Available: https://www.cdc.gov/media/releases/2019/s0817-pulmonary-disease-ecigarettes.html (accessed 2019 Aug 20). 19 Canadian Medical Association (CMA). Health Canada Consultation on Edible Cannabis, Extracts & Topicals Ottawa: CMA; 2019 Feb 20. Available: https://policybase.cma.ca/en/permalink/policy14020 (accessed 2019 Aug 6). 20 Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis Submission to Health Canada. 2018 Jan 19 Available: https://policybase.cma.ca/en/permalink/policy13838. (accessed 2019 Aug 6).

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Organ and tissue donation and transplantation

https://policybase.cma.ca/en/permalink/policy14126

Date
2019-12-07
Topics
Ethics and medical professionalism
Health care and patient safety
  2 documents  
Policy Type
Policy document
Date
2019-12-07
Replaces
Organ and tissue donation and transplantation (update 2015)
Topics
Ethics and medical professionalism
Health care and patient safety
Text
Organ and Tissue Donation and Transplantation (OTDT) is a rapidly changing area of medical science and practice. Organ and tissue transplantations represent significant lifesaving and life-enhancing interventions that require careful consideration by multiple stakeholders spanning medical disciplines. Technological and pharmacological advancements have made organ and tissue transplantation increasingly viable for treating related medical conditions. Changing social norms have also led to shifting perceptions of the acceptability of organ and tissue donation. Within this context, there is a need for renewed consideration of the ethical issues and principles guiding organ and tissue donation and transplantation in Canada. The overarching principle that guides OTDT is public trust, which requires that the expressed intent either for or against donation will be honoured and respected within the donation and medical systems, and that the best interests of the potential donor are always of paramount importance; policies and mechanisms that guide OTDT should aim to maintain and foster that public trust. The CMA acknowledges and respects the diverse viewpoints, backgrounds, and religious views of physicians and patients and therefore encourages physicians to confront challenges raised by OTDT in a way that is consistent with both standards of medical ethics and patients’ values and beliefs. SCOPE This policy identifies foundational principles to address the challenges surrounding deceased and living donation. In conjunction with applicable laws and regulations in Canada, the Declaration of Istanbul, the World Health Organization (WHO) Guiding Principles on Human Cell, Tissue and Organ Transplantation, and leading clinical practices this policy aims to inform physicians and other interested parties on the guiding principles of OTDT in Canada. This policy is intended to address OTDT in adult populations; the challenges, considerations, legislation, and policy surrounding pediatric and neonatal OTDT are unique and deserve focused attention. Physicians should be aware of relevant legislation, regulatory requirements, and policies in the jurisdiction in which they practice. Physicians are encouraged to refer to the various Canadian specialty societies that deal directly with OTDT for up-to-date information and policy, as well as innovative techniques and approaches. GUIDING PRINCIPLES The practice of OTDT is of great value to patients and society. The CMA supports the continued development of greater capacity, efficiency, and accessibility in OTDT systems in co-ordination with comprehensive and compassionate end-of-life care for Canadians while acknowledging the importance of justice, informed consent, beneficence, and confidentiality to this practice. 1. JUSTICE There is a continuous need to improve the efficiency and effectiveness of OTDT in an effort to narrow the gap between demand and supply in what remains a scarce, lifesaving resource. The principle of justice should continue to guide the equitable allocation of organs and tissues in a manner that is externally justifiable, open to public scrutiny, and balances considerations of fairness (e.g., medical need or length of time on the wait-list) with medical utility (e.g., transplantation success). There should be no discrimination based on social status or perceived social worth. Lifestyle or behavioral factors should only be considered when clear evidence indicates that those factors will impact the medical probability of success. OTDT should also not rely on the patient’s ability to pay; such actions are inconsistent with the principles that underlie Canada’s publicly-funded health system. Of note, living donation to a loved one or acquaintance (via a directed donation) is regarded as ethically acceptable if potential donors are informed of all options, including that of donating in a non-directed fashion. All levels of government should continue to support initiatives to improve the OTDT system, raise public awareness through education and outreach campaigns, and fund ongoing research, such that any Canadian who may wish to donate their tissues or organs are given every reasonable opportunity to do so. Potential donor identification and referral, while legislated in many jurisdictions, is an important area of continued development as failure to identify donors deprives families of the opportunity to donate and deprives patients of potential transplants. To diminish inequities in the rates of organ donation between jurisdictions, federal and provincial governments should engage in consultations with a view to implementing a coordinated, national strategy on OTDT that provides consistency and clarity on medical and legal standards of informed consent and determination of death, and institutes access to emerging best practices that support physicians, providers, and patients. Efforts should be made to ensure adequate engagement with potential donors from communities that have historically had lower living donor rates to help reduce inequities in access to living donation. Policymakers should also continue to explore and appraise the evidence on policy interventions to improve the rates of organ donation in Canada – for example, see a brief overview of opt-in vs. opt-out donation systems in the background to this policy. 2. INFORMED CONSENT AND VOLUNTARINESS Organ and tissue donation must always be an autonomous decision, free of undue pressure or coercion. By law, the potential organ donor, or their substitute decision-maker, must provide informed consent. Physicians should direct patients to appropriate resources if that patient has expressed interest to become a donor after their death. If a potential donor has not made an expression of intent for or against donation, substitute decision-makers, families, or loved ones may be approached to provide authorization for donation. It should also be noted that consent indicates a willingness to donate, but that donation itself hinges on factors such as medical suitability and timing. End-of-life decisions must be guided by an individual's values and religious or philosophical beliefs of what it means to have a meaningful life and death. The autonomy of an individual should always be respected regarding their wish, intent, or registered commitment to become a donor after death. Input from family and loved-ones should always be considered in the context of the potential donor’s wishes or commitments – these situations must be handled on a case-by-case basis with respect for cultural and religious views while maintaining the autonomously expressed wishes of the potential donor. Physicians should make every reasonable effort to be aware and considerate of the cultural and religious views of their patients as they pertain to OTDT. Likewise, Canadian medical schools, relevant subspecialties, and institutions should provide training and continuing professional development opportunities on OTDT, including both medicolegal implications and cultural competency. To protect the voluntariness of the potential donor’s decision, public appeals to encourage altruistic donation should not seek to compensate potential donors through payment and should not subvert established systems of organ allocation. Any exploitation or coercion of a potential donor must be avoided. However, remuneration from officially sanctioned sources for the purpose of reimbursement of costs associated with living donation (e.g., transfer to another location or lost wages during the procedure), may be considered when no party profits financially from the exchange. The CMA supports proposed amendments to the Criminal Code and the Immigration and Refugee Protection Act that criminalizes or otherwise seeks to prevent the coercive collection and transplantation of organs domestically and internationally (i.e., organ trafficking – see relevant guidelines on trafficking ). The CMA also discourages Canadians from participating in organ tourism as either a recipient or donor; physicians should not take part in transplantation procedures where it is reasonable to suspect that organs have been obtained without the donor’s informed consent or where the donor received payment (from WHO Guiding Principle 7); however, in accordance with physicians’ commitment to the well-being of the patient and the professional responsibilities relating to the patient-physician relationship in the CMA Code of Ethics and Professionalism, physicians have an obligation to treat a post-tranplant patient if requested after the patient has participated in organ tourism; physicians should be aware of any legal or regulatory obligations they may have to report a patient’s organ tourism to national authorities, taking into consideration their duties of privacy and confidentiality to the patient. , 3. BALANCING BENEFICENCE AND NON-MALEFICENCE Balancing beneficence and non-maleficence means to: Consider first the well-being of the patient; always act to benefit and promote the good of the patient; provide appropriate care and management across the care continuum; take all reasonable steps to prevent or minimize harm to the patient; disclose to the patient if there is a risk of harm or if harm occurs; recognize the balance of potential benefits and harms associated with any medical act; and act to bring about a positive balance of benefits over harms. Deceased Donation Prospective donors can benefit from the knowledge that they can potentially save lives after their own deaths. However, potential donors must not be harmed by the act of donating. In accordance with the Dead Donor Rule, organ or tissue procurement should never be the cause of death. Moreover, the care of the dying patient must never be compromised by the desire to protect organs for donation or expedite death to allow timely organ retrieval. Physicians determining that a potential donor has died should not be directly involved in tissue or organ removal from the donor or subsequent transplantation procedures, nor should they be responsible for the care of any intended recipients of such tissues and organs (from WHO Guiding Principle 2). Leading clinical criteria, in conjunction with legally prescribed definitions of death and procedures, should inform the determination of death before donation procedures are initiated. DCD should be practiced in compliance with the regulations of individual transplant centers, relevant legislation, and leading Canadian clinical guidelines including the national recommendations for donation after cardiocirculatory death in Canada and the guidelines for the withdrawal of life-sustaining measures. Patients undergoing medical assistance in dying (MAiD) may also be eligible for organ and tissue donation – see relevant policy guidelines. Living Donation Living donors are motivated to act primarily for the benefit of the recipient. The perceived acceptability of living donation varies from person to person; living donation is deemed to be ethically acceptable when the potential benefits outweigh the potential risks of living donation; living donation is not ethically acceptable where there is a material risk of death of the donor; living donors must provide informed consent, meet medical and psychological requirements, and receive appropriate follow-up care. It is not necessary for the potential donor to be biologically or emotionally related to the recipient. 4. CONFIDENTIALITY AND PRIVACY Current practice protects the privacy of both donor and recipient and does not allow donation teams, organ donation organizations, or transplant teams to inform either party of the other’s identity. The continuation of this practice is encouraged at the present time to protect the privacy of both donors and recipients. In addition, healthcare providers should consider the privacy and confidentiality implications of practices employed throughout the assessment and post-operative periods – patient consent should be obtained for practices involving any loss of privacy or confidentiality (e.g. group education sessions, etc.). Deceased Donation A person’s choice about whether or not they intend to donate organs and tissues after their death is individual and, like other health-related information, should be considered private. The right to privacy regarding personal health information extends beyond the declaration of death. Living Donation Whenever possible, potential donor and recipients should be cared for and evaluated by separate medical teams. In the case of non-directed donations, it may be necessary for information to be shared between donor and recipient teams (e.g. recipient’s underlying disease and risk for recurrence); however, such information should be limited to what is necessary for making an informed choice. Conversely, the CMA recognizes that the choice and process of directed donation is one that is deeply personal, which is likely to result in the intersection of both donor and recipient pathways of care. In such cases, the same onus of confidentiality may not apply given the choices of the donor and recipient involved. Approved by the CMA Board of Directors December 2019

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Tamper Resistance under the Controlled Drugs and Substances Act

https://policybase.cma.ca/en/permalink/policy11295

Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2014-08-26
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide its response to the Tamper resistance under the Controlled Drugs and Substances Act consultation, published in the Canada Gazette on June 28, 2014. The CMA encourages Health Canada to accelerate the development of regulations to require products containing specified controlled substances, or classes thereof, to have tamper-resistant properties in order to be sold in Canada. The CMA reiterates its overarching recommendation to the House of Commons Standing Committee on Health during its 2014 study on addressing prescription drug abuse1; that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada. The CMA recommends that such a strategy must include prevention, treatment, surveillance and research, as well as consumer protection. One form of consumer protection is the requirement of modifications to the drugs themselves with the intent of minimizing their abuse potential. The CMA also reiterates its recommendation made to Health Canada during the consultation on the Controlled Drugs and Substances Act (CDSA) and its regulations in 20142, that Health Canada establish higher levels of regulatory scrutiny for controlled prescription medication, with more stringent pre-approval requirements. In that brief, the CMA recommends that prescription opioid medication or other potentially addictive medications have tamper- resistant formulations3 to reduce the potential for misuse or abuse. A similar position is taken by the National Advisory Council on Substance Misuse's strategy, First Do No Harm: Responding to Canada's Prescription Drug Crisis4, where one of the 58 recommendations made is that governments and other stakeholders "review existing evidence and/or conduct objective and independent research on the effectiveness of tamper-resistant and abuse-deterrent technology and packaging and make recommendations as needed to reduce the harms associated with prescription drugs and paediatric exposure." Tamper-resistant technology aims to reduce abuse readiness and reduce dependence potential of psychoactive medications, by reducing or impeding the achievement of a rapid euphoric effect ("high") from tampering of the formulation. This can be accomplished by altering physical or chemical properties or absorption rate, prolonging half-life, developing 1 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: https://www.cma.ca/Assets/assets- library/document/en/advocacy/Prescription-Drug- Abuse_en.pdf#search=The%20need%20for%20a%20national%20strategy%20to%20address%20abuse%20and%20misuse%20of%20prescription 2 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: https://www.cma.ca/Assets/assets- library/document/en/advocacy/CMA_SubmissiontoHealthCanada- CDSA_Modernization.pdf#search=Submission%20to%20Health%20Canada%20in%20response%20to%20the%20consultation%20on%20the%20 Controlled%20Drugs%20and%20Substances%20Act%20and%20its%20regulations%2E 3 There are different terms to characterize efforts to prevent the manipulation of psychoactive medications for abuse purposes: abuse or tamper resistant formulations, abuse or tamper deterrent formulations and others. In the literature, and for the purpose of this submission, terms are sometimes used interchangeably. 4 National Advisory Committee on Prescription Drug Misuse (2013) First do no harm: Responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse (p30). Retrieved from: http://www.ccsa.ca/resource%20library/canada-strategy-prescription-drug-misuse- report-en.pdf prodrugs (inactive forms that are converted to active forms in the human body), or adding ingredients that are unattractive to users when the drug is altered. The science around tamper resistance is relatively recent, and analytical, clinical and other methods for developing and evaluating such technologies is increasing. The regulations will have to account for this new and evolving area of expertise, in maintaining scientific rigour in the assessment and evaluation of new formulations both in the pre-approval stage as well as in the post-approval monitoring, while still ensuring efficacy for their target indication.5 Pre-marketing evaluations assess the potentially tamper-resistant properties of a product under controlled circumstances. They should include laboratory-based, pharmacokinetic and clinical abuse potential studies. Post-approval monitoring seeks to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. It is important to understand whether there have been successful attempts to defeat or compromise such formulations. In the U.S., the Food and Drug Administration has not approved explicit label claims of abuse deterrence and will wait until there is sufficient post-marketing data.6 7 Generic manufacturers would have to be held to the same standards. The availability of good quality, systematic surveillance data from Canadian populations is essential to demonstrate epidemiological trends, and would inform these regulations. Regulations must take into consideration the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are most affected. As stated previously, it is essential that such regulations be part of a comprehensive strategy to reduce abuse of prescription medications. Studies have shown that if no other measures are taken, people who are dealing with addiction and dependence will simply shift to another prescription drug that is not tamper-resistant, or even to illegal drugs. Deterrence is specific to the drug in question. Such has been the case with the introduction of oxycodone with the tamper-resistant formulation, OxyNEO(r), with a significant reduction of oxycodone as a drug of choice. However, at the same time, there was a rise in the use of heroin and other opioids which did not have abuse deterrent technology8, 9. Tamper-resistant technologies have not been proven to be 100% effective in preventing abuse. They are not successful in preventing the most common form of abuse, which is the ingestion of a large number of intact pills, although there have been some attempts at the addition of aversive agents. There is, however, the potential for a significant reduction in the 5 Center for Drug Evaluation and Research (2013) Guidance for Industry: abuse-deterrent opioids - evaluation and labeling. Draft Guidance. Food and Drug Administration. US Department of Health and Human Services. Retrieved from: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM334743.pdf 6 Romach, MK, Schoedel, KA, & Sellers, EM (2013) Update on tamper-resistant drug formulations. Drug and Alcohol Dependence 130: 13-23. 7 Shaeffer, T (2012) Abuse-deterrent formulations, an evolving technology against the abuse and misuse of opioid analgesics. J.Med.Toxicol. 8:400-407. 8 Cicero, TJ, Ellis, MS, Surratt, HL (2012 Jul 12). Effect of abuse-deterrent formulation of OxyContin. N Engl J Med. 367(2): 187-9. 9 The Conference Board of Canada (2014) Innovations and policy solutions for addressing prescription drug abuse: summary report. Retrieved from: http://www.conferenceboard.ca/Libraries/CONF_PDFS_PUBLIC/14-0131_SummaryReport_June6.sflb progression from oral to other forms of use, such as chewing, snorting, smoking and injecting. There is an additional challenge, which is the fact that information about procedures and recipes for drug tampering is available among people who use drugs, and sometimes is found on the Internet. There is the possibility of negative unintended consequences in mandating tamper-resistant properties as a condition of sale for selected prescription drugs. There have been anecdotal reports that such forms might not be as effective in addressing the therapeutic needs of some patients. As well, some patients have had difficulties in swallowing tamper-resistant formulations of some drugs. It is essential that the regulations ensure that these medications have adequate clinical testing to ensure bioequivalence to the original formulations, without added adverse effects. The regulations must also take into account the affordability of the new formulations - that the development costs of the tamper-resistant technology not result in an excessive increase in the cost to patients. This must be closely monitored so that there are adequate options for pain management. Prescription drug abuse is a complex and very concerning health problem, and it will require more than a single policy solution. Safer drug formulations have the potential to be an important element of a comprehensive strategy, as medications are necessary tools for the treatment of pain. However, other components such as better surveillance and monitoring, clinical guidelines and tools, and enhanced access to withdrawal and addiction treatment services, as well as mental health and specialized pain services are also essential. The CMA is pleased to provide the recommendations listed below on the development and establishment of new regulations and encourages Health Canada to accelerate the advancement of the draft regulations. Recommendations The CMA recommends that: 1. Health Canada accelerate the establishment requirements for tamper-resistant formulations with the intent of minimizing their abuse potential, as part of a comprehensive national strategy to address the misuse and abuse of prescription medication in Canada, in collaboration with provincial/territorial governments and other stakeholders. 2. both brand name and generic manufacturers be held to the same standards regarding tamper-resistant formulations. 3. the regulations account for the new and evolving area of expertise in tamper-resistance formulations, in maintaining scientific rigour in the assessment and evaluation of new formulations in the pre-approval and post-marketing stages. 4. the regulations ensure that tamper-resistant formulations maintain the same levels of efficacy for their target therapeutic indication as the original formulations, without added adverse effects. 5. the regulations include requirements for post-approval monitoring to determine whether the marketing of the potentially tamper-resistant formulation results in changes in patterns of use, addiction, overdoses and deaths. 6. Health Canada strengthen surveillance systems to collect necessary data from Canadian populations to inform these regulations regarding epidemiological trends, including the drugs that are most frequently diverted for abuse, the most frequent forms of abuse of each drug, those causing most overdoses and deaths and the populations that are affected.

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9 records – page 1 of 1.