The Canadian Medical Association (CMA) is pleased to provide its comments with respect to the Government of Canada's consultation on the Proposed Excise Duty Framework for Cannabis Products published November 10.1
In the move towards the legalization and regulation of cannabis, there are many economic interests at play; private corporations and different levels of government stand to benefit greatly with sales and considerable tax revenue.2 It is essential that the federal and provincial/territorial governments be held accountable to the public health and safety objectives set out for the new regime for legal access to cannabis, particularly that of protecting children and youth.3 It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls.
Final pricing must be such as to discourage the illegal production and trafficking of cannabis. However, a balance must be found with the use of taxation and pricing levers to discourage use. Revenues need to be clearly earmarked to cover the health and social costs of legalization. In some U.S. jurisdictions, for example, some of the revenue is directed to recovering the costs of regulatory programs as well as in substance use treatment programs, and for social programs.
Most of the future tax revenues should be redistributed to the provinces and territories. This is because they have jurisdiction over services that will likely feel the impact with legalization, such as health care, education, social and other services, as well as enforcement of legislation and regulations. A public health approach to legalization will emphasize prevention, education and treatment initiatives which require adequate and reliable funding. It will also require strong surveillance and monitoring activities to adjust measures should unintended harms be detected. Resources need to be promptly available to address potential negative impacts.
CMA recommends that the revenue resulting from the taxation of cannabis production and sales be earmarked to address health and social harms of cannabis use and its commercialization, in line with a public health approach to the legalization of cannabis.
The proposal states that "Any cannabis products sold under the proposed Cannabis Act for medical purposes will be subject to the duty rates and conditions of the excise duty framework, which will become applicable as per the transitional rules (...) Cannabis products that are produced by an individual (or a designated person) for the individual's own medical purposes in accordance with the proposed Cannabis Act will not be subject to the excise duty. Seeds and seedlings used in this production will be subject to duty."1
The CMA is supportive of similar taxation treatment of cannabis products, regardless of whether they are used for medical or non-medical purposes.
The CMA has long called for more research to better understand potential therapeutic indications of cannabis, as well as its risks.4 5 Physicians recognize that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with cannabis used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency, interactions with medications and adverse effects. Health Canada does not approve of cannabis as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. It is important that there be support for cannabis research in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol(r)), nabilone (Cesamet(r)) and THC/CBD (Sativex(r)).
The experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the different standards.6 A lower tax rate on cannabis for medical use could potentially provide an incentive for people to seek a medical authorization, and that was observed initially in Colorado.7
The CMA recommends that the same tax rates be applied to the production and sales of both the medical and the non-medical use of cannabis products.
The move towards the legalization and regulation of cannabis will require a balanced approach to discourage the illegal production and trafficking of cannabis while also using taxation and pricing levers to discourage use. Much of the revenues raised should be redistributed to the provinces and territories to enable them to cover the health and social costs of legalization.
A public health approach to legalization will emphasize prevention, education, treatment and surveillance initiatives which requires adequate and reliable funding.
1 Department of Finance Canada. Proposed excise duty framework for cannabis products. Ottawa: Department of Finance Canada; 2017. Available: http://www.fin.gc.ca/n17/data/17-114_1-eng.asp (accessed 2017 Dec 05).
2 Sen A, Wyonch R. Don't (over) tax that joint, my friend. Intelligence MEMOS. Ottawa: CD Howe Institute; 2017 Jul 19. Available: https://www.cdhowe.org/sites/default/files/blog_Anindya%20and%20Rosalie_0719.pdf (accessed 2017 Dec 06).
3 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed 2017 Dec 05).
4 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://www.cma.ca/Assets/assets-library/document/en/advocacy/cannabis.pdf (accessed 2017 Dec 05).
5 Canadian Medical Association (CMA). Medical Marijuana. CMA Policy. Ottawa: CMA; 2011. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/PD11-02-e.pdf (accessed 2017 Dec 05).
6 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2017 Dec 05).
7 Office of the Parliamentary Budget Officer. Legalized cannabis: Fiscal considerations. Ottawa: Office of the Parliamentary Budget Officer; 2016. Available: http://www.pbo-dpb.gc.ca/web/default/files/Documents/Reports/2016/Legalized%20Cannabis/Legalized%20Canabis%20Fiscal%20Considerations_EN.pdf (accessed 2017 Dec 05).
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.
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
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,
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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)
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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))
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The Canadian Medical Association (CMA) is pleased to provide this brief in response to Health Canada's consultation on the Controlled Drugs and Substances Act (CDSA) "regarding any challenges, gaps or suggested improvements."
The CMA welcomes the consultation and review of the CDSA and its associated regulations. This is an important legislative framework with direct implications for public health, quality care and patient safety.
The CMA's recommendations outlined in this brief aim to establish new measures and mechanisms under the CDSA that would contribute to improved public health and patient safety. The CMA looks forward to the opportunity to discuss these issues in greater detail with Health Canada as this consultation proceeds.
Part 1: Supporting a Regulatory Approach that Advances Public Health, Quality Care and Patient Safety
As an overarching principle, it is the CMA's position that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety.
In enacting the CDSA and promulgating its regulations, enforcement objectives have been emphasized, as demonstrated by the report on program spending in the National Anti-Drug Strategy Evaluation. The modernization of the CDSA legislative framework offers a significant opportunity to contribute to the greater advancement of public health and patient safety goals by establishing mechanisms that support prevention, treatment and harm reduction. This approach supports the Government of Canada's Throne Speech commitment to address prescription drug abuse as part of the National Anti-Drug Strategy.
In 2013, the CMA's General Council, often referred to the Parliament of Canadian Medicine, recommended "that there be an increased emphasis on public health-oriented approaches by regulatory authorities responsible for psychoactive substances." Substance abuse is a complex behaviour influenced by many factors, and a therefore a public health approach to addressing it should incorporate a comprehensive multi-factorial strategy.
A public health approach would place an increased focus on preventing drug abuse and misuse; on treatment of addiction and other consequences of misuse; on monitoring, surveillance and research; and on harm reduction. It would seek to ensure the harms associated with enforcement (e.g. crime, disease due to use of dirty needles) are not out of proportion to the direct harms caused by substance abuse. The CMA recommends that the modernization of the CDSA legislative framework focus on enabling and supporting such a public health approach.
It should be noted that the substances governed by the CDSA include medications used by patients and prescribed by health care professionals for legitimate therapeutic purposes. We note that the schedules attached to the CDSA do not make a distinction between illicit substances of abuse and prescription medication. For example, Schedule I includes both illicit substances such as heroin, and opioid prescription medicines like oxycodone and hydrocodone. The potential of a drug or medication to cause harm has little if anything to do with its legal status. Therefore, the CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule. The purpose of this review is to ensure that: (1) the schedules are up-to-date; (2) the CDSA allows for the incorporation of new illicit substances and prescription medication on the basis of available evidence and in a timely manner; and, (3) the schedules are organized based on risk status, legal status or other consideration.
In the following sections, the CMA outlines recommendations that would facilitate the expansion of a public health approach.
A) Establish Mechanisms to Address Prescription Drug Misuse and Abuse
The misuse and abuse of controlled psychoactive prescription medicines, notably opioids such as oxycodone, fentanyl and hydrocodone, is a significant public health and patient safety issue. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States.
The abuse and misuse of prescription opioids among vulnerable populations, remains a significant concern. For instance, in 2013 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. While accurate data on the prevalence of the misuse of prescription medication among seniors is lacking, the CMA is concerned that as Canada's population ages, an increasing number of seniors will need treatment for harms related to prescription medication use, such as drug interactions, falls due to drowsiness or lack of coordination.
Controlled prescription medications are legal products intended for legitimate therapeutic purposes, i.e. to control pain from cancer or terminal illness, or from chronic conditions such as nerve damage due to injury. However, they may also be misused or abused, and addiction may drive some users to illegal behaviour such as doctor-shopping, forging prescribers' signatures, or buying from street dealers.
Canada's physicians are deeply concerned about the misuse and abuse of prescription opioid medication for a number of reasons. First, physicians need to assess the condition of the patient who requests the medication, and consider whether its use is clinically indicated and if the benefits outweigh the risks. Secondly, they may need to prescribe treatment for patients who have become addicted to the medication. Finally, they are vulnerable to patients who forge the physician's signature or use other illegal means to obtain prescriptions, or who present with fraudulent symptoms, or plead or threaten when denied the drugs they have requested.
The 2014 federal budget promises $44.9 million over 5 years to the National Anti-Drug Strategy to address prescription drug abuse, and CMA believes that this is a positive step. Health Canada, in its role as drug regulator, could use the Controlled Drugs and Substances Act to help further this strategy in the following ways:
i) Improving the approval, labelling and safety monitoring of controlled substances
The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny for controlled prescription medication, during both the approval process and post-approval surveillance. Specifically, the CDSA should be amended to require:
* More stringent pre-approval requirements for controlled prescription medication. Because of their high level of risk, Health Canada could require that they be subject to higher levels of scrutiny than other medications during the review of pre-approval clinical trial results, special post-approval conditions(e.g. formal post-market studies);
* Stricter conditions on the marketing of controlled medication by the pharmaceutical industry to health professionals.
* Tamper-resistant formulations of prescription opioid medication. New opioid medication or potentially addictive formulations should be tamper-resistant to reduce the potential for misuse or abuse.
* Improved patient information and counseling to be offered to prescribers, dispensers, and patients receiving opioid prescriptions.
ii) Establishing consistent requirements for prescription monitoring
In our brief to the House of Commons Standing Committee on Health (see Appendix A), during its study on prescription drug abuse, the CMA encouraged all levels of government to work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring and surveillance. Indeed, all stakeholders who testified before the Committee recognized the importance of prescription monitoring programs in addressing prescription drug abuse.
While prescription monitoring programs (PMPs) exist in most provinces, they vary considerably in terms of quality, the nature of the information they require, whether health care practitioners have real-time access, and in the purpose for which the data is collected. Standardization of surveillance and monitoring systems can contribute to addressing the misuse and abuse of prescription medication by:
* Allowing health care practitioners to identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers, at the time the prescription is requested or filled.
* Deter interprovincial or jurisdictional fraud, again, by allowing health care practitioners to identify fraudulent attempts at the time the prescription is requested or filled.
* Improve professional regulatory bodies' capacity for oversight and intervention, by establishing a mechanism for real-time monitoring.
* Finally, help Canada's researchers improve our knowledge of this serious public health concern, identify research priorities, and determine best practices to address crucial issues.
Such a system should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases such as that of British Columbia. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. Integration with electronic health records and the widespread use of electronic databases and transmission would go far to minimize the potential burden.
The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders, in order to establish consistent standards for prescription monitoring. This regulation should:
* Enable inter-jurisdictional accessibility and operability;
* Ensure that practitioners have real-time access to the monitoring system;
* Enable electronically-based prescription monitoring; and;
* Conform to privacy laws, protecting patient confidentiality while enabling the sharing of necessary information. (Privacy concerns are addressed in greater detail in Part 2).
B) Supporting harm reduction as a component of a drug strategy
The CMA fully endorses harm reduction strategies and tools, including supervised injection sites, and believes that the CDSA should support and enable them. It is the CMA's position that addiction should be recognized and treated as a serious medical condition.
Section 56 of the CDSA sets out conditions under which applicants may obtain exemptions from the provisions of the Act. Bill C-2, currently at Second Reading in the House of Commons, proposes new, far reaching, and stringent conditions that must be met by a proponent who is applying to establish a supervised injection site. The CMA maintains that safe injection sites are a legitimate form of treatment for the disease of addiction, that their benefit is supported by a body of research, and that the conditions proposed under Bill C-2 are overly restrictive.
In addition, to support harm reduction, the CMA encourages Health Canada to amend section 2 (2) (b) (ii) (B) of the CDSA that states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body" in order to enable the important role of safe injection sites.
C) Developing clinical knowledge base about the medical use of marijuana
The CMA has already made its position on the Marihuana for Medical Purposes Regulations known to Health Canada (see Appendix B). Despite repeated revisions since they were first established in 2001, the regulations do not address CMA's primary concern; that physicians are made gatekeepers for a product whose medical benefits have not been sufficiently researched, and which has not undergone the clinical trial process required for therapeutic products under the Food and Drugs Act. The absence of clinical evidence means that physicians lack scientific information and guidance on the uses, benefits and risks of marijuana when used for medicinal purposes. To address these issues, the CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives for Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians.
Part 2: Ensuring protection of patient privacy
In any legislative framework pertaining to patient care, physicians consider protecting the privacy of patient information to be paramount; indeed, privacy, confidentiality and trust are cornerstones of the patient-physician relationship (see Appendix C). For these reasons, the CMA strongly recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as of future proposed amendments. The CMA encourages Health Canada to make this assessment available to stakeholders as part of its consultation process on this legislative framework.
As previously mentioned, the new regulation proposed under Part 1 (A) (ii) above must conform to privacy laws, and protect patient confidentiality while enabling the sharing of necessary information.
The CMA is deeply concerned with the search provision under s.31 of the CDSA in which an exception to this broad authority for patient records is mentioned in subsection (1) (c). The CMA is concerned that this exception may not be sufficient to meet the existing privacy laws governing patient information and records, both federally and provincially. As such, the CMA recommends that the CDSA be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions.
Part 3: Enabling e-prescribing
As part of the review of the CDSA and its associated regulations, Health Canada should assess how this legislative framework may be used to facilitate and support the advancement of e-health, specifically e-prescribing. Electronic health records can support individual physicians or pharmacists to quickly identify potential diversion and double-doctoring, at the point where a prescription is written or filled. The electronic health record also facilitates the sharing of information among health professionals, as well as programs that allow physicians to compare their prescribing practices to those of their peers.
For instance, sections of the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations, establish the conditions within which pharmacists may accept a prescription. The CMA recommends that these regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist. This recommendation is consistent with the joint statement by the CMA and the Canadian Pharmacists Association on e-prescribing (see Appendix D).
Health Canada should also ensure that regulatory amendments facilitate prescription monitoring, as discussed in a previous section.
Part 4: Establishing a mechanism for changes to scope of practice
The New Classes of Prescribers Regulations, promulgated in 2012, grants nurse practitioners, midwives and podiatrists the authority to prescribe controlled substances if their provincial scope of practice laws permit. The CMA's 2012 submission in response to this regulatory change is attached to this brief for information (Appendix E.) In it, the CMA recommended that "A regulatory framework governing prescribing authority, or any other aspect of scope of practice, should always put patient safety first. The primary purpose of scope of practice determination is to meet the health care needs and serve the health interests of patients and the public safely, efficiently, and competently." One of our main concerns at the time was that the more practitioners who could prescribe controlled substances, the greater the potential for the illegal diversion of products to street dealers. This remains a concern for us.
Given the significance of scope-of-practice determinations to patient safety and patient care, the CMA strongly recommends that future changes to the scope of practice of a health care practitioner be undertaken only within a defined, transparent evaluation process based on clinical criteria and protection of patient safety.
To this end, the CMA strongly recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice. These clauses should require, prior to the implementation of any change:
* Demonstration that it will improve public health and patient safety;
* Meaningful consultation with professional organizations and regulatory authorities; and,
* Support of provincial and territorial ministers of health.
Further, the CMA recommends that such a new regulation governing possible future changes to scope of practice require:
* That new classes of prescribers have conflict of interest policies;
* That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and
* That a mandatory five-year review be established for new classes of prescribers.
Part 5: Recognizing the authority of physician regulatory colleges
As previously mentioned, many controlled substances governed under the CDSA and its associated regulations are prescribed by physicians and other health professionals, for therapeutic purposes.
Medicine is a regulated profession, and the colleges of physicians have ultimate authority and responsibility for the oversight of physician practice, including monitoring prescribing activity, investigating practice and when required, taking disciplinary action.
In its present form, section 59 of the Narcotic Control Regulations includes a duplicative and redundant provision for oversight and disciplinary action. The CMA strongly recommends that this section be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.
The CMA welcomes the consultation and review of the Controlled Drugs and Substances Act and its associated regulations. As mentioned before, this submission is not an exhaustive analysis of the Controlled Drugs and Substances Act¸ but an initial summary of CMA's position on issues of particular concern to patient safety and public health. This brief outlines numerous opportunities within the CDSA and its associated regulations to establish new measures and mechanisms that would contribute to improved public health and patient safety.
In light of the breadth and importance of the issues raised in this review, CMA encourages further consultation and welcomes the opportunity to discuss these issues in greater detail.
List of Appendices:
* Appendix A: CMA Brief to the House of Commons Standing Committee on Health - The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada
* Appendix B: CMA Policy Statement - Medical Marijuana
* Appendix C: CMA Policy Statement - Principles for the Protection of Patient's Personal Health Information
* Appendix D: CMA Policy Statement - Vision for e-Prescribing: a joint statement by the Canadian Medical Association and the Canadian Pharmacists Association
* Appendix E: CMA submission - Response to the proposed New Classes of Practitioners regulations published in the Canada Gazette Part I (Vol. 146, No. 18 - May 5, 2012)
Overview of recommendations
The CMA recommends that the modernization of the CDSA legislative and regulatory framework should be guided first and foremost by the objective of improving public health, promoting quality care and enhancing patient safety.
The CMA recommends that as part of the review of the CDSA and its regulations, Health Canada undertake a review of the schedules, including the organization of the schedules, and the listing of substances within each schedule.
The CMA recommends that new sections be introduced to the CDSA to require higher levels of regulatory scrutiny as part of the approval and post-approval process for prescription opioid medication.
The CMA recommends that a new reporting regulation be promulgated under the CDSA that addresses reporting requirements and disclosure requirements of practitioners, manufacturers and other stakeholders in order to establish consistent standards for prescription monitoring.
To support harm reduction, the CMA recommends an amendment to section 2 (b) (ii) of the CDSA, which states a controlled substance includes "any thing that contains or has on it a controlled substance and that is used or intended or designed for use... in introducing the substance into a human body".
The CMA recommends that Health Canada invest in scientific research on the medical uses of marijuana. This could include establishing market incentives that require Licensed Producers to undertake research, or requiring them to contribute to a research fund administered by the Canadian Institutes of Health Research. In addition, the CMA encourages the development and dissemination of evidence-based clinical support tools for physicians.
The CMA recommends that Health Canada undertake a privacy impact assessment of the existing CDSA and its regulations as well as future proposed amendments, and provide this assessment to stakeholders as part of its consultation process on this legislative framework.
The CMA recommends that the CDSA, specifically s.31 (1) (c), be amended to ensure that patient information and records are exempt from search authorities, consistent with the most stringent privacy laws at the federal and provincial jurisdictions.
The CMA recommends that the CDSA and its regulations be amended to specifically include electronic prescriptions in addition to verbal and written prescriptions among the forms that may be accepted by a pharmacist, including sections within the Benzodiazepines and Other Targeted Substances Regulations, Narcotic Control Regulations, and Precursor Control Regulations.
The CMA recommends the introduction of new clauses to the CDSA and its associated regulations to establish a mechanism that governs future changes to scope of practice, based on the introduction of a new regulation governing changes to scope of practice that will require, prior to the implementation of any change:
* Demonstration of public health and patient safety improvement;
* Meaningful consultation with professional organizations and regulatory authorities; and,
* Support of provincial and territorial ministers of health.
The CMA recommends that the new mechanism of the CDSA legislative framework governing possible future changes to scope of practice require:
* That new classes of prescribers have conflict of interest policies;
* That new classes of prescribers be incorporated under the prescription monitoring regulation recommended under Part 1 (A) (ii) above; and
* That a mandatory five-year review be established for new classes of prescribers.
The CMA strongly recommends that s.59 of the Narcotic Control Regulations be amended to recognize the established authority of physician regulatory colleges for the oversight of the medical profession.