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Policies that advocate for the medical profession and Canadians


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Antimicrobial stewardship and antimicrobial resistance surveillance

https://policybase.cma.ca/en/permalink/policy13710
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-11
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-11
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
Text
The Canadian Medical Association calls on the federal government to use Canada’s term as G7 President in 2018 to add antimicrobial stewardship and antimicrobial resistance surveillance as part of their agenda.
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Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act)

https://policybase.cma.ca/en/permalink/policy11297
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-10-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of House of Commons Standing Committee on Public Safety and National Security's study of Bill C-2, An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act).1 Prior to a discussion on CMA's position regarding the substance of Bill C-2, the CMA firstly recommends that legislation pertaining to harm reduction services requires study by parliamentary committees responsible for health or social matters in addition to public safety. Bill C-2 (formerly Bill C-65) is subsequent to the 2011 unanimous ruling of the Supreme Court of Canada2 that recognized the significant evidence on the benefits of Insite, Vancouver's supervised injection site. The Supreme Court ordered that the federal government grant the exemption for medical and scientific purposes to Insite. The ruling left decisions regarding future applications for exemptions to the Controlled Drugs and Substances Act (CDSA) for Insite and other potential supervised injection sites up to the discretion of the Minister of Health, with the provision that the Minister seek to strike the appropriate balance between the public health and public safety goals, and suggests the decision be based on five elements: "evidence, if any, on the impact of such a facility on crime rates, the local conditions indicating a need for such a supervised injection site, the regulatory structure in place to support the facility, the resources available to support its maintenance and expressions of community support or opposition." 3 In response, the Minister of Health proposed Bill C-2, which amends the CDSA to include section 56.1, and provides a federal regulatory framework for supervised consumption sites.* CMA is deeply concerned with the proposed legislation, as it has the potential to create unnecessary obstacles and burdens that would ultimately deter the creation of new supervised consumption sites, even in municipalities where the need and cost-effectiveness has been well researched and the health and safety benefits clearly established. Moreover, it does not strike the appropriate balance between public health and public safety, as is the spirit and intent of the Supreme Court of Canada ruling on Insite. This will make the renewal of exemptions for Insite, the very facility which the Supreme Court ruled "saves lives", very difficult. Public health approach to addiction Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. The CMA has long called for a comprehensive national drug strategy that addresses addiction, and includes prevention, treatment, harm reduction and enforcement components. Public health objectives in addressing addictions will vary depending upon the circumstances: preventing drug use in those who have not initiated use (e.g. pre-teens); avoiding use in circumstances associated with a risk of adverse outcomes (e.g. drug use and driving motor vehicle); assisting those who wish to stop using drugs (e.g. treatment, rehabilitation); and assisting those who continue to use drugs to do so in such a manner as to reduce the risk of adverse effects (e.g. needle distribution program). Despite drug use being primarily a health and social issue, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach, as evidenced by a recent evaluation.4 This approach does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. Other models are more effective in achieving the desired objectives and more investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system.5 Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Harm reduction is part of health practice Harm reduction is not restricted to services for people who use drugs; it is an approach that is adopted routinely in every health and social program. For example, seat belts, air bags and helmets are encouraged and even mandated to reduce some of the possible harmful consequences of driving or cycling - regardless of who is at fault. Many medications do not cure diseases, and are essential to prevent complications. An example is the use of insulin by people with diabetes.6 There are many programs created to reduce the harms created by alcohol, a legal substance that contributes to a significant burden of disease, disability and deaths. Examples include low risk drinking guidelines, designated driver or alternate driver programs for drinkers, graduated licenses and changes in the hours of liquor stores to reduce the use of non-beverage alcohol.7 While the risk is still present, this approach reduces harms. Harm reduction related to psychoactive substances, "refers to policies, programmes and practices that aim primarily to reduce the adverse health, social and economic consequences of the use of legal and illegal psychoactive drugs without necessarily reducing drug consumption. Harm reduction benefits people who use drugs, their families and the community".8 They are part of a comprehensive approach which also includes abstinence-based programs. The CMA fully supports harm reduction strategies as they aim to reduce mortality and morbidity even in the face of continued exposure to a potentially harmful substance. Addiction is an illness, and harm reduction is a clinically mandated and ethical method of care and treatment. Physicians must treat patients as a matter of good medical practice and ethical obligation, whether the patient is believed to contribute to his or her injury or not. Section 31 of CMA's Code of Ethics provides that all physicians must "recognize the responsibility of physicians to promote fair access to health care resources".9 Harm reduction information, services and interventions are respectful and non-judgmental, and have the purpose of promoting health and safety. These strategies were developed in response to critical situations and high costs to the health, social and criminal justice systems. Harm reduction approaches are evidence-based, cost effective and have a high impact on individual and community health. Such programs for injection drug users are now well established within every province and territory in Canada, in the form of needle and syringe distribution programs, methadone maintenance and the provision of sterilized equipment.10 Supervised Consumption Sites are evidence-based Supervised consumption sites, within a comprehensive drug strategy, are another example of a harm reduction program. They were developed to reduce the harms of Injection drug use, which are an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; and increased hospital and emergency service utilization. Many of these health problems are not due to the drugs themselves, but to the injection method and equipment. Supervised consumption sites are "specialized facilities that provide injection drug users with a clean, safe, unhurried environment. Sterile injection equipment is provided and health care and social service professionals are available to deal with health issues, provide counselling, and facilitate access to detoxification and treatment programs. Supervision is provided by health professionals trained in low-risk injection techniques and overdose intervention."11 The drugs are acquired elsewhere, and they are located in areas of concentrated and highly visible drug scenes. Such services have existed for many years in many countries, and there are over 90 sites operating in countries such as Australia, Germany, Luxembourg, the Netherlands, Norway, Spain and Switzerland.12 Clients of these sites have complex histories of trauma, mental illness and drug use, and live at the margins of society, unreached by traditional health and social services. Supervised consumption sites are developed as low threshold services for hard-to-reach populations which are experiencing unacceptable levels of deaths and diseases. Existing outreach and treatment programs are insufficient to meet the needs of this population, and these sites are a point of entry into health and social services. Insite, the first supervised injection site in North America, operates in Vancouver's downtown east side as part of the 'four pillars' drug strategy: prevention, treatment, harm reduction, and enforcement.13 14 In 2012, Insite had an average of 1028 visits per day. There were 497 overdose incidents with no fatalities and 3418 clinical treatment interventions. Insite staff made 4564 referrals for further health care, housing and social supports, and the vast majority was for detox and addiction treatment.15 Insite has been one of the most researched public health interventions to date.16 Research was conducted by the BC Centre for Excellence on HIV/AIDS, funded partially by Health Canada, and there are over 30 publications in leading peer-reviewed scientific and medical journals.17 18The evidence shows that there has been: * A reduction in the overall rate of needle sharing in the area;19 * A reduction in deaths due to overdose in the area, with no overdose deaths in the facility;20 21 * Increased access to addiction counseling and increased enrolment in detox programs;22 23 * Opportunities for HIV prevention through education, and increased links between patients and HIV treatment and services;24 * Improvements in measures of public order including reduced public drug injections and publicly discarded syringes;25 and * No increase in levels of drug dealing or other drug related crime in the area in which the facility is located. 26 * Cost savings to health and social systems, reducing risks of infectious diseases, intervening early when there are issues, and reducing the need for emergency care.27 28 Reports from other countries show similar results.29 30 However, "research evidence, even if it meets rigorous academic standards, might be insufficient to sway opinions among those who hold a firm view of addiction as a moral failure."31 Assertions that supervised consumption sites will not reduce disease transmission, exacerbate crime, encourage drug use, have destructive effects on local businesses and residents are not based on evidence. Physicians believe that medical decisions must be based on evidence, not ideology or public opinion, and the evidence shows that supervised injection reduces the spread of infectious diseases, decreases the incidence of overdose and death and increases access to much needed services, without increasing problems with public safety. Significantly, the Court accepted the evidence that "Insite has saved lives and improved health without increasing the incidence of drug use and crime in the surrounding area."32 It also stated that Insite is supported by the Vancouver police, the city and provincial governments. Supervised consumption rooms aim to address problems of specific, high-risk populations of people who use drugs, particularly those who consume in public and other high risk situations. They seek to meet the needs of those who use drugs, but also of the communities that are struggling with a crisis situation. The CMA has the following concerns with Bill C-2: 1. Bill C-2 does not strike a balance between the public health and public safety goals of the CDSA. As written, Bill C-2 disregards the strong evidence of important positive impacts on public health and public safety and giving undue emphasis on public opinion, which might not be fully informed or experienced. Although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites (Insite and the Dr Peter Centre) and in European countries. "Health problems have been reduced, and law and order have been improved. Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication."33 The Supreme Court states that there has been "no discernible negative impact on the public safety and health objectives of Canada during its [Insite's] eight years of operation." 2. Bill C-2 contradicts the spirit and intent of the unanimous decision of the 2011 Supreme Court of Canada regarding Insite which states that "the potential denial of health services and the correlative increase in the risk of death and disease to injection drug users outweigh any benefit that might be derived from maintaining an absolute prohibition on possession of illegal drugs".34 Bill C-2 does not acknowledge the extensive evidence that exists regarding supervised consumption sites both internationally and in Canada, as discussed previously. Passing Bill C-2 in its current form could potentially prevent the renewal of the exemption to Section 56 of the CDSA for Insite. A likely consequence will be further costly litigation. 3. Bill C-2 would impose multiple and significant barriers that providers of health services to obtain an exemption to section 56 of the CDSA. From five criteria in the Supreme Court decision concerning Insite, Bill C-2 lists 27 requirements (Section 56(1)(3)), which include demographic and scientific data, letters of opinions from representatives of local police and local and provincial governments, information about proposed staff, descriptions of planned procedures and reports from community consultations. Such evidence could require extensive resources and funding by local public health units and community agencies. Some of the data required may only be available in the context of a research project. The data is not only influenced by the existence or not of a supervised consumption site, but by many other factors, such as poverty, enforcement resources and others. Community opinion of supervised consumption sites can also change to be significantly positive after experiencing months of its operation. Finally, Bill C-2 does not address how the Minister is to weigh the information submitted, to guarantee impartiality, or even if he or she must consider an application. Even after meeting all those requirements, the Minister has the sole discretion to decide whether a site can open, and the preamble states that exemptions will only be granted in "exceptional circumstances". 4. Bill C-2 did not involve consultation with provincial and territorial ministries of health, community agencies and professional associations, such as the CMA. Public health authorities and particularly health professionals, who work with people with addictions on a daily basis, recognize the dire need for complementary approaches to substance use that address different needs. The exemption to section 56 is for medical purposes, and public health agencies have the competency to determine when there is a need. It is the CMA's ultimate position that Bill C-2, the Respect for Communities Act must be withdrawn, and that it be replaced with legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services. * "Supervised consumption site" is the term used in Bill C-2, section 56.1, and defined as "a location specified in the terms and conditions of an exemption, granted by the Minister under subsection (2) for a medical purpose, that allows any person or class of persons described in the exemption to engage in certain activities in relation to an illicit substance within a supervised and controlled environment." The Supreme Court of Canada and other documents use terms such as "supervised injection site" "supervised injection services", "drug consumption rooms" or "safer injection site". In the literature, supervised consumption sites could also include supervised inhalation services. 1 Bill C-2: An Act to amend the Controlled Drugs and Substances Act. 2nd Session, 41st Parliament. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=6256959&File=4 2 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 3 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 4 Department of Justice (2013) National Anti-Drug Strategy Evaluation. Retrieved from: http://www.justice.gc.ca/eng/rp-pr/cp-pm/eval/rep-rap/12/nas-sna/p1.html#sec23 5 Day, Brian (2008) "Ottawa's bad prescription on addiction." Toronto Star, Sunday June 8, 2008. Retrieved from: http://www.thestar.com/comment/article/438967 6 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 7 National Alcohol Strategy Working Group (2007) Reducing Alcohol-Related Harm in Canada: toward a culture of moderation. Recommendations for a National Alcohol Strategy. Retrieved from: http://ccsa.ca/Resource%20Library/ccsa-023876-2007.pdf 8 International Harm Reduction Association (2010) Harm Reduction: A position statement from the International Harm Reduction Association. IHRA Briefing. Retrieved from: http://www.ihra.net/files/2010/08/10/Briefing_What_is_HR_English.pdf 9 Canadian Medical Association (2010) Factum of the Intervener. Supreme Court of Canada (Appeal from the British Columbia Court of Appeal) between the Attorney General of Canada and Minister of Health for Canada and PHS Community Services Society, Dean Edward Wilson and Shelly Tomic, Vancouver Area Network of Drug Users. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/CMA-Factum_filed14April2011.pdf 10 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 11 Canadian Centre on Substance Abuse (2008) Harm reduction: what's in a name? Retrieved from: http://www.ccsa.ca/Resource%20Library/ccsa0115302008e.pdf 12 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 13 City of Vancouver Four Pillars Drug Strategy (2008) Limiting the harms of drug use. Retrieved from: http://vancouver.ca/fourpillars/harmReduction/limitHarmDrugUse.htm 14 Vancouver Coastal Health. Supervised Injection Site (N.D.) Services. Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/services/services 15 Vancouver Coastal Health. Supervised Injection Site (N.D.). Accessed September 19, 2014 at: http://supervisedinjection.vch.ca/research/supporting_research/user_statistics 16 Urban Health Research Initiative (2010). Insight into Insite. Retrieved from: http://www.cfenet.ubc.ca/sites/default/files/uploads/publications/insight_into_insite.pdf 17 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 18 Wood, E. et al. (2006) Summary of findings from the evaluation of a pilot medically supervised safer injecting facility. Canadian Medical Association J, 175(11): 1399-1404. 19 Kerr, T. et al. (2005) Safer injection facility use and syringe sharing in injection drug users. The Lancet 366: 316-18. 20 Milloy M.J., Kerr, T., Tyndall, M., Montaner, J., & Wood E. (2008) Estimated drug overdose deaths averted by North America's first medically-supervised safer injection facility. PLoS ONE 3(10):e3351. 21 Marshall B. D. L., Milloy, M.-J., Wood, E., Montaner, J. S. G., & Kerr, T. (2011). Reduction in overdose mortality after the opening of North America's first medically supervised safer injecting facility: A retrospective population-based study. Lancet. Published online April 18, 2011. doi: 10.1016/S0140-6736(10)62353-7. 22 Wood, E. et al. (2007) Rate of detoxification service use and its impact among a cohort of supervised injecting facility users. Addiction 102: 916-919. 23 Tyndall, M.W. et al. (2005) Attendance, drug use patterns, and referrals made from North America's first supervised injection facility. Drug and Alcohol Dependence. 24 Tyndall, M.W. et al. (2006) HIV seroprevalence among participants at a medically supervised injection facility in Vancouver Canada: Implications for prevention, care and treatment. Harm Reduction J 3:36. 25 Wood, E. et al. (2004) "Changes in public order after the opening of a medically supervised safer injecting facility for illicit injection drug users." Canadian Medical Association J 171(7): 731-34. 26 Health Canada. Vancouver's Insite service and other supervised injection sites: what has been learned from Research? Final Report of the Expert Advisory Committee. Ottawa: Health Canada, 2008. Prepared for the Hon. Tony Clement, Minister of Health, Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/_sites-lieux/insite/index-eng.php 27 Andresen, M.A. & Boyd, N. (2010) A cost-benefit and cost-effectiveness analysis of Vancouver's supervised injection facility. Int.J.DrugPolicy 21(1): 70-76. 28 Pinkerton, S.D. (2010) Is Vancouver Canada's supervised injection facility cost-saving? Addiction 105(8): 1429-36. 29 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. 30 Hedrich, D. (2004) European report on drug consumption rooms. Report prepared for the European Monitoring Centre on Drugs and Drug Addiction. 31 Watson, T.M. et al. (2012) Police Perceptions of Supervised Consumption Sites (SCSs): A Qualitative Study. Substance Use & Misuse, 47:364-374. 32 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p. 136 33 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) 34 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra (p.188).
Documents
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Bill C-17 An Act to amend the Food and Drugs Act

https://policybase.cma.ca/en/permalink/policy11196
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-06-11
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this brief to the House of Commons Standing Committee on Health for consideration as part of its study of Bill C-17, Protecting Canadians from Unsafe Drugs Act, which proposes amendments to the Food and Drugs Act. The CMA has over 80,000 physician-members. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription medication has a very important role as part of a high-quality, patient-centred and cost-effective health care system. Prescription medication can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. As such, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription medication. Over the last several years, the CMA has prepared several briefs and reports on pharmaceutical medication and prescribing-related issues.1 It is a priority to physicians that all Canadians have access to medically-necessary drugs that are safe, effective, affordable, appropriately prescribed and administered, as part of a comprehensive, patient-centered health care and treatment plan. The CMA supports a robust legislative framework and unbiased, evidence-based system for the oversight of pharmaceutical products. As outlined below, the CMA has identified opportunities to strengthen elements of Bill C-17 toward this end. 1) Clarify ministerial authority and responsibility The current legislative limit to the health minister's authorities is troubling. The CMA, along with many other stakeholders, has long called for an expansion of ministerial authorities related to the pharmaceutical legislative framework, including both pre- and post-approval, in support of patient safety. The CMA supports the underlying intent to expand the authority of the health minister to require the submission of information, modify the label or replace the package, to order a recall or relocation of a product. However, the CMA has two concerns regarding the limitations to this expanded authority (section 3, proposed new FDA sections 21.1, 21.2 and 21.3): * Firstly, that the threshold for the new authorities in section 3 (new proposed section 21.1, 21.2, and 21.3 of the FDA) may be too high. The term "serious risk of injury to health" will be the standard for these new ministerial powers and may limit the authority of the minister to take action when the concern may be serious, but not necessarily permanently debilitating or life threatening. * Secondly, that the minister is not required to take any of the actions proposed in Bill C-17 even if the threshold is met (these sections specify that the minister "may" take the specified action, rather than the minister "shall"). While seemingly minor, the difference between "may" and "shall" is the difference between having the authority to take action and being responsible to take this action. This difference is critical to a robust legislative framework for patient safety. Recommendation 1 In order to clarify the health minister's authority to take appropriate measures to protect patient safety, the CMA recommends that the standard "a serious risk of injury to human health" in section 3 proposed new FDA section 21.1 and "serious or imminent risk of injury to health" in section 3 proposed new FDA section 21.3 be amended to ensure an appropriate threshold that does not constrain ministerial authority. Recommendation 2: To ensure that the health minister has the clear responsibility to take appropriate measures to protect patient safety, the CMA recommends that the word "may" is replaced with "shall" in section 3, proposed new FDA sections 21.1, 21.2 and 21.3. 2) Oversight of natural health products The extensive use of natural health products, such as vitamins and herbal medicines, is partially due to a belief that such products are "natural" and thus low risk. Increasingly, it has become clear that these products can have adverse effects, including drug interactions. However, relatively little is known about the adverse effects associated with natural health products due to its limited legislative and regulatory requirements, including reporting. To ensure that patient safety risks associated with natural health products are addressed, these products should be included in the new patient safety legislation, as proposed in the previous iteration of this legislation in 2008, Bill C-51 An act respecting foods, therapeutic products and cosmetics. The CMA encourages the Health Committee to include natural health products within the scope of Bill C-17, as a first step toward ensuring that natural health products are subject to the same regulatory requirements and oversight as are prescription and over-the-counter pharmaceuticals in order to promote patient safety. Recommendation 3: The ministerial authorities and measures proposed in Bill C-17 should be extended to include natural health products and, as such, CMA recommends that the definition of "therapeutic product" in section 2(3), be amended to include natural health products. 3) Comprehensive post-market surveillance and response system The CMA has advocated for significant improvements to Health Canada's post-market surveillance and response system in light of significant shortcomings. A) Increasing accountability and public transparency Robust accountability and transparency are important elements in the legislative framework governing the post-market surveillance and response system. The 2011 report of the Office of the Auditor General of Canada (OAG) highlighted significant concerns regarding this system, not least of which being Health Canada's failure to meet its own benchmarks in reviewing and responding to pharmaceutical safety issues. While there was no assessment of the benchmarks themselves, as is typical with an audit, the OAG report highlighted a number of issues with Health Canada's approach to measuring its performance against its benchmarks. Following the publication of the OAG audit report, Health Canada's 2013-14 Main Estimates and Report of Plans and Priorities2 shows cuts in both budget and staff allocation for health products (which includes drug oversight). The 2011 OAG report states that "Canada's small population reduces the likelihood of serious, rare adverse drug reactions being identified in this country; therefore, the capacity to search and analyze foreign reports electronically would contribute to more comprehensive safety monitoring."3 Of note, the audit found that Health Canada "does not take timely action in its regulatory activities" (...). "In particular, the Department is slow to assess potential safety issues. It can take more than two years to complete an assessment of potential safety issues and to provide Canadians with new safety information."4 Despite Health Canada's March 2013 update on its efforts to address the OAG recommendations5 the status of the improvements to the reporting tools, timeliness of information or quality of information provided to practitioners and patients remains unclear. The preceding paragraphs capture a number of issues pertaining to the post-approval surveillance and response system; it is imperative that Health Canada not only address these issues, but that Health Canada has adequate resources to do so. This is paramount prior to any consideration of expanding the input of reporting data. Recommendation 4: The CMA recommends that Bill C-17 be amended to require Health Canada undertake public consultations in establishing its performance benchmarks related to adverse drug reaction reporting, analysis and response communication. Recommendation 5: The CMA recommends that Bill C-17 be amended to establish a new public reporting requirement of its performance in meeting its performance benchmarks. B) Improving the reporting and communication system The CMA cautions against the advancement of new legislative authority with respect to mandatory reporting of serious adverse drug reactions prior to the improvement of the system and model currently in place. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction report has been received. Monitoring capacity requires rigorous data analysis and, to be useful in preventing further adverse events, it must be timely. As well, it should also provide information about a drug's efficacy and effectiveness. When new information is uncovered about a prescription drug, it is important that health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information in a manner that allows them to incorporate it into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Such feedback will encourage further reporting. In order to improve patient safety, the CMA recommends that Health Canada's establish a model that includes: * Making it easier for physicians and other health professionals to report adverse drug reactions by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Currently the existing system imposes an unnecessary administrative burden that comes at the expense of time dedicated to patient care. * Making the reporting process even more efficient by incorporating it directly into the Electronic Health Record systems. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of reports over the past 10 years, but being able to connect patient information with drugs they are taking, reporting of adverse drug reactions and safety information would improve care on the front line. * Augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report adverse drug reactions in detail, and who would be committed to assiduous reporting. * Linking to international post-approval surveillance systems, thus increasing the body of data at researchers' disposal, as well as the capacity for meaningful analysis. Health Canada should take a leadership role in ensuring that the public has access to appropriate information on drugs and drug safety, engaging civil society at the appropriate phases of the process. In providing this information, Health Canada should consider the management and communication of risk, and take into account the diversity of Canada's population. Access to accurate, unbiased information allows people to make decisions regarding their own health. In addition to ensuring a comprehensive model is in place, it is essential that there be more clarity in Bill C-17 regarding what constitutes a "prescribed health care institution". There are very different changes to the system that would need to be in place should it refer to tertiary care hospitals, community hospitals, clinics or doctors in family practice. Bill C-17 must not place an unnecessary administrative burden, which would ultimately fall on health professionals. Further, it is unclear whether a cost assessment of the proposed new requirements for health care institutions with respect to provincial/territorial resources has been undertaken. Only those health care institutions that are best positioned to improve the quantity and quality of reporting should be required to report. Another term that requires clarification in the legislation is "serious adverse drug reaction". It should be clear whether it means adverse drug reactions that require visits to emergency departments or hospitalization, or whether there are other criteria to define it. Recommendation 6: The CMA recommends that Bill C-17 be amended to require that Health Canada implement comprehensive post-surveillance monitoring and reporting model that includes: * Accessible, comprehensive and user-friendly reporting tools that are clinically relevant and linked to electronic health records; * Rigorous and timely analysis of reports for the early identification and response to emerging drug safety threats; and * Communication of timely, user-friendly and clinically-relevant information to health care practitioners and the public. Recommendation 7: The CMA recommends amendment of Bill C-17 section 5, proposed new FDA section 21.8, to require that an assessment by the minister for reporting regulations be undertaken following a prescribed period after this new model is established; that this assessment precede the coming into force of expanded mandatory reporting. Recommendation 8: The CMA recommends that essential terminology be defined in Bill C-17, including (a) "serious adverse drug reaction" and (b) "health care institution". Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective. 1 Canadian Medical Association (2005) Building a Comprehensive Post-Market Surveillance System. CMA's Response to Health Canada's Discussion Paper 'Designing a Mandatory System for Reporting Serious Adverse Reactions'. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2005/English/Mandatory_Response.pdf Canadian Medical Association (2014) Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/SOCI_BriefEnglish-Final.pdf Canadian Medical Association (2008) Post-Market Surveillance of Pharmaceutical Products. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf Canadian Medical Association (2012) Prescription Drugs: Clinical Trials and Approval. CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology. CMA. Retrieved from: https://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-ClinicalTrials_en.pdf Canadian Medical Association (2012) Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals. CMA Submission to the Senate Committee on Social Affairs, Science and Technology. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2012/Senate-Pharmaceuticals-Oct2012_en.pdf Canadian Medical Association (2014) Review of Controlled Drugs and Substances Act. Submission to Health Canada in response to the consultation on the Controlled Drugs and Substances Act and its regulations. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2014/CMA_SubmissiontoHealthCanada-CDSA_Modernization.pdf Canadian Medical Association (2013) The need for a national strategy to address abuse and misuse of prescription drugs in Canada. CMA Submission to the House of Commons Standing Committee on Health. CMA. Retrieved from: http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2013/Prescription-Drug-Abuse_en.pdf 2 Health Canada (2013) 2013-14 Report on Plans and Priorities. Government of Canada. http://www.hc-sc.gc.ca/ahc-asc/alt_formats/pdf/performance/estim-previs/plans-prior/2013-2014/report-rapport-eng.pdf (pg 30) 3 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 21) 4 Office of the Auditor General of Canada (2011) Chapter 4 Regulating Pharmaceutical Drugs - Health Canada. 2011 Fall Report of the Auditor General of Canada. Government of Canada. Retrieved from: http://www.oag-bvg.gc.ca/internet/docs/parl_oag_201111_04_e.pdf (pg 2) 5 Health Canada (2013) Update and response to OAG recommendations for the regulation of pharmaceutical drugs in Fall 2011. Government of Canada. Retrieved from: http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/oag-bvg-eng.php
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Bill C-45: The Cannabis Act

https://policybase.cma.ca/en/permalink/policy13723
Date
2017-08-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-08-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The CMA is pleased to provide this submission to the House of Commons Standing Committee on Health on Bill C-45, the Cannabis Act. The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development. i The term cannabis is used, as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant. ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on 1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27). 2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27). 4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27). 5 Riley D, O’Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000. 6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1–e12. 7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27). 9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27). 10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. 12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017. 13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13. 14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1–8. The CMA’s approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4 Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research. There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like “deep inhalation” to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6 Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation (“the Task Force”).7 Overview According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%–30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis’ increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27). and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results. The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles. Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force’s recommendations,12 the bill addresses several aspects of a legal-regulatory framework “to provide legal access to cannabis and to control and regulate its production, distribution and sale.”13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3 There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16 15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657–64 16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1–4. 17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303–310. 18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496–506. 19 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington (DC): The National Academies Press; 2017. 20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27). 21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27) 22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383–91. 23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27). 24 Miech RA, Johnston LD, O’Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975–2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011. 25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785–7. 26 Health Canada. Strong foundation, renewed focus: an overview of Canada’s Federal Tobacco Control Strategy 2012–2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27). 27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9. Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18 This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use. Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades. The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5 The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug’s physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a “ticketable” offence rather than a criminal one. iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002). iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003. v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27). Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25. Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach. We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians’ perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21 A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence — double the rate for any other drug — because of the high prevalence of cannabis use.23 The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis’ general risks but also on its special risks for the young and its harmful effects on them. This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs. The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26 vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years. The Lower-Risk Cannabis Use Guidelines were developed as a “science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks.”6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings. Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada’s usual pharmaceutical regulatory approval process. The Task Force’s discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place. Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review — specifically, a program evaluation of the medical access framework in five years.11 If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed, especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach’s short- and long-term impact on the reduction of harms.5 vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review). viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4). The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process. Conclusion Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis’ production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction. Recommendations 1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use. 2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis. 3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age). 3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years.
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Canada’s lower-risk cannabis use guidelines (LRCUG)

https://policybase.cma.ca/en/permalink/policy13726
Date
2017-05-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy endorsement
Date
2017-05-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Canada’s Lower-Risk Cannabis Use Guidelines (LRCUG) Recommendations
Cannabis use has health risks best avoided by abstaining
Delay taking up cannabis use until later in life
Identify and choose lower-risk cannabis products
Don’t use synthetic cannabinoids
Avoid smoking burnt cannabis—choose safer ways of using
If you smoke cannabis, avoid harmful smoking practices
Limit and reduce how often you use cannabis
Don’t use and drive, or operate other machinery
Avoid cannabis use altogether if you are at risk for mental health problems or are pregnant
Avoid combining these risks Reference summary Fischer, B., Russell, C., Sabioni, P., van den Brink, W., Le Foll, B., Hall, W., Rehm, J. & Room, R. (2017). Lower-Risk Cannabis Use Guidelines (LRCUG): An evidence-based update. American Journal of Public Health, 107(8). DOI: 10.2105/AJPH.2017.303818. Endorsements summary The LRCUG have been endorsed by the following organizations: Council of Chief Medical Officers of Health (in principle) Acknowledgment The Lower-Risk Cannabis Use Guidelines (LRCUG) are an evidence-based intervention project by the Canadian Research Initiative in Substance Misuse (CRISM), funded by the Canadian Institutes of Health Research (CIHR). A longer evidence summary of the guidelines, aimed at health professionals, is available at camh.ca. Cannabis use is a personal choice, but it comes with risks to your health and well-being. Follow these recommendations to reduce your risks. Cannabis use is a personal choice, but it comes with risks to your health and well-being. Follow these recommendations to reduce your risks. Health risks of cannabis use There is strong scientific evidence that cannabis use is associated with a variety of health risks. The risks depend on your constitution, which kinds of cannabis products you use and how or how often you use them. Some of the main health risks are:
problems with thinking, memory or physical co-ordination
impaired perceptions or hallucinations
fatal and non-fatal injuries, including those from motor-vehicle accidents, due to impairment
mental health problems and cannabis dependence
chronic respiratory or lung problems
reproductive problems. Reducing health risks related to cannabis use Cannabis use has health risks best avoided by abstaining To avoid all risks, do not use cannabis. If you decide to use, you could experience immediate, as well as long-term risks to your health and well-being. Any time you choose not to use, you avoid these risks. Delay taking up cannabis use until later in life Using cannabis at a young age, particularly before age 16, increases the likelihood of developing health, educational and social problems. Avoid cannabis use during adolescence. Generally, the later in life you begin to use cannabis, the lower the risk of problems. Identify and choose lower-risk cannabis products High-potency cannabis products, with high tetrahydro­cannabinol (THC) content, are more likely to result in harms. Some products contain a higher dose of canna­bidiol (CBD), which counteracts some of THC’s adverse effects. This means that products with high CBD-to-THC ratios reduce some of the risks. Know what you’re using. Ideally, choose cannabis products with lower risk of harms. Don’t use synthetic cannabinoids Compared with natural cannabis products, synthetic cannabis products (e.g., K2 or Spice) can lead to more severe health problems, even death. If you use, give preference to natural cannabis products and abstain from synthetics. Avoid smoking burnt cannabis—choose safer ways of using Smoking burnt cannabis, especially when combined with tobacco, can harm your lungs and respiratory system. Choose other methods, such as vaporizers or edibles instead—but recognize that they also come with some risks. For example, edibles are safer for your lungs, but you may consume larger doses and experience more severe impairment because psychoactive effects are delayed. If you smoke cannabis, avoid harmful smoking practices If you smoke cannabis, avoid “deep inhalation” or “breath-holding.” These practices are meant to increase psychoactive experiences, but they increase the amount of toxic material absorbed by your lungs and into your body. Limit and reduce how often you use cannabis Frequent cannabis use (i.e., daily or almost every day) is strongly linked to a higher risk of health and social problems. Limit yourself—and ideally your friends or others you may be using with—to occasional use, such as on weekends or one day a week at most. Don’t use and drive, or operate other machinery Driving while impaired by cannabis substantially increases your risk of being involved in a motor-vehicle accident resulting in injury or death. Don’t use and drive, or use other machinery. Wait at least six hours after using cannabis—or even longer if you need. Combining cannabis and alcohol further increases impairment, so be sure to avoid this combination if you plan to drive. Avoid cannabis use altogether if you are at risk for mental health problems or are pregnant Some individuals should not use cannabis because of specific risk profiles. If you or an immediate family mem­ber has a history of psychosis or substance use disorder, your risk of cannabis-related mental health problems increases, and you should abstain from use. Pregnant women should not use cannabis because it could harm the fetus or newborn. Avoid combining the risks identified above The more of these risky behaviours you engage in when using cannabis, the higher your risk of harms. For ex­ample, initiating cannabis use at a young age and smok­ing high-potency products every day puts you at much higher risk of both immediate and long-term problems. Avoid combining these high-risk choices. When choosing to use cannabis, you can actively take steps to reduce risks to your health. Below are 10 science-based recommendations for how to do so. These recommendations are aimed mainly at non-medical cannabis use. © 2017 CAMH 5638 / 06-2017
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Canadian Medical Association submission to the Standing Senate Committee on Banking, Trade and Commerce: Higher rate now: Why excise tax on tobacco is long overdue for an increase

https://policybase.cma.ca/en/permalink/policy11129
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-05-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide input to the Standing Senate Committee on Banking, Trade and Commerce study of Bill C-31 the Budget Implementation Bill, in particular the section concerned with tobacco taxation. Tobacco use is still the number one cause of preventable disease and death in Canada, claiming 37,000 or more Canadians' lives every year. It is a major risk factor for the chronic diseases that burden Canadians and their health care system, and it costs the country over $17 billion per year for medical treatment, social assistance, lost productivity and reduced quality of life. While progress has been made in lowering smoking rates and changing attitudes towards smoking much work remains - nearly 4.6 million Canadians still smoke. Physicians have been warning of the dangers of smoking for over 50 years. Canada's doctors treat the harmful effects of tobacco use every day in their offices, and see first-hand the devastation it causes to patients and their families. The CMA has consistently recommended tough legislative and regulatory measures to control tobacco use. Comprehensive tobacco control efforts must include legislation, regulation, together with public education and smoking cessation programs. Impact of Price on Smoking Research has shown that an increase in cigarette prices has an impact on reducing both the number of cigarettes smoked and smoking prevalence rates. Permanent, inflation-adjusted increases in cigarette prices, which could be achieved by increasing cigarette taxes, will contribute to reducing cigarette smoking rates in Canada. Youth are up to three times more sensitive to price than adults, with a 10 per cent price increase estimated to reduce youth smoking prevalence by 5 per cent or more and also to reduce cigarette consumption among continuing young smokersi With the current smoking rate of 20 per cent among Canadian young adults, higher than the smoking rate for the rest of Canada which is 16 per cent, additional initiatives to reduce smoking in this population are urgently required. Research has also shown that persons of low socioeconomic status are more responsive to price than the general population but it is less clear on the impact on long-term heavy smokers and aboriginal smokersii Estimates imply that the long-run effect of a permanent price increase is approximately double the short-run impact. Thus, a 10 per cent increase in cigarette price is expected to reduce the prevalence of cigarette smoking by approximately 8 per cent in the long run.iii Excise Tax Adjustments The current proposal to adjust the domestic rate of excise duty on tobacco products to account for inflation and eliminate the preferential excise duty treatment of tobacco products available through duty free markets will increase the cost of cigarettes and other tobacco products like fine-cut tobacco for use in roll-your-own cigarettes, chewing tobacco and cigars. For example, the government has stated that the excise "duty free" rate for cigarettes will increase from $15.00 to $21.03 per carton of 200 cigarettes. The commitment to make an automatic inflation adjustment every 5 years is a means to ensure that tobacco tax rates retain their real value in the future. The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. This proposal represents a positive step toward the development of a federal integrated tobacco tax strategy for both domestic and imported products, and speaks to the importance of the relationship between health policy and tax policy. Unintended Consequences There is a risk that a rise in tobacco taxes with the resultant rise in the cost of smoking will lead to an increase in the smuggling of lower-cost cigarettes. To avoid potential unintended consequences, such as smuggling, the CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders. In addition, all levels of government should take the most stringent measures possible to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. Investing Tobacco Taxes in Health Promotion The Minister of Finance has estimated that increasing tobacco taxes, including excise taxes on tobacco products, will increase federal tax revenues by $96 million in 2013-14, 685 million in 2014-15 and $660 million in 2015-16. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The federal government should place a high priority for funding tobacco prevention and evidence-based cessation programs for young Canadians as early as primary school age. For these, substantial and sustainable funding is required. A portion of these tobacco taxes should also be used to defray the costs of tobacco interventions, including physician-based clinical tobacco intervention services and up to 12 weeks stop-smoking medication annually per smoker. We encourage the government to focus their efforts on "high-risk" and "hard-to-reach" populations. Research For Canada's Tobacco Control strategy to continue to reduce smoking rates in Canada we must continue to assess evolving best practices in smoking cessation programs, and conduct research on the impact of policies on high risk populations. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. This evidence comes from surveying Canadians on smoking behavior, conducting research and evaluation, and keeping track of trends and emerging issues. Conclusion The CMA supports increasing the excise duty on tobacco products. An increase in the excise duty tax on tobacco products is long overdue and a welcome contribution to efforts already underway to further reduce smoking rates in Canada. Summary of Recommendations The CMA recommends passage of the proposal under Part 3 of Bill C-31 to increase the domestic rate of excise duty, accounting for inflation and eliminating the preferential excise duty treatment of tobacco products. The CMA recommends that the federal government work with other countries to ensure that tobacco prices are harmonized across national borders to avoid potential unintended consequences, such as smuggling. The CMA recommends that the revenue from increased taxation should be directed towards strengthening Canada's tobacco control strategy. The CMA recommends that tobacco taxation policy should be used in conjunction with other strategies for promoting healthy public policy, such as public education programs to reduce tobacco use. The CMA recommends that a portion of the revenues from tobacco taxes can be directed towards supporting evidence-based action to reduce tobacco use. i The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula ii Effects of Tobacco Taxation and Pricing on Smoking Behavior in High Risk Populations: A Knowledge Synthesis Pearl Bader, David Boisclair, Roberta Ferrence Int J Environ Res Public Health. 2011 November; 8(11): 4118-4139. Published online 2011 October 26. doi: 10.3390/ijerph8114118 PMCID: PMC3228562 iii The Impact of Price on Youth Tobacco Use, Tobacco Control Monograph NO. 14 Frank J. Chaloupka, Rosalie Liccardo Pacula
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CMA response to patented medicines regulations consultations

https://policybase.cma.ca/en/permalink/policy13690
Date
2017-06-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-06-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
To Whom It May Concern: The Canadian Medical Association (CMA) is pleased to provide its comments with respect to Health Canada’s Patented Medicines Regulations Consultations. The CMA is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. As the second-largest share of total health expenditures in Canada, forecast to be 16% in 2016, the cost of drugs is of significant concern to physicians.1 In 2014, 42.6% of prescribed drug spending ($12.5 billion) came from the public sector.2 Pharmaceuticals play an important role in overcoming disease and maintaining health but access to these drugs can be problematic outside of hospital care due to their cost. This is why the CMA has called for a pan-Canadian system of catastrophic coverage for prescription drugs.3 We viewed this as a step toward the development of comprehensive, universal coverage for prescription medicines in Canada.4 1 CIHI. National Health Expenditure Trends 1975-2016, December 15, 2016 2 Ibid 3 Canadian Medical Association (CMA). A New Vision for Health Care in Canada: Addressing the Needs of an Aging Population. 2016 Pre-budget Submission to the Minister of Finance. Ottawa: The Association; 2016 Feb 12 4 Ibid In its brief to the Commission of Inquiry on the Pharmaceutical Industry in August, 1984, the CMA stated that we “fully support the objective of providing prescription drugs to patients at the lowest possible cost that is consistent with wise health care delivery.”5 This remains our objective. This submission will address the proposed improvements to the regulations raised in the consultation document from a broad perspective. 5 Canadian Medical Association (CMA). Brief to the Commission of Inquiry on the Pharmaceutical Industry August 15, 1984 6 Gray C. Patented drugs: Is the price right? CMAJ 1998 158:1645 7 Silversides A. Monitoring the price of new drugs CMAJ 2006 174(11):1548-1549 8 The Commission of Inquiry on the Pharmaceutical Industry. The Report of the Commission of Inquiry on the Pharmaceutical Industry H.C. Eastman, Commissioner. Ottawa Minister of Supply and Services 1985 p. 347 9 Industry Canada. Pharmaceutical industry profile. https://www.ic.gc.ca/eic/site/lsg-pdsv.nsf/eng/h_hn01703.html (Accessed 2017 June 20) 10 Morgan SG, Leopold C, Wagner AK. Drivers of expenditures on primary care prescription drugs in 10 high-income countries with universal health coverage. CMAJ 2017;189:E794-9 Economic Considerations The ability of the PMPRB to monitor drug prices has long been the subject of review and concern.6,7 The CMA is pleased that the Government of Canada is undertaking this review to provide the Patented Medicines Prices review Board (PMPRB) with a new regulatory framework to protect Canadians from excessive prices and improving the regulatory process. The board needs to use every economic measure and tool at its disposal to ensure Canadians pay fair and equitable prescription drug prices. As the Eastman Commission pointed out in its 1985 report, “Canadian consumption is a small proportion of world consumption so that Canadian patent policy has little effect on the world-wide profitability of the pharmaceutical industry.”8 Indeed, Canadian pharmaceutical sales represent 2% of the global market which makes us the tenth largest world market.9 Yet our small size with respect to the global market has not shielded us from high prices. For example, a recent study found that although the volume of therapies purchased in Canada across six classes of “primary care medicines” was similar, we paid an estimated $2.3 billion more for them in 2015 than if these treatments had the “same average cost per day in Canada as in the nine comparator countries combined.”10 Prescription medication spending is an issue for many Canadians, especially when it has an impact on compliance with prescription regimes, an unintended consequence of the manner in which the board’s regulatory framework has been applied. On the Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.11 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.12 11 Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15. 12 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23. 13 Vebeeten D, Astiles P, Prada, G. Understanding Health and Social Services for seniors in Canada. Ottawa: The Conference Board of Canada, 2015. 14 Ibid 15 Ibid 16 Morgan SG, Lee A. Cost-related non-adherence to prescribed medicines among older adults: a cross-sectional analysis of a survey in 11 developed countries BMJ Open 2017;7: e014287. doi:10.1136/bmjopen-2016-014287 (access 2017 Jun 16) 17 Zhang R., Martin D., Naylor CD., Regulator or regulatory shield? The case for reforming Canada’s Patented Medicines Prices review Board. CMAJ 2017 April 10;189:E515-6. doi: 10.1503/cmaj.161355 The CMA is especially worried about the impact high drug costs have on seniors in the absence of universal drug coverage. They have access to some level of drug coverage in all provinces and territories but it is not even.13 Eight provinces have an income-test that determines the deductibles they will pay while in two they pay a small portion of the cost with the province or a third-party insurer covering the rest.14 All three territories have plans for those who qualify but the provisions may be limited.15 A recent study found that older Canadian adults (55 and older) had the second-highest prevalence (8.3%) of cost-related non-adherence (CRNA) for prescribed medications.16 CRNA was higher among those with lower incomes and lower among those over 65. Finally, the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures the government undertakes to strengthen and improve the PMPRB do not exacerbate drug shortages. International Comparisons The PMPRB’s current benchmark “that Canadian prices for patented drugs should be less than the median of prices in selected comparison countries” places us at a distinct disadvantage.17 As the authors note, “it puts Canada well above the OECD average by aligning Canada with countries that spend more from the outset.”18 The PMBRB should expand its range of comparator countries beyond those identified originally (France, Germany, Italy, Sweden, Switzerland, the United Kingdom and the United States) to include those OECD countries with middle to low patent drug pricing.19 18 Ibid 19 Ibid 20 Ibid Furthermore, to ensure that the process is clear and transparent for Canadians, the PMPRB should “set prices closer to what comparator countries actually pay for their drugs as opposed to the “sticker” prices that most commonly represent the starting point for confidential negotiations.”20 Canadians deserve that much after years of paying such high prices for their patented medicines. The CMA is very concerned about the cost of medications. In the absence of universal drug coverage and, at a minimum, a pan-Canadian system of catastrophic coverage of prescription drug costs, a strengthened and robust regulatory framework for the pricing of patented medicines in Canada is crucial. The CMA calls on the federal government to revise the PMPRB regulations such that it provides Canadians with transparency and clarity around the setting of patented medicines prices while achieving the lowest costs possible and ensuring we continue to have access to a wide array of pharmaceutical products. Sincerely, Granger R. Avery, MB BS, FRRMS President
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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

https://policybase.cma.ca/en/permalink/policy13641
Date
2017-04-07
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-07
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
CMA Submission: 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 Submission to the Senate Standing Committee on Social Affairs, Science and Technology On behalf of its more than 85,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. April 7, 2017 The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. Introduction The Canadian Medical Association (CMA) is pleased to provide this submission to the Senate Social Affairs, Science and Technology Committee for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. 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. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada the most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. 1 Statistics Canada. Smoking, 2015 Health Fact Sheets Canadian Community Health Survey, 2015 82-625-X March 22, 2017 While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). 2 Czoli CD., Hammond D., White CM., Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health 2014;105(2):e97-e102 3 Filippos FT., Laverty AA., Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control 2017;26:98-104 4 Malas M., van der Tempel J., Schwartz R., et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine & Tobacco Research 2016, 1-12 doi:10.1093/ntr/ntw119 5 Ibid 6 Ibid 7 Ibid Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”5 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”6 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”7 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.8 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”9 8 O’Leary R., MacDonald M., Stockwell T., & Reist D. (2017) Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addiction Research for BC 9 Ibid 10 El Dib R. Suzumura EA., Akl EA, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco or reduction: A systematic review and meta-analysis. BMJ Open 2017;7: e012680. Doi10:1136/bmjopen-2016-012680 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”10 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”11 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e-cigarettes.”12 11 Shahab L, Goniewicz M., Blount B., et al. Nicotine, carcinogen, and toxin exposure in long-term e-cigarette and nicotine replacement therapy users. Annals of Internal Medicine doi:10.7326/M16-1107 7 February 2017 12 Collier R. E-cigs have lower levels of harmful toxins. CMAJ 2017 February 27;189:E331. doi: 10.1503/cmaj.1095396 13 Sleiman M., Logue J., Montesinos VN. et al. Emmissions from electronic cigarettes : Key parameters affecting the release of harmful chemicals. Environmental Science and Technology July 2016 doi:10.1021/acs.est.6b01741 14 Ibid 15 England LJ., Bunnell RE., et al. Nicotine and the developing human. Am J. Prev Med 2015 16 Editorial. Use of Electronic Cigarettes by Adolescents. Journal of Adolescent Health 57 (2015) 569-570 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”13 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.14 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”15 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.16 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.17 17 Khoury M., Manlhiot C., et al Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ 2016 DOI:10.1503/cmaj.151169 18 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. The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent 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.”18 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”19 They base this on the decline in youth smoking while rates of the use of vaping devices rise.20 Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”21 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e-cigarettes to adolescents and young adults.”22 19 Op cit. O’Leary R., MacDonald M., Stockwell T., & Reist D. (2017) Clearing the Air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. 20 Ibid 21 Miech R., Patrick ME., O’Malley PM., et al E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob. Control 2017;0:1-6. doi:10.1136/tobaccocontrol-2016-053291 22 Primack BA., Soneji S., Stoolmiller M., et al Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015;169(11): 1018-1023.doi:10.1001/jamapediatrics.2015.1742 23 Hoek J., Thrul J. Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open 2017;7:e014990.doi:10 24 Ibid However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”23 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”24 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 1) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 2) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 3) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products 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 when we passed a resolution at our General Council in Vancouver 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.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e-cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de-normalize smoking.”25 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”26 Further research is needed to explore these findings. 25 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 26 K. Choi et al. Electronic nicotine delivery systems and acceptability of adult smoking among Florida youth: Renormalization of Smoking? Journal of Adolescent Health (2016) 1-7 Recommendations: 1) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 2) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 3The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology as part of its study on prescription pharmaceuticals: Federal levers to address unintended consequences of prescription pharmaceuticals and support public health, quality care, and patient safety

https://policybase.cma.ca/en/permalink/policy11125
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2014-03-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to present this submission to the Senate Standing Committee on Social Affairs, Science and Technology for consideration as part of its study on prescription pharmaceuticals in Canada. In this phase, the Committee is studying the unintended consequences of pharmaceuticals, and witnesses to date have identified a broad range of such consequences. In recognition of the important role of prescription medication in patient care, the CMA has developed an extensive body of policy on pharmaceutical medication and prescribing-related issues, some of which we have shared with this Committee on previous occasions. Physicians are concerned that all Canadians have access to medically-necessary medication that is safe, effective, affordable, appropriately prescribed and administered, and part of a comprehensive, patient-centered health care and treatment plan. In this brief, the CMA identifies and discusses five issues that are unintended consequences of prescription pharmaceuticals related to public health, quality care and patient safety. These are: addressing shortages in the supply of prescription pharmaceuticals; addressing the abuse and misuse of prescription medication; improved post-market surveillance and reporting tools; supporting optimal prescribing; and, addressing gaps in insurance coverage. 1) Addressing shortages in the supply of prescription medication Over the past few years Canada's doctors have become deeply concerned about the persistent shortages of prescription medication. Drug shortages have serious consequences for patient care. For example, if a patient on long-term therapy has been stabilized on a drug which becomes unavailable, and is switched to another drug that produces poorer results, this can lead to a decline in health status. The cost of the substitute medication might be beyond a patient's financial capacity. In some cases a therapeutic alternative may not be available at all. The CMA has participated on a Multi Stakeholder Working Group on Drug Shortages, with Health Canada, the pharmaceutical industry and health professional organizations, to establish a Canadian drug shortage reporting website. Although a drug shortage reporting website has been established, there is significant room for improvement. While this website may provide information on products in shortage, it is not clear that all shortages are reported, no mechanism for redress is identified, and most importantly drug shortages are persisting. The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. One frequently cited reason for shortages is product manufacturing disruptions, such as the 2011 production stoppage at a Sandoz facility in Quebec which resulted in a scramble to find alternate sources of many essential medications. Such disruptions are of particular concern when the drugs in question have been "single sourced" due to government bulk purchasing policies, and no clear substitutes are available. Therefore, the CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The CMA continues to call on governments and manufacturers to take meaningful action to address the impacts of shortages includingdeveloping appropriate mitigation strategies to reduce the number of drug shortages in Canada and their impact on patient health and patient care. To support this goal, the CMA recommends that the Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) Addressing the misuse and abuse of prescription medication The use of prescription opioid pain relievers is on the rise, in Canada and internationally. Latest reports indicate that Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Canada's physicians are concerned about the abuse and misuse of prescription medication for a number of reasons. For one, physicians need to assess the condition of patients who request the medication, and consider whether the use is clinically indicated and whether the benefits outweigh the risks. This can be challenging as there is no objective test for assessing pain, and therefore the prescription of opioids rests to a great extent on mutual trust between the physician and the patient. For another, physicians may need to prescribe treatment for patients who become addicted to the medications. Finally, they are vulnerable to patients who forge their signatures 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. Opioid prescription pharmaceuticals are legal products intended for legitimate therapeutic purposes, such as pain management or palliative and end-of-life care. However, they may also be used for recreational purposes or to feed an addiction. It must be recognized that it is addiction which drives the drugs' illegal acquisition through means such as doctor-shopping, forging prescribers' signatures, or buying from street dealers or the Internet. The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. Such a strategy should include: a) Programs to prevent misuse: The aim of prevention programs should be to reduce both recreational use and inappropriate therapeutic use. Awareness programs and social marketing campaigns could include: * Information on the benefits and harms of prescription drug misuse, and signs of abuse, addiction or overdose; * Instructions regarding safe storage and disposal. This is important since young recreational users frequently report that they obtain drugs from the family medicine cabinet. CMA supports national prescription drug "take back" days, and recommends that patients be educated about the importance of returning unused prescription drugs to the pharmacy. b) Measures to reduce the risk of overdose: Overdose deaths due to opioid use have grown dramatically over the past ten years. The risk of harm from overdose may be compounded if recreational users are afraid to call for emergency assistance for fear of facing criminal charges. However, opioid overdoses can be prevented with appropriate medication and prompt emergency response. c) Access to treatment services: A national strategy should also improve patient access to specialized pain management services, and to treatment for opioid addiction. Many believe that if specialized pain treatments were widely available, patients and prescribers would be less likely to rely solely on medication to treat their often debilitating pain. d) A pan-Canadian prescription monitoring program: Programs to monitor the prescribing of opioids and other controlled substances exist in most provinces, but they vary in quality, in the nature of the information they require, and in the purpose for which data is collected. The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. This should include the development of national standards for prescription monitoring, to ensure that all jurisdictions across Canada are collecting the same information in a standard way. Standardization of surveillance and monitoring systems can have a number of positive effects, including: * Identifying fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * Deterring inter-provincial fraud. * Supporting professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, supporting researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on prescription drug abuse issues, and we hope that this will result in a coherent national system for monitoring and surveillance, and thus to improved knowledge about the nature of the problem and its most effective solutions. 3) Improving post-market surveillance and reporting tools Health Canada has traditionally approved drugs for general use based on clinical trials that tend to be of short duration and have relatively few participants. As a result, when a prescription pharmaceutical comes on the market there is still limited information about its safety or effectiveness, and there is a need to keep gathering information from people who are using it in "real-world" conditions. As a consequence, adverse drug reactions (ADRs) are all too common in Canada; according to the Canadian Institute for Health Information, one in 200 patients over 65 are hospitalized because of adverse reactions to their medication. As such, CMA once again recommends that Health Canada work to strengthen the capacity of its post-market surveillance system by ensuring that it includes: a) Comprehensive processes for gathering drug safety and effectiveness data: Since most safety data reaches Health Canada in the form of spontaneous adverse drug reaction (ADR) reports, reporting processes should make it easier for physicians and other health professionals to report ADRs voluntarily, by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Ideally, ADR reporting could be incorporated directly into the Electronic Medical Record (EMR) as this is developed. Spontaneous reports could be augmented with information gathered through other, more systematic means such as formal post-market studies. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety: The monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received are critical elements of the post-surveillance system. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious public health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. c) Communication of useful information to health care providers and the public: When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. The CMA supports the expanded ministerial authorities of recall proposed in Bill C-17, the Protecting Canadians from Unsafe Drugs Act, and the intent to address the short-comings of Canada's post-market surveillance system. We will be providing comments on this legislation in the near future. 4) Supporting Optimal Prescribing In an ideal world, all patients would be prescribed the medications that have the most beneficial effect on their condition while doing the least possible harm. The CMA encourages collaborative efforts toward the achievement of this ideal. For example, medication misuse among seniors is a major concern. According to a 2011 report from the Canadian Institute for Health Information (CIHI), 62% of seniors on public drug programs use five or more drug classes, and nearly 30% of those 85 and older have claims for 10 or more prescription drugs. Heavy medication use by people over 65 has a number of consequences: * The risk of adverse drug reactions is several-fold higher for older patients than for younger; * Medication regimes, particularly for those taking several drugs a day on different dosage schedules, can be confusing and lead to errors or non-adherence; and, * Patients may receive prescriptions from multiple providers who, if they have not been communicating with each other, may not know what other medications have been prescribed. This increases the risk of duplicate prescriptions, harmful drug interactions and other medication errors. It is to address such concerns that the CMA developed its 2010 position statement: "A Prescription for Optimal Prescribing This statement recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. This strategy should include, among other elements: a) Provision of Relevant, Objective Information: The CMA supports the development and dissemination of information for prescribers that is based on the best available scientific evidence, relevant to clinical practice, and easy to incorporate into a practitioner's daily workflow. At present, physicians receive much of their information from pharmaceutical manufacturers. Since manufacturers have generous budgets to support their information dissemination, their campaigns are impressive and effective; but their impartiality has frequently been called into question. Objective, evidence-based information to health professionals on prescription drugs and their uses could be disseminated in the following ways: * Well-crafted online continuing medical education (CME), funded by objective sources. * Academic detailing, in which teams of experts visit prescribers to provide impartial prescribing advice. Academic detailing programs have demonstrated success; but because they are expensive and labour intensive, it has often been difficult to persuade governments to invest in them. * Making drug information available to prescribers at the point of care, through such means as mobile phone apps and electronic health records. * Programs that monitor a prescriber's habits and compare them to those of peers. CMA encourages such programs if their purpose is to educate rather than to enforce a certain behaviour. Information for prescribers should be augmented by unbiased, up-to-date, practical information for consumers about prescription drugs and their appropriate use. b) Support e-prescribing. Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system could: * List all the drugs a patient is taking, and identify duplicate prescriptions for the same drug from different providers, thus helping to reduce medication error and prescription fraud; * Incorporate decision-support tools; for example, a warning could appear on the screen if a physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. * Improve decision making and communication between providers, providing all of a patient's caregivers access to a common, comprehensive medication profile; and * Increase convenience for the patient and eliminate illegible handwriting, which is a major cause of medication error. The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 5) Addressing gaps in insurance coverage for prescription medication Finally, another consequence of the increased role of pharmaceuticals in health care is that, because they are not generally covered by the Canada Health Act, many Canadians, particularly those in the lowest income groups, are unable to afford them. Data from the 2007 Community Health Survey estimate that 1 in 10 Canadians does not adhere to their prescription regimes for reasons of cost. The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies. Conclusion As previously mentioned, CMA has focussed its discussion of unintended consequences on recommendations to support public health, quality care, and patient safety. The CMA commends the Committee for making this issue the subject of study, and hope that our recommendations, and those of other witnesses, will lead to action to address the unintended consequences of prescription pharmaceuticals in Canada. Summary of Recommendations 1) The CMA recommends that the Senate Social Affairs, Science and Technology Committee extend its study on prescription pharmaceuticals to explore the root causes of shortages in the supply of prescription medication in Canada and strategies to mitigate the impacts on patients and patient care. 2) The CMA recommends that the federal government work with provincial/territorial governments and other stakeholders to develop and implement a comprehensive national strategy to address the problem of prescription drug misuse and abuse in Canada. 3) The CMA recommends that all levels of government work with one another and health professional regulatory agencies to develop a pan-Canadian system of real-time prescription drug abuse monitoring and surveillance. 4) The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports * Analyze the data that has been gathered, in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. 5) The CMA recommends that governments at all levels work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. 6) The CMA supports the development and dissemination of prescribing information that is: * based on the best available scientific evidence; * relevant to clinical practice; and, * easy to incorporate into a physician's workflow. 7) The CMA calls on governments to support and deliver funding for impartial continuing medical education programs on optimal prescribing. 8) The CMA recommends that governments, health care leadership and clinical organizations in all jurisdictions commit to make e-prescribing a reality by 2015, and ensure the policy/regulatory environment that supports e-prescribing. 9) The CMA recommends that governments, in consultation with the life and health insurance industry and the public, establish a program of comprehensive prescription drug coverage to be administered through reimbursement of provincial/territorial and private prescription drug plans to ensure that all Canadians have access to medically necessary drug therapies.
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CMA submission to the study of Bill C-37

https://policybase.cma.ca/en/permalink/policy13617
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Committee on Legal and Constitutional Affairs’ study of Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts.1 1 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 The CMA is deeply concerned with the opioid crisis in Canada, with unprecedented levels of harms, including overdose deaths. The crisis is taking a toll on individuals, families and communities, as well as first responders and health professionals at the front lines. The most recent BC Coroner’s Report indicates there were about 3.6 illicit drug overdose deaths per day in February 2017, an increase of 72.9% over the number of deaths in February of last year.2 Other provinces are also facing critical situations. The CMA welcomes the introduction of Bill C-37, proposed by the Minister of Health to address various portions of the Controlled Drugs and Substances Act (CDSA), among other changes. * We are particularly appreciative, given that this is part of a new federal strategy that promises to “replace the existing National Anti-Drug Strategy with a more balanced approach (…) and restores harm reduction as a core pillar of Canada’s drug policy, alongside prevention, treatment and enforcement and supports all pillars with a strong evidence base.3 This is necessary to ensure a public health approach to drug use and addiction. * For further discussion of CMA’s position on addiction, harm reduction and supervised consumption sites, as well as terminology, such as supervised consumption sites or supervised injection sites, see CMA’s submission to the Senate Standing Committee on Legal and Constitutional Affairs. Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf This proposed legislation includes various objectives, including “to prohibit the unregistered import of pill presses, and remove the exception currently placed on border officers to only open mail weighing more than 30 grams,” (…) to “make it a crime to possess or transport anything intended to be used to produce controlled substances, allow for temporary scheduling of new psychoactive substances, and support faster and safer disposal of seized chemicals and other dangerous substances.”4 CMA is supportive of actions by the federal government that advance the work at national, provincial and local levels to address the opioid crisis. Application for a Supervised Consumption Site The objective of Bill C-37 that CMA would like to provide recommendations for is the one that seeks to “simplify the process of applying for an exemption that would allow certain activities to take place at a supervised consumption site, as well as the process of applying for subsequent exemptions.5 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 The Bill proposes to repeal the 26 requirements to apply for an exemption to the CDSA, in Section 56.1, established by the Respect for Communities Act (former Bill C-26). The CMA supports the repeal, as we have repeatedly called for the withdrawal of the amendments made by former Bill C-2, and their replacement with “legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.”7 Bill C-37 proposes to replace those 26 requirements with the five elements cited in the 2011 Supreme Court of Canada unanimous ruling on Insite8, Vancouver’s supervised injection site. These elements are, “evidence, if any, on: . the impact of such a facility on crime rates, . the local conditions indicating a need for such a supervised injection site, . the regulatory structure in place to support the facility, . the resources available to support its maintenance and . expressions of community support or opposition.”9 These elements are proposed to reduce the unnecessary obstacles and burdens on local health departments and community organizations that would deter the creation of new supervised consumption sites, even when the health and safety benefits have been clearly established. Because of this cumbersome process, the BC Ministry of Health recently authorized the creation of “overdose prevention sites” in various locations where there are concerning numbers of overdose deaths, while the ministry “wait(s) for Health Canada approval of supervised consumption services”.10 This was after the creation of unsanctioned popup sites by community groups in the downtown eastside.11 Only Insite and the Dr Peter Centre operate with approved exemptions to date, with Montreal having recently received approval for three sites.12 Many other applications have been submitted for sites in Vancouver, Victoria, Toronto and Ottawa, and others are in preparation. Although a welcome reduction to only five elements, the CMA believes that these elements require more clarity, as they can be subject to interpretation, and undue influence, and could still demand unnecessary and significant time and resources on the part of provincial and local agencies. As well, the present crisis would require an expedited process that would not delay local responses to the crisis. Hence, our first recommendation is that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. Further, CMA recommends that the elements required for an application for opening a supervised consumption site proposed in Bill C-37 be more clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. The central element to be considered is that of “the local conditions indicating a need for such a supervised injection site”. Local health authorities and community organizations struggle with the issues related to drug use, including rising rates of infections, overdoses and deaths, and this is the fundamental reason to open a supervised consumption site. The regulatory structure and the resources available to support a supervised consumption site’s maintenance are issues that local health authorities deal with regularly for any health service, given the need to provide care with reduced risk of liability. The impact of a facility on crime rates is difficult to quantify before such a site is created. Further, the government must consider the experience of the many sites both in Canada and internationally, where law and order have improved in the areas surrounding those sites. The Supreme Court stated that there has been “no discernible negative impact on the public safety and health objectives of Canada during its [Insite’s] eight years of operation.”13 As well, the crime rate is not only influenced by the existence or not of a site, but by many other factors, such as unemployment and enforcement resources. A site would necessarily be located where there are high rates of drug use, for the very purpose of offering people who use drugs much needed harm reduction and support services. The last element, expressions of community support or opposition, should not represent a burden to applicants. As stated in our brief on Bill C-2, “although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites and in European countries.”14 Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication.15 Bill C-2 is an example of how this element could be interpreted. There was an extensive list of letters of opinion required, including from representatives of local police and local and provincial governments (ministers of health and public safety), chief public health officer, professional licensing authorities for physicians and for nurses, as well as reports from community consultations.16 Such a requirement represented a cumbersome and unnecessary burden. The CMA looks forward to continued collaboration with the federal government and other organizations in the development of further action as part of the much needed comprehensive approach to address the opioid crisis. Recommendations 1. The CMA recommends that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. 2. The CMA recommends that the elements required for an exemption application to the CDSA to open a supervised consumption site, proposed in Bill C-37, be clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 7 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1
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27 records – page 1 of 3.