text:
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs 15
Policy resolution 1
Response to consultation 3
topic:"Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs"
Health Canada consultation on Canadian drugs and substances strategy
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Response to consultation
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's consultation on new and innovative ideas on how to further strengthen the federal government's health-focussed approach to substance use issues through the Canadian Drugs and Substances Strategy (CDSS) Question 1 What sorts of circumstances do you see within your networks, communities or in society that you think contribute to problematic substance use? There are multiple factors that contribute to problematic substance use. It is a serious, chronic and relapsing medical condition for which there are effective treatments. However, using the social determinants as a framework, most health promotion and prevention efforts will take place outside of the traditional health and medical care services. . Many Canadians face barriers in their physical, social and economic environments which can contribute to problematic substance use, and certain populations are at higher risk given these circumstances. For example, early childhood is a critical time in the social, emotional, cognitive and physical development of a person. Experiences in early life can 'get under the skin', changing the ways that genes are expressed. Negative experiences such as poverty or family or parental violence can have significant impacts on this important period of development. What is necessary is a coordinated effort across government sectors to ensure that all policy decisions serve to increase opportunities for health. Improving population health and reducing inequities should be an overall objective for all governments in Canada. Question 2 Have you seen or experienced programs, practices or models at the local or regional level that could be expanded, or implemented more broadly, to improve circumstances or social determinants of health that influence substance use? Income is critical to individual health and is closely linked to many of the other social determinants of health. These include but are not limited to: education, employment, early childhood development, housing, social exclusion, and physical environment. Adequate consideration must be given to the social and economic determinants of health, factors such as income and housing that have a major impact on health outcomes. Minimizing poverty should be a top priority. In 2015, the CMA passed a resolution endorsing the concept of a basic income guarantee, which is a cash transfer from government to citizens not tied to labour market participation. It ensures sufficient income to meet basic needs and live with dignity, regardless of employment status. A basic income guarantee has the potential to alleviate or even eliminate poverty. It has the potential to reduce the substantial, long-term social consequences of poverty, including higher crime rates and fewer students achieving success in the educational system. Drug use must not be treated with a criminal justice approach, which does not address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. More investments need to be made in prevention, harm reduction and treatment, keeping individuals out of the criminal justice system. Drug use is a complex issue, and collaboration among health and public safety professionals, and society at large, is essential. Question 3 What needs to change to make sure that opioid medications are being provided and used appropriately, based on the needs of each patient? Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. Doctors support patients in the management of acute and chronic pain, as well as problematic substance use, and as such have long been concerned about the harms associated with opioid use. Treatment options and services for both problematic substance use as well as pain management are woefully under-resourced in Canada. Experts believe that improved access to specialized pain treatment could reduce inappropriate use of pain medications. Current best practices in pain management include care by an interprofessional team that could include physiotherapists, occupational therapists, psychologists and other health professionals; non-pharmaceutical interventions such as therapy for trauma and social pain, social supports and coping strategies; appropriate pharmaceutical prescription options, covered by provincial formularies; and a focus on patient participation and empowerment.12 Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. It is also important to support clinicians in their practice. The 2017 Opioid Prescribing Guidelines need to be kept current through ongoing funding. Physicians require tools, including those that facilitate monitoring of effectiveness and tolerance by tracking pain and physical function; screening for past and current substance use; screening for depression; and, tapering of problematic or ineffective doses. Question 4 How can we make sure that those who require prescription opioids to manage their pain have access to them, without judgement or discrimination? Governments need to incorporate the identification and elimination of stigma as a quality of care indicator in the ongoing monitoring of health system performance at all levels. They also need to implement and evaluate national public awareness and education strategies to counteract the stigma associated with substance use issues as well as enforcing legislation and regulations to guard against discrimination against people with mental and substance use issues. Health professionals need to have access to education on pain management and treatment of problematic substance use, recognizing both issues as serious medical conditions for which there are effective treatments. Question 5 Which kinds of messages would work best to help Canadians understand the serious harms that can result from stigma around substance use? A recent report from the Canadian Centre on Substance Use and Addiction (CCSA) and Public Safety Canada cited stigma as "an enormous barrier to individuals seeking and maintaining treatment." Even though there is broad recognition that we are in a public health crisis, until very recently the focus of the federal National Anti-Drug Strategy was heavily skewed towards a criminal justice approach rather than a public health approach with an emphasis on enforcement, as opposed to prevention, treatment and harm reduction.8 This has serious implications in how society views people who use drugs. As noted in the CCSA-Public Safety report, "Language matters. Speak about people first, with compassion and respect."13 A stigma reduction strategy must be core to the activities of the federal government. Stigma involves thoughts, emotions and behaviours; thus, a comprehensive approach includes interventions to target each of these dimensions at both the individual and population level. The strategy should include aspects of: * Public awareness and education to facilitate understanding about the importance of early diagnosis, treatment, recovery and prevention; * Enhanced provider/student education and support; * Policy analysis and modification of discriminatory legislation; * Support for a strong voluntary sector to voice the concerns of patients and their families; * Exposure to positive spokespeople (e.g. prominent Canadians) who have mental illness and/or addiction in order to highlight success stories; * Researching stigma. Question 6 How can we best act to reduce stigma across the country? Engagement with people who use drugs to help them share their stories and experiences with stigma with the public Question 7 What would you recommend to improve substance use treatment services in Canada? This challenge requires a complex and multifaceted solution; and to further this aim, Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs in Canada, whether illegal or prescription-based, complementing existing strategies to address the harms associated with the other two legal drugs - alcohol and tobacco. This comprehensive approach is necessary, as isolated measures can have unintended consequences, such as under-medicating people that require a medical treatment or constraining people to seek illegal drugs as an option when medications are made tamper-resistant. One of the fundamental principles of health care is that it be patient centred.11 CMA defines patient-centred care as "seamless access to the continuum of care in a timely manner … that takes into consideration the individual needs and preferences of the patient and his/her family and treats the patient with respect and dignity." It is essential that patients be core members of the health care team, working with health care providers to address their individual needs, preferences and aspirations and to seek their personal paths to well-being. Physicians and other health professionals can help patients make choices about their treatment and can provide information and support to patients and their families as they seek to cope with the effects of problematic use and live functional lives. The health care provider community needs tools to assist in the reduction of stigma, access to resources and supportive environments. Question 8 What obstacles or barriers do people face when they want to access treatment in Canada? Obstacles to treatment include the lack of publicly-funded treatment centres, access to locations for remote areas, limited number of beds available, the cost of private treatment (lack of insurance), and stigma. The CMA supports the enhancement of access to options for treatment that address different needs.12 Treatment programs must be coordinated and patient-centred, and address physical, psychological, social and spiritual circumstances. For example, it is important that treatment programs be culturally relevant for Indigenous communities. Question 10 In addition to current harm reduction initiatives – such as supervised consumption sites, needle exchange programs – what other harm reduction services should governments consider implementing in Canada? There is a dire need to address harm reduction in prisons. Even back in 2005, the CMA recommended to the Correctional Service of Canada that it develop, implement and evaluate a pilot needle exchange program in prison(s) under its jurisdiction. These services are not widespread and accessible to prison populations. In Canada, people in prison face far greater risk of HIV and hepatitis C infection because they are denied access to sterile injection equipment as a harm reduction strategy. Hospitals need to incorporate harm reduction strategies as well, allowing people who use drugs to access much needed health services. Question 12 How can we better bring public health and law enforcement together to explore ways to reduce the cycle of involvement for people who use substances with the criminal justice system? Training for police and other frontline criminal justice and corrections workers in how to interact with people with substance use issues is essential. The CMA believes that the government must take a broad public health policy approach. Changes to the criminal law affecting cannabis must not promote normalization of its use and must be tied to a national drug strategy that promotes awareness and prevention and provides for comprehensive treatment.13 The CMA recognized that a blanket prohibition of possession for teenagers and young adults would not reflect current reality or a harm reduction approach. 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. Question 13 What further steps can the federal government take to better address current regulation and enforcement priorities, such as addressing organized drug crime and the dangerous illegal drugs like fentanyl being brought into Canada? The federal government must continue to work closely with the RCMP, local and provincial law enforcement agencies, Canada Post, the Canadian Border Services Agency, Crown attorneys, the Canadian military, and international health officials and law enforcement agencies to address this issue. This topic was covered in the recent CCSA/Public Safety Canada report.10 Question 14 Recognizing Indigenous rights and self-determination, how can all governments work together to address the high rates of problematic substance use faced by some Indigenous communities? Difficulties in access are particularly acute for Canada's Indigenous peoples. Many live in communities with limited access to health care services, sometimes having to travel hundreds of miles to access care. Additionally, there are jurisdictional challenges; many fall through the cracks between the provincial and federal health systems. While geography is a significant barrier for Indigenous peoples, it is not the only one. Indigenous peoples living in Canada's urban centres also face difficulties. Poverty, social exclusion and discrimination can be barriers to needed health care. Of all federal spending on indigenous programs and services only 10% is allocated to urban Aboriginals. This means that Aboriginals living in urban areas are unable to access programs such as Aboriginal head start, or alcohol and drug services, which would be available if they were living on reserve. Further, even when care is available it may not be culturally appropriate. Canada's indigenous peoples tend to be over-represented in populations most at risk and with the greatest need for care, making the lack of access a much greater issue for their health status. It is important that problematic substance use programs be culturally relevant for Indigenous communities. It is clear that the First Nations and Inuit peoples of Canada experience mental illness, problematic substance use and poor mental health at rates exceeding that of other Canadians.11 Individual, community and population level factors contribute to this including socioeconomic status, social environment, child development, nutrition, maternal health, culture and access to health services. The urgent need to work with these communities and identify the structures and interventions to reduce the burden of mental illness and substance use is critical to the health and wellness and future of First Nations and Inuit peoples. Enhanced federal capacity should be created through First Nations and Inuit Health that will provide increased funding and support for First Nations and Inuit community health strategies. The establishment of a working groups comprised of First Nations and Inuit health experts and accountable to First Nations and Inuit leadership is essential for the success of this initiative. Both expert and resource supports are integral elements to facilitate and encourage culturally appropriate strategies and programming in these communities. Question 15 What can we learn from Indigenous approaches to problematic substance use, such as using holistic approaches, that may help inform activities under the CDSS? The federal government must consult First Nations, Inuit, and Métis representatives to develop programs that are culturally relevant and appropriate for Indigenous communities. Question 16 How can governments, and the health, social, and law enforcement sectors design more effective substance use policies and programs for at-risk populations? The government must identify and consult those communities and populations most at risk. This includes First Nations, Inuit, and Métis representatives, community advocates, municipalities, and provincial and local public health officers. Data that describes rates of use and issues specific to each at risk group is important to be able to better understand and address needs. Question 17 What are effective policies and programs to help improve access to prevention, treatment, and harm reduction services for at-risk populations? There are innovative approaches to address the needs of high-volume users as well as at-risk populations. As many of these involve greater integration between health and the community sector and attention to issues not traditionally funded through health care payment systems, there is a need to provide access to funds to enable these innovations to continue and be spread across the country. A targeted, integrated approach to identify communities in need is required and this must be based on reliable community data (i.e., meaningful use of patient data) which can be used to integrate resources to improve health status. For example, the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) is Canada's first multi-disease electronic medical records (EMR) surveillance and research system that allows family physicians, epidemiologists and researchers from across the country to better understand and manage chronic care conditions for their patients. Health information is collected from EMRs in the offices of participating primary care providers (e.g. family physicians) for the purposes of improving the quality of care for Canadians suffering from chronic and mental health conditions and three neurologic conditions including Alzheimer's and related dementias. CPCSSN makes it possible to securely collect and report on vital information from Canadians' health records to improve the way these chronic diseases and neurologic conditions are managed (http://cpcssn.ca/). Question 18 What urgent gaps related to substance use (in terms of data, surveillance, and/or research) need to be addressed in Canada? Improvements are being made in the collection of data in Canada. This is crucial to be able to assess the harms and track the trends and impact of the introduction of policy changes.12 As well, the government must continue to improve the ability of the Public Health Agency of Canada, the Canadian Institute of Health Information, the chief coroners of Canada and related agencies to collect, analyze and report data. One such program is the surveillance system in the United States called RADARS (Researched Abuse, Diversion and Addiction-Related Surveillance system) that is "a surveillance system that collects product-and geographically-specific data on abuse, misuse, and diversion of prescription drugs." It surveys data involving opioids including poison control centres, treatment programs, on the "illicit acquisition or distribution of prescription opioids, stimulants, and other prescription drugs of interest from entities investigating drug diversion cases," among other opioid-related issues. The CMA has recommended that all levels of government work with one another and with health professional regulatory agencies to develop a pan-Canadian system of real-time prescription monitoring. As a first step, the CMA recommends the establishment of consistent national standards for prescription monitoring. Prescription Monitoring Programs (PMP) should be compatible with existing electronic medical and pharmacy record systems and with provincial pharmaceutical databases. Participation in prescription monitoring programs should not impose an onerous administrative burden on health care providers. PMPs should not deter physicians from using controlled medications when necessary. Further, PMPs are a valuable component in addressing the gaps related to substance use. Question 19 How can we use research tools to better identify emerging substance use issues as early as possible? See above response to question 18 - "RADARS" Government of Canada. Consultation on strengthening Canada's approach to substance use issues. Ottawa: Health Canada; 2018. Available: https://www.canada.ca/en/health-canada/programs/consultation-strengthening-canada-approach-substance-use-issues.html (accessed 2018 Sep 5). Canadian Medical Association (CMA). Health in all policies. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-10.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Early childhood development. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-03.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Canadian Medical Association Submission on Motion 315 (Income Inequality). Ottawa: The Association; 2013. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2013-07.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). CMA's recommendations for effective poverty reduction strategies. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-04.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Bill C-2 An Act to amend the Controlled Drugs and Substances Act. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-11.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed: 2018 Nov 26). Canadian Medical Association (CMA). Non-prescription availability of low-dose codeine products. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-04.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Health Canada consultation on restriction of marketing and advertising of opioids. Ottawa: The Association; 2018. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2018-13.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Joint Canadian Medical Association & Canadian Psychiatric Association Policy - Access to mental health care. Ottawa: The Association; 2016. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf (accessed 2018 Nov 26). Canadian Medical Association (CMA). Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-15.pdf (accessed 2018 Nov 26). Public Safety Canada, Canadian Centre on Substance Use and Addiction. 2018 Law Enforcement Roundtable on the Opioid Crisis. Meeting Summary. Ottawa; 2018. Available: https://www.publicsafety.gc.ca/cnt/rsrcs/pblctns/lw-nfrcmnt-rndtbl-pd-crss-2018/index-en.aspx?utm_source=stakeholders&utm_medium=email&utm_campaign=opioidcrisis (accessed 2018 Nov 29). Canadian Medical Association (CMA). Study on Mental Health, Mental Illness and Addiction in Canada: Supplementary Submission to the Senate Standing Committee on Social Affairs, Science and Technology. Ottawa: The Association; 2006. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2006-01.pdf (accessed 2018 Nov 29). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Nov 2018). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Ottawa: The Association; 2017. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2017-09.pdf (accessed 2018 Nov 28). Canadian Medical Association (CMA). Ensuring equitable access to health care: Strategies for governments, health system planners, and the medical profession. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD14-04.pdf (accessed 2018 23 Nov). Canadian Medical Association (CMA). Submission to Advisory Panel on Healthcare Innovation. Ottawa: The Association; 2014. Available: http://policybase.cma.ca/dbtw-wpd/Briefpdf/BR2015-06.pdf (accessed 2018 Nov 29). Radars System. 2018. Available: https://www.radars.org/. (accessed: 2018 Nov 29). Canadian Medical Association (CMA). Harms associated with opioids and other psychoactive prescription drugs. Ottawa: The Association; 2015 Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-06.pdf (accessed 2018 Dec 4). Sproule B. Prescription Monitoring Programs in Canada: Best Practice and Program Review. Ottawa, ON, 2015 Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Prescription-Monitoring-Programs-in-Canada-Report-2015-en.pdf (accessed 2018 Dec 4).
Health Canada consultation on edible cannabis, extracts & topicals
The Canadian Medical Association appreciates this opportunity to respond to Health Canada's consultation on the proposed regulations for edible cannabis, cannabis extracts, and cannabis topicals. The CMA's approach to cannabis is grounded in public health policy. It includes promotion of health and prevention of problematic use; access to assessment, counselling and treatment services; and a harm reduction perspective. The CMA endorsed the Lower-Risk Cannabis Use Guidelines and has expressed these views in our recommendations to the Task Force on Cannabis Legalization and Regulation, recommendations regarding Bill C-45. As well, we submitted comments to Health Canada with respect to the consultation on the proposed regulatory approach for the Cannabis Act, Bill C-45. Canada's physicians have a longstanding concern about the health risks associated with consuming cannabis. , Consumers use these products for both recreational and medical purposes, compelling the need for accuracy in the labeling as well as quality control in the manufacturing process.10 Cannabis Edibles, Extracts and Topicals Cannabis will have a different effect on the user, depending on whether it is smoked or ingested, as in an edible. It has been found that "smoking marijuana results in clinical effects within 10 minutes, peak blood concentrations occur between 30 and 90 minutes, and clearance is complete within 4 hours of inhalation. Oral THC does not reach significant blood concentration until at least 30 minutes, with a peak at approximately 3 hours, and clearance approximately 12 hours after ingestion." Because of the delay in absorption when ingested, people might consume more to feel the psychoactive effects faster. This might lead to the consumption of very high doses and result in toxic effects, such as anxiety, paranoia and in rare cases, a psychotic reaction with delusions, hallucinations, incoherent speech and agitation. Rates of use of edibles are not well known. A recent study in California high schools found that "polyuse via multiple administration methods was a predominant pattern of cannabis use and report the first evidence, to our knowledge, of triple product polyuse of combustible, edible, and vaporized cannabis among youths." We are limiting our response to Health Canada's consultation questions that pertain to the CMA's position with respect to cannabis and relate to our expertise and knowledge base. Proposed THC limits for the new classes of cannabis products Standardization within all classes of cannabis products in a legal regime is essential. Tetrahydrocannabinol (THC) levels in black market products can vary widely so one can never be assured of the strength being purchased, creating the potential for significant harm. , Experience in jurisdictions where cannabis has been legalized has shown that restrictions on the potency of products (i.e., THC limits) are necessary, given the higher risks of harm associated with higher potencies.2 Prohibition of high potency products is important.3 THC limits should be based on the best available evidence of safety for consumers. The increased potency of cannabis over the years raises concerns about its use in edibles, extracts and topicals, offering a significant challenge with respect to regulating their use. This becomes particularly worrisome with respect to preadolescents and adolescents who should avoid using cannabis due to concerns with the impact on the developing brain.2 Use has been associated with a "significant increased risk of developing depression or suicidality in young adulthood." More research is needed with respect to the effects of cannabis on all age groups, especially children, adolescents and seniors. Saunders et al describe the case of an elderly patient with a history of coronary artery disease suffering what appears to have been a myocardial infarction after ingesting most of a marijuana lollipop that contained 90 mg of THC. Such cases demonstrate how crucial it is to establish appropriate levels of THC. This is an especially important consideration because "consuming cannabis-infused edibles may inadvertently result in toxicity because absorption can take hours, compared with minutes when smoking. An individual who does not yet feel an effect may over-consume." Small children and people with cognitive impairment will not be able to read labels, so preventive measures are very important, as with any pharmaceutical. Since legalizing cannabis, Colorado's Rocky Mountain Poison & Drug Center has reported an increase in calls related to edible exposures. Children can accidentally eat products that contain cannabis, making them ill enough to seek medical assistance. The CMA maintains that the proposed draft regulations of 10 mg per discrete unit and package is too high and should be established at a maximum of 5 mg per dose, given the higher risks of overconsumption with edibles, the risks of accidents in children and the experience in other jurisdictions. Colorado's limit was set at 10 mg per unit, and health authorities recognize that a lower limit would have been warranted to prevent more accidents. Other preventive measures, such as child proof packaging, are considered in other sections of this brief. The amount of THC must be displayed clearly and prominently on the package to help prevent accidental or overconsumption of the product. Rules addressing the types of ingredients and additives that could be used in edible cannabis, cannabis extracts, and cannabis topicals appropriately address public health and safety risks while enabling sufficient product diversity The CMA concurs with the proposed regulations. Experience in areas such as caffeinated, high-sugar alcoholic beverages provides ample evidence to proceed with restraint concerning the types of ingredients and additives that may be permitted in edible cannabis, cannabis extracts, and cannabis topicals. Proposed new rules for the packaging and labelling of the new classes of cannabis products The CMA reiterates its position with respect to the packaging and labelling of cannabis products as presented in its submission on the proposed approach to the regulation of cannabis.5 This includes:
a requirement for plain and standard packaging
prohibition of the use of appealing flavours and shapes,
a requirement for adequate content and potency labelling,
a requirement for comprehensive health warnings,
a requirement for childproof packaging, and
a requirement that the content in a package should not be sufficient to cause an overdose. Plain and standardized packaging is necessary with respect to edibles as their wider availability raises several public health issues, not the least of which is ingestion by young children. It is imperative that the packages and labels of edibles not resemble popular confectionaries, for example. As the Canadian Paediatric Society has noted, "the unintended consumption of edibles manufactured to look like sweets by younger children is particularly concerning."15 Also, by "restricting the extent to which marijuana edibles can look and taste like familiar sweets, (it) could also keep the psychological barriers to marijuana initiation among children and adolescents from being lowered." The CMA has adopted similar positions with respect to tobacco and vaping products. , , It is recognized that these regulations are targeted at products meant for the adult market, but the entry of these new classes also creates challenges beyond that audience. Teens are attracted to vaping cannabis rather than smoking it because "smoke is not combusted and also may allow for more covert use given the reduction in odor." , As well, as "edibles have no odor, they are largely undetectable to parents."23 The CMA views this as an opportunity to educate Canadians about the health, social and economic harms of cannabis especially in young people. Package inserts must outline and reinforce the health risks involved; they must also be designed by governments and health professionals, not cannabis producers or distributors. Inserts should include:5
information on securing the product in the home to prevent access by youth and children,
recommendations not to drive or to work with hazardous chemicals or operate equipment while using the contents of the package,
information on the health and social consequences (including legal penalties) of providing cannabis to those under a designated minimum age for purchasing, and
contact information for hotlines for poison control and for crisis support. Cannabis topicals, as outlined in the proposed regulations, would fall under the category of health products and be found in non-prescription drugs, natural health products, and cosmetics. The CMA believes that all health claims need to be substantiated with sufficient evidence that meets standards for efficacy, besides safety and quality, to protect Canadians from misleading claims.5 This is important because the level of proof required to obtain a Drug Identification Number (DIN) for prescription drugs is considerably higher than the level of proof required for a Natural Product Number (NPN); rigorous scientific evidence for effectiveness is needed for a DIN but not for an NPN. Consumers generally do not know about this distinction, believing that Health Canada has applied the same level of scrutiny to the health claims made for every product.5 Requirements for tamper-resistant and child-proof containers need to be in place to enhance consumer safety. More research is required to address the environmental concerns with extra packaging, which would result from single dose packaging. It is critical to put in place measures that make it difficult to ingest large doses of THC. Simply adding grooves to chocolate bars or baked goods, for example, separating different doses, is insufficient to prevent people, particularly children, from ingesting more than a dose (which in of itself is designed for an adult). As well, there is no guarantee that the THC is spread out uniformly throughout the product. More research is needed with respect to "determining risks and benefits through proper clinical trials;" that includes determining the safest level of THC for extracts and topicals to reassure consumers will not be harmed by these products.18 With regards to cannabidiol (CBD), it would seem that "published data from around the world has taught us that misleading labels as well as harmful contaminants are real and actual problems for CBD products."18 Health claims need to be substantiated via a strong evidentiary process. There will be a need for careful monitoring of the health products released in the market and the health claims made.5 Experience has shown that regulations can and will be circumvented, and these activities will have to be addressed. Edible cannabis and the requirement for all products to be labelled with a cannabis-specific nutrition facts table Yes. The CMA supports the use of a cannabis-specific nutrition facts table (NFT) as described in the proposed regulations.1 These products should have the same standards and regulations applied to them as traditional food products do under the Food and Drugs Regulations. As such, a cannabis-specific nutrition facts table will help consumers differentiate them from standard food products. The proposal for the labelling of small containers and the option to display certain information on a peel-back or accordion panel The size of the container should not be an impediment to supplying consumers with the necessary information to make informed choices. Manufacturers should be required to use whatever method (peel-back or accordion panel) is most efficient and conveys all the necessary information. As the CMA noted in a recent brief with respect to tobacco labeling the "amount of space given to the warnings should be sufficient to convey the maximum amount of information while remaining clear, visible, and legible. The warnings should be in proportion to the packaging available, like that of a regular cigarette package."20 Adding warnings on individual cigarettes, as we recommended, illustrates that it is feasible to apply important information to even the smallest surfaces.20 It is important to note that key information should be visible on the external part of the container, including the standardized cannabis symbol, ingredients and warnings. Proposal that the standardized cannabis symbol would be required on vaping devices, vaping cartridges, and wrappers Yes. As noted earlier, the CMA called for strict packaging requirements around both tobacco and vaping products.22 The requirement for the standardized cannabis symbol is an extension of that policy and to the labelling of cannabis products in general.5 Proposed new good production practices, such as the requirement to have a Preventive Control Plan, appropriately address the risks associated with the production of cannabis, including the risk of product contamination and cross-contamination Yes. The CMA concurs with this requirement. The requirement that the production of edible cannabis could not occur in a building where conventional food is produced Yes. The CMA concurs with this requirement. Separate facilities are necessary to prevent cross-contamination for the protection of consumer health and safety. Conclusion The CMA supports the federal government's commitment to a three-year legislative review as it affords the opportunity to evaluate the regulations' impact and adjust them as needed. It continues to be important to have good surveillance and monitoring systems, as well as to continue to learn from other jurisdictions where cannabis is legal for recreational purposes. Public education and awareness must accompany the introduction of new forms of cannabis, emphasizing the risks of accidental ingestion and overconsumption. It should also emphasize the need for safe storage of cannabis products, as well as personal possession limits. Much more research is needed into the impact of these new classes across all age groups, and into public health strategies that discourage use and increase harm reduction practices. It is fundamental that profit driven commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls, in a manner that is consistent with a public health approach. Government of Canada. Canada Gazette, Part I, Volume 152, Number 51: Regulations Amending the Cannabis Regulations (New Classes of Cannabis) Ottawa: Health Canada; 2018. Available: http://www.gazette.gc.ca/rp-pr/p1/2018/2018-12-22/html/reg4-eng.html (accessed 2018 Dec 22). Fischer B, Russell C, Sabioni P, et al. Lower-risk cannabis use guidelines: A comprehensive update of evidence and recommendations. AJPH. 2017 Aug;107(8):e1-e12. Available: https://ajph.aphapublications.org/doi/abs/10.2105/AJPH.2017.303818?url_ver=Z39.88-2003&rfr_id=ori%3Arid%3Acrossref.org&rfr_dat=cr_pub%3Dpubmed& (accessed 2019 Feb 01). Canadian Medical Association (CMA). Legalization, regulation and restriction of access to marijuana. CMA submission to the Government of Canada – Task Force on cannabis, legalization and regulation. Ottawa: CMA; 2016 Aug 29. Available: https://policybase.cma.ca/en/permalink/policy11954 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Bill C-45: The Cannabis Act. Submission to the House of Commons Health Committee. Ottawa: CMA; 2017 Aug 18. Available: https://policybase.cma.ca/en/permalink/policy13723 (accessed 2019 Feb 01). Canadian Medical Association (CMA). Proposed Approach to the Regulation of Cannabis. Ottawa: CMA; 2018 Jan 19. Available: https://policybase.cma.ca/en/permalink/policy13838 (accessed 2019 Feb 04). Canadian Medical Association (CMA). Health risks and harms associated with the use of marijuana. CMA Submission to the House of Commons Standing Committee on Health. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11138 (accessed 2019 Feb 14). Canadian Medical Association (CMA). A public health perspective on cannabis and other illegal drugs. CMA Submission to the Special Senate Committee on Illegal Drugs. Ottawa: CMA; 2002. Available: https://policybase.cma.ca/en/permalink/policy1968 (accessed 2019 Feb 14). Monte A, Zane R, Heard K. The Implications of Marijuana Legalization in Colorado JAMA. 2015 January 20; 313(3): 241–242 Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/ (accessed 2019 Feb 15). Peters E, Bae D, Barrington-Trimis J, et al. Prevalence and Sociodemographic Correlates of Adolescent Use and Polyuse of Combustible, Vaporized, and Edible Cannabis Products JAMA Network Open. 2018;1(5): e182765. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2703946 (accessed 2019 Feb 15). Wyonch R. Regulation of Edible and Concentrated Marijuana Products Intelligence Memos. Toronto: CD Howe Institute: 2018 Oct 2. Available: https://www.cdhowe.org/sites/default/files/blog_Rosalie_1002.pdf (accessed 2019 Feb 01). Vandrey R, Raber JC, Raber ME, et al. Cannabinoid Dose and Label Accuracy in Edible Medical Cannabis Products. Research Letter JAMA 2015 Jun 23-30;313(24):2491-3. Available: https://jamanetwork.com/journals/jama/fullarticle/2338239 (accessed 2019 Feb 06). Cascini F, Aiello C, Di Tanna G. Increasing Delta-9-Tetrahydrocannabinol ( -9-THC) Content in Herbal Cannabis Over Time: Systematic Review and Meta-Analysis. Curr Drug Abuse Rev. 2012 Mar;5(1):32-40. Available: https://www.datia.org/datia/resources/IncreasingDelta9.pdf (accessed 2019 Feb 14). Gobbi G, Atkin T, Zytynski T, et al. Association of Cannabis Use in Adolescence and Risk of Depression, Anxiety, and Suicidality in Young Adulthood. A Systematic Review and Meta-analysis JAMA Psychiatry. 2019 Feb 13. doi: 10.1001/jamapsychiatry.2018.4500. Available: https://jamanetwork.com/journals/jamapsychiatry/article-abstract/2723657 (accessed 2019 Feb 15). Saunders A, Stevenson RS. Marijuana Lollipop-Induced Myocardial Infarction. Can J Cardiol. 2019 Feb;35(2):229. Available: https://www.onlinecjc.ca/article/S0828-282X(18)31324-2/fulltext (accessed: 2019 Feb 11). Grant CN, Bélanger RE.Cannabis and Canada's children and youth. Paediatr Child Health. 2017 May;22(2):98-102. Available: https://www.cps.ca/en/documents/position/cannabis-children-and-youth (accessed 2019 Feb 06). Denver Public Heath. Substance Use Exposure Dashboard. Denver: Denver Public Health; 2018. Available: http://www.denverpublichealth.org/community-health-promotion/substance-misuse/substance-use-exposure-dashboard (accessed 2019 Feb 06). Neuwirth, J. (Colorado Department of Public Health and Environment). Personal interview. (2019 Jan 30). Paradis C, April N, Cyr C, et al. The Canadian alcopop tragedy should trigger evidence-informed revisions of federal alcohol regulations. Drug Alcohol Rev. 2019 Feb 4. Available: https://onlinelibrary.wiley.com/doi/epdf/10.1111/dar.12896 (accessed 2019 Feb 14). MacCoun, RJ, Mello MM, Half-Baked — The Retail Promotion of Marijuana Edibles. N Engl J Med 2015; 372:989-991. Available: https://www.nejm.org/doi/full/10.1056/NEJMp1416014 (accessed 2019 Feb 5). Canadian Medical Association (CMA). Health Canada Consultation on Tobacco Products Regulations (Plain and Standardized Appearance). Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13930 (accessed 2019 Feb 05). Canadian Medical Association (CMA). Health Canada's Consultation on New Health-related Labelling for Tobacco Products Ottawa: CMA; 2018. Available: https://policybase.cma.ca/en/permalink/policy13939 (accessed 2019 Feb 05). Canadian Medical Association (CMA) CMA's Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Non-smokers' Health Act and to make consequential amendments to other Acts Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 Feb 05). Johnson RM, Brooks-Russell A, Ma M, et al. Usual Modes of Marijuana Consumption Among High School Students in Colorado. J Stud Alcohol Drugs. 2016;77(4):580-8. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4987070/pdf/jsad.2016.77.580.pdf (accessed 2019 Feb 06). Friese B, Slater MD, Annechino R, et al. Teen Use of Marijuana Edibles: A Focus Group Study of an Emerging Issue. J Prim Prev. 2016 June 37(3):303–309. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4864086/pdf/nihms-766186.pdf (accessed 2019 Feb 06).
Health Canada consultation on reducing youth access and appeal of vaping products
The Canadian Medical Association (CMA) appreciates this opportunity to respond to Health Canada's consultation on Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures.1 Canada's physicians, who see the devastating effects of tobacco use every day in their practices, have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has always supported strong, comprehensive tobacco control legislation, enacted and enforced by all levels of government, and we continue to do so. This includes electronic cigarettes (e-cigarettes). Our approach to tobacco and vaping products is grounded in public health policy. We believe it is incumbent on all levels of government in Canada to continue working on comprehensive, coordinated and effective tobacco control strategies, including vaping products, to achieve the goal of reducing smoking prevalence. The CMA has stated its position to the federal government on electronic cigarettes and vaping clearly in recent years.2,3 In our April 2017 submission on Bill S-5 to the Senate Standing Committee on Social Affairs, Science and Technology we recommended that the restrictions on promotion of vaping products and devices should be the same as those for tobacco products.2 We also argued that the government should take the same approach to plain and standardized packaging regulations for e-cigarettes as has now been implemented for tobacco products.2 In our most recent brief we addressed the two main issues outlined in the government's Notice of Intent with respect to the advertising of vaping products: the placement of that advertising and the use of health warnings.3,4 We expressed concerns that the proposed regulations leave too wide an opening for vaping manufacturers to promote their products, especially to youth. Further, we reiterated our position that health warnings for vaping should be like those being considered for tobacco packages. This brief will address the issues of greatest concern to the CMA with respect to vaping and youth. This includes marketing, flavours, nicotine levels, and reducing vaping and e-cigarette use among youths. Introduction The Council of Chief Medical Officers of Health have expressed alarm at the rising number of Canadian youths who are vaping, finding this trend "very troubling."5 The Canadian Medical Association concurs with this assessment and appeals to the federal government to move urgently on this important public health issue. As our knowledge about the risks of using e-cigarettes increases, there is an even greater imperative to dissuade youth from taking up the habit. This is important because those youth "who believe that e-cigarettes are not harmful or are less harmful than cigarettes are more likely to use e-cigarettes than youth with more negative views of e-cigarettes."6 Marketing The e-cigarette marketplace is evolving quickly as new products emerge. The industry has made clever use of social media channels to promote their wares by taking advantage of the belief that they are a safer alternative to cigarettes.7 They have also promoted "innovative flavoring and highlighted the public performance of vaping."7 It is no surprise that the United States Food and Drug Administration (FDA) has referred to youth vaping as an "epidemic," calling it "one of the biggest public health challenges currently facing the FDA."8 As the US National Academies of Sciences, Engineering, and Medicine has noted "young people who begin with e-cigarettes are more likely to transition to combustible cigarette use and become smokers who are at risk to suffer the known health burdens of combustible tobacco cigarettes."9 However, some of the efforts employed to convince youth to take up vaping are especially troublesome. As the 4 US Centers for Disease Control and Prevention (CDC) reported, "one in 5 (US) high school students and 1 in 20 middle school students reported using e-cigarettes in the past 30 days in 2018," a significant rise in the number of high school students between 2011 and 2018.10 The use of social media campaigns employing "influencers" to capture more of the youth and young adult market or influence their choices shows the need to be especially vigilant.11 In an attempt to counter this influence, a group of over 100 public health and anti-tobacco organizations from 48 countries "are calling on Facebook, Instagram, Twitter and Snap to take "swift action" to curb advertising of tobacco products on their platforms."12 As much as the industry is making major efforts to attract or sway customers through advertising, youth themselves may hold the key to countering that pressure. A recent US study found that "adolescents generally had somewhat negative opinions of other adolescents who use e-cigarettes. Building on adolescents' negativity toward adolescent e-cigarette users may be a productive direction for prevention efforts, and clinicians can play an important role by keeping apprised of the products their adolescent patients are using and providing information on health effects to support negative opinions or dissuade formation of more positive ones."13 Health Canada can play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers.14 We reiterate the concerns we expressed in our recent brief on the potential measures to reduce advertising of vaping products and to help diminish their appeal to youth. The CMA noted that the sections most problematic to the Association were those encompassing public places, broadcast media, and the publications areas.3 Vaping advertisements should not be permitted at all in any of these spaces, with no exceptions.3 These areas need to be addressed on an urgent basis. Flavours As of 2013, over 7,000 flavours had been marketed in the US.15 The data indicated that "about 85% of youth who used e-cigarettes in the past 30 days adopted non-tobacco flavors such as fruit, candy, and dessert."15 Flavours are helpful in attracting youth, especially when coupled with assertions of lower harm.13 And they have been successful in doing so, as evidenced by the rise in the rates of vaping among youth.8, 16 The addition of a wide variety of flavours available in the pods makes them taste more palatable and less like smoking tobacco.16,17,18 The concern is that e-cigarettes "may further entice youth to experiment with e-cigarettes and boost e-cigarettes' influence on increased cigarette smoking susceptibility among youth."15 More worrisome, flavoured e-cigarettes "are recruiting females and those with low smoking-risk profile to experiment with conventional cigarettes."19 Limiting the availability of "child-friendly flavors" should be considered to reduce the attraction of vaping to youth.19 In a recent announcement, the US FDA has proposed to tighten e-cigarette sales and "remove from the market many of the fruity flavors …blamed on fueling "epidemic" levels of teen use."20 As we have noted in previous submissions, the CMA would prefer to see flavours banned to reduce the attractiveness of vaping to youth as much as possible, a sentiment shared by other expert groups. 2,3,21 Nicotine Levels One of the most popular devices to vape with is JUUL™, entering the US market in 2015.22 JUUL's™ nicotine pods contain 5% nicotine salt solution consisting of 59 mg/mL in 0.7 mL pods.17 Some of JUUL's™ competition have pods containing even higher levels (6% and 7%).17 The CMA is very concerned about the rising levels of nicotine available through the vaping process, especially by the newer delivery systems. They supply "high levels of nicotine with few of the deterrents that are inherent in other tobacco products. Traditional e-cigarette products use solutions with free-base nicotine formulations in which stronger nicotine concentrations can cause aversive user experiences."23 Nicotine, among other issues, "affects the developing brain by increasing the risk of addiction, mood disorders, lowered impulse control, and cognitive impairment.15,24 In addition to flavours, and to ease delivery and to make the taste more pleasant, nicotine salts are added to make the e-liquid "less harsh and less bitter" and "more 5 palatable despite higher nicotine levels."17 Addressing the Rise in Youth Vaping There are many factors that lead youth to experiment with vaping and e-cigarettes. For some it is simple curiosity, for others it is the availability of different flavours while still others perceive vaping as "cool," especially when they can use the vapour to perform "smoke tricks."25 The pod devices themselves (e.g., JUUL™) help enhance the allure because of the "unique aesthetic appeal of pod devices, ability to deliver nicotine at high concentrations and the convenience of using them quickly and discreetly."26 As vaping continues to grow in popularity, it will not be easy to curb youths' enthusiasm for it. However, it is too important of a public health issue to not intervene More research is needed into how youth perceive vaping and e-cigarettes as they do not hold a universally positive view of the habit.7,13 As well, there is evidence to suggest that many are coming to see vaping as being "uncool" and that there are potential health consequences to continued use.25 In view of the still-evolving evidence of the safety of vaping and e-cigarettes, "strategic and effective health communication campaigns that demystify the product and counteract misconceptions regarding e-cigarette use are needed."25 Further, "to reduce youth appeal, regulation efforts can include restricting the availability of e-cigarette flavors as well as visible vapors."25 Another approach to consider is the state of Colorado's recent creation of "a health advisory recommending that health care providers screen all youth specifically for vaping, in addition to tobacco use, because young people may not necessarily associate tobacco with vaping."27 Recommendations 1. The CMA calls for all vaping advertising to be strictly limited. The restrictions on the marketing and promotion of vaping products and devices should be the same as those for tobacco products. 2. The CMA recommends the limitation of number of flavours available to reduce the attractiveness of vaping to youth. 3. Health Canada should work to restrict the level of nicotine available for vaping products to avoid youth becoming addicted. 4. Health Canada must play a major role in encouraging and facilitating peer-to-peer discussions on the risks associated with vaping and help to offset the social media influencers. 5. Health Canada must develop communication campaigns directed at youth, parents and health care providers to demystify vaping and e-cigarettes and that create a link between tobacco and vaping. 1 Government of Canada. Reducing Youth Access and Appeal of Vaping Products - Consultation on Potential Regulatory Measures. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-reducing-youth-access-appeal-vaping-products-potential-regulatory-measures.html (accessed 2019 Apr 11). 2 Canadian Medical Association (CMA). CMA's Recommendations for Bill S-5: An Act to amend the Tobacco Act and the Nonsmokers' Health Act and to make consequential amendments to other Acts. Ottawa: CMA; 2017 Apr 7. Available: https://policybase.cma.ca/en/permalink/policy13641 (accessed 2019 May 13). 3 Canadian Medical Association (CMA). Health Canada consultation on the impact of vaping products advertising on youth and non-users of tobacco products. Ottawa: CMA; 2019 Mar 22. Available: https://policybase.cma.ca/en/permalink/policy14022 (accessed 2019 May 13). 4 Government of Canada. Notice to Interested Parties – Potential Measures to Reduce the Impact of Vaping Products Advertising on Youth and Non-users of Tobacco Products. Ottawa: Health Canada; 2019. Available: https://www.canada.ca/en/health-canada/programs/consultation-measures-reduce-impact-vaping-products-advertising-youthnon-users-tobacco-products.html (accessed 2019 Feb 27). 5 Public Health Agency of Canada. Statement from the Council of Chief Medical Officers of Health on the increasing rates of youth vaping in Canada. Health Canada; 2019. Available: https://www.newswire.ca/news-releases/statement-from-the-council-of-chief-medical-officers-of-health-on-the-increasing-rates-of-youth-vaping-in-canada-812817220.html (accessed 2019 May 14). 6 6 Glantz SA. The Evidence of Electronic Cigarette Risks Is Catching Up with Public Perception. JAMA Network Open 2019;2(3):e191032. doi:10.1001/jamanetworkopen.2019.1032. Available: https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2729460 (accessed 2019 May 14). 7 McCausland K., et al. The Messages Presented in Electronic Cigarette–Related Social Media Promotions and Discussion: Scoping Review. J Med Internet Res 2019;21(2):e11953). Available: https://www.jmir.org/2019/2/e11953/ (accessed 2019 May 14). 8 Food and Drug Administration (FDA). Statement from FDA Commissioner Scott Gottlieb, M.D., on new data demonstrating rising youth use of tobacco products and the agency's ongoing actions to confront the epidemic of youth e-cigarette use. Silver Spring, MD: FDA; February 11, 2019. Available: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-new-data-demonstrating-rising-youth-use-tobacco (accessed 2019 May 17). 9 National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. Washington, DC: The National Academies Press; 2018. Available: https://www.nap.edu/catalog/24952/public-health-consequences-of-e-cigarettes (accessed 2019 May 17). 10 Kuehn B. Youth e-Cigarette Use. JAMA. 2019;321(2):138. Available: https://jamanetwork.com/journals/jama/fullarticle/2720740 (accessed 2019 May 14). 11 Kirkum C. Philip Morris suspends social media campaign after Reuters exposes young 'influencers'. New York: Reuters; May 10, 2019. Available: https://www.reuters.com/article/us-philipmorris-ecigs-instagram-exclusiv/exclusive-philip-morris-suspends-social-media-campaign-after-reuters-exposes-young-influencers-idUSKCN1SH02K (accessed 2019 May 13). 12 Kirkham C. Citing Reuters report, health groups push tech firms to police tobacco marketing. New York: Reuters; May 22, 2109. Available: https://www.reuters.com/article/us-philipmorris-ecigs-socialmedia/citing-reuters-report-health-groups-push-tech-firms-to-police-tobacco-marketing-idUSKCN1SS1FX (accessed 2019 May 22). 13 McKelvey K, Popova L, Pepper JK, Brewer NT, Halpern-Felsher. Adolescents have unfavorable opinions of adolescents who use e-cigarettes. PLoS ONE 2018;13(11): e0206352. Available: https://doi.org/10.1371/journal.pone.0206352 (accessed 2019 May 14). 14 Calioa D. Vaping an 'epidemic,' Ottawa high school student says. Ottawa: CBC News; November 27, 2018. Available: https://www.cbc.ca/news/canada/ottawa/vaping-epidemic-ottawa-high-school-student-says-1.4918672 (accessed 2019 May 14). 15 Chen-Sankey JC, Kong G, Choi K. Perceived ease of flavored e-cigarette use and ecigarette use progression among youth never tobacco users. PLoS ONE 2019;14(2): e0212353. Available: https://doi.org/10.1371/journal.pone.0212353 (accessed 2019 May 17). 16 Drazen JM, Morrissey S, Campion EW. The Dangerous Flavors of E-Cigarettes. N Engl J Med 2019; 380:679-680. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMe1900484?articleTools=true (accessed 2019 May 17). 17 Jackler RK, Ramamurthi D. Nicotine arms race: JUUL and the high-nicotine product market Tob Control 2019;0:1–6. Available: https://www.ncbi.nlm.nih.gov/pubmed/30733312 (accessed 2019 May 20). 18 Reichardt EM., Guichon J. Vaping is an urgent threat to public health. Toronto: The Conversation; March 13, 2019. Available: https://theconversation.com/vaping-is-an-urgent-threat-to-public-health-112131 (accessed 2019 May 20). 19 Chen JC. et al. Flavored E-cigarette Use and Cigarette Smoking Susceptibility among Youth. Tob Regul Sci. 2017 January ; 3(1): 68–80. Available: https://www.ncbi.nlm.nih.gov/pubmed/30713989 (accessed 2019 May 20). 20 LaVito A. FDA outlines e-cigarette rules, tightens restrictions on fruity flavors to try to curb teen vaping. New Jersey: CNBC; March 13, 2019 Available: https://www.cnbc.com/2019/03/13/fda-tightens-restrictions-on-flavored-e-cigarettes-to-curb-teen-vaping.html (accessed 2019 Mar 20). 21 Ireland N. Pediatricians call for ban on flavoured vaping products — but Health Canada isn't going there. Toronto: CBC News; November 17, 2018 Available: https://www.cbc.ca/news/health/canadian-pediatricians-flavoured-vaping-second-opinion-1.4910030 (accessed 2019 May 20). 22 Huang J, Duan Z, Kwok J, et al. Vaping versus JUULing: how the extraordinary growth and marketing of JUUL transformed the US retail e-cigarette market. Tobacco Control 2019;28:146-151. Available: https://tobaccocontrol.bmj.com/content/tobaccocontrol/28/2/146.full.pdf (accessed 2019 May 21). 23 Barrington-Trimis JL, Leventhal AM. Adolescents' Use of "Pod Mod" E-Cigarettes — Urgent Concerns. N Engl J Med 2018; 379:1099-1102. Available: https://www.nejm.org/doi/pdf/10.1056/NEJMp1805758?articleTools=true (accessed 2019 May 20). 24 U.S. Department of Health and Human Services. E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health; 2016. Available: https://e-cigarettes.surgeongeneral.gov/documents/2016_sgr_full_report_non-508.pdf (accessed 2019 May 20). 25 Kong G. et al. Reasons for Electronic Cigarette Experimentation and Discontinuation Among Adolescents and Young Adults. Nicotine & Tobacco Research, 2015 Jul;17(7):847-54. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4674436/pdf/ntu257.pdf (accessed 2019 May 21). 26 Keamy-Minor E, McQuoid J, Ling PM. Young adult perceptions of JUUL and other pod electronic cigarette devices in California: a qualitative study. BMJ Open. 2019;9:e026306. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6500190/pdf/bmjopen-2018-026306.pdf (accessed 2019 May 21). 27 Ghosh TS, Et al. Youth Vaping and Associated Risk Behaviors — A Snapshot of Colorado. N Engl J Med 2019; 380:689-690.Available: https://www.nejm.org/doi/full/10.1056/NEJMc1900830 (accessed 2019 May 21).
Psycho-active substances and the operation of motor vehicles and industrial equipment
https://policybase.cma.ca/en/permalink/policy781
That the membership of the Canadian Medical Association clearly inform its patients, and the general public at large, of the hazards associated with the operation of motor vehicles, industrial equipment, etc., while under the influence of psycho-active substances, especially alcohol and antihistamines, and particularly the combination of such substances.
The Right Drugs, at the Right Times, for the Right Prices: Toward a Prescription Drug Policy for Canada : CMA Presentation to House of Commons Standing Committee on Health
Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada. Prescription drugs have benefited both the health of Canadians, and the health care system itself; they have meant dramatically improved quality of life for many Canadians, and have saved the country a great deal in hospitalization, social benefits and other expenses. However, it could be questioned whether all of Canada's prescription drug use is appropriate; patients may be receiving too few medications, too many medications or suboptimal medications for their conditions. In addition, prescription drugs carry a price tag of their own. Since 1975, expenditures on prescription medication have risen faster than any other category in the health sector in Canada, and more is now spent on prescription drugs than on physician services. Governments, health care providers, drug manufacturers and the public must constantly strive to ensure that Canadians receive optimal and appropriate prescription drug therapy: the right drugs, at the right times, for the right prices. A considered, coherent, comprehensive, "made in Canada" approach to prescription drug policy should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. Prescription drug policy in Canada should address: Access: to * efficacious new drugs within an appropriate time; * coverage for medically necessary drugs for catastrophic care; * generic drugs at reasonable prices; * a patient/physician consultation as part of the prescribing process; * continued research and development capacity in Canada. Information for health care providers and the public that is balanced and accurate. Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada's doctors are committed to working with others to ensure that Canadians receive the right drugs, at the right times, for the right prices. Summary of CMA Recommendations: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to all drugs that demonstrate a substantial improvement over products already on the market. 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for all Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship which exists between the patient and the physician. 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. PURPOSE The Canadian Medical Association (CMA) has prepared this submission for the House of Commons Standing Committee on Health's review of prescription drugs in Canada. We applaud this review and welcome the opportunity to present the views of Canada's medical community. Our vision is simple: that all Canadians should receive, if appropriate, the right drugs for their conditions, at the right times, for the right prices. Governments, health care providers, drug manufacturers and the public should all work together to develop a "made in Canada" prescription drug policy to realize this vision. This policy must be considered, coherent and comprehensive, and should: * Put the health of the patient first; * Promote and enhance quality prescribing; * Respect, sustain and enhance the therapeutic relationship between patients and health professionals; * Promote patient compliance with drug therapy; * Respect the principles of patient confidentiality and the privacy of patient and prescriber information. In developing this policy we consider it particularly important to address the issues of: Access to quality health care In this context, the CMA's vision of a National Access Strategy includes appropriate access to * efficacious new drugs within an appropriate time, * coverage for medically necessary drugs for catastrophic care, * generic drugs at reasonable prices, * a patient/physician consultation as part of the prescribing process, * continued research and development capacity in Canada. * Information for health care providers and the public that is balanced and accurate. * Safety: through mechanisms for the systematic monitoring of prescription drugs and their effects. Canada's doctors look forward to working with others to realize our vision. In this submission we will discuss the steps that the CMA recommends be taken. INTRODUCTION The value of prescription medications Prescription drugs play an important role in preventing and treating health conditions. Every year, three hundred million prescriptions – about 10 for every man, woman and child – are filled in Canada1. In recent years, powerful new medications have meant dramatically improved quality of life, or substantial change in modes and patterns of treatment, for many Canadians. Anti-retroviral treatment has saved thousands of people with HIV infection from rapid, fatal progression to AIDS. Thanks to selective serotonin reuptake inhibitors (SSRIs) millions of people with chronic depression who might otherwise have been incapacitated or institutionalized can lead normal, productive lives in the community. Drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. Though the cumulative savings on hospital care, lost workforce productivity, social benefits and disability insurance payments due to prescription drug use have not been quantified, they have undoubtedly been significant. Areas of Concern In short, prescription drugs have benefited both the health of Canadians, and the health care system itself. However, they have also created concerns that must be addressed. Utilization: is it Appropriate? Experts have questioned whether all of Canada's prescription drug use is appropriate: are patients receiving too many medications, too few medications, or suboptimal medications for their conditions? Over-utilization of prescription drugs has been a topic of some attention, but under-utilization also exists. For example, as many as 60% of people with high blood pressure may not be receiving treatment; many of these people do not even know they have the condition.2 In addition, patient compliance with prescription drug therapy is increasingly recognized as a problem, especially for long-term or chronic conditions. Compliance is a potential issue in all treatments but is of special concern in conditions where few clinical symptoms are present: for example in hypertension, where lack of treatment over the long term may result in kidney damage, vascular and opthalmological damage, stroke or heart disease. One study found that only 50% of patients comply with long-term drug therapy, and an even smaller percentage comply with lifestyle alterations.3 Partial compliance with antibiotic therapy for infectious diseases is well recognized as one cause of anti-microbial resistance to common infectious pathogens. Cost: is it too high? More is now spent on prescription medicine than on physician services. Since 1975, expenditures on prescription medication have risen faster than any other category;4 during the 1990's they rose more than twice as quickly as overall spending on health care.5 In 2002 retail spending on drugs in Canada (prescribed and non-prescribed) was estimated to be at least 16% of total health care spending. Prescription medication accounts for 80% of this category, up from 70.3% in 1990. What drives drug expenditure in Canada? There is considerable debate on this subject, but some of the drivers are believed to be: * Increased utilization: as the population ages there is an increased prevalence of conditions such as hypertension, type 2 diabetes mellitus and osteoarthritis, which often require pharmacological treatment. * Newer (patented) drugs, which are more expensive than generics, dominate the prescription market. Between 1995 and 2000, five drug categories (including cholesterol lowering agents, high blood pressure drugs, acid-reducing agents and anti-depressants) contributed significantly to the overall rise in drug costs.5 These categories are dominated by newer, patented drugs, many of which are heavily promoted. * Prices of generic drugs, though lower than those of patented drugs, are higher in Canada than in some other countries. For example, generic drug prices are 26% lower in Germany and 68% lower in New Zealand.6 * Marketing practices such as mass media direct to consumer advertising (DTCA) in the United States, and its attendant "spillover" into the Canadian marketplace, may contribute to increased utilization. In Canada the Patent Medicine Prices Review Board (PMPRB) maintains price controls on brand-name drugs. Similar price-control mechanisms exist in European Union countries. However, no such controls exist for generic medications in Canada. All in all, prescription medications can be costly for Canadians, especially for those who lack any kind of insurance coverage. The Role of Physicians and the Canadian Medical Association Canada's doctors are committed to ensuring that Canadians have access to the right drugs, at the right times, at the right prices, to help them achieve the right results – in other words, the best possible health outcomes. The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Patients, physicians and pharmacists must work in collaboration to achieve this goal. The physician's role in drug therapy goes well beyond the act of writing out a prescription; it encompasses: * Diagnosing diseases, assessing the need for drug therapy and designing the medication regime; * Working with patients to set treatment goals and monitor progress toward them; * Monitoring the patient's response to drug therapy, revising the care plan when necessary to support compliance and achieve the best possible health outcomes; * Sharing with the patient specific information about the diseases and the drug therapy, including its effects and potential side effects (including, in some cases, the potential for prescription drug addiction).7 The CMA's activity has been focused on promoting excellence in prescribing, and on disseminating drug information to physicians.8 In 1999, the CMA worked with Health Canada and the Canadian Pharmacists Association (CPhA) to convene an expert roundtable on the subject of "Best Practices in Prescribing". This was but one effort of the profession to explore why some therapies appear to be under-prescribed, while others may be over-prescribed. CMA has developed principles on the issues of physician information and of providing information on prescription drugs to consumers; both these documents will be discussed later in this submission. CMA and CPhA have also developed a joint policy statement on approaches to enhancing the quality of drug therapy (attached as Appendix I). In addition CMA is co-funding, with the Canadian Institute of Health Research, an interdisciplinary research team focussed on Drug Policy Futures. The team's identified areas of study include: financing and public expectations; improving quality; health care evaluation and technology assessment; and public advice-seeking in the era of e-health. The CMA publishes Drugs of Choice, a definitive Canadian guide to first- and second-line drug therapies for hundreds of clinical conditions. It is now in its third edition. In addition CMA maintains an extensive database of clinical practice guidelines, including prescribing guidelines, available to physicians and the public through the CMA Web site, and has developed an on line course for physicians on Safe Medication Practices. The cma.ca web site also provides access to a Canadian online drug database that can be downloaded and used with state-of-the-art PDA (personal device) technology at the point of clinical care. CMA'S PRIORITIES FOR ACTION A) Access to quality health care CMA's history of advocating for access to needed health care services goes back many years. In 2004, a National Access Strategy will be one of the association's highest-priority activities. With respect to prescription drugs there are several access-related problems: slow approval of new drugs, uneven insurance coverage, and the possible consequences of cross-border shopping on the availability of drugs in Canada. i) Drug Approvals: The Right Drug at the Right Time CMA recommends: 1. That the federal government implement a timely and efficient drug review process to reduce review times to a level at or better than that in other OECD countries. 2. That the pharmaceutical industry give priority to research and development on drugs and delivery mechanisms that demonstrate a substantial improvement over products already on the market. 3. That Health Canada apply a priority review process to drugs that demonstrate a substantial improvement over products already on the market. Stakeholders have repeatedly drawn attention to the slowness of Canada's drug review process. Between 1996 and 1998 Canadian approval times (median 518 days) were significantly longer than Sweden (median 371 days), the UK (median 308 days) and the United States (median 369 days). These have not improved significantly even after Health Canada implemented a cost-recovery approach to funding the drug review process. Delays in the drug review process mean delays in access to new, potentially life-saving medications. For example, 15 other countries approved Singulair, a major breakthrough in asthma therapy, before it was approved in Canada, even though the drug was developed in Montreal! Approximately 10% of children between 5 and 14 years of age have asthma and could have benefited from this relatively safe drug. Intravenous tissue plasminogen activator (tPA), a medication for treatment of acute stroke, was approved for use in the United States in 1996 but was not approved in Canada until 1999. Canada's long drug review times are mainly attributed to lack of resources at Health Canada. CMA recommends that Canada implement a timely and efficient drug review process to reduce these times to an appropriate level. The 2003 federal budget announcement of $190 million over five years to improve the timeliness of the regulatory process was encouraging. We hope that this will soon translate into a significant reduction in drug review times. Many drugs submitted for approval are not genuinely innovative; some are virtual copies of drugs already on the market. Others, however, could offer substantial improvement over what is currently available. They could be more clinically effective; or they could have fewer side effects; or their mechanism of delivery could increase compliance (for example, medication that can be taken only once a day instead of three or four times a day). CMA recommends that the pharmaceutical industry give priority to research and development on products and delivery mechanisms that offer substantial additional benefit to Canadian patients. It seems logical that drugs that offer benefits not yet available to Canadians should reach patients who need them more quickly. Recently, Health Canada implemented a priority review process for drugs to treat serious, life threatening or debilitating conditions, for which there is substantial evidence that the drug is a significant improvement over existing therapies. This is a promising step. CMA recommends that Health Canada apply a priority review process to all drugs deemed to offer substantial improvement over what is already on the market. This will also serve as an incentive to the pharmaceutical industry to emphasize drugs that offer substantial benefit in their research and development plans. ii) Coverage: Making the System Work CMA recommends: 4. That governments and insurance providers conduct research to identify the current gaps in prescription drug coverage for Canadians, and develop policy options for providing this coverage, including consideration of the roles of public and private payers. Coverage for all Canadians. Prescription drugs are Canada's most notable example of a public/ private partnership in health services delivery. Our country's blend of public and private drug insurance coverage has worked reasonably well; but there is room for improvement. The Canada Health Act's mandate covers "drugs, biologicals and related preparations when administered in the hospital". Provincial and territorial drug programs vary with most covering only seniors and people on social assistance.9 Many Canadians get their drug coverage through private plans offered by their employers. But many people in Canada lack any kind of drug coverage. We do not know exactly how many. According to a report prepared for the Canadian Life and Health Insurance Association, 2% to 4% of Canadians have no coverage, but other reports place the number closer to 10%.10,11 At a minimum, 1 million to 3 million Canadians are in need of basic prescription drug coverage. Drug therapy may be more cost-efficient than some forms of hospital care. Is the current health care system promoting inefficiency by covering hospital services more completely than prescription drug therapy? In 1997 the National Forum on Health recommended that drugs become part of the publicly funded system. However, such a system would be prohibitively expensive; estimates range from $12.4 billion for a combined public and private model (with co-payments) to $13.8 billion for fully funded, public only model (no co-payments).12 The report of the Romanow Commission acknowledged this when it emphasized the need to "move in a gradual but deliberate and dedicated way to integrate prescription drugs more fully into the continuum of care". For the short term, the report recommended a Catastrophic Drug Transfer to ensure that Canadians who face the greatest financial burden can continue to access the medications they need. The Trillium program in Ontario is an example of such a program. We need to know more about both the number of people who need drug coverage and the best means of providing them with it. As a first step, CMA recommends that the government, insurance providers and all partners in the public and private sectors conduct research to more accurately identify current gaps in prescription drug coverage, and develop policy options for bridging them. Given the ever larger role that prescription drug therapy is playing in health care in Canada, governments should consider expanding the current basket of "core services" to include prescription drugs. Under the Canada Health Act provinces and territories must ensure that medically necessary physician and hospital services are provided on a first-dollar basis. CMA has recommended that the scope of the basket of core services be updated regularly to reflect the realities of health care delivery and the needs of Canadians. Given the potential of prescription drugs to improve the system's cost-effectiveness, we believe that Canadian governments must consider whether the concept of "core services" needs to be revised to reflect their importance, provided that this does not further compromise access to medically necessary hospital and physician services. Drug Pricing Policies: Toward a Policy for All Drugs in Canada. As mentioned previously, PMPRB controls the prices of brand-name patent medications in Canada. However, generic drug make up 40% of the drugs prescribed in this country. Canada has no mechanism to control the prices of generic drugs, as do some other countries (France, for example, has a decree stating that the price of a generic product must be at least 30% less than the price of the original patented brand.) 6 Most provinces have policies encouraging substitution of a brand drug by a comparable generic where appropriate. CMA believes it is time for Canadian governments to explore mechanisms for ensuring appropriate pricing of generic medications. Product Substitution: Making health the first priority. Even under their current system of limited coverage, federal and provincial governments have expressed concern about the cost of their drug programs, and implemented measures to reduce this cost. One of these is drug product substitution. Generic substitution, discussed in the previous section, is now commonplace; British Columbia has taken the concept further with its system of reference-based pricing. While CMA recognizes the motives behind drug product substitution, we believe that it should only be implemented if it does not jeopardize quality of care or patient confidentiality. Doctors would be happy to participate in discussion of initiatives around drug product substitution, to ensure that the health of the patient continues to be the highest priority to all stakeholders. iii) Access and Cross-Border Prescribing CMA recommends: 5. That the federal government monitor and, if necessary, regulate the export of prescription medications to ensure their continued availability to Canadians. 6. That prescribing of medication be done within the context of the therapeutic relationship that exists between the patient and the physician. Prices of brand-name prescription drugs prices are higher in the US, where no price review body exists, than they are in Canada. As a result access to the need for prescription medication can pose considerable financial hardship, particularly for America's elderly and poor. The rising cost of brand-name medications in the United States has led many Americans to look to Canada for less expensive alternatives. At least one US city, Springfield, Massachusetts, has begun a voluntary program to purchase prescription medication from Canada for its workers and retirees13 and the State of Illinois is examining the feasibility of following Springfield's lead.14 US drug costs have also spurred a growth industry in Canada: Internet pharmacies. According to estimates in US media, approximately $650 million (US) worth of prescriptions are sold online every year.15 The prospect of accessing cheaper Canadian drugs is particularly appealing to elderly Americans who have turned to the Internet to purchase prescriptions they would be unable to afford at home. The burgeoning cross-border export of pharmaceuticals has had its consequences. Several brand-name multinational pharmaceutical manufactures have moved to stop or limit supplies to those Canadian pharmacies they believe are selling drugs over the Internet. They must now order directly from the manufacturer instead of from wholesalers.16 The brand-name companies have also held out the prospect of boycotting Canada in response to legislation passed by the US House of Representatives that would allow the importation of drugs by Americans.17 This legislation is now before the US Senate Health, Education, Labor and Pensions Committee. The US Food and Drug Administration has opposed importation on safety grounds. The CMA shares the increasingly prevalent concern that cross-border export will result in reduced access to prescription drugs in Canada, and damage the research and development capacity of brand-name prescription drug manufacturers in Canada. Therefore the CMA recommends that Canada monitor and, if necessary, regulate the export of brand-name drugs to ensure their continued availability in this country. Many Internet pharmacies offer the services of physicians who will sign prescriptions without seeing the patient in a consultation. This is not acceptable to the CMA, or to the regulatory Colleges of Physicians and Surgeons or the Canadian Medical Protective Association. It is clear that, in principle, to form an appropriate therapeutic relationship a physician must take a history, perform an appropriate physical examination, and order and interpret appropriate diagnostic tests on her patients. The role of the physician in drug therapy is a complex one; to be most effective it requires a strong ongoing professional relationship between patient and physician. This relationship is the foundation of medical practice; it is key to a prescribing decision and it must be maintained. Our position is discussed in greater detail in CMA's Statement on Internet Prescribing (attached as Appendix II). B) Consumer Drug Information: From DTCA to DTCI CMA recommends: 7. That brand-specific direct to consumer prescription drug advertising (DTCA) not be permitted in Canada. 8. That the federal government enforce the existing restrictions on DTCA found in the Food and Drug Act to the full extent of the law. 9. That the federal government develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. In the past few years an increasing amount of information on prescription medication has become available to consumers. Much of this reaches Canadians in the form of direct to consumer advertising (DTCA) for specific brands, transmitted across the border from the United States, where it is a billion-dollar-a-year business. DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, advertisers have taken advantage of loopholes in the law to promote brand-name drugs in this country – for example, the controversial television campaign for Viagra. DTCA is also transmitted by print and TV across the border from the United States, and worldwide through the Internet. There is a strong lobby for a relaxation of the DTCA restrictions in Canada. DTCA boosts sales of advertised drugs. In 1999, 25 drugs accounted for 40% of that year's increase in retail drug spending in the US; all these drugs were advertised to the public.18 Further, DTCA adversely affects the patient/physician relationship. Doctors report feeling pressure and ambivalence when patients ask them to prescribe a specific brand-name drug. 19,20 About 20% of respondents to the CMA's 2003 physician survey felt patients' request for advertised drugs had a negative impact on the patient/physician relationship.21 Advocates for DTCA maintain that it provides "consumers" with the information they need to become partners in their own health care. They maintain that DTCA does not undermine the patient/physician relationship, because it does not alter the fact that ultimate prescribing authority remains in the hands of the physician. However, the CMA believes that direct to consumer advertising of prescription drugs is inappropriate. DTCA * does not communicate risk adequately, or provide enough information to allow the consumer to make appropriate drug selections. Generally it does not provide information about other products or therapies that could be used to treat the same condition, * stimulates demand by exaggerating the risks of a disease and generating unnecessary fear, * contributes to a culture of "overmedicalization" by treating normal human conditions such as aging and baldness as diseases, and offering "a pill for every ill". Brand-specific direct to consumer prescription drug advertising should not be permitted in Canada. CMA calls on the federal government to enforce the existing restrictions on DTCA found in the Food and Drug Act and its regulations to the full extent of the law. We believe that the public has a right to accurate, unbiased direct to consumer information (DTCI) on drugs and other therapies, to enable patients to make decisions regarding their own health care. This information may increase the appropriateness of prescription drug use. For example, it may encourage consumers to get treatment for conditions that are currently under-treated. However, there are more effective ways to provide this information than brand-name advertising. CMA has developed "Principles for Providing Information about Prescription Drugs to Consumers" as an alternative to DTCA; these are attached as Appendix III. We call on Canadian stakeholders, including governments, health professionals, consumer groups and industry, to work together to provide information for the public based on these principles. Further, the CMA calls on the federal government to develop and fund a comprehensive program to provide accurate, unbiased prescription drug information to patients. C) Safety: Ensuring Best Practices in Prescribing CMA recommends: 10. That all stakeholders join in supporting and encouraging outcome-based research to ascertain best practices in prescribing. 11. That government accelerate activities to establish the Patient Safety Institute using a systems approach to support a culture of safety. 12. That a post-marketing surveillance system be implemented to monitor the ongoing safety of marketed drugs. The health care system is complex, involving many inter-related and interdependent factors which could influence the frequency and intensity of medication incidents. Such "systems factors" might include * shortage of qualified health professionals (physicians, nurses and others), * inappropriate use of new technology, * unclear labeling or similar-looking drug preparations, * prescription drug misuse, including over-prescribing or under-prescribing of certain medications. Canada's doctors are working to promote drug safety on a number of fronts. For example, CMA is working with governments at all levels to ensure that we do not "enrich the nation's urine" through unnecessary prescribing. The Canadian Medical Association Journal regularly publishes research on prescribing practices. CMA also publishes Safe Medication Practices, a physician guide to patient safety; a companion online course is available on the cma.ca web site. We propose that the health care system work to create a culture that promotes optimal prescribing, by fostering outcomes research, creating supportive infrastructures, strengthening the capacity for post-marketing surveillance, and making the best possible use of technology. Our suggestions are discussed below. Closing the Care Gap. Given our present knowledge base, it is often difficult to ascertain whether current drug utilization patterns lead to improvements in health. For example, research on compliance with drug therapy, and the factors that improve it, is in its infancy and though we know that direct-to-consumer advertising affects drug sales we have yet to determine whether it affects health outcomes. A commitment to outcome-based research on drug utilization would help us find the answers to these and other questions. Research on prescribing patterns should respect the conditions outlined in CMA's "Principles Concerning Physician Information" (attached as Appendix IV). The CMA calls on all stakeholders (governments, health professionals and the private sector) to join in supporting and encouraging outcome-based research to ascertain best practices in drug utilization and prescribing, and close care gaps when they are identified. Creating an infrastructure for safety. The CMA has no doubt of the overall quality of the prescription medications approved for use in Canada. However, the more drugs are used, the greater their potential for unintended harm. Studies in the United States have found that almost 2% of patients admitted to hospitals experienced a significant adverse drug event, and that the number of deaths due to medications increased over 200% over five years.22 Though studies are still in progress in Canada, we assume that rates of adverse medication events are similar in the two countries. The 2003 federal budget committed $10 million per year to establish a Patient Safety Institute to monitor and prevent medical incidents. This is an important step toward building a safer health care system, and Canada's doctors are committed to moving this initiative forward. The CMA, with 11 other health care organizations, is a member of the Canadian Coalition on Medication Incident Reporting and Prevention. This initiative is led by Health Canada and has recently been funded through the Patient Safety Initiative. The federal government has also recently funded the Canadian Medication Incident Reporting and Prevention System to collect data on medication incidents and disseminate information designed to reduce their risk. The CMA believes that to be effective a patient safety initiative must * be voluntary, * be non-punitive; and * protect the privacy and confidentiality of physicians and patients. Further, efforts towards ensuring patient safety should address in a timely manner the "systems" issues referred to above, supporting and fostering a culture of safety. CMA is calling on governments to accelerate activities to establish the Patient Safety Institute using a "systems" approach. Strengthening Post-Marketing Surveillance. No matter how rigourous the drug approval and review process, it cannot identify all of a medication's effects; many of these are only identified once the drug is in widespread use in the general population. A strong post-marketing surveillance system is needed to gather this knowledge and ensure patient safety. A post marketing surveillance system should include timely collection of data related to * adverse drug reactions, * medication incidents, * targeted drug effectiveness studies, * optimal utilization of medications. The goal of an enhanced post-marketing surveillance system is to monitor the ongoing safety and risk/benefit ratio of medications once they have been approved and are being used in the broad population. An ideal surveillance system would go beyond collecting and collating data, to analyze it and produce information that health care professionals and policy makers can use in decision-making at the population level. For example, data could be used to * communicate product related risks to health professionals and patients, * determine the incidence of adverse drug reactions and medication incidents in the Canadian population as a whole and various subgroups over time, as well as their health and economic impact. Currently post-marketing surveillance of drugs in Canada is inadequate, relying on reporting which is often erratic and inconsistent, and for which reporters are not compensated. Canada needs a coordinated post-marketing surveillance system to monitor the ongoing safety of marketed drugs. Surveillance should include medication incidents and adverse drug reactions, and should document and consider the effect of the "systems factors" contributing to these events. Making use of supportive technology. We mentioned that the current reporting system is erratic and inconsistent. An investment in supportive technology would reduce inconsistencies by increasing physicians' capacity to report and even prevent medication incidents. Under the September 2000 federal/provincial Health Accord, the Government of Canada announced $500 million to expand the use of health information and communications technologies, including the adoption of electronic health records (EHRs). One of the advantages cited for a pan-Canadian EHR is that it could reduce the occurrence of adverse drug events – for example, handwritten prescription and interpretation errors. Progress has been slow, but CMA will follow with interest the pilot EHR program just announced in Alberta. While we expect improvement in prescribing practices and outcomes under such programs, we expect them to respect the principles of patient confidentiality and the right of prescribers to the privacy of their prescribing information. Technology can also make real-time communication within the health care system much easier. and CMA strongly recommends an investment in systems that can link physicians to one another and to the rest of the health care system. In its 2003 brief to the Finance Committee's pre budget hearings, CMA recommended that the federal government immediately fund dedicated Internet connectivity for all physicians in Canada. CMA has also repeatedly called for sustained and substantial investment in a "REAL" (rapid, effective, accessible and linked) Health Communications and Coordination Initiative to improve technical capacity to communicate with front-line health providers in real time. Real-time information is essential for effective day-to-day health care and will form the cornerstone of an adverse drug reaction communication program for the 21st century. Conclusion It is vital to Canada's physicians that our patients receive the right medications for their condition, at the right times, at the right prices. CMA calls on the federal government and all other stakeholders to work together to develop a comprehensive "made in Canada" prescription drug policy to realize this vision – one that promotes optimal prescribing, puts the health of patients first, respects the relationships of patient and physician and of patient and pharmacist, and honours the principle of patient confidentiality and the privacy of patient and prescriber information. The reports of the Romanow Commission on the Future of Health Care in Canada and the Senate Standing Committee on Science, Social Affairs and Technology review discussed issues surrounding prescription drug policy in Canada. We hope that the review by this parliamentary committee will lead to prompt and decisive action. APPENDIX I CMA POLICY APPROACHES TO ENHANCING THE QUALITY OF DRUG THERAPY A JOINT STATEMENT BY THE CMA ANDTHE CANADIAN PHARMACEUTICAL ASSOCIATION This joint statement was developed by the CMA and the Canadian Pharmaceutical Association, a national association of pharmacists, and includes the goal of drug therapy, strategies for collaboration to optimize drug therapy and physicians' and pharmacists' responsibilities in drug therapy. The statement recognizes the importance of patients, physicians and pharmacists working in close collaboration and partnership to achieve optimal outcomes from drug therapy. Goal of This Joint Statement The goal of this joint statement is to promote optimal drug therapy by enhancing communication and working relationships among patients, physicians and pharmacists. It is also meant to serve as an educational resource for pharmacists and physicians so that they will have a clearer understanding of each other's responsibilities in drug therapy. In the context of this statement, a "patient" may include a designated patient representative, such as a parent, spouse, other family member, patient advocate or health care provider. Physicians and pharmacists have a responsibility to work with their patients to achieve optimal outcomes by providing high-quality drug therapy. The important contribution of all members of the health care team and the need for cooperative working relationships are recognized; however, this statement focuses on the specific relationships among pharmacists, physicians and patients with respect to drug therapy. This statement is a general guide and is not intended to describe all aspects of physicians' or pharmacists' activities. It is not intended to be restrictive, nor should it inhibit positive developments in pharmacist-physician relationships or in their respective practices that contribute to optimal drug therapy. Furthermore, this statement should be used and interpreted in accordance with applicable legislation and other legal requirements. This statement will be reviewed and assessed regularly to ensure its continuing applicability to medical and pharmacy practices. Goal of Drug Therapy The goal of drug therapy is to improve patients' health and quality of life by preventing, eliminating or controlling diseases or symptoms. Optimal drug therapy is safe, effective, appropriate, affordable, cost-effective and tailored to meet the needs of patients, who participate, to the best of their ability, in making informed decisions about their therapy. Patients require access to necessary drug therapy and specific, unbiased drug information to meet their individual needs. Providing optimal drug therapy also requires a valid and accessible information base generated by basic, clinical, pharmaceutical and other scientific research. Working Together for Optimal Drug Therapy Physicians and pharmacists have complementary and supportive responsibilities in providing optimal drug therapy. To achieve this goal, and to ensure that patients receive consistent information, patients, pharmacists and physicians must work cooperatively and in partnership. This requires effective communication, respect, trust, and mutual recognition and understanding of each other's complementary responsibilities. The role of each profession in drug therapy depends on numerous factors, including the specific patient and his or her drug therapy, the prescription status of the drug concerned, the setting and the patient physician pharmacist relationship. However, it is recognized that, in general, each profession may focus on certain areas more than others. For example, when counselling patients on their drug therapy, a physician may focus on disease-specific counselling, goals of therapy, risks and benefits and rare side effects, whereas a pharmacist may focus on correct usage, treatment adherence, dosage, precautions, dietary restrictions and storage. Areas of overlap may include purpose, common side effects and their management and warnings regarding drug interactions and lifestyle concerns. Similarly, when monitoring drug therapy, a physician would focus on clinical progress toward treatment goals, whereas a pharmacist may focus on drug effects, interactions and treatment adherence; both would monitor adverse effects. Both professions should tailor drug therapy, including education, to meet the needs of individual patients. To provide continuity of care and to promote consistency in the information being provided, it is important that both pharmacists and physicians assess the patients' knowledge and identify and reinforce the educational component provided by the other. Strategies for Collaborating to Optimize Drug Therapy Patients, physicians and pharmacists need to work in close collaboration and partnership to achieve optimal drug therapy. Strategies to facilitate such teamwork include the following. Respecting and supporting patients' rights to make informed decisions regarding their drug therapy. Promoting knowledge, understanding and acceptance by physicians and pharmacists of their responsibilities in drug therapy and fostering widespread communication of these responsibilities so they are clearly understood by all. Supporting both professions' relationship with patients, and promoting a collaborative approach to drug therapy within the health care team. Care must be taken to maintain patients' trust and their relationship with other caregivers. Sharing relevant patient information for the enhancement of patient care, in accordance and compliance with all of the following: ethical standards to protect patient privacy, accepted medical and pharmacy practice, and the law. Patients should inform their physician and pharmacist of any information that may assist in providing optimal drug therapy. Increasing physicians' and pharmacists' awareness that it is important to make themselves readily available to each other to communicate about a patient for whom they are both providing care. Enhancing documentation (e.g., clearly written prescriptions and communication forms) and optimizing the use of technology (e.g., e-mail, voice mail and fax) in individual practices to enhance communication, improve efficiency and support consistency in information provided to patients. Developing effective communication and administrative procedures between health care institutions and community-based pharmacists and physicians to support continuity of care. Developing local communication channels and encouraging dialogue between the professions (e.g., through joint continuing education programs and local meetings) to promote a peer-review-based approach to local prescribing and drug-use issues. Teaching a collaborative approach to patient care as early as possible in the training of pharmacists and physicians. Developing effective communication channels and encouraging dialogue among patients, physicians and pharmacists at the regional, provincial, territorial and national levels to address issues such as drug-use policy, prescribing guidelines and continuing professional education. Collaborating in the development of technology to enhance communication in practices (e.g., shared patient databases relevant to drug therapy). Working jointly on committees and projects concerned with issues in drug therapy such as patient education, treatment adherence, formularies and practice guidelines, hospital-to-community care, cost-control strategies, sampling and other relevant policy issues concerning drug therapy. Fostering the development and utilization of a high-quality clinical and scientific information base to support evidence-based decision making. The Physician's Responsibilities Physicians and pharmacists recognize the following responsibilities in drug therapy as being within the scope of physicians' practice, on the basis of such factors as physicians' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of pharmacists (see The Pharmacist's Responsibilities). In addition, it is recognized that practice environments within medicine may differ and may affect the physician's role. Assessing health status, diagnosing diseases, assessing the need for drug therapy and providing curative, preventive, palliative and rehabilitative drug therapy in consultation with patients and in collaboration with caregivers, pharmacists and other health care professionals, when appropriate. Working with patients to set therapeutic goals and monitor progress toward such goals in consultation with caregivers, pharmacists and other health care providers, when appropriate. Monitoring and assessing response to drug therapy, progress toward therapeutic goals and patient adherence to the therapeutic plan; when necessary, revising the plan on the basis of outcomes of current therapy and progress toward goals of therapy, in consultation with patients and in collaboration with caregivers, pharmacists and other health care providers, when appropriate. Carrying out surveillance of and assessing patients for adverse reactions to drugs and other unanticipated problems related to drug therapy, revising therapy and, when appropriate, reporting adverse reactions and other complications to health authorities. Providing specific information to patients and caregivers about diagnosis, indications and treatment goals, and the action, benefits, risks and potential side effects of drug therapy. Providing and sharing general and specific information and advice about disease and drugs with patients, caregivers, health care providers and the public. Maintaining adequate records of drug therapy for each patient, including, when applicable, goals of therapy, therapy prescribed, progress toward goals, revisions of therapy, a list of drugs (both prescription and over-the-counter drugs) currently taken, adverse reactions to therapy, history of known drug allergies, smoking history, occupational exposure or risk, known patterns of alcohol or substance use that may influence response to drugs, history of treatment adherence and attitudes toward drugs. Records should also document patient counselling and advice given, when appropriate. Ensuring safe procurement, storage, handling, preparation, distribution, dispensing and record keeping of drugs (in keeping with federal and provincial regulations and the CMA policy summary "Physicians and the Pharmaceutical Industry (Update 1994)" (Can Med Assoc J 1994;150:256A-C.) when the patient cannot reasonably receive such services from a pharmacist. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Care also should be provided in accordance with accepted scientific and ethical standards and procedures. The Pharmacist's Responsibilities Pharmacists and physicians recognize the following responsibilities as being within the scope of pharmacists' practice, on the basis of such factors as pharmacists' education and specialized skills, relationship with patients and practice environment. Some responsibilities may overlap with those of physicians (see The Physician's Responsibilities). In addition, it is recognized that, in selected practice environments, the pharmacists' role may differ considerably. Evaluating the patients' drug-therapy record ("drug profile") and reviewing prescription orders to ensure that a prescribed therapy is safe and to identify, solve or prevent actual or potential drug-related problems or concerns. Examples include possible contraindications, drug interactions or therapeutic duplication, allergic reactions and patient nonadherence to treatment. Significant concerns should be discussed with the prescriber. Ensuring safe procurement, storage, preparation, distribution and dispensing of pharmaceutical products (in keeping with federal, provincial and other applicable regulations). Discussing actual or potential drug-related problems or concerns and the purpose of drug therapy with patients, in consultation with caregivers, physicians and health care providers, when appropriate. Monitoring drug therapy to identify drug-related problems or concerns, such as lack of symptomatic response, lack of adherence to treatment plans and suspected adverse effects. Significant concerns should be discussed with the physician. Advising patients and caregivers on the selection and use of nonprescription drugs and the management of minor symptoms or ailments. Directing patients to consult their physician for diagnosis and treatment when required. Pharmacists may be the first contact for health advice. Through basic patient assessment (i.e., observation and interview) they should identify the need for referral to a physician or an emergency department. Notifying physicians of actual or suspected adverse reactions to drugs and, when appropriate, reporting such reactions to health authorities. Providing specific information to patients and caregivers about drug therapy, taking into account patients' existing knowledge about their drug therapy. This information may include the name of the drug, its purpose, potential interactions or side effects, precautions, correct usage, methods to promote adherence to the treatment plan and any other health information appropriate to the needs of the patient. Providing and sharing general and specific drug-related information and advice with patients, caregivers, physicians, health care providers and the public. Maintaining adequate records of drug therapy to facilitate the prevention, identification and management of drug-related problems or concerns. These records should contain, but are not limited to, each patient's current and past drug therapy (including both prescribed and selected over-the-counter drugs), drug-allergy history, appropriate demographic data and, if known, the purpose of therapy and progress toward treatment goals, adverse reactions to therapy, the patient's history of adherence to treatment, attitudes toward drugs, smoking history, occupational exposure or risk, and known patterns of alcohol or substance use that may influence his or her response to drugs. Records should also document patient counselling and advice given, when appropriate. Maintaining a high level of knowledge about drug therapy through critical appraisal of the literature and continuing professional development. Care must be provided in accordance with legislation and in an atmosphere of privacy, and patient confidentiality must be maintained. Products and services should be provided in accordance with accepted scientific and ethical standards and procedures. APPENDIX II CMA POLICY Statement on Internet Prescribing The act of prescribing medication is a medical act carried out in the context of a patient-physician relationship. As such, it is subject to the clinical standards of practice, as well as the ethical guidelines of the medical profession and applicable law. Physicians should be aware of and comply with the legal requirements in their province or territory. If a physician wishes to sign a prescription for an individual who has not previously been his/her patient or a patient of his/her group practice or shared call group, basic principles of assessment and diagnosis must be applied. It is incumbent upon the physician to obtain an adequate history and perform an appropriate physical examination to reach a diagnosis which will ensure that the prescribed medications are appropriate. The physician should be expected to provide advice about any prescribed medication, and, where appropriate, would be expected to provide advice about appropriate monitoring requirements. The physician is advised to fully document the encounter. It is not acceptable for a physician to sign a prescription without properly assessing the patient. APPENDIX III CMA POLICY Principles for Providing Information about Prescription Drugs to Consumers Approved by the CMA Board of Directors, March 2003 Since the late 1990's expenditures on direct to consumer advertising (DTCA) of prescription drugs in the United States have increased many-fold. Though U.S.-style DTCA is not legal in Canada23, it reaches Canadians through cross-border transmission of print and broadcast media, and through the Internet. It is believed to have affected drug sales and patient behaviour in Canada. Other therapeutic products, such as vaccines and diagnostic tests, are also being marketed directly to the public. Proponents of DTCA argue that they are providing consumers with much-needed information on drugs and the conditions they treat. Others argue that the underlying intent of such advertising is to increase revenue or market share, and that it therefore cannot be interpreted as unbiased information. The CMA believes that consumers have a right to accurate information on prescription medications and other therapeutic interventions, to enable them to make informed decisions about their own health. This information is especially necessary as more and more Canadians live with chronic conditions, and as we anticipate the availability of new products that may accompany the "biological revolution", e.g. gene therapies. The CMA recommends a review of current mechanisms, including mass media communications, for providing this information to the public. CMA believes that consumer information on prescription drugs should be provided according to the following principles. 24 Principle #1: The Goal is Good Health The ultimate measure of the effectiveness of consumer drug information should be its impact on the health and well-being of Canadians and the quality of health care. Principle #2: Ready Access Canadians should have ready access to credible, high-quality information about prescription drugs. The primary purpose of this information should be education; sales of drugs must not be a concern to the originator. Principle #3: Patient Involvement Consumer drug information should help Canadians make informed decisions regarding management of their health, and facilitate informed discussion with their physicians and other health professionals. CMA encourages Canadians to become educated about their own health and health care, and to appraise health information critically. Principle #4: Evidence-Based Content Consumer drug information should be evidence based, using generally accepted prescribing guidelines as a source where available. Principle #5: Appropriate Information Consumer drug information should be based as much as possible on drug classes and use of generic names; if discussing brand-name drugs the discussion should not be limited to a single specific brand, and brand names should always be preceded by generic names. It should provide information on the following: * indications for use of the drug * contraindications * side effects * relative cost. In addition, consumer drug information should discuss the drug in the context of overall management of the condition for which it is indicated (for example, information about other therapies, lifestyle management and coping strategies). Principle #6: Objectivity of Information Sources Consumer drug information should be provided in such a way as to minimize the impact of vested commercial interests on the information content. Possible sources include health care providers, or independent research agencies. Pharmaceutical manufacturers and patient or consumer groups can be valuable partners in this process but must not be the sole providers of information. Federal and provincial/territorial governments should provide appropriate sustaining support for the development and maintenance of up-to-date consumer drug information. Principle #7: Endorsement/ Accreditation Consumer drug information should be endorsed or accredited by a reputable and unbiased body. Information that is provided to the public through mass media channels should be pre-cleared by an independent board. Principle #8: Monitoring and Revision Consumer drug information should be continually monitored to ensure that it correctly reflects current evidence, and updated when research findings dictate. Principle #9: Physicians as Partners Consumer drug information should support and encourage open patient-physician communication, so that the resulting plan of care, including drug therapy, is mutually satisfactory. Physicians play a vital role in working with patients and other health-care providers to achieve optimal drug therapy, not only through writing prescriptions but through discussing proposed drugs and their use in the context of the overall management of the patient's condition. In addition, physicians and other health care providers, and their associations, can play a valuable part in disseminating drug and other health information to the public. Principle #10: Research and Evaluation Ongoing research should be conducted into the impact of drug information and DTCA on the health care system, with particular emphasis on its effect on appropriateness of prescribing, and on health outcomes. APPENDIX IV CMA POLICY PRINCIPLES CONCERNING PHYSICIAN INFORMATION In an environment in which the capacity to capture, link and transmit information is growing and the need for fuller accountability is being created, the demand for physician information, and the number of people and organizations seeking to collect it, is increasing. Physician information, that is, information that includes personal health information about and information that relates or may relate to the professional activity of an identifiable physician or group of physicians, is valuable for a variety of purposes. The legitimacy and importance of these purposes varies a great deal, and therefore the rationale and rules related to the collection, use, access and disclosure of physician information also varies. The Canadian Medical Association (CMA) developed this policy to provide guiding principles to those who collect, use, have access to or disclose physician information. Such people are termed "custodians," and they should be held publicly accountable. These principles complement and act in concert with the CMA Health Information Privacy Code,25 which holds patient health information sacrosanct. Physicians have legitimate interests in what information about them is collected, on what authority, by whom and for what purposes it is collected, and what safeguards and controls are in place. These interests include privacy and the right to exercise some control over the information; protection from the possibility that information will cause unwarranted harm, either at the individual or the group level; and assurance that interpretation of the information is accurate and unbiased. These legitimate interests extend to information about physicians that has been rendered in non-identifiable or aggregate format (e.g., to protect against the possibility of individual physicians being identified or of physician groups being unjustly stigmatized). Information in these formats, however, may be less sensitive than information from which an individual physician can be readily identified and, therefore, may warrant less protection. The purposes for the use of physician information may be more or less compelling. One compelling use is related to the fact that physicians, as members of a self-regulating profession, are professionally accountable to their patients, their profession and society. Physicians support this professional accountability purpose through the legislated mandate of their regulatory colleges. Physicians also recognize the importance of peer review in the context of professional development and maintenance of competence. The CMA supports the collection, use, access and disclosure of physician information subject to the conditions outlined below. 1. Purpose(s): The purpose(s) for the collection of physician information, and any other purpose(s) for which physician information may be subsequently used, accessed or disclosed, should be precisely specified at or before the collection. There should be a reasonable expectation that the information will achieve the stated purpose(s). The policy does not prevent the use of information for purposes that were not intended and not reasonably anticipated if principles 3 and 4 of this policy are met. 2. Consent: As a rule, information should be collected directly from the physician. Subject to principle 4, consent should be sought from the physician for the collection, use, access or disclosure of physician information. The physician should be informed about all intended and anticipated uses, accesses or disclosures of the information. 3. Conditions for collection, use, access and disclosure: The information should: * be limited to the minimum necessary to carry out the stated purpose(s), * be in the least intrusive format required for the stated purpose(s), and its collection, use, access and disclosure should not infringe on the physician's duty of confidentiality with respect to that information. 4. Use of information without consent: There may be justification for the collection, use, access or disclosure of physician information without the physician's consent if, in addition to the conditions in principle 3 being met, the custodian publicly demonstrates with respect to the purpose(s), generically construed, that: * the stated purpose(s) could not be met or would be seriously compromised if consent were required, * the stated purpose(s) is(are) of sufficient importance that the public interest outweighs to a substantial degree the physician's right to privacy and right of consent in a free and democratic society, and * that the collection, use, access or disclosure of physician information with respect to the stated purpose(s) always ensures justice and fairness to the physician by being consistent with principle 6 of this policy. 5. Physician's access to his or her own information: Physicians have a right to view and ensure, in a timely manner, the accuracy of the information collected about them. This principle does not apply if there is reason to believe that the disclosure to the physician will cause substantial adverse effect to others. The onus is on the custodian to justify a denial of access. 6. Information quality and interpretation: Custodians must take reasonable steps to ensure that the information they collect, use, gain access to or disclose is accurate, complete and correct. Custodians must use valid and reliable collection methods and, as appropriate, involve physicians to interpret the information; these physicians must have practice characteristics and credentials similar to those of the physician whose information is being interpreted. 7. Security: Physical and human safeguards must exist to ensure the integrity and reliability of physician information and to protect against unauthorized collection, use, access or disclosure of physician information. 8. Retention and destruction: Physician information should be retained only for the length of time necessary to fulfill the specified purpose(s), after which time it should be destroyed. 9. Inquiries and complaints: Custodians must have in place a process whereby inquiries and complaints can be received, processed and adjudicated in a fair and timely way. The complaint process, including how to initiate a complaint, must be made known to physicians. 10. Openness and transparency: Custodians must have transparent and explicit record-keeping or database management policies, practices and systems that are open to public scrutiny, including the purpose(s) for the collection, use, access and disclosure of physician information. The existence of any physician information record-keeping systems or database systems must be made known and available upon request to physicians. 11. Accountability: Custodians of physician information must ensure that they have proper authority and mandate to collect, use, gain access to or disclose physician information. Custodians must have policies and procedures in place that give effect to the principles in this document. Custodians must have a designated person who is responsible for monitoring practices and ensuring compliance with the policies and procedures. 1 Romanow R. Building on Values: the Future of Health Care in Canada. Report of the Commission on the Future of Health Care in Canada; November 2002. 2 Chobanian et al. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation and Treatment of High Blood Pressure. JAMA 2003; 289. 3 Butler C, Rollnick S, Stott N. The practitioner, the patient and resistance to change. Recent Ideas on Compliance 1996;14(9):1357-62. 4 Canadian Institute for Health Information. Health spending to top $112 billion in 2002, reports CIHI. Media release. December 18, 2002. http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=media_18dec2002_e 5 Patent Medicine Prices Review Board. Pharmaceutical Trends, 1995/96 – 1999/00. Prepared for the Federal/Provincial/Territorial Working Group on Drug Prices; September 2001. 6 Patent Medicine Prices Review Board, A study of the Prices of the Top Selling Multiple Source Medicines in Canada. November 2002. 7 Approaches to Enhancing the Quality of Drug Therapy." Joint policy of the Canadian Medical Association and Canadian Pharmacists Association. 8 It should be noted that the CMA does not have the authority to enforce directives on physicians with regard to prescribing. The provincial and Territorial Colleges of Physicians handle licensing and regulatory matters. 9 Manitoba, British Columbia and Saskatchewan provide some coverage to all residents after the co-payments and deductibles are paid. Quebec provides universal coverage to those not in a private plan. 10 Fraser Group/Tristat Resources. Drug Expense Coverage in the Canadian Population – Protection from Severe Drug Expenses. CLHIA. August 2002. 11 Palmer D'Angelo Consulting Inc. National Pharmacare Cost Impact Update Study. Executive Summary. September 4, 2002. 12 Ibid 13 Tynan T. Cash-strapped Springfield, Mass., begins buying Canadian prescription drugs. Edmonton Journal July 29, 2003. http://www.canada.com/edmonton/story.asp?id=21FB8445-1143-4C13-B282-76F380CB4FE1 14 CBSNews.com. Illinois looks to Canada for drugs. CBS News September 15, 2003. http://www.cbsnews.com/stories/2003/07/29/health/main565611.shtml 15Kedrosky P. Dangerous popularity of online pharmacies. National Post August 13, 2003. 16 Harris G. Pfizer moves to stem Canadian drug imports. New York Times August 7, 2003. http://www.nytimes.com/2003/08/07/business/07DRUG.html 17 Cusack B., Stinson S. US drug firms set to boycott Canada. National Post August 7, 2003. http://www.nationalpost.com/home/story.html?id=363CC2EA-1832-42F2-954C-0F52D1828E23 18 "Prescription Drugs and Mass Media Advertising." National Institute for Health Care Management Research. Washington, DC, 2001. 19 Mintzes B, Barer ML, Kravitz RL at al. How does direct to consumer advertising affect prescribing? a survey in primary care environments with and without legal DTCA. CMAJ 169 (2003): 405 –412. 20 Food and Drug Administration. Direct to consumer advertising of prescription drugs: physician survey preliminary results. Accessed at www.fda.gov/cder/ddmac. 21Survey shows strong opposition to direct to consumer advertising. Accessed at http://www.cma.ca/cma/ 22 Canadian Coalition on Medication Incident Reporting and Prevention. A medication incident reporting and prevention system for Canada: business Plan. March 2002. 23 DTCA is not legal in Canada, except for notification of price, quantity and the name of the drug. However, "information-seeking" advertisements for prescription drugs, which may provide the name of the drug without mentioning its indications, or announce that treatments are available for specific indications without mentioning drugs by name, have appeared in Canadian mass media. 24 Though the paper applies primarily to prescription drug information, its principles are also applicable to health information in general. 25 Canadian Medical Association. Health Information Privacy Code. CMAJ 1998;159(8):997-1016.
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