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Policies that advocate for the medical profession and Canadians


13 records – page 1 of 2.

Antibiotics for agricultural use

https://policybase.cma.ca/en/permalink/policy10916
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-99
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-99
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
Text
The Canadian Medical Association recommends that the Food and Drugs Act and its regulations be amended to close the "own use" provision for the unmanaged importation of antibiotics for agricultural use.
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Antibiotics for use in food animals

https://policybase.cma.ca/en/permalink/policy10913
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-97
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
Policy Type
Policy resolution
Last Reviewed
2020-02-29
Date
2013-08-21
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC13-97
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
Text
The Canadian Medical Association supports the development of a national system to identify and report the identities and quantities of antibiotics acquired domestically or imported for use in food animals.
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Antibiotics used in the raising of farm animals

https://policybase.cma.ca/en/permalink/policy10211
Last Reviewed
2018-03-03
Date
2011-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC11-88
The Canadian Medical Association recommends that a prescription from a veterinarian be required for all antibiotics used in the raising of farm animals or for any other agricultural purpose.
Policy Type
Policy resolution
Last Reviewed
2018-03-03
Date
2011-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC11-88
The Canadian Medical Association recommends that a prescription from a veterinarian be required for all antibiotics used in the raising of farm animals or for any other agricultural purpose.
Text
The Canadian Medical Association recommends that a prescription from a veterinarian be required for all antibiotics used in the raising of farm animals or for any other agricultural purpose.
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CMA Response: Health Canada's Medical Marijuana Regulatory Proposal

https://policybase.cma.ca/en/permalink/policy10702
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-02-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association welcomes the opportunity to comment on proposed changes to Health Canada's Marihuana for Medical Purposes Regulations, published in the Canada Gazette, Part I on December 15, 2012. CMA provided comments on the proposed changes when Health Canada first announced them in June 2011. Our position on these changes, and indeed on the entire Medical Marihuana Access Program (MMAP), has been consistent since the program was initiated. We remain deeply concerned that, though the program has made a physician's authorization the key to a patient's access to medical marijuana, physicians and other health professionals have little to no evidence-based information about its use as medical therapy. As our President, Dr. Anna Reid, noted in December, the regulatory proposals are "equivalent to asking doctors to prescribe while blindfolded." Health Canada gives two reasons for its regulatory proposal: first, to address concerns about the safety of home grow-ops; and secondly, to reduce the cost of administering a program that has proven more popular than anticipated. Neither of these reasons is related to improving patient care or advancing our clinical knowledge of marijuana as a medical treatment. CMA understands that many Canadians suffer constant pain from chronic or terminal illnesses and are searching for anything that will provide relief. We know that some patients find that use of marijuana relieves their symptoms and that some health professionals also believe it has therapeutic value. However, we are concerned that these claims remain inadequately supported by scientific research. Controlled studies of medical marijuana have been published recently and some have shown benefits. However, these studies are few in number, of short duration and with small samples, and knowledgeable clinicians say that more research is required. In addition, some say that marijuana has become more potent since it became a popular recreational drug in the 1960s, though others disagree,1 and growers say they can develop strains tailored to the needs of individual medical users.2 Though these claims are part of the popular understanding of medical marijuana, there is no scientifically valid evidence that supports them. What Physicians Have Told Us In May 2012, CMA surveyed members of its "e-panel" of physicians to obtain more information about their attitudes and needs regarding medical marijuana. The survey received just over 600 responses out of more than 2,200, for a 27 per cent response rate. Among the findings: * About 70 per cent of respondents had been asked by patients to approve medical marijuana, though only four per cent said they were asked to do so "often." Of those who were asked, one-third reported that they "never" supported such requests, while 18 per cent "usually" did so. * 64 per cent of respondents were concerned that patients who request medical marijuana may actually be using it for recreational purposes; * A large majority of respondents said they would find more information on the appropriate use of marijuana for medicinal purposes, and on its therapeutic benefits and risks, useful or very useful. * About two-thirds agreed or strongly agreed that they would feel more comfortable if: o Physicians wishing to use medical marijuana in their practices were required to undergo special training and licensing; and, o Health Canada offered them protection from liability. * In open-ended questions, some respondents expressed favourable views on marijuana's medical benefits. However, a larger number expressed concern over its harmful effects, such as: psychotic symptoms, especially in younger people; potential for addiction and dependency; and the risks to lung health from smoking it or any other substance. Marijuana is Not Like Other Therapeutic Products Theoretically, marijuana, when used for medicinal purposes, is regulated under the Food and Drugs Act. However, because of its unique legal position, Health Canada has exempted it from the applications of the Act and its regulations, and it has not undergone the scrutiny of benefits and risks required of other therapeutic products approved for use in Canada, be they prescription-only or over-the-counter. According to the Food and Drugs Act (FDA), all drugs requiring a health professional's authorization must be approved for use by Health Canada, based on evidence of effectiveness obtained from controlled clinical trials, which remain the best currently available means of validating knowledge. In addition, Health Canada has a system of post-market surveillance to keep track of problems that arise with prescription drugs in real-world use. Though the CMA has been critical of some aspects of this system,3 we acknowledge that it has added to our body of knowledge on drug safety risks. If marijuana were not an illegal product, it might have been assessed through some form of pre-approval and post-approval surveillance. By exempting marijuana from the FDA's pre-approval and post-approval requirements, Health Canada has lost an opportunity to improve our knowledge of the drug's therapeutic uses. The Views of Canadians A recent online survey conducted by Ipsos-Reid on behalf of the CMA provides insight into the views of Canadians on Health Canada's regulatory proposal.4 The survey found: * 92 per cent of Canadians think it is very or somewhat important that Health Canada not remove itself from its oversight role until guidelines are put in place for physicians; * 90 per cent believe that research on the effectiveness, safety and risks of medical marijuana is needed before Health Canada removes itself from the authorization process; * 85 per cent of Canadians believe medical marijuana should be subject to the same rigorous testing and approval standards as other medicines; * 79 per cent agree that Health Canada has a responsibility to maintain its role in the authorization process.; The Role of the Physician The CMA cannot with certainty predict the consequences of these regulatory changes for the practising physician (and, if the regulations are approved, for the nurse practitioner as well). However, we have several causes for concern: * The gatekeeper role of health professionals: The most significant change, from our point of view, is that Health Canada is removing itself from the approval process, making it a transaction between the patient, the practitioner and the licensed producer. In addition, Section 125 of the regulatory proposal would reduce the content of the authorization form, from its current two-page format to a brief document requiring little more information than is required for a standard medical prescription. We are concerned that these changes will put an even greater onus on physicians than do the current regulations. The CMA agrees with the Federation of Medical Regulatory Authorities that the lack of evidence to support the use of marijuana for medicinal purposes signifies that it is not a medical intervention. In our opinion, putting physicians in the role of gatekeeper for access to marijuana is inappropriate and may be an abdication of responsibility on Health Canada's part.5 Such a move could increase physicians' liability risk and put them at odds with their medical regulatory authorities, which have no choice but to continue to advise physicians to exercise extreme caution. The CMA believes, as does the Canadian Medical Protective Association, that a drug's approval under the Food and Drugs Act does not impose a legal obligation on physicians or nurse practitioners to authorize its use if, in their judgment, it is clinically inappropriate. The Ontario Court of Appeal reached a similar decision recently in the case of R. v. Mernagh. * Protection of Physician Privacy. Under the proposed regulations, health information and physician data - such as the patient's name and date of birth, or the provider's licence number - will be collected by licensed producers who may not be subject to the same regulatory and privacy constraints as the health care sector. The draft regulations also indicate that the licensed producer is expected to confirm that the data on the "medical document" is correct and complete - in other words, health providers who authorize medical marijuana use will receive correspondence from the producer. We are very concerned about the risks this would pose to the privacy of patient and health care provider information. We believe Health Canada should conduct a privacy impact assessment of its proposed regulations or, if it has done so, to share the results. * Physicians as Dispensers. Section 124 of the proposed regulations would allow authorized health care practitioners to "sell, provide or administer dried marijuana." This is contrary to Article 46 of the CMA Guidelines for Physicians in Interactions with Industry, which states that "Physicians should not dispense pharmaceuticals or other products unless they can demonstrate that these cannot be provided by an appropriate other party."6 * Other possible consequences. We are also concerned about other potential consequences of the regulatory changes. Will more people go to health professionals requesting an authorization, on the assumption that the new regulations will make it easier to get? Will entrepreneurs seize the opportunity to establish "dispensaries" whose intended clientele are not those in legitimate medical need, as recent news stories have suggested?7 Will medical marijuana advocates put increased pressure on physicians to authorize its use? Meeting the Information Needs of Physicians In one respect, Health Canada has listened to physicians' concerns regarding the lack of evidence about medical marijuana, and acknowledged the need to remedy this problem. Though it is not addressed in the draft regulations, Health Canada has established an Expert Advisory Committee (EAC) to help provide comprehensive information to health professionals. The CMA has attended meetings of this committee in an observer capacity, suggested the names of practising physicians to serve as members, and made a presentation to the committee at its meeting in November 2012. If the EAC follows the CMA's suggestions, it will consider actively supporting the following activities: * Funding of scientific research on the clinical risks and benefits of marijuana; * Knowledge translation activities to convert this research into accessible, user-friendly tools for education and practice; * Development of best practice guidelines in the therapeutic use of marijuana. Though this guideline would of necessity be based on "C" level evidence, it would be an improvement on what now exists; and * Support for a compulsory training and licensing program for physicians wanting to authorize marijuana for medicinal purposes. The CMA believes that the EAC should be given the mandate and resources to undertake these activities. Conclusion Health Canada's stated mission is to help the people of Canada maintain and improve their health. The CMA believes that if Health Canada wants its Medical Marihuana Access Program to serve this mission, it should not withdraw from administering the program, leaving it to health professionals working within a large knowledge gap. Rather, it should support solid research into the use of marijuana as medication and make a commitment to share this knowledge with the health professional community and to support best clinical practices. 1 Bonsor K: "How marijuana works". Accessed at http://science.howstuffworks.com/marijuana5.htm 2 http://medicalmarijuana.ca/learning-center/marijuana-strains 3 CMA Submission to the House of Commons Standing Committee on Health: Post-Market Surveillance of Prescription Drugs (February 28, 2008). Accessed at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Submissions/2008/brief-drug-en-08.pdf 4 Online survey of 1,000 Canadians the week of Feb. 24, 2013 conducted by Ipsos-Reid. Summary report of the poll can be accessed at www.cma.ca/advocacy/cma-media-centre. 5 Letter to Health Canada from Yves Robert, MD, President of the Federation of Medical Regulatory Authorities of Canada, November 4, 2011. 6 CMA. 2004. Guidelines for Physicians in Interactions with Industry. Guideline can be accessed online: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf 7 Lee J. "Ross Rebagliati to Open medical marijuana franchise." Vancouver Sun. January 23, 2013. Accessed at http://www.vancouversun.com/health/Ross+Rebagliati+open+medical+marijuana+franchise/7860946/story.html
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Health Canada consultation on edible cannabis, extracts & topicals

https://policybase.cma.ca/en/permalink/policy14020
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-02-20
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association appreciates this opportunity to respond to Health Canada’s consultation on the proposed regulations for edible cannabis, cannabis extracts, and cannabis topicals. The CMA’s approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation, recommendations regarding Bill C-45. As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45. Canada’s physicians have a longstanding concern about the health risks associated with consuming cannabis. , Consumers use these products for both recreational and medical purposes, compelling the need for accuracy in the labeling as well as quality control in the manufacturing process.10 Cannabis Edibles, Extracts and Topicals Cannabis will have a different effect on the user, depending on whether it is smoked or ingested, as in an edible. It has been found that “smoking marijuana results in clinical effects within 10 minutes, peak blood concentrations occur between 30 and 90 minutes, and clearance is complete within 4 hours of inhalation. Oral THC does not reach significant blood concentration until at least 30 minutes, with a peak at approximately 3 hours, and clearance approximately 12 hours after ingestion.” Because of the delay in absorption when ingested, people might consume more to feel the psychoactive effects faster. This might lead to the consumption of very high doses and result in toxic effects, such as anxiety, paranoia and in rare cases, a psychotic reaction with delusions, hallucinations, incoherent speech and agitation. Rates of use of edibles are not well known. A recent study in California high schools found that “polyuse via multiple administration methods was a predominant pattern of cannabis use and report the first evidence, to our knowledge, of triple product polyuse of combustible, edible, and vaporized cannabis among youths.” We are limiting our response to Health Canada’s consultation questions that pertain to the CMA’s position with respect to cannabis and relate to our expertise and knowledge base. Proposed THC limits for the new classes of cannabis products Standardization within all classes of cannabis products in a legal regime is essential. Tetrahydrocannabinol (THC) levels in black market products can vary widely so one can never be assured of the strength being purchased, creating the potential for significant harm. , Experience in jurisdictions where cannabis has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies.2 Prohibition of high potency products is important.3 THC limits should be based on the best available evidence of safety for consumers. The increased potency of cannabis over the years raises concerns about its use in edibles, extracts and topicals, offering a significant challenge with respect to regulating their use. This becomes particularly worrisome with respect to preadolescents and adolescents who should avoid using cannabis due to concerns with the impact on the developing brain.2 Use has been associated with a “significant increased risk of developing depression or suicidality in young adulthood.” More research is needed with respect to the effects of cannabis on all age groups, especially children, adolescents and seniors. Saunders et al describe the case of an elderly patient with a history of coronary artery disease suffering what appears to have been a myocardial infarction after ingesting most of a marijuana lollipop that contained 90 mg of THC. Such cases demonstrate how crucial it is to establish appropriate levels of THC. This is an especially important consideration because “consuming cannabis-infused edibles may inadvertently result in toxicity because absorption can take hours, compared with minutes when smoking. An individual who does not yet feel an effect may over-consume.” Small children and people with cognitive impairment will not be able to read labels, so preventive measures are very important, as with any pharmaceutical. Since legalizing cannabis, Colorado’s Rocky Mountain Poison & Drug Center has reported an increase in calls related to edible exposures. Children can accidentally eat products that contain cannabis, making them ill enough to seek medical assistance. The CMA maintains that the proposed draft regulations of 10 mg per discrete unit and package is too high and should be established at a maximum of 5 mg per dose, given the higher risks of overconsumption with edibles, the risks of accidents in children and the experience in other jurisdictions. Colorado’s limit was set at 10 mg per unit, and health authorities recognize that a lower limit would have been warranted to prevent more accidents. Other preventive measures, such as child proof packaging, are considered in other sections of this brief. The amount of THC must be displayed clearly and prominently on the package to help prevent accidental or overconsumption of the product. Rules addressing the types of ingredients and additives that could be used in edible cannabis, cannabis extracts, and cannabis topicals appropriately address public health and safety risks while enabling sufficient product diversity The CMA concurs with the proposed regulations. Experience in areas such as caffeinated, high-sugar alcoholic beverages provides ample evidence to proceed with restraint concerning the types of ingredients and additives that may be permitted in edible cannabis, cannabis extracts, and cannabis topicals. Proposed new rules for the packaging and labelling of the new classes of cannabis products The CMA reiterates its position with respect to the packaging and labelling of cannabis products as presented in its submission on the proposed approach to the regulation of cannabis.5 This includes:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause an overdose. Plain and standardized packaging is necessary with respect to edibles as their wider availability raises several public health issues, not the least of which is ingestion by young children. It is imperative that the packages and labels of edibles not resemble popular confectionaries, for example. As the Canadian Paediatric Society has noted, “the unintended consumption of edibles manufactured to look like sweets by younger children is particularly concerning.”15 Also, by “restricting the extent to which marijuana edibles can look and taste like familiar sweets, (it) could also keep the psychological barriers to marijuana initiation among children and adolescents from being lowered.” The CMA has adopted similar positions with respect to tobacco and vaping products. , , It is recognized that these regulations are targeted at products meant for the adult market, but the entry of these new classes also creates challenges beyond that audience. Teens are attracted to vaping cannabis rather than smoking it because “smoke is not combusted and also may allow for more covert use given the reduction in odor.” , As well, as “edibles have no odor, they are largely undetectable to parents.”23 The CMA views this as an opportunity to educate Canadians about the health, social and economic harms of cannabis especially in young people. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Inserts should include:5
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. Cannabis topicals, as outlined in the proposed regulations, would fall under the category of health products and be found in non-prescription drugs, natural health products, and cosmetics. The CMA believes that all health claims need to be substantiated with sufficient evidence that meets standards for efficacy, besides safety and quality, to protect Canadians from misleading claims.5 This is important because the level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence for effectiveness is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product.5 Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. More research is required to address the environmental concerns with extra packaging, which would result from single dose packaging. It is critical to put in place measures that make it difficult to ingest large doses of THC. Simply adding grooves to chocolate bars or baked goods, for example, separating different doses, is insufficient to prevent people, particularly children, from ingesting more than a dose (which in of itself is designed for an adult). As well, there is no guarantee that the THC is spread out uniformly throughout the product. More research is needed with respect to “determining risks and benefits through proper clinical trials;” that includes determining the safest level of THC for extracts and topicals to reassure consumers will not be harmed by these products.18 With regards to cannabidiol (CBD), it would seem that “published data from around the world has taught us that misleading labels as well as harmful contaminants are real and actual problems for CBD products.”18 Health claims need to be substantiated via a strong evidentiary process. There will be a need for careful monitoring of the health products released in the market and the health claims made.5 Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Edible cannabis and the requirement for all products to be labelled with a cannabis-specific nutrition facts table Yes. The CMA supports the use of a cannabis-specific nutrition facts table (NFT) as described in the proposed regulations.1 These products should have the same standards and regulations applied to them as traditional food products do under the Food and Drugs Regulations. As such, a cannabis-specific nutrition facts table will help consumers differentiate them from standard food products. The proposal for the labelling of small containers and the option to display certain information on a peel-back or accordion panel The size of the container should not be an impediment to supplying consumers with the necessary information to make informed choices. Manufacturers should be required to use whatever method (peel-back or accordion panel) is most efficient and conveys all the necessary information. As the CMA noted in a recent brief with respect to tobacco labeling the “amount of space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available, like that of a regular cigarette package.”20 Adding warnings on individual cigarettes, as we recommended, illustrates that it is feasible to apply important information to even the smallest surfaces.20 It is important to note that key information should be visible on the external part of the container, including the standardized cannabis symbol, ingredients and warnings. Proposal that the standardized cannabis symbol would be required on vaping devices, vaping cartridges, and wrappers Yes. As noted earlier, the CMA called for strict packaging requirements around both tobacco and vaping products.22 The requirement for the standardized cannabis symbol is an extension of that policy and to the labelling of cannabis products in general.5 Proposed new good production practices, such as the requirement to have a Preventive Control Plan, appropriately address the risks associated with the production of cannabis, including the risk of product contamination and cross-contamination Yes. The CMA concurs with this requirement. The requirement that the production of edible cannabis could not occur in a building where conventional food is produced Yes. The CMA concurs with this requirement. Separate facilities are necessary to prevent cross-contamination for the protection of consumer health and safety. Conclusion The CMA supports the federal government’s commitment to a three-year legislative review as it affords the opportunity to evaluate the regulations’ impact and adjust them as needed. It continues to be important to have good surveillance and monitoring systems, as well as to continue to learn from other jurisdictions where cannabis is legal for recreational purposes. Public education and awareness must accompany the introduction of new forms of cannabis, emphasizing the risks of accidental ingestion and overconsumption. It should also emphasize the need for safe storage of cannabis products, as well as personal possession limits. Much more research is needed into the impact of these new classes across all age groups, and into public health strategies that discourage use and increase harm reduction practices. It is fundamental that profit driven commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls, in a manner that is consistent with a public health approach. Government of Canada. Canada Gazette, Part I, Volume 152, Number 51: Regulations Amending the Cannabis Regulations (New Classes of Cannabis) Ottawa: Health Canada; 2018. Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-12-22/html/reg4-eng.html (accessed 2018 Dec 22). Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed& (accessed 2019 Feb 01). Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Feb 04). Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11138 (accessed 2019 Feb 14). Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://policybase.cma.ca/en/permalink/policy1968 (accessed 2019 Feb 14). Monte A, Zane R, Heard K. The Implications of Marijuana Legalization in Colorado JAMA. 2015 January 20; 313(3): 241–242 Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ (accessed 2019 Feb 15). Peters E, Bae D, Barrington-Trimis J, et al. Prevalence and Sociodemographic Correlates of Adolescent Use and Polyuse of Combustible, Vaporized, and Edible Cannabis Products JAMA Network Open. 2018;1(5): e182765. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703946 (accessed 2019 Feb 15). Wyonch R. Regulation of Edible and Concentrated Marijuana Products Intelligence Memos. Toronto: CD Howe Institute: 2018 Oct 2. Available: https://www.cdhowe.org/sites/default/files/blog_Rosalie_1002.pdf (accessed 2019 Feb 01). Vandrey R, Raber JC, Raber ME, et al. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. Research Letter JAMA 2015 Jun 23-30;313(24):2491-3. Available: https://jamanetwork.com/journals/jama/fullarticle/2338239 (accessed 2019 Feb 06). Cascini F, Aiello C, Di Tanna G. Increasing Delta-9-Tetrahydrocannabinol ( -9-THC) Content in Herbal Cannabis Over Time: Systematic Review and Meta-Analysis. Curr Drug Abuse Rev. 2012 Mar;5(1):32-40. Available: https://www.datia.org/datia/resources/IncreasingDelta9.pdf (accessed 2019 Feb 14). Gobbi G, Atkin T, Zytynski T, et al. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood. A Systematic Review and Meta-analysis JAMA Psychiatry. 2019 Feb 13. doi: 10.1001/jamapsychiatry.2018.4500. Available: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2723657 (accessed 2019 Feb 15). Saunders A, Stevenson RS. Marijuana Lollipop-Induced Myocardial Infarction. Can J Cardiol. 2019 Feb;35(2):229. Available: https://www.onlinecjc.ca/article/S0828-282X(18)31324-2/fulltext (accessed: 2019 Feb 11). Grant CN, Bélanger RE.Cannabis and Canada’s children and youth. Paediatr Child Health. 2017 May;22(2):98-102. Available: https://www.cps.ca/en/documents/position/cannabis-children-and-youth (accessed 2019 Feb 06). Denver Public Heath. Substance Use Exposure Dashboard. Denver: Denver Public Health; 2018. Available: http://www.denverpublichealth.org/community-health-promotion/substance-misuse/substance-use-exposure-dashboard (accessed 2019 Feb 06). Neuwirth, J. (Colorado Department of Public Health and Environment). Personal interview. (2019 Jan 30). Paradis C, April N, Cyr C, et al. The Canadian alcopop tragedy should trigger evidence-informed revisions of federal alcohol regulations. Drug Alcohol Rev. 2019 Feb 4. Available: https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.12896 (accessed 2019 Feb 14). MacCoun, RJ, Mello MM, Half-Baked — The Retail Promotion of Marijuana Edibles. N Engl J Med 2015; 372:989-991. Available: https://www.nejm.org/doi/full/10.1056/NEJMp1416014 (accessed 2019 Feb 5). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Feb 05). Canadian Medical Association (CMA). Health Canada’s Consultation on New Health-related Labelling for Tobacco Products Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13939 (accessed 2019 Feb 05). Canadian Medical Association (CMA) CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Feb 05). Johnson RM, Brooks-Russell A, Ma M, et al. Usual Modes of Marijuana Consumption Among High School Students in Colorado. J Stud Alcohol Drugs. 2016;77(4):580-8. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987070/pdf/jsad.2016.77.580.pdf (accessed 2019 Feb 06). Friese B, Slater MD, Annechino R, et al. Teen Use of Marijuana Edibles: A Focus Group Study of an Emerging Issue. J Prim Prev. 2016 June 37(3):303–309. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4864086/pdf/nihms-766186.pdf (accessed 2019 Feb 06).
Documents
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Health Canada consultation on reducing youth access and appeal of vaping products

https://policybase.cma.ca/en/permalink/policy14078
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
  1 document  
Policy Type
Response to consultation
Date
2019-05-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Text
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada’s consultation on Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures.1 Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. The CMA has stated its position to the federal government on electronic cigarettes and vaping clearly in recent years.2,3 In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.2 We also argued that the government should take the same approach to plain and standardized packaging regulations for e-cigarettes as has now been implemented for tobacco products.2 In our most recent brief we addressed the two main issues outlined in the government’s Notice of Intent with respect to the advertising of vaping products: the placement of that advertising and the use of health warnings.3,4 We expressed concerns that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. Further, we reiterated our position that health warnings for vaping should be like those being considered for tobacco packages. This brief will address the issues of greatest concern to the CMA with respect to vaping and youth. This includes marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths. Introduction The Council of Chief Medical Officers of Health have expressed alarm at the rising number of Canadian youths who are vaping, finding this trend “very troubling.”5 The Canadian Medical Association concurs with this assessment and appeals to the federal government to move urgently on this important public health issue. As our knowledge about the risks of using e-cigarettes increases, there is an even greater imperative to dissuade youth from taking up the habit. This is important because those youth “who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes.”6 Marketing The e-cigarette marketplace is evolving quickly as new products emerge. The industry has made clever use of social media channels to promote their wares by taking advantage of the belief that they are a safer alternative to cigarettes.7 They have also promoted “innovative flavoring and highlighted the public performance of vaping.”7 It is no surprise that the United States Food and Drug Administration (FDA) has referred to youth vaping as an “epidemic,” calling it “one of the biggest public health challenges currently facing the FDA.”8 As the US National Academies of Sciences, Engineering, and Medicine has noted “young people who begin with e-cigarettes are more likely to transition to combustible cigarette use and become smokers who are at risk to suffer the known health burdens of combustible tobacco cigarettes.”9 However, some of the efforts employed to convince youth to take up vaping are especially troublesome. As the 4 US Centers for Disease Control and Prevention (CDC) reported, “one in 5 (US) high school students and 1 in 20 middle school students reported using e-cigarettes in the past 30 days in 2018,” a significant rise in the number of high school students between 2011 and 2018.10 The use of social media campaigns employing “influencers” to capture more of the youth and young adult market or influence their choices shows the need to be especially vigilant.11 In an attempt to counter this influence, a group of over 100 public health and anti-tobacco organizations from 48 countries “are calling on Facebook, Instagram, Twitter and Snap to take “swift action” to curb advertising of tobacco products on their platforms.”12 As much as the industry is making major efforts to attract or sway customers through advertising, youth themselves may hold the key to countering that pressure. A recent US study found that “adolescents generally had somewhat negative opinions of other adolescents who use e-cigarettes. Building on adolescents’ negativity toward adolescent e-cigarette users may be a productive direction for prevention efforts, and clinicians can play an important role by keeping apprised of the products their adolescent patients are using and providing information on health effects to support negative opinions or dissuade formation of more positive ones.”13 Health Canada can play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers.14 We reiterate the concerns we expressed in our recent brief on the potential measures to reduce advertising of vaping products and to help diminish their appeal to youth. The CMA noted that the sections most problematic to the Association were those encompassing public places, broadcast media, and the publications areas.3 Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.3 These areas need to be addressed on an urgent basis. Flavours As of 2013, over 7,000 flavours had been marketed in the US.15 The data indicated that “about 85% of youth who used e-cigarettes in the past 30 days adopted non-tobacco flavors such as fruit, candy, and dessert.”15 Flavours are helpful in attracting youth, especially when coupled with assertions of lower harm.13 And they have been successful in doing so, as evidenced by the rise in the rates of vaping among youth.8, 16 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.16,17,18 The concern is that e-cigarettes “may further entice youth to experiment with e-cigarettes and boost e-cigarettes’ influence on increased cigarette smoking susceptibility among youth.”15 More worrisome, flavoured e-cigarettes “are recruiting females and those with low smoking-risk profile to experiment with conventional cigarettes.”19 Limiting the availability of “child-friendly flavors” should be considered to reduce the attraction of vaping to youth.19 In a recent announcement, the US FDA has proposed to tighten e-cigarette sales and “remove from the market many of the fruity flavors …blamed on fueling “epidemic” levels of teen use.”20 As we have noted in previous submissions, the CMA would prefer to see flavours banned to reduce the attractiveness of vaping to youth as much as possible, a sentiment shared by other expert groups. 2,3,21 Nicotine Levels One of the most popular devices to vape with is JUUL™, entering the US market in 2015.22 JUUL’s™ nicotine pods contain 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods.17 Some of JUUL’s™ competition have pods containing even higher levels (6% and 7%).17 The CMA is very concerned about the rising levels of nicotine available through the vaping process, especially by the newer delivery systems. They supply “high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences.”23 Nicotine, among other issues, “affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.15,24 In addition to flavours, and to ease delivery and to make the taste more pleasant, nicotine salts are added to make the e-liquid “less harsh and less bitter” and “more 5 palatable despite higher nicotine levels.”17 Addressing the Rise in Youth Vaping There are many factors that lead youth to experiment with vaping and e-cigarettes. For some it is simple curiosity, for others it is the availability of different flavours while still others perceive vaping as “cool,” especially when they can use the vapour to perform “smoke tricks.”25 The pod devices themselves (e.g., JUUL™) help enhance the allure because of the “unique aesthetic appeal of pod devices, ability to deliver nicotine at high concentrations and the convenience of using them quickly and discreetly.”26 As vaping continues to grow in popularity, it will not be easy to curb youths’ enthusiasm for it. However, it is too important of a public health issue to not intervene More research is needed into how youth perceive vaping and e-cigarettes as they do not hold a universally positive view of the habit.7,13 As well, there is evidence to suggest that many are coming to see vaping as being “uncool” and that there are potential health consequences to continued use.25 In view of the still-evolving evidence of the safety of vaping and e-cigarettes, “strategic and effective health communication campaigns that demystify the product and counteract misconceptions regarding e-cigarette use are needed.”25 Further, “to reduce youth appeal, regulation efforts can include restricting the availability of e-cigarette flavors as well as visible vapors.”25 Another approach to consider is the state of Colorado’s recent creation of “a health advisory recommending that health care providers screen all youth specifically for vaping, in addition to tobacco use, because young people may not necessarily associate tobacco with vaping.”27 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. The CMA recommends the limitation of number of flavours available to reduce the attractiveness of vaping to youth. 3. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth becoming addicted. 4. Health Canada must play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers. 5. Health Canada must develop communication campaigns directed at youth, parents and health care providers to demystify vaping and e-cigarettes and that create a link between tobacco and vaping. 1 Government of Canada. Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-reducing-youth-access-appeal-vaping-products-potential-regulatory-measures.html (accessed 2019 Apr 11). 2 Canadian Medical Association (CMA). CMA’s Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Nonsmokers’ Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 May 13). 3 Canadian Medical Association (CMA). Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products. Ottawa: CMA; 2019 Mar 22. Available: https://policybase.cma.ca/en/permalink/policy14022 (accessed 2019 May 13). 4 Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youthnon-users-tobacco-products.html (accessed 2019 Feb 27). 5 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 May 14). 6 6 Glantz SA. The Evidence of Electronic Cigarette Risks Is Catching Up with Public Perception. JAMA Network Open 2019;2(3):e191032. doi:10.1001/jamanetworkopen.2019.1032. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2729460 (accessed 2019 May 14). 7 McCausland K., et al. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review. J Med Internet Res 2019;21(2):e11953). Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 May 14). 8 Food and Drug Administration (FDA). Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency’s ongoing actions to confront the epidemic of youth e-cigarette use. Silver Spring, MD: FDA; February 11, 2019. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-data-demonstrating-rising-youth-use-tobacco (accessed 2019 May 17). 9 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 May 17). 10 Kuehn B. Youth e-Cigarette Use. JAMA. 2019;321(2):138. Available: https://jamanetwork.com/journals/jama/fullarticle/2720740 (accessed 2019 May 14). 11 Kirkum C. Philip Morris suspends social media campaign after Reuters exposes young 'influencers'. New York: Reuters; May 10, 2019. Available: https://www.reuters.com/article/us-philipmorris-ecigs-instagram-exclusiv/exclusive-philip-morris-suspends-social-media-campaign-after-reuters-exposes-young-influencers-idUSKCN1SH02K (accessed 2019 May 13). 12 Kirkham C. Citing Reuters report, health groups push tech firms to police tobacco marketing. New York: Reuters; May 22, 2109. Available: https://www.reuters.com/article/us-philipmorris-ecigs-socialmedia/citing-reuters-report-health-groups-push-tech-firms-to-police-tobacco-marketing-idUSKCN1SS1FX (accessed 2019 May 22). 13 McKelvey K, Popova L, Pepper JK, Brewer NT, Halpern-Felsher. Adolescents have unfavorable opinions of adolescents who use e-cigarettes. PLoS ONE 2018;13(11): e0206352. Available: https://doi.org/10.1371/journal.pone.0206352 (accessed 2019 May 14). 14 Calioa D. Vaping an 'epidemic,' Ottawa high school student says. Ottawa: CBC News; November 27, 2018. Available: https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 May 14). 15 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://doi.org/10.1371/journal.pone.0212353 (accessed 2019 May 17). 16 Drazen JM, Morrissey S, Campion EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMe1900484?articleTools=true (accessed 2019 May 17). 17 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 May 20). 18 Reichardt EM., Guichon J. Vaping is an urgent threat to public health. Toronto: The Conversation; March 13, 2019. Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 May 20). 19 Chen JC. et al. Flavored E-cigarette Use and Cigarette Smoking Susceptibility among Youth. Tob Regul Sci. 2017 January ; 3(1): 68–80. Available: https://www.ncbi.nlm.nih.gov/pubmed/30713989 (accessed 2019 May 20). 20 LaVito A. FDA outlines e-cigarette rules, tightens restrictions on fruity flavors to try to curb teen vaping. New Jersey: CNBC; March 13, 2019 Available: https://www.cnbc.com/2019/03/13/fda-tightens-restrictions-on-flavored-e-cigarettes-to-curb-teen-vaping.html (accessed 2019 Mar 20). 21 Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there. Toronto: CBC News; November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 May 20). 22 Huang J, Duan Z, Kwok J, et al. Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tobacco Control 2019;28:146-151. Available: https://tobaccocontrol.bmj.com/content/tobaccocontrol/28/2/146.full.pdf (accessed 2019 May 21). 23 Barrington-Trimis JL, Leventhal AM. Adolescents’ Use of “Pod Mod” E-Cigarettes — Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 May 20). 24 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 May 20). 25 Kong G. et al. Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults. Nicotine & Tobacco Research, 2015 Jul;17(7):847-54. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674436/pdf/ntu257.pdf (accessed 2019 May 21). 26 Keamy-Minor E, McQuoid J, Ling PM. Young adult perceptions of JUUL and other pod electronic cigarette devices in California: a qualitative study. BMJ Open. 2019;9:e026306. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500190/pdf/bmjopen-2018-026306.pdf (accessed 2019 May 21). 27 Ghosh TS, Et al. Youth Vaping and Associated Risk Behaviors — A Snapshot of Colorado. N Engl J Med 2019; 380:689-690.Available: https://www.nejm.org/doi/full/10.1056/NEJMc1900830 (accessed 2019 May 21).
Documents
Less detail

Insite: CMA submission regarding Insite supervised injection site and program.

https://policybase.cma.ca/en/permalink/policy14129
Date
2011-02-17
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Court submission
Date
2011-02-17
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
S.C.C. File No.: 33556 IN THE SUPREME COURT OF CANADA (APPEAL FROM THE BRITISH COLUMBIA COURT OF APPEAL) BETWEEN: ATTORNEY GENERAL OF CANADA AND MINISTER OF HEALTH FOR CANADA Appellants (Appellants/Cross-Respondents) —and — PHS COMMUNITY SERVICES SOCIETY, DEAN EDWARD WILSON and SHELLY TOMIC, VANCOUVER AREA NETWORK OF DRUG USERS (VANDU) Respondents (Respondents/Cross-Appellants) —and — ATTORNEY GENERAL OF BRITISH COLUMBIA Respondent (Respondent) —and — ATTORNEY GENERAL OF QUEBEC, DR. PETER AIDS FOUNDATION, VANCOUVER COASTAL HEALTH AUTHORITY, CANADIAN CIVIL LIBERTIES ASSOCIATION, CANADIAN HIV/AIDS LEGAL NETWORK, INTERNATIONAL HARM REDUCTION ASSOCIATION AND CACTUS MONTREAL, CANADIAN NURSES ASSOCIATION, REGISTERED NURSES' ASSOCIATION OF ONTARIO AND ASSOCIATION OF REGISTERED NURSES OF BRITISH COLUMBIA, CANADIAN PUBLIC HEALTH ASSOCIATION, CANADIAN MEDICAL ASSOCIATION, BRITISH COLUMBIA CIVIL LIBERTIES ASSOCIATION, BRITISH COLUMBIA NURSES'S UNION Interveners FACTUM OF THE INTERVENER, CANADIAN MEDICAL ASSOCIATION BORDEN LADNER GERVAIS LLP 100 Queen Street — Suite 1100 Ottawa, ON KIP 1J9 Guy J. Pratte/Nadia Effendi Tel: (613) 237-5160 Fax: (613) 230-8842 Counsel for the Intervener, Canadian Medical Association 2 TO: Roger Bilodeau, Q.C. REGISTRAR SUPREME COURT OF CANADA AND TO: Robert J. Frater Attorney General of Canada Bank of Canada Building 234 Wellington Street, Room 1161 Ottawa, Ontario KlA OH8 Telephone: (613) 957-4763 FAX: (613) 954-1920 E-mail: robert.fratergustice.gc.ca Counsel for Appellant/Respondent on Cross- Appeal, the Attorney General of Canada Robert J. Frater Attorney General of Canada Bank of Canada Building 234 Wellington Street, Room 1161 Ottawa, Ontario KlA OH8 Telephone: (613) 957-4763 FAX: (613) 954-1920 E-mail: robert.frater@justice.gc.ca Counsel for Appellant/Respondent on Cross- Appeal, the Minister of Health for Canada Joseph H. Arvay, Q.C. Arvay Finlay 1350 - 355 Burrard Street Vancouver, British Columbia V6C 2G8 Telephone: (604) 689-4421 FAX: (604) 687-1941 E-mail: jarvay@arvayfinlay.com Counsel for Respondent, PHS Community Services Society Jeffrey W. Beedell McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: jeffbeedell@mcmillan.ca Agent for Respondent, PHS Community Services Society 3 Joseph H. Arvay, Q.C. Arvay Finlay 1350 - 355 Burrard Street Vancouver, British Columbia V6C 2G8 Telephone: (604) 689-4421 FAX: (604) 687-1941 E-mail: jarvay@arvayfinlay.com Counsel for Respondent, Dean Edward Wilson and Shelly Tomic John W. Conroy, Q.C. Conroy & Company 2459 Pauline St Abbotsford, British Columbia V2S 3S1 Telephone: (604) 852-5110 FAX: (604) 859-3361 E-mail: jconroy@johnconroy.com Counsel for Respondent/Appellant on Cross- Appeal, Vancouver Area Network of Drug Users (VANDU) Craig E. Jones Attorney General of British Columbia 1001 Douglas Street, 6th floor Victoria, British Columbia V8V 1X4 Telephone: (250) 387-3129 FAX: (250) 356-9154 E-mail: craigjones@gov.bc.ca Counsel for Respondent, the Attorney General of British Columbia Hugo Jean Procureur general du Quebec 1200 Route de l'Èglise, 2e etage Ste-Foy, Quebec G1V 4M1 Telephone: (418) 643-1477 FAX: (418) 644-7030 E-mail: hjean@justice.gouv.qc.ca Counsel for Intervener, Attorney General of Quebec Jeffrey W. Beedell McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: jeffbeedell@mcmillan.ca Agent for Respondent, Dean Edward Wilson and Shelly Tomic Henry S. Brown, Q.C. Gowling Lafleur Henderson LLP 2600 - 160 Elgin St P.O. Box 466, Stn "D" Ottawa, Ontario KIP 1C3 Telephone: (613) 233-1781 FAX: (613) 788-3433 E-mail: henry.brown@gowlings.com Agent for Respondent/Appellant on Cross- Appeal, Vancouver Area Network of Drug Users (VANDU) Robert E. Houston, Q.C. Burke-Robertson 70 Gloucester Street Ottawa, Ontario K2P 0A2 Telephone: (613) 566-2058 FAX: (613) 235-4430 E-mail: rhouston@burkerobertson.com Agent for Respondent, the Attorney General of British Columbia Pierre Landry Noel & Associes 111, rue Champlain Gatineau, Quebec J8X 3R1 Telephone: (819) 771-7393 FAX: (819) 771-5397 E-mail: p.landry@noelassocies.com Agent for Intervener, Attorney General of Quebec 4 Andrew I. Nathanson Fasken Martineau DuMoulin LLP 2900 - 550 Burrard Street Vancouver, British Columbia V6C 0A3 Telephone: (604) 631-4908 FAX: (604) 631-3232 Counsel for Intervener, Dr. Peter AIDS Foundation Ryan D. W. Dalziel Bull, Housser & Tupper LLP 3000 - 1055 West Georgia Street Vancouver, British Columbia V6E 3R3 Telephone: (604) 641-4881 FAX: (604) 646-2671 E-mail: rdd@bht.com Counsel for Intervener, British Columbia Civil Liberties Association Sheila Tucker Davis LLP 2800 Park Place 666 Burrard Street Vancouver, British Columbia V6C 2Z7 Telephone: (604) 643-2980 FAX: (604) 605-3781 E-mail: stuckergdavis.ca Counsel for Intervener, Vancouver Coastal Health Authority Paul F. Monahan Fasken Martineau DuMoulin LLP 333 Bay Street, Suite 2400 Bay Adelaide Centre, Box 20 Toronto, Ontario M5H 2T6 Telephone: (416) 366-8381 FAX: (416) 364-7813 E-mail: pmonahan@fasken.com Counsel for Intervener, Canadian Civil Liberties Association Scott M. Prescott Fasken Martineau DuMoulin LLP 1300 - 55 Metcalfe Street Ottawa, Ontario K1P 6L5 Telephone: (613) 236-3882 FAX: (613) 230-6423 E-mail: sprescott@fasken.com Agent for Intervener, Dr. Peter AIDS Foundation Brian A. Crane, Q.C. Gowling Lafleur Henderson LLP 2600 - 160 Elgin St Ottawa, Ontario K1P 1C3 Telephone: (613) 233-1781 FAX: (613) 563-9869 E-mail: brian.crane@gowlings.com Agent for Intervener, British Columbia Civil Liberties Association Marie-France Major McMillan LLP 300 - 50 O'Connor Street Ottawa, Ontario K113 6L2 Telephone: (613) 232-7171 FAX: (613) 231-3191 E-mail: mane-france.maior@mcmillan.ca Agent for Intervener, Vancouver Coastal Health Authority Julia Kennedy Fasken Martineau DuMoulin LLP 55 Metcalfe Street Suite 1300 Ottawa, Ontario K1P 6L5 Telephone: (613) 236-3882 FAX: (613) 230-6423 E-mail: ikennedy(&fasken.com Agent for Intervener, Canadian Civil Liberties Association Michael A. Feder McCarthy Tétrault LLP Suite 1300, 777 Dunsmuir Street Vancouver, British Columbia V7Y 1 K2 Telephone: (604) 643-5983 FAX: (604) 622-5614 E-mail: mfeder(qmccarthv.ca Counsel for Intervener, the Canadian HIV/AIDS Legal Network, International Harm Reduction Association and CACTUS Montréal Rahool P. Agarwal Ogilvy Renault LLP 3800 - 200 Bay Street Toronto, Ontario M5J 2Z4 Telephone: (416) 216-3943 FAX: (416) 216-3930 E-mail: ragarwal(iogilvyrenaul1.com Counsel for Intervener, Canadian Nurses Association, Registered Nurses' Association of Ontario and Association of Registered Nurses of British Columbia Owen M. Rees Stockwoods LLP 77 King Street West Suite 4130, P.O. Box 140 Toronto, Ontario M5K IHI Telephone: (416) 593-7200 FAX: (416) 593-9345 E-mail: owenr~stockwoods.ca Counsel for Intervener, Canadian Public Health Association 5 Brenda C. Swick McCarthy Tétrault LLP 200 - 440 Laurier Avenue West Ottawa, Ontario KIR 7X6 Telephone: (613) 238-2000 FAX: (613) 563-9386 Agent for Intervener, the Canadian HIV/AIDS Legal Network, International Harm Reduction Association and CACTUS Montréal Sally A. Gomery Ogilvy Renault LLP 1500 - 45, O'Connor Street Ottawa, Ontario KIP lA4 Telephone: (613) 780-8661 FAX: (613) 230-5459 E-mail: sgomery(qogilvyrenaul1.com Agent for Intervener, Canadian Nurses Association, Registered Nurses' Association of Ontaro and Association of Registered Nurses of British Columbia Dougald E. Brown Nelligan O'Brien Payne LLP 1500 - 50 O'Connor S1. Ottawa, Ontario KIP 6L2 Telephone: (613) 231-8210 FAX: (613) 788-3661 E-mail: dougald.brown(inelligan.ca Agent for Intervener, Canadian Public Health Association Marjorie Brown Victory Square Law Office 100 West Pender Street Suite 500 Vancouver, British Columbia V6B 1R8 Telephone: (604) 684-8421 FAX: (604) 684-8427 E-mail: mbrown(avslo.ca Counsel for Intervener, British Columbia Nurses' Union Michael A. Chambers Maclaren Corlett 50 O'Connor Street, Suite 1625 Ottawa, Ontario KIP 6L2 Telephone: (613) 233-1146 FAX: (613) 233-7190 E-mail: mchambers(amacorlaw.com Counsel for Intervener, Real Women Canada 6 Colleen Bauman Sack Goldblatt Mitchell LLP 500 - 30 Metcalfe St. Ottawa, Ontario KIP 5L4 Telephone: (613) 235-5327 FAX: (613) 235-3041 E-mail: cbauman~sgmlaw.com Agent for Intervener, British Columbia Nurses' Union TABLE OF CONTENTS Part I — Statement of Facts ........................................................................................................... .1 A. Overview ......................................................................................................................... 1 B. CMA's Interest in the Appeal ............................................................................................ 1 C. CMA's Position on the Facts ............................................................................................ 1 Part II — Statement of the Questions in Issue ................................................................................3 Part III — Statement of Argument .................................................................................................3 A. Charter Interpretation Must be Guided by Reality, Not Ideology ......................................... 3 B. The Impugned Provisions Infringe Section 7 of the Charter ................................................. 5 (1)Denying Access to Necessary Health care Infringes Section 7 of the Charter.................. 5 (2)The Rights to Life and Security of Patients Have Been Infringed ................................... 5 (3)Drug Addicts Have Not Waived Their Statutory and Constitutional Right to Treatment .................................................................................................................. 6 (4)The Rights to Liberty of the Individual Respondents Have Been Infringed ..................... 8 (5)The Principles of Fundamental Justice Have Not Been Respected ................................. 8 a) The Impugned Provisions Are Arbitrary ..................................................................... 8 b) The Impugned Provisions Are Overbroad ................................................................... 9 C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the Charter ................................................................................................................................ 9 D. Remedy ......................................................................................................................... 10 Part IV — Submissions as to Costs .............................................................................................. 10 Part V — Order Sought ................................................................................................................10 Part VI — Table of Authorities .................................................................................................... 11 Part VII — Statutes, Regulations, Rules ...................................................................................... 13 PART I — STATEMENT OF FACTS A. Overview 1. Fair and equitable access to medically necessary, evidenced-based health care is of fundamental importance to Canadian patients and physicians, as this Court recognized in Chaoulli. 2. Where life and security of a person is at risk because of a medical condition, like drug addiction, the Court's delineation of a government or legislature's constitutional obligations should be guided by facts. Unfounded ideological assumptions about the character of patients must not trump clinical judgment based on the best medical evidence available; otherwise, the life, liberty and security of patients is put at risk arbitrarily, contrary to section 7 of the Charter. 3. The Appellants' position that those addicted to drugs have foregone any right to access medical treatment is antithetical to the raison d'être of the Canadian health care system and inconsistent with the federal government's obligations under section 7 of the Charter. 4. Neither the statutory law nor the Constitution allows the state to deny access to health care because of "lifestyle" choices or presumed waiver of legal or constitutional rights. B. CMA's Interest in the Appeal 5. The Canadian Medical Association ("CMA") is the national voice of Canadian physicians with over 74,000 members across the country. Its mission is to serve and to 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 heath care. 6. Critical to CMA's role is the upholding of harm reduction as one pillar in a comprehensive public health approach to disease prevention and health promotion. Further, the CMA possesses a distinct expertise and broad-based knowledge of many aspects of policy and law concerning harm reduction as a clinically mandated and ethical method of care and treatment. C. CMA's Position on the Facts 7. By Order dated February 17, 2011, the CMA was granted leave to intervene in this Appeal. 2 8. The CMA accepts the facts as stated by the Respondents. 9. This appeal flows from separate actions commenced by some of the Respondents seeking relief that would obviate the need for exemptions granted by the Federal Minister of Health under section 56 of the Controlled Drugs and Substances Act (the "Act"), S.C. 1996 c. 19. Thus, when within the confines of the Vancouver Safe Injection Site ("Insite"), patient drug users were not liable to prosecution for possession of a controlled substance contrary to section 4(1) of the Act, or staff for trafficking contrary to section 5(1). The initial exemptions, based on "necessity for a scientific purpose", were granted for a term of three years commencing September 12, 2003. They were thereafter extended to December 31, 2007, and then to June 30, 2008. Insite's ability to operate was dependent upon the exemptions. However, no further extensions were forthcoming. 10. In their actions, the Respondents, in addition to the division of powers argument, contended that sections 4(1) and 5(1) of the Act violated section 7 of the Charter, were unconstitutional, and should be struck down. The Respondents were successful before the Applications Judge and the Court of Appeal. 11. The Applications Judge found that sections 4(1) and 5(1) of the Act infringed section 7 of the Charter and declared them to be of no force and effect. 12. On appeal by the Attorney General of Canada and cross-appeal by the Respondents, PHS, Wilson and Tomic, the majority of the Court of Appeal found that sections 4(1) and 5(1) of the Act were inapplicable to Insite by reason of the application of the doctrine of interjurisdictional immunity. 13. In concurring reasons, Rowles J.A. also found that sections 4(1) and 5(1) engaged section 7 of the Charter and that such application did not accord with the principles of fundamental justice because of overbreadth. 14. The findings of the Applications Judge and Rowles J.A. under the Charter are, the CMA submits, premised on the correct and supported fact that harm reduction is an evidenced-based form of medical treatment for patient drug addicts suffering from the illness of addiction. It is unconstitutional for governments to prevent access to treatment on pain of criminal penalty and deprivations of life, liberty and security of the person on grounds informed by ideological 3 assumptions and not the evidence. PART II - STATEMENT OF THE QUESTIONS IN ISSUE 15. The following constitutional questions, as stated by the Chief Justice on September 2, 2010, are to be determined in this appeal: 1. Are ss. 4(1) and 5(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, constitutionally inapplicable to the activities of staff and users at Insite, a health care undertaking in the Province of British Columbia? 2. Does s. 4(1) of the Controlled Drugs and Substances Act, S.c. 1996, c. 19, infringe the rights guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms? 3. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms? 4. Does s. 5(1) of the Controlled Drugs and Substances Act, S.C. 1996, c. 19, infringe the rights guaranteed by s. 7 of the Canadian Charter of Rights and Freedoms? 5. If so, is the infringement a reasonable limit prescribed by law as can be demonstrably justified in a free and democratic society under s. 1 of the Canadian Charter of Rights and Freedoms? 16. Questions two to five, which relate to the Charter, are of particular importance for the CMA, and are addressed in more detail below. The CMA submits that sections 4(1) and 5(1) of the Act infrnge the rights guaranteed by section 7 of the Charter and are not justified under section 1. PART III - STATEMENT OF ARGUMENT A. Charter Interpretation Must be Guided by Reality, Not Ideology 17. When determining whether or not impugned legislation infringes the Charter, courts must not play host to political debates, but instead must rise above them by ensuring that public policy passes constitutional muster. Chaoull v. Québec (Attorney General), (2005) 1 S.c.R. 791, at para. 89 (CMA Authorities, Tab 2). R. v. Morgentaler, (1988)1 S.C.R. 30 at 45-46 (CMA Authorities, Tab 13). 18. The Appellants' position is clearly premised on ideological preconceptions with regard to individuals suffering from addictions. Yet, as the history of birth control legislation in Canada shows, a legal framework informed by ideological assumptions about the morality of patients seeking to control their reproduction can violate a person's most fundamental rights. See R. v. Morgentaler, supra at 62 where the Court rejected arguments that it should assess administrative structures in the abstract: "when denial of a right as basic as security of the person is infringed by the procedure and administrative structures created by the law itself, the courts are empowered to act" (CMA Authorities, Tab 13). 4 19. In order for the courts to meet their role in determining whether a particular piece of legislation is constitutional, it must consider Parliament's enactments by relying on the available evidence. In fact, it is well established that a deprivation of the rights to life, liberty or security of the person must be proven by solid evidence. Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15 [CMA Authorities, Tab 20]. 20. The presentation of facts is not a mere technicality, but rather it is essential to a proper consideration of Charter issues: Charter cases will frequently be concerned with concepts and principles that are of fundamental importance to Canadian society. For example, issues pertaining to freedom of religion, freedom of expression and the right to life, liberty and the security of the individual will have to be considered by the courts. Decisions on these issues must be carefully considered as they will profoundly affect the lives of Canadians and all residents of Canada. In light of the importance and the impact that these decisions may have in the future, the courts have every right to expect and indeed to insist upon the careful preparation and presentation of a factual basis in most Charter cases. The relevant facts put forward may cover a wide spectrum dealing with scientific, social, economic and political aspects. Often expert opinion as to the future impact of the impugned legislation and the results of the possible decisions pertaining to it may be of great assistance to the courts. MacKay v. Manitoba, [1989] 2 S.C.R. 357 at 361 [CMA Authorities, Tab 5]. 21. Specifically, with respect to section 7 of the Charter, this Court has confirmed that the task of the courts is to evaluate the issue in "the light, not just of common sense or theory, but of the evidence". The Court dispenses with unsubstantiated theoretical arguments, relying instead on empirical and scientific evidence presented by the parties: In support of this contention, the government called experts in health administration and policy. Their conclusions were based on the "common sense" proposition that the improvement of health services depends on exclusivity (R.R., at p. 591). They did not profess expertise in waiting times for treatment. Nor did they present economic studies or rely on the experience of other countries. They simply assumed, as a matter of apparent logic, that insurance would make private health services more accessible and that this in turn would undermine the quality of services provided by the public health care system. The appellants, relying on other health experts, disagreed and offered their own conflicting "common sense" argument for the proposition that prohibiting private health insurance is neither necessary nor related to maintaining high quality in the public health care system. Quality public care, they argue, depends not on a monopoly, but on money and management. They testified that permitting people to buy private insurance would make alternative medical care more accessible and reduce the burden on the public system. The result, they assert, would be better care for all [...] To this point, we are confronted with competing but unproven "common sense" arguments, amounting to little more than assertions of belief. We are in the realm of theory. But as discussed above, a theoretically defensible limitation may be arbitrary if in fact the limit lacks a connection to the goal. This brings us to the evidence called by the appellants at trial on the experience of other developed countries with public health care systems which permit access to private health care. The experience of these countries suggests that there is no real connection in fact between prohibition of health insurance and the goal of a quality public health system. 5 Chaoulli, supra at paras. 136-149 (see also paras. 115, 117, 136-149, 150, 152 where the Court refers to Statistics Canada studies and evidence from other western democracies) [CMA Authorities, Tab 2]. See also Rodriguez v. British Columbia (Attorney General), [1993] 3 S.C.R. 519 at 601-602 [CMA Authorities, Tab 16]. 22. Drug addicts suffer from a medical condition that can be treated. Hence, Insite is designed as a health treatment aimed at reducing the harmful consequences of drug use as well as exposing its vulnerable patients to other health care options. In this context, the federal legislation and government actions at issue amount to a denial of evidence-based medical treatment whose effect is to put the life and security of patients at great risk. 23. Charter interpretation should generally be grounded on fact rather than speculation or ideological assumptions, especially where life and security of the person (i.e., the patient) is at risk because of a medical condition (such as addiction). In such cases, the Court's delineation of the state's constitutional obligations should be guided by evidence-based medicine and independent clinical judgment. Chaoulli, supra at paras. 85, 107 [CMA Authorities, Tab 2]. See also Operation Dismantle Inc. v. The Queen, [1985] 1 S.C.R. 441 at 452-454 [CMA Authorities, Tab 7]; Auton (Guardian ad litem of) v. British Columbia (Attorney General), [2004] 3 S.C.R. 657, at para. 66 [CMA Authorities, Tab 1]. 24. Accordingly, CMA submits that, at the very least, in the health care field where lives are at risk, there must be sound evidentiary basis for legislative and government action that deny medical care. B. The Impugned Provisions Infringe Section 7 of the Charter (1) Denying Access to Necessary Health care Infringes Section 7 of the Charter 25. While the legislature is generally entitled to enact legislation prohibiting drug use or trafficking, this legislation (however well-intended) cannot have the effect of putting the lives of affected persons at risk. This Court has already found in Chaoulli that section 7 of the Charter was infringed when governments impeded timely patient access to care. (2) The Rights to Life and Security of Patients Have Been Infringed 26. Both the Applications Judge and the Court of Appeal found that the right to life and security was engaged in the present case. The evidence on these issues was plentiful: 1. Addiction is an illness. One aspect of the illness is the continuing need or craving to consume the substance to which the addiction relates; 6 2. Injection drug use leads to an increased incidence and prevalence of infectious diseases including HIV/AIDS, Hepatitis A, B and C, and skin- and blood-borne infections; frequent drug overdoses resulting in significant morbidity and mortality; increased hospital and emergency service utilization; 3. The risk of morbidity and mortality associated with addiction and injection is ameliorated by injection in the presence of qualified health professionals at Insite; 4. User of Insite who are addicted to heroin, cocaine and other controlled substances are not engaged in recreation. Their addiction is an illness frequently, if not invariably, accompanied by serious infections and the real risk of overdose. Reasons for Judgment of the Applications Judge, paras. 87, 89, 135-136, Appellants' Record, Vol. I, pp. 24-25, 34. See also Reasons for Judgment of the B.C. Court of Appeal, para. 30, Appellants' Record, Vol. I, p. 65. (3) Drug Addicts Have Not Waived Their Statutory and Constitutional Right to Treatment 27. The Appellants did not really dispute the medical evidence to the effect that addiction to drugs was a disease. They sought instead to justify their position by claiming that drug addicts had "chosen" their lifestyle and were solely responsible for their medical condition. For the following reasons, this "rationale" does not pass constitutional muster. 28. The Appellants assert that the section 7 rights are not engaged as they stem from an alleged "choice made by the consumer", relying on the fact that 95% of the injections in the downtown east side of Vancouver do not take place at Insite. The Appellants do not explain how this assertion demonstrates why addicts are able to make a choice not to inject themselves, given that it only addresses where they inject themselves. In any event, contrary to the Appellants' choice theory, the evidence before the Applications Judge and his findings were to the contrary: the reasons for the addiction and resulting need are based on a complicated combination of personal, governmental and legal factors, some of which lend themselves to choice and others that do not.' Further, the Applications Judge found that it is the illness of addiction, and the failure to manage it, that has led to further illness and death. Reasons for Judgment of the Applications Judge, paras. 65, 89, 142, Appellants' Record, Vol. I, pp. 21, 24-25, 35. See also Reasons for Judgment of the B.C. Court of Appeal, para. 39, Appellants' Record, Vol. I, p. 67. Contra the facts in R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571 [Malmo-Levine] [CMA Authorities, Tab 12]. 29. The Appellants' position amounts to a claim that the users of Insite have effectively waived their constitutional rights under section 7. Notwithstanding that the jurisprudence is In fact, the evidence is clear that in the case of the Respondent Tomic, her first experience with illegal drugs was not a personal choice [Reasons for Judgment of the Applications Judge, para. 65, Appellants' Record, Vol. I, p. 21]. 7 unclear as to whether a right under section 7 can actually be waived, it is well established that a waiver or a renunciation of any right under the Charter must be voluntary, freely expressed and accompanied with a clear understanding of the purpose the right was meant to serve and the consequences of declining its protection. There is no evidence whatsoever that the patients of Insite who suffer from addiction, knowingly and unequivocally waived their rights under the Charter, and more specifically their right to access medical treatment. See e.g. Godbout v. Longueuil (City), [1997] 3 S.C.R. 844, at paras. 71-72; Syndicat Northcrest v. Amselem, [2004] 2 S.C.R. 551, at paras. 96-102; R. v. Richard, [1996] 3 S.C.R. 525, at paras. 22-26; R. v. L.T.H., [2008] 2 S.C.R. 739, at paras. 41-42; R. v. Clarkson, [1986] 1 S.C.R. 383 at 394-396; Korponay v. Canada (Attorney General), [1982] 1 S.C.R. 41 at 49; Yorkton Union Hospital v. S.U.N. (1993), 16 Admin. L.R. (2d) 272, at para. 44 (C.A.) [CMA Authorities, Tabs 3, 17, 15, 11, 8, 4, 18 respectively]. 30. Indeed, Canadians do not forego their right to health care or to protection from section 7 violations because of their "choice" of lifestyles. The Appellants' position that addicts must take responsibility for the choice they make undermines the raison d'être of the Canadian health care system, namely (as found by the Applications Judge and the Court of Appeal) the fundamental right of Canadians to access medical treatment and the ethical and clinical responsibilities of their health care providers. 31. The Appellants' position skirts the clinical question at issue for physicians and their patients: 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. In Canada, neither the ethical obligations of physicians to treat patients, nor the patients' legal right to treatment, are subject to a moral assessment of a patient's lifestyle. Behaviours that might be deemed "risky" do not deprive patients of their rights of access to clinically required medical care. 32. Section 31 of CMA's Code of Ethics (relied on by the Court in the past e) provides that all physicians must "[r]ecognize the responsibility of physicians to promote fair access to health care resources". The patients at Insite would be deprived of positive health outcomes if Insite were to close or even continue to operate under the ongoing threat of closure. 33. Adopting the Appellants' approach to Charter interpretation would set an extremely dangerous precedent. Thus, if one were to apply the rationale of "choice" to other medical 2 See e.g. R. v. Dersch, [1993] 3 S.C.R. 768 at 784-785, where the Court refers to CMA's Code of Ethics [CMA Authorities, Tab 9]. 8 contexts, such as chronic disease, patients suffering from diabetes because of contributing factors such as poor nutrition and lack of exercise would, under the same logic, be denied medical care. Indeed, many of the complex elements beyond individual choice such as socio-economic and genetic factors found by the Applications Judge in the case at bar to shape addiction as an ilness are prevalent in other diseases. This approach would be not only unethical and clinically unsound, but unconstitutionaL. (4) The Rights to Liberty of the Individual Respondents Have Been Infringed 34. The courts have recognized that the threat of criminal prosecution and possibility of imprisonment for an offence is suffcient to trigger the liberty interest and scrutiny under section 7. Malmo-Levine, supra at para. 84 ICMA Authorities, Tab 12). R. v. Parker (2000),188 D.L.R. 4th 385, at para. 101 (Ont. C.A.) ICMA Authorities, Tab 14). 35. Vulnerable patients suffering from addiction and the health care providers who provide treatment at Insite suffer violations of their constitutionally guaranteed rights (section 7 of the Charter) because of the threat of prosecution under the Act. The uncertainty associated with a ministerial exemption mechanism for Insite from certain provisions of the Act imposes a great burden on those already labouring under the weight of addiction. Moreover, health care providers are also put at risk in their ability to provide medically necessary and evidence-based health care services in a timely manner to all citizens by the capricious exemption mechanism contained in the Act. (5) The Principles of Fundamental Justice Have Not Been Respected 36. It is well established that a law that is arbitrary or overbroad will constitute a breach of the principles of fundamental justice. The CMA submits that the Applications Judge was correct when he found that the impugned provisions were arbitrary, or if not arbitrary, grossly disproportionate and overbroad. The Court of Appeal agreed that the provisions were overbroad. P. Hogg, Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52 to 47-60.1 ICMA Authorities, Tab 19). R. v. Heywood, (1994) 3 S.c.R. 761 at 792-794 ICMA Authorities, Tab 10). Chaoull, supra at para. 127 ICMA Authorities, Tab 2). Rodriguez, supra at 590-591 ICMA Authorities, Tab 16). a) The Impugned Provisions Are Arbitrary 37. A law is arbitrary when it bears no relation to, or is inconsistent with, the objective that 9 lies behind it. In order not to be arbitrary, a limit on the section 7 right requires not only a theoretical connection between the limit and the legislative goal, but a real connection on the facts. Chaoulli, supra at paras. 130-131 [CMA Authorities, Tab 2]. 38. In the present case, by prohibiting access to evidence-based, medically necessary care, the government has contributed to the very harm it claims it seeks to prevent, i.e. drug possession and addiction. The best available medical evidence suggests that clinics such as Insite not only protect life, but offer positive health outcomes and care alternatives to vulnerable patients. 39. Moreover, the justification of any denial of access to necessary medical care based on ideology rather than facts is arbitrary since, by definition, it bears no real connection to the facts. b) The Impugned Provisions Are Overbroad 40. It is a well-established principle of fundamental justice that criminal legislation must not be overbroad. If the government, in pursuing a legitimate objective, uses means which are broader than is necessary to accomplish that objective, the principles of fundamental justice will be violated. Heywood, supra at 792-793 [CMA Authorities, Tab 10]. See also Malmo-Levine, supra at paras. 130-131 [CMA Authorities, Tab 12]. 41. A fortiori, that will be true when the state itself has a particular interest in acting to protect vulnerable persons. In the present case, the evidence before the Applications Judge demonstrated that harm reduction has been a component of Canada's drug strategy for many years. In 2002, the House of Commons Special Committee on the Non-Medical Use of Drugs rejected the dichotomy between harm reduction and an abstinence-based treatment model. It also specifically considered the creation of a safe injection facility in the downtown east side of Vancouver because it recognized that that community presented a "public health disaster". 42. Hence, while the government may be justified in preventing drug possession and trafficking, it cannot cast a legislative prohibition so widely that it captures persons in need of medical care. C. If There is an Infringement of Section 7, the Law is Not Saved by Section 1 of the Charter 43. Should the Court find that sections 4(1) and 5(1) of the Act infringe the rights guaranteed Guy Pratt /Nadia ffend Borden L dner Gervais L 1 0 by section 7 of the Charter, the CMA submits that the provisions cannot be justified under section 1 of the Charter as any law that offends the principles of fundamental justice cannot be justified, and more specifically, meet the minimal impairment branch of the section 1 analysis. See e.g. New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46, at para. 99 [CMA Authorities, Tab 6]; Heywood, supra at 802-803 [CMA Authorities, Tab 10]. D. Remedy 44. Fundamental justice requires either permanent exemptions or a declaration that the impugned law, as it applies to users of supervised injection sites, is invalid. The CMA submits that this position is consistent with sound constitutional interpretation of section 7 of the Charter, while protecting the most vulnerable patient populations in accordance with evidence-based medicine and physicians' ethical obligations. PART IV — SUBMISSIONS AS TO COSTS 45. The CMA seeks no costs and asks that none be awarded against it. PART V — ORDER SOUGHT 46. The CMA submits that constitutional questions two and four should be answered affirmatively. Should the Court answer these questions in the affirmative, however, constitutional questions three and five should be answered negatively. 47. The CMA seeks leave of this Court, pursuant to rule 59(2) of the Rules of the Supreme Court of Canada, to present oral argument at the hearing of this appeal. Rules of the Supreme Court of Canada, SOR/83-74, as amended, Rule 59(2) [Part VII of Factum]. ALL OF WHICH IS RESPECTFULLY SUBMITTED THIS 13th DAY OF APRIL, 2011. OTTO1 \ 4423086 \ 7 11 PART VI — TABLE OF AUTHORITIES TAB SOURCES Paras. in factum where cited Cases 1. Auton (Guardian a litem of) v. British Columbia (Attorney General), [2004] 3 S.C.R. 657 23 2. Chaoulli v. Quebec (Attorney General), [2005] 1 S.C.R. 791 17, 21, 23, 36, 37 3. Godbout v. Longueuil (City), [1997] 3 S.C.R. 844 29 4. Korponay v. Canada (Attorney General), [1982] 1 S.C.R. 41 29 5. MacKay v. Manitoba, [1989] 2 S.C.R. 357 20 6. New Brunswick (Minister of Health and Community Services) v. G. (J.), [1999] 3 S.C.R. 46 43 7. Operation Dismantle Inc. v. The Queen, [1985] 1 S.C.R. 441 23 8. R. v. Clarkson, [1986] 1 S.C.R. 383 29 9. R. v. Dersch, [1993] 3 S.C.R. 768 32 10. R. v. Heywood, [1994] 3 S.C.R. 761 36, 40, 43 11. R. v. L.T.H., [2008] 2 S.C.R. 739 29 12. R. v. Malmo-Levine; R. v. Caine, [2003] 3 S.C.R. 571 28, 34, 40 13. R. v. Morgentaler, [1988] 1 S.C.R. 30 17, 18 14. R. v. Parker (2000), 188 D.L.R. 4th 385 (Ont. C.A.) 34 15. R. v. Richard, [1996] 3 S.C.R. 525 29 16. Rodriguez v. British Columbia (Attorney General), [1993] 3 S.C.R. 519 21, 36 17. Syndicat Northcrest v. Amselem, [2004] 2 S.C.R. 551 29 18. Yorkton Union Hospital v. S. UN. (1993), 16 Admin. L.R. (2d) 272 (Sask. C.A.) 29 12 TAB SOURCES Paras. where in factum cited Secondary Sources 19. Hogg, P., Constitutional Law of Canada, 5th ed., loose-leaf (Carswell: Toronto, 2007) at 47-52 to 47-60.1. 36 20. Taylor, M. and Jamal, M., The Charter of Rights in Litigation, loose-leaf (Canada Law Book: Aurora, 2010) at para. 17:15 19 13 PART VII — STATUTES, REGULATIONS, RULES
Canadian Charter of Rights and Freedom, sections 1 and 7
Controlled Drugs and Substances Act, S.C. 1996, c. 19, sections 4(1), 5(1), 56
Rules of Supreme Court of Canada, SOR/83-74, as amended, Rule 59 14 Canadian Charter of Rights and Freedoms PART I OF THE CONSTITUTION ACT, 1982 Charte canadienne des droits et libertes PARTIE I DE LA LOI CONSTITUTIONNELLE DE 1982 Rights and freedoms in Canada 1. The Canadian Charter of Rights and Freedoms guarantees the rights and freedoms set out in it subject only to such reasonable limits prescribed by law as can be demonstrably justified in a free and democratic society. Life, liberty and security of person 7. Everyone has the right to life, liberty and security of the person and the right not to be deprived thereof except in accordance with the principles of fundamental justice. Droits et libertes au Canada 1. La Charte canadienne des droits et libertes garantit les droits et libertós qui y sont enonces. Its ne peuvent etre restreints que par une regle de droit, dans des limites qui soient raisonnables et dont la justification puisse se demontrer dans le cadre d'une society libre et democratique. Vie, liberte et securite 7. Chacun a droit a la vie, a la liberte et a la securite de sa personne; it ne peut etre porte atteinte a ce droit qu'en conformite avec les principes de justice fondamentale. 15 Controlled Drugs and Substances Act S.C. 1996, c. 19 Possession of substance 4. (1) Except as authorized under the regulations, no person shall possess a substance included in Schedule I, II or III. Trafficking in substance 5. (1) No person shall traffic in a substance included in Schedule I, II, III or IV or in any substance represented or held out by that person to be such a substance. Exemption by Minister 56. The Minister may, on such terms and conditions as the Minister deems necessary, exempt any person or class of persons or any controlled substance or precursor or any class thereof from the application of all or any of the provisions of this Act or the regulations if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest. Loi reglementant certaines drogues et autres substances L.C. 1996, ch. 19 Possession de substances 4. (1) Sauf dans les cas autorises aux termes des reglements, la possession de toute substance inscrite aux annexes I, II ou III est interdite. Trafic de substances 5. (1) Il est interdit de faire le trafic de toute substance inscrite aux annexes I, II, III ou IV ou de toute substance presentee ou tenue pour telle par le trafiquant. Exemption par le ministre 56. S'il estime que des raisons medicales, scientifiques ou d'interet public le justifient, le ministre peut, aux conditions qu'il fixe, soustraire a l'application de tout ou partie de la presente loi ou de ses reglements toute personne ou categorie de personnes, ou toute substance designee ou tout precurseur ou toute categorie de ceux-ci. 16 Rules of the Supreme Court of Canada (in force on October 13, 2006) Regles de la Cour supreme du Canada. (en vigueur le 13 octobre 2006) 59. (1) In an order granting an intervention, the judge may (a) make provisions as to additional disbursements incurred by the appellant or respondent as a result of the intervention; and (b)impose any terms and conditions and grant any rights and privileges that the judge may determine, including whether the intervener is entitled to adduce further evidence or otherwise to supplement the record. (2)In an order granting an intervention or after the time for filing and serving all of the memoranda of argument on an application for leave to appeal or the facta on an appeal or reference has expired, a judge may, in their discretion, authorize the intervener to present oral argument at the hearing of the application for leave to appeal, if any, the appeal or the reference, and determine the time to be allotted for oral argument. (3)An intervener is not permitted to raise new issues unless otherwise ordered by a judge. 59. (1) Dans l'ordonnance octroyant l'autorisation d'intervenir, le juge petit : a) prevoir comment seront supportes les &pens supplementaires de l'appelant ou de l'intime resultant de l'intervention; b) imposer des conditions et octroyer les droits et privileges qu'il determine, notamment le droit d'apporter d'autres elements de preuve ou de completer autrement le dossier. (2)Dans l'ordonnance octroyant l'autorisation d'intervenir ou aprês l'expiration du Mai de depOt et de signification des memoires de demande d'autorisation d'appel, d'appel ou de renvoi, le juge peut, a sa discretion, autoriser l'intervenant a presenter une plaidoirie orale a l'audition de la demande d'autorisation d'appel, de l'appel ou du renvoi, selon le cas, et determiner le temps alloue pour la plaidoirie orale. (3) Sauf ordonnance contraire d'un juge, l'intervenant n'est pas autorise a soulever de nouvelles questions.
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Medication use and seniors (Update 2017)

https://policybase.cma.ca/en/permalink/policy10151
Last Reviewed
2019-03-03
Date
2011-05-28
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2011-05-28
Replaces
Medication use and seniors
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Older Canadians represent the fastest-growing segment of our population and are the largest users of prescription drugs. Seniors take more drugs than younger Canadians because, on average, they have a higher number of chronic conditions. According to the Canadian Institute for Health Information, in 2012, nearly two-thirds of seniors had claims for 5 or more drug classes, and more than one-quarter of seniors had claims for 10 or more drug classes. The number of drugs used by seniors increased with age. The use of multiple medications, or polypharmacy, is of concern in the senior population. The risk of drug interactions and adverse drug reactions is several-fold higher for seniors than for younger people. This phenomenon is associated with pharmacokinetic and pharmacodynamics factors in seniors, including changes in renal and hepatic function, increased sensitivity to drugs and, potentially, multiple medical problems. In older persons, adverse drug reactions are often complex and may be the direct cause of hospital admissions for acute care. Cognitive and affective disorders, for example, may be due to adverse reactions to sedatives or hypnotic drugs. Chronic pain is a common issue, and it is important to carry out research into and education for health care providers concerning the unique challenges of managing pain in older adults. The CMA supports the development of a coordinated national approach to reduce polypharmacy and prevent adverse drug reactions. Prescribers must be vigilant to optimize pharmacotherapy and in reconciling medications, taking into consideration physiological changes as a person ages. Deprescribing should be considered, reducing or stopping medications that may be harmful or no longer be of benefit, seeking to improve quality of life. There has been considerable interest in determining which factors affect prescribing behavior and how best to influence these factors. Strategies that improve prescribing practices include evidence-based drug information provided through academic detailing; objective continuing medical education; accessible, user-friendly decision support tools available at point of care; and electronic prescribing systems that allow physicians access to their patient's treatment and medication profiles. The following principles define the basic steps to appropriate prescribing for seniors.
Know the patient.
Know the diagnosis.
Know the drug history. Keep a medication list for each patient and review, update, reconcile and evaluate adherence at each visit. Instruct the patient to bring all prescription and over-the-counter medications, including medications prescribed by other physicians, and natural health products, to each appointment. In some provinces, pharmacists conduct medication use reviews for patients on public drug benefit programs.
Know the history of use of other substances such as alcohol, tobacco, cannabis, opioids and caffeine.
Consider non-pharmacologic therapy, including diet, exercise, psychotherapy or community resources. Continuing medical education in specific non-pharmacologic therapies is valuable. For example, evaluation and management of behavioural and psychological symptoms of dementia should be considered before anti-psychotic therapy. As well, Canadian standardized non-pharmacologic order sets should be developed for the treatment of delirium.
Know the drugs. Critically evaluate all sources of drug information and use multiple sources such as clinical practice guidelines, medical journals and databases, continuing medical education and regional drug information centres. Monitor patients continually for adverse drug reactions. Appropriate drug dosage depends on factors such as age, sex, body size, general health, concurrent illnesses and medications, and hepatic, renal and cognitive function (for example, older people are particularly sensitive to drugs that affect the central nervous system).
Keep drug regimens simple. Avoid mixed-frequency schedules when possible. Try to keep the number of drugs used for long-term therapy under five to minimize the chance of drug interactions and improve adherence.
Establish treatment goals. Determine how the achievement of goals will be assessed. Regularly re-evaluate goals, adequacy of response and justification for continuing therapy. Time to benefit of prescribed medications should be a key consideration when providing care to seniors at end of life.
Encourage patients to be responsible medication users. Verify that the patient and, if necessary, the caregiver, understands the methods and need for medication. Recommend the use of daily or weekly medication containers, calendars, diaries or other reminders, as appropriate, and monitor regularly for compliance. Encourage the use of one dispensary. The Institute for Safe Medication Practices Canada has developed a program, Knowledge is the best medicine (https://www.knowledgeisthebestmedicine.org), that can be helpful to seniors and their healthcare team manage medicines safely and appropriately. Approved by the Board on May 28, 2011 Update approved by the Board on March 02, 2019
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The Need for a National Strategy to Address Abuse and Misuse of Prescription Drugs in Canada: Canadian Medical Association Submission to the House of Commons Standing Committee on Health

https://policybase.cma.ca/en/permalink/policy11035
Date
2013-11-27
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2013-11-27
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 on the government's role in addressing prescription drug abuse in Canada. It is increasingly recognized that while prescription medication has an important role in health care, the misuse and abuse of controlled psychoactive prescription medications, notably opioids such as oxycodone, fentanyl and hydromorphone, is emerging as a significant public health and safety issue. The use of prescription opioids is on the rise, in Canada and internationally. Canada has the second highest per capita consumption of prescription opioids in the world, after the United States. The CMA is particularly concerned about the impact of prescription drug abuse and misuse on vulnerable populations; notably, seniors, youth and First Nations. We note, for example, that in 2011 opioids were reported as the third most common drug (after alcohol and marijuana) used by students in Ontario. Controlled prescription medications 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. Though many patients are prescribed controlled drugs to treat medical conditions, 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. 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. Canada's physicians believe that the misuse and abuse of prescription medication is a serious problem and because of its complexity, requires a complex and multifaceted solution. Therefore, the CMA makes the following recommendations to the Committee: 1) A National Strategy to Address the Abuse and Misuse of Prescription Medication 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 misuse and abuse of prescription medication in Canada. The CMA has consistently recommended a comprehensive national strategy to address the problems of drug abuse in Canada, whether of illegal or prescription-based substances. The Canadian Centre on Substance Abuse, in its report First Do No Harm: Responding to Canada's Prescription Drug Crisis, has offered nearly 60 recommendations toward the development of a strategy to combat misuse of prescription medications. The CMA believes that such a strategy should include: a) Prevention: Existing community programs and social marketing campaigns to address prescription drug abuse are generally aimed at young recreational users. For example, since many such users report that they get drugs from their parents' or friends' medicine cabinets, many jurisdictions have implemented prescription "take-back" programs, and education campaigns to promote safe storage and disposal of medications. Prevention strategies aimed at other types of prescription drug abuse, and targeting other populations such as health care providers, are still required. b) Treatment: Appropriate services for the treatment of addiction to prescription drugs are also a vital part of a national strategy. The CMA recommends that all partners work to improve and promote access to treatment programs - not only for treatment of addiction, such as pharmacological interventions, support and counselling, and withdrawal management, but also to treat and manage pain. In particular, the CMA recommends improving access to culturally appropriate treatment, counselling and withdrawal management programs in rural and remote areas, and for First Nations. c) Consumer Protection: There are several ways in which consumer protection strategies may form part of a strategy. One is modifications to the drugs themselves. For example, opioid manufacturers have developed formulations of their products intended to minimize their abuse potential, such as "slow-release" formulations and other forms of tamper-proofing to reduce a drug's potential for abuse. CMA supports further investigation into abuse-deterrent technologies. d) Surveillance and Research: Our knowledge of the extent of the prescription drug abuse problem in Canada, and the effectiveness of strategies proposed to combat it, is limited by a number of factors. These will be more specifically addressed later in this brief. 2) Strategies to Enhance Optimal Prescribing in Canada The CMA recommends that governments at all levels work with prescribers and the public, industry and other stakeholders to develop and implement a nationwide strategy to support optimal prescribing and medication use in Canada. 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 acknowledges that we have not yet achieved that ideal, but believes that optimal prescribing in Canada is a goal worth achieving. Our 2010 position statement "A Prescription for Optimal Prescribing" (Appendix A) recommends a national strategy to promote best practices in prescribing, and its recommendations can be applied to the specific situation of prescription drug abuse. Key elements of this strategy are: * Relevant, objective and easily accessible information for prescribers, which can readily be incorporated into every day practice. This can include clinical decision-support tools for use at the point of care. * Ongoing development and dissemination of clinical guidance in pain management. A Canadian practice guideline for use of opioids to treat chronic non-cancer pain, prepared under the direction of the multi-stakeholder National Opioid Use Guideline Group (NOUGG), was published in the Canadian Medical Association Journal on June 15, 2010. A number of plans for dissemination of this guideline are under way, under the direction of the Michael G. DeGroote National Pain Centre at McMaster University. They include an online CME module, co-sponsored by the CMA, which is now being finalized by MDcme.ca, a professional education group based at Memorial University. * Educational programs for prescribers in pain management and in the management of addictions. Both addiction treatment and pain management should be part of the educational curriculum in medical school and residency training as well as in continuing education. Educational programs could also provide prescribers with advice on how to recognize addiction in a patient, or on how to deal with fraudulent or aggressive patients. * Ensuring that prescribers have access to expert advice if required. This could be achieved through such means as: o Academic detailing programs, which use personalized one-on-one techniques to deliver impartial prescribing information to practitioners. o Communities of practice and clinical support networks that link practitioners with experts in the field. Experts can not only provide clinical information, but can provide mentorship and personal advice on best practices. 3) Monitoring and Surveillance of Prescription Drug Abuse 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. One of the challenges in dealing with prescription drug abuse is the incompleteness of our knowledge of the extent of the problem, or of the most effective ways to address it. This means that physicians do not have access in real time to the information they need, at the point of care. For example, except in Prince Edward Island, physicians do not have the ability to look up a patient's medical history to determine if he or she has received a prescription from another source. Prescription monitoring programs 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. Some are administered by regulatory colleges, others by governments. The CMA recommends that national standards be developed for prescription monitoring programs, 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: * It can help identify fraudulent attempts to obtain a prescription, such as an attempt to fill prescriptions from a number of different providers. * It can help deter cross-provincial fraud. * It can help professional regulatory bodies actively monitor and intervene, as needed, with practitioners suspected of over-prescribing or over-dispensing frequently-misused medications. * Finally, it will help researchers gather consistent data to improve our knowledge of the problem, identify research priorities, and determine best practices to address crucial issues. The CMA also recommends that this system be electronic and that it be compatible with electronic medical and pharmacy record systems, and with provincial pharmaceutical databases such as British Columbia's. Provincial and territorial governments should work with the federal government and with health care providers to improve the standardization and sharing of information where appropriate. Prescription monitoring programs should be evaluated to ascertain their effectiveness in reducing misuse and abuse. We are pleased that federal, provincial and territorial health ministries have expressed interest in working together on issues related to prescription drug abuse, 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. In conclusion, the Canadian Medical Association reiterates the deep concern of Canada's physicians about prescription drug abuse and misuse in this country. We are committed to enhancing optimal prescribing and to working with governments to develop and implement a strong, coherent plan of action to address this pressing national problem.
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Position statement on prescription drug shortages in Canada

https://policybase.cma.ca/en/permalink/policy10756
Last Reviewed
2017-03-04
Date
2013-05-25
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2017-03-04
Date
2013-05-25
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Position Statement on Prescription Drug Shortages in Canada The escalation in shortages of prescription drugs in the past few years and the ongoing disruptions to supply experienced in Canada and globally are matters of grave concern to the Canadian Medical Association (CMA) and its members. Drug shortages are having a detrimental impact on the delivery of patient care and treatment and the availability of health care services across the country. CMA has advocated for a thorough examination of the drug supply system to identify points where we in Canada can influence supply problems. Solutions will have to involve the various players in the drug supply chain, from manufacturers through to healthcare providers and levels of government. Background Drug shortages are not a problem confined to Canada. In the United States the number of drug shortages from 2006 to 2010 grew by more than 200 per cent.1 In 2011, 251 shortages were reported to the FDA. 2 Canada has not had an accurate record of the number of drugs in short supply over past years but in April 2013 253 drugs were listed on the industry sponsored Canadian Drug Shortage Website.3 Factors that influence the occurrence of a drug shortage can occur at any stage of the drug supply chain and any disruptions can ripple through the system. Figure 1 Drug supply chain in Canada4 [See PDF] There are many causes that can lead to a drug shortage. Disruptions in the supply of an active or key ingredient contribute to drug shortages and this is exacerbated when the active ingredient is produced by a single raw material supplier. If the supplier is unable to meet demand than all manufacturers relying on that supply become vulnerable to disruptions. The sourcing of raw materials from outside of North America, primarily China and India, whose safety and regulatory standards may not be stringently enforced can result in regulatory authorities closing down facilities thereby impacting supply of active ingredients or necessitating a lengthy search for a new supplier. Additional manufacturing issues contributing to shortages can include complex manufacturing processes like those used to make sterile injectables, changes in product formulations, problems in the production process or regulatory enforcement of good manufacturing processes, limited capacity, an unexpected surge in demand, regulatory delays in product approvals and business decisions. 5 Shortages may also be due to factors outside the manufacturers control such as various interruptions in the normal delivery of medicines through the pharmacy supply chain and distribution network6. Just in time inventory management practices can lead to a reduction of available drug inventories. In addition procurement strategies that lead to sole source contracts for bulk purchases has been identified as the single most avoidable cause of drug shortages. 7 Health Consequences Disruptions in the supply of medications have the potential to impact patient care, patient health and the efficiency of the overall health care system. Among the impacts of drug shortages are: - delays in access to needed medication; - delays or disruptions to clinical treatment; - delayed or cancelled surgeries, - loss of therapeutic effectiveness when an appropriate alternate therapy is not available; - increased risk of side effects; - increased non-compliance when changes in medication make it confusing and harder to comply with a new medication regime particularly for those on long term therapy.8 Any and all of these situations can result in a disruption to clinical stability and deterioration, particularly in patients with complex problems. Drug substitution can also result in unintended consequences. In 2010 an Institute of Safe Medication Practices survey of 1800 US health professionals revealed that in one year drug shortages caused over 1000 incidents involving negative side effects or medical errors. 9 In many instances shortages can lead to an increase in the use of the health care system, be it in physician or emergency room visits or treatments. A CMA survey of physicians in September 2012 found that 66% of respondents indicated that drug shortages have gotten worse since 2010 and 64% stated that the shortages have had consequences for their patients or practice. Similarly, the results of the 2012 Canadian Pharmacists Association (CPhA) survey of pharmacists found that over 91% of pharmacists indicated that patients had been inconvenienced by shortages and 51% indicated that patients' care had been compromised.10 Drug shortages also have an impact on the practices of physicians and pharmacists. Sixty seven percent of the respondents to the CMA survey stated that drug shortages do have an impact on their practice most notably by increasing time spent on research or consultation with health professional colleagues to source alternative medicine, increase in length of patient visits due to medication substitution concerns, and increase in time spent on forms such as insurance claims. Seventy six percent of hospital pharmacists and 76 percent of community pharmacists also report an impact on their workload and practice.11 Recommendations Since as early as 2005, the CMA has supported a comprehensive strategy and adequately resourced system for monitoring domestic drug supply. In response to a Health Canada consultation in October 2005 on a report entitled "Developing a Drug Supply Network" CMA recommended that Canada needs such a system to identify shortages and respond quickly to remedy them, and to ensure that policy and regulatory decisions are founded on accurate and reliable knowledge. In March 2011 this position was reinforced in communication with the Government of Canada stating that Canada needs a sustainable, adequately resourced process to identify shortages, rapidly communicate them to health professionals and respond quickly to resolve them. 1. The Canadian Medical Association supports an investigation into the underlying causes of prescription drug shortages in Canada. 2. The Canadian Medical Association recommends the creation of a monitoring unit to track drug production disruptions in Canada and abroad. The communication of information to health professionals once a shortage occurs, or is expected, is critical to their ability to make patient centered decisions and provide continuity of optimum care. CMA has participated on a Multi Stakeholder Working Group on Drug Shortages that has had the pharmaceutical industry and health professional organizations working together to establish a national drug shortage reporting website. CMA provided key input on the needs of needs of physicians to ensure that information required to provide optimum care when managing a drug shortage such as product information including name, manufacturer, formulation, strength, package size, expected duration of shortage, notification that shortage is resolved as well as automatic alerts and search and sort functionality was included on the website. The establishment of the Canadian drug shortage website marks an improvement in the management of drug shortages but significant issues remain. Of great concern are drugs that are 'single sourced'. When there are shortages of single sourced medications there are no clear substitutes. Related to this are the unintended consequences of sole sourcing products from one manufacturer to secure a lower price. This introduces a vulnerability to the marketplace if the sole supplier experiences production disruptions. The 2011 production stoppage at a Sandoz facility in Quebec due to regulatory compliance issues and a subsequent fire in the plant resulted in a scramble to find alternate sources of many essential medications. The CMA supports the development of strategies at the provincial/territorial and federal level to discourage single source purchasing decisions. The inclusion of incentives or penalties for guaranteed supplies, or a contingency plan for supply disruptions should be inserted into purchase contracts. We must be extremely careful not to exacerbate supply problems while trying to address cost issues. 3. The Canadian Medical Association calls for a review of the supply processes in place for drugs and equipment considered essential for medical practice. 4. The Canadian Medical Association supports strategies to discourage single-source purchasing decisions for prescription medications. Advance notice, by manufacturers to Health Canada, of expected drug shortages can provide a window of opportunity for the manufacturer and regulators to work together to resolve production problems or identify alternate supply. We are encouraged by recent initiatives by Health Canada to collect information on planned discontinuances from manufacturers. 5. The Canadian Medical Association calls for the establishment of a legislative framework requiring pharmaceutical companies to provide advance notice of production stoppages and any forecast disruptions in the drug supply. Because of the complexity of the drug supply system, to effectively identify the situations that lead to drug shortages and find Canadian based solutions that can decrease the incidence of shortages or mitigate their impact requires the involvement and cooperation of all players in the process. CMA has consistently asked the government of Canada to work with the provinces and territories, the private sector and health professionals to address this potentially dangerous threat to the lives of Canadian patients. 6. The CMA supports the provinces and territories in their efforts to prevent drug shortages. We are heartened by actions of Health Canada in 2012 to bring together representatives of industry, federal, provincial and territorial governments and health professional associations in a Multi Stakeholder Steering Committee on Drug Shortages to respond to the need for the mitigation of drug shortages. We trust that processes can be put in place and supported by key players to allow Canada to respond in a coordinated, transparent and accountable fashion to future or actual drug shortages. Conclusions Drug Shortages represent an ongoing worry for physicians. The impact on patients, health professionals and the health care system can be significant. Substantial progress has been made since 2011 in terms of gathering and sharing drug shortage information and improving our understanding of the drug supply processes but much still remains to be done. Although complex and challenging, ongoing attention to the issue is required to ensure that Canadians can count on a secure supply of medication into the future. The CMA will continue to represent the best interests of patients and physicians to ensure that Canada's health care system delivers on patient-centered care. References 1 DRUG SHORTAGES FDA's Ability to Respond Should be Strengthened, Statement of Marcie Cross, Director, Health Care, United States Government Accountability Office, Testimony before the Committee on Health, Education, Labor, and Pensions, U.S. Senate, December 15, 2011. 2 FDA is asking the public to send in ideas for combatting drug shortages, FDA Voice, Feb. 13, 2013, U.S. Food and Drug Administration, available at http://blogs.fda.gov/fdavoice/index.php/tag/drug-shortages/ (accessed 2013 April 2). 3 Canadian Drug Shortages Database available at http://www.drugshortages.ca/drugshortages.asp (accessed 2013 April 5). 4 Drug Supply In Canada: A Multi-stakeholder Responsibility, Report of the Standing Committee on Health, 41st Parliament, First session, June 2012. 5 Drug Supply Disruptions, Environmental Scan, Canadian Agency for Drugs and Technologies in Health, Issue 17, March 2011. 6 Canadian Drug Shortages Database available at http://www.drugshortages.ca/drugshortages.asp (accessed 2013April 5). 7 Drug Supply In Canada: A Multi-stakeholder Responsibility, Report of the Standing Committee on Health, 41st Parliament, First session, June 2012. 8 Prescription Drug Shortages, E Panel Survey, Canadian Medical Association, December 2010. 9 Drug Shortages, Recommendations of the Working Group on Drug Shortages, Ordre des Pharmaciens du Québec, March 2012. 10 Impact of Drug Shortages, Member survey, Canadian Pharmacists Association, October 2012. 11 BACKGROUNDER - DRUG SHORTAGES SURVEY, Canadian Pharmacists Association, Canadian Society of Hospital Pharmacists, Canadian Medical Association, January 2013, available at http://www.cma.ca/multimedia/CMA/Content_Images/Inside_cma/Media_Release/2013/Backgrounder-Drug-shortages_en.pdf ( assessed 2013 April 2).
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13 records – page 1 of 2.