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Cannabis for Medical Purposes

https://policybase.cma.ca/en/permalink/policy10045
Last Reviewed
2019-03-03
Date
2010-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2019-03-03
Date
2010-12-04
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) has always recognized the unique requirements of those individuals suffering from a terminal illness or chronic disease for which conventional therapies have not been effective and for whom cannabis may provide relief. However, there are a number of concerns, primarily related to the limited evidence to support many of the therapeutic claims made regarding cannabis for medical purposes, and the need to support health practitioners in their practice.1,2,3,4 While the indications for using cannabis to treat some conditions have been well studied, less information is available about many potential medical uses. Physicians who wish to authorize the use of cannabis for patients in their practices should consult relevant CMPA policy5 and guidelines developed by the provincial and territorial medical regulatory authorities to ensure appropriate medico-legal protection. The CMA’s policy Authorizing Marijuana for Medical Purposes6, as well as the CMA’s Guidelines For Physicians In Interactions With Industry7 should also be consulted. The CMA makes the following recommendations: 1. Increase support for the advancement of scientific knowledge about the medical use of cannabis. The CMA encourages the government to support rigorous scientific research into the efficacy for therapeutic claims, safety, dose-response relationships, potential interactions and the most effective routes of delivery, and in various populations. 2. Apply the same regulatory oversight and evidence standards to cannabis as to pharmaceutical products under the Food and Drug Act, designed to protect the public by the assessment for safety and efficacy. 3. Increase support for physicians on the use of cannabis for medical purposes in their practice settings. As such, CMA calls on the government to work with the CMA, The College of Family Physicians of Canada, the Royal College of Physicians and Surgeons, 2 and other relevant stakeholders, to develop unbiased, accredited education options and licensing programs for physicians who authorize the use of cannabis for their patients based on the best available evidence. Background In 2001, Health Canada enacted the Marihuana Medical Access Regulations (MMAR). These were in response to an Ontario Court of Appeal finding that banning cannabis for medicinal purposes violated the Charter of Rights and Freedoms.8 The MMAR, as enacted, was designed to establish a framework to allow legal access to cannabis, then an illegal drug, for the relief of pain, nausea and other symptoms by people suffering from serious illness where conventional treatments had failed. While recognizing the needs of those suffering from terminal illness or chronic disease, CMA raised strong objections to the proposed regulations. There were concerns about the lack of evidence on the risks and benefits associated with the use of cannabis. This made it difficult for physicians to advise their patients appropriately and manage doses or potential side effects. The CMA believes that physicians should not be put in the untenable position of gatekeepers for a proposed medical intervention that has not undergone established regulatory review processes as required for all prescription medicines. Additionally, there were concerns about medico-legal liability, and the Canadian Medical Protective Association (CMPA), encouraged those physicians that were uncomfortable with the regulations to refrain from authorizing cannabis to patients. Various revisions were made to the MMAR, and then these were substituted by the Marihuana for Medical Purposes Regulations (MMPR) in 2013/ 2014 and subsequently by the Access to Cannabis for Medical Purposes Regulations (ACMPR) in 2016 and now as part of the Cannabis Act (Section 14)9. Healthcare practitioners that wish to authorize cannabis for their patients are required to sign a medical document, indicating the daily quantity of dried cannabis, expressed in grams. For the most part, these revisions have been in response to decisions from various court decisions across the country.10,11,12 Courts have consistently sided with patients’ rights to relieve symptoms of terminal disease or certain chronic conditions, despite the limited data on the effectiveness of cannabis. Courts have not addressed the ethical position in which physicians are placed as a result of becoming the gate keeper for access to a medication without adequate evidence. The CMA participated in many Health Canada consultations with stakeholders as well as scientific advisory committees and continued to express the concerns of the physician community. As previously noted, the Federal government has been constrained by the decisions of Canadian courts. 3 The current state of evidence regarding harms of cannabis use is also limited but points to some serious concerns. Ongoing research has shown that regular cannabis use during brain development (up to approximately 25 years old) is linked to an increased risk of mental health disorders including depression, anxiety, and schizophrenia, especially if there is a personal or family history of mental illness. Long term use has also been associated with issues of attention, impulse control and emotional regulation. Smoking of cannabis also has pulmonary consequences such as chronic bronchitis. It is also linked to poorer pregnancy outcomes. Physicians are also concerned with dependence, which occurs in up to 10% of regular users. From a public and personal safety standpoint, cannabis can impact judgement and increases the risk of accidents (e.g. motor vehicle incidents). For many individuals, cannabis use is not without adverse consequences.3,13,14 Pharmaceutically prepared alternative options, often administered orally, are also available and regulated in Canada.15 These drugs mimic the action of delta-9-tetra-hydrocannabional (THC) and other cannabinoids and have undergone clinical trials to demonstrate safety and effectiveness and have been approved for use through the Food and Drug Act. Of note is that in this format, the toxic by-products of smoked marijuana are avoided.16 However, the need for more research is evident. Approved by the CMA Board in December 2010. Last reviewed and approved by the CMA Board in March 2019. References 1 Allan GM, Ramji J, Perry D, et al. Simplified guideline for prescribing medical cannabinoids in primary care. Canadian Family Physician, 2018;64(2):111-120. Available: http://www.cfp.ca/content/cfp/64/2/111.full.pdf (accessed 2019 Jan 8). 2 College of Family Physicians of Canada (CFPC). Authorizing Dried Cannabis for Chronic Pain or Anxiety: Preliminary Guidance. Mississauga: CFPC; 2014. Available: https://www.cfpc.ca/uploadedFiles/Resources/_PDFs/Authorizing%20Dried%20Cannabis%20for%20Chronic%20Pain%20or%20Anxiety.pdf (accessed 2019 Jan 8). 3 The National Academies of Sciences, Engineering and Medicine. The health effects of cannabis and cannabinoids: the current state of evidence and recommendations for research. Washington, DC: National Academies Press; 2017. 4 Whiting PF, Wolff RF, Deshpande S, et al. Cannabinoids for medical use: a systematic review and meta-analysis. JAMA 2015;313(24):2456-73. 5 Canadian Medical Protective Association (CMPA). Medical marijuana: considerations for Canadian doctors. Ottawa: CMPA; 2018. Available: https://www.cmpa-acpm.ca/en/advice-publications/browse-articles/2014/medical-marijuana-new-regulations-new-college-guidance-for-canadian-doctors (accessed 2019 Jan 8). 6 Canadian Medical Association (CMA). Authorizing marijuana for medical purposes. Ottawa: CMA; 2014. Available: https://policybase.cma.ca/en/permalink/policy11514 http://policybase.cma.ca/dbtw-wpd/Policypdf/PD15-04.pdf (accessed 2019 Jan 8). 7 Canadian Medical Association. (CMA) Guidelines for Physicians In Interactions With Industry. Ottawa: CMA; 2007. Available: http://policybase.cma.ca/dbtw-wpd/Policypdf/PD08-01.pdf. (accessed 2019 Jan22). 4 8 R. v. Parker, 2000 CanLII 5762 (ON CA). Available: http://canlii.ca/t/1fb95 (accessed 2019 Jan 8). 9 Cannabis Act. Access to Cannabis for Medical Purposes. Section 14. 2018. Available: https://laws-lois.justice.gc.ca/eng/regulations/SOR-2018-144/page-28.html#h-81 (accessed 2019 Jan 8). 10 Hitzig v. Canada, 2003 CanLII 3451 (ON SC). Available: http://canlii.ca/t/1c9jd (accessed 2019 Jan 8). 11 Allard v. Canada, [2016] 3 FCR 303, 2016 FC 236 (CanLII), Available: http://canlii.ca/t/gngc5 (accessed 2019 Jan 8). 12 R. v. Smith, 2014 ONCJ 133 (CanLII). Available: http://canlii.ca/t/g68gk (accessed 2019 Jan 8). 13 Volkow ND, Baler RD, Compton WM, Weiss SRB. Adverse health effects of marijuana use. N Engl J Med. 2014;370(23):2219–2227. 14 World Health Organization. The health and social effects of nonmedical cannabis use. Geneva: World Health Organization; 2016. Available: https://www.who.int/substance_abuse/publications/msbcannabis.pdf (accessed 2019 Jan 8). 15 Ware MA. Is there a role for marijuana in medical practice? Can Fam Physician 2006;52(12):1531-1533. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1952544/pdf/0530022a.pdf (accessed 2019 Jan 8). 16 Engels FK, de Jong FA, Mathijssen RHJ, et.al. Medicinal cannabis in oncology. Eur J Cancer. 2007;43(18):2638-2644. Available: https://www.clinicalkey.com/service/content/pdf/watermarked/1-s2.0-S0959804907007368.pdf?locale=en_US (accessed 2019 Jan 8).
Documents
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Chalk River National Research Universal reactor

https://policybase.cma.ca/en/permalink/policy9919
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Policy Type
Policy resolution
Last Reviewed
2017-03-04
Date
2010-08-25
Topics
Health systems, system funding and performance
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC10-102
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
Text
The Canadian Medical Association urges the federal government to make a public commitment to keep the Chalk River National Research Universal reactor operational for as long as necessary beyond the announced date of 2016 and until secure alternative supplies of isotopes or alternative radiopharmaceuticals are proven and available.
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CMA Letter to the Senate Committee on Legal and Constitutional Affairs regarding Bill C-2, An Act to amend the Criminal Code and to make consequential amendments to other Acts

https://policybase.cma.ca/en/permalink/policy9110
Last Reviewed
2020-02-29
Date
2008-02-19
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Last Reviewed
2020-02-29
Date
2008-02-19
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) welcomes the opportunity to provide comments to the Senate Committee on Legal and Constitutional Affairs concerning its study of Bill C-2 (An Act to amend the Criminal Code and to make consequential amendments to other Acts). We will confine our comments to the portion of the proposed legislation that relates to impaired driving. Canada's physicians support measures aimed at reducing the incidence of drug-impaired driving. We believe impaired driving, whether by alcohol or another drug, to be an important public health issue for Canadians that requires action by all governments and other concerned groups. Published reports indicate that the prevalence of driving under the influence of cannabis is on the rise in Canada. We note that: * Results from the Canadian Addictions Survey suggest that 4% of the population have driven under the influence of cannabis in the past year, an increase from the 1.5% in 2003 and that rates are higher among young people.1 * It was estimated that in 2003, 27.45% of traffic fatalities involved alcohol, 9.15% involved alcohol and drugs, and 3.66% involved drugs alone while 13.71% of crash injuries involved only alcohol, 4.57% involved alcohol and drugs, and 1.83% involved drugs alone.2 * In a 2002 survey, 17.7% of drivers reported driving within 2 hours of using a prescribed medication, over-the-counter remedy, marijuana, or other illicit drug during the past 12 months. * These results suggest that an estimated 3.7 million Canadians drove after taking some medication or drug that could potentially affect their ability to drive safely. * The most common drugs used were over-the-counter medications (15.9%), prescription drugs (2.3%), marijuana (1.5%), and other illegal drugs (0.9%). * Young males were most likely to report using marijuana and other illegal drugs. * While 86% of the drivers were aware that a conviction for impaired driving results in a criminal record, 66% erroneously believed that the penalties for drug-impaired driving were less severe than those for alcohol-impaired driving. In fact, the penalties are identical. * Over 80% of drivers agreed that drivers suspected of being under the influence of drugs should be required to participate in physical coordination testing for drug impairment. However, only about 70% of drivers agreed that all drivers involved in a serious collision or suspected of drug impairment should be required to provide a blood sample.3 The CMA has, on several occasions, provided detailed recommendations on legislative changes concerning impaired driving. In 1999, the CMA presented a brief to the House of Commons Standing Committee on Justice and Human Rights during its review of the impaired driving provisions of the Criminal Code. While our 1999 brief focused primarily on driving under the influence of alcohol, many of the recommendations are also relevant to the issue of driving under the influence of drugs. In June 2007, the CMA provided comments to the Standing Committee on Justice and Human Rights of the House of Commons during their study of Bill C-32 (An Act to amend the Criminal Code (impaired driving) and to make consequential amendments to other Acts) which was later incorporated in the omnibus Bill now before your Committee. Last year, the CMA published the 7th edition of its guide, Determining Medical Fitness to Operate Motor Vehicles. It includes chapters on the importance of screening for alcohol or drug dependency and states that the abuse of such substances is incompatible with the safe operation of a vehicle. This publication is widely viewed by clinical and medical-legal practitioners as the authoritative Canadian source on the topic of driver competence. While changing the Criminal Code is an important step, the CMA believes further actions are also warranted. In our 2002 presentation to the Special Senate Committee on Illegal Drugs, the CMA put forth our long standing position regarding the need for a comprehensive long-term effort that incorporates both deterrent legislation and public awareness and education campaigns. We believe such an approach, together with comprehensive treatment and cessation programs, constitutes the most effective policy in attempting to reduce the number of lives lost and injuries suffered in crashes involving impaired drivers. Drug-impaired drivers may be occasional users of drugs or they may also suffer from substance dependence, a well-recognized form of disease. Physicians should be assisted to screen for drug dependency, when indicated, using validated instruments. Government must create and fund appropriate assessment and treatment interventions. Physicians can assist in establishing programs in the community aimed at the recognition of the early signs of dependency. These programs should recognize the chronic, relapsing nature of drug addiction as a disease, as opposed to simply viewing it as criminal behaviour. While supporting the intent of the proposed legislation, the CMA urges caution on several significant issues, with regard to Clause 20 that amends the act as follows: 254.1 (1) The Governor in Council may make regulations (a) respecting the qualifications and training of evaluating officers; (b) prescribing the physical coordination tests to be conducted under paragraph 254(2)(a); and (c) prescribing the tests to be conducted and procedures to be followed during an evaluation under subsection 254(3.1). CMA contends that it is important that medical professionals and addiction medicine specialists in particular, should be consulted regarding the training offered to officers to conduct roadside assessment and sample collection. Provisions in the Act conferring upon police the power to compel roadside examination raises the important issue of security of the person and the privacy of health information. As well, information obtained at the roadside is personal medical information and regulations must ensure that it be treated with the same degree of confidentiality as any other element of an individual's medical record. Thus, the CMA would respectfully submit that Clause 25 of Bill-C2 on the issue of unauthorized use or disclosure of the results needs to be strengthened because the wording is too broad, unduly infringes privacy and shows insufficient respect for the health information privacy interests at stake. For instance, clause 25(2) would permit the use, or allow the disclosure of the results "for the purpose of the administration or enforcement of the law of a province". This latter phrase needs to be narrowed in its scope so that it would not, on its face, encompass such a broad category of laws. Moreover, clause 25(4) would allow the disclosure of the results "to any other person, if the results are made anonymous and the disclosure is made for statistical or other research purposes" CMA would expect the federal government to exercise great caution in this instance, particularly since the results could concern individuals who are not actually convicted of an offence. One should query whether the Clause 25(4) should even exist in a Criminal Code as it would not appear to be a matter required to be addressed. If it is, then CMA would ask the government to conduct a rigorous privacy impact assessment on these components of the Bill, studying in particular, such matters as sample size, degree of anonymity, and other privacy related issues, especially given the highly sensitive nature of the material. CMA would ask whether clause 25(5) should specify that the offence for improper use or disclosure should be more serious than a summary conviction. Finally, it is important to base any roadside testing methods and threshold decisions on robust biological and clinical research. CMA also notes with interest Clause 21, specifically the creation of a new offence of being "over 80" (referring to 80mg of alcohol in 100ml of blood, or a .08 blood alcohol concentration level or BAC) and causing an accident that results in bodily harm which will carry a maximum sentence of 10 years and life imprisonment for causing an accident resulting in death. (Clause 21) We would also urge the Committee to take the opportunity that the review of this proposed legislation provides to recommend to Parliament a lower BAC level. Since 1988 the CMA has supported 50 mg% as the general legal limit. Studies suggest that a BAC limit of 50 mg% could translate into a 6% to 18% reduction in total motor vehicle fatalities or 185 to 555 fewer fatalities per year in Canada.4 A lower limit would recognize the significant detrimental effects on driving-related skills that occur below the current legal BAC.5 In our 1999 response to the Standing Committee on Justice and Human Rights' issue paper on impaired driving6 and again in 2002 when we joined forces with Mothers Against Drunk Driving (MADD), CMA has consistently called for the federal government to reduce Canada's legal BAC to .05. Canada continues to lag behind countries such as Austria, Australia, Belgium, Denmark, France and Germany, which have set a lower legal limit. 7 CMA expressed the opinion that injuries and deaths resulting from impaired driving must be recognized as a major public health concern. Therefore we once again recommend lowering the legal BAC limit to 50 mg%. or .05%. We also wanted to note our support for Clause 23 which addresses the issue of liability by extending the existing umbrella of immunity for qualified medical practitioners to the new provision under 254(3.4) 23. Subsection 257(2) of the Act is replaced by the following: (2) No qualified medical practitioner by whom or under whose direction a sample of blood is taken from a person under subsection 254(3) or (3.4) or section 256, and no qualified technician acting under the direction of a qualified medical practitioner, incurs any criminal or civil liability for anything necessarily done with reasonable care and skill when taking the sample. Finally, CMA believes that comprehensive long-term efforts that incorporate deterrent legislation, such as Bill C-2, must be accompanied by a public awareness and education strategy. This constitutes the most effective long-term approach to reducing the number of lives lost and injuries suffered in crashes involving impaired drivers. The CMA supports this multidimensional approach to the issue of the operation of a motor vehicle regardless of whether impairment is caused by alcohol or drugs. Again, the CMA appreciates the opportunity to provide input into the legislative proposal on drug-impaired driving. We stress that these legislative changes alone would not adequately address the issue of reducing injuries and fatalities due to drug-impaired driving, but support their intent as a partial, but important measure. Yours sincerely, Brian Day, MD President 1 Bedard, M, Dubois S, Weaver, B. The impact of cannabis on driving, Canadian Journal of Public Health, Vol 98, 6-11, 2006 2 G. Mercer, Estimating the Presence of Alcohol and Drug Impairment in Traffic Crashes and their Costs to Canadians: 1999 to 2003 (Vancouver: Applied Research and Evaluation Services, 2005). 3 D. Beirness, H. Simpson and K. Desmond, The Road Safety Monitor 2002: Drugs and Driving (Ottawa: Traffic Injury Research Foundation, 2003). Online: www.trafficinjuryResearch.com/whatNew/newsItemPDFs/RSM_02_Drugs_and_ Driving.pdf 4 Mann, Robert E., Scott Macdonald, Gina Stoduto, Abdul Shaikh and Susan Bondy (1998) Assessing the Potential Impact of Lowering the Blood Alcohol Limit to 50 MG % in Canada. Ottawa: Transport Canada, TP 13321 E. 5 Moskowitz, H. and Robinson, C.D. (1988). Effects of Low Doses of Alcohol on Driving Skills: A Review of the Evidence. Washington, DC: National Highway Traffic Safety Administration, DOT-HS-800-599 as cited in Mann, et al., note 8 at page 12-13 6 Proposed Amendments to the Criminal Code of Canada (Impaired Driving): Response to Issue Paper of the Standing Committee on Justice and Human Rights. March 5, 1999 7 Mann et al
Documents
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Health Canada consultation on edible cannabis, extracts & topicals

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

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

A Prescription for Optimal Prescribing

https://policybase.cma.ca/en/permalink/policy10016
Last Reviewed
2016-05-20
Date
2010-08-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Policy document
Last Reviewed
2016-05-20
Date
2010-08-26
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
This paper presents the position of the Canadian Medical Association on what physicians can do, working with others, to ensure that Canadians are prescribed the drugs that will give them the most benefit. It also makes recommendations for future action that physicians, governments and others might take to foster optimal prescribing practices. CMA believes that optimal prescribing is the prescription of a drug that is: - The most clinically appropriate for the patient's condition; - Safe and effective; - Part of a comprehensive treatment plan; and - The most cost-effective drug available to meet the patient's needs. Choices made by prescribers are subject to a number of influences, including education (undergraduate, residency and continuing); availability of useful point of care information; drug marketing and promotion; patient preferences and participation, and drug cost and coverage. The CMA proposes a "prescription for optimal prescribing" that encompasses six elements, and makes the following recommendations: A National Strategy 1) Governments at all levels should work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. Element 1: Relevant, Objective Information for Physicians 2) The CMA supports the development and dissemination of prescribing information that is: - based on the best available scientific evidence; -relevant to clinical practice; - easy to incorporate into a physician's workflow. 3) The CMA encourages all medical educational bodies to support a comprehensive program of education in pharmaceuticals, pharmacology and optimal prescribing, at the undergraduate, residency and continuing medical education levels. 4) The CMA and provincial/territorial medical associations call on governments to support and fund impartial continuing medical education programs on optimal prescribing. 5) The CMA calls on appropriate educational bodies to develop policies or guidelines to ensure the objectivity and impartiality of continuing medical education. 6) The CMA recommends that governments, research institutes and other stakeholders fund and conduct ongoing clinical research on the effectiveness of interventions designed to change behaviour, and allocate resources to those interventions that demonstrate the greatest effectiveness. Element 2: Electronic Prescribing 7) The CMA, provincial/territorial medical associations and affiliates encourage governments to give active support to physicians in their transition to electronic prescribing, through a comprehensive strategy that includes financial support for acquisition of hardware and software, and dissemination of appropriate training and knowledge transfer tools. 8) The CMA calls on governments to incorporate into electronic prescribing the following principles: - Measures to ensure patients' privacy and confidentiality, as well as confidentiality of physician prescribing information; - A link with a formulary, to provide physicians with best practice information including drug cost data; - Guidelines for data sharing among health professionals and others; - Standards for electronic signature that are not overly restrictive. Element 3: Programs by Payers 9) The CMA recommends that formularies, in both the public and private sectors, simplify administrative requirements on patients and physicians, reducing paperwork to the minimum necessary to ensure optimal patient care. Element 4: Collaboration among Health Care Providers 10) The CMA recommends that formalized and clearly articulated collaborative arrangements be in place for practitioners who jointly manage a patient's drug therapy. Element 5: Impartial, Evidence-based Information for Patients 11) The CMA calls on governments to fund and facilitate the development and provision of unbiased, up-to-date, practical information to consumers about prescription drugs and their appropriate use, and support physicians and pharmacists in disseminating this information to patients. 12) The CMA calls on the Government of Canada to continue to enforce the current ban on direct-to-consumer prescription drug advertising in Canada, and close the loopholes that currently allow a limited amount of drug promotion. Element 6: Research, Monitoring and Evaluation 13) The CMA calls on those who fund and produce research on drug safety and effectiveness, prescribing guidelines and programs to enhance prescribing practices, to include physicians and medical organizations meaningfully in this activity. 1 Introduction In an ideal world, all patients would be prescribed the drugs that have the most beneficial effect on their condition while doing the least possible harm, at the most appropriate cost to the patient and the health care system. It is generally agreed that we have not yet achieved that ideal. But the Canadian Medical Association (CMA) and the physicians of Canada believe it is a goal worth striving to attain. The CMA has a long-standing commitment to fostering high-quality health care. One of the key elements of the long-term Health Care Transformation project, in which CMA is currently involved, is ensuring that systems are in place to foster health care that is of high quality. One such system would be the active encouragement of optimal prescribing. This paper presents the CMA's position and recommendations on what physicians can do, working with others, to ensure that Canadians are prescribed the drugs that will give them the most benefit. It looks at prescribing mainly from the perspective of the practicing physician who is seeking the most appropriate treatments for individual patients. However it also comments on the effects of prescribing on the broader health care system, both on Canadians' overall health status and on the costs of delivering health care. 2) Optimal Prescribing: CMA's Definition and Principles a) What is Optimal Prescribing? Prescribing is not an exact science; the choice of a particular drug to treat a particular patient depends on that patient's unique circumstances. CMA's proposed definition and principles for optimal prescribing is as follows: Optimal prescribing is the prescription of a drug that is - the most clinically appropriate drug for the patient's condition; - safe and effective; - part of a comprehensive treatment plan; and - the most cost-effective drug available to best meet the patient's needs. b) Principles for Optimal Prescribing CMA believes that in an optimal prescribing environment, the following principles should apply: Principles for Optimal Prescribing 1) The primary goal of prescribing should be to improve or maintain the health of the patient. 2) Prescribing should take place in the context of overall patient care which involves diagnosis of the condition, other forms of treatment including rehabilitation, counselling and lifestyle adjustments, ongoing monitoring and re-evaluation of the patient's condition and treatment to make sure the patient is responding appropriately, ensuring patient adherence to medication regimen, and discontinuation of drug treatment when it is no longer needed. 3) Patients should be actively involved in decisions regarding their drug treatment; for this, useful and practical patient information is required. 4) Prescribing decisions should be based on the best available scientific evidence, which is continually evaluated and updated as need arises. 5) Physicians should retain clinical autonomy in deciding which drugs to prescribe. 6) Prescribing decisions should take into account the cost to the patient, and strive to achieve cost-effectiveness as long as this does not conflict with the goal of optimal patient care. 7) Physicians should be updated on new developments in pharmacotherapy, through an ongoing process of relevant, objective continuing education. 8) Health professionals should take a leadership role in developing and evaluating strategies and tools to enhance best practices in prescribing. Though these principles may also apply to the optimal use of medical devices, prescription drugs are the primary focus of the paper. 3 Why Optimal Prescribing is Important Prescription drugs are an increasingly important part of patient care in Canada. Fifty years ago, they were used mainly for short periods of time to treat acute conditions, and their contribution to overall health care costs was small. But in 2005, Canadians received 14 prescriptions per capita; that number rose to 74 for people 80 years and over.i Many Canadians now take prescription drugs over the long term to manage chronic conditions such as diabetes, osteoporosis or high cholesterol. Increased drug utilization, and the high prices of many new drug therapies, have increased the cost of prescription drugs to Canadians and to the health care system. In 2008 Canadians spent about $25.4 billion on prescription drugs. This, in constant dollars, is roughly triple what was spent in 1985.ii Together, prescription and over-the-counter drugs consume a larger portion of overall costs than do physicians' services; in fact, only hospitals consume a larger share. In many cases prescription drugs have reduced reliance on hospitalization and surgical procedures. For example, over the past decades drugs to treat peptic ulcer disease have changed its treatment profile from one based mainly on surgery to a largely medical one. On the other hand, patients may take certain medications or classes of medications for many years, and this long-term use may have health consequences that are currently unknown. As their role in health care increases, there is increasing public scrutiny over whether the prescription drugs Canadians use are safe and effective, whether they give good value for money, and whether they are being prescribed and taken optimally for maximum patient benefit. As mentioned before, prescribing is not an exact science; what in some cases might be considered "suboptimal" is in other cases quite appropriate. In most instances, drugs are prescribed appropriately. However, evidence suggests that in some areas there is room for improvement. Prescribers can enhance patient care and improve Canadians' health by adopting strategies such as the following: - Reducing overprescribing of certain drugs. For example, overuse of antibiotics is a worldwide concerniii since it may hasten the development of antibiotic resistance, thereby reducing the physician's therapeutic arsenal. - Reducing underprescribing of certain drugs. A study of primary care practices in Ontario found that while 14% of adult patients had dyslipidemia, 63.2 % were untreated and, of those treated, 47.2% were not adequately controlled .iv - Prescribing drugs according to generally accepted clinical practice guidelines to ensure that first-line drugs are used where indicated. Second-line therapies are frequently newer and less established than first-line ones, and are thus more likely to have unidentified safety risks. - Ensuring that drugs are prescribed and taken safely, to reduce the harm caused by adverse interactions with other drugs, natural health products, alcohol or other agents in the patient's system. Activities in support of the above strategies should be included in any program or initiative aimed at improving health care in Canada. CMA believes they will contribute to Canadians' overall health status, and may have the additional benefit of reducing health care costs if the prescribed drugs are the most cost-effective available to appropriately treat patients' conditions. 4) Many Factors Affect Prescribing Prescribing does not occur in a vacuum, but is the result of a number of factors that influence physicians. It may be questioned whether these factors provide the necessary support to physicians as they seek to prescribe optimally. Some of these influences are discussed below: a) The Challenge Of Acquiring Information Our knowledge of prescription drugs and their effects is continually being updated, and physicians are required to absorb new information throughout their careers. But are physicians receiving the information they most need, in such a way that they can easily and painlessly incorporate it into their practices? CMA's answer is: there is room for improvement. The major information sources available to physicians are discussed below: i) Physician Education Medical school and residency training - Medical schools vary in how they discuss pharmacological issues, and critics have questioned whether Canada's current medical school curriculum is training future physicians adequately in the art and science of prescribing.v In some cases, pharmacotherapy is taught in the context of each individual body system - cardiac, renal, etc. - rather than as a discrete subject. With this approach, some valuable unifying elements of pharmacology may go untaught. Continuing medical education (CME) - For physicians, CME is an important source of information on new drugs and new indications for existing drugs. But is it imparting the most necessary or appropriate information? Concerns have been raised as to its impartiality; it is estimated that pharmaceutical industry sponsorship accounts for 65% of the total revenue of CME programs in the U.S. and the figure is assumed to be much the same in Canada.vi ii) Point-of-care information With increasingly heavy patient loads, the time at physicians' disposal for research is limited. Often new information is required at the point of care; for example, in the examination room during a patient encounter, when the physician requires an answer quickly. The clinical practice guidelines and point of care reference guides in common use may not be readily accessible in a concise, user-friendly format when needed. In addition, it is of concern that some experts who develop practice guidelines have ties to pharmaceutical manufacturers, which could affect the guidelines' impartiality. To compound the problem, widely used sources of information may not be giving physicians the material they most need. Physicians often receive new safety information, such as warnings of recently discovered drug risks, in the form of advisories from Health Canada or elsewhere. These advisories may not provide physicians with prescribing advice, or information about other treatment options if the drug is considered too dangerous for use. iii) Drug promotion and marketing Much of physicians' information about drugs and prescribing comes from the pharmaceutical industry representatives who visit them in their offices. Drugs promoted in this manner tend to be newer; consequently they are often more expensive than established medications and less is known about their efficacy and possible side effects. Drug promotion might help instil in some physicians' minds the perception that when it comes to medication, "new" equals "better," when this is not always the case. Industry marketing also comes in more subtle forms, such as: - Free drug samples provided to physicians; since samples tend to be mainly for new drugs, it has been suggested that they encourage these drugs' use at the expense of possibly cheaper and safer alternatives. - Collection, by commercial data management companies, of information on physicians' prescribing patterns , which is then sold to pharmaceutical companies to help tailor sales messages to individual physicians. - Manipulation of the medical publication process, through: design of clinical trials so as to get the most positive results; selective publication of clinical trial results; or "ghostwriting" of scholarly research articles by pharmaceutical industry contractors.vii b) Patient education and participation When considering a patient's drug therapy, the physician must consider the possible effect of the patient's behaviour on treatment. A patient may require counselling on the impact of natural health products, alcohol and other substances when mixed with their prescribed medications; on the importance of adherence to the prescribed treatment; or on the need for changes in behaviour (improved diet, increased physical activity) to augment the medication's benefits. This requires open and honest dialogue between patient and physician. Patient knowledge and preferences can influence both over- and under-prescribing. Some patients may not feel that they have been "treated" unless they leave the doctor's office with a prescription. A physician may prescribe a drug if a patient requests it, despite feeling ambivalent about the choice of treatment.viii On the other hand, a physician may not prescribe a needed medication because a patient insists he or she does not want to be "on drugs." The pharmaceutical industry directs promotional activities at patients as well as physicians. Though direct-to consumer advertising (DTCA) or prescription drugs is technically illegal in Canada, loopholes in the law permit a limited amount of Canadian-based drug promotion, and drug ads are often beamed across the border from the United States, one of only two countries (the other being New Zealand) where DTCA is legal. DTCA has a strong influence on patient behaviour; according to one survey by the U.S. Government Accounting Office, 27% of people who saw prescription drug advertisements, requested and received these drugs from their physicians.ix DTCA has been widely criticized for overstating drugs' benefits, playing down their risks, and contributing to a "pill for every ill" mindset and the "medicalization" of conditions that could be more appropriately managed by lifestyle changes or other non-drug therapies. In addition, the pharmaceutical industry can exert indirect influence on patient attitudes through funding of patient advocacy groups and disease-specific web sites. A patient's social context may also motivate a physician to prescribe a drug that may not be clinically indicated. For example, an antipsychotic may be prescribed to calm a patient with dementia, not so much for the patient's benefit as for that of tired and stressed-out caregivers, despite growing evidence of the drugs' health and safety risks and lack of efficacyx. Ideally, prescribing recommendations and guidelines should take into account the broader context in which a drug is prescribed. c) Drug cost and coverage The physician's prescribing of a drug and the patient's purchase of it are separate and unconnected acts. As a result, physicians may not have access to reliable, convenient information on drug costs; or if they do, they may have little reason to use this information if the patient has insurance coverage. However, rising drug prices, and the increased use of drug therapy, may require them to take cost into consideration more often. Provincial and territorial governments, and increasingly, private insurers as well, can influence physician and patient choice of drugs by restricting what medications are covered on their formularies. In addition, many payers have programs to encourage the prescribing of certain drugs such as generics. If, as not infrequently happens, a patient's condition requires a drug not on the formulary, obtaining coverage for this drug requires time-consuming paperwork. The administrative burden this imposes can be a barrier to optimal prescribing. d) The policy context Canadian decision makers have already recognized that action on prescribing is needed. One of the original nine elements of the federal/provincial/territorial National Pharmaceuticals Strategy (NPS), announced in 2004, was "Enhance action to influence the prescribing behaviour of health care professionals so that drugs are used only when needed and the right drug is used for the right problem." However, this was not considered a priority, and the entire NPS is now dormant. In 2009, the Health Council of Canada recommended that optimal prescribing be a priority element in a revived pharmaceutical strategy, noting the need for easily accessible, evidence-based information on the proper use and risks of each medication, and for national co-ordination of efforts toward improved prescribing.xi 5. The CMA's Prescription The previous sections have described the problems that currently exist with prescribing in Canada, and factors that contribute to these problems. In this section the CMA discusses what can be done to make prescribing optimal. Even as a variety of factors influence prescribing, so a variety of elements can contribute to optimizing it. What should be done to encourage optimal prescribing in Canada? The CMA believes that optimal prescribing should be addressed through the development and implementation of a national strategy comprising the six elements discussed in the following pages: Recommendation 1 Governments at all levels should work with prescribers, the public, industry and other stakeholders to develop and implement a nationwide strategy to encourage optimal prescribing and medication use. Element 1: Relevant, Objective Information for Prescribers As our knowledge base on prescription drugs expands, it is communicated to physicians by many different means. The CMA believes it is possible to improve these communications and make them more relevant and useful to prescribing physicians. Recommendation 2 The CMA supports the development and dissemination of prescribing information that is: o based on the best available scientific evidence o relevant to clinical practice o easy to incorporate into a physician's workflow. a) Undergraduate medical education and residency training A basic grounding in pharmacology is a vital part of undergraduate medical education. Appendix 1, which was taken from a 2009 report prepared by Britain's Royal College of Physicians, contains a specific proposal for a core undergraduate curriculum in therapeutics. Basic education in pharmacology should, among other things, help prepare future physicians for the challenge of maintaining their knowledge base in practice. The academic community has a role to play, during undergraduate training and residency, in providing impartial advice on pharmaceutical matters, and ensuring that students and residents can appraise drug research and prescribing guidance critically. Recommendation 3 The CMA encourages all medical educational bodies to support a comprehensive program of education in pharmaceuticals, pharmacology and optimal prescribing, at the undergraduate, residency and continuing medical education levels. b) Continuing medical education (CME) Traditionally, CME meant face-to-face seminars or conferences; however, studies are demonstrating that Internet-based learning is as effective as face-to-face CME.xii Developers and practitioners are increasingly looking at delivering CME online. Of particular promise are formats that deliver information electronically in short, summary bullet points, presenting the most pertinent information on a single screen where feasible. As mentioned before, a large proportion of CME is sponsored by the pharmaceutical industry. Like pharmaceutical detailing, industry-sponsored CME might steer physicians toward newer drugs which may not be first-line therapies, and which are often less thoroughly evaluated and more expensive than established treatments. Therefore, in order that physicians can be assured of receiving objective information, there is an urgent need for objective funding sources for CME, that are as distant as possible from potential sources of bias. Recommendation 4 The CMA and provincial/territorial medical associations call on governments to support and fund objective and impartial continuing medical education programs on optimal prescribing. Recommendation 5 The CMA calls on appropriate educational bodies to develop policies or guidelines to ensure the objectivity of continuing medical education. CMA's Guidelines for Physicians in Interaction with Industry (2007) proposes ways in which physicians, medical associations and medical educational bodies can minimize bias when collaborating with industry on CME and continuing professional development programs. c) New Forms of Education Besides formal CME, there are many ways of conveying information to physicians with the intent of influencing prescribing behaviour. One promising intervention is academic detailing, in which trained physicians or pharmacists use the personalized, one-on-one techniques employed by pharmaceutical detailers to encourage adoption of a desired behaviour (e.g., prescribing of a particular drug or treatment regimen) rather than specific drugs, to counterbalance marketing by pharmaceutical representatives. Academic detailing has demonstrated some success. Because it is expensive and labour intensive, it has often been difficult to persuade governments to invest in it. However, a growing number of provinces have developed, or are considering, academic detailing programs. Another promising intervention is physician self-directed learning. In Alberta two medical schools are preparing to perform an analysis of physicians' perceived and unperceived learning needs with the intention of developing individualized learning programs to address the needs of physicians in their practices. The effectiveness of various learning programs in changing behaviour is being studied on an ongoing basisxiii, through means such as the Rx for Change database, a collaborative effort between two Cochrane Collaboration groups and the Canadian Agency for Drugs and Technologies in Health. This database summarizes current research evidence, regularly updated, about the effects of strategies to improve drug prescribing practice and drug use. Because different physicians have different needs, goals and styles of learning, multiple formats are required to address them. Though one intervention in and of itself may not produce widespread, immediate or dramatic changes in behaviour, the cumulative effect of multiple messages over time can be very strong. Recommendation 6 The CMA recommends that governments, research institutes and other stakeholders fund and conduct ongoing research on the effectiveness of interventions designed to change clinical behaviour, and allocate resources to those interventions that demonstrate the greatest effectiveness. d) Point-of-care information In addition to formal education programs, information on pharmaceuticals and prescribing is also available to physicians at the point of care. Physicians' preference is for brief summaries of key points, which can be absorbed quickly and be accessed at point of care through hand-held personal digital assistants (PDA's) or, increasingly, through electronic health and prescription records. Drug information compendia are available in electronic and print format. For example, cma.ca provides information about prescription drugs through a program called Lexi-Drugs Online. e-Therapeutics+, developed by the Canadian Pharmacists Association, is another online resource for prescribing and managing drug therapy at the point of care. Online programs are also available that monitor physicians' prescribing habits and compare them to those of their peers. Such programs are to be encouraged if their purpose is to educate rather than to enforce a certain behaviour. However, they will require additional investment, particularly in information technology and software development. Element 2: Electronic Prescribing Electronic prescribing has the potential to dramatically improve drug therapy. For example an effective e-prescribing system has the potential to: - list all the drugs a patient is taking. It could also identify duplicate prescriptions for the same drug from different providers, thus helping to reduce prescription fraud and prescription drug abuse; - provide decision-support tools; for example, a warning could appear on the screen if the physician proposes to prescribe a drug that interacts harmfully with another the patient is already taking. This decision support should ideally be updated in real time so the physician has access to the most current information. - Enable the improvement of patient adherence to drug therapy, perhaps by generating reminders to patients to refill and take prescriptions. - Transmit prescriptions to pharmacies electronically, increasing convenience for the patient and eliminating a major cause of medication errors, illegible handwriting. - Automatically link to a formulary to enable the prescriber to see whether the patient's insurer has approved the medication, or to find the lowest-cost drug in a class. Two-way electronic communication with formulary managers may also help reduce some of the administrative paperwork which is a barrier to optimal prescribing. - Automatically notify physicians of drug shortages, recalls or other urgent situations. In the U.S., e-prescribing is being actively encouraged. Since January 2009, the American Medicare system provides financial incentives for its physicians who adopt e-prescribing. In Canada adoption has been slow;xiv it is estimated that fewer than 10% of physicians e-prescribe. This may be due partly to the expense, and partly because of issues which remain to be addressed, such as: - How do we assure that the confidentiality of patients' health information, and of physicians' prescribing information, is protected? - What information should be shared with other health professionals? - What legally constitutes a "signature," or other means of authenticating a prescription? - Can we ensure that pharmacies as well as physicians' offices are equipped to receive electronic prescriptions? - Can we ensure that e-prescribing software is designed so as to be practical and user-friendly for physicians; for example, that pop-up warnings contain the most important and relevant information? - Can we ensure that e-prescribing protocols simplify a physician's workload rather than adding to it - for example, that they eliminate duplication of prescription writing? E-prescribing is in its early stages, and knowledge and policy in this area are developing rapidly. CMA will continue to study the issue in the coming years. Several provinces maintain electronic prescription databases and others are in development. For example, BC PharmNet provides drug-to-drug interaction checking and patient medication profiles to pharmacists, emergency rooms and physicians with controlled access. In most provinces and territories, medical associations are working with governments on standards to implement e-prescribing. Recommendation 7: The CMA, provincial/territorial medical associations and affiliates encourage governments to give active support to physicians in their transition to electronic prescribing, through a comprehensive strategy that includes financial support for acquisition of hardware and software, and dissemination of appropriate training and knowledge transfer tools. Recommendation 8: The CMA calls on governments to incorporate into electronic prescribing the following principles: - measures to ensure patients' privacy and confidentiality, as well as confidentiality of physician prescribing information - a link with a formulary, to provide physicians with best practice information including drug cost data - guidelines for data sharing among health professionals and others - standards for electronic signature that are not overly restrictive. Element 3: Programs by Payers Government drug plans and, increasingly, private insurance companies, have instituted programs to encourage prescription of certain drugs. Such programs, which are often motivated by the desire to control rising drug costs, can include the following: a) Formularies There are 18 public drug formularies in Canada managed by federal or provincial/territorial governments. These formularies often use various means to help control drug costs. For example, if a generic drug is available to treat a given condition, a payer may reimburse patients only for the generic rather than for brand-name equivalents. Or if several related drugs exist in the same class, a formulary could reimburse only for the lowest-priced drug in that class, as British Columbia's reference-based drug pricing (RDP) program does for five drug categories that contain several drugs with equal efficacy; if patients want to purchase a higher-priced drug they must pay the difference out of pocket. Such programs are not confined to Canada; Britain's National Health Services funds specific treatments only if recommended by the National Institute for Clinical Excellence (NICE) which assesses new drugs for efficacy and cost-effectiveness. Under New Zealand's PHARMAC system the government reimburses only for one drug in each class. A formulary's cost-control objectives can sometimes conflict with the goal of physician and patient to obtain the care they believe will be most optimal. For example, formulary rules limiting the length of chronic prescriptions can make it difficult for physicians to prescribe over the long term to patients who manage their conditions well. It is important that formulary rules be based on the best available scientific evidence. The ideal formulary will be designed to improve clinical care, optimize patients' health outcomes, promote patient safety, and reduce the administrative burden on the physician. Recommendation 9 The CMA recommends that formularies, in both the public and private sectors, simplify administrative requirements on patients and physicians, reducing paperwork to the minimum necessary to ensure optimal patient care. b) Prescribing incentives Sometimes, payers may provide incentives such as reward payments for physicians who prescribe in a desired way (for example, who prescribe more than a certain percentage of a given drug class as generics), or impose a financial penalty for physicians who do not exhibit the desired behaviour. Financial incentives to physicians to provide preventive care services have been used effectively but their effect on prescribing practices is only beginning to be evaluated. A study of U.K. prescribing incentive schemes concluded that reward payments may have contributed to cost control, but their effect on prescribing quality remained uncertain. xv CMA's ongoing Health Care Transformation initiative will provide decision makers with blueprint for a high-performing, patient-centered health care system. Among its other activities over the next few years, this initiative will be examining in greater detail the effect of pay-for-performance schemes on the quality of care in Canada. Element 4: Collaboration Among Health Care Providers No health professional is an island. Increasingly health care providers are working in collaborative teams to manage drug therapy and other forms of patient care. In such teams, for example, pharmacists may perform a variety of functions, such as reviewing patients' medication profiles to catch medication related problems such as inappropriate dosing, duplicate or unnecessary therapies; or managing long-term drug therapy for patients with chronic conditions such as asthma or diabetes. At their most effective, such collaborative arrangements could greatly improve drug therapy, and patient care in general, by allowing the team to draw on a common pool of expertise. However, if improperly implemented, they could lead to breakdown of communication and fragmentation of care. To ensure that collaborative management of a patient's drug therapy functions smoothly, it is important that clearly articulated arrangements be in place. CMA's position statement Achieving Patient-Centered Collaborative Care (2007), includes the following principles: - Patient-centered care. Patient care (including drug therapy) must be aligned around the values and needs of the patient. - Clear communication. Effective communication is essential to ensure safe and coordinated drug therapy and to ensure that the patient is receiving timely, clear and consistent messaging. For example, if a physician and pharmacist are both managing and monitoring a patient with asthma, it is essential that they notify each other if a change is made to a prescription, such as a new drug or a new dosage. Electronic health records have the potential to greatly improve communication among providers. - Clinical leader. CMA's position statement defines a clinical leader as "the individual who, based on his or her training, competency and experience, is best able to synthesize and interpret the evidence and data provided by the patient and the team, make a differential diagnosis and deliver comprehensive care for the patient." In most cases the physician, by virtue of training, knowledge, background and patient relationship, is best positioned to assume this role. Recommendation 10: The CMA recommends that formalized and clearly articulated collaborative arrangements be in place for practitioners who jointly manage a patient's drug therapy. The CMA, recognizing the need for and value of collaboration in the management of drug therapy, will continue to explore and encourage the most effective models for collaborative practice among health professionals. Element 5: Impartial, Evidence-based Information for Patients Canadians have the right to accurate, reliable information on prescription drugs and their uses, so that they can become knowledgeable partners in their care. A good deal of information is already available to patients, and there are ways in which it could be improved and made more accessible and relevant. One way would be to improve its clarity and readability, to address the needs of the estimated 6 in 10 Canadians who lack the health literacy necessary to properly manage their health and engage in preventive practices.xvi Another way would be to provide more information from impartial sources, to reduce the impact of direct-to-consumer advertising. The CMA believes that in general, brand specific advertising is a less than optimal way of providing drug information, and that the laws currently banning direct-to-consumer prescription drug advertising in Canada should remain in effect, and tightened to eliminate existing loopholes. Physicians and other health care providers can also play an important role in providing patients with guidance and with accurate information on the medications they take. CMA and the Canadian Pharmacists Association have collaborated with Canada's Research-based Drug Companies (Rx&D) to produce a pamphlet called "Knowledge is the Best Medicine" which provides consumers with advice on safe medication use, and guidance on how to interact effectively with their physician or pharmacist. Recommendation 11: The CMA calls on governments to fund and facilitate the development and provision of unbiased, up-to-date, practical information to consumers on prescription drugs and their appropriate use, and support physicians and pharmacists in disseminating this information to their patients. Recommendation 12: The CMA calls on the Government of Canada to continue to enforce the current ban on direct-to-consumer prescription drug advertising in Canada, and close the loopholes that currently allow a limited amount of drug promotion. Element 6: Research, Monitoring and Evaluation Drug development is an ongoing process, and the evaluation of drugs and their prescribing should be ongoing as well. Canada already supports a certain amount of research activity in this area. For example, Health Canada funds the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS), a collaborative, pan-Canadian service to identify and promote optimal drug therapy. COMPUS collects and evaluates relevant existing evidence, and provides advice, tools, and strategies to implement and support the adoption of optimal drug therapy. COMPUS has produced, or is producing, evidence-based recommendations for prescribing proton pump inhibitors and drugs for diabetes management. COMPUS has established links to university-based providers of CME, and with academic detailing groups, who help to disseminate its recommendations and materials. It also manages the Rx for Change database previously mentioned. The federal government has recently established and funded a national Drug Safety and Effectiveness Network. This network will link researchers to help coordinate and fund independent research on the risks and benefits of drugs that are on the market. We hope that this signifies a long-term commitment on the country's part to optimal drug therapy. CMA believes Canada should build on this activity by encouraging research on an ongoing basis on: - prescribing guidelines and what drugs work best for which conditions - dissemination of prescribing information - what interventions most effectively influence practice? - effect of changes in prescribing on patient health outcomes, and on utilization of health services; - the safety and effectiveness of drugs, building on what currently exists (such as Health Canada's system for reporting adverse drug reactions and communicating drug safety advisories), so that information derived from post-market surveillance quickly reaches health care providers and patients and becomes part of our body of knowledge. Since the great majority of prescriptions in Canada are written by physicians, it is essential that the medical community participate actively in evaluation of prescribing practices, and disseminating and implementing the results of research. Recommendation 13: The CMA calls on those who fund and produce research on drug safety and effectiveness, prescribing guidelines and programs to enhance prescribing practices, to include physicians and medical organizations meaningfully in this activity. 5 Conclusion It is likely that drug therapy will continue to increase in importance as a component of patient care and that it will continue to become more complex and, in many cases, more costly. As a result, we expect that health professionals and the Canadian public will continue to need readily available and up-to-date information on prescription drugs: the availability of new products; the results of safety and effectiveness studies; and advice on how to prescribe and take these medications for the best health outcome. It is also likely that electronic prescribing systems, formularies and other monitoring methods will continue to be developed, and that these will influence physicians' prescribing habits. To deliver evidence-based prescribing information effectively, and encourage its smooth incorporation into clinical practice, Canada needs a comprehensive, multi-disciplinary strategy in which physicians and other health care providers, governments, patients, industry and other stakeholders work together to encourage and support optimal prescribing, in the interest of achieving the best possible health for Canadians with the most effective use of resources. The CMA is ready to join with others in developing and implementing such a strategy, in the hope that eventually, all patients will receive the prescription drugs they need, when they need them. Appendix 1 A core undergraduate curriculum for prescribers in therapeutics Core knowledge and understanding Basic pharmacology Clinical pharmacokinetics Monitoring drug therapy Adverse drug reactions Drug interactions Medication errors Poisoned patients Prescribing for patients with special requirements (e.g., the elderly, children, women of childbearing potential, pregnant and breastfeeding women, and patients with renal or liver disease) Legal aspects of prescribing drugs Developing new drugs Medicines management Ethics of prescribing Commonly used drugs Common therapeutic problems Complementary and alternative medicine Integration of therapeutics into understanding of disease management. Core skills Taking a drug history Prescription writing Drug administration Prescribing drugs in special groups Prescribing drugs to relieve pain and distress Adverse drug reactions and interactions Drug allergy Clinical pharmacokinetics Monitoring drug therapy Analysing new evidence Obtaining accurate objective information to support safe and effective prescribing Obtaining informed consent to treatment Core attitudes A rational approach to prescribing and therapeutics Risk-benefit analysis Recognizing the responsibilities of a physician as part of the prescribing community Recognizing personal limitations in knowledge Responding to the future SOURCE: Maxwell S, Walley T. Teaching safe and effective prescribing in UK medical schools: a core curriculum for tomorrow's doctors. Br J Clin Pharmacol 2003;55:496-503.100. Cited in Innovating For Health: Patients, physicians, the pharmaceutical industry and the NHS. A report from the Royal College of Physicians (UK) February 2009 References i Metge C, Sketris I. "Pharmaceutical Policy." In MacKinnon NJ, ed. Safe and Effective: the Eight Essential Elements of an Optimal Medication Use System. Canadian Pharmacists Association, 2007. ii Canadian Institute for Health Information. Drug Expenditure in Canada, 1985 to 2009. Released April 2010. Accessed at https://secure.cihi.ca/estore/productFamily.htm?locale=en&pf=PFC1428&lang=en&media=0. iii Wang E, Einarson T, Kellner J, Conly. Antibiotic prescribing for Canadian preschool children: evidence of overprescribing for viral respiratory infections. Clin Infect Dis. 1999; 29(1):155-60. iv Petrella R, Merikle E, Jones J. Prevalence and treatment of dyslipidemia in Canadian primary care: a retrospective cohort analysis. Clin Ther. 2007; 29(4):742-50. v Dr. Jean Gray, speaking at the Health Council of Canada symposium, "Safe and Sound: Optimizing Prescribing Behaviours"; Montreal, June 2007 vi Steinman MA, Baron RB. Is continuing medical education a drug promotion tool? Yes. Can Fam Phys 2007: 53(10); 1650-53. vii Angell M. Industry-sponsored clinical research: a broken system. JAMA 2008: 300 (Sept. 3); 1069-1071. viii Mintzes B, Barer ML, Kravitz RL et al. Influence of direct to consumer pharmaceutical advertising and patients' requests on prescribing decisions: a two-site cross-sectional survey. BMJ 2002; 324 (2 February): 278-279. ix "Should Canada allow direct-to-consumer advertising of prescription drugs?" (Debate) Can Fam PhysicianVol. 55, No. 2, February 2009, pp.130 - 133. x Valiyeva E, Herrmann M, Rochon PA. Effect of regulatory warnings on antipsychotic prescription rates among elderly patients with dementia: a population-based time series analysis. Can Med Assoc J 2008; 179(5) doi 10.1503. xi Health Council of Canada. "A commentary on The National Pharmaceuticals Strategy: a Prescription Unfilled." (January 2009) xii Cook DA, Levinson AJ, Garside S et al. Internet-based learning in the health professions: a meta-analysis. JAMA 2008; 300 (10): 1181-1196. xiii Rx for Change database; accessed at http://www.acmts.ca/index.php/en/compus/optimal-ther-resources/interventions. xiv Canadian Medical Association. "Information technology and health care in Canada: 2008 status report." xv Ashworth M, Lee R, Gray H et al. How are primary care organizations using financial incentives to influence prescribing? J Public Health 2004: 26(1); doi: 10.1093. xvi Canadian Council on Learning. Health literacy in Canada: initial results from the International Adult Literacy and Health Skills Survey (September 2007). Accessed at http://www.ccl-cca.ca/ccl/Reports/HealthLiteracy/HealthLiteracy2007.html.
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Taking action on drug shortages during Covid-19 - open letter

https://policybase.cma.ca/en/permalink/policy14261
Date
2020-08-13
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2020-08-13
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Dear Prime Minister, We are writing to you today to ask you to bring attention and resources to Canada’s drug supply challenges. These shortages have existed for the past decade but have been greatly exacerbated due to the COVID-19 pandemic. As frontline pharmacists and physicians, we have seen and heard of serious shortages of essential, critical medications. These drugs are often used simultaneously in ORs, ERs and palliative care wards, as well as ICUs. And while our ICUs are thankfully seeing fewer COVID-19 patients, the pandemic has been placing a heavy burden on their drug supply, where patients often require weeks’ worth of treatment on ventilators. The shortages of these drugs imperil the lives of patients seeking care all over the country. Currently, the vast majority (24/32) of the drugs on Health Canada’s own Tier 3 list, which represents drugs for which there are no suitable alternatives, are essential for treating COVID-19. With the likely upcoming second wave in Canada, the potential for further exacerbation of these shortages is inevitable unless we implement rigorous preparedness measures. At first glance, the federal government may conclude that this is a provincial and territorial area of jurisdiction. We can assure you, that there is a considerable role for the federal government to play on this issue of national concern if you so choose to take action. We believe you should. Many of these critical care drugs should be part of the National Strategic Emergency Stockpile. However, it is clear that Canada simply did not invest enough into its stockpiles to meet the demand during the COVID-19 pandemic. In order for the stockpiling strategy to be effective, it is vital that the federal, provincial, and territorial governments work closely with hospitals, long-term care facilities, hospices and primary care facilities nationwide to establish a 2 comprehensive list of critical medicines and develop a plan to procure medicines in a coordinated manner to prevent unintended competition for resources. The 2019 budget had earmarked funds for a new Canada Drug Agency which would have oversight over a national formulary. This proposed agency could similarly identify essential medicines to aid in an efficient stockpiling response, whether through stimulating domestic production or through importation and coordination of purchasing strategies to ensure that jurisdictions that have a greater need for medications gain access to them. We know that COVID-19’s impact on the health system across provinces and territories and within each and every jurisdiction was not equal or consistent. We appreciate the active efforts of Health Canada to resolve current or projected shortages of critical drugs through its Tier Assignment Committees. Furthermore, Ontario has a Critical Care COVID-19 Command Centre and has created a Critical Care Drug Shortage Task Team. Certainly, the short-term deficit will need to be resolved through this mechanism and importing from all available suppliers. However, to support the system at large, provincial and territorial governments will need national support, resources and (where welcomed by provinces) a certain level of national coordination. Regardless of well-established Federal-Provincial-Territorial dynamics, without concrete preventative action, Canada will perpetually face drug shortages. This is why we recommend that your government commit to working on a long-term solution involving a three-pronged strategy: 1. Stockpiling of a Critical Medications List which the government commits to ensuring are always in stock for long enough to meet the needs in an emergency (likely through the Canada Drug Agency). a. A Critical Medications List would allow the parties involved in addressing the drug shortages to have a clear picture of what drugs to monitor closely, and provides a more comprehensive approach to the problem. 2. A publicly owned generic, critical drugs manufacturer, or at the bare minimum, public support for spare capacity by Canadian-based and controlled drug manufacturers to be used for critical drugs. a. This manufacturer or manufacturers would specialize in manufacturing the critical drugs on the Critical Medications List, and would be primarily involved in satisfying significant portions of our national demands. 3. Greater transparency and communications to and from governments and the health sector around the essential drug supply. This would include efforts to 3 better track the supply of drugs in hospitals across the country and push notifications on shortages through the appropriate channels to frontline workers. We encourage your government to give this urgent issue attention and efforts now, so that Canadians can have the confidence that their healthcare system will be there when they most need it.
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