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A Prescription for Optimal Prescribing

https://policybase.cma.ca/en/permalink/policy10016
Last Reviewed
2016-05-20
Date
2010-08-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2016-05-20
Date
2010-08-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
This paper presents the position of the Canadian Medical Association on what physicians can do, working with others, to ensure that Canadians are prescribed the drugs that will give them the most benefit. It also makes recommendations for future action that physicians, governments and others might take to foster optimal prescribing practices. CMA believes that optimal prescribing is the prescription of a drug that is: - The most clinically appropriate for the patient's condition; - Safe and effective; - Part of a comprehensive treatment plan; and - The most cost-effective drug available to meet the patient's needs. Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage. The CMA proposes a "prescription for optimal prescribing" that encompasses six elements, and makes the following recommendations: A National Strategy 1) Governments at all levels should work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. Element 1: Relevant, Objective Information for Physicians 2) The CMA supports the development and dissemination of prescribing information that is: - based on the best available scientific evidence; -relevant to clinical practice; - easy to incorporate into a physician's workflow. 3) The CMA encourages all medical educational bodies to support a comprehensive program of education in pharmaceuticals, pharmacology and optimal prescribing, at the undergraduate, residency and continuing medical education levels. 4) The CMA and provincial/territorial medical associations call on governments to support and fund impartial continuing medical education programs on optimal prescribing. 5) The CMA calls on appropriate educational bodies to develop policies or guidelines to ensure the objectivity and impartiality of continuing medical education. 6) The CMA recommends that governments, research institutes and other stakeholders fund and conduct ongoing clinical research on the effectiveness of interventions designed to change behaviour, and allocate resources to those interventions that demonstrate the greatest effectiveness. Element 2: Electronic Prescribing 7) The CMA, provincial/territorial medical associations and affiliates encourage governments to give active support to physicians in their transition to electronic prescribing, through a comprehensive strategy that includes financial support for acquisition of hardware and software, and dissemination of appropriate training and knowledge transfer tools. 8) The CMA calls on governments to incorporate into electronic prescribing the following principles: - Measures to ensure patients' privacy and confidentiality, as well as confidentiality of physician prescribing information; - A link with a formulary, to provide physicians with best practice information including drug cost data; - Guidelines for data sharing among health professionals and others; - Standards for electronic signature that are not overly restrictive. Element 3: Programs by Payers 9) The CMA recommends that formularies, in both the public and private sectors, simplify administrative requirements on patients and physicians, reducing paperwork to the minimum necessary to ensure optimal patient care. Element 4: Collaboration among Health Care Providers 10) The CMA recommends that formalized and clearly articulated collaborative arrangements be in place for practitioners who jointly manage a patient's drug therapy. Element 5: Impartial, Evidence-based Information for Patients 11) The CMA calls on governments to fund and facilitate the development and provision of unbiased, up-to-date, practical information to consumers about prescription drugs and their appropriate use, and support physicians and pharmacists in disseminating this information to patients. 12) The CMA calls on the Government of Canada to continue to enforce the current ban on direct-to-consumer prescription drug advertising in Canada, and close the loopholes that currently allow a limited amount of drug promotion. Element 6: Research, Monitoring and Evaluation 13) The CMA calls on those who fund and produce research on drug safety and effectiveness, prescribing guidelines and programs to enhance prescribing practices, to include physicians and medical organizations meaningfully in this activity. 1 Introduction In an ideal world, all patients would be prescribed the drugs that have the most beneficial effect on their condition while doing the least possible harm, at the most appropriate cost to the patient and the health care system. It is generally agreed that we have not yet achieved that ideal. But the Canadian Medical Association (CMA) and the physicians of Canada believe it is a goal worth striving to attain. The CMA has a long-standing commitment to fostering high-quality health care. One of the key elements of the long-term Health Care Transformation project, in which CMA is currently involved, is ensuring that systems are in place to foster health care that is of high quality. One such system would be the active encouragement of optimal prescribing. This paper presents the CMA's position and recommendations on what physicians can do, working with others, to ensure that Canadians are prescribed the drugs that will give them the most benefit. It looks at prescribing mainly from the perspective of the practicing physician who is seeking the most appropriate treatments for individual patients. However it also comments on the effects of prescribing on the broader health care system, both on Canadians' overall health status and on the costs of delivering health care. 2) Optimal Prescribing: CMA's Definition and Principles a) What is Optimal Prescribing? Prescribing is not an exact science; the choice of a particular drug to treat a particular patient depends on that patient's unique circumstances. CMA's proposed definition and principles for optimal prescribing is as follows: Optimal prescribing is the prescription of a drug that is - the most clinically appropriate drug for the patient's condition; - safe and effective; - part of a comprehensive treatment plan; and - the most cost-effective drug available to best meet the patient's needs. b) Principles for Optimal Prescribing CMA believes that in an optimal prescribing environment, the following principles should apply: Principles for Optimal Prescribing 1) The primary goal of prescribing should be to improve or maintain the health of the patient. 2) Prescribing should take place in the context of overall patient care which involves diagnosis of the condition, other forms of treatment including rehabilitation, counselling and lifestyle adjustments, ongoing monitoring and re-evaluation of the patient's condition and treatment to make sure the patient is responding appropriately, ensuring patient adherence to medication regimen, and discontinuation of drug treatment when it is no longer needed. 3) Patients should be actively involved in decisions regarding their drug treatment; for this, useful and practical patient information is required. 4) Prescribing decisions should be based on the best available scientific evidence, which is continually evaluated and updated as need arises. 5) Physicians should retain clinical autonomy in deciding which drugs to prescribe. 6) Prescribing decisions should take into account the cost to the patient, and strive to achieve cost-effectiveness as long as this does not conflict with the goal of optimal patient care. 7) Physicians should be updated on new developments in pharmacotherapy, through an ongoing process of relevant, objective continuing education. 8) Health professionals should take a leadership role in developing and evaluating strategies and tools to enhance best practices in prescribing. Though these principles may also apply to the optimal use of medical devices, prescription drugs are the primary focus of the paper. 3 Why Optimal Prescribing is Important Prescription drugs are an increasingly important part of patient care in Canada. Fifty years ago, they were used mainly for short periods of time to treat acute conditions, and their contribution to overall health care costs was small. But in 2005, Canadians received 14 prescriptions per capita; that number rose to 74 for people 80 years and over.i Many Canadians now take prescription drugs over the long term to manage chronic conditions such as diabetes, osteoporosis or high cholesterol. Increased drug utilization, and the high prices of many new drug therapies, have increased the cost of prescription drugs to Canadians and to the health care system. In 2008 Canadians spent about $25.4 billion on prescription drugs. This, in constant dollars, is roughly triple what was spent in 1985.ii Together, prescription and over-the-counter drugs consume a larger portion of overall costs than do physicians' services; in fact, only hospitals consume a larger share. In many cases prescription drugs have reduced reliance on hospitalization and surgical procedures. For example, over the past decades drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. On the other hand, patients may take certain medications or classes of medications for many years, and this long-term use may have health consequences that are currently unknown. As their role in health care increases, there is increasing public scrutiny over whether the prescription drugs Canadians use are safe and effective, whether they give good value for money, and whether they are being prescribed and taken optimally for maximum patient benefit. As mentioned before, prescribing is not an exact science; what in some cases might be considered "suboptimal" is in other cases quite appropriate. In most instances, drugs are prescribed appropriately. However, evidence suggests that in some areas there is room for improvement. Prescribers can enhance patient care and improve Canadians' health by adopting strategies such as the following: - Reducing overprescribing of certain drugs. For example, overuse of antibiotics is a worldwide concerniii since it may hasten the development of antibiotic resistance, thereby reducing the physician's therapeutic arsenal. - Reducing underprescribing of certain drugs. A study of primary care practices in Ontario found that while 14% of adult patients had dyslipidemia, 63.2 % were untreated and, of those treated, 47.2% were not adequately controlled .iv - Prescribing drugs according to generally accepted clinical practice guidelines to ensure that first-line drugs are used where indicated. Second-line therapies are frequently newer and less established than first-line ones, and are thus more likely to have unidentified safety risks. - Ensuring that drugs are prescribed and taken safely, to reduce the harm caused by adverse interactions with other drugs, natural health products, alcohol or other agents in the patient's system. Activities in support of the above strategies should be included in any program or initiative aimed at improving health care in Canada. CMA believes they will contribute to Canadians' overall health status, and may have the additional benefit of reducing health care costs if the prescribed drugs are the most cost-effective available to appropriately treat patients' conditions. 4) Many Factors Affect Prescribing Prescribing does not occur in a vacuum, but is the result of a number of factors that influence physicians. It may be questioned whether these factors provide the necessary support to physicians as they seek to prescribe optimally. Some of these influences are discussed below: a) The Challenge Of Acquiring Information Our knowledge of prescription drugs and their effects is continually being updated, and physicians are required to absorb new information throughout their careers. But are physicians receiving the information they most need, in such a way that they can easily and painlessly incorporate it into their practices? CMA's answer is: there is room for improvement. The major information sources available to physicians are discussed below: i) Physician Education Medical school and residency training - Medical schools vary in how they discuss pharmacological issues, and critics have questioned whether Canada's current medical school curriculum is training future physicians adequately in the art and science of prescribing.v In some cases, pharmacotherapy is taught in the context of each individual body system - cardiac, renal, etc. - rather than as a discrete subject. With this approach, some valuable unifying elements of pharmacology may go untaught. Continuing medical education (CME) - For physicians, CME is an important source of information on new drugs and new indications for existing drugs. But is it imparting the most necessary or appropriate information? Concerns have been raised as to its impartiality; it is estimated that pharmaceutical industry sponsorship accounts for 65% of the total revenue of CME programs in the U.S. and the figure is assumed to be much the same in Canada.vi ii) Point-of-care information With increasingly heavy patient loads, the time at physicians' disposal for research is limited. Often new information is required at the point of care; for example, in the examination room during a patient encounter, when the physician requires an answer quickly. The clinical practice guidelines and point of care reference guides in common use may not be readily accessible in a concise, user-friendly format when needed. In addition, it is of concern that some experts who develop practice guidelines have ties to pharmaceutical manufacturers, which could affect the guidelines' impartiality. To compound the problem, widely used sources of information may not be giving physicians the material they most need. Physicians often receive new safety information, such as warnings of recently discovered drug risks, in the form of advisories from Health Canada or elsewhere. These advisories may not provide physicians with prescribing advice, or information about other treatment options if the drug is considered too dangerous for use. iii) Drug promotion and marketing Much of physicians' information about drugs and prescribing comes from the pharmaceutical industry representatives who visit them in their offices. Drugs promoted in this manner tend to be newer; consequently they are often more expensive than established medications and less is known about their efficacy and possible side effects. Drug promotion might help instil in some physicians' minds the perception that when it comes to medication, "new" equals "better," when this is not always the case. Industry marketing also comes in more subtle forms, such as: - Free drug samples provided to physicians; since samples tend to be mainly for new drugs, it has been suggested that they encourage these drugs' use at the expense of possibly cheaper and safer alternatives. - Collection, by commercial data management companies, of information on physicians' prescribing patterns , which is then sold to pharmaceutical companies to help tailor sales messages to individual physicians. - Manipulation of the medical publication process, through: design of clinical trials so as to get the most positive results; selective publication of clinical trial results; or "ghostwriting" of scholarly research articles by pharmaceutical industry contractors.vii b) Patient education and participation When considering a patient's drug therapy, the physician must consider the possible effect of the patient's behaviour on treatment. A patient may require counselling on the impact of natural health products, alcohol and other substances when mixed with their prescribed medications; on the importance of adherence to the prescribed treatment; or on the need for changes in behaviour (improved diet, increased physical activity) to augment the medication's benefits. This requires open and honest dialogue between patient and physician. Patient knowledge and preferences can influence both over- and under-prescribing. Some patients may not feel that they have been "treated" unless they leave the doctor's office with a prescription. A physician may prescribe a drug if a patient requests it, despite feeling ambivalent about the choice of treatment.viii On the other hand, a physician may not prescribe a needed medication because a patient insists he or she does not want to be "on drugs." The pharmaceutical industry directs promotional activities at patients as well as physicians. Though direct-to consumer advertising (DTCA) or prescription drugs is technically illegal in Canada, loopholes in the law permit a limited amount of Canadian-based drug promotion, and drug ads are often beamed across the border from the United States, one of only two countries (the other being New Zealand) where DTCA is legal. DTCA has a strong influence on patient behaviour; according to one survey by the U.S. Government Accounting Office, 27% of people who saw prescription drug advertisements, requested and received these drugs from their physicians.ix DTCA has been widely criticized for overstating drugs' benefits, playing down their risks, and contributing to a "pill for every ill" mindset and the "medicalization" of conditions that could be more appropriately managed by lifestyle changes or other non-drug therapies. In addition, the pharmaceutical industry can exert indirect influence on patient attitudes through funding of patient advocacy groups and disease-specific web sites. A patient's social context may also motivate a physician to prescribe a drug that may not be clinically indicated. For example, an antipsychotic may be prescribed to calm a patient with dementia, not so much for the patient's benefit as for that of tired and stressed-out caregivers, despite growing evidence of the drugs' health and safety risks and lack of efficacyx. Ideally, prescribing recommendations and guidelines should take into account the broader context in which a drug is prescribed. c) Drug cost and coverage The physician's prescribing of a drug and the patient's purchase of it are separate and unconnected acts. As a result, physicians may not have access to reliable, convenient information on drug costs; or if they do, they may have little reason to use this information if the patient has insurance coverage. However, rising drug prices, and the increased use of drug therapy, may require them to take cost into consideration more often. Provincial and territorial governments, and increasingly, private insurers as well, can influence physician and patient choice of drugs by restricting what medications are covered on their formularies. In addition, many payers have programs to encourage the prescribing of certain drugs such as generics. If, as not infrequently happens, a patient's condition requires a drug not on the formulary, obtaining coverage for this drug requires time-consuming paperwork. The administrative burden this imposes can be a barrier to optimal prescribing. d) The policy context Canadian decision makers have already recognized that action on prescribing is needed. One of the original nine elements of the federal/provincial/territorial National Pharmaceuticals Strategy (NPS), announced in 2004, was "Enhance action to influence the prescribing behaviour of health care professionals so that drugs are used only when needed and the right drug is used for the right problem." However, this was not considered a priority, and the entire NPS is now dormant. In 2009, the Health Council of Canada recommended that optimal prescribing be a priority element in a revived pharmaceutical strategy, noting the need for easily accessible, evidence-based information on the proper use and risks of each medication, and for national co-ordination of efforts toward improved prescribing.xi 5. The CMA's Prescription The previous sections have described the problems that currently exist with prescribing in Canada, and factors that contribute to these problems. In this section the CMA discusses what can be done to make prescribing optimal. Even as a variety of factors influence prescribing, so a variety of elements can contribute to optimizing it. What should be done to encourage optimal prescribing in Canada? The CMA believes that optimal prescribing should be addressed through the development and implementation of a national strategy comprising the six elements discussed in the following pages: Recommendation 1 Governments at all levels should work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. Element 1: Relevant, Objective Information for Prescribers As our knowledge base on prescription drugs expands, it is communicated to physicians by many different means. The CMA believes it is possible to improve these communications and make them more relevant and useful to prescribing physicians. Recommendation 2 The CMA supports the development and dissemination of prescribing information that is: o based on the best available scientific evidence o relevant to clinical practice o easy to incorporate into a physician's workflow. a) Undergraduate medical education and residency training A basic grounding in pharmacology is a vital part of undergraduate medical education. Appendix 1, which was taken from a 2009 report prepared by Britain's Royal College of Physicians, contains a specific proposal for a core undergraduate curriculum in therapeutics. Basic education in pharmacology should, among other things, help prepare future physicians for the challenge of maintaining their knowledge base in practice. The academic community has a role to play, during undergraduate training and residency, in providing impartial advice on pharmaceutical matters, and ensuring that students and residents can appraise drug research and prescribing guidance critically. Recommendation 3 The CMA encourages all medical educational bodies to support a comprehensive program of education in pharmaceuticals, pharmacology and optimal prescribing, at the undergraduate, residency and continuing medical education levels. b) Continuing medical education (CME) Traditionally, CME meant face-to-face seminars or conferences; however, studies are demonstrating that Internet-based learning is as effective as face-to-face CME.xii Developers and practitioners are increasingly looking at delivering CME online. Of particular promise are formats that deliver information electronically in short, summary bullet points, presenting the most pertinent information on a single screen where feasible. As mentioned before, a large proportion of CME is sponsored by the pharmaceutical industry. Like pharmaceutical detailing, industry-sponsored CME might steer physicians toward newer drugs which may not be first-line therapies, and which are often less thoroughly evaluated and more expensive than established treatments. Therefore, in order that physicians can be assured of receiving objective information, there is an urgent need for objective funding sources for CME, that are as distant as possible from potential sources of bias. Recommendation 4 The CMA and provincial/territorial medical associations call on governments to support and fund objective and impartial continuing medical education programs on optimal prescribing. Recommendation 5 The CMA calls on appropriate educational bodies to develop policies or guidelines to ensure the objectivity of continuing medical education. CMA's Guidelines for Physicians in Interaction with Industry (2007) proposes ways in which physicians, medical associations and medical educational bodies can minimize bias when collaborating with industry on CME and continuing professional development programs. c) New Forms of Education Besides formal CME, there are many ways of conveying information to physicians with the intent of influencing prescribing behaviour. One promising intervention is academic detailing, in which trained physicians or pharmacists use the personalized, one-on-one techniques employed by pharmaceutical detailers to encourage adoption of a desired behaviour (e.g., prescribing of a particular drug or treatment regimen) rather than specific drugs, to counterbalance marketing by pharmaceutical representatives. Academic detailing has demonstrated some success. Because it is expensive and labour intensive, it has often been difficult to persuade governments to invest in it. However, a growing number of provinces have developed, or are considering, academic detailing programs. Another promising intervention is physician self-directed learning. In Alberta two medical schools are preparing to perform an analysis of physicians' perceived and unperceived learning needs with the intention of developing individualized learning programs to address the needs of physicians in their practices. The effectiveness of various learning programs in changing behaviour is being studied on an ongoing basisxiii, through means such as the Rx for Change database, a collaborative effort between two Cochrane Collaboration groups and the Canadian Agency for Drugs and Technologies in Health. This database summarizes current research evidence, regularly updated, about the effects of strategies to improve drug prescribing practice and drug use. Because different physicians have different needs, goals and styles of learning, multiple formats are required to address them. Though one intervention in and of itself may not produce widespread, immediate or dramatic changes in behaviour, the cumulative effect of multiple messages over time can be very strong. Recommendation 6 The CMA recommends that governments, research institutes and other stakeholders fund and conduct ongoing research on the effectiveness of interventions designed to change clinical behaviour, and allocate resources to those interventions that demonstrate the greatest effectiveness. d) Point-of-care information In addition to formal education programs, information on pharmaceuticals and prescribing is also available to physicians at the point of care. Physicians' preference is for brief summaries of key points, which can be absorbed quickly and be accessed at point of care through hand-held personal digital assistants (PDA's) or, increasingly, through electronic health and prescription records. Drug information compendia are available in electronic and print format. For example, cma.ca provides information about prescription drugs through a program called Lexi-Drugs Online. e-Therapeutics+, developed by the Canadian Pharmacists Association, is another online resource for prescribing and managing drug therapy at the point of care. Online programs are also available that monitor physicians' prescribing habits and compare them to those of their peers. Such programs are to be encouraged if their purpose is to educate rather than to enforce a certain behaviour. However, they will require additional investment, particularly in information technology and software development. Element 2: Electronic Prescribing Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system has the potential to: - list all the drugs a patient is taking. It could also identify duplicate prescriptions for the same drug from different providers, thus helping to reduce prescription fraud and prescription drug abuse; - provide decision-support tools; for example, a warning could appear on the screen if the physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. This decision support should ideally be updated in real time so the physician has access to the most current information. - Enable the improvement of patient adherence to drug therapy, perhaps by generating reminders to patients to refill and take prescriptions. - Transmit prescriptions to pharmacies electronically, increasing convenience for the patient and eliminating a major cause of medication errors, illegible handwriting. - Automatically link to a formulary to enable the prescriber to see whether the patient's insurer has approved the medication, or to find the lowest-cost drug in a class. Two-way electronic communication with formulary managers may also help reduce some of the administrative paperwork which is a barrier to optimal prescribing. - Automatically notify physicians of drug shortages, recalls or other urgent situations. In the U.S., e-prescribing is being actively encouraged. Since January 2009, the American Medicare system provides financial incentives for its physicians who adopt e-prescribing. In Canada adoption has been slow;xiv it is estimated that fewer than 10% of physicians e-prescribe. This may be due partly to the expense, and partly because of issues which remain to be addressed, such as: - How do we assure that the confidentiality of patients' health information, and of physicians' prescribing information, is protected? - What information should be shared with other health professionals? - What legally constitutes a "signature," or other means of authenticating a prescription? - Can we ensure that pharmacies as well as physicians' offices are equipped to receive electronic prescriptions? - Can we ensure that e-prescribing software is designed so as to be practical and user-friendly for physicians; for example, that pop-up warnings contain the most important and relevant information? - Can we ensure that e-prescribing protocols simplify a physician's workload rather than adding to it - for example, that they eliminate duplication of prescription writing? E-prescribing is in its early stages, and knowledge and policy in this area are developing rapidly. CMA will continue to study the issue in the coming years. Several provinces maintain electronic prescription databases and others are in development. For example, BC PharmNet provides drug-to-drug interaction checking and patient medication profiles to pharmacists, emergency rooms and physicians with controlled access. In most provinces and territories, medical associations are working with governments on standards to implement e-prescribing. Recommendation 7: The CMA, provincial/territorial medical associations and affiliates encourage governments to give active support to physicians in their transition to electronic prescribing, through a comprehensive strategy that includes financial support for acquisition of hardware and software, and dissemination of appropriate training and knowledge transfer tools. Recommendation 8: The CMA calls on governments to incorporate into electronic prescribing the following principles: - measures to ensure patients' privacy and confidentiality, as well as confidentiality of physician prescribing information - a link with a formulary, to provide physicians with best practice information including drug cost data - guidelines for data sharing among health professionals and others - standards for electronic signature that are not overly restrictive. Element 3: Programs by Payers Government drug plans and, increasingly, private insurance companies, have instituted programs to encourage prescription of certain drugs. Such programs, which are often motivated by the desire to control rising drug costs, can include the following: a) Formularies There are 18 public drug formularies in Canada managed by federal or provincial/territorial governments. These formularies often use various means to help control drug costs. For example, if a generic drug is available to treat a given condition, a payer may reimburse patients only for the generic rather than for brand-name equivalents. Or if several related drugs exist in the same class, a formulary could reimburse only for the lowest-priced drug in that class, as British Columbia's reference-based drug pricing (RDP) program does for five drug categories that contain several drugs with equal efficacy; if patients want to purchase a higher-priced drug they must pay the difference out of pocket. Such programs are not confined to Canada; Britain's National Health Services funds specific treatments only if recommended by the National Institute for Clinical Excellence (NICE) which assesses new drugs for efficacy and cost-effectiveness. Under New Zealand's PHARMAC system the government reimburses only for one drug in each class. A formulary's cost-control objectives can sometimes conflict with the goal of physician and patient to obtain the care they believe will be most optimal. For example, formulary rules limiting the length of chronic prescriptions can make it difficult for physicians to prescribe over the long term to patients who manage their conditions well. It is important that formulary rules be based on the best available scientific evidence. The ideal formulary will be designed to improve clinical care, optimize patients' health outcomes, promote patient safety, and reduce the administrative burden on the physician. Recommendation 9 The CMA recommends that formularies, in both the public and private sectors, simplify administrative requirements on patients and physicians, reducing paperwork to the minimum necessary to ensure optimal patient care. b) Prescribing incentives Sometimes, payers may provide incentives such as reward payments for physicians who prescribe in a desired way (for example, who prescribe more than a certain percentage of a given drug class as generics), or impose a financial penalty for physicians who do not exhibit the desired behaviour. Financial incentives to physicians to provide preventive care services have been used effectively but their effect on prescribing practices is only beginning to be evaluated. A study of U.K. prescribing incentive schemes concluded that reward payments may have contributed to cost control, but their effect on prescribing quality remained uncertain. xv CMA's ongoing Health Care Transformation initiative will provide decision makers with blueprint for a high-performing, patient-centered health care system. Among its other activities over the next few years, this initiative will be examining in greater detail the effect of pay-for-performance schemes on the quality of care in Canada. Element 4: Collaboration Among Health Care Providers No health professional is an island. Increasingly health care providers are working in collaborative teams to manage drug therapy and other forms of patient care. In such teams, for example, pharmacists may perform a variety of functions, such as reviewing patients' medication profiles to catch medication related problems such as inappropriate dosing, duplicate or unnecessary therapies; or managing long-term drug therapy for patients with chronic conditions such as asthma or diabetes. At their most effective, such collaborative arrangements could greatly improve drug therapy, and patient care in general, by allowing the team to draw on a common pool of expertise. However, if improperly implemented, they could lead to breakdown of communication and fragmentation of care. To ensure that collaborative management of a patient's drug therapy functions smoothly, it is important that clearly articulated arrangements be in place. CMA's position statement Achieving Patient-Centered Collaborative Care (2007), includes the following principles: - Patient-centered care. Patient care (including drug therapy) must be aligned around the values and needs of the patient. - Clear communication. Effective communication is essential to ensure safe and coordinated drug therapy and to ensure that the patient is receiving timely, clear and consistent messaging. For example, if a physician and pharmacist are both managing and monitoring a patient with asthma, it is essential that they notify each other if a change is made to a prescription, such as a new drug or a new dosage. Electronic health records have the potential to greatly improve communication among providers. - Clinical leader. CMA's position statement defines a clinical leader as "the individual who, based on his or her training, competency and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient." In most cases the physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume this role. Recommendation 10: The CMA recommends that formalized and clearly articulated collaborative arrangements be in place for practitioners who jointly manage a patient's drug therapy. The CMA, recognizing the need for and value of collaboration in the management of drug therapy, will continue to explore and encourage the most effective models for collaborative practice among health professionals. Element 5: Impartial, Evidence-based Information for Patients Canadians have the right to accurate, reliable information on prescription drugs and their uses, so that they can become knowledgeable partners in their care. A good deal of information is already available to patients, and there are ways in which it could be improved and made more accessible and relevant. One way would be to improve its clarity and readability, to address the needs of the estimated 6 in 10 Canadians who lack the health literacy necessary to properly manage their health and engage in preventive practices.xvi Another way would be to provide more information from impartial sources, to reduce the impact of direct-to-consumer advertising. The CMA believes that in general, brand specific advertising is a less than optimal way of providing drug information, and that the laws currently banning direct-to-consumer prescription drug advertising in Canada should remain in effect, and tightened to eliminate existing loopholes. Physicians and other health care providers can also play an important role in providing patients with guidance and with accurate information on the medications they take. CMA and the Canadian Pharmacists Association have collaborated with Canada's Research-based Drug Companies (Rx&D) to produce a pamphlet called "Knowledge is the Best Medicine" which provides consumers with advice on safe medication use, and guidance on how to interact effectively with their physician or pharmacist. Recommendation 11: The CMA calls on governments to fund and facilitate the development and provision of unbiased, up-to-date, practical information to consumers on prescription drugs and their appropriate use, and support physicians and pharmacists in disseminating this information to their patients. Recommendation 12: The CMA calls on the Government of Canada to continue to enforce the current ban on direct-to-consumer prescription drug advertising in Canada, and close the loopholes that currently allow a limited amount of drug promotion. Element 6: Research, Monitoring and Evaluation Drug development is an ongoing process, and the evaluation of drugs and their prescribing should be ongoing as well. Canada already supports a certain amount of research activity in this area. For example, Health Canada funds the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS), a collaborative, pan-Canadian service to identify and promote optimal drug therapy. COMPUS collects and evaluates relevant existing evidence, and provides advice, tools, and strategies to implement and support the adoption of optimal drug therapy. COMPUS has produced, or is producing, evidence-based recommendations for prescribing proton pump inhibitors and drugs for diabetes management. COMPUS has established links to university-based providers of CME, and with academic detailing groups, who help to disseminate its recommendations and materials. It also manages the Rx for Change database previously mentioned. The federal government has recently established and funded a national Drug Safety and Effectiveness Network. This network will link researchers to help coordinate and fund independent research on the risks and benefits of drugs that are on the market. We hope that this signifies a long-term commitment on the country's part to optimal drug therapy. CMA believes Canada should build on this activity by encouraging research on an ongoing basis on: - prescribing guidelines and what drugs work best for which conditions - dissemination of prescribing information - what interventions most effectively influence practice? - effect of changes in prescribing on patient health outcomes, and on utilization of health services; - the safety and effectiveness of drugs, building on what currently exists (such as Health Canada's system for reporting adverse drug reactions and communicating drug safety advisories), so that information derived from post-market surveillance quickly reaches health care providers and patients and becomes part of our body of knowledge. Since the great majority of prescriptions in Canada are written by physicians, it is essential that the medical community participate actively in evaluation of prescribing practices, and disseminating and implementing the results of research. Recommendation 13: The CMA calls on those who fund and produce research on drug safety and effectiveness, prescribing guidelines and programs to enhance prescribing practices, to include physicians and medical organizations meaningfully in this activity. 5 Conclusion It is likely that drug therapy will continue to increase in importance as a component of patient care and that it will continue to become more complex and, in many cases, more costly. As a result, we expect that health professionals and the Canadian public will continue to need readily available and up-to-date information on prescription drugs: the availability of new products; the results of safety and effectiveness studies; and advice on how to prescribe and take these medications for the best health outcome. It is also likely that electronic prescribing systems, formularies and other monitoring methods will continue to be developed, and that these will influence physicians' prescribing habits. To deliver evidence-based prescribing information effectively, and encourage its smooth incorporation into clinical practice, Canada needs a comprehensive, multi-disciplinary strategy in which physicians and other health care providers, governments, patients, industry and other stakeholders work together to encourage and support optimal prescribing, in the interest of achieving the best possible health for Canadians with the most effective use of resources. The CMA is ready to join with others in developing and implementing such a strategy, in the hope that eventually, all patients will receive the prescription drugs they need, when they need them. Appendix 1 A core undergraduate curriculum for prescribers in therapeutics Core knowledge and understanding Basic pharmacology Clinical pharmacokinetics Monitoring drug therapy Adverse drug reactions Drug interactions Medication errors Poisoned patients Prescribing for patients with special requirements (e.g., the elderly, children, women of childbearing potential, pregnant and breastfeeding women, and patients with renal or liver disease) Legal aspects of prescribing drugs Developing new drugs Medicines management Ethics of prescribing Commonly used drugs Common therapeutic problems Complementary and alternative medicine Integration of therapeutics into understanding of disease management. Core skills Taking a drug history Prescription writing Drug administration Prescribing drugs in special groups Prescribing drugs to relieve pain and distress Adverse drug reactions and interactions Drug allergy Clinical pharmacokinetics Monitoring drug therapy Analysing new evidence Obtaining accurate objective information to support safe and effective prescribing Obtaining informed consent to treatment Core attitudes A rational approach to prescribing and therapeutics Risk-benefit analysis Recognizing the responsibilities of a physician as part of the prescribing community Recognizing personal limitations in knowledge Responding to the future SOURCE: Maxwell S, Walley T. Teaching safe and effective prescribing in UK medical schools: a core curriculum for tomorrow's doctors. Br J Clin Pharmacol 2003;55:496-503.100. Cited in Innovating For Health: Patients, physicians, the pharmaceutical industry and the NHS. A report from the Royal College of Physicians (UK) February 2009 References i Metge C, Sketris I. "Pharmaceutical Policy." In MacKinnon NJ, ed. Safe and Effective: the Eight Essential Elements of an Optimal Medication Use System. Canadian Pharmacists Association, 2007. ii Canadian Institute for Health Information. Drug Expenditure in Canada, 1985 to 2009. Released April 2010. Accessed at https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1428&lang=en&media=0. iii Wang E, Einarson T, Kellner J, Conly. Antibiotic prescribing for Canadian preschool children: evidence of overprescribing for viral respiratory infections. Clin Infect Dis. 1999; 29(1):155-60. iv Petrella R, Merikle E, Jones J. Prevalence and treatment of dyslipidemia in Canadian primary care: a retrospective cohort analysis. Clin Ther. 2007; 29(4):742-50. v Dr. Jean Gray, speaking at the Health Council of Canada symposium, "Safe and Sound: Optimizing Prescribing Behaviours"; Montreal, June 2007 vi Steinman MA, Baron RB. Is continuing medical education a drug promotion tool? Yes. Can Fam Phys 2007: 53(10); 1650-53. vii Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008: 300 (Sept. 3); 1069-1071. viii Mintzes B, Barer ML, Kravitz RL et al. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: a two-site cross-sectional survey. BMJ 2002; 324 (2 February): 278-279. ix "Should Canada allow direct-to-consumer advertising of prescription drugs?" (Debate) Can Fam PhysicianVol. 55, No. 2, February 2009, pp.130 - 133. x Valiyeva E, Herrmann M, Rochon PA. Effect of regulatory warnings on antipsychotic prescription rates among elderly patients with dementia: a population-based time series analysis. Can Med Assoc J 2008; 179(5) doi 10.1503. xi Health Council of Canada. "A commentary on The National Pharmaceuticals Strategy: a Prescription Unfilled." (January 2009) xii Cook DA, Levinson AJ, Garside S et al. Internet-based learning in the health professions: a meta-analysis. JAMA 2008; 300 (10): 1181-1196. xiii Rx for Change database; accessed at http://www.acmts.ca/index.php/en/compus/optimal-ther-resources/interventions. xiv Canadian Medical Association. "Information technology and health care in Canada: 2008 status report." xv Ashworth M, Lee R, Gray H et al. How are primary care organizations using financial incentives to influence prescribing? J Public Health 2004: 26(1); doi: 10.1093. xvi Canadian Council on Learning. Health literacy in Canada: initial results from the International Adult Literacy and Health Skills Survey (September 2007). Accessed at http://www.ccl-cca.ca/ccl/Reports/HealthLiteracy/HealthLiteracy2007.html.
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Chalk River National Research Universal reactor

https://policybase.cma.ca/en/permalink/policy9919
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Text
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
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Proposed approach to the regulation of cannabis

https://policybase.cma.ca/en/permalink/policy13838
Date
2018-01-19
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2018-01-19
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association appreciates this opportunity to respond to Health Canada's public consultation on the proposed regulatory approach for the proposed Cannabis Act, Bill C-45. Our approach to cannabis is grounded in broad public health policy. It includes promotion of health and prevention of drug dependence and addiction; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines1 and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation,2 recommendations regarding Bill C-453 and submission on the cannabis excise duty framework.4 Therefore, we are limiting our response to those consultation questions that pertain to that approach and relate to our expertise and knowledge base. We are providing responses to questions 9, 10 and 11. Consultation questions Packaging and labelling 9. What do you think about the proposed rules for the packaging and labelling of cannabis products? Do you think additional information should be provided on the label? The CMA concurs with the proposed regulations. Packaging and labelling of cannabis products should include measures such as:
a requirement for plain and standard packaging,5 6
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause an overdose. Education is required to develop awareness among Canadians of the health, social and economic harms of cannabis use especially in young people. In that regard, the regulations with respect to packaging and labelling should be viewed as an opportunity to maximize educational opportunities. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Package inserts should include:
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. In addition, the regulations for the marketing and advertising of cannabis should use an approach similar to those in place for tobacco and cigarettes.7 8 9 Cannabis for medicinal purposes 10. What do you think about the proposed approach to providing cannabis for medical purposes? Do you think there should be any specific additional changes? CMA maintains its position that there should be one system with one set of regulations for medical and recreational cannabis. The CMA believes that once the Act and regulations are in force, there will be no need for two systems. Cannabis will be available for those who wish to use it for medicinal purposes, either with or without medical authorization, and for those who wish to use it for other purposes. The medical profession does not need to authorize use once cannabis is legalized, especially given that cannabis has not undergone Health Canada's usual pharmaceutical regulatory approval process, and its anticipated removal as a controlled substance from the Controlled Drugs and Substances Act. Those who have experienced a two-system approach in Washington and Colorado have remarked on the challenges of having dual standards and regulations (e.g., purchase and possession quantities, taxation levelsa 4) and the contribution to the grey market.b 11 Consistent with the advice it received from the Task Force on Legalization and Regulation of Cannabis,12 the government intends on pursuing both a medicinal and retail cannabis system at this time. In this instance the CMA supports regulations for each system being as similar as possible. Furthermore, the CMA strongly supports the need for appropriate and relevant data collection (e.g., interaction of individuals between the medicinal and retail systems) to provide the necessary evidence for the future legislative review, anticipated in three years' time. The CMA would expect to be involved and looks forward to participating in the criteria development, evaluation and performance review of the systems. Sale of health products containing cannabis 11. What do you think about the proposed restrictions on the sale of health products containing cannabis authorized by Health Canada? Do they strike an appropriate balance between facilitating access to safe, effective and high quality health products, and deterring illegal activities and youth access? Health products include prescription health products, non-prescription drugs, natural health products, cosmetics and medical devices. Although all these products are regulated by Health Canada, they undergo different levels of scrutiny for safety, efficacy and quality, and in some cases industry does not need to provide scientific evidence to support the claims made on the label. The level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence is needed for a DIN but not for a NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product. As a result, consumers presently do not have sufficient information to choose appropriate products. Health Canada launched a consultation in 201613 on the approval process of the categories of non-prescription drugs, natural health products and cosmetics ("self-care products") with the intent of modernizing the present regulations. The CMA fully supports this work and hopes it will be brought to a timely conclusion.14 With respect to all health products, the CMA supports a risk-based approach in which higher risk products, for example, those for which health claims are made, must meet a higher standard of review. Rigorous scientific evidence is needed to support claims of health benefits and to identify potential risks and adverse reactions. All health products containing cannabis must meet a high standard of review for safety, efficacy and quality, equivalent to that of the approval of prescription drugs (e.g., Marinol(r) and Sativex(r)), to protect Canadians from further misleading claims. Prescription drugs are subject to Health Canada's pharmaceutical regulatory approval process, based on each drug's specific indication, dose, route of administration and target population. Health claims need to be substantiated via a strong evidentiary process. With respect to the sale of cannabis products to youth, the CMA recommends the adoption of strict controls as outlined in the proposed regulations; as per the proposal, "All health products would be subject to provisions that control against practices that may appeal to youth, or the use of testimonials, real or fictional characters or animals, or lifestyle branding. Tamper-evident and child-resistant packaging requirements would also apply."15 We also support the additional precautions around medical devices, especially those sold to young persons. The CMA urges caution around the exemption for paediatric formulations that would allow for traits that would "appeal to youth." The CMA understands that these products, used under strict health professional supervision, should be child friendly, for example, regarding palatability, but we do not support marketing strategies that would suggest their use is recreational (e.g., producing them in candy or animal formats). There will be a need for careful monitoring of the health products released in the market and the health claims made. Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Various examples have been reported in the media highlighting the need to be vigilant, as illustrated in Switzerland regarding health and other products with cannabis and high cannabidiol content.16 17 a The CMA supports similar taxation treatment of cannabis products for medical and non-medical purposes. b Grey market refers to products produced or distributed in ways that are unauthorized or unregulated, but not strictly illegal. 1 Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH 2017 Aug;107(8):e1-e12. Available: http://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed& (accessed 2017 Jul 27). 2 Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada - Task Force on cannabis, legalization and regulation. Ottawa: The Association; 2016 Aug 29. Available: www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/2016-aug-29-cma-submission-legalization-and-regulation-of-marijuana-e.pdf (accessed 2017 Jul 27). 3 Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: The Association; 2017 Aug 18. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Jan 17). 4 Canadian Medical Association (CMA). Excise duty framework for cannabis products. Submission to the Government of Canada consultation on the proposed excise duty framework for cannabis products. Ottawa: The Association; 2017 Dec 7. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2018-06.pdf (accessed 2018 Jan 17). 5 Vardavas C, Filippidis F, Ward B, et al. Plain packaging of tobacco products in the European Union: an EU success story? European Respiratory Journal 2017;50:1701232 Available: http://erj.ersjournals.com/content/erj/50/5/1701232.full.pdf (accessed 2018 Jan 17). 6 Torjesen I. Standardised packs cut adult smoking as well as discouraging young people, evidence indicates BMJ 2015;350:h935. Available: http://www.bmj.com/content/350/bmj.h935 (accessed 2018 Jan 17). 7 Hughes N, Arora M, Grills N. Perceptions and impact of plain packaging of tobacco products in low and middle income countries, middle to upper income countries and low-income settings in high-income countries: a systematic review of the literature. BMJ Open 2016;6:e010391. doi:10.1136/bmjopen-2015-010391. Available: http://bmjopen.bmj.com/content/bmjopen/6/3/e010391.full.pdf (accessed 2018 Jan 17). 8 White V, Williams T, Wakefield M. Has the introduction of plain packaging with larger graphic health warnings changed adolescents' perceptions of cigarette packs and brands? Tob Control 2015;24:ii42-ii49. Available: http://tobaccocontrol.bmj.com/content/tobaccocontrol/24/Suppl_2/ii42.full.pdf (accessed 2018 Jan 17). 9 Smith C, Kraemer J, Johnson A, Mays D. Plain packaging of cigarettes: do we have sufficient evidence? Risk Management and Healthcare Policy 2015;8:21-30. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4396458/pdf/rmhp-8-021.pdf (accessed 2018 Jan 17). 10 Canadian Centre on Substance Use and Addiction (CCSA). Cannabis regulation: Lessons learned in Colorado and Washington State. Ottawa: CCSA; 2015 Nov. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2018 Jan 18). 11 Task Force on Cannabis Legalization and Regulation. A framework for the legalization and regulation of cannabis in Canada: final report. Ottawa: Health Canada; 2016. Available: https://www.canada.ca/content/dam/hc-sc/healthy-canadians/migration/task-force-marijuana-groupe-etude/framework-cadre/alt/framework-cadre-eng.pdf (accessed 2018 Jan 18). 12 Government of Canada. Consultation on the regulation of self-care products. Ottawa: Government of Canada; n/d. Available: https://www.canada.ca/en/health-canada/programs/consultation-regulation-self-care-products.html (accessed 2018 Jan 17). 13 Canadian Medical Association (CMA). Regulation of self-care products in Canada. Ottawa: The Association; 2016. Available: http://www.cma.corp/dbtw-wpd/Briefpdf/BR2017-11.pdf (accessed 2018 Jan 17). 14 Health Canada. Proposed approach to the regulation of cannabis [consultation]). Ottawa: Health Canada; 2017 Nov. Available: https://www.canada.ca/content/dam/hc-sc/documents/programs/consultation-proposed-approach-regulation-cannabis/proposed-approach-regulation-cannabis.pdf (accessed 2018 Jan 17). 15 Knodt M. In Switzerland, high-CBD cannabis being sold legally as 'Tobacco Substitute'. Seattle: Leafly; 2018. Available: https://www.leafly.com/news/politics/switzerland-high-cbd-cannabis-sold-legally-tobacco-substitute (accessed 2018 Jan 17). 16 Wiley C. Could a legal quirk bring cannabis tourism to Switzerland? The Telegraph 2017 Jul 28;Travel Section. Available: http://www.telegraph.co.uk/travel/destinations/europe/switzerland/articles/cannabis-tourism-has-arrived-in-switzerland/ (accessed 2018 Jan 17).
Documents
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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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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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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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Health Canada consultation on restriction of marketing and advertising of opioids

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

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

https://policybase.cma.ca/en/permalink/policy13931
Date
2018-08-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy endorsement
Date
2018-08-30
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Dear Premier Ford and Minister Elliott: We write to you as organizations concerned about the health and welfare of some of the most vulnerable Ontarians, following reports that your government plans to undertake an unnecessary review of the evidence on supervised consumption sites (SCS),1 and the even more troubling announcement that you are imposing a moratorium on the approval of new overdose prevention sites (OPS).2 All the available evidence, including substantial peer-reviewed scientific literature, demonstrates conclusively that these health services save lives and promote the health of people who use drugs. This includes opening doors to treatment. Rather than conduct an unnecessary review and delay expansion of these services, the Ontario government should work with community organizations and health providers to rapidly scale up these services. Delays mean more preventable overdose deaths and new infections of HIV, hepatitis C and other illnesses that could be averted. Multiple reviews of the evidence have already been done, and have established that SCS and OPS:
provide a needed health service, reducing overdose deaths and the sharing of drug-injection equipment (and the associated risk of transmission of blood-borne infections);
increase access to addiction treatment and other necessary health services; and
benefit public order by reducing public injecting.3 As you know, Canada is experiencing a large-scale opioid overdose crisis. In Ontario alone, overdose deaths related to opioids increased by 45 per cent in 2017, with more than three people dying every day during that year.4 The opioid overdose epidemic has been called “the worst drug safety crisis in Canadian history.”5 HIV, hepatitis C and other infections, as well as overdose deaths, are preventable if the right measures are taken. These include increasing voluntary access to treatment for problematic drug use (where Ontario must do better), and also simultaneously scaling up evidence-based harm reduction services such as SCS and OPS. We urge you to heed the recommendations of experts in public health, front-line clinicians, harm reduction staff, and people with lived experience of drug use. Rather than impeding access to life-saving health services, we urge you to work with community organizations and other health services providers to ensure greater, equitable access to SCS and OPS for the people of Ontario. Signed: Aboriginal Legal Services ACAS—Asian Community AIDS Services Action Canada for Sexual Health and Rights Addiction Services of Thames Valley Addictions and Mental Health Ontario Africans in Partnership Against AIDS AIDS Coalition of Nova Scotia AIDS Committee of North Bay and Area AIDS Committee of Toronto AIDS Committee of Windsor AIDS Committee of York Region AIDS Vancouver Island Alliance for Healthier Communities Atlantic Interdisciplinary Research Network on Hepatitis C and HIV Black Coalition for AIDS Prevention Breakaway Addiction Services Broadbent Institute Butterfly (Asian and Migrant Sex Workers Support Network) CACTUS Canadian Aboriginal AIDS Network Canadian AIDS Society Canadian Association of Community Health Centres Canadian HIV/AIDS Legal Network Canadian Medical Association Canadian Mental Health Association—Thunder Bay Branch Canadian Nurses Association Canadian Positive People Network Canadian Public Health Association Canadian Research Initiative on Substance Misuse—Prairie Node Canadian Students for Sensible Drug Policy Canadian Treatment Action Council Casey House CATIE Centre for Addiction and Mental Health (CAMH) Centre for Social Innovation Centre on Drug Policy Evaluation Chinese and Southeast Asian Legal Clinic Community Legal Assistance Sarnia Community Legal Services of Ottawa / Services juridiques communautaires d’Ottawa Community YWCA Muskoka Courage Co-Lab Inc. Direction 180 Dopamine Dr. Peter AIDS Foundation Elevate NWO Elgin-Oxford Legal Clinic Four Counties Addiction Services Team Gerstein Crisis Centre Guelph Community Health Centre Haliburton, Kawartha, Pine Ridge Drug Strategy Halifax Area Network of Drug Using People (HANDUP) Harm Reduction Nurses Association Health Providers Against Poverty HIV & AIDS Legal Clinic Ontario HIV Edmonton HIV/AIDS Regional Services HIV/AIDS Resources and Community Health Houselink Community Homes Housing Action Now! Huron Perth Community Legal Clinic Income Security Advocacy Centre (ISAC) Injured Workers Community Legal Clinic Inner City Health and Wellness Program Interagency Coalition on AIDS and Development (ICAD) Kensington-Bellwoods Community Legal Services Lake Country Community Legal Clinic Lakeside HOPE House Lanark County Interval House L’Anonyme Legal Clinic of Guelph and Wellington County Maggie’s Toronto Sexwork Action Project Maison Fraternité Mission Services of Hamilton Inc. Mississauga Community Legal Services MODIFY: Drug Insight From Youth Moms Stop the Harm mumsDU - moms united and mandated to saving the lives of Drug Users Native Youth Sexual Health Network Neighbourhood Legal Services London & Middlesex Nipissing Community Legal Clinic OHIP for All Ontario AIDS Network (OAN) Ontario Nurses’ Association Ontario Positive Asians (OPA+) Ottawa Salus Overdose Prevention Ottawa Parkdale Activity Recreation Centre Parkdale Community Legal Services Parkdale Queen West Community Health Centre PASAN PHS Community Services Society Planned Parenthood Toronto Queer Ontario Racial Health Equity Network Realize Reelout Arts Project Regent Park Community Health Centre Regional HIV/AIDS Connection Registered Nurses’ Association of Ontario (RNAO) Rideauwood Addiction and Family Services Sandy Hill Community Health Centre South Riverdale Community Health Centre Stonegate Community Health Centre Street Health Students for Sensible Drug Policy, Ryerson Chapter Superior North Emergency Medical Service Syme Woolner Neighbourhood and Family Centre Tanner Steffler Foundation The AIDS Committee of Cambridge, Kitchener, Waterloo and Area The Children’s Aid Society of the District of Thunder Bay The Interfaith Coalition to Fight Homelessness The Mental Health Consumer Survivor Project for Simcoe County Thunder Bay Catholic District School Board Thunder Bay Drug Strategy Timmins-Temiskaming Community Legal Clinic Toronto Overdose Prevention Society Toronto People With AIDS Foundation Waterloo Region Community Legal Services WellFort Community Health Services West Neighbourhood House West Toronto Community Legal Services Women & HIV/AIDS Initiative, Ontario YW Kitchener–Waterloo YWCA Hamilton YWCA Niagara Region YWCA Toronto Endnotes 1 F. Merali, “PCs ‘playing politics with people’s lives’ on injection sites, drug policy expert warns,” CBC News, August 4, 2018. Available at: www.cbc.ca/news/canada/toronto/supervised-injection-sites-waiting-1.4771143. 2 K. Bueckert, “Ontario puts new overdose prevention sites approvals on hold,” CBC News, August 11, 2018. Available at: www.cbc.ca/news/canada/kitchener-waterloo/ontario-overdose-prevention-sites-approval-hold-1.4782132. 3 E.g., M. Kennedy, M. Karamouzian & T. Kerr. “Public Health and Public Order Outcomes Associated with Supervised Drug Consumption Facilities: A Systematic Review,” Current HIV/AIDS Reports, 2017; 14(5): 161-183, doi: 10.1007/s11904-017-0363-y. Available at: www.salledeconsommation.fr/_media/public-health-and-public-order-outcomes-associated-with-supervised-drug-consumption-facilities-a-systematic-review.pdf. 4 Public Health Ontario, “Opioid-related morbidity and mortality in Ontario,” May 23, 2018. Available at: www.publichealthontario.ca/en/dataandanalytics/pages/opioid.aspx#/trends. 5 Municipal Drug Strategy Coordinators’ Network of Ontario, “Opioid Epidemic: Call for Urgent Action That Can Save Lives Now,” December 9, 2015.
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Health Canada consultation on tobacco products regulations (plain and standardized appearance)

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