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Policies that advocate for the medical profession and Canadians


24 records – page 1 of 3.

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 in animals

https://policybase.cma.ca/en/permalink/policy10534
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-114
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Policy Type
Policy resolution
Last Reviewed
2019-03-03
Date
2012-08-15
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC12-114
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
Text
The Canadian Medical Association supports regulations to severely limit the use of medically important antibiotics on animals being raised for human consumption.
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Bill C-45: The Cannabis Act

https://policybase.cma.ca/en/permalink/policy13861
Date
2018-04-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2018-04-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The CMA is pleased to provide this submission to the Senate Standing Committee, Social Affairs, Science &Technology on Bill C-45, the Cannabis Act. The CMA has long-standing concerns about the health risks associated with consuming cannabis,i particularly in its smoked form.1,2 Children and youth are especially at risk for cannabis-related harms, given their brains are undergoing rapid and extensive development. The CMA's approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA believes that harm reduction encompasses policies, goals, strategies and programs directed at decreasing adverse health, social and economic consequences of drug use for the individual, the community and the society while allowing the user to continue to use drugs, not precluding abstinence.3,4 Specifically, the CMA recommends a multi-faceted cannabis public health strategy that prioritizes impactful and realistic goals before, and certainly no later than, any legalization of cannabis.5 We propose that the first goal should be to develop educational interventions for children, teenagers and young adults. Other goals relate to data collection; monitoring and surveillance; ensuring a proportionate balance between enforcement harms and the direct and indirect harms caused by cannabis use; and research. There is an ongoing need for research into the medicinal and harmful effects of cannabis use. As noted by the Lower-Risk Cannabis Use Guidelines, 6 there is limited evidence on such subjects as synthetic cannabinoids; practices like "deep inhalation" to increase the psychoactive effects of cannabis; and the combination of risky behaviours, like early-onset and frequent use, associated with experiencing acute or chronic health problems.6 Since 2002, the CMA has taken a public health perspective regarding cannabis and other illegal drugs. More recently, the CMA endorsed the Lower-Risk Cannabis Use Guidelines, and we submitted 22 recommendations to the Task Force on Cannabis Legalization and Regulation ("the Task Force").7 Overview According to the recent Canadian Tobacco, Alcohol and Drugs Survey, cannabis is the most used illicit drug in Canada.8 In particular, 25%-30% of adolescents or youth report past-year cannabis use.9 This concerns the CMA. The increasing rate of high usage, despite the fact that non-medical use of cannabis is illegal, coupled with cannabis' increased potency (from 2% in 1980 to 20% in 2015 in the United States),10 the complexity and versatility of the cannabis plant,ii the variable quality of the end product, and variations in the frequency, age of initiation and method of use make it difficult to study the full health impacts and produce replicable, reliable scientific results. The CMA submits, therefore, that any legalization of cannabis for non-medical use must be guided by a comprehensive cannabis public health strategy and include a strong legal-regulatory framework emphasizing harm reduction principles. Given that the Task Force employed a minimizing of harms approach11 and given how the proposed legislation aligns with the Task Force's recommendations,12 the bill addresses several aspects of a legal-regulatory framework "to provide legal access to cannabis and to control and regulate its production, distribution and sale."13 This work provides the starting point for creating a national cannabis public health strategy. The CMA has long called for a comprehensive drug strategy that addresses addiction, prevention, treatment, enforcement and harm reduction.3 There are, however, key public health initiatives that the Canadian government has not adequately addressed and should be implemented before, or no later than, the implementation of legislation. One such initiative is education. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. Supporting a Legal-Regulatory Framework that Advances Public Health and Protection of Children and Youth From a health perspective, allowing any use of cannabis by people under 25 years of age, and certainly those under 21 years of age, is challenging for physicians given the effects on the developing brain.1,3,14 The neurotoxic effect of cannabis, especially with persistent use, on the adolescent brain is more severe than on the adult brain.15,16 Further, neurological studies have shown that adolescent-onset cannabis use produces greater deficits in executive functioning and verbal IQ and greater impairment of learning and memory than adult-onset use.17,18 This underscores the importance of protecting the brain during development. Since current scientific evidence indicates that brain development is not completed until about 25 years of age,19 this would be the ideal minimum age for legal cannabis use. Youth and young adults are among the highest users of cannabis in Canada. Despite non-medical use of cannabis being illegal in Canada since 1923, usage has increased over the past few decades. The CMA recognizes that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach.3 Harm reduction is not one of polarities rather it is about ensuring the quality and integrity of human life and acknowledging where the individual is at within his/her community and society at large.5 The possibility that a young person might incur a lifelong criminal record for periodic use or possession of small amounts of cannabis for personal use means that the long-term social and economic harms of cannabis use can be disproportionate to the drug's physiological harm. The Canadian government has recognized this disproportionality for over 15 years. Since 2001, there have been two parliamentary committee reportsiii and two billsiv introduced to decriminalize possession of small amounts of cannabis (30 g). It was recommended that small amounts of cannabis possession be a "ticketable" offence rather than a criminal one. Given all of the above, the CMA recommends that the age of legalization should be 21 years of age and that the quantities and the potency of cannabis be more restricted to those under age 25. Supporting a Comprehensive Cannabis Public Health Strategy with a Strong, Effective Education Component The CMA recognizes that Bill C-45 repeals the prohibition against simple possession while increasing penalties against the distribution and sale of cannabis to young people, but this is not enough to support a harm reduction approach. We note that the Federal Tobacco Control Strategy, with its $38 million budget, is intended to help reduce smoking rates and change Canadians' perceptions toward tobacco.20 Similarly, there are extensive education programs concerning the dangers of alcohol, particularly for young people.v The government of Canada has proposed a modest commitment of $9.6 million to a public awareness campaign to inform Canadians, especially youth, of the risks of cannabis consumption, and to surveillance activities.21 A harm reduction strategy should include a hierarchy of goals with an immediate focus on groups with pressing needs. The CMA submits that young people should be targeted first with education. The lifetime risk of dependence to cannabis is estimated at 9%, increasing to almost 17% in those who initiate use in adolescence.22 In 2012, about 1.3% of people aged 15 years and over met the criteria for cannabis abuse or dependence - double the rate for any other drug - because of the high prevalence of cannabis use.23 The strategy should include the development of educational interventions, including skills-based training programs, social marketing interventions and mass media campaigns. Education should focus not only on cannabis' general risks but also on its special risks for the young and its harmful effects on them. This is critical given that for many, the perception is that (i) legalization of possession for both adults and young people translates into normalization of use and (ii) government control over the source of cannabis for sale translates into safety of use. Complicating this has been the fear-mongering messaging associated with illegal drugs. The evidence shows that fewer adolescents today believe that cannabis use has any serious health risks24 and that enforcement policies have not been a deterrent.25 Having an appropriate education strategy rolled out before legalization of possession would reduce the numbers of uninformed young recreational users. It would also provide time to engage in meaningful research on the impact of the drug on youth. Such strategies have been successful in the past; for example, the long-termvi Federal Tobacco Control Strategy has been credited with helping reduce smoking rates to an all-time low in Canada.26 The Lower-Risk Cannabis Use Guidelines were developed as a "science-based information tool for cannabis users to modify their use toward reducing at least some of the health risks."6 The CMA urges the government to support the widespread dissemination of this tool and incorporation of its messages into educational efforts. Other strategies must include plain packaging and labelling with health information and health warnings. Supporting a One-System Approach. Alternatively, a Review of Legislation in Five Years The CMA believes that once the act is in force, there will be little need for two systems (i.e., one for medical and one for non-medical cannabis use). Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization (some people may self-medicate with cannabis to alleviate symptoms but may be reluctant to raise the issue with their family physician for fear of being stigmatized), and for those who wish to use it for other purposes. The medical profession does not need to continue to be involved as a gatekeeper once cannabis is legal for all, especially given that cannabis has not undergone Health Canada's usual pharmaceutical regulatory approval process. The Task Force's discussion reflects the tension it heard between those who advocated for one system and those who did not. One concern raised by patients was about the stigma attached to entering retail outlets selling non-medical cannabis. The CMA submits that this concern would be alleviated if the federal government continued the online purchase and mail order system that is currently in place. Given that there is a lack of consensus and insufficient data to calculate how much of the demand for cannabis will be associated with medical authorization, the Task Force recommended that two systems be established, with an obligation to review - specifically, a program evaluation of the medical access framework in five years.11 If there are two systems, then in the alternative, the CMA recommends a review of the legislation within five years. This would allow time to ensure that the provisions of the act are meeting their intended purposes, as determined by research on the efficacy of educational efforts and other research. Five-year legislative reviews have been previously employed, especially where legislation must balance individual choice with protecting public health and public safety.vii For example, like Bill C-45, the purpose of the Controlled Drugs and Substances Act is to protect public health and public safety.27 Its review within five years is viewed as allowing for a thorough, evidence-based analysis to ensure that the provisions and operations of the act are meeting their intended purpose(s).viii Furthermore, a harm reduction approach lends itself to systematic evaluation of the approach's short- and long-term impact on the reduction of harms.5 The CMA, therefore, submits that if a two-system approach is implemented when the legislation is enacted, the legislation should be amended to include the requirement for evaluation within five years of enactment. Criteria for evaluation may include the number of users in the medical system and the number of physicians authorizing medical cannabis use. The CMA would expect to be involved in the determination of such criteria and evaluation process. Conclusion Support has risen steadily in Canada and internationally for the removal of criminal sanctions for simple cannabis possession, as well as for the legalization and regulation of cannabis' production, distribution and sale. The CMA has long-standing concerns about the health risks associated with consuming cannabis, especially by children and youth in its smoked form. Weighing societal trends against the health effects of cannabis, the CMA supports a broad legal-regulatory framework as part of a comprehensive and properly sequenced public health approach of harm reduction. Recommendations 1. The CMA recommends that the legalization age be amended to 21 years of age, to better protect the most vulnerable population, youth, from the developmental neurological harms associated with cannabis use. 2. The CMA recommends that a comprehensive cannabis public health strategy with a strong, effective health education component be implemented before, and no later than, the enactment of any legislation legalizing cannabis. 3a. The CMA recommends that there be only one regime for medical and non-medical use of cannabis, with provisions for the medical needs of those who would not be able to acquire cannabis in a legal manner (e.g., those below the minimum age). 3b. Alternatively, the CMA recommends that the legislation be amended to include a clause to review the legislation, including a review of having two regimes, within five years. i The term cannabis is used as in Bill C-45: that is, referring to the cannabis plant or any substance or mixture that contains any part of the plant. ii The plant contains at least 750 chemicals, of which there are over 100 different cannabinoids. Madras BK. Update of cannabis and its medical use. Agenda item 6.2. 37th Meeting of the Expert Committee on Drug Dependence, Department of Essential Medicines and Health Products, World Health Organization; 2015. Available: www.who.int/medicines/access/controlled-substances/6_2_cannabis_update.pdf (accessed 2017 Jul 27). iii House of Commons Special Committee on the Non-Medical Use of Drugs (2001) and the Senate Special Committee on Illegal Drugs (2002). iv An Act to amend the Contraventions Act and the Controlled Drugs and Substances Act (Bill C-38), which later was reintroduced as Bill C-10 in 2003. v For example, the Substance Use and Addictions Program (SUAP), a federal contributions program, is delivered by Health Canada to strengthen responses to drug and substance use issues in Canada. See Government of Canada. Substance Use and Addictions Program. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/services/health/campaigns/canadian-drugs-substances-strategy/funding/substance-abuse-addictions-program.html (accessed 2017 Jul 27). vi The Federal Tobacco Control Strategy was initiated in 2001 for 10 years and renewed in 2012 for another five years. vii Several federal acts contain review provisions. Some examples include the Controlled Drugs and Substances Act, SC b1996, c 19, s 9 (five-year review); the Preclearance Act, SC 1999, c 20, s 39 (five-year review); the National Defence Act, RSC 1985, c N-5, s 273.601(1) (seven-year review); the Public Servants Disclosure Protection Act, SC 2005, c 46, s 54 (five-year review); and the Red Tape Reduction Act, SC 2015, c 12 (five-year review). viii The 2012 amendments to the Controlled Drugs and Substances Act were adopted from Bill S-10, which died on order papers in March 2011. The Senate Standing Committee on Legal and Constitutional Affairs reviewed Bill S-10 and recommended that the review period should be extended from two to five years as two years is not sufficient to allow for a comprehensive review. See Debates of the Senate, 40th Parliament, 3rd Session, No 147:66 (2010 Nov 17) at 1550; see also Senate Standing Committee on Legal and Constitutional Affairs, Eleventh Report: Bill S-10, An Act to Amend the Controlled Drugs and Substances Act and to Make Related and Consequential Amendments to Other Acts, with Amendments (2010 Nov 4). 1 Canadian Medical Association. Health risks and harms associated with the use of marijuana. CMA submission to the House of Commons Standing Committee on Health. Ottawa: The Association; 27 May 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2017 Jul 27). 2 Canadian Medical Association. A public health perspective on cannabis and other illegal drugs. CMA submission to the Special Senate Committee on Illegal Drugs. Ottawa: The Association; 11 Mar 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association. Bill C-2 An Act to Amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the House of Commons Standing Committee on Public Safety and National Security. Ottawa: The Association; 28 Oct 2014. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/CMA_Brief_C-2_Respect%C3%A9-for_Communities_Act-English.pdf (accessed 2017 Jul 27). 4 Harm Reduction International. What is harm reduction? A position statement from Harm Reduction International. London, UK: Harm Reduction International; 2017. Available: www.hri.global/what-is-harm-reduction (accessed 2017 Jul 27). 5 Riley D, O'Hare P. Harm reduction: history, definition and practice. In: Inciardi JA, Harrison LD, editors. Harm reduction: national and international perspectives. Thousand Oaks, CA: Sage Publications; 2000. 6 Fischer B, Russel C, Sabioni P, et al. Lower-risk cannabis use guidelines: a comprehensive update of evidence and recommendations. Am J Public Health 2017;107(8):e1-e12. 7 Canadian Medical Association. Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada - Task Force on Cannabis Legalization and Regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 8 Government of Canada. Canadian Tobacco, Alcohol and Drugs Survey (CTADS): 2015 summary. Ottawa: Government of Canada; 2017. Available: www.canada.ca/en/health-canada/services/canadian-tobacco-alcohol-drugs-survey/2015-summary.html (accessed 2017 Jul 27). 9 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS): summary of results for 2012. Ottawa: Health Canada; 2014. Available: www.canada.ca/en/health-canada/services/health-concerns/drug-prevention-treatment/drug-alcohol-use-statistics/canadian-alcohol-drug-use-monitoring-survey-summary-results-2012.html (accessed 2017 Jul 27). 10 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: http://apps.who.int/iris/bitstream/10665/251056/1/9789241510240-eng.pdf?ua=1 (accessed 2017 Jul 27). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. 12 Government of Canada. Legislative background: an Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts (Bill C-45). Ottawa: Government of Canada; 2017. 13 An Act respecting cannabis and to amend the Controlled Drugs and Substances Act, the Criminal Code and other Acts, Bill C-45, First Reading 2017 Apr 13. 14 Crean RD, Crane NA, Mason BJ. An evidence based review of acute and long-term effects of cannabis use on executive cognitive functions. J Addict Med 2011;5(1):1-8. 15 Meier MH, Caspi A, Ambler A, et al. Persistent cannabis users show neuropsychological decline from childhood to midlife. Proc Natl Acad Sci USA 2012;109(40):E2657-64 16 Crépault JF, Rehm J, Fischer B. The cannabis policy framework by the Centre for Addiction and Mental Health: a proposal for a public health approach to cannabis policy in Canada. Int J Drug Policy 2016;34:1-4. 17 Pope HG Jr, Gruber AJ, Hudson JI, et al. Early-onset cannabis use and cognitive deficits: What is the nature of the association? Drug Alcohol Depend 2003;69(3):303-310. 18 Gruber SA, Sagar KA, Dahlgren MK, et al. Age of onset of marijuana use and executive function. Psychol Addict Behav 2011;26(3):496-506. 19 National Academies of Sciences, Engineering, and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington (DC): The National Academies Press; 2017. 20 Canadian Cancer Society. 2017 federal pre-budget submission. Canadian Cancer Society submission to the Standing Committee on Finance. 2014 Aug. Available: www.ourcommons.ca/Content/Committee/421/FINA/Brief/BR8398102/br-external/CanadianCancerSociety-e.pdf (accessed 2017 Jul 27). 21 Health Canada. Backgrounder: legalizing and strictly regulating cannabis: the facts. Ottawa: Health Canada; 2017. Available: www.canada.ca/en/health-canada/news/2017/04/backgrounder_legalizingandstrictlyregulatingcannabisthefacts.html (accessed 2017 Jul 27) 22 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. Lancet 2009;374(9698):1383-91. 23 Statistics Canada. Canadian Community Health Survey: Mental Health, 2012. The Daily. 2013 Sep 18. Statistics Canada cat. No. 11-001-X. Available: www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2017 Jul 27). 24 Miech RA, Johnston LD, O'Malley PM, Bachman JG, Schulenberg, JE. Monitoring the future national survey results on drug use, 1975-2010. Vol 1: Secondary students. Ann Arbor: Institute for Social Research, University of Michigan; 2011. 25 Spithoff S, Kahan M. Cannabis and Canadian youth: evidence, not ideology. Can Fam Physician 2014;60(9):785-7. 26 Health Canada. Strong foundation, renewed focus: an overview of Canada's Federal Tobacco Control Strategy 2012-2017. Ottawa: Health Canada; 2012. Available: www.canada.ca/content/dam/canada/health-canada/migration/healthy-canadians/publications/healthy-living-vie-saine/tobacco-strategy-2012-2017-strategie-tabagisme/alt/tobacco-strategy-2012-2017-strategie-tabagisme-eng.pdf (accessed 2017 Jul 27). 27 Controlled Drugs and Substances Act, SC 1996, c 19, s 9.
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CMA Presentation to the Senate Standing Committee on Social Affairs, Science and Technology - Prescription Drugs: Clinical Trials and Approval

https://policybase.cma.ca/en/permalink/policy10437
Date
2012-05-09
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-05-09
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Good afternoon. My name is Dr. Maura Ricketts and I am the Director of Public Health for the Canadian Medical Association. The CMA appreciates the opportunity to appear before this Committee today as part of your study of clinical trials and drug approvals. The CMA represents more than 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with all Canadians, for the highest standards of health and health care. Because prescription drugs are an essential component of health care, the CMA has developed a considerable body of policy on pharmaceutical issues. This work can be distilled into one fundamental principle: The CMA believes that our country requires a National Pharmaceutical Strategy to ensure every individual has timely access to safe, effective and affordable prescription drugs. Despite the commitment in the 2004 Health Accord to the creation of such a strategy, Canadians continue to wait for government leadership on this issue. Drugs replace more costly and invasive medical interventions. They are an essential tool in the physician's tool box. To ensure safety and effectiveness, the CMA also believes in the need for a strong, unbiased, evidence-based system for research and approval. This is at the heart of our commitment to patient-centred care. In evaluating whether to prescribe a new drug to a patient, a physician will weigh several factors: Does this product offer any benefits over what I am prescribing now? Will it be more effective? Will this new drug be safer? Will it solve any tricky clinical problems, such as drug interactions, or reduce side effects that prevent a medication from being used properly? The physician may also ask: What is the evidence that this new drug is an improvement? Can I trust the evidence? Where can I get access to accurate, reliable information and data on this drug? Pre-approval drug research must provide answers to these fundamental questions. Clinical Trials I will now focus on two particular issues of concern to practising physicians with regard to clinical trials: * First, what is being compared to what? Clinical trials may be sufficient for Health Canada's regulatory purposes, but may provide only part of the information a physician needs. For example, is a new cholesterol drug effective on all patients, or only on some of them? Would other patients derive equal benefit from an already existing drug, or from a lifestyle change such as diet or exercise? The CMA recommends that researchers compare a new product to other drugs on the market - and to other interventions, as well. * Second, is timely, reliable and objective information available on all clinical trial results, not just the positive ones? Canadians need to be informed when a drug has performed disappointingly in trials if they are to make informed decisions about their health care. The CMA, therefore, recommends the results of all clinical trials, not just those with positive results, be made available to health professionals and the public. I would like to add that the current documentation is not very user-friendly. We recommend that Health Canada prepare summaries of the most essential data, not only for physicians, but for all Canadians to be able to access this information. The Drug Approval Process Turning now to the drug approval process, the CMA believes the following principles should apply: * The primary criteria for approval should be whether the drug improves health outcomes and offers an improvement over products currently on the market. * The review process should be as timely as is consistent with ensuring optimal health outcomes and the safety of the drug supply. * The review process should be impartial and founded on the best available scientific evidence. * The review process should be open and transparent. * Finally, approval of a drug is not an endpoint, but rather one step in that drug's life cycle. It is not uncommon to identify serious safety hazards after a drug has been approved, because that's when it first goes into wide use. It is important that the approval process be complemented by a rigorous and vigilant post-market surveillance process. We look forward to presenting our recommendations on this subject to your Committee at a future session. Before closing, I would like to briefly address two other matters: First, the issue of drugs for rare disorders. We are aware that the current clinical trial and approval processes, which place a high value on studies with large population samples, may be unable to adequately capture the value of drugs that are prescribed to only a handful of people. Some patient groups active in the area of rare disorders, such as the Canadian MPS Society and Alpha-1 Canada, have shared their concerns about this with us. These groups, along with the Canadian Organization for Rare Disorders, have been advocating for years for a fair process for evaluating drugs for rare diseases. Because Canada doesn't have a rare disorders strategy, Canadian patients have access to fewer therapies than patients in other developed countries. The issue of how to approve drugs for rare disorders merits closer consideration. The CMA recommends that the federal government develop a policy on drugs for rare disorders that encourages their development, call for ongoing evaluation of their effectiveness, and ensures fairness so that all patients who might benefit have reasonable access to them. The second matter is that Health Canada's review process provides little guidance on another question which physicians are increasingly asking: Can my patient afford this drug? It is not sufficient that the Common Drug Review conducts reviews of the cost effectiveness of drugs and that provincial/territorial formularies undertake similar studies, as the fact remains that cost is one of the factors physicians need to consider when deciding whether to prescribe a new drug. This is especially true in the case of new biologics, which are very expensive. Canadian doctors believe that the difficulty of making effective prescribing decisions without information about cost needs to be overcome. This only underscores the necessity of a National Pharmaceutical Strategy. Thank you. We would be happy to answer your questions.
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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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CMA’s Recommendations for Bill S-5 An Act to amend the Tobacco Act and the Non-smokers’ Health Act and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy13918
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2018-02-15
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Health care and patient safety
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Standing Committee on Health for its study of Bill S-5, An Act to amend the Tobacco Act and the Non-Smokers Health Act and to make consequential amendments to other Acts. We support the government’s effort to implement a new legislative and regulatory framework to address vaping products and related matters. Vaping products, such as electronic cigarettes (or e-cigarettes) replicate the act and taste of smoking but do not contain tobacco. We also recognize that the federal government is attempting to find a balance between regulating vaping devices and making them available to adults. Canada’s physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. Our most recent efforts centred on our participation in the 2016 Endgame Summit, held late last year in Kingston, Ontario. This brief will focus on three areas: supporting population health; the importance of protecting youth; and, the promotion of vaping products. Overview Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Smoking has been on the decline in Canada the most recent Canadian Community Health Survey reports that 17.7% of the population aged 12 and older were current daily or occasional smokers in 2015 (5.3 million smokers); that is down from 18.1% in 2014.1 Many strong laws and regulations have already been enacted but some areas remain to be addressed and strengthened especially as the 1 Statistics Canada. Smoking, 2015. Health Fact Sheets. Statistics Canada Cat. 82-625-X. Ottawa: Statistics Canada; 2016. Available: http://www.statcan.gc.ca/pub/82-625-x/2017001/article/14770-eng.htm (accessed 2018 Feb 1). 2 Czoli CD, Hammond D, White CM. Electronic cigarettes in Canada: Prevalence of use and perceptions among youth and young adults. Can J Public Health. 2014;105(2):e97-e102. 3 Filippos FT, Laverty AA, Gerovasili V, et al. Two-year trends and predictors of e-cigarette use in 27 European Union member states. Tob Control. 2017;26:98-104. 4 Malas M, van der Tempel J, Schwartz R, Minichiello A, Lightfoot C, Noormohamed A, et al. Electronic cigarettes for smoking cessation: A systematic review. Nicotine Tob Res. 2016;18(10):1926–36. 5 O’Leary R, MacDonald M, Stockwell T, Reist D. Clearing the air: A systematic review on the harms and benefits of e-cigarettes and vapour devices. Victoria, BC: Centre for Addictions Research of BC; 2017. Available: http://ectaofcanada.com/clearing-the-air-a-systematic-review-on-the-harms-and-benefits-of-e-cigarettes-and-vapour-devices/ (accessed 2018 Feb 1). 6 El Dib R, Suzumura EA, Akl EA, Gomaa H, Agarwal A, Chang Y, et al. Electronic nicotine delivery systems and/or electronic non-nicotine delivery systems for tobacco smoking cessation or reduction: a systematic review and meta-analysis. BMJ Open. 2017 23;7:e012680. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5337697/pdf/bmjopen-2016-012680.pdf (accessed 2018 Feb 1). 7 Shahab L, Goniewicz M, Blount B, et al. Nicotine, carcinogen, and toxin exposure in long-term e- cigarette and nicotine replacement therapy users: A cross sectional study. Annals of Internal Medicine. 2017;166(6):390-400. 8 Collier R. E-cigs have lower levels of harmful toxins. CMAJ. 2017 Feb 27;189:E331. 9 Sleiman M, Logue J, Montesinos VN, et al. Emissions from electronic cigarettes: Key parameters affecting the release of harmful chemicals. Environmental Science and Technology. 2016 Jul 27;50(17):9644-9651. 10 England LJ, Bunnell RE, Pechacek TF, Tong VT, McAfee TA. Nicotine and the developing human: A neglected element in the electronic cigarette debate. Am J Prev Med. 2015 Aug;49(2):286-93. 11 Foulds J. Use of Electronic Cigarettes by Adolescents. J Adolesc Health. 2015 Dec;57(6):569-70. 12 Khoury M, Manlhiot C, Fan CP, Gibson D, Stearne K, Chahal N, et al. Reported electronic cigarette use among adolescents in the Niagara region of Ontario. CMAJ. 2016 Aug 9;188(11):794-800. 13 U.S. National Cancer Institute and World Health Organization. The Economics of Tobacco and Tobacco Control. National Cancer Institute Tobacco Control Monograph 21. NIH Publication No. 16-CA- 8029A. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute; and Geneva, CH: World Health Organization; 2016. 14 Miech R, Patrick ME, O’Malley PM, Johnston LD. E-cigarette use as a predictor of cigarette smoking: results from a 1-year follow-up of a national sample of 12th grade students. Tob Control. 2017 Dec;26(e2):e106–11. 15 Primack BA, Soneji S, Stoolmiller M, Fine MJ, Sargent JD. Progression to traditional cigarette smoking after electronic cigarette use among US adolescents and young adults. JAMA Pediatr. 2015 Nov;169(11):1018–23. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800740/pdf/nihms768746.pdf (accessed 2018 Feb 1). 16 Hoe J, Thrul J, Ling P. Qualitative analysis of young adult ENDS users’ expectations and experiences. BMJ Open. 2017;7:e014990. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5353280/pdf/bmjopen-2016-014990.pdf (accessed 2018 Feb 1). 17 Fairchild AL, Bayer R, Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco “endgame.” N Engl J Med. 2014 Jan 23;370:4 Available: http://www.nejm.org/doi/pdf/10.1056/NEJMp1313940 (accessed 2018 Feb 1). 18 Choi K, Grana R, Bernat D. Electronic nicotine delivery systems and acceptability of adult cigarette smoking among Florida youth: Renormalization of smoking? J Adolesc Health. 2017 May;60(5):592–8. tobacco industry continues to evolve. Electronic cigarettes and vaping represents the next step in that evolution. While Canada is to be congratulated on its success to date, it needs to maintain an environment that encourages Canadians to remain tobacco-free if smoking prevalence is to be reduced further in Canada. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Supporting Population Health The arrival of vaping products in Canada placed them in a “grey zone” with respect to legislation and regulation. Clarification of their status is crucial from a public health perspective because of their growing popularity, particularly among youth.2 E-cigarettes have both defenders and opponents. Proponents say they are safer than tobacco cigarettes since they do not contain the tar and other toxic ingredients that are the cause of tobacco related disease. Indeed, some believe they serve a useful purpose as a harm reduction tool or cessation aid (though it is forbidden to market them as such since that claim has never been approved by Health Canada). Opponents are concerned that the nicotine delivered via e-cigarettes is addictive and that the cigarettes may contain other toxic ingredients such as nitrosamines. Also, they worry that acceptance of e-cigarettes will undermine efforts to de-normalize smoking, and that they may be a gateway to the use of tobacco by people who might otherwise have remained smoke-free. This issue will be addressed later in this brief. This difference of opinion certainly highlights the need for more research into the harms and benefits of vaping products and the factors that cause people to use them.3 Encouraging smokers to move from combustible tobacco products to a less harmful form of nicotine may be a positive step. However the current available evidence is not yet sufficient to establish them as a reliable cessation method. A systematic review published by M. Malas et al. (2016) concluded that while “a majority of studies demonstrate a positive relationship between e-cigarette use and smoking cessation, the evidence remains inconclusive due to the low quality of the research published to date.”4 Indeed, some are helped by these devices to quit smoking but “more carefully designed and scientifically sound studies are urgently needed to establish unequivocally the long-term cessation effects of e-cigarettes and to better understand how and when e-cigarettes may be helpful.”4 The authors found that the evidence examining e-cigarettes as an aid to quitting smoking was determined to be “very low to low.”4 A similar result was found for their use in reducing smoking; the quality of the evidence was revealed as being “very low to moderate.”4 This conclusion is supported by another review conducted by the University of Victoria (2017). It too indicates that there are not enough studies available to fully determine the efficacy of vaping devices as a tobacco cessation device.5 This review also noted that there is “encouraging evidence that vapour devices can be at least as effective as other nicotine replacements.”5 Another review by R. El Dib et al. (2017) reinforces these findings. Limited evidence was also found with respect to the impact of electronic devices to aide cessation. They also noted that the data available from randomized control trials are of “low certainty” and the “observational studies are of very low certainty.”6 The wide range of devices available makes it very difficult to test which are the most effective in helping cessation efforts. Many of the studies are on older devices so it is possible that as second-generation technology becomes available they will prove to be more successful. In view of this uncertainty, the CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. Physicians need to be confident that if they recommend such therapy to their patients it will have the desired outcome. To that end, we are pleased that Health Canada will continue to require manufacturers to apply for authorization under the Food and Drugs Act to sell products containing nicotine and make therapeutic claims. Risk and Safety In addition to the discussion concerning the usefulness of vaping devices as cessation devices, concerns from a public health standpoint involve the aerosol or vapour produced by heating the liquids used in these devices, and the nicotine some may contain. The tube of an e-cigarette contains heat-producing batteries and a chamber holding liquid. When heated, the liquid is turned into vapour which is drawn into the lungs. Ingredients vary by brand but many contain nicotine and/or flavourings that are intended to boost their appeal to young people. The CMA is concerned that not enough is known about the safety of the ingredients in the liquids being used in vaping devices. While it is the case that because e-cigarettes heat rather than burn the key constituent, they produce less harmful toxins and are much safer than conventional cigarettes. Research in the UK suggested that “long-term Nicotine Replacement Therapy (NRT)-only and e-cigarette-only use, but not dual-use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes.”7 However, this study has been criticized because “it only looked at a few toxins and didn’t test for any toxins that could be produced by e- cigarettes.”8 The variety of flavourings and delivery systems available make it imperative that the risks associated with these products be fully understood. As one study noted “analysis of e-liquids and vapours emitted by e-cigarettes led to the identification of several compounds of concern due to their potentially harmful effects on users and passively exposed non-users.”9 The study found that the emissions were associated with both cancer and non-cancer health impacts and required further study.9 There is another aspect of the public health question surrounding vaping devices. There is data to support the idea that “nicotine exposure during periods of developmental vulnerability (e.g., fetal through adolescent stages) has multiple adverse health consequences, including impaired fetal brain and lung development.”10 Therefore it is imperative that pregnant women and youth be protected. There is not enough known about the effects of long-term exposure to the nicotine inhaled through vaping devices at this time.11 Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. Protecting Youth The CMA is encouraged by the government’s desire to protect youth from developing nicotine addiction and inducements to use tobacco products. Young people are particularly vulnerable to peer pressure, and to tobacco industry marketing tactics. The CMA supports continued health promotion and social marketing programs aimed at addressing the reasons why young people use tobacco and have been drawn to vaping devices, discouraging them from starting to use them and persuading them to quit, and raising their awareness of tobacco industry marketing tactics so that they can recognize and counteract them. These programs should be available continuously in schools and should begin in the earliest grades. The “cool/fun/new” factor that seems to have developed around vaping devices among youth make such programs all the more imperative.12 The CMA recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. We are pleased to see that Bill S-5 aims to restrict access to youth, including prohibiting the sale of both tobacco and vaping products in vending machines as well as prohibiting sales of quantities that do not comply with the regulations. In fact, the CMA recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. The more restricted is availability, the easier it is to regulate. The CMA considers prohibiting the promotion of flavours in vaping products that may appeal to youth, such as soft drinks and cannabis, to be a positive step. A recent report published by the World Health Organization and the US National Cancer Institute indicated that websites dedicated to retailing e-cigarettes “contain themes that may appeal to young people, including images or claims of modernity, enhanced social status or social activity, romance, and the use of e-cigarettes by celebrities.”13 We are therefore pleased that sales of vaping products via the internet will be restricted through prohibiting the sending and delivering of such products to someone under the age of 18. This will be critical to limiting the tobacco industry’s reach with respect to youth. There have also been arguments around whether vaping products will serve as gateways to the use of combusted tobacco products. The University of Victoria (2017) paper suggests this isn’t the case; it notes that “there is no evidence of any gateway effect whereby youth who experiment with vapour devices are, as a result, more likely to take up tobacco use.”5) They base this on the decline in youth smoking while rates of the use of vaping devices rise.Error! Bookmark not defined. Others contend that vaping is indeed a gateway, saying it acts as a “one-way bridge to cigarette smoking among youth. Vaping as a risk factor for future smoking is a strong, scientifically-based rationale for restricting access to e-cigarettes.”14 Further, in a “national sample of US adolescents and young adults, use of e-cigarettes at baseline was associated with progression to traditional cigarette smoking. These findings support regulations to limit sales and decrease the appeal of e- cigarettes to adolescents and young adults.”15 However, there may be a role for vaping products in relation to young users. A New Zealand study conducted among young adults that examined how electronic nicotine delivery systems (ENDS) were used to recreate or replace smoking habits. It found that study participants “used ENDS to construct rituals that recreated or replaced smoking attributes, and that varied in the emphasis given to device appearance.”16 Further, it was suggested that ascertaining how “ENDS users create new rituals and the components they privilege within these could help promote full transition from smoking to ENDS and identify those at greatest risk of dual use or relapse to cigarette smoking.”16 The CMA believes that further research is needed on the question of the use of vaping products as a gateway for youth into combustible tobacco products. Recommendations: 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. Promotion of Vaping Products The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words “this product is injurious to your health” printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” The CMA would like to see the proposed plain packing provisions for tobacco be extended to vaping products as well. The inclusion of the health warning messages on vaping products is a good first step but efforts should be made to ensure that they are of similar size and type as those on tobacco as soon as possible. The restrictions being applied to the promotion of vaping products is a positive step, especially those that could be aimed at youth, but they do not go far enough. The CMA believes the restrictions on promotion should be the same as those for tobacco products. As the WHO/U.S. National Cancer Institute has already demonstrated, e- cigarette retailers are very good at using social media to promote their products, relying on appeals to lifestyle changes to encourage the use of their products. The CMA is also concerned that e-cigarette advertising could appear in locations and on mediums popular with children and youth if they are not prohibited explicitly in the regulations. This would include television and radio advertisements during times and programs popular with children and youth, billboards near schools, hockey arenas, and on promotional products such as t-shirts and ball caps. As efforts continue to reduce the use of combustible tobacco products there is growing concern that the rising popularity of vaping products will lead to a “renormalization” of smoking. In fact, worry has been expressed that the manner they have been promoted “threaten(s) to reverse the successful, decades-long public health campaign to de- normalize smoking.”17 A recent US study indicated that students that use vaping products themselves, exposure to advertising of these devices, and living with other users of vaping products is “associated with acceptability of cigarette smoking, particularly among never smokers.”18 Further research is needed to explore these findings. Recommendations: 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products. Conclusion Tobacco is an addictive and hazardous product, and a leading cause of preventable disease and death in Canada. Our members see the devastating effects of tobacco use every day in their practices and to that end the CMA has been working for decades toward the goal of a smoke-free Canada. The tobacco industry continues to evolve and vaping represents the next step in that evolution. The CMA believes it is incumbent on all levels of government in Canada to keep working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve that goal. Bill S-5 is another step in that journey. Researchers have identified potential benefits as well as harms associated with these products that require much more scrutiny. The association of the tobacco industry with these products means that strong regulations, enforcement, and oversight are needed. Recommendations: 1) Given the scarcity of research on e-cigarettes the Canadian Medical Association calls for ongoing research into the potential harms of electronic cigarette use, including the use of flavourings and nicotine. 2) The CMA calls for more scientific research into the potential effectiveness and value of these devices as cessation aids.. 3) The Canadian Medical Association supports efforts to expand smoke-free policies to include a ban on the use of electronic cigarettes in areas where smoking is prohibited. 4) The Canadian Medical Association recommends a ban on the sale of all electronic cigarettes to Canadians younger than the minimum age for tobacco consumption in their province or territory. 5) The Canadian Medical Association calls for ongoing research into the potential harms and benefits of electronic cigarette use among youth. 6) The Canadian Medical Association recommends tightening the licensing system to limit the number of outlets where tobacco products, including vaping devices, can be purchased. 7) The Canadian Medical Association recommends similar plain packaging provisions proposed for tobacco be extended to vaping products. 8) Health warning messages on vaping products should be of similar size and type as those on tobacco as soon as possible 9) The Canadian Medical Association believes the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.
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CMA's Submission to the House of Commons Standing Committee on Health: Drug Shortages

https://policybase.cma.ca/en/permalink/policy10382
Date
2012-03-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-03-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission to the House of Commons Health Committee for consideration as part of its study on drug supply in Canada. The severe impact of the disruption in production at one pharmaceutical company's manufacturing facility has demonstrated the significant shortcomings in how drug shortages are managed in Canada. This submission focuses on what is needed to ensure Canada's health care system delivers patient-centred care. In order to deliver the best possible care to patients, physicians require timely, comprehensive and accurate information about current and anticipated drug supply shocks and constraints. With this objective in mind, we have provided input to the government and to the pharmaceutical industries. Further, Canada requires an uninterrupted supply of medically necessary medication for patients. Impacts on Patients and the Health Care System Canada's doctors are deeply concerned about the persistent shortages of drugs that they and their patients are encountering. Prescription drugs can prevent serious disease, reduce hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Pharmaceuticals benefit the health care system by reducing costs in other areas such as hospital stays and disability payments. Disruptions in the supply of pharmaceuticals can impact patient care, patient health and the efficiency of the overall health care system. At the CMA, patient organizations are telling us about the anxiety, pain and harm that drug shortages are inflicting on patients. Below are excerpts of these experiences: * According to the Brain Injury Association of Canada: "Any drug medication shortage endangers Canadian patients. In the brain injury community, anti-depressants are prescribed to some, as is pain medication, so if there is a shortage some members in the community will be endangered even if the medication is altered." * The interim-president of the Canadian Arthritis Patient Alliance, Louise Bergeron, wrote CMA to say: "Actually, I have had this happen to me on three occasions and it is quite scary when you know you will not have access to certain drugs for an extended period of time, since you know your health will be on the line." * Sharon Baxter, Executive Director, of the Canadian Hospice Palliative Care Association, says: "All are encouraging the government to find a solution very quickly as pain medication at the end of life is essential and urgent. I don't think we are at the stage where people are dying without access, but getting to that end is totally unacceptable in a country like Canada." 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 when alternate therapies are used; and * increased non-compliance when patients, particularly those on long-term therapy, find it harder to comply with a new medication regime. Any one of these situations can impact patient health, particularly in patients with complex problems. In many instances, this in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. In a survey of physicians conducted by the CMA in 2011, two-thirds of respondents said that the shortage of generic drugs had had negative consequences for their patients or practice. Of these physicians, 22 per cent indicated that the consequences were that their patient suffered clinical deterioration because an alternate drug was substituted. Similarly, in a survey of pharmacists by the Canadian Pharmacists Association in 2011, 69 per cent of respondents indicated that they believed that patients' health outcomes had been adversely affected by drug shortages. Notably, of the physicians who indicated the shortage of generics resulted in consequences to their patients or practice, 28 per cent reported that their patient did not fill the substitution prescription due to the cost of the medication. Numerous respondents raised concerns about the financial impact of substitute medications on patients. Survey responses also shed light on the increased demand on the health care system created by the lack of information on drug shortages provided to physicians. When physicians are not made aware of a drug shortage, and prescribe that medication, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Better informing physicians about drug shortages can reduce demand on the health care system by eliminating the inefficiencies associated with drug shortages. Scope of Drug Shortages In an attempt to outline the scope of the problem, the Canadian Agency for Drugs and Technologies in Health (CADTH) stated that: "It is difficult to quantify and determine the extent of drug shortages in Canada because manufacturers are not required to report disruptions in drug supply to Health Canada and because there is no single accountable Canadian organization that provides system-wide drug distribution oversight."i Surveys by the CMA and the Canadian Pharmacists Association (CPA) shed light on the lack of drug shortages management in Canada. Taken together, the results of these surveys paint an alarming picture of drug shortages management in Canada and underscore the need to improve our system. In terms of notification, the majority of physicians and pharmacists indicated they never (51 per cent and 29 per cent) or infrequently (32 per cent and 33 per cent) receive advance notice of shortages. Ironically, given the high proportion of pharmacists reporting they never or infrequently receive notice, 65 per cent of physicians indicated that they receive notification from pharmacists. Meanwhile, 30 per cent of physicians also indicated that they were notified of drug shortages by their patients. Alarmingly, 81 per cent of the pharmacists surveyed indicated they had trouble locating medications to fill a prescription during their last shift prior to completing the survey and 93 per cent had difficulty over the week prior. This is not a new problem, but since we surveyed CMA members in the fall of 2011, the situation has worsened. Currently about 250 medications are listed on Canadian drug shortage websites. Before the dire impact of the loss of production at Sandoz, Canadian hospitals were already dealing with shortages in the supply of sterile injectables - critical in specialties like surgery, oncology and anesthesia. What Canada's Doctors Require to Provide Care Physicians have expressed their frustration at the time it takes to find an appropriate drug for substitution - time taken from the physician, the pharmacy and the patient. Time better spent with patients is being used by physicians to work with pharmacists to identify alternative drugs and therapies. Of greatest concern are those drugs that are single sourced. When single source medications are in short supply, there are no clear substitutes. The impact of this is being felt now in hospitals across the country as they grapple with the loss of numerous Sandoz products and are forced to ration the remaining stock. The majority of physicians surveyed by the CMA indicated that greater knowledge of drug supply issues would allow them to deliver better patient care. To this end, the CMA strongly supports the development of a comprehensive system for monitoring and responding to domestic shortages of medically necessary drugs. Canada needs a sustainable, adequately resourced system to: identify shortages, rapidly and proactively inform health care professionals, and respond quickly to allocate supply as needed to resolve shortages. The CMA has provided input to both industry and government on the key information needs of doctors. These are: * Information about the product in short supply; * Expected duration of the shortage; * Therapeutic alternatives; * Regions affected; * Notification of the end of the shortage. While the recent establishment of the online inventories by the pharmaceutical industry associations marks an improvement in Canada's management of drug shortages, significant issues remain to be addressed. These include the need for: complete and more consistent information; automatic notifications to alert physicians, pharmacists and other health care providers; a mechanism to prevent potential disruptions; and a mechanism to seek new or interim sources of supply during a shortage. The CMA recognizes that other countries are also grappling with drug shortages. Canada must also work with its partners abroad to find an international solution to this phenomenon. Conclusion Drug shortages management in Canada has significant shortcomings that impact patients, doctors and the health care system. With the current shortage of injectable drugs teetering on the verge of a crisis, quick action and cooperation are required to address the supply shock. The CMA calls on Members of Parliament to exercise leadership to ensure that Canada's health care providers have access to the information necessary for them to care for their patients, and that Canadians have access to medically necessary drugs. i Canadian Agency for Drugs and Technologies in Health. (2011) "Environmental Scan: Drug Supply Disruptions." Ottawa: CADTH, accessed online at: http://www.cadth.ca/media/pdf/Drug_Supply_Disruptions_es-18_e.pdf, 1.
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CMA's Submission to the Senate Committee on Social Affairs, Science and Technology - Prescription Pharmaceuticals in Canada: The Post-Approval Monitoring of Prescription Pharmaceuticals

https://policybase.cma.ca/en/permalink/policy10631
Date
2012-10-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2012-10-24
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association is pleased to take part in the second phase of the study of prescription pharmaceuticals by the Senate Standing Committee on Social Affairs, Science and Technology. During the first phase, we presented the CMA's policy position regarding clinical trials and the process for approving new drugs for use. In this phase we will discuss our position and recommendations on post-approval surveillance of prescription drugs. The Canadian Medical Association represents 76,000 physicians in Canada. Its mission is to serve and unite the physicians of Canada and to be the national advocate, in partnership with the people of Canada, for the highest standards of health and health care. Prescription drugs are a very important part of high quality and cost-effective health care. They can prevent serious disease, reduce the need for hospital stays, replace surgical treatment and improve a patient's capacity to function productively in the community. Therefore, the CMA has developed a substantial body of policy on pharmaceutical issues, including on the post-approval surveillance of prescription drugs. The essence of our position is contained in our first recommendation: Recommendation 1: The CMA recommends that federal and provincial/territorial governments collaborate to develop and implement a national pharmaceutical strategy to ensure that every Canadian has timely access to an adequate supply of safe and effective prescription drugs. This recommendation has two elements: "safe and effective" and "adequate supply," both of which we will discuss in this submission. 2) Ensuring Safety and Effectiveness As we have previously told this Committee, the CMA supports a robust regulatory framework and system for researching and approving new pharmaceutical products. But however strong Canada's pre-approval system is, it will not identify all potential problems with a new drug. Pre-approval clinical trials tend to focus on small numbers of patients, and exclude vulnerable groups such as children and the elderly. They also tend to be of short duration, whereas in the real world, patients may take these drugs for years. As a consequence, problems with a drug are often identified only after widespread, long-term use in the general population. For this reason, it is essential that Canada have in place a robust regulatory framework that includes a timely system to monitor the performance of prescription drugs after they come on the market. The Government of Canada has taken several recent steps to enhance its drug surveillance system. In 2009, it established the Drug Safety and Effectiveness Research Network. In 2008, it introduced Bill C-51, An Act to Amend the Food and Drugs Act, to improve drug safety and effectiveness monitoring by Health Canada. Unfortunately, the bill died with the 2008 election call and has not been re-introduced. That is why we are pleased that the Senate has chosen to re-open this issue. What would a comprehensive post-approval surveillance regulatory framework and system look like? In order to effectively monitor the safety and effectiveness of the country's drug supply, the CMA believes it should include: a) Comprehensive processes for gathering drug safety and effectiveness data In gathering data about adverse drug reactions (ADRs) in Canada, Health Canada has traditionally relied on spontaneous reports from manufacturers and health professionals. The government could enhance its capacity to gather information by: * making it easier for physicians and other health professionals to report ADRs voluntarily. This can be accomplished by making the reporting system user-friendly and easy to incorporate into a practitioner's busy schedule. Health Canada has improved the process by introducing online reporting, which may have contributed to the significant increase in the number of ADR reports over the past 10 years. The reporting process could be made even more efficient by incorporating it directly into the Electronic Medical Record (EMR) as this is developed. * augmenting spontaneous reports with information gathered through other, more systematic means. These could include formal post-market studies of specific drugs, or recruitment of "sentinel" groups of health care providers who would contract to report ADRs in detail, and who, because of these contractual obligations, would be committed to assiduous reporting. b) A capacity for rigorous and timely data analysis to identify significant threats to drug safety. Information gathering does not in itself constitute post-market surveillance. In our opinion, the most important element of the process is the monitoring and analysis that occurs once an adverse drug reaction (ADR) report has been received. Monitoring capacity requires rigorous data analysis that can sort "signal from noise" - in other words, sift through the reports, find the ones that indicate unusual events, investigate their cause, and isolate those that indicate a serious health risk. It also requires that the analysis be timely: we note that in 2011 the Auditor General was particularly critical of Health Canada's post-market surveillance timeliness, noting that it could take several years for reports to be reviewed internally. Post-market monitoring should do more than identify safety risks. It should also provide information about a drug's efficacy and effectiveness. Does it achieve the health outcome for which it is being marketed? Does it perform better than other drugs or therapies for the same condition? c) Communication of useful information to health care providers and the public. When new information is uncovered about a prescription drug, it is important that physicians and other health professionals are made aware of it as quickly and efficiently as possible. Therefore, post-approval surveillance requires a system for communicating timely, reliable and objective information to physicians and other health professionals, which they can absorb quickly and incorporate into their everyday practice. Ideally, this communication would report not the safety problem alone but also its implications for their patients and practice: for example, whether some patients are particularly at risk, or whether therapeutic alternatives are available. Recommendation 2: The CMA recommends that Health Canada continue to improve the capacity of its post-approval surveillance system to: * Make it easier for health professionals to submit voluntary ADR reports; * Analyze the data that has been gathered in a rigorous and timely manner; and * Communicate essential information to health care providers and the public in a timely and user-friendly manner. d) Increased regulatory authority for Health Canada Drug safety is a serious issue; recent research has revealed that nearly a quarter of new drugs approved in Canada will eventually receive a serious safety warning1. Given the potential risks to patient safety we believe Health Canada should have the legal authority to take strong action when a safety problem is identified. The CMA recommends that Health Canada should be given the authority to: * require post-market studies of newly approved drugs if clinical trials identify possible safety risks; * require manufacturers to disclose information if Health Canada thinks it germane to making a decision in the interest of patient safety; and * take action if post-market research uncovers new safety concerns. This could mean ordering changes to product labels, or pulling a product off the market. Granting Health Canada this regulatory authority is only the first step. Health Canada should not hesitate to use this authority if the situation warrants. 3) Ensuring an Adequate Drug Supply In the past few years Canada's doctors have become deeply concerned about the persistent shortages of drugs that they and their patients are encountering. In a survey of physicians conducted by the CMA in September 2012, two-thirds of respondents said that the shortage of drugs was a significant issue in terms of its impact on patient care and outcomes. Of these physicians, 70 per cent indicated that their patient received a less effective medication, and 20 per cent had patients who had suffered clinical deterioration because an alternate drug was substituted. This in turn leads to a greater demand on the health care system, whether in physician visits or emergency room treatments. Twenty-three per cent reported that their patient suffered financially due to the cost of the substituted medication, since many of the drugs in short supply are older, low-cost generics. The lack of information about shortages compounds the stress of dealing with them. When physicians prescribe a medication, unaware that it is in short supply, they later have to provide the patient with a new prescription, which often requires an additional patient visit. Physicians have expressed their frustration at the time it takes to find an appropriate substitute drug - time which could better be spent in patient care. As a consequence, the CMA strongly supports the development of a comprehensive system for monitoring domestic shortages of medically necessary drugs. To be of greatest benefit to doctors, such a system should include: * Information about the product in short supply; * Expected duration of the shortage; * Therapeutic alternatives; * Regions affected; * Notification of the end of the shortage. Although pharmaceutical industry associations and drug manufacturers are now supporting a drug shortage reporting website (http://www.drugshortages.ca/drugshortages.asp), there is room for improvement. The reporting website does not yet capture all of the drug product shortages. It must become more user friendly for health practitioners and the public, with search and sort functions to easily find product listings. In addition, a mechanism to obtain information on possible therapeutic substitutions would be of value to practitioners. Recommendation 3: The CMA recommends that Health Canada work with provincial and territorial governments, industry groups and health professionals to enhance the current system for reporting drug shortages and ensure its sustainability. Finally, while a reporting system to provide information to health professionals and Canadians on drug shortages is valuable, it is essential that Canada address the root causes of drug shortages. A review of the supply processes, both domestic and international, is strongly recommended. While the CMA acknowledges that provinces are responsible for purchasing drugs, we believe that solutions will be stronger if all provinces, and the federal government, work together on them. And since drug shortages are an international concern, it is the responsibility of the Government of Canada to work with other countries in seeking solutions. Recommendation 4: The CMA supports an investigation into the underlying causes of prescription drug shortages in Canada. 4) Other Important Elements of a National Pharmaceutical Strategy As Recommendation 1 states, the CMA believes that Canada's federal and provincial/territorial governments should implement a national pharmaceutical strategy, one of whose objectives would be to ensure an adequate supply of prescription drugs. The strategy should address other important objectives, as well, notably: * ensuring comprehensive prescription drug coverage for all Canadians. According to a recent CMA survey, one in 10 Canadians has gone without a prescription drug because they couldn't afford it. Governments should work with private insurers and other stakeholders to develop a system to provide equitable, comprehensive prescription drug coverage to all Canadians. * encouraging optimal prescribing by health professionals. To accomplish this, the CMA has recommended a strategy that includes education, user-friendly guidelines and practice tools, and the provision of impartial information to health professionals and the public. 5) Conclusion Once again, we commend the Senate Social Affairs Committee for bringing this issue to your table. Canada's physicians are prepared to work with governments, health professionals and the public in strengthening Canada's post-approval surveillance system, to ensure that the prescription drugs Canadians receive are safe and effective and in adequate supply. 1 Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012;():1-2. doi:10.1001/archinternmed.2012.4444.
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Consultation on proposed front-of-package labelling

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