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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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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 reducing youth access and appeal of vaping products

https://policybase.cma.ca/en/permalink/policy14078
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures.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. The CMA has stated its position to the federal government on electronic cigarettes and vaping clearly in recent years.2,3 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.2 We also argued that the government should take the same approach to plain and standardized packaging regulations for e-cigarettes as has now been implemented for tobacco products.2 In our most recent brief we addressed the two main issues outlined in the government’s Notice of Intent with respect to the advertising of vaping products: the placement of that advertising and the use of health warnings.3,4 We expressed concerns that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. Further, we reiterated our position that health warnings for vaping should be like those being considered for tobacco packages. This brief will address the issues of greatest concern to the CMA with respect to vaping and youth. This includes marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths. Introduction The Council of Chief Medical Officers of Health have expressed alarm at the rising number of Canadian youths who are vaping, finding this trend “very troubling.”5 The Canadian Medical Association concurs with this assessment and appeals to the federal government to move urgently on this important public health issue. As our knowledge about the risks of using e-cigarettes increases, there is an even greater imperative to dissuade youth from taking up the habit. This is important because those youth “who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes.”6 Marketing The e-cigarette marketplace is evolving quickly as new products emerge. The industry has made clever use of social media channels to promote their wares by taking advantage of the belief that they are a safer alternative to cigarettes.7 They have also promoted “innovative flavoring and highlighted the public performance of vaping.”7 It is no surprise that the United States Food and Drug Administration (FDA) has referred to youth vaping as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.”8 As the US National Academies of Sciences, Engineering, and Medicine has noted “young people who begin with e-cigarettes are more likely to transition to combustible cigarette use and become smokers who are at risk to suffer the known health burdens of combustible tobacco cigarettes.”9 However, some of the efforts employed to convince youth to take up vaping are especially troublesome. As the 4 US Centers for Disease Control and Prevention (CDC) reported, “one in 5 (US) high school students and 1 in 20 middle school students reported using e-cigarettes in the past 30 days in 2018,” a significant rise in the number of high school students between 2011 and 2018.10 The use of social media campaigns employing “influencers” to capture more of the youth and young adult market or influence their choices shows the need to be especially vigilant.11 In an attempt to counter this influence, a group of over 100 public health and anti-tobacco organizations from 48 countries “are calling on Facebook, Instagram, Twitter and Snap to take “swift action” to curb advertising of tobacco products on their platforms.”12 As much as the industry is making major efforts to attract or sway customers through advertising, youth themselves may hold the key to countering that pressure. A recent US study found that “adolescents generally had somewhat negative opinions of other adolescents who use e-cigarettes. Building on adolescents’ negativity toward adolescent e-cigarette users may be a productive direction for prevention efforts, and clinicians can play an important role by keeping apprised of the products their adolescent patients are using and providing information on health effects to support negative opinions or dissuade formation of more positive ones.”13 Health Canada can play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers.14 We reiterate the concerns we expressed in our recent brief on the potential measures to reduce advertising of vaping products and to help diminish their appeal to youth. The CMA noted that the sections most problematic to the Association were those encompassing public places, broadcast media, and the publications areas.3 Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.3 These areas need to be addressed on an urgent basis. Flavours As of 2013, over 7,000 flavours had been marketed in the US.15 The data indicated that “about 85% of youth who used e-cigarettes in the past 30 days adopted non-tobacco flavors such as fruit, candy, and dessert.”15 Flavours are helpful in attracting youth, especially when coupled with assertions of lower harm.13 And they have been successful in doing so, as evidenced by the rise in the rates of vaping among youth.8, 16 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.16,17,18 The concern is that e-cigarettes “may further entice youth to experiment with e-cigarettes and boost e-cigarettes’ influence on increased cigarette smoking susceptibility among youth.”15 More worrisome, flavoured e-cigarettes “are recruiting females and those with low smoking-risk profile to experiment with conventional cigarettes.”19 Limiting the availability of “child-friendly flavors” should be considered to reduce the attraction of vaping to youth.19 In a recent announcement, the US FDA has proposed to tighten e-cigarette sales and “remove from the market many of the fruity flavors …blamed on fueling “epidemic” levels of teen use.”20 As we have noted in previous submissions, the CMA would prefer to see flavours banned to reduce the attractiveness of vaping to youth as much as possible, a sentiment shared by other expert groups. 2,3,21 Nicotine Levels One of the most popular devices to vape with is JUUL™, entering the US market in 2015.22 JUUL’s™ nicotine pods contain 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods.17 Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).17 The CMA is very concerned about the rising levels of nicotine available through the vaping process, especially by the newer delivery systems. 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.”23 Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.15,24 In addition to flavours, and to ease delivery and to make the taste more pleasant, nicotine salts are added to make the e-liquid “less harsh and less bitter” and “more 5 palatable despite higher nicotine levels.”17 Addressing the Rise in Youth Vaping There are many factors that lead youth to experiment with vaping and e-cigarettes. For some it is simple curiosity, for others it is the availability of different flavours while still others perceive vaping as “cool,” especially when they can use the vapour to perform “smoke tricks.”25 The pod devices themselves (e.g., JUUL™) help enhance the allure because of the “unique aesthetic appeal of pod devices, ability to deliver nicotine at high concentrations and the convenience of using them quickly and discreetly.”26 As vaping continues to grow in popularity, it will not be easy to curb youths’ enthusiasm for it. However, it is too important of a public health issue to not intervene More research is needed into how youth perceive vaping and e-cigarettes as they do not hold a universally positive view of the habit.7,13 As well, there is evidence to suggest that many are coming to see vaping as being “uncool” and that there are potential health consequences to continued use.25 In view of the still-evolving evidence of the safety of vaping and e-cigarettes, “strategic and effective health communication campaigns that demystify the product and counteract misconceptions regarding e-cigarette use are needed.”25 Further, “to reduce youth appeal, regulation efforts can include restricting the availability of e-cigarette flavors as well as visible vapors.”25 Another approach to consider is the state of Colorado’s recent creation of “a health advisory recommending that health care providers screen all youth specifically for vaping, in addition to tobacco use, because young people may not necessarily associate tobacco with vaping.”27 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 the limitation of number of flavours available to reduce the attractiveness of vaping to youth. 3. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth becoming addicted. 4. Health Canada must play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers. 5. Health Canada must develop communication campaigns directed at youth, parents and health care providers to demystify vaping and e-cigarettes and that create a link between tobacco and vaping. 1 Government of Canada. Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-reducing-youth-access-appeal-vaping-products-potential-regulatory-measures.html (accessed 2019 Apr 11). 2 Canadian Medical Association (CMA). CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Nonsmokers’ 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 May 13). 3 Canadian Medical Association (CMA). Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products. Ottawa: CMA; 2019 Mar 22. Available: https://policybase.cma.ca/en/permalink/policy14022 (accessed 2019 May 13). 4 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-youthnon-users-tobacco-products.html (accessed 2019 Feb 27). 5 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. 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 May 14). 6 6 Glantz SA. The Evidence of Electronic Cigarette Risks Is Catching Up with Public Perception. JAMA Network Open 2019;2(3):e191032. doi:10.1001/jamanetworkopen.2019.1032. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2729460 (accessed 2019 May 14). 7 McCausland K., et al. 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 May 14). 8 Food and Drug Administration (FDA). 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. Silver Spring, MD: FDA; February 11, 2019. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-data-demonstrating-rising-youth-use-tobacco (accessed 2019 May 17). 9 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 May 17). 10 Kuehn B. Youth e-Cigarette Use. JAMA. 2019;321(2):138. Available: https://jamanetwork.com/journals/jama/fullarticle/2720740 (accessed 2019 May 14). 11 Kirkum C. Philip Morris suspends social media campaign after Reuters exposes young 'influencers'. New York: Reuters; May 10, 2019. Available: https://www.reuters.com/article/us-philipmorris-ecigs-instagram-exclusiv/exclusive-philip-morris-suspends-social-media-campaign-after-reuters-exposes-young-influencers-idUSKCN1SH02K (accessed 2019 May 13). 12 Kirkham C. Citing Reuters report, health groups push tech firms to police tobacco marketing. New York: Reuters; May 22, 2109. Available: https://www.reuters.com/article/us-philipmorris-ecigs-socialmedia/citing-reuters-report-health-groups-push-tech-firms-to-police-tobacco-marketing-idUSKCN1SS1FX (accessed 2019 May 22). 13 McKelvey K, Popova L, Pepper JK, Brewer NT, Halpern-Felsher. Adolescents have unfavorable opinions of adolescents who use e-cigarettes. PLoS ONE 2018;13(11): e0206352. Available: https://doi.org/10.1371/journal.pone.0206352 (accessed 2019 May 14). 14 Calioa D. Vaping an 'epidemic,' Ottawa high school student says. Ottawa: CBC News; November 27, 2018. Available: https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 May 14). 15 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://doi.org/10.1371/journal.pone.0212353 (accessed 2019 May 17). 16 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/pdf/10.1056/NEJMe1900484?articleTools=true (accessed 2019 May 17). 17 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 May 20). 18 Reichardt EM., Guichon J. Vaping is an urgent threat to public health. Toronto: The Conversation; March 13, 2019. Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 May 20). 19 Chen JC. et al. Flavored E-cigarette Use and Cigarette Smoking Susceptibility among Youth. Tob Regul Sci. 2017 January ; 3(1): 68–80. Available: https://www.ncbi.nlm.nih.gov/pubmed/30713989 (accessed 2019 May 20). 20 LaVito A. FDA outlines e-cigarette rules, tightens restrictions on fruity flavors to try to curb teen vaping. New Jersey: CNBC; March 13, 2019 Available: https://www.cnbc.com/2019/03/13/fda-tightens-restrictions-on-flavored-e-cigarettes-to-curb-teen-vaping.html (accessed 2019 Mar 20). 21 Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there. Toronto: CBC News; November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 May 20). 22 Huang J, Duan Z, Kwok J, et al. Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tobacco Control 2019;28:146-151. Available: https://tobaccocontrol.bmj.com/content/tobaccocontrol/28/2/146.full.pdf (accessed 2019 May 21). 23 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 May 20). 24 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 May 20). 25 Kong G. et al. Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults. Nicotine & Tobacco Research, 2015 Jul;17(7):847-54. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674436/pdf/ntu257.pdf (accessed 2019 May 21). 26 Keamy-Minor E, McQuoid J, Ling PM. Young adult perceptions of JUUL and other pod electronic cigarette devices in California: a qualitative study. BMJ Open. 2019;9:e026306. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500190/pdf/bmjopen-2018-026306.pdf (accessed 2019 May 21). 27 Ghosh TS, Et al. Youth Vaping and Associated Risk Behaviors — A Snapshot of Colorado. N Engl J Med 2019; 380:689-690.Available: https://www.nejm.org/doi/full/10.1056/NEJMc1900830 (accessed 2019 May 21).
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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)
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Health Canada consultation on edible cannabis, extracts & topicals

https://policybase.cma.ca/en/permalink/policy14020
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association appreciates this opportunity to respond to Health Canada’s consultation on the proposed regulations for edible cannabis, cannabis extracts, and cannabis topicals. 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, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation, recommendations regarding Bill C-45. 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. Canada’s physicians have a longstanding concern about the health risks associated with consuming cannabis. , Consumers use these products for both recreational and medical purposes, compelling the need for accuracy in the labeling as well as quality control in the manufacturing process.10 Cannabis Edibles, Extracts and Topicals Cannabis will have a different effect on the user, depending on whether it is smoked or ingested, as in an edible. It has been found that “smoking marijuana results in clinical effects within 10 minutes, peak blood concentrations occur between 30 and 90 minutes, and clearance is complete within 4 hours of inhalation. Oral THC does not reach significant blood concentration until at least 30 minutes, with a peak at approximately 3 hours, and clearance approximately 12 hours after ingestion.” Because of the delay in absorption when ingested, people might consume more to feel the psychoactive effects faster. This might lead to the consumption of very high doses and result in toxic effects, such as anxiety, paranoia and in rare cases, a psychotic reaction with delusions, hallucinations, incoherent speech and agitation. Rates of use of edibles are not well known. A recent study in California high schools found that “polyuse via multiple administration methods was a predominant pattern of cannabis use and report the first evidence, to our knowledge, of triple product polyuse of combustible, edible, and vaporized cannabis among youths.” We are limiting our response to Health Canada’s consultation questions that pertain to the CMA’s position with respect to cannabis and relate to our expertise and knowledge base. Proposed THC limits for the new classes of cannabis products Standardization within all classes of cannabis products in a legal regime is essential. Tetrahydrocannabinol (THC) levels in black market products can vary widely so one can never be assured of the strength being purchased, creating the potential for significant harm. , Experience in jurisdictions where cannabis has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies.2 Prohibition of high potency products is important.3 THC limits should be based on the best available evidence of safety for consumers. The increased potency of cannabis over the years raises concerns about its use in edibles, extracts and topicals, offering a significant challenge with respect to regulating their use. This becomes particularly worrisome with respect to preadolescents and adolescents who should avoid using cannabis due to concerns with the impact on the developing brain.2 Use has been associated with a “significant increased risk of developing depression or suicidality in young adulthood.” More research is needed with respect to the effects of cannabis on all age groups, especially children, adolescents and seniors. Saunders et al describe the case of an elderly patient with a history of coronary artery disease suffering what appears to have been a myocardial infarction after ingesting most of a marijuana lollipop that contained 90 mg of THC. Such cases demonstrate how crucial it is to establish appropriate levels of THC. This is an especially important consideration because “consuming cannabis-infused edibles may inadvertently result in toxicity because absorption can take hours, compared with minutes when smoking. An individual who does not yet feel an effect may over-consume.” Small children and people with cognitive impairment will not be able to read labels, so preventive measures are very important, as with any pharmaceutical. Since legalizing cannabis, Colorado’s Rocky Mountain Poison & Drug Center has reported an increase in calls related to edible exposures. Children can accidentally eat products that contain cannabis, making them ill enough to seek medical assistance. The CMA maintains that the proposed draft regulations of 10 mg per discrete unit and package is too high and should be established at a maximum of 5 mg per dose, given the higher risks of overconsumption with edibles, the risks of accidents in children and the experience in other jurisdictions. Colorado’s limit was set at 10 mg per unit, and health authorities recognize that a lower limit would have been warranted to prevent more accidents. Other preventive measures, such as child proof packaging, are considered in other sections of this brief. The amount of THC must be displayed clearly and prominently on the package to help prevent accidental or overconsumption of the product. Rules addressing the types of ingredients and additives that could be used in edible cannabis, cannabis extracts, and cannabis topicals appropriately address public health and safety risks while enabling sufficient product diversity The CMA concurs with the proposed regulations. Experience in areas such as caffeinated, high-sugar alcoholic beverages provides ample evidence to proceed with restraint concerning the types of ingredients and additives that may be permitted in edible cannabis, cannabis extracts, and cannabis topicals. Proposed new rules for the packaging and labelling of the new classes of cannabis products The CMA reiterates its position with respect to the packaging and labelling of cannabis products as presented in its submission on the proposed approach to the regulation of cannabis.5 This includes:
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 an overdose. Plain and standardized packaging is necessary with respect to edibles as their wider availability raises several public health issues, not the least of which is ingestion by young children. It is imperative that the packages and labels of edibles not resemble popular confectionaries, for example. As the Canadian Paediatric Society has noted, “the unintended consumption of edibles manufactured to look like sweets by younger children is particularly concerning.”15 Also, by “restricting the extent to which marijuana edibles can look and taste like familiar sweets, (it) could also keep the psychological barriers to marijuana initiation among children and adolescents from being lowered.” The CMA has adopted similar positions with respect to tobacco and vaping products. , , It is recognized that these regulations are targeted at products meant for the adult market, but the entry of these new classes also creates challenges beyond that audience. Teens are attracted to vaping cannabis rather than smoking it because “smoke is not combusted and also may allow for more covert use given the reduction in odor.” , As well, as “edibles have no odor, they are largely undetectable to parents.”23 The CMA views this as an opportunity to educate Canadians about the health, social and economic harms of cannabis especially in young people. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Inserts should include:5
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. Cannabis topicals, as outlined in the proposed regulations, would fall under the category of health products and be found in non-prescription drugs, natural health products, and cosmetics. The CMA believes that all health claims need to be substantiated with sufficient evidence that meets standards for efficacy, besides safety and quality, to protect Canadians from misleading claims.5 This is important because 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 for effectiveness 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.5 Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. More research is required to address the environmental concerns with extra packaging, which would result from single dose packaging. It is critical to put in place measures that make it difficult to ingest large doses of THC. Simply adding grooves to chocolate bars or baked goods, for example, separating different doses, is insufficient to prevent people, particularly children, from ingesting more than a dose (which in of itself is designed for an adult). As well, there is no guarantee that the THC is spread out uniformly throughout the product. More research is needed with respect to “determining risks and benefits through proper clinical trials;” that includes determining the safest level of THC for extracts and topicals to reassure consumers will not be harmed by these products.18 With regards to cannabidiol (CBD), it would seem that “published data from around the world has taught us that misleading labels as well as harmful contaminants are real and actual problems for CBD products.”18 Health claims need to be substantiated via a strong evidentiary process. There will be a need for careful monitoring of the health products released in the market and the health claims made.5 Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Edible cannabis and the requirement for all products to be labelled with a cannabis-specific nutrition facts table Yes. The CMA supports the use of a cannabis-specific nutrition facts table (NFT) as described in the proposed regulations.1 These products should have the same standards and regulations applied to them as traditional food products do under the Food and Drugs Regulations. As such, a cannabis-specific nutrition facts table will help consumers differentiate them from standard food products. The proposal for the labelling of small containers and the option to display certain information on a peel-back or accordion panel The size of the container should not be an impediment to supplying consumers with the necessary information to make informed choices. Manufacturers should be required to use whatever method (peel-back or accordion panel) is most efficient and conveys all the necessary information. As the CMA noted in a recent brief with respect to tobacco labeling the “amount of 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, like that of a regular cigarette package.”20 Adding warnings on individual cigarettes, as we recommended, illustrates that it is feasible to apply important information to even the smallest surfaces.20 It is important to note that key information should be visible on the external part of the container, including the standardized cannabis symbol, ingredients and warnings. Proposal that the standardized cannabis symbol would be required on vaping devices, vaping cartridges, and wrappers Yes. As noted earlier, the CMA called for strict packaging requirements around both tobacco and vaping products.22 The requirement for the standardized cannabis symbol is an extension of that policy and to the labelling of cannabis products in general.5 Proposed new good production practices, such as the requirement to have a Preventive Control Plan, appropriately address the risks associated with the production of cannabis, including the risk of product contamination and cross-contamination Yes. The CMA concurs with this requirement. The requirement that the production of edible cannabis could not occur in a building where conventional food is produced Yes. The CMA concurs with this requirement. Separate facilities are necessary to prevent cross-contamination for the protection of consumer health and safety. Conclusion The CMA supports the federal government’s commitment to a three-year legislative review as it affords the opportunity to evaluate the regulations’ impact and adjust them as needed. It continues to be important to have good surveillance and monitoring systems, as well as to continue to learn from other jurisdictions where cannabis is legal for recreational purposes. Public education and awareness must accompany the introduction of new forms of cannabis, emphasizing the risks of accidental ingestion and overconsumption. It should also emphasize the need for safe storage of cannabis products, as well as personal possession limits. Much more research is needed into the impact of these new classes across all age groups, and into public health strategies that discourage use and increase harm reduction practices. It is fundamental that profit driven commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls, in a manner that is consistent with a public health approach. Government of Canada. Canada Gazette, Part I, Volume 152, Number 51: Regulations Amending the Cannabis Regulations (New Classes of Cannabis) Ottawa: Health Canada; 2018. Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-12-22/html/reg4-eng.html (accessed 2018 Dec 22). 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 Feb 01). 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 Feb 01). 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 Feb 01). 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 Feb 04). Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11138 (accessed 2019 Feb 14). Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://policybase.cma.ca/en/permalink/policy1968 (accessed 2019 Feb 14). Monte A, Zane R, Heard K. The Implications of Marijuana Legalization in Colorado JAMA. 2015 January 20; 313(3): 241–242 Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ (accessed 2019 Feb 15). Peters E, Bae D, Barrington-Trimis J, et al. Prevalence and Sociodemographic Correlates of Adolescent Use and Polyuse of Combustible, Vaporized, and Edible Cannabis Products JAMA Network Open. 2018;1(5): e182765. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703946 (accessed 2019 Feb 15). Wyonch R. Regulation of Edible and Concentrated Marijuana Products Intelligence Memos. Toronto: CD Howe Institute: 2018 Oct 2. Available: https://www.cdhowe.org/sites/default/files/blog_Rosalie_1002.pdf (accessed 2019 Feb 01). Vandrey R, Raber JC, Raber ME, et al. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. Research Letter JAMA 2015 Jun 23-30;313(24):2491-3. Available: https://jamanetwork.com/journals/jama/fullarticle/2338239 (accessed 2019 Feb 06). Cascini F, Aiello C, Di Tanna G. Increasing Delta-9-Tetrahydrocannabinol ( -9-THC) Content in Herbal Cannabis Over Time: Systematic Review and Meta-Analysis. Curr Drug Abuse Rev. 2012 Mar;5(1):32-40. Available: https://www.datia.org/datia/resources/IncreasingDelta9.pdf (accessed 2019 Feb 14). Gobbi G, Atkin T, Zytynski T, et al. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood. A Systematic Review and Meta-analysis JAMA Psychiatry. 2019 Feb 13. doi: 10.1001/jamapsychiatry.2018.4500. Available: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2723657 (accessed 2019 Feb 15). Saunders A, Stevenson RS. Marijuana Lollipop-Induced Myocardial Infarction. Can J Cardiol. 2019 Feb;35(2):229. Available: https://www.onlinecjc.ca/article/S0828-282X(18)31324-2/fulltext (accessed: 2019 Feb 11). Grant CN, Bélanger RE.Cannabis and Canada’s children and youth. Paediatr Child Health. 2017 May;22(2):98-102. Available: https://www.cps.ca/en/documents/position/cannabis-children-and-youth (accessed 2019 Feb 06). Denver Public Heath. Substance Use Exposure Dashboard. Denver: Denver Public Health; 2018. Available: http://www.denverpublichealth.org/community-health-promotion/substance-misuse/substance-use-exposure-dashboard (accessed 2019 Feb 06). Neuwirth, J. (Colorado Department of Public Health and Environment). Personal interview. (2019 Jan 30). Paradis C, April N, Cyr C, et al. The Canadian alcopop tragedy should trigger evidence-informed revisions of federal alcohol regulations. Drug Alcohol Rev. 2019 Feb 4. Available: https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.12896 (accessed 2019 Feb 14). MacCoun, RJ, Mello MM, Half-Baked — The Retail Promotion of Marijuana Edibles. N Engl J Med 2015; 372:989-991. Available: https://www.nejm.org/doi/full/10.1056/NEJMp1416014 (accessed 2019 Feb 5). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Feb 05). Canadian Medical Association (CMA). Health Canada’s Consultation on New Health-related Labelling for Tobacco Products Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13939 (accessed 2019 Feb 05). 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 Feb 05). Johnson RM, Brooks-Russell A, Ma M, et al. Usual Modes of Marijuana Consumption Among High School Students in Colorado. J Stud Alcohol Drugs. 2016;77(4):580-8. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987070/pdf/jsad.2016.77.580.pdf (accessed 2019 Feb 06). Friese B, Slater MD, Annechino R, et al. Teen Use of Marijuana Edibles: A Focus Group Study of an Emerging Issue. J Prim Prev. 2016 June 37(3):303–309. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4864086/pdf/nihms-766186.pdf (accessed 2019 Feb 06).
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Health Canada’s consultation on new health-related labelling for tobacco products

https://policybase.cma.ca/en/permalink/policy13939
Date
2018-12-14
Topics
Health care and patient safety
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2018-12-14
Topics
Health care and patient safety
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “New Health-Related Labelling for Tobacco Products - Document for Consultation, October 2018”. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use and for the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. Our response will follow the questions posed in the consultation document. Labelling on Individual Cigarettes Displaying a warning on individual cigarettes provides another means of conveying important health warnings about the hazards of smoking. The warnings should be like those that will be displayed on the leaflets included in the cigarette packages as well as the packages themselves. They should be of sufficient size, font and colour that will draw the attention of the smoker to the message. They should also be placed as close to the filter end of the cigarette as possible to remain visible for as long as possible. Health Information Messages The CMA has always supported educational and public health initiatives aimed at countering tobacco manufacturers messages that would render smoking attractive and glamorous to their customers. The health information messages and any leaflets included in the package must be of sufficient size, colour and font to prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior. The CMA supports strongly the concept of tobacco products being sold in standardized packages and we have recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would allow for the largest possible surface area to be used to convey health warnings and other health-related information. The CMA has recommended that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions. Toxic Statements (Includes Toxic Emissions Statements and Toxic Constituents Statements) The size, colour and design of new Toxic Statements proposed in the consultation document should be sufficient to be read and easily understood. The Statements should be rotated periodically to include new and updated information related to emissions and toxic constituents. Connecting Labelling Elements/ Quitline Information Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous, especially to young people. The CMA supports packages displaying prominent, simple and powerful health warnings, such as the graphic pictorial warnings, as well as quit tips and information on product content and health risks.2 Connecting the themes should help to reinforce the messages being conveyed with these labels. The size, colour, and placement of the proposed quitline and website information should be sufficient to maximize the noticeability of the information on various types of tobacco product packaging. Percentage of Coverage/Minimum Size of Health Warnings on Tobacco Products Other than Cigarettes and Little Cigars The amount of 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, like that of a regular cigarette package. Labelling for All Tobacco Products that Do Not Currently Require Labels The CMA supports mandatory health warnings being applied equally to all tobacco products. If package size allows, Health Warnings, Health Information Messages, and Toxic Statements should all be included. The messages should be relevant to the types of tobacco products they are covering. Labelling Rotation The rotation timeframe suggested in the consultation document of 12 to 18 months is a reasonable period. Government of Canada. New Health-Related Labelling for Tobacco Products. Document for Consultation Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-tobacco-labelling.html (accessed 2018 Oct 29). Canadian Medical Association (CMA) Tobacco Control (Update 2008). Ottawa: The Association; 2008. Available: http:// policybase.cma.ca /dbtw-wpd/Policypdf/PD08-08.pdf (accessed 2018 Dec 5). Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Nov 19). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2019-01.pdf (accessed 2018 Nov 19). Canadian Medical Association (CMA). Policy Resolution BD88-03-64 - Smokeless tobacco. Ottawa: The Association; 1987. Available: https://tinyurl.com/y7eynl5q (accessed 2018 Dec 5).
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Health Canada consultation on Canadian drugs and substances strategy

https://policybase.cma.ca/en/permalink/policy14017
Date
2018-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2018-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s consultation on new and innovative ideas on how to further strengthen the federal government’s health-focussed approach to substance use issues through the Canadian Drugs and Substances Strategy (CDSS) Question 1 What sorts of circumstances do you see within your networks, communities or in society that you think contribute to problematic substance use? There are multiple factors that contribute to problematic substance use. It is a serious, chronic and relapsing medical condition for which there are effective treatments. However, using the social determinants as a framework, most health promotion and prevention efforts will take place outside of the traditional health and medical care services. . Many Canadians face barriers in their physical, social and economic environments which can contribute to problematic substance use, and certain populations are at higher risk given these circumstances. For example, early childhood is a critical time in the social, emotional, cognitive and physical development of a person. Experiences in early life can ‘get under the skin’, changing the ways that genes are expressed. Negative experiences such as poverty or family or parental violence can have significant impacts on this important period of development. What is necessary is a coordinated effort across government sectors to ensure that all policy decisions serve to increase opportunities for health. Improving population health and reducing inequities should be an overall objective for all governments in Canada. Question 2 Have you seen or experienced programs, practices or models at the local or regional level that could be expanded, or implemented more broadly, to improve circumstances or social determinants of health that influence substance use? Income is critical to individual health and is closely linked to many of the other social determinants of health. These include but are not limited to: education, employment, early childhood development, housing, social exclusion, and physical environment. Adequate consideration must be given to the social and economic determinants of health, factors such as income and housing that have a major impact on health outcomes. Minimizing poverty should be a top priority. In 2015, the CMA passed a resolution endorsing the concept of a basic income guarantee, which is a cash transfer from government to citizens not tied to labour market participation. It ensures sufficient income to meet basic needs and live with dignity, regardless of employment status. A basic income guarantee has the potential to alleviate or even eliminate poverty. It has the potential to reduce the substantial, long-term social consequences of poverty, including higher crime rates and fewer students achieving success in the educational system. Drug use must not be treated with a criminal justice approach, which does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. More investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system. Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Question 3 What needs to change to make sure that opioid medications are being provided and used appropriately, based on the needs of each patient? Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. Doctors support patients in the management of acute and chronic pain, as well as problematic substance use, and as such have long been concerned about the harms associated with opioid use. Treatment options and services for both problematic substance use as well as pain management are woefully under-resourced in Canada. Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals; non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies; appropriate pharmaceutical prescription options, covered by provincial formularies; and a focus on patient participation and empowerment.12 Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. It is also important to support clinicians in their practice. The 2017 Opioid Prescribing Guidelines need to be kept current through ongoing funding. Physicians require tools, including those that facilitate monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; and, tapering of problematic or ineffective doses. Question 4 How can we make sure that those who require prescription opioids to manage their pain have access to them, without judgement or discrimination? Governments need to incorporate the identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. They also need to implement and evaluate national public awareness and education strategies to counteract the stigma associated with substance use issues as well as enforcing legislation and regulations to guard against discrimination against people with mental and substance use issues. Health professionals need to have access to education on pain management and treatment of problematic substance use, recognizing both issues as serious medical conditions for which there are effective treatments. Question 5 Which kinds of messages would work best to help Canadians understand the serious harms that can result from stigma around substance use? A recent report from the Canadian Centre on Substance Use and Addiction (CCSA) and Public Safety Canada cited stigma as “an enormous barrier to individuals seeking and maintaining treatment.” Even though there is broad recognition that we are in a public health crisis, until very recently the focus of the federal National Anti-Drug Strategy was heavily skewed towards a criminal justice approach rather than a public health approach with an emphasis on enforcement, as opposed to prevention, treatment and harm reduction.8 This has serious implications in how society views people who use drugs. As noted in the CCSA-Public Safety report, “Language matters. Speak about people first, with compassion and respect.”13 A stigma reduction strategy must be core to the activities of the federal government. Stigma involves thoughts, emotions and behaviours; thus, a comprehensive approach includes interventions to target each of these dimensions at both the individual and population level. The strategy should include aspects of: * Public awareness and education to facilitate understanding about the importance of early diagnosis, treatment, recovery and prevention; * Enhanced provider/student education and support; * Policy analysis and modification of discriminatory legislation; * Support for a strong voluntary sector to voice the concerns of patients and their families; * Exposure to positive spokespeople (e.g. prominent Canadians) who have mental illness and/or addiction in order to highlight success stories; * Researching stigma. Question 6 How can we best act to reduce stigma across the country? Engagement with people who use drugs to help them share their stories and experiences with stigma with the public Question 7 What would you recommend to improve substance use treatment services in Canada? This challenge requires a complex and multifaceted solution; and to further this aim, Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the other two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant. One of the fundamental principles of health care is that it be patient centred.11 CMA defines patient-centred care as “seamless access to the continuum of care in a timely manner … that takes into consideration the individual needs and preferences of the patient and his/her family and treats the patient with respect and dignity.” It is essential that patients be core members of the health care team, working with health care providers to address their individual needs, preferences and aspirations and to seek their personal paths to well-being. Physicians and other health professionals can help patients make choices about their treatment and can provide information and support to patients and their families as they seek to cope with the effects of problematic use and live functional lives. The health care provider community needs tools to assist in the reduction of stigma, access to resources and supportive environments. Question 8 What obstacles or barriers do people face when they want to access treatment in Canada? Obstacles to treatment include the lack of publicly-funded treatment centres, access to locations for remote areas, limited number of beds available, the cost of private treatment (lack of insurance), and stigma. The CMA supports the enhancement of access to options for treatment that address different needs.12 Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that treatment programs be culturally relevant for Indigenous communities. Question 10 In addition to current harm reduction initiatives – such as supervised consumption sites, needle exchange programs – what other harm reduction services should governments consider implementing in Canada? There is a dire need to address harm reduction in prisons. Even back in 2005, the CMA recommended to the Correctional Service of Canada that it develop, implement and evaluate a pilot needle exchange program in prison(s) under its jurisdiction. These services are not widespread and accessible to prison populations. In Canada, people in prison face far greater risk of HIV and hepatitis C infection because they are denied access to sterile injection equipment as a harm reduction strategy. Hospitals need to incorporate harm reduction strategies as well, allowing people who use drugs to access much needed health services. Question 12 How can we better bring public health and law enforcement together to explore ways to reduce the cycle of involvement for people who use substances with the criminal justice system? Training for police and other frontline criminal justice and corrections workers in how to interact with people with substance use issues is essential. The CMA believes that the government must take a broad public health policy approach. Changes to the criminal law affecting cannabis must not promote normalization of its use and must be tied to a national drug strategy that promotes awareness and prevention and provides for comprehensive treatment.13 The CMA recognized that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach. The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug's physiological harm. Question 13 What further steps can the federal government take to better address current regulation and enforcement priorities, such as addressing organized drug crime and the dangerous illegal drugs like fentanyl being brought into Canada? The federal government must continue to work closely with the RCMP, local and provincial law enforcement agencies, Canada Post, the Canadian Border Services Agency, Crown attorneys, the Canadian military, and international health officials and law enforcement agencies to address this issue. This topic was covered in the recent CCSA/Public Safety Canada report.10 Question 14 Recognizing Indigenous rights and self-determination, how can all governments work together to address the high rates of problematic substance use faced by some Indigenous communities? Difficulties in access are particularly acute for Canada's Indigenous peoples. Many live in communities with limited access to health care services, sometimes having to travel hundreds of miles to access care. Additionally, there are jurisdictional challenges; many fall through the cracks between the provincial and federal health systems. While geography is a significant barrier for Indigenous peoples, it is not the only one. Indigenous peoples living in Canada's urban centres also face difficulties. Poverty, social exclusion and discrimination can be barriers to needed health care. Of all federal spending on indigenous programs and services only 10% is allocated to urban Aboriginals. This means that Aboriginals living in urban areas are unable to access programs such as Aboriginal head start, or alcohol and drug services, which would be available if they were living on reserve. Further, even when care is available it may not be culturally appropriate. Canada's indigenous peoples tend to be over-represented in populations most at risk and with the greatest need for care, making the lack of access a much greater issue for their health status. It is important that problematic substance use programs be culturally relevant for Indigenous communities. It is clear that the First Nations and Inuit peoples of Canada experience mental illness, problematic substance use and poor mental health at rates exceeding that of other Canadians.11 Individual, community and population level factors contribute to this including socioeconomic status, social environment, child development, nutrition, maternal health, culture and access to health services. The urgent need to work with these communities and identify the structures and interventions to reduce the burden of mental illness and substance use is critical to the health and wellness and future of First Nations and Inuit peoples. Enhanced federal capacity should be created through First Nations and Inuit Health that will provide increased funding and support for First Nations and Inuit community health strategies. The establishment of a working groups comprised of First Nations and Inuit health experts and accountable to First Nations and Inuit leadership is essential for the success of this initiative. Both expert and resource supports are integral elements to facilitate and encourage culturally appropriate strategies and programming in these communities. Question 15 What can we learn from Indigenous approaches to problematic substance use, such as using holistic approaches, that may help inform activities under the CDSS? The federal government must consult First Nations, Inuit, and Métis representatives to develop programs that are culturally relevant and appropriate for Indigenous communities. Question 16 How can governments, and the health, social, and law enforcement sectors design more effective substance use policies and programs for at-risk populations? The government must identify and consult those communities and populations most at risk. This includes First Nations, Inuit, and Métis representatives, community advocates, municipalities, and provincial and local public health officers. Data that describes rates of use and issues specific to each at risk group is important to be able to better understand and address needs. Question 17 What are effective policies and programs to help improve access to prevention, treatment, and harm reduction services for at-risk populations? There are innovative approaches to address the needs of high-volume users as well as at-risk populations. As many of these involve greater integration between health and the community sector and attention to issues not traditionally funded through health care payment systems, there is a need to provide access to funds to enable these innovations to continue and be spread across the country. A targeted, integrated approach to identify communities in need is required and this must be based on reliable community data (i.e., meaningful use of patient data) which can be used to integrate resources to improve health status. For example, the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) is Canada's first multi-disease electronic medical records (EMR) surveillance and research system that allows family physicians, epidemiologists and researchers from across the country to better understand and manage chronic care conditions for their patients. Health information is collected from EMRs in the offices of participating primary care providers (e.g. family physicians) for the purposes of improving the quality of care for Canadians suffering from chronic and mental health conditions and three neurologic conditions including Alzheimer's and related dementias. CPCSSN makes it possible to securely collect and report on vital information from Canadians' health records to improve the way these chronic diseases and neurologic conditions are managed (http://cpcssn.ca/). Question 18 What urgent gaps related to substance use (in terms of data, surveillance, and/or research) need to be addressed in Canada? Improvements are being made in the collection of data in Canada. This is crucial to be able to assess the harms and track the trends and impact of the introduction of policy changes.12 As well, the government must continue to improve the ability of the Public Health Agency of Canada, the Canadian Institute of Health Information, the chief coroners of Canada and related agencies to collect, analyze and report data. One such program is the surveillance system in the United States called RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance system) that is “a surveillance system that collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs.” It surveys data involving opioids including poison control centres, treatment programs, on the “illicit acquisition or distribution of prescription opioids, stimulants, and other prescription drugs of interest from entities investigating drug diversion cases,” among other opioid-related issues. The CMA has recommended that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring. Prescription Monitoring Programs (PMP) should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary. Further, PMPs are a valuable component in addressing the gaps related to substance use. Question 19 How can we use research tools to better identify emerging substance use issues as early as possible? See above response to question 18 - “RADARS” Government of Canada. Consultation on strengthening Canada’s approach to substance use issues. Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-strengthening-canada-approach-substance-use-issues.html (accessed 2018 Sep 5). Canadian Medical Association (CMA). Health in all policies. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-10.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Early childhood development. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Canadian Medical Association Submission on Motion 315 (Income Inequality). Ottawa: The Association; 2013. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2013-07.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). CMA’s recommendations for effective poverty reduction strategies. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-04.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Bill C-2 An Act to amend the Controlled Drugs and Substances Act. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-11.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed: 2018 Nov 26). Canadian Medical Association (CMA). Non-prescription availability of low-dose codeine products. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-04.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Health Canada consultation on restriction of marketing and advertising of opioids. Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-13.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Joint Canadian Medical Association & Canadian Psychiatric Association Policy - Access to mental health care. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed 2018 Nov 26). Public Safety Canada, Canadian Centre on Substance Use and Addiction. 2018 Law Enforcement Roundtable on the Opioid Crisis. Meeting Summary. Ottawa; 2018. Available: https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/lw-nfrcmnt-rndtbl-pd-crss-2018/index-en.aspx?utm_source=stakeholders&utm_medium=email&utm_campaign=opioidcrisis (accessed 2018 Nov 29). Canadian Medical Association (CMA). Study on Mental Health, Mental Illness and Addiction in Canada: Supplementary Submission to the Senate Standing Committee on Social Affairs, Science and Technology. Ottawa: The Association; 2006. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2006-01.pdf (accessed 2018 Nov 29). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 2018). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Nov 28). Canadian Medical Association (CMA). Ensuring equitable access to health care: Strategies for governments, health system planners, and the medical profession. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-04.pdf (accessed 2018 23 Nov). Canadian Medical Association (CMA). Submission to Advisory Panel on Healthcare Innovation. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-06.pdf (accessed 2018 Nov 29). Radars System. 2018. Available: https://www.radars.org/. (accessed: 2018 Nov 29). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Dec 4). Sproule B. Prescription Monitoring Programs in Canada: Best Practice and Program Review. Ottawa, ON, 2015 Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Prescription-Monitoring-Programs-in-Canada-Report-2015-en.pdf (accessed 2018 Dec 4).
Documents
Less detail

Implementation of National Pharmacare

https://policybase.cma.ca/en/permalink/policy13933
Date
2018-10-02
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-10-02
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes this opportunity to provide input to the Advisory Council on the Implementation of National Pharmacare (Advisory Council) on the issues set out in its discussion paper.1 The striking of the Advisory Council by the federal government is long overdue. We will focus on the questions set out in the discussion paper and draw attention to more specific issues that the Advisory Council should consider as it develops its final report. At the outset, Canada’s physicians are very concerned about their patients’ access to prescription medicines. A June 2018 survey of the CMA member e-panel found the following:
71% reported that they always/often ask their patients if they have prescription drug coveragebefore writing a prescription;
60% reported that greater than 20% of their patients are either uncovered or inadequatelycovered for prescription drugs; and
79% reported that copayments pose affordability challenges among their patients with drugcoverage and that they resort to a variety of strategies to help them. Indeed, when asked to pick one of three options for a national prescription program, the results were as follows:
57% - a single, national, public pharmacare plan operated by the federal government and fundedby taxes collected by the federal government;
34% - a mix of private prescription drug plans operated by private insurance companies andpublic drug plans run by the provinces and territories, supplemented by a prescription drug planprovided by the federal government for persons with high out-of-pocket drug costs; and
9% - separate regional, public pharmacare plans in each province and territory, funded by taxescollected by both the federal government and the provincial governments. Who should be covered under national pharmacare? / How should national pharmacare be delivered? The CMA’s position is that all Canadians should have access to medically necessary drugs regardless of their ability to pay. The challenge is how to resolve the issue of the most expedient and affordable means of achieving this in a manner that is acceptable to the provincial/territorial governments. At the present time there are two main options that are being discussed. The first is the approach recommended by the Standing Committee on Health (HESA) that calls for the development of a common national prescription drug formulary and the amendment of the Canada Health Act to include out-of-hospital prescription drugs in the definition of insured health services; essentially a universal, single public payer program.2 The second is the “closing the gap” or “catastrophic coverage” approach recommended previously by the Kirby and Romanow commissions, and which was one of the unfulfilled commitments that First Ministers made in the 2003 Health Accord. There is a large difference in the cost of these two approaches. Regarding the first, the federal Parliamentary Budget Office (PBO) has estimated the net cost to the federal government of assuming the cost of a pharmacare program modelled on the Quebec drug formulary at $19.3 billion in 2015-16, increasing to $22.6 billion in 2020-21.3 Regarding the second approach, in 2002 the Kirby commission suggested that a catastrophic drug program with a cap of 3% of family income would cost $500 million per year.4 A 2015 study by the Conference Board estimated that a program with a cap of 3% of household income or $1,500 would cost the federal government $1.6 billion in 2016, increasing to $1.8 billion in 2020.5 There are parallels between the present situation with insurance coverage for prescription drugs and the insurance coverage for medical services that existed at the time of the Hall Commission (1961-1964). 4 In 1961 there were 9.6 million Canadians with some form of medical insurance or prepayment coverage, representing 53% of the population.6 Almost one-half of this number (4.5 million) were covered by the physician-sponsored not-for-profit Trans-Canada Medical Plans.7 In its 1962 brief to the Hall Commission the CMA projected that this percentage would increase to 67% by 1970 and it recommended a “closing the gap” approach for the uninsured and under-insured: That, for the 1,520,000 persons, or approximately 8% of Canada’s population who may adjudged to be medically indigent, tax funds be used to provide comprehensive medical insurance on services…for persons in economic circumstances just superior to the identifiable indigent we recommend the application of tax funds on proof of need to permit the partial assistance which they require.8 After Hall reported in 1964 with the recommendation of first dollar public Medicare, as they say, the rest is history. More than 50 years after the initial passage of the Medical Care Act in 1966, virtually nobody would suggest that Canada got it wrong. In the case of pharmacare today, the circumstances are somewhat different. First the prevalence of prescription drug insurance is much higher today than medical insurance was back in the early 1960s. A 2017 report from the Conference Board estimates that just 5.2% of Canadians are uninsured for prescription drugs.9 Other survey estimates indicate that roughly one in 10 Canadians report financial difficulty in filling prescriptions10, although some surveys have yielded higher results, such as a September, 2018 Abacus Data poll that found that 23% of Canadians reported that the medicines they need are unaffordable.11 Second, the role of the provincial/territorial (PT) governments paying for prescription drugs today is much greater than their role in paying for medical services prior to Medicare. In 1961 it was estimated that all public sources accounted for 12.4% of medical care expenditures.12 In 2017, PT governments accounted for an estimated 37% of prescription drug spending.13 It is also instructive to consider how Medicare ramped up from its initial spending under the Hospital Insurance and Diagnostic Services Act in 1958-59 through to the first payments under the Medical Care Act a decade later, shown in Table 1. The table shows clearly that Medicare payments increased gradually over the two stages. Medicare as a share of total federal program spending increased from 1% in 1958-59 to a high of 11% in 1971-72. Interestingly, federal spending on Medicare never reached the 50/50 cost-sharing that was offered, reaching 36% in 1976-77, the year prior to the Established Programs Financing Act coming into effect. As an aside, according to the 2017 Fall Economic statement the Canada Health Transfer, valued at $37.1 billion in 2017-18 represents 12.2% of program spending.14 This history highlights the need to consider how the federal government might phase in the program recommended by HESA given the cost estimated by the PBO at $19.3 billion. This appears a daunting challenge in light of the recent increases in federal health funding, which amount to annual increases in the Canada Health Transfer of just over $1 billion plus the $11 billion allocated in the 2017 federal budget over a 10-year period for home care and mental health.15 There is no disagreement that at the present time the fiscal prospects are better for the federal than the PT governments. In its 2018 Fiscal Sustainability Report, the PBO reported that over the 2018-92 projection period the federal government could either increase annual spending or reduce taxes by 1.4% of Gross Domestic Product ($29 billion) and maintain its net debt at the current (2017) level.16 However, the government has many other spending priorities. Conversely, sub-national governments would be required to either increase taxes or reduce spending by 0.8% of GDP or ($18 billion) to maintain net debt at the current level. The CMA has previously recommended that the federal government pursue a “close the gap” approach in partnership with the PT governments and the private insurance industry. This approach could be scaled up toward a full national public pharmacare by either or both of lowering the household income threshold or raising the level of federal contribution.17 However this has never developed any serious momentum. While the first Ministers committed in their 2003 Accord to take measures, by the end of 2005/06 to ensure that Canadians, wherever they live, have reasonable access to catastrophic coverage,18 this ran aground with the first and only progress report of the National Pharmaceuticals Strategy in 2006.19 It was 5 evident in the report that much of the current public funding had been shifted into the catastrophic category, ranging from $6.6 billion to $10.3 billion across the four scenarios presented. The only further public PT government pronouncement on a catastrophic drug plan was a three-point proposal set out in a backgrounder for the PT health Ministers meeting in 2008 calling for a funding formula that would: protect the autonomy of the PTs in program design; set a ceiling of 5% of income; and recognize the federal government’s role as an equal partner with 50/50 cost sharing of a total estimate cost of $5.03 billion (2006).20 The amount of $5.03 billion would have represented 62% of PT spending on prescription drugs in 2006. More recently, an “essential medicines” approach to universal pharmacare has been put forward by Morgan and colleagues, modelled on 2015 data. Essential medicines are defined by the World Health Organization (WHO) as those that satisfy the priority health care needs of the population.21 WHO maintains a model list of essential medicines, and the 2017 version contains some 430 medications.22 Using a multi-step review process, Taglione and colleagues adapted the 2013 version of the WHO list to produce a shorter list of 125 medications that they assessed against the prescription audits of two Toronto-based family health teams comprising 4,777 and 35,554 patients in 2014. They reported 90.8% and 92.6% coverage with the preliminary list of 125 medications in the two sites respectively.23 The list is now called the CLEAN Meds list (http://cleanmeds.ca/). Morgan and colleagues used 117 items from the CLEAN Meds list to model the impact of adding universal public coverage of an essential medicines list to the existing public drug plans in Canada, based on 2015 data. They reported the following base case results:
Total public expenditure would increase by $1.229 billion to $11.99 billion;
Total private expenditure would decrease by $4.272 billion to $11.172 billion; and
Public expenditure on essential medicines would be $6.14 billion, representing 51% of the total$12 billion in total public expenditure.24 In further research conducted for the Patented Medicine Prices Review Board (PMPRB), Morgan examined the listing of the CLEAN Meds list across the public formularies in Canada for 2015 and found that the public plans listed 93% on average of the 125 medicines, and that this increased to 98% when weighted by drug plan costs.25 The Institute of Fiscal Studies and Democracy at the University of Ottawa has done a similar analysis of 128 medications on the CLEAN Meds list and coverage ranged across provinces from Manitoba at the bottom (with 88 covered completely and 8 requiring special authorization) to Quebec at the top with coverage of 121 items.26 This would suggest that one approach would be for the federal government to offer to cover universal coverage for essential medicines, which would cost at least $6 billion. There would be coordination issues with both public and private plans, as was the case when Ontario introduced OHIP + in early 2018 to extend coverage to persons under 25.27 This could be subsequently scaled up by adding coverage for additional medications. In terms of how pharmacare should be delivered, that will depend on how far the federal government wants to go. Could the federal government administer a national pharmacare program? It already controls levers including drug approval by Health Canada and price-setting through the PMPRB, and it provides the majority (70%) of funding to the Canadian Agency for Drugs and Technologies and Health which oversees the Common Drug Review.28 In May, 2015 Canadian Blood Services (CBS) CEO Dr. Graham Sher proposed that CBS could be considered as a model for national pharmacare, given its history of running a national (except Quebec) formulary of plasma protein drugs at no cost to patients.29 In his subsequent testimony to the HESA pharmacare study Sher described CBS’ success in negotiating price reductions through public tendering and bulk purchasing’ although he did also note that their formulary includes 45 brands and classes of plasma protein products, far fewer than the thousands of items in PT formularies.30 More recently Flood et al. have suggested that one option for pharmacare could involve the PT governments delegating authority to an arm’s-length agency similar to CBS that would purchase drugs and administer drug benefits.31 6 However, in the comuniqué following their June 2018 meeting the PT health Ministers emphasized that provinces and territories must retain responsibility for the design and delivery of public drug coverage…Quebec will maintain its own program and will receive comparable compensation if the federal government puts a pan-Canadian program in place.32 This was repeated by the Premiers in their communiqué three weeks later, which would suggest that a national agency approach is a non-starter. Moreover, none of the PT drug plans testified to the HESA pharmacare study. One issue that has received scant attention in all of the discussions about pharmacare since 2015 is the future role of private supplementary health insurance. When Medicare came in in the late 1960s, while the expenditures increased steadily, enrolment in non-profit medical insurance plans disappeared virtually overnight, dropping from 8.3 million enrollees in 1968 to 1.1 million in 1970 and none thereafter.33 This appears unlikely to happen to private insurance in the foreseeable future. For example, in the essential medicines modeling done by Morgan et al. the essential medicines would represent just 27% of total prescription drug expenditures and all public drug expenditures would account for 52% of the total.24 If the federal and PT governments were able to collectively “wave a magic wand” and come up with the PBO’s $19.3 billion and a purchasing and distribution strategy it seems likely that this would raise questions about the continued viability of the health insurance benefits industry. In their testimony to HESA, the Canadian Life and Health Insurance Association did allude to an impact on the industry should prescription drugs become a public program but was not specific.34 We have been unable to locate any international comparative literature on the structure of the health benefits industry. In 2017 CLHIA’s members paid out $11.3 billion in drug benefits, representing 44% of the $25.5 billion total. Dental benefits accounted for $8.1 billion, or 32% of the total.35 Dental benefits paid by CLHIA members accounted for two-thirds (65%) of the estimated total expenditures on dental benefits in Canada in 2017; just 6% were publicly funded.13 Socio-economic inequalities in access to dental care are well-documented36, but this issue is nowhere on the public policy agenda. In addition, any transition from private to public coverage will require some administrative coordination. As noted above, Morgan et al. estimated that an essential medicines approach would reduce private spending by $4.2 billion, a large proportion of which would be currently paid for by private insurance.24 Which drugs should be covered/how much variability across jurisdictions should there be? In terms of which drugs should be covered, the CMA believes that optimal prescribing is the prescription of a drug that is:
The most clinically appropriate for the patient’s condition;
Safe and effective;
Part of a comprehensive treatment plan; and
The most cost-effective drug available to meet the patient’s needs.37 There is no dispute that private insurance companies offer wider formularies than the public drug programs. In their 2017 study the Conference Board compiled information on the number of drugs dispensed in 2015 through: both public and private plans, public plans only; and private plans only. This was presented for nine provinces, excluding PEI. Across the nine provinces, the following averages were observed:
4,878 drugs were dispensed from both public and private plans;
336 drugs were dispensed from public plans only;
1,938 drugs were dispensed from private plans only.9 On the 2018 CMA member e-panel survey, physicians were much more likely to report formulary coverage issues with their patients who with public coverage than they were for their patients with Private coverage. More than five in 10 (54%) physicians reported that they always/often have formulary coverage 7 issues with their publicly insured patients versus just over one in 10 (13%) for their privately insured patients. If the federal government plans to pursue national pharmacare Canadians should be well-informed about the range of prescription drugs that will be available to them. In terms of the variability of coverage, if pharmacare or some portion of it becomes a publicly insured service it should be offered to all Canadians under uniform terms and conditions, as specified in the CHA. In practical terms, Morgan and colleagues have previously demonstrated that there is a high degree of commonality in the formularies across the public drug programs. Based on a review of 2006 formulary listings of 796 drugs across all provincial formularies except PEI, they found that coverage ranged from 55% to 73%, but when weighted by national retail sales the measure of formulary coverage exceeded 86% in all 9 provinces.38 More recently, in the 2017 PMPRB study of formulary coverage Morgan studied 729 drugs across all provinces and the Non-Insured Health Benefits Plan for 2015. The public plans listed an average of 79% of the 729 drugs, and this increased to 95% when drug costs were factored in.25 These findings would lend further support to the case for an essential medicines approach to national pharmacare. Should patients pay a portion of the cost of drugs/should employers continue to play a role? If the federal government intends to define out-of-hospital prescription drugs as an insured service under the CHA it will be necessary to address the feasibility of first dollar coverage in light of the accessibility criterion that prohibits user charges. The CMA addressed this issue in our 2016 brief to the HESA pharmacare study with reference to Scotland, which eliminated prescription charges in April, 2011.39 There are now more recent data. In the four years leading up to the elimination of prescription charges the volume of prescriptions dispensed increased by 3.6% annually. In the seven years since the charges were eliminated, the annual increase has been 1.8%; indeed between 2016/17 and 2017/18 there was a decrease of 0.06%.40 It should be added however that dispensing charges only accounted for 3% of prescription costs in 2008/09. Wales and Northern Ireland have also eliminated prescription charges for their citizens. The experiences of these countries should be examined more closely. There has been very little research on how employers would react to the implementation of a full or partial public pharmacare plan. Ipsos conducted research among the employer community in 2012. Just under one in two (47) of respondents indicated that they would support a public program for supplementary benefits introduced by the federal government that was funded by increased taxes, but nearly nine in ten agreed that even if the government implemented a program I would recommend that our company/organization still offer a supplementary health benefits program (over and above the government offer) because it would give us an advantage in recruiting/retaining employees.41 If some form of a public pharmacare program is implemented, this will reduce the amount of drug benefits that private insurance companies are required to pay out, which should result in lower premiums for those employers who provide supplementary benefits. The implications of this in terms of how a pharmacare program might be funded have not received much scrutiny to date. However, regardless of the notionally ear-marked health taxes or premiums that are levied against businesses or individuals, Medicare has been paid for out of general tax revenues. Conclusion In conclusion, the initial modeling study published by Morgan et al. in 201542 has resulted in welcome attention to the longstanding issue of access to prescription drugs for Canadians who are either uninsured or under-insured. However the discussions have been light on how we could transition to a situation where Canadians can access prescription drugs on the same basis as they access medical and hospital services. This would require concerted discussion between the federal and PT governments and 8 the health insurance benefits industry and this has not yet occurred. The discussions since 2015 have mainly ignored the issue of highly expensive drugs for rare diseases and very expensive drugs for more common diseases, such as biologic drugs for rheumatoid arthritis. The CMA is pleased to see that HESA is launching a study on the barriers to access to treatment and drugs for Canadians with rare diseases and disorders.43 Recommendations The Canadian Medical Association recommends that the Advisory Committee on the Implementation of National Pharmacare: 1.Engage with the federal and provincial/territorial governments and the health insuranceindustry on the feasibility of a universal federally funded “essential medicines”prescription drug plan as a scalable approach to the implementation of a nationalpharmacare plan. 2.Engage the business community and the health insurance industry on the question of thecontinued viability of the provision of supplementary health benefits (e.g. dental care)should a national pharmacare plan be implemented. 3.Study the international experience of Scotland and other countries with respect to theprovision of first dollar coverage of prescription drugs. 9 Table 1. The Evolution of Medicare ($ million) Year HIDS Medical Care Act Total program spend Medicare as a % of total program Total hospital spend Total physician spend Medicare as a % of total H&P 1958-59 54.7 0 4716 1% 640.608 301.337 6% 1959-60 150.6 0 4919.4 3% 735.626 325.689 14% 1960-61 189.4 0 5160.5 4% 834.932 355.014 16% 1961-62 283.9 0 5681.6 5% 930.568 388.305 22% 1962-63 336.7 0 5652.5 6% 1031.749 406.075 23% 1963-64 392.2 0 5878.7 7% 1150.306 453.395 24% 1964-65 433.9 0 6167 7% 1273.38 495.657 25% 1965-66 319.6 0 6623.9 5% 1434.274 545.056 16% 1966-67 397.4 0 7589.2 5% 1637.647 605.2 18% 1967-68 468.6 0 8497 6% 1880.699 686.189 18% 1968-69 561.9 33 9258 6% 2179.906 788.089 20% 1969-70 635.9 181 10204 8% 2456.687 901.435 24% 1970-71 734.3 400.5 11262 10% 2775.391 1031.555 30% 1971-72 844.6 576.5 12831 11% 3095.367 1239.775 33% 1972-73 960.5 630.8 16324 10% 3384.801 1375.127 33% 1973-74 1065.7 677.9 20247 9% 3803.61 1471.971 33% 1974-75 1307.6 762.7 26037 8% 4579.041 1647.025 33% 1975-76 1709.2 795.8 30023 8% 5533.707 1900.483 34% 1976-77 2030.5 1003.6 34209 9% 6357.3 2071 36% Sources: Hospital Insurance and Diagnostic Services (HIDs) and Medical Care Act – Public Accounts of Canada Issues 1958-59 – 1976-77. Spending by National Health and Welfare. Total program spend – Public Accounts of Canada Issues 1958-59-1976-77. Budgetary Expenditures Classified by Function – Total spend less public debt charges. Total hospital and physician spend – calendar year data 1958 – 1975 in Statistics Canada, Historical Statistics of Canada. Series B504-513 Health expenditures, Canada, 1926 to 1975. 1976 – Canadian Institute for Health Information. National Health Expenditures Data Tables Table A.3.1.1. 1 Government of Canada. Towards implementation of national pharmacare. Discussion paper. https://www.canada.ca/content/dam/hc-sc/documents/corporate/publications/council_on_pharmacare_EN.PDF. Accessed 10/02/18. 2 House of Commons Standing Committee on Health. Pharmacare now: prescription medicine coverage for all Canadians. http://www.ourcommons.ca/Content/Committee/421/HESA/Reports/RP9762464/hesarp14/hesarp14-e.pdf. Accessed 10/02/18. 3 Office of the Parliamentary Budget Officer. Federal cost of a national pharmacare program. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2017/Pharmacare/Pharmacare_EN_2017_11_07.pdf. Accessed10/02/18. 10 4 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. https://sencanada.ca/content/sen/committee/372/soci/rep/repoct02vol6-e.pdf. Accessed 10/-2/18.5 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 10/02/18.6 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965.7 Clarkson G. The role of Trans-Canada Medical plans in Canadian medical insurance. News & Views on the Economics of Medicine 1966, Number 136.8 Canadian Medical Association. Submission of the Canadian Medical Association to the Royal Commission on Health Services. Toronto, 1962.9 Conference Board of Canada. Understanding the gap: a pan-Canadian analysis of prescription drug insurance coverage. https://www.conferenceboard.ca/temp/7bef4501-6ba6-4527-8b99-8b788c461d14/9326_Understanding-the-Gap__RPT.pdf. Accessed 10/02/18.10 Canadian Institute for Health Information. How Canada compares: Results from the Commonwealth Fund’s 2016 International Health Policy Survey of Adults in 11 Countries.https://www.cihi.ca/sites/default/files/document/commonwealth-fund-2016-chartbook-en-web-rev.pptx. Accessed10/02/18.11 Abacus Data. Canadian perspectives on pharmacare. http://abacusdata.ca/canadian-perspectives-on-pharmacare/. Accessed 10/02/18.12 Royal Commission on Health Services. 1964—Report Volume 1. Ottawa: Queen’s Printer, 1964.13 Canadian Institute for Health Information. National health expenditure trends 1975 to 2017: data tables.https://www.cihi.ca/sites/default/files/document/series_b-nhex2017-en.xlsx. Accessed 10/02/18.14 Department of Finance Canada. Progress for the middle class. Fall economic statement 2017.https://www.budget.gc.ca/fes-eea/2017/docs/statement-enonce/fes-eea-2017-eng.pdf. Accessed 10/02/18.15 Department of Finance Canada. Building a strong middle class. Budget plan 2017. https://www.budget.gc.ca/2017/docs/plan/budget-2017-en.pdf. Accessed 10/02/18. 16 Office of the Parliamentary Budget Officer. Fiscal sustainability report 2018. https://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2018/FSR%20Sept%202018/FSR_2018_25SEP2018_EN_2.pdf. Accessed 10/02/18. 17 Canadian Medical Association. Funding the continuum of care. https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD10-02-e.pdf. Accessed 1-/-2/18. 18 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ Accord on Health Care Renewal. http://www.scics.ca/wp-content/uploads/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 10/02/18. 19 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. June 2006. https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 10/02/18. 20 Canadian Intergovernmental Conference Secretariat. Annual conference of provincial-territorial Ministers of health. Backgrounder: National pharmaceutical strategy decision points. http://www.scics.ca/en/product-produit/backgrounder-national-pharmaceutical-strategy-decision-points/. Accessed 10/02/18. 21World Health Organization. Essential medicines and health products. http://www.who.int/medicines/services/essmedicines_def/en/. Accessed 10/02/18. 22World Health Organization. WHO model list of essential medicines. 20th list (Amended August 2017). http://www.who.int/medicines/publications/essentialmedicines/20th_EML2017.pdf?ua=1. Accessed 10/02/18. 23 Taglione M, Ahmad H, Slater M, Aliarzadeh B, Glazier R, Laupacis A, Persaud N. Development of a preliminary essential medicines list for Canada. CMAJ Open 2017, 5(1):E137-43. 24 Morgan S, Li W, Yau B, Persaud N. Estimated effects of adding universal public coverage of an essential medicines list to existing public drug plans in Canada. CMAJ 2017;189(8):E295-302. 25 Patented Medicine Prices Review Board. Alignment among public formularies in Canada. Part 1: General overview. http://www.pmprb-cepmb.gc.ca/CMFiles/NPDUIS/NPDUIS_formulary_report_part_1_en.pdf. Accessed 10/02/18. 26 Institute for Fiscal Studies and Democracy. National pharmacare in Canada: Choosing a path forward. http://www.ifsd.ca/web/default/files/Presentations/Reports/18006%20-%20National%20Pharmacare%20in%20Canada-%20Choosing%20a%20Path%20Forward%20-%2016%20July%202018%20-%20Final.pdf. Accessed 10/02/18. 27 CTV News. Ottawa dad raising red flag about OHIP+. https://ottawa.ctvnews.ca/ottawa-dad-raising-red-flag-about-ohip-1.3759115. Accessed 10/02/18. 28 Canadian Agency for Drugs and Technologies in Health. Financial statements March 31, 2018. https://www.cadth.ca/sites/default/files/corporate/planning_documents/CADTH-FS-FY17-18-e.pdf. Accessed 10/02/18. 29 Sher G. Canadian Blood Services as a model for national pharmacare. National Post, April 15, 2015. https://blood.ca/en/media/graham-sher-canadian-blood-services-as-a-model-for-national-pharmacare. Accessed 10/02/18. 11 30 House of Commons Standing Committee on Health. Evidence. Monday, May 2, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8226056/HESAEV09-E.PDF. Accessed 10/02/18. 31 Flood C, Thomas B, Moten A, Fafard P. Universal pharmacare and federalism: policy options for Canada. http://irpp.org/wp-content/uploads/2018/09/Universal-Pharmacare-and-Federalism-Policy-Options-for-Canada.pdf. Accessed 10/02/18. 32 Canadian Intergovernmental Conference Centre. Conference of provincial and territorial Ministers of health. Provincial/territorial health Ministers meeting communiqué. June 28, 2018. http://www.scics.ca/en/product-produit/news-release-provincial-territorial-health-ministers-meeting-communique/. Accessed 10/02/18. 33 Statistics Canada. Historical Statistics of Canada. Series 8514-516. Estimated enrolment in non-profit medical insurance plans, Canada, at 31 December, 1937 to 1975. https://www150.statcan.gc.ca/n1/en/pub/11-516-x/pdf/5500093-eng.pdf?st=W5ksoTqs. Accessed 10/02/18. 34 House of Commons Standing Committee on Health. Evidence. Monday, May 9, 2016. https://www.ourcommons.ca/Content/Committee/421/HESA/Evidence/EV8251913/HESAEV10-E.PDF. Accessed 10/02/18. 35 Canadian Life and Health Insurance Association. Canadian life and health insurance facts 2018 edition. https://www.clhia.ca/web/clhia_lp4w_lnd_webstation.nsf/resources/Factbook_2/$file/2018+FB+EN.pdf. Accessed 10/02/18. 36 Farmer J, Phillips R, Singhal S, Quinonez C. Inequalities in oral health: understanding the contributions of education and income. Canadian Journal of Public Health 2017;108(3):3240-5. 37 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 10/02/18. 38 Morgan S, Hanley G, Raymond C, Blais R. Breadth, depth and agreement among provincial formularies in Canada. Healthcare Policy 2009;4(4):e162-84. 39 Canadian Medical Association. National pharmacare in Canada: getting there from here. https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/national-pharmacare-canada-e.pdf. Accessed 10/02/18. 40 ISD Scotland. Data Tables Prescribing and Medicines. Volume and cost (NHSScotland) (Financial years 2008-09-2017/18). http://www.isdscotland.org/Health-Topics/Prescribing-and-Medicines/Publications/data-tables2017.asp?id=2204#2204. Accessed 10/02/18. 41 Ipsos Reid. Two in ten (18%) Canadians have no supplementary health coverage. https://www.ipsos.com/sites/default/files/publication/2012-08/5714.pdf. Accessed 10/02/18. 42 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ 2015;187(7):491-7. 43 House of Commons Standing Committee on Health Minutes of Proceedings, Meeting No. 100 April 18, 2018. http://www.ourcommons.ca/DocumentViewer/en/42-1/HESA/meeting-100/minutes. Accessed 10/02/18.
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Health Canada consultation on tobacco products regulations (plain and standardized appearance)

https://policybase.cma.ca/en/permalink/policy13930
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-09-06
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s proposed regulations entitled Tobacco Products Regulations (Plain and Standardized Appearance) and an Order to amend Schedule 1 to the Tobacco and Vaping Products Act with respect to colouring agents, in Canada Gazette, Part 1. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use and for the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 in a resolution recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” We are pleased to support the proposed regulations and that they will apply to the packaging of all tobacco products and that brand colours, graphics and logos will be prohibited on packages. No exceptions, including for cigars and pipe tobacco, should be considered. These measures will assist in promoting harm reduction efforts and further the goal of reducing and eliminating smoking. In 2017, 16.2% of Canadians aged 12 and older smoked either daily or occasionally; this is down from 17.7% in 2015. These proposed regulations will be a significant step in the goal of further reducing the smoking rate. However, there are three areas that the CMA would like to see strengthened and are described below. Slide and Shell Packaging – Minimum package dimensions and warning surface area The CMA supports strongly the concept of tobacco products being sold in standardized packages. We recommended that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one type and allow for the largest possible surface area to be used to convey health warnings and other health-related information. With respect to the draft regulation (s.39) concerning the dimensions of the new packages when closed, the CMA recommends that the measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions.1 The Quebec requirement for a warning surface area of 46.5 sq. cm should be the minimum across Canada. To achieve that, we suggest that the new slide and shell package for regular size cigarettes have the following dimensions when it is closed: (a) its height must be no less than 74 mm and no more than 77 mm; (b) its width must be no less than 84 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. A similar adjustment is recommended for the width of packages of king size cigarettes when closed: (a) its width must be no less than 83 mm and no more than 87 mm for a package of 20 cigarettes, and no less 103mm and no more than 106 mm for a package of 25 cigarettes. In both cases, this is over and above the dimensions in s.39 (1)(a) and (b) for regular size cigarettes and s.39(2)(b) for king size cigarettes. We also recommend that the number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. This would also prohibit manufacturers from adding one or two additional cigarettes as a “bonus” or “premium.” Brand names The appearance of brand names on the packages should be in a manner that is standard for all brands. Tobacco manufacturers should not be able to include terms such as “organic” or “natural” as part of a brand name. These descriptions would convey the perception that these products are somehow better or are healthier for the consumer. As well, they may be used to evoke a lifestyle or are fashionable. Such terms and phrases should be banned in the regulations; the European Union’s Directive 2014/40/EU of the European Parliament and of the Council could serve as the guide is this instance. Leaflets Tobacco manufacturers make frequent use of subtle marketing messages to render smoking attractive and glamorous to their customers. The CMA has always supported educational and public health initiatives aimed at countering these messages. Permitting a leaflet inside packages “that warns consumers of the health hazards arising from the use of the tobacco product or that provides instructions for its use” (draft regulation s. 36.3) is a positive step but should not provide manufacturers with a potential loophole to exploit. The draft regulation should be amended to indicate that the only instance where any instructions are permitted on the leaflet are when the product has an electronic component. This would prevent manufacturers from using the leaflet as any sort of a promotional platform to minimize, for example, the impact of health warnings on the package exterior. Summary Canada's physicians have been working for decades toward the goal of a smoke-free Canada and we are pleased to support the proposed regulations. We recommend that the draft regulations be strengthened in the following manner: 1) The measurements for the regular and king size cigarette packages be amended to allow for more surface area for warnings and to standardize packaging regulations across all Canadian jurisdictions. 2) The number of cigarettes permitted in both package sizes be limited to 20 and 25 respectively, reflecting the quantities sold in the current market. 3) Use of terms and phrases such as “organic” and “natural” in brand names should be banned in the regulations. 4) The only instance where any instructions are permitted on the proposed leaflets are when the product has an electronic component. Tobacco and Vaping Products Act: Tobacco Products Regulations (Plain and Standardized Appearance) Canada Gazette, Part I, 2018 Jun 23 152(25). Available: http://gazette.gc.ca/rp-pr/p1/2018/2018-06-23/html/reg9-eng.html (accessed 2018 Aug 7). Statistics Canada. Smoking, 2017 Health Fact Sheets Cat. No. 82-625-X June 26, Ottawa, Ont.: Statistics Canada, 2018. Available: https://www150.statcan.gc.ca/n1/en/pub/82-625-x/2018001/article/54974-eng.pdf?st=7HkJdkUB (accessed 2018 Sep 5). Canadian Medical Association (CMA). Letter in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation. Ottawa: CMA; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2016-09.pdf (accessed 2018 Aug 29). The European Parliament and The Council of the European Union. Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive. 2001/37/EC. Brussels: Official Journal of the European Union, 2014. Available: https://ec.europa.eu/health/sites/health/files/tobacco/docs/dir_201440_en.pdf (accessed 2018 Sep 4).
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Health Canada consultation on regulatory amendments regarding tramadol

https://policybase.cma.ca/en/permalink/policy13927
Date
2018-08-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-08-14
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's notice as published in the Canada Gazette, Part 1 for interested stakeholders to provide comments on Health Canada's intent to amend Schedule 1 to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives.1 Tramadol has been marketed in Canada since 2005 and is available only by prescription.1 The CMA is concerned that, despite tramadol being judged low-risk in terms of addiction, it is nevertheless an opioid and should be placed in the Controlled Drugs and Substances Act, under Schedule 1.2 The Canadian Institute for Health Information reports that tramadol is one of six opioids accounting for 96% of all opioid prescriptions between 2012 and 2016.3 The report noted that there was a significant increase in tramadol prescriptions and Defined Daily Doses (DDDs) in that same 2012 to 2016 timeframe that may have been due in part to a decrease in prescriptions and DDDs for codeine. Tramadol is considered a weak opioid and is used to treat "moderate pain that has not responded to first-line treatments."4 It is regarded as having a lower rate of overdose, misuse and addiction than more powerful opioids.4 However, it is not without risks. The addition of tramadol to the CDSA, Schedule 1, is important because, as with any opioid, dependence on tramadol can occur with use over prolonged periods. According to the World Health Organization "dependence to tramadol may occur when used within the recommended dose range of tramadol but especially when used at supra-therapeutic doses."5 Physical dependence is "distinct from addiction, which includes behavioural elements and harm despite continued drug use." Maintenance of patients on opioids sometimes is only to avoid withdrawal symptoms, caused by physical dependence, as opposed to being used to treat pain.6 Tramadol must be tapered under supervision from a health professional. In addition, tramadol's analgesic effect can be unpredictable depending on a person's genetic capacity to metabolize the drug. Success or failure will be predicated "on it being converted by CYP2D6 to an active metabolite, O-desmethyltramadol."7 If there is a CYP2D6 inhibitor present or if the person's genetic make-up is such that they do not metabolize the enzyme very well, "conversion can be blocked so that little or none of the metabolite is produced and little analgesic effect is achieved."7 These tramadol pathways may also be blocked which could lead to the drug being "present at higher concentrations for longer periods."7 As one expert has noted "when a doctor prescribes tramadol, he or she rolls the dice, not knowing whether the patient will get a bit of opioid, a lot of opioid or none at all."6 The risks associated with tramadol with respect to children are such that the United States Food and Drug Administration (FDA) recently recommended that tramadol (and codeine) should not be given to children under 12.8 Their concern stems from the potential for tramadol (and codeine) to "cause life-threatening breathing problems in children."9 The FDA also recommended that breast-feeding women not be given tramadol because of the potential harm to the child. As well, teens 12 to 18 should not be given the drug "if there is a history of obesity, obstructive sleep apnea, or severe lung disease."9 Further, it warned that it should not "be given to children or adolescents as a pain medication after surgery to remove the tonsils or adenoids."9 It is very important for the health and safety of Canadians that tramadol be placed on CDSA's Schedule 1. As described in the Notice of Intent for this consultation, this change will "prevent diversion of tramadol and protect Canadians from the health risks associated with unauthorized use."1 Further, pharmacists will not be able to follow verbal prescriptions and or provide refills of tramadol, and other controls outlined in the Narcotic Control Regulations within the Controlled Drugs and Substances Act.10 In conclusion, the CMA is concerned that, despite tramadol being judged low-risk in terms of addiction, it is nevertheless an opioid and carries dangers similar to its stronger counterparts. Doctors support patients in the management of acute and chronic pain, as well as addictions, and as such we have long been concerned about the harms associated with opioid use. Therefore, as part of our advocacy, the CMA supports Health Canada's intent to amend Schedule 1 to the Controlled Drugs and Substances Act (CDSA) and the Schedule to the Narcotic Control Regulations (NCR) to include tramadol, its salts, isomers and derivatives and the salts and isomers of its derivatives. By doing so it will "help dispel the perception that it's somehow safer than other opioids."6 The CMA continues to urge governments to increase access to services and treatment options for addiction and pain management, as well as harm reduction.11 1 Controlled Drugs and Substances Act: Notice to interested parties - Proposal to add tramadol to Schedule I to the Controlled Drugs and Substances Act and the Schedule to the Narcotic Control Regulations Canada Gazette, Part I, 2018 Jun 16 152(24) Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-06-16/html/notice-avis-eng.html#ne2 (accessed 2018 Jun 25) 2 Young JWS, Juurlink DN. Five things to know about Tramadol. CMAJ May 2013 185(5) Available: http://www.cmaj.ca/content/cmaj/185/8/E352.full.pdf (accessed 2018 Jul 31) 3 Canadian Institute for Health Information. Pan-Canadian Trends in the Prescribing of Opioids, 2012 to 2016. Ottawa, ON: CIHI; 2017. 4 Kahan M, Mailis-Gagnon A, Wilson L, et al. Canadian guideline for safe and effective use of opioids for chronic noncancer pain; clinical summary for family physician. Part 1: general population. Can Fam Physician November 2011 011;57:1257-66. Available: http://www.cfp.ca/content/cfp/57/11/1257.full.pdf (accessed 2018 Jul 30) 5 World Health Organization. Tramadol Update Review Report Expert Committee on Drug Dependence. Thirty-sixth Meeting Geneva, 16-20 June 2014 Available: http://www.who.int/medicines/areas/quality_safety/6_1_Update.pdf (accessed: 2018 Aug 1) 6 Juurlink DN. Why Health Canada must reclassify tramadol as an opioid. The Globe and Mail November 27, 2017 7 Flint, A., Merali, Z., and Vaccarino, F. (Eds.). (2018). Substance use in Canada: improving quality of life: substance use and aging. Ottawa, Ont: Canadian Centre on Substance Use and Addiction. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Substance-Use-and-Aging-Report-2018-en.pdf#search=all%28aging%29 (accessed 2018 Aug 1) 8 Jin J. Risks of Codeine and Tramadol in Children. JAMA 2017;318(15):1514. doi:10.1001/jama.2017.13534 Available: https://jamanetwork.com/journals/jama/fullarticle/2657378 (accessed: 2018 Aug 2) 9 United States Food and Drug Administration. Codeine and Tramadol Can Cause Breathing Problems for Children. Consumer Update April 20, 2017 Available: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm315497.htm (accessed: 2018 Aug 14) 10 Minister of Justice. Narcotic Control Regulations C.R.C., c. 1041. Current to July 5, 2018. Last amended on May 20, 2018 Available: http://laws-lois.justice.gc.ca/PDF/C.R.C.,_c._1041.pdf (accessed: 2018 Aug 14) 11 Canadian Medical Association. Harms Associated with Opioids and Other Psychoactive Prescription Drugs. CMA Policy, 2015. Ottawa: The Association; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed: 2018 Aug 2).
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Health Canada consultation on restriction of marketing and advertising of opioids

https://policybase.cma.ca/en/permalink/policy13921
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-07-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to Health Canada in response to the publication of the Notice of Intent to restrict the marketing and advertising of opioids.1 The CMA is very concerned with the high rates of overdose deaths due to opioids2 and supports a comprehensive, multi-pronged approach to address this public health crisis.3 As part of the Government of Canada's strategy, the Minister of Health's 2017 mandate letter committed to "consult with provinces, territories, and professional regulatory bodies to introduce appropriate prescribing guidelines to curb opioid misuse, ensure prescriptions are appropriately tracked in a consistent and patient-centred way, and increase transparency in the marketing and promotion of therapies."4 Health Canada is proposing to further restrict drug manufacturers' advertising of opioids and is consulting on the scope and intent of the restrictions. The Food and Drugs Act defines advertisement as "any representation by any means for the purpose of promoting, directly or indirectly, the sale of any drug or device".5 Opioids are important therapeutic tools and serve legitimate purposes, when prescribed in an appropriate manner with proper assessment, and as part of a comprehensive therapeutic strategy and monitoring. These medications have been essential in areas such as palliative and cancer care and have contributed to the alleviation of suffering.3 Any measures to address advertising must not restrict appropriate access. Limiting access without appropriate alternatives and careful tapering can lead to undue suffering and seeking of drugs, potentially tainted, on the illegal market. However, of great concern, opioid dispensing levels have been shown to be strongly correlated with increased mortality, morbidity and treatment admissions for substance use.6,7 Many patients were prescribed these medications and developed dependence.8 Since the 1990s, opioids have been recommended for longer-term treatment of chronic non-cancer pain, and have become widely used due in part to aggressive promotion and marketing for this indication.9,10 However, there is evidence for pain relief in the short term but insufficient evidence regarding maintenance of pain relief over longer periods of time, or for improved physical function.11,12,13 There was also a concerted effort by industry to minimize the risk of addiction in the use of opioids for the treatment of chronic non-cancer pain. While stating that the risk of addiction was less than one percent, many studies have shown that the risk varies from 0 to 50% depending on the criteria used and sub population studied.14 Marketing significantly influences the type and amount of opioids consumed.15 Substantial tension exists between the competitive pressures that manufacturers face to expand product sales and support for limited, evidence-based use of most cost-effective available alternatives.16 Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage.17 Important contributing factors for the increase in opioid prescriptions are also the lack of supports and incentives for the treatment of complex cases, including availability and funding for treatment options for pain and addictions. Alternate approaches to pain management require more time with patients. Prescriptions also increased due to the availability of new, highly potent opioid drugs.18,19 Addressing advertising is only one component of the issue, and significant efforts need to be made to address issues such as access to alternatives for pain management and treatment of addiction. Presently, advertising of opioids is prohibited to the public, and only permitted to health care professionals if the claims are consistent with the terms of market authorization by Health Canada. Pharmaceutical industry's marketing practices to health care practitioners "can take many forms of direct and indirect activities and incentives, including, for example, manufacturer-sponsored presentations at conferences, continuing education programs, advertisements in medical journals, and personal visits from sales representatives. It can also include use of promotional brochures, fees for research, consulting or speaking, reimbursement for travel and hospitality expenses to attend industry-sponsored events, and gifts of meals, equipment, and medical journals and texts."1 As well, industry has sponsored advocacy organizations dedicated to the treatment of pain and key opinion leaders.15,20 Studies have shown that marketing influences prescribing patterns.21 Initiatives to regulate advertising and the promotion of prescription drugs have come from industry, nongovernmental organizations and government. The pharmaceutical industry itself is voluntarily self-regulated in Canada through the Pharmaceutical Advertising Advisory Board (PAAB), pre-clearing marketing initiatives based on a Code of Advertising.22 The CMA recommends that marketing initiatives could be vetted for accuracy and truthfulness through a pre-clearance mechanism such as PAAB. Faced with multiple legal challenges in the U.S., some opioid manufacturers have limited marketing, however, such measures had not been taken in Canada. The federal government has a complaints-based system and hasn't been proactive in the regulation and monitoring of advertising and marketing of opioids. In recently published regulations amending the Food and Drug Regulations,23 the Minister of Health can require companies to develop and implement risk management plans, which include the preclearance of opioid-related materials to be provided to health care professionals. Product information prepared by manufacturers, summarizing scientific evidence on effects and setting out conditions for use, as well as promotional activities are subject to regulatory approval. The authority conferred to the Minister has the objective of allowing Health Canada to "appropriately monitor, quantify, characterize, and mitigate the risks associated with post-market use" of opioids. CMA supports such actions. As Van Zee has noted in the case of the United States, "modifications of the promotion and marketing of controlled drugs by the pharmaceutical industry and an enhanced capacity of the Food and Drug Administration to regulate and monitor such promotion can have a positive impact on public health".14 This approach would confer a similar benefit for Canada in that, if effective, could contribute to unbiased, evidence-based prescribing. There are important guidelines and standards in place, developed by physicians, to guide relationships with the pharmaceutical industry. CMA's "Guidelines for Physicians in Interactions with Industry"24 were developed as a resource tool both for physicians, medical students and residents, as well as medical organizations, to support decisions as to appropriate relationships with industry, in conjunction with CMA's Code of Ethics.25 In summary, physicians have a responsibility to ensure that their interaction with the pharmaceutical industry is in keeping with their primary obligation to their patients and duties to society, and to avoid situations of conflict of interest where possible, appropriately managing these situations when necessary. These guidelines include principles for continuing medical education and continuing professional development (CME/CPD) and are the basis for the National Standard for Support of Accredited CPD Activities, developed by the Royal College of Physicians and Surgeons of Canada (RCPSC), the College of Family Physicians of Canada (CFPC) and the Collège des médecins du Québec. According to the Standard, "the interests of organizations that provide financial and in-kind support for the development of accredited CPD activities cannot be assumed to always be congruent with the goal of addressing the educational needs of the medical profession. Therefore, it is essential that the medical profession define and assume their responsibility for setting standards that will guide the development, delivery, and evaluation of accredited CPD activities."26 Physicians must complete CPD credits to maintain their professional license, and the accreditation bodies (such as CFPC, RCPSC) have processes in place to assure that these courses are evidence-based and free from industry bias. In recognition of the importance of opioid prescribing, and the key role that physicians play in this field, the CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids. This funding could include unconditional contribution from the opioid manufacturers, to ensure independence. The CMA appreciates the role that Health Canada has had in funding evidence-based guidelines.27 This has been a key initiative, which sought to provide physicians with unbiased information. Ongoing funding to maintain their currency would be warranted. The CMA supports long overdue actions related to the restriction of the marketing of opioids and looks forward to collaboration between Health Canada and the physician community. Recommendations The CMA supports Health Canada's efforts to place significant restrictions on the ability of drug manufacturers to advertise opioids to health care practitioners. Marketing initiatives should be vetted for accuracy and truthfulness through a pre-clearance mechanism. The CMA recommends that the measures chosen to constrain advertising do not unduly restrict access to opioids for appropriate use. The CMA recommends that the government fund certified / accredited CPDs on pain management addressing non-pharmacologic and pharmacologic options, including opioids, and consider unconditional funding from opioid manufacturers. The CMA recommends that the government support keeping the 2017 Opioid Prescribing Guidelines current through ongoing funding. The CMA recognizes that restricting advertising is only one, overdue, measure to address the opioid crisis, and recommends that issues such as access to alternatives for pain management and addiction treatment urgently be addressed. 1 Government of Canada. Notice of intent to restrict the marketing and advertising of opioids. Ottawa: Government of Canada; 2018. Available: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/restrict-advertising-opioids.html (accessed 2018 Jul 17). 2 Public Health Agency of Canada. National report: apparent opioid-related deaths in Canada (released June 2018). Ottawa: Public Health Agency of Canada; 2018. Available: https://www.canada.ca/en/public-health/services/publications/healthy-living/national-report-apparent-opioid-related-deaths-released-june-2018.html (accessed 2018 Jul 17). 3 Canadian Medical Association. Harms associated with opioids and other psychoactive prescription drugs. Ottawa: Canadian Medical Association; 2009. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Jul 17). 4 Trudeau J. Minister of Health mandate letter. Ottawa: Office of the Prime Minister; 2017 Oct 4. Available: https://pm.gc.ca/eng/minister-health-mandate-letter (accessed 2018 Jul 17). 5 Government of Canada. Food and Drugs Act. Ottawa: Government of Canada; 1985. Available: http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html (accessed 2018 Jul 17). 6 Fischer B, Jones W, Rehm J. High correlations between levels of consumption and mortality related to strong prescription opioid analgesics in British Columbia and Ontario, 2005-2009. Pharmacoepidemiol Drug Saf 2013;22(4):438-42. 7 Gomes T, Juurlink DN, Moineddin R, et al. Geographical variation in opioid prescribing and opioid-related mortality in Ontario. Healthc Q 2011;14(1):22-4. 8 Brands B, Blake J, Sproule B, et al. Prescription opioid abuse in patients presenting for methadone maintenance treatment. Drug Alcohol Depend 2004;73(2):199-207. 9 Manchikanti L, Atluri S, Hansen H, et al. Opioids in chronic noncancer pain: have we reached a boiling point yet? Pain Physician 2014;17(1):E1-10. 10 Dhalla IA, Persaud N, Juurlink DN. Facing up to the prescription opioid crisis. BMJ 2011;343:d5142 DOI: 10.1136/bmj.d5142. 11 Franklin GM. Opioids for chronic noncancer pain. A position paper of the American Academy of Neurology. Neurology 2014;83:1277-84. 12 Chou R, Ballantyne JC, Fanciullo GJ, et al. Research gaps on use of opioids for chronic noncancer pain: Findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain 2009;10:147-59. 13 Noble M, Treadwell JR, Tregear SJ, et al. Long-term opioid management for chronic noncancer pain. Cochrane Database Syst Rev 2010;(1):CD006605. 14 Van Zee A. The promotion and marketing of OxyContin: Commercial triumph, public health tragedy. Am J Public Health 2009;99:221-27. 15 Hamunen K, Paakkari P, Kalso E. Trends in opioid consumption in the Nordic countries 2002-2006. Eur J Pain 2009;13:954-962. 16 Alves TL, Lexchin J, Mintzes B. Medicines information and the regulation of the promotion of pharmaceuticals. Sci Eng Ethics 2018:1-26. 17 Canadian Medical Association. Optimal prescribing. Ottawa: Canadian Medical Association; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf (accessed 2018 Jul 17). 18 Fischer B, Goldman B, Rehm J, et al. Non-medical use of prescription opioids and public health in Canada. Can J Public Health 2008;99(3):182-4. 19 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction 2013;109:177-81. 20 Dyer O. OxyContin maker stops marketing opioids, as report details payments to advocacy groups. BMJ 2018;360:k791. 21 Katz D, Caplan AL, Merz JF. All gifts large and small: toward an understanding of the ethics of pharmaceutical industry gift-giving. Am J Bioethics 2003;3(3):39-46. 22 Pharmaceutical Advertising Advisory Board. PAAB Code. Ottawa: PAAB; 2018. Available: http://code.paab.ca/ (accessed 2018 Jul 17). 23 Regulations Amending the Food and Drug Regulations (Opioids), SOR/2018-77. Canada Gazette, Part II 2018 May 2;152(9). Available: http://gazette.gc.ca/rp-pr/p2/2018/2018-05-02/html/sor-dors77-eng.html (accessed 2018 Jul 17). 24 Canadian Medical Association. Guidelines for physicians in interactions with industry. Ottawa: Canadian Medical Association; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf (accessed 2018 Jul 17). 25 Canadian Medical Association. CMA Code of Ethics (Update 2004). Ottawa: Canadian Medical Association; 2004. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/policy-research/CMA_Policy_Code_of_ethics_of_the_Canadian_Medical_Association_Update_2004_PD04-06-e.pdf (accessed 2018 Jul 17). 26 Royal College of Physicians and Surgeons of Canada. National standard for support of accredited CPD activities. Ottawa: Royal College of Physicians and Surgeons of Canada; 2017. Available: http://www.royalcollege.ca/rcsite/cpd/providers/tools-resources-accredited-cpd-providers/national-standard-accredited-cpd-activities-e (accessed 2018 Jul 17). 27 Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ 2017;189:E659-66.
Documents
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Canada's Food Guide

https://policybase.cma.ca/en/permalink/policy13920
Date
2018-06-06
Topics
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2018-06-06
Topics
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health with respect to its study of Canada’s Food Guide. The CMA supports access to healthy foods to improve individual health and well-being and the overall health status of the population.1 1 Canadian Medical Association (CMA). Obesity in Canada: Causes, consequences and the way forward. Ottawa: CMA; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-12.pdf (accessed 2018 Feb 5). 2 Colapinto C, Graham J, St. Pierre S. Trends and correlates of frequency of fruit and vegetable consumption, 2007 to 2014. Health Reports. 2018 January;29(1):9-14. Available: http://www.statcan.gc.ca/pub/82-003-x/2018001/article/54901-eng.pdf (accessed 2018 Feb 5). 3 Van Vliet B, Campbell N. Efforts to reduce sodium intake in Canada: Why, what, and when? Can J Cardiol. 2011;27(4):437–445. 4 Canadian Medical Association (CMA). Early childhood development. Ottawa: CMA; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Feb 2). 5 Canadian Medical Association (CMA). Health equity and the social determinants of health: A role for the medical profession. Ottawa: CMA; 2013. Available http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-03.pdf (accessed 2018 Jan 30). 6 Health Canada. Eating well with Canada’s food guide. Ottawa: Health Canada; 2007. Available: https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/fn-an/alt_formats/hpfb-dgpsa/pdf/food-guide-aliment/view_eatwell_vue_bienmang-eng.pdf (accessed 2018 Jan 30). 7 Collier R. Calls for a better food guide. CMAJ. 2018 November 18;186(17):1281. Available: https://doi.org/10.1503/cmaj.109-4911 (accessed 2018 Jan 30). 8 Ministry of Health of Brazil. Dietary guidelines for the Brazilian population. 2nd ed. Brazil: Ministry of Health of Brazil; 2014. Available: http://www.foodpolitics.com/wp-content/uploads/Brazilian-Dietary-Guidelines-2014.pdf (accessed 2018 Feb 1). 9 Report of the Standing Committee on Social Affairs, Science and Technology. Obesity in Canada. A whole-of-society approach for a healthier Canada. Ottawa: Senate of Canada; 2016 March. Available: https://sencanada.ca/content/sen/committee/421/soci/rms/01mar16/Report-e.htm (accessed 2018 Feb 2). 10 Health Canada. Evidence review for dietary guidance: summary of results and implications for Canada’s food guide. Ottawa: Health Canada; 2015. Available: https://www.canada.ca/content/dam/canada/health-canada/migration/publications/eating-nutrition/dietary-guidance-summary-resume-recommandations-alimentaires/alt/pub-eng.pdf (accessed 2018 Feb 2). 11 Government of Canada. Guiding principles [Canada’s food guide consultation]. Ottawa: Government of Canada; 2017 April 5. Available: https://www.foodguideconsultation.ca/guiding-principles-detailed (accessed 2018 Feb 5). The CMA has been active on nutritional issues for many years, both directly through its policy and government advocacy as well as through membership in various coalitions. Some of the issues addressed include the nutrition facts table, front-of-package labelling, a ban on the marketing of food and beverages to children younger than 16 years of age, and a levy on the manufacturers of sugar-sweetened beverages. Canadians’ self-reported dietary intakes do not meet national dietary recommendations despite public education efforts concerning healthy eating and healthy diets. Children and adults are consuming fewer than the recommended number of servings of vegetables and fruits, an established proxy for healthy eating habits, and they are exceeding daily recommended intakes of sodium.2,3 The protection of vulnerable populations including children is of paramount concern to the CMA. Access to nutritious food is essential in early childhood development in support of later adult health.4 The availability of food security programs is a key element in preventing children from developing dietary deficiencies that would lead to an increased risk of chronic disease and greater difficulty in disease management later in life.5 The Food Guide has historically been a valued resource for Canadians, and physicians have found it useful in counselling their patients about healthy eating. However, there are serious concerns with the present Food Guide,6 which was released in 2007, and physicians have increasingly called for it to be reviewed.7 Other countries have made significant changes to their dietary guidelines. Brazil, for example, has developed a guideline that incorporates simple-to-follow, common-sense messaging, such as encouraging Brazilians to prepare meals from scratch and promoting the value of family meals.8 A new, modern Canadian guide is needed. Witnesses appearing before the Senate Committee on Social Affairs, Science and Technology characterized the current version as being “at best ineffective, and at worst enabling, with respect to the rising levels of unhealthy weights and diet-related chronic diseases in Canada.”9 Health Canada is in the process of revising the Food Guide, having done an extensive review of the evidence10 and releasing Guiding Principles.11 Recommendations for a revised Food Guide A new approach to a food guide that addresses the larger picture, beyond daily nutrient consumption recommendations, is fundamental to the effort to improve the health of all Canadians and to the larger goal of developing a food policy for Canada. Indeed, “coordinated investments in health promotion and disease and injury prevention, including attention to the role of the social determinants of health, are critical to the future health and wellness of Canadians and to the viability of the health care system.”12 12 Canadian Medical Association (CMA) and Canadian Nurses Association (CNA). Principles for health care transformation in Canada. Ottawa: CMA and CNA; 2011. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD1113.pdf (accessed 2018 Jan 30). 13 Nexus H. Primer to action: Social determinants of health. Toronto: Ontario Chronic Disease Prevention Alliance; 2007. Available: http://www.ocdpa.ca/sites/default/files/publications/PrimertoAction-EN.pdf (accessed 2018 Feb 1). 14 Tarasuk V, Mitchell A, Dachner N. Household food insecurity in Canada. Toronto: PROOF; 2016. Available: http://proof.utoronto.ca/resources/proof-annual-reports/annual-report-2014/ (accessed 2018 Feb 5). 15 Rao M, Afshin A, Singh G, et al. Do healthier foods and diet patterns cost more than less healthy options? A systematic review and meta-analysis. BMJ Open. 2013;3:e004277. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3855594/pdf/bmjopen-2013-004277.pdf (accessed 2018 Feb 5). 16Lee A, Mhurchu CN, Sacks G, et al. Monitoring the price and affordability of foods and diets globally. Obes Rev. 2013 Oct;14 Suppl 1:82–95. 17 Food Banks Canada. Hungercount2016: A comprehensive report on hunger and food bank use in Canada, and recommendations for change. Toronto: Food Banks Canada; 2016. Available: https://www.foodbankscanada.ca/hungercount2016 (accessed 2018 Jan 30). 18 Raine K. Improving nutritional health of the public through social change: Finding our roles in collective action. Can J Diet Pract Res. 2014;75(3):160-164. Available: https://doi.org/10.3148/cjdpr-2014-017 (accessed 2018 Feb 2). 19 Canadian Medical Association (CMA). CMA’s Support for Bill S-228: An Act to amend the Food and Drugs Act (prohibiting food and beverage marketing directed at children).Ottawa: CMA; 2017.Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-07.pdf (accessed 2018 Feb 2). 20 Howard, C., Culbert I., Food Guide revamp encouraging plant-based, low-meat diet is good for people and the planet CBC February 11, 2018 Available: http://www.cbc.ca/news/canada/manitoba/opinion-canada-food-guide-1.4530058 (accessed 2018 Feb 12) CMA recommendations: 1. The Food Guide must go hand in hand with efforts to increase access to affordable, healthy food Food insecurity does not affect all Canadians equally, and there are very clear social patterns of vulnerability.13 Analyses of population survey data consistently identify low income as a predictor of household food insecurity. In addition, rates of food insecurity are highest among Aboriginal Canadians, households reliant on social assistance, households headed by single mothers, and those renting rather than owning a home.14 More research is needed to understand decisions surrounding the purchase of healthy foods versus unhealthy foods.15,16 Food Banks Canada reported that in March 2016, 863,492 people received food from a food bank, an increase of 1.3% over 2015, with eight of 10 provinces showing an increase.17 As the report notes, “approximately 1.7 million Canadian households, encompassing 4 million people, experience food insecurity each year” with 340,000 of them experiencing severe food insecurity.17 Other determinants of healthy eating include a wide range of contextual factors, such as the interpersonal environment created by family and peers, the physical environment, which determines food availability and accessibility, the economic environment, in which food is a commodity to be marketed for profit, and the social environment. Within the social environment, social status (income, education and gender) and cultural milieu are determinants of healthy eating that may be working "invisibly" to structure food choice.15 2. The Food Guide must be based on sound nutritional research With unhealthy diets consistently linked with chronic disease such as cardiovascular diseases (heart disease, stroke, hypertension, diabetes, dyslipidemia) and with an estimated 60% of Canadian adults and close to one-third of children being overweight or obese, there is a need for evidence-based approaches in the development of healthy eating policies and practices in Canada. As the links between nutrition and disease and other impacts of nutrition on the health of our society are revealed and better understood, it is more important than ever to identify what influences healthy eating behaviours.18 Food choices are structured by a variety of individual determinants of behaviour, including one's physiological state, food preferences, nutritional knowledge, perceptions of healthy eating and psychological factors. The Food Guide needs to incorporate emerging research on nutrition and health, for example, by emphasizing the need to replace saturated fats with unsaturated fats, as opposed to focusing on total fats. It also must take into account the changes in consumer behaviour and in the food supply. 3. The Government of Canada must assure Canadians that the revision process is evidence based Canadians must be able to trust Canada’s Food Guide as a source of unbiased information, based on evidence. The Food Guide must be part of a larger coordinated approach that also looks at other critical issues, such as the role of the marketing of unhealthy foods and beverages to children.19 CMA is concerned that conflict-of-interest situations have arisen in the past where recommendations might favour certain products or food groups over others.20 Canadians must have confidence that their health and wellness is the primary focus of an evidence-based revision process. 4. The Food Guide must reflect changing eating patterns reflective of our evolving and increasingly multicultural society Canadian society is more ethnically diverse than in the past, so it is necessary to keep in mind cultural preferences. The current food groups do not always take into account an understanding of traditional foods and cultural eating practices. These are intrinsically linked to identity and culture and contribute to overall health. Advice needs to be tailored to different ages and cultural groups. There is also a need to emphasize patterns of eating, as opposed to a focus almost exclusively on nutrient requirements. It is important to promote eating as a social undertaking, recognizing the essential role that food has in bringing people together. It is also important to support the development of basic, practical culinary skills, which will reduce Canadians’ dependence on restaurant meals and ultra-processed foods. 5. The Food Guide must encourage Canadians to reduce their reliance on processed foods The production and consumption of ultra-processed foods has increased drastically in the last decades in both higher and lower income countries. Highly or ultra-processed food tends to contain less protein and dietary fibre than less processed foods and include high proportions of free sugar, total saturated fat, trans fat and salt. Typically, processed foods are energy dense (high in calories) but have fewer beneficial nutrients such as vitamins and proteins. Most processed foods encourage unhealthy ways of eating and have become popular because of their accessibility and convenience. These features have changed the way food and in particular these products are consumed compared with unprocessed foods: increased “grazing,” eating alone or eating while carrying out other activities such as work or driving. In addition, many calories consumed come in liquid form. Physicians are concerned with the Food Guide’s support for fruit juices, given the plethora of sugar-sweetened beverages, including milk and milk alternatives. There should be a maximum amount of juice recommended for children, and the Food Guide should instead support the consumption of actual fruit. 6. The Government of Canada must produce simple, practical products for Canadians and clear dietary guidance for health professionals Reliable, trustworthy sources of information are essential to support healthy eating. However, the new Food Guide must not be just another set of rules and lists or a long, cumbersome document. The challenge will be to take the evidence around nutrition and health and make it meaningful and useful. This is the only way that the Food Guide will actually be able to support and even provoke change. To do that it must focus on the needs of the Canadians, with tools that personalize information for different age and cultural groups. It should also be useful to people with certain health conditions who require regulation of their diet to improve health (e.g., people with diabetes or hypertension). It should support couples during pregnancy and breastfeeding. There can’t be only one set of guidance; rather, various versions should be produced that are adapted to different audiences. The Food Guide needs to be practical and simple to use. The concept of the number and size of servings of different foods, for example, has been very confusing. Research has shown that Canadians do not weigh or measure their foods and serving sizes are often underestimated, promoting overconsumption. The Food Guide must support Canadians in deciphering food labels and making informed choices about what they consume. The use of technology will allow information to be more accessible. The guidance must be sensitive to issues related to the social determinants of health and food security, with attention to the cost and accessibility of foods. A focus on good sources of proteins, for example, as opposed to red meats and dairy, could allow for more choice. The Food Guide should provide guidance to food banks and other programs that seek to provide food to low-income families in terms of what foods they should procure for their clients. As one of the most trusted sources of health information, physicians also need to be able to access the latest evidence in a user-friendly manner. Resources must be succinct and easy for physicians to access in a busy practice. They should allow a physician to go into more depth should that be required. As well, point-of-care tools that help clinicians explain technical facts to their patients in an accessible manner are needed. Recommendations 1. The Food Guide must go hand in hand with efforts to increase access to affordable, healthy food 2. The Food Guide must be based on sound nutritional research 3. The Government of Canada must assure Canadians that the revision process is evidence based 4. The Food Guide must reflect changing eating patterns reflective of our evolving and increasingly multicultural society 5. The Food Guide must encourage Canadians to reduce their reliance on processed foods 6. The Government of Canada must produce simple, practical products for Canadians and clear dietary guidance for health professionals
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Consultation on proposed front-of-package labelling

https://policybase.cma.ca/en/permalink/policy13882
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-04-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Dear Mr. Rodrigue: The Canadian Medical Association is pleased to have this opportunity to participate in the consultation on the proposed front-of-packaging labelling (FOP) as posted in the Canada Gazette Part One on February 9, 2018.1 This new requirement will “provide clear and consistent front-of-package information and updated nutrient content claims to help protect Canadians from the risks of chronic diseases” related to the intake of foods high in sugar, sodium, saturated fats and trans fat.2 1 Canada Gazette Part One. Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) Department of Health Vol. 152, No. 6 — February 10, 2018 2 Ibid pg.1 3 Presentation to the House of Commons Standing Committee on Health, Nutrition Labelling, Canadian Medical Association, March 3, 2011 accessed at http://policybase.cma.ca The CMA believes that governments have a responsibility to provide guidance on healthy eating that can be easily incorporated into daily lives, and that the federal government has a continuous obligation to promulgate policies, standards, regulations and legislations that support healthy food and beverage choices; provide user-friendly consumer information including complete nutritional content and accurate advertising claims; and increase the amount of information provided on product labels. We also commend Health Canada for its current work on revising the Canada Food Guide. Front-of-Packaging Labelling The CMA has supported a standard “at a glance” approach to FOP food labelling that can reduce confusion and help consumers make informed dietary choices since 2011.3 FOP labelling on packaged foods will help Canadians make healthier food and beverage choices. It will draw attention to those ingredients to be avoided in higher levels and can reinforce public health messaging on healthy eating. An added benefit may be an incentive to the food industry to reformulate processed foods with lower amounts of those nutrients highlighted in FOP labelling. The CMA supports the placement of the proposed symbol on the upper and/or right hand side of the packaging, covering 25% of the principal display surface. The symbol must be clearly delineated from the product packaging so that it stands out and can be located with relative ease. It is important for the symbol to convey to the consumer that there is a certain degree of risk involved in consuming these foods, hence the colours used and the shape will be important. Of the four symbols proposed by Health Canada, our preference is for the one displayed here but with a more defined, thicker border, that includes a small outer buffer (in white). It will be essential for Health Canada to ensure that the symbol design has been tested thoroughly with consumers and is effective in conveying the intended “high in” message. As such, manufacturers will need clear guidance about the constraints on the use and placement of these symbols to ensure they cannot be misconstrued and to prevent the use of configurations that will diminish their effectiveness. Manufacturers must not be permitted to place voluntary nutrient content or health claims below or near the main symbol that would distort the message and create confusion. Foods to be exempted from front-of-package nutrition labelling There will be foods that are exempt from the labelling requirements and consumers will need clear explanations with respect to those that are exempt and why; some will be obvious, some will not. The CMA supports the proposed exemptions for eggs, fruits, vegetables and unsweetened, unsalted plain milk, and whole milk. However, we do not believe flavoured and/or seasoning salts and “sea salts” should be exempted from the requirement to have an FOP symbol on the package. Health Canada will need to undertake an education program to explain to consumers that these products are actually high in sodium. Nutrient thresholds for sodium, sugar & saturated fat CMA policy has encouraged governments to continue to work to reduce the salt, sugar, saturated fat, trans-fat and calorie content of processed foods and prepared meals.4 The nutrient levels chosen will therefore be critical in that regard. The CMA supports the proposed levels to identify foods high in sugar, salt or saturated fats. The CMA believes that it is important that there is consistency across all nutritional and healthy eating information and advice for Canadians. Ensuring consistency between the “high in” threshold and the 15% “a lot” daily value (DV) message delivers a clear message of concern. 4 Healthy Behaviours: Promoting Physical Activity and Healthy Eating, Canadian Medical Association Policy, 2014, accessed at http://policybase.cma.ca. While we understand the rationale behind increasing the nutrient threshold for prepackaged meals to 30% of the DV, we recommend that the threshold for “high in” sugar of 30 grams or more total sugars per serving of stated size may be too high and should be reconsidered. It should also be noted that the different thresholds on prepackaged foods and prepackaged meals may cause confusion for consumers and should be introduced with some consumer education. Nutrient content claims, in relation to Front-of-Packaging Labelling symbol Allowing a food that qualifies for a “high in” sugar FOP symbol to also display a “no added sugars” claim would be very confusing to consumers. The product label information would appear as quite contradictory; therefore the CMA does support not allowing “no added sugar” claims on these foods. The CMA would suggest that a food that is high in two or more of sugar, sodium or saturated fats not be allowed to display any content claims to avoid any consumer confusion. High-intensity sweetener labelling Canadians have come to rely on easy-to-recognize information that alerts them that food may contain artificial sweeteners. Therefore, we do not support the elimination of the labelling requirement for artificial sweeteners on the principal display panel. For products that have high intensity sweeteners added and which bear claims such as “unsweetened” or “no sugar added,” a declaration of “artificially sweetened” should be clearly visible on the FOP. The specific sweetener does not need to be identified so long as it is declared in the list of ingredients. As long as quantity is displayed on the nutrition facts table it doesn’t need to be on the principal display. Further, while we recognize that harmonizing with USA labelling regulations is desirable, we recommend strongly against the use of the term “phenylketonurics.” The proper approach would be to use the phrase “people with phenylketonuria” for any warnings on products containing aspartame, which contains phenylalanine. Consumer education For many Canadians, their diet can have a negative rather than positive impact on their overall health. There is a particular concern for children and youth who are growing up in increasingly obesogenic environments that reinforce practices that work against a healthy diet and healthy lifestyle. Determined action is required for children and youth to learn and acquire healthy behaviours that they will maintain throughout their life. The CMA supports the government’s Healthy Living Strategy and their efforts to create a healthier food environment. The addition of FOP nutrition labelling is an important tool to make the healthy choice the easy choice. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-president, Medical Professionalism
Documents
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Federal monitoring of medical assistance in dying regulations

https://policybase.cma.ca/en/permalink/policy13856
Date
2018-02-13
Topics
Ethics and medical professionalism
  1 document  
Policy Type
Response to consultation
Date
2018-02-13
Topics
Ethics and medical professionalism
Text
The Canadian Medical Association (CMA) is pleased to provide input on the proposed regulations of the federal monitoring of Medical Assistance in Dying in Canada. The CMA fully supports the proposed intent of the regulations, in particular, public accountability and transparency and safeguards for vulnerable patient populations. Tracking trends and carrying out research is very important to monitor the implementation and implications of medical assistance in dying. The CMA further supports the intent to provide electronic reporting and guidance documents, and to leverage any synergies between the federal and provincial/territorial governments, especially to prevent duplication and to promote consistency in reporting across the country. The CMA would like to raise the following critical areas for your consideration: 1. Definitions/parameters of terms There continues to be a need to more clearly define several terms to ensure consistency of reporting. For example: a. Who constitutes a “practitioner”? One can argue that there is a broad scope of who is “a medical practitioner or nurse practitioner”. Is it the practitioner who provides MAiD? Or he practitioner who first reads a patient’s request for MAiD? Or is the first practitioner? Or second practitioner who assesses the patient? b. What constitutes a therapeutic relationship (as one of the eight proposed items to be collected about the practitioner)? A therapeutic relationship is not required to access MAiD. This criterion should be removed and if not, given the differences in opinion in the health professions as to what constitutes a therapeutic relationship includes, it should be clearly defined. c. What constitutes a request, a written request, the receipt of a request? If reporting obligations are “triggered” by a patient’s “written request”, at what point is that request actually triggered? The very first practitioner who receives the patient’s written request? Or the practitioner who conducts the eligibility assessment upon receipt of the written request? Or the practitioner who provides the prescription or carries out the procedure? d. On a related point, without clear definitions, any future comparative analysis of research or trends will be difficult as there will be no common starting point. e. There continues to be confusion on how to count or when to start counting the required 10 clear days. There are many reasons why this requires more clarity. 2. Collection and protection of data We applaud Health Canada for further reducing and revising data requirements. We submit, however, that further reductions are required for several reasons, including adherence to privacy best practices that require the collection of the least amount of data necessary to achieve reasonable purposes. In particular: a. In view of the quantity and highly personal and sensitive data that will be collected about patients and practitioners, data sharing agreements should be required; for example, agreements between the federal government and provincial/territorial governments or between researchers and others requesting use of the data to facilitate the appropriate sharing of data. b. Collection of personal information should be limited to what is relevant to the purpose of monitoring medical assistance in dying. Personal information, such as the patient’s full postal code, marital status, or principal occupation is beyond the scope of the eligibility criteria outlined in the legislation and thus beyond the scope of the purpose of monitoring the impact of the legislation. c. Any “characteristics” of the patient should refer only to the eligibility criteria. If other data will be collected beyond that scope, the justification for doing so, and the characteristics themselves, should be clearly outlined. d. The scope of the information collected about the practitioner could be narrowed. As is, it is very broad – a list of eight items – while the Quebec regulations, as a comparator, have only three-four items that must be collected in relation to the physician who administers MAiD. 3. Additional requirements Schedule 4 [section 2(i)] of the proposed regulations requires that the practitioner opine as to whether the patient met, or did not meet, all of the eligibility criteria outlined in the legislation – with two significantly expanded requirements; the requirements that the practitioner: 1) provide an estimate as to the amount of time MAiD shortened the patient’s life; and 2) indicate the anticipated likely cause of natural death of the patient. These additional requirements are beyond the letter and spirit of the legislation and, in many ways, are in direct contradiction to the legislation. The Legislature was not unaware when it drafted the Act that it did not follow other jurisdictions’ criteria requiring either a terminal illness or a prognosis of time within which the practitioner believed the patient would die, e.g., “within the next 6 months”. It is specifically the lack of a timeframe that makes the legislation unique and provides flexibility for both patients and practitioners. By adding these two additional criteria for reporting, in effect, they become additional criteria for eligibility which is, as stated above, beyond the scope, and in contradiction to, the legislation. 4. Lack of clarity of reasons for ineligibility There is a potential for misunderstanding as to whether reasons are required when the patient does not meet the criteria under Schedule 4, section 2(a) – (h). The introduction to section 2 speaks to the practitioner giving an indication as to (a) whether the patient met or (b) did not meet the criteria. However, in the itemized criteria [2(a)-(h)] it only speaks to the practitioner having to provide reasons when the patient meets the criteria (and not when the patient has not met the criteria). It would be helpful to specify that reasons should be required when the patient does and does not meet the criteria. This is also crucial for the publication of the Minister of Health’s annual report requiring that the reasons, and which eligibility criteria were not met, be addressed. Conclusion The CMA recognizes the importance of regulations to capture the provision, collection, use, and disposal of information for the purpose of monitoring MAiD. The CMA cautions against introducing reporting requirements that are beyond the scope of the legislation. As noted in the legislation, practitioners who fail to provide information under the regulations may be found guilty under the Criminal Code and subject to possible imprisonment. It is thus imperative that the federal government drafts clear regulations that respect the legislation, privacy, research ethics, and a de minimus approach. .
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Proposed approach to the regulation of cannabis

https://policybase.cma.ca/en/permalink/policy13838
Date
2018-01-19
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-01-19
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association appreciates this opportunity to respond to Health Canada's public consultation on the proposed regulatory approach for the proposed Cannabis Act, Bill C-45. Our approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines1 and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation,2 recommendations regarding Bill C-453 and submission on the cannabis excise duty framework.4 Therefore, we are limiting our response to those consultation questions that pertain to that approach and relate to our expertise and knowledge base. We are providing responses to questions 9, 10 and 11. Consultation questions Packaging and labelling 9. What do you think about the proposed rules for the packaging and labelling of cannabis products? Do you think additional information should be provided on the label? The CMA concurs with the proposed regulations. Packaging and labelling of cannabis products should include measures such as:
a requirement for plain and standard packaging,5 6
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 an overdose. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. In that regard, the regulations with respect to packaging and labelling should be viewed as an opportunity to maximize educational opportunities. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Package inserts should include:
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. In addition, the regulations for the marketing and advertising of cannabis should use an approach similar to those in place for tobacco and cigarettes.7 8 9 Cannabis for medicinal purposes 10. What do you think about the proposed approach to providing cannabis for medical purposes? Do you think there should be any specific additional changes? CMA maintains its position that there should be one system with one set of regulations for medical and recreational cannabis. The CMA believes that once the Act and regulations are in force, there will be no need for two systems. Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization, and for those who wish to use it for other purposes. The medical profession does not need to authorize use once cannabis is legalized, especially given that cannabis has not undergone Health Canada's usual pharmaceutical regulatory approval process, and its anticipated removal as a controlled substance from the Controlled Drugs and Substances Act. Those who have experienced a two-system approach in Washington and Colorado have remarked on the challenges of having dual standards and regulations (e.g., purchase and possession quantities, taxation levelsa 4) and the contribution to the grey market.b 11 Consistent with the advice it received from the Task Force on Legalization and Regulation of Cannabis,12 the government intends on pursuing both a medicinal and retail cannabis system at this time. In this instance the CMA supports regulations for each system being as similar as possible. Furthermore, the CMA strongly supports the need for appropriate and relevant data collection (e.g., interaction of individuals between the medicinal and retail systems) to provide the necessary evidence for the future legislative review, anticipated in three years' time. The CMA would expect to be involved and looks forward to participating in the criteria development, evaluation and performance review of the systems. Sale of health products containing cannabis 11. What do you think about the proposed restrictions on the sale of health products containing cannabis authorized by Health Canada? Do they strike an appropriate balance between facilitating access to safe, effective and high quality health products, and deterring illegal activities and youth access? 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 undergo 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. 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 is needed for a DIN but not for a 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 sufficient information to choose appropriate products. Health Canada launched a consultation in 201613 on the approval process of the categories of non-prescription drugs, natural health products and cosmetics ("self-care products") with the intent of modernizing the present regulations. The CMA fully supports this work and hopes it will be brought to a timely conclusion.14 With respect to all health products, the CMA supports a risk-based approach in which higher risk products, for example, those for which health claims are made, must meet a higher standard of review. Rigorous scientific evidence is needed to support claims of health benefits and to identify potential risks and adverse reactions. All health products 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(r) and Sativex(r)), to protect Canadians from further misleading claims. 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. With respect to the sale of cannabis products to youth, the CMA recommends the adoption of strict controls as outlined in the proposed regulations; as per the proposal, "All health products would be subject to provisions that control against practices that may appeal to youth, or the use of testimonials, real or fictional characters or animals, or lifestyle branding. Tamper-evident and child-resistant packaging requirements would also apply."15 We also support the additional precautions around medical devices, especially those sold to young persons. The CMA urges caution around the exemption 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). There will be a need for careful monitoring of the health products released in the market and the health claims made. Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Various examples have been reported in the media highlighting the need to be vigilant, as illustrated in Switzerland regarding health and other products with cannabis and high cannabidiol content.16 17 a The CMA supports similar taxation treatment of cannabis products for medical and non-medical purposes. b Grey market refers to products produced or distributed in ways that are unauthorized or unregulated, but not strictly illegal. 1 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: http://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 2017 Jul 27). 2 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: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: The Association; 2017 Aug 18. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Jan 17). 4 Canadian Medical Association (CMA). Excise duty framework for cannabis products. Submission to the Government of Canada consultation on the proposed excise duty framework for cannabis products. Ottawa: The Association; 2017 Dec 7. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2018-06.pdf (accessed 2018 Jan 17). 5 Vardavas C, Filippidis F, Ward B, et al. Plain packaging of tobacco products in the European Union: an EU success story? European Respiratory Journal 2017;50:1701232 Available: http://erj.ersjournals.com/content/erj/50/5/1701232.full.pdf (accessed 2018 Jan 17). 6 Torjesen I. Standardised packs cut adult smoking as well as discouraging young people, evidence indicates BMJ 2015;350:h935. Available: http://www.bmj.com/content/350/bmj.h935 (accessed 2018 Jan 17). 7 Hughes N, Arora M, Grills N. Perceptions and impact of plain packaging of tobacco products in low and middle income countries, middle to upper income countries and low-income settings in high-income countries: a systematic review of the literature. BMJ Open 2016;6:e010391. doi:10.1136/bmjopen-2015-010391. Available: http://bmjopen.bmj.com/content/bmjopen/6/3/e010391.full.pdf (accessed 2018 Jan 17). 8 White V, Williams T, Wakefield M. Has the introduction of plain packaging with larger graphic health warnings changed adolescents' perceptions of cigarette packs and brands? Tob Control 2015;24:ii42-ii49. Available: http://tobaccocontrol.bmj.com/content/tobaccocontrol/24/Suppl_2/ii42.full.pdf (accessed 2018 Jan 17). 9 Smith C, Kraemer J, Johnson A, Mays D. Plain packaging of cigarettes: do we have sufficient evidence? Risk Management and Healthcare Policy 2015;8:21-30. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396458/pdf/rmhp-8-021.pdf (accessed 2018 Jan 17). 10 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015 Nov. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2018 Jan 18). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. Available: https://www.canada.ca/content/dam/hc-sc/healthy-canadians/migration/task-force-marijuana-groupe-etude/framework-cadre/alt/framework-cadre-eng.pdf (accessed 2018 Jan 18). 12 Government of Canada. Consultation on the regulation of self-care products. Ottawa: Government of Canada; n/d. Available: https://www.canada.ca/en/health-canada/programs/consultation-regulation-self-care-products.html (accessed 2018 Jan 17). 13 Canadian Medical Association (CMA). Regulation of self-care products in Canada. Ottawa: The Association; 2016. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2017-11.pdf (accessed 2018 Jan 17). 14 Health Canada. Proposed approach to the regulation of cannabis [consultation]). Ottawa: Health Canada; 2017 Nov. Available: https://www.canada.ca/content/dam/hc-sc/documents/programs/consultation-proposed-approach-regulation-cannabis/proposed-approach-regulation-cannabis.pdf (accessed 2018 Jan 17). 15 Knodt M. In Switzerland, high-CBD cannabis being sold legally as 'Tobacco Substitute'. Seattle: Leafly; 2018. Available: https://www.leafly.com/news/politics/switzerland-high-cbd-cannabis-sold-legally-tobacco-substitute (accessed 2018 Jan 17). 16 Wiley C. Could a legal quirk bring cannabis tourism to Switzerland? The Telegraph 2017 Jul 28;Travel Section. Available: http://www.telegraph.co.uk/travel/destinations/europe/switzerland/articles/cannabis-tourism-has-arrived-in-switzerland/ (accessed 2018 Jan 17).
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Letter on cross-border pharmacy control

https://policybase.cma.ca/en/permalink/policy1947
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Last Reviewed
2013-03-02
Date
2005-11-08
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of the Canadian Medical Association (CMA) I would like to respond to Health Canada’s papers, released on October 7, 2005, “Developing a Drug Supply Network and an Export Restriction Scheme” and “Requiring a Patient-Practitioner Relationship as a Condition of Sale of Prescription Drugs in Canada,” which invite discussion on the Minister of Health’s June 29, 2005 proposals to control cross-border pharmacy and ensure that Canadians have a continued supply of prescription drugs. The CMA agrees that Canadians must have a supply of drugs adequate to meet their needs. Currently the most serious threat to this supply appears to be the legislative proposals, currently before the United States Congress, that would allow Americans to purchase Canadian drugs in bulk. Proactive measures to protect our drug supplies are warranted to guard against this threat. In summary, our response to the Minister’s three proposals is as follows: * Supply monitoring network: We support supply monitoring as a necessary activity. * Export restrictions: We believe that all Canadian drugs should be subject to export restriction, and the Government of Canada should grant itself the power to enact bans on export as needed. * Requiring a patient-physician relationship: We do not believe this proposal can be enforced, or that it will contribute materially to securing an adequate drug supply for Canada. We recommend that Health Canada instead support the activities of medical and pharmacy regulatory authorities in ensuring that prescribing behaviour is appropriate. Our detailed comments on the proposals are below. 1) Drug supply monitoring system The CMA strongly supports the development of a comprehensive strategy and an adequately resourced system for monitoring domestic drug supply. Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. We recommend that more careful consideration be given to the most effective design and functioning for a supply-monitoring network. It is our understanding that manufacturers and distributors currently monitor supply of their own products. Ideally, a mechanism should be found to unite these individual activities into a robust and effective network without creating a costly parallel effort. Specific comments follow: * 2.1 Gathering Drug Shortage Information: Voluntary reporting is a preferred approach. In designing a voluntary scheme, it should be taken into account that soliciting reports from a wide variety of players, including the public, may result in a flood of anecdotal, poorly documented reports that will require expert analysis to verify and put into context. Regardless of who is solicited for shortage reports, the reporting process should be made as clear, simple and user-friendly as possible, and all stakeholders who might be in a position to make reports should be made aware of its existence. * 2.2 Assessment and Verification: We agree that a baseline of drug inventory data is required, as are benchmarks for what constitutes an appropriate drug supply for Canada. These should be established as a first step, before the implementation of a voluntary reporting scheme. * 2.3 Communication of Information: While physicians may seldom be in a position to report drug shortages, it is essential that they be informed at once when a shortage exists, and how long it is expected to last. Guidance for physicians on measures they might take while the shortage lasts (for example, other drugs they might prescribe as substitutes) is highly desirable. Medical associations could help Health Canada communicate this information to their members. The paper makes reference to Health Canada’s preference for collaboration in this endeavour “without assuming responsibility for becoming the primary source of information for Canadians on drug shortages or for resolving all reported drug shortages.” This is not appropriate. Leadership responsibilities and public expectations preclude the Minister from shirking responsibility for these functions. Accountability for such a complex network must be vested in one authority, i.e. Health Canada. * 2.4 Response measures: Though the paper lists response capacity as an element of drug supply monitoring, it does not contain practical suggestions for responding in the event of a shortage. This is a crucial element and needs to be developed. There is no point in monitoring supply without a plan for managing shortages. 2) Export Restriction CMA supports this proposal. The power to restrict export of drugs offers Canada its best chance of protection should the U.S. legalize bulk purchasing. This power should be strong and far-reaching. Serious consideration should be given to the June 2005 motion from the House Standing Committee on Health motion to ban all bulk exports of prescription drugs. Specific comments follow: * 3.4.2 Drug products deemed necessary for human health: The discussion paper proposes to restrict export only under certain circumstances, e.g. if the drug is deemed necessary to human health, and to establish criteria to determine whether a drug meets this condition. All prescription drugs are necessary for human health; certainly those who are taking them consider them so. For equity’s sake - and also because establishing and abiding by criteria may prove impossible - we believe every prescription drug in Canada should be considered a candidate for export restriction. * 3.4.3 Implications for patient care: We acknowledge that in many cases, other effective therapies can be substituted for drugs in short supply. Many physicians will make these substitutions as needed; but they must first be made aware of the shortages. Physicians must be advised of available alternatives if an unavoidable shortage exists; however, we caution that the existence of alternatives should not be used as justification for not taking action if a drug is in shortage. The final decision as to the most appropriate available therapy should remain a matter to be determined by the patient and physician and consultation. 3) Requiring a Patient-Practitioner Relationship The Minister has expressed his desire to ensure that physicians maintain high ethical and professional prescribing standards. The CMA shares this desire. As discussed in the attached CMA Statement on Internet Prescribing (Appendix I), we hold that prescriptions should be written in the context of an appropriate patient-physician relationship. However, we do not accept that the proposed option of requiring an established patient-practitioner relationship for every prescription issued in Canada will have a meaningful effect on ensuring adequate drug supply, for the following reasons: * The proposal does not target the real problem. Most current drug shortages are caused by raw material shortages, inventory management disruptions, unexpected spikes in demand, and other conditions that have nothing to do with the clinical encounter. More important, targeting the patient-practitioner relationship will not protect Canadians from the impact of U.S. bulk purchasing should legislation pass Congress. * Prescribing outside the context of the patient-physician relationship is already subject to sanction by medical regulatory authorities. The vast majorities of Canada’s physicians conduct themselves ethically and only prescribe for patients in the context of a professional relationship. Those who do not, contravene both the CMA’s policy and the standards of practice for provincial/territorial regulatory Colleges of Physicians and Surgeons. These regulatory authorities, and the long and effective tradition of professional self-regulation they represent, should be respected and supported. * The proposal is burdensome and will be difficult to enforce. The proposal places the onus for evaluating the patient-practitioner relationship on pharmacists. While pharmacists are required, as part of their professional responsibility, to ensure that a prescription has been written by a physician licensed to practice in that jurisdiction, they are not customarily familiar with the details of the interaction leading up to the prescription. Requiring them to formally screen for this will impose a heavy administrative burden, and will compromise patient confidentiality. In addition, compliance monitoring by Health Canada will be complex, if feasible at all. For example, despite the Minister’s recent comment that prescriptions “can only be signed by a medical practitioner who actually sees and treats the patient in question”, it is generally accepted that perfectly legitimate prescribing can take place without a face-to-face encounter (e.g. through telemedicine) or an “ongoing” patient-physician relationship (e.g. in an emergency). While it is easy to detect flagrant infractions (such as a hundred prescriptions a day written for American patients by the same Canadian doctor) it will be much harder to precisely identify the boundary between what is legitimate prescribing behaviour and what is not. Many provincial regulatory authorities have already developed definitions of the patient-physician relationship, which Health Canada includes in the discussion document. It is unlikely that Health Canada will be able to improve on them. * Determining an appropriate relationship may be more appropriately a provincial or territorial responsibility. The patient-physician interaction, like other scope-of-practice issues, is regulated at the provincial level. We do not believe the cross-border prescribing problem justifies Health Canada’s overarching federal-level intervention. In conclusion, we support further exploration of the supply-monitoring and export-restriction options, and believe that existing medical and pharmaceutical regulatory authorities should be respected and supported in enforcing appropriate prescribing behaviour. We appreciate the opportunity to comment on your proposals. We look forward to further opportunities for input during the development of legislation. Yours truly, Briane Scharfstein, MD, CCFP, MBA Associate Secretary General, Professional Affairs cc: Ms. Meena Ballantyne, Director General, Health Care Strategies and Policy Directorate, Health Canada CMA Provincial/Territorial Divisional CEO’s
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16 records – page 1 of 1.