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Policies that advocate for the medical profession and Canadians


16 records – page 1 of 2.

Bill C-224, Good Samaritan Drug Overdose Act

https://policybase.cma.ca/en/permalink/policy11910
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-40
The Canadian Medical Association supports Bill C-224, Good Samaritan Drug Overdose Act.
Policy Type
Policy resolution
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-40
The Canadian Medical Association supports Bill C-224, Good Samaritan Drug Overdose Act.
Text
The Canadian Medical Association supports Bill C-224, Good Samaritan Drug Overdose Act.
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Canadian guideline for safe and effective use of opioids for chronic pain

https://policybase.cma.ca/en/permalink/policy11901
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-30
The Canadian Medical Association recommends that the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain include consideration of pharmacokinetic and pharmacodynamic factors specific to older adults.
Policy Type
Policy resolution
Date
2016-08-24
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC16-30
The Canadian Medical Association recommends that the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain include consideration of pharmacokinetic and pharmacodynamic factors specific to older adults.
Text
The Canadian Medical Association recommends that the Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-Cancer Pain include consideration of pharmacokinetic and pharmacodynamic factors specific to older adults.
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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).
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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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Consultation on the prescription drug list: Naloxone

https://policybase.cma.ca/en/permalink/policy11847
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide comment on the proposal by Health Canada1 to revise the listing for naloxone on the Prescription Drug List (PDL) to allow the non-prescription use of naloxone, "when indicated for emergency use for opioid overdose outside hospital settings". The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The harms associated with opioids, which include prescription medicines such as oxycodone, hydromorphone and fentanyl, as well as illegal drugs such as heroin, is a significant public health and patient safety issue. Harms include addiction, diversion, overdose and death. According to 2013 estimates2, Canada has one of the highest per capita consumptions of prescription opioids in the world. In North America, about 5% of the adult population, and substantially higher rates for teens and young adults, reported non-medical opioid use in the previous year. This rate is higher than all other illegal drugs, with the exception of marijuana.3 Data on the harms caused by opioids are not collected systematically in Canada; however, practitioners have seen the significant impact of these drugs on their patients and to whole communities, including indigenous peoples. Opioid addiction rates from 43% to 85% have been reported in some indigenous communities.4 5 In Ontario, according to the Office of the Chief Coroner, opioid-related deaths nearly tripled from 2002 to 2010.6 Canada's physicians believe that Canada needs a comprehensive national strategy to address the harms associated with psychoactive drugs, whether illegal or prescription-based.7 One component of this strategy is the prevention of overdose deaths and complications with appropriate medication and prompt emergency response. For over four decades, naloxone (or Narcan(r)) has been used as a prescription drug for the complete or partial reversal of opioid overdoses. Naloxone counteracts the life-threatening depression of the central nervous system and respiratory system, allowing an overdose victim to breathe normally. The World Health Organization placed naloxone on its list of essential medications in 1983. Physicians have been encouraged to identify patients who could benefit from the co-prescription of naloxone, along with opioids, when these are necessary. Increased risk for opioid overdose includes previous episodes of overdose, history of substance use disorder, higher opioid dosages, or concurrent benzodiazepine use.8 9 More recently, with the increase in opioid overdoses, different provinces have created programs to increase access to naloxone outside of health care settings, such as "take-home naloxone programs". The experience in Canada and in other countries has been shown to have various benefits, including reducing overdose deaths.10 11 In Canada, naloxone has been administered through intramuscular or subcutaneous injection in these community-based programs, but in other countries it has also been available in a nasal spray form or in a pre-filled auto-injector format. Those that receive the naloxone kit are trained in the recognition of signs and symptoms of opioid overdose, in the administration of naloxone and first aid and in the need to call for medical follow-up. In its 2015 policy on Harms associated with Opioids and other Psychoactive Prescription Drugs, the CMA supports the improvement of access to naloxone, particularly by individuals who are at a high risk of overdose as well as third parties who can assist a person experiencing an opiate-related overdose. The CMA also encourages the creation and scaling up of community-based programs that offer access to naloxone and other opioid overdose prevention tools and services. This would include training for health workers, first responders, as well as opioid users, families and peers about the prevention of overdose fatalities.12 Also in 2015, the CMA approved a resolution supporting "the development and implementation of a national strategy on the use of naloxone".13 A report issued by the United Nations Office on Drugs and Crime and the World Health Organization supports making naloxone available to first responders as well as to people dependent on opioids, their peers and family members who are likely to be present when an overdose occurs.14 Many other organizations, such as the Canadian Pharmacists Association, the American Medical Association and the American Public Health Association, are also supportive of enhanced access to naloxone in the community.15 16 17 The prescription status has been one of the barriers to increased access to naloxone. It is more likely that a family member, partner or friend would need to administer the naloxone in an overdose than the person who is prescribed the drug. Community-based programs have had to work with standing orders from prescribers. First responders, such as police officers and firefighters, should be able to carry and administer the drug, given they are often the first professionals to arrive at a scene where someone has overdosed. According to Health Canada, the provinces and territories have collectively asked that the prescription status be re-evaluated. Health Canada has undertaken a Benefit-Harm-Uncertainty assessment of naloxone, and come to the following conclusions: This assessment recommended that naloxone could safely be administered without the direct supervision of a physician if the person administering the drug has appropriate training. The main risks associated with the unsupervised use of the drug are: * the administrator may have difficulty filling the syringe and administering the drug under pressure in an emergency situation; * the administrator may not seek professional care for follow-up of the patient after injection; * chance of the patient relapsing since the effects of naloxone may only last for up to one hour depending on amount and type of opioid causing the overdose; * that the patient may become very agitated and aggressive after coming out of the opioid depression (Acute Opioid Withdrawal Syndrome). These risks can be mitigated with appropriate training of the potential administrator before naloxone is distributed. The benefit of quickly responding to an overdose far outweighed these risks. Evidence from provincial take-home programs indicates that naloxone can be administered (intramuscularly or subcutaneously) by a layperson and its effects monitored successfully without practitioner supervision. Although an opioid overdose might be mistakenly diagnosed by a layperson, the injection of naloxone in a person not overdosing on an opioid will cause no serious harm.18 Various jurisdictions have delisted or are studying special conditions for the status of naloxone as a prescription drug, including Italy and some U.S. States.19 The CMA appreciates the opportunity to provide feedback on this important matter to physicians, and congratulates Health Canada in taking the initiative to make naloxone more accessible in the community; thereby helping to address the concerning levels of opioid overdoses in Canada. CMA Recommendations: That Health Canada proceed with the revisions to the listing for naloxone on the Prescription Drug List, to allow the non-prescription use of naloxone when indicated for emergency use for opioid overdose outside hospital settings. As outlined in Health Canada's assessment, the potential risks can be mitigated by well-designed community-based programs. That Health Canada assess the option of licensing naloxone products that don't require training for intramuscular or subcutaneous injection, such as nasal sprays or automated handheld injectors (similar to epinephrine auto-injectors for use in serious allergic reactions), in order to further increase accessibility. References 1 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17). 2 International Narcotics Control Board. Narcotics drugs: estimated world requirements for 2013; statistics for 2011. New York: United Nations; 2013. Available: https://www.incb.org/documents/Narcotic-Drugs/Technical-Publications/2012/NDR_2012_Annex_2_EFS.pdf (accessed 2016 March 17). 3 Fischer B, Keates A, Buhringer G, et al. Non-medical use of prescription opioids and prescription opioid-related harms: why so markedly higher in North America compared to the rest of the world? Addiction. 2013;109:177-81. 4 Chiefs of Ontario. Prescription drug abuse strategy: 'Take a stand.' Final report. Toronto: Chiefs of Ontario; 2010. Available: www.chiefs-of-ontario.org/sites/default/files/files/Final%20Draft%20Prescription%20Drug%20Abuse%20Strategy.pdf (accessed 2016 March 17). 5 Health Canada. Honouring our strengths: a renewed framework to address substance use issues among First Nations people in Canada. Ottawa: Health Canada; 2011. Available: http://nnadaprenewal.ca/wp-content/uploads/2012/01/Honouring-Our-Strengths-2011_Eng1.pdf (accessed 2016 March 17). 6 National Advisory Council on Prescription Drug Misuse. First do no harm: responding to Canada's prescription drug crisis. Ottawa: Canadian Centre on Substance Abuse; 2013. 7 Canadian Medical Association. Policy Document PD15-06 - Harms associated with opioids and other psychoactive prescriptions drugs. Ottawa: The Author; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed 2016-March 17). 8 National Opioid Use Guideline Group. Canadian guideline for safe and effective use of opioids for chronic non-cancer pain. Hamilton, ON: McMaster University; 2010. Available: http://nationalpaincentre.mcmaster.ca/opioid/ (accessed 2016 March 17). 9 Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain-United States, 2016. MMWR Recomm Rep. 2016;65(RR-1):1-49. Available: http://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1er.htm?s_cid=rr6501e1er_w (accessed 2016 March 17). 10 Walley AY, Xuan Z, Hackman HH, et al. Opioid overdose rates and implementation of overdose education and nasal naloxone distribution in Massachusetts: Interrupted time series analysis. BMJ. 2013;346:f174. Available: http://www.bmj.com/content/bmj/346/bmj.f174.full.pdf (accessed 2016 March 17). 11 Banjo, O, Tzemis, D, Al-Outub, D, et al. A quantitative and qualitative evaluation of the British Columbia Take Home Naloxone program. CMAJ Open, August 21, 2014;2(3) E153-E161. Available: http://cmajopen.ca/content/2/3/E153.full (accessed 2016 March 17). 12 Carter CI, Graham B. Opioid overdose prevention & response in Canada. Policy brief series. Vancouver: Canadian Drug Policy Coalition; 2013. Available: http://drugpolicy.ca/solutions/publications/opioid-overdose-prevention-and-response-in-canada/ (accessed 2016 March 17). 13 Canadian Medical Association. Policy Resolution GC15-18 - National strategy on the use of naloxone. Ottawa: The Author; 2015. Available: policybase.cma.ca/dbtw-wpd/CMAPolicy/PublicB.htm (accessed 2016 March 17). 14 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17). 15 American Medical Association. AMA adopts new policies at annual meeting. Press Release. New York, NY: Reuters; June 19, 2012. Available: http://www.reuters.com/article/idUS182652+19-Jun-2012+GNW20120619 (accessed 2016 March 17). 16 Drug Policy Alliance. American Public Health Association Policy Statement on Preventing Overdose Through Education and Naloxone Distribution. New York, NY: Drug Policy Alliance; October 30, 2012. Available: http://www.drugpolicy.org/resource/american-public-health-association-policy-statement-preventing-overdose-through-education-a (accessed 2016 March 17). 17 Canadian Pharmacists Association. CPhA Welcomes Health Canada Move to Change Prescription Status of Naloxone. News Release. January 14, 2016. Available: https://www.pharmacists.ca/news-events/news/cpha-welcomes-health-canada-move-to-change-prescription-status-of-naloxone/ (accessed 2016 March 17). 18 Health Canada. Consultation on the Prescription Drug List: Naloxone. File number: 16-100479-342. January 14 2016. Ottawa. Available: http://www.hc-sc.gc.ca/dhp-mps/consultation/drug-medic/pdl_ldo_consult_naloxone-eng.php (accessed 2016 March 17). 19 United Nations Office on Drugs and Crime / World Health Organization Opioid overdose: preventing and reducing opioid overdose mortality. Discussion Paper UNODC/WHO 2013. Available: http://www.unodc.org/docs/treatment/overdose.pdf (accessed 2016 March 17).
Documents
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Essential drugs for the exclusive use of developing countries

https://policybase.cma.ca/en/permalink/policy415
Last Reviewed
2014-03-01
Date
2000-08-16
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC00-221
The CMA calls on governments and pharmaceutical manufacturers in Canada to ensure a supply of essential drugs for the exclusive use of developing countries, and to offset the numerous barriers hindering access to these drugs.
Policy Type
Policy resolution
Last Reviewed
2014-03-01
Date
2000-08-16
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Resolution
GC00-221
The CMA calls on governments and pharmaceutical manufacturers in Canada to ensure a supply of essential drugs for the exclusive use of developing countries, and to offset the numerous barriers hindering access to these drugs.
Text
The CMA calls on governments and pharmaceutical manufacturers in Canada to ensure a supply of essential drugs for the exclusive use of developing countries, and to offset the numerous barriers hindering access to these drugs.
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Health Canada’s Consultation on “Plain and Standardized Packaging”

https://policybase.cma.ca/en/permalink/policy13817
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2016-08-12
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada’s Consultation on “Plain and Standardized Packaging” for Tobacco Products. Potential Measures for Regulating the Appearance, Shape and Size of Tobacco Packages and of Tobacco Products. Document for Consultation, May 2016. Canada's physicians have been working for decades toward the goal of a smoke-free Canada. The CMA issued its first public warning concerning the hazards of tobacco in 1954 and has continued to advocate for the strongest possible measures to control its use. The CMA has been a leader in advocating for plain and standardized packaging for tobacco products for many years. We established our position in 1986 when we passed a resolution at our General Council in Vancouver recommending to the federal government “that all tobacco products be sold in plain packages of standard size with the words "this product is injurious to your health" printed in the same size lettering as the brand name, and that no extraneous information be printed on the package.” Over the past 30 years we have reiterated our long-standing support for the concept of tobacco products being sold in standardized packages in several briefs and policy statements. The current Health Canada proposal will help realize that goal and the CMA supports the measures outlined in the consultation paper. There are two elements that the CMA recommend be addressed in this consultation. The CMA recommends that only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed. This would reduce the permitted style to one standard package and allow for the largest possible surface area to be used to convey health warnings and other health-related information. In a similar vein, the CMA recommends a single allowable length of cigarette and that a minimum diameter or width be established. The purpose is to eliminate the sale of “slims” and “super slims” cigarettes to eliminate the possibility of these products as being considered “healthier.” While the CMA supports these measures, they must be part of the overall goal of further reducing and eliminating smoking. These measures will be an essential element of a sustained, well-funded and comprehensive program to reduce tobacco use, combining policy interventions with educational and social-marketing interventions including mass media campaigns. These programs should reflect current best practices, and be evaluated regularly for effectiveness and impact. To that end, the CMA calls on the federal government to renew the Tobacco Strategy before it expires in March 2017. At the same time, the CMA also recommends that the government allocate adequate funding to ensure implementation of the strategy. Finally, the consultation paper closes with some potential challenges to the implementation of these proposals. With respect to the problem of counterfeit cigarettes, all levels of government should take the strongest possible measures to control the sale and distribution of contraband tobacco, on their own and in cooperation with other affected jurisdictions. The problem of retailers having difficulty implementing the regulations, resulting in service delays to their customers, is not really an issue related to these proposals. It is very doubtful that the retailers will experience such problems for very long and will find ways of resolving such difficulties. As for the problem of the manufacturers continuing to innovate in order to circumvent these measures, there should be sufficient enforcement tools within the regulations that will enable Health Canada to deal with such infractions. The Canadian Medical Association remains committed to working with governments and stakeholders to address this issue. We reiterate our long-standing support for plain and standardized packaging for tobacco products. In summary, the CMA recommends that: 1) only the “slide-and-shell” style of package be authorized and that the “flip-top” package be removed; 2) a single allowable length of cigarette and that a minimum diameter or width be established; 3) the federal government renew the Tobacco Strategy before it expires in March 2017 and that that the government allocate adequate funding to ensure implementation of the strategy. Sincerely, Jeff Blackmer, MD, MHSc, FRCPC Vice-President, Medical Professionalism
Vice-président, Professionnalisme médicale Canadian Medical Association
Association médicale canadienne
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Legalization, regulation and restriction of access to marijuana

https://policybase.cma.ca/en/permalink/policy11954
Date
2016-08-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  2 documents  
Policy Type
Response to consultation
Date
2016-08-29
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) is pleased to make this submission in response to the consultation led by the federal Task Force on Marijuana Legalization and Regulation, which has the objective of providing advice to the government on the design of a new framework for marijuana for non-medical, or recreational, purposes. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. The CMA has over 83,000 physician-members. Its mission is helping physicians care for patients and its vision is to be the leader in engaging and serving physicians, and the national voice for the highest standards for health and health care. The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. The Government of Canada has made a commitment to legalize, strictly regulate and restrict access to marijuana in response to the high rates of marijuana use among Canadians, particularly youtha 1 2, despite its current illegal status. The existing approach to drugs has resulted in high rates of criminal records for non-violent drug offences each yearb 3, affecting disadvantaged groups disproportionately. Organized crime is supported by these high levels of use. This situation has resulted in considerable harm to society. a Marijuana is the most commonly used illegal substance in Canada. 43% of Canadians claim to have used marijuana at some point in their life, despite almost a century of prohibition. Canadian youth has the highest rate of marijuana use among 29 developed countries. Almost a quarter of the population aged 15 to 24 years reported past-year use. b According to a Stats Canada report, there were 73 thousand marijuana-related criminal offences (67% of all police-reported drug offences) in 2013. 1 Rotermann M, Langlois, K. Prevalence and correlates of marijuana use in Canada, 2012. Health Reports. 2015 Apr;26(4):10-5. Statistics Canada Catalogue no. 82-003-X. Available: http://www.statcan.gc.ca/pub/82-003-x/2015004/article/14158-eng.pdf (accessed August 12, 2016). 2 UNICEF Office of Research. Child Well-being in Rich Countries: A Comparative overview. Innocenti Report Card 11. Florence: UNICEF Office of Research; 2013. Available: https://www.unicef-irc.org/publications/pdf/rc11_eng.pdf (accessed August 12, 2016). 3 Cotter A, Greenland J, Karam M. Drug-Related Offences in Canada, 2013. Juristat. 2015 Jun 25;1-38. Catalogue no. 85-002-X. Available: http://www.statcan.gc.ca/pub/85-002-x/2015001/article/14201-eng.pdf (accessed 2016 Aug 11). 4 Task Force on Marijuana Legalization and Regulation. Ministry of Justice, Ministry of Public Safety and Emergency Preparedness and Ministry of Health. Toward the legalization, regulation and restriction of access to marijuana. Discussion paper. Ottawa: Cannabis Legalization and Regulation Secretariat; 2016. Available: http://www.healthycanadians.gc.ca/health-system-systeme-sante/consultations/legalization-marijuana-legalisation/alt/legalization-marijuana-legalisation-eng.pdf (accessed July 25, 2016). 5 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: Canadian Medical Association; 2014. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/Brief-Marijuana-Health_Committee_May27-2014-FINAL.pdf (accessed 2016 Aug 12). Public opinion in Canada and internationally has risen steadily in support of the removal of criminal sanctions for simple marijuana possession, as well as for the legalization and regulation of marijuana. The federal Task Force has developed a discussion paper, Toward the Legalization, Regulation and Restriction of Access to Marijuana4, which includes the following objectives for the new regime for legal access to marijuana:
Protect young Canadians by keeping marijuana out of the hands of children and youth;
Keep profits out of the hands of criminals, particularly organized crime;
Reduce the burdens on police and the justice system associated with simple possession of marijuana offences;
Prevent Canadians from entering the criminal justice system and receiving criminal records for simple marijuana possession offences;
Protect public health and safety by strengthening, where appropriate, laws and enforcement measures that deter and punish more serious marijuana offences, particularly selling and distributing to children and youth, selling outside of the regulatory framework, and operating a motor vehicle while under the influence of marijuana;
Ensure Canadians are well-informed through sustained and appropriate public health campaigns, and, for youth in particular, ensure that risks are understood;
Establish and enforce a system of strict production, distribution and sales, taking a public health approach, with regulation of quality and safety (e.g., child-proof packaging, warning labels), restriction of access, and application of taxes, with programmatic support for addiction treatment, mental health support and education programs;
Continue to provide access to quality-controlled marijuana for medical purposes consistent with federal policy and Court decisions; and
Conduct ongoing data collection, including gathering baseline data, to monitor the impact of the new framework. Context The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in its smoked form.5 6 Children and youth are especially at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. 6 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: Canadian Medical Association; 2002. Available: http://policybase.cma.ca/dbtw-wpd/BriefPDF/BR2002-08.pdf (accessed 2016 Aug 16). 7 Volkow ND, Baler RD, Compton WM, Weiss SR. Adverse health effects of marijuana use. N Engl J Med. 2014 Jun 5;370(23):2219–2227. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4827335/pdf/nihms762992.pdf (accessed 2016 Aug 15). 8 Wilkinson ST, Yarnell S, Radhakrishnan R, Ball SA, D'Souza DC. Marijuana Legalization: Impact on Physicians and Public Health. Annu Rev Med. 2016 Jan 14;67:453-466. doi: http://dx.doi.org/10.1146/annurev-med-050214-013454. (accessed 2016 Aug 12). 9 World Health Organization (WHO). Management of substance abuse: Cannabis. Geneva: World Health Organization; 2016. Available: http://www.who.int/substance_abuse/facts/cannabis/en/ (accessed 2016 Aug 16). 10 Hall W, Degenhardt L. Adverse health effects of non-medical cannabis use. The Lancet, 2009 Oct 23;374(9698):1383-91. doi: http://dx.doi.org/10.1016/S0140-6736(09)61037-0. (accessed 2016 Aug 12). 11 Statistics Canada. Canadian Community Health Survey – Mental Health, 2012. The Daily. Ottawa: Statistics Canada; 2013 Sep 18. Component of Statistics Canada catalogue no. 11-001-X. p. 1-2. Available: http://www.statcan.gc.ca/daily-quotidien/130918/dq130918a-eng.htm (accessed 2016 Aug 12). 12 Shenfeld A. Growing Their Own Revenue: The Fiscal Impacts of Cannabis Legalization. Economic Insights. Toronto: CIBC World Markets Inc.; 2016 Jan 28. p. 7-8. Available: http://research.cibcwm.com/economic_public/download/eijan16.pdf (accessed 2016 Aug 11). 13 Canadian Centre on Substance Abuse (CCSA). Cannabis Regulation: Lessons Learned In Colorado and Washington State. Ottawa: Canadian Centre on Substance Abuse, 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Cannabis-Regulation-Lessons-Learned-Report-2015-en.pdf (accessed 2016 Aug 15). 14 Canadian Centre on Substance Abuse (CCSA). Marijuana for Non-Therapeutic Purposes: Policy Considerations. Ottawa: Canadian Centre on Substance Abuse, 2014. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Non-Therapeutic-Marijuana-Policy-Brief-2014-en.pdf (accessed 2016 Aug 15). 15 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16). 16 Blue Ribbon Commission on Marijuana Policy. Pathways Report: Policy Options for Regulating Marijuana in California. Denver (CO): Blue Ribbon Commission on Marijuana Policy; 2015. Available: https://www.safeandsmartpolicy.org/wp-content/uploads/2015/07/BRCPathwaysReport.pdf (accessed 2016 Aug 15). 17 Walsh J, Ramsey G. Uruguay’s Drug Policy: Major Innovations, Major Challenges. Washington (DC): Brookings Institution, Washington Office on Latin America; 2015. Available: https://www.brookings.edu/wp-content/uploads/2016/07/Walsh-Uruguay-final.pdf (accessed 2016 Aug 15). 18 Centre for Addiction and Mental Health (CAMH). Cannabis Policy Framework. Toronto: Centre for Addiction and Mental Health; 2014. Available: http://www.camh.ca/en/hospital/about_camh/influencing_public_policy/documents/camhcannabispolicyframework.pdf (accessed 2016 Aug 10). Our understanding of the health effects of marijuana continues to evolve. c 7 8 9 Marijuana use is linked to several adverse health outcomes, including addiction, cardiovascular and pulmonary effects (e.g., chronic bronchitis), mental illness, and other problems, including cognitive impairment and reduced educational attainment. There seems to be an increased risk of chronic psychosis disorders, including schizophrenia, in persons with a predisposition to such disorders. The use of high potency products, higher frequency of use and early initiation are predictors of worse health outcomes. c Unlike pharmaceuticals, marijuana is a complex combination of more than 100 different chemicals. The main psychoactive component is delta-9-tetrahydrocannabinol (THC), but other components, such as cannabidiol (CBD), also act on the central nervous system and may modify the effects of THC. The concentration of these compounds can vary substantially, making it difficult to characterize the specific positive or negative health effects of marijuana, especially in uncontrolled and epidemiological studies. As well, the average content of THC in marijuana has increased substantially in the last 30 years. For these and other reasons, research and attribution of harm and benefit are challenging. d Similar estimates for other substances are 15% for alcohol, 23% for heroin and 32% for nicotine. e Abuse is characterized by a pattern of recurrent use where at least one of the following occurs: failure to fulfill major roles at work, school or home, use in physically hazardous situations, recurrent alcohol or drug related problems, and continued use despite social or interpersonal problems caused or intensified by alcohol or drugs. f Dependence is when at least three of the following occur in the same 12 month period: increased tolerance, withdrawal, increased consumption, unsuccessful efforts to quit, a lot of time lost recovering or using, reduced activity, and continued use despite persistent physical or psychological problems caused or intensified by alcohol or drugs. The lifetime risk of dependence to marijuana is estimated at about 9%d, increasing to almost 17% in those who initiate use in adolescence.10 In 2012, about 1.3% of people aged 15 and over met the criteria for marijuana abusee or dependencef – double that of any other drugs – due to the high prevalence of marijuana use. 11 Another area of great concern is that of impairment and the operation of vehicles, as well as the performing of work in an unsafe manner. There is an increased risk of motor vehicle collisions up to 6 hours after use, depending on method of use, dose and tolerance. As well, experience in the U.S. and even in Canada has shown that there can be an increased risk of unintentional overdoses in children due to marijuana edibles. The CMA’s overarching recommendation to the federal government is that the government must take a broad public health policy approach to address the legalization and regulation of marijuana for non-medical use. A public health approach would place an increased focus on: preventing drug abuse and dependence; the availability of assessment, counselling and treatment services for those who wish to stop using; and harm reduction to increase the safety for those who are using. This approach seeks to ensure that the harms associated with enforcement are not out of proportion to the direct harms caused by substance abuse. Individuals with drug dependency should be diverted, whenever possible, from the criminal justice system to treatment and rehabilitation. Monitoring, surveillance and research of marijuana use are essential to better understand the short and long term harms as well as to develop policy options to address prevention, treatment, harm reduction and enforcement. There are huge economic pressures at play that need to be considered in a new regime and it is essential that public health objectives be central to the process of legalization and regulation. A recent report12 estimates that it could create a $10 billion a year industry in Canada, including production and distribution. As well, legalizing marijuana will bring in considerable tax revenue, and governments could collect as much as 50% or more of that if the rate of taxation is high, as in the ‘sin’ tax on the sale of alcohol and tobacco. As well, legalization could also lead to substantial savings in enforcement and incarceration. Given these pressures by private corporations, governments and other lobby groups, it is essential that the federal and provincial/territorial governments be held accountable to public health objectives of decreasing harms of marijuana use, particularly in children and youth. The CMA’s submission does not address the question of whether marijuana should be legal; the current federal government has already made it clear that this is their intent. Instead, this submission focuses on specific recommendations from physicians as they apply to the regulatory framework, with the objective of protecting individual and public health. It is based on input from CMA’s members, discussions with key stakeholders and experts from specialty societies, a review of reports on the experience in jurisdictions that have legalized marijuana for non-medical use, such as Colorado, Washington and Uruguay13 14 15 16 17, as well as expert literature18 19. 19 George T, Vaccarino F. (eds.). Substance abuse in Canada: The effects of cannabis use during adolescence. Ottawa: Canadian Centre on Substance Abuse; 2015. Available: http://www.ccsa.ca/Resource%20Library/CCSA-Effects-of-Cannabis-Use-during-Adolescence-Report-2015-en.pdf (accessed 2016 Aug 16). 20 Centers for Disease Control and Prevention (CDC). Behavioral Risk Factor Surveillance System (BRFSS) Survey. Atlanta (GA): Centers for Disease Control and Prevention; 2016. Available: http://www.cdc.gov/brfss/ (accessed 2016 Aug 10). 21 Rocky Mountain High Intensity Drug Trafficking Area (RMHIDTA). Legalization of Marijuana in Colorado. The Impact. 2014 Aug;2:1-166. Available: http://www.rmhidta.org/html/august%202014%20legalization%20of%20mj%20in%20colorado%20the%20impact.pdf (accessed 2016 Aug 15). 22 Monte AA, Zane RD, Heard KJ. The implications of marijuana legalization in Colorado. JAMA. 2015;313(3):241-42. Available: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4404298/pdf/nihms679104.pdf (accessed 2016 Aug 15). 23 Retail Marijuana Public Health Advisory Committee. Monitoring Health Concerns Related to Marijuana in Colorado: 2014. Denver (CO): Colorado Department of Public Health and Environment; 2015. Available: http://www2.cde.state.co.us/artemis/hemonos/he1282m332015internet/he1282m332015internet01.pdf (accessed 2016 Aug 16). 24 Cunningham JA, Blomqvist J, Koski-Jannes A, Raitasalo K. Societal Images of Cannabis use: Comparing Three Countries. Harm Reduct J. 2012 Jun 18;9:21. Available: http://www.biomedcentral.com/content/pdf/1477-7517-9 -21.pdf (accessed 2016 Aug 15). 25 Porath-Waller A, Brown J, Frigon A, Clark H. What Canadian youth think about cannabis: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2013. Available: http://www.ccsa.ca/Resource%20Library/CCSA-What-Canadian-Youth-Think-about-Cannabis-2013-en.pdf (accessed 2016 Aug 12). 26 Health Canada. Canadian Addiction Survey (CAS): A national survey of Canadians' use of alcohol and other drugs: Public opinion, attitudes and knowledge. Ottawa: Health Canada; 2006. Available: http://publications.gc.ca/site/eng/349980/publication.html (accessed 2016 Aug 15). 27 Fischer B, Jeffries V, Hall W, Room R, Goldner E, Rehm J. Lower Risk Cannabis Use Guidelines for Canada (LRCUG): A Narrative Review of Evidence and Recommendations. Can J Public Health. 2011 Sep-Oct;102(5):324-27. Available: http://journal.cpha.ca/index.php/cjph/article/view/2758 (accessed 2016 Aug 16). 28 Health Canada. Canadian Alcohol and Drug Use Monitoring Survey (CADUMS). Ottawa: Health Canada; 2013. Available: http://www.hc-sc.gc.ca/hc-ps/drugs-drogues/stat/_2012/summary-sommaire-eng.php (accessed 2016 Aug 12). 29 Young MM, Student Drug Use Surveys Working Group (SDUS). Cross-Canada report on student alcohol and drug use: Technical report. Ottawa: Canadian Centre on Substance Abuse; 2011. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16). 30 Young, M.M. et al. (2011) Cross-Canada report on student alcohol and drug use: Technical report. Ottawa, ON: Canadian Centre on Substance Abuse. Available: http://www.ccsa.ca/Resource%20Library/2011_CCSA_Student_Alcohol_and_Drug_Use_en.pdf (accessed 2016 Aug 16). The Task Force’s discussion paper presents the potential elements of a new system, which were grouped into five themes: 1) minimizing harms of use; 2) establishing a safe and responsible production system; 3) designing an appropriate distribution system; 4) enforcing public safety and protection; and 5) accessing marijuana for medical purposes. Each theme includes questions on specific concerns for which the Task Force is seeking input. Presented below are the CMA’s recommendations to the federal government for each section of the discussion paper. A summary of all recommendations is listed at the end of the brief. RECOMMENDATION: The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives. 1. MINIMIZING HARMS OF USE 1.1. Do you believe that these measures are appropriate to achieve the overarching objectives to minimize harms, and in particular to protect children and youth? Are there other actions which the government should consider enacting alongside these measures? Legalization and strict regulation of marijuana for recreational use seeks to reduce health and social harms, particularly in higher risk groups; however, with the increased access, there could be an inverse effect, with the potential that harms could be intensified. There is also the considerable risk that the degree of “normalization” of use that already exists could increase. Colorado has seen an increase in marijuana-related traffic deaths and an increase in the use of health care due to intoxication, burns and cyclic vomiting syndrome, as well as overdoses in children due to marijuana in edibles.20 21 22 Many of the regulatory interventions used in reducing tobacco normalization and rates, as well as controlling the harms of alcohol at a population level, are proposed in the Task Force’s discussion paper as part of a framework for marijuana legalization and regulation. These include: 1) Minimum age for legal purchase with the objective of protecting children and youth, particularly since the risks of marijuana use are higher in ages where the brain is still in development. 2) Advertising and marketing restrictions to minimize the profile and attractiveness of products, seeking to prevent or at least reduce the “normalization” of use in society, particularly among children and youth. 3) Taxation and pricing to discourage use and provide the government with revenues to offset related costs (such as substance abuse services, law enforcement and regulatory oversight). 4) Restrictions on marijuana products, particularly with regards to the THC component, given higher concentration products have added risks and unknown long term impacts, with most impact on children and youth. Restrictions would include maximum THC limits and prohibition of high-potency products. 5) Restrictions on types of marijuana products, particularly edibles, to prevent accidental or unintentional ingestion, particularly by children. Limits would be placed on dosing and potency. 6) Limitations on quantities for personal possession, with the objective of helping to reduce demand and to minimize opportunities for resale of legally purchased marijuana on the illicit market (particularly to children and youth). 7) Limitation on where marijuana can be sold in order to minimize harms. Despite the merit of each of the proposed measures, collectively these may not adequately protect children and youth. A pathway to better implementation would require: . Taking the time to adequately prepare for the implementation, including developing the capacity to meet demand, administer the system, enforce regulations and deal with adverse effects. A phased-in approach or pilots in certain jurisdictions should be considered before going nationwide. . Learning from the lessons gained in jurisdictions that have made changes in drug policy, including the U.S. states of Colorado and Washington, Uruguay, the Netherlands and Portugal. . Learning from successes and failures in the regulation of tobacco and alcohol, with respect to the objectives of reducing or eliminating use for all Canadians (tobacco) and promoting responsible use among adults, while prohibiting use in youth (alcohol). . Developing the capacity to carry out a rigorous national-level evaluation of the impact of legalization of marijuana on the health and safety of Canadians. Data collection and analysis cannot be conducted if national surveillance systems do not exist. Important data to be monitored include marijuana-related emergency room visits and hospitalizations, rates of drug-impaired driving, recreational injuries, unintentional poisonings, product contamination, overconsumption and food-borne illness from edible products.23 . Support for a research agenda to better understand harms of marijuana, particularly among vulnerable groups such as children and youth, pregnant women, people with mental illness and chronic diseases. Research should also support policy interventions, including those to address second hand smoke, harm reduction measures, treatments and effective education strategies. The CMA is supportive of the regulatory interventions proposed by the government to reduce the harms, regarding: Marketing and advertising: The CMA recommends that the marketing and advertising of marijuana be prohibited, as is currently the case for tobacco and cigarettes. Measures such as plain packaging, prohibition of appealing flavours and shapes, adequate content and potency labelling, as well as health warnings, should be incorporated to discourage experimentation. A package insert should outline health risks and supporting references, the need for securing the product in the home, preventing access by youth and children, and recommendations not to drive or work with hazardous chemicals or equipment. The insert should include information detailing the health and social consequences, including legal penalties for providing marijuana to those under a designated minimum age for purchasing. Taxation and pricing: Taxation and pricing levers should be used to discourage use, with revenues clearly earmarked for covering the health and social costs of legalization. In Colorado, for example, revenue is used in substance abuse programs, regulation of marijuana and for public school construction. However, as with tobacco, final pricing must be such as to discourage the illegal production and trafficking of marijuana. Most of future tax revenues should be redistributed to the provinces and territories. This is because they will feel the impact of legalization directly as they have jurisdiction over health care, education, social and other services, as well as responsibility for enforcement. Restrictions on the potency of marijuana products: Experience in jurisdictions where marijuana 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. Prohibition of high potency products is important. However, there is a risk that the prohibition could lead to an illicit market of more potent marijuana preparations. Restrictions on types of marijuana products: It is essential that restrictions be placed on the dosing of products, particularly of edibles, given the incidence of accidental overdoses of children. Content in a package should not be sufficient to cause an overdose. Because of these incidents, child proof packaging should also be required. Limitations on quantities for personal possession: Placing maximum limits on quantities that can be purchased would help to reduce the opportunities for illegal distribution and sale, especially to those below the established minimum age limit. The proposed measures related to minimum age for legal purchase and limitation on where marijuana can be sold are discussed in Sections 1.2 and 3, respectively, below. In addition to the regulatory interventions proposed in the “Minimizing Harms of Use” section of the discussion paper, others are equally fundamental, including: A clear process for identifying, testing and charging individuals who are driving under the influence of marijuana should be in place prior to legalization (see further discussion under Section 4). Public education: The use of public education tools to inform youth and families of the risks and harms of marijuana use is necessary. Awareness of Canadians of the harms of marijuana is generally low.24 25 26 Youth tend to emphasize the drug’s ability to help them focus, relax, sleep, reduce violent behaviour and improve creativity. There are also many dangerous myths, such as that marijuana can counter the harmful effects of smoking tobacco by preventing cancer or that marijuana makes people better drivers. There is also a perception amongst some that marijuana is not an addictive substance because it is “natural”. However, traditional public campaigns and educational programs for youth have been shown to be minimally effective. There is a need for more effective programs, including those that incorporate skills-based training that teaches youth how to handle situations that involve drugs and/or alcohol. Harm reduction measures, such as those outlined in the Lower Risk Cannabis Use Guidelines for Canadag 27 should be discussed, particularly with teens, in an effort to minimize harm, even if they choose to continue to use. g These include delaying use until early adulthood; avoiding frequent use; preferring smokeless delivery systems; using less potent products; not driving after use; and abstaining from use when at higher risk of cannabis-related problems (people with a personal or family history of psychosis, cardiovascular problems and pregnant women). It is important that these education programs be designed by governments and health professionals, and not marijuana producers or distributers. However, costs of such programs could come from the profits of such industries. Expanded access and immediate availability of substance use, mental health and social stabilization services is another very important measure to minimize harm. These services are currently difficult to access in the community and have long wait times; in many parts of Canada they are simply unavailable. A plan to expand training programs in addiction medicine and access to treatment should be in place prior to legalization. Enforcement of regulations: Licensed producers and retail outlets should be held accountable in their compliance with policies, guidance and good practices to prevent contaminants that may cause additional health issues if consumed, particularly by minors (See also Section 3). 1.2. What are your views on the minimum age for purchasing and possessing marijuana? Should the minimum age be consistent across Canada, or is it acceptable that there be variation amongst provinces and territories? In order to achieve the first objective of legalization, i.e., to protect young Canadians by keeping marijuana out of the hands of children and youth, a minimum age for its purchase and possession must be adopted. This has been an important measure in tobacco and alcohol regulations. Existing evidence on marijuana points to the importance of protecting the brain during its development. Since that development is only finalized by about 25 years of age, this would be an ideal minimum age based on currently accepted scientific evidence, although knowledge on brain development is still evolving. However, marijuana use among youth (ages 15 to 24) is still double that of the general population, at 20%, even though there has been a slight decrease in use in recent years.28 A 2011 report on student alcohol and drug use in Canada showed that of those youth who had used marijuana in the past 3 months, 25% had used it daily. The average age of initiation was 16.1 years. In some provinces, about 50% of students in grade 12 have reported using marijuana in the past year.29 A minimum age lower than 25 years should be considered in order to deter youth from seeking marijuana from organized crime groups, where they are exposed to other more dangerous drugs, sometimes even laced into marijuana. In jurisdictions where marijuana has been legalized, the minimum age has been set at the same minimum age for purchase of alcohol, i.e., 21 years. In Canada, the age limits for acquiring alcohol and tobacco are either 18 or 19 years of age, depending on the province or territory. In a survey carried out with a sample of the CMA membership, 25.4% recommended age 21, 20.3% age 25, 19.7% age 18, and 14.2% age 19. The CMA recommends that the minimum age should be set at 21, and that quantities and the potency of marijuana be more restricted to those under age 25 to discourage use and sharing with underage friends. The CMA recommends that the minimum age be established at the national level, and federally regulated, to avoid differences at the provincial/territorial level. This would reduce problems with enforcement in areas near provincial/territorial borders. SECTION 1 RECOMMENDATIONS: The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana: a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out; b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach; c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and, d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation. e) Support for a research agenda. The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes. The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services. The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies. The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles. The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased. The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage. The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana. As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine. The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25. The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions. 2. ESTABLISHING A SAFE AND RESPONSIBLE PRODUCTION SYSTEM 2.1. What are your views on the most appropriate production model? Which production model would best meet consumer demand while ensuring that public health and safety objectives are achievable? What level and type of regulation is needed for producers? There will be no perfect production model, with each one having its risks and benefits. The CMA would support a tightly regulated competitive model. A set number of licenses should be granted to producers, who are part of a competitive system, and there should be a reasonable cost associated to offset regulatory expenses. Producers would have to comply with policies and guidelines set by Health Canada, and be subject to inspections. It is fundamental that commercialization is rigorously controlled through taxation, regulation, monitoring and advertising controls. 2.2. To what extent, if any, should home cultivation be allowed in a legalized system? What, if any, government oversight should be put in place? The CMA does not recommend home cultivation in a legalized system for non-medical purposes, as it presents many challenges to municipal, enforcement and public health authorities, particularly given the potentially high number of homes that could seek to cultivate marijuana. There are many health and safety hazards in cultivation, such as high humidity and temperatures, risk of fire, as well as the use of hazardous chemicals, including pesticides used for the control of fungi, bacteria and insects. There is little quality control regarding contamination and potency of the product. As well, home cultivation has an enhanced risk of abuse, if individuals use the production for sale rather than exclusively for personal use. Access to marijuana by children and youth is also a serious concern with home cultivation. In the present marijuana for medical purposes system, where some users have been allowed to continue to grow for personal use, there is great difficulty in monitoring and inspecting these properties. However, this has been allowed given the Allard v Canada court decision, to not hinder access for medical purposes. Washington has not permitted home cultivation, but Colorado has allowed the growth of a small number of plants for personal use (up to 6 plants, with a maximum 3 mature ones, in an enclosed, locked space). 2.3. Should a system of licensing or other fees be introduced? Should limited home cultivation for non-medical purposes be an option, a system of registration and licensing would have to be set up to allow for tracking and inspections of home production. It would also allow penalties for non-registered producers as well as larger scale operations. This would be a system that would require intense government regulation, oversight and tremendous resources to be effective. 2.4. The MMPR set out rigorous requirements over the production, packaging, storage and distribution of marijuana. Are these types of requirements appropriate for the new system? Are there features that you would add or remove? The requirements for production, packaging, storage and distribution of marijuana set out by the MMPR are appropriate for the new system. However, a rigorous review of the MMPR should be conducted to determine if there are weaknesses that need to be corrected before expanding to a non-medical market. Ongoing evaluation will be warranted as well. Distribution would have to expand beyond the mail service. 2.5. What role, if any, should existing licensed producers under the MMPR have in the new system (either in the interim or the long-term)? The CMA’s policy position does not extend to whether the existing licensed producers should be suppliers to the recreational market. The experience in Colorado, however, showed that having the industry set up for medical purposes first allowed a smoother transition, in contrast with Washington, which did not have an industry. SECTION 2 RECOMMENDATIONS: The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight. The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use. The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use. 3. DESIGNING AN APPROPRIATE DISTRIBUTION SYSTEM 3.1. Which distribution model makes the most sense and why? There is the need to continue mail availability for patients accessing marijuana for medical purposes to ensure nationwide access, however, a distribution system based exclusively on mail service would probably not meet the objectives of a recreational system. When a sample of our membership was asked about distribution models, first preference was given to existing non-health care structures, such as liquor stores. In some provinces, they would have the additional benefit of having a tightly regulated government monopoly by control board entities with a social responsibility mandate. Restrictions could be placed to limit the acquisition of both alcohol and marijuana. As stated earlier, marketing should be prohibited. Staff in these stores receives training and hours can be limited. A close second preference was given to legal storefronts, similar to the independent dispensaries. Several municipalities have been in varied degrees of discussion on the regulation of the presently illegal dispensaries, and those regulations could be looked at as models in a legalized environment. When asked about health care settings, such as pharmacies, respondents to the survey did not support this model. Almost 60% disagreed or strongly disagreed. A reason for this lack of support could be that placing marijuana in pharmacies could lend it credibility as a pharmaceutical medication, whereas placing it in liquor stores would send the message that it needs strict and formal controls. As per previous discussion, the creation of private industries for production and distribution would have to be very tightly controlled to avoid commercialization. As we have learned from the alcohol and tobacco industries, private companies have an interest in recruiting customers and encouraging high levels of ongoing consumption. It is important that the regulatory framework be protected from these commercial and fiscal interests. Regardless of the actual point of sale, storefront densities should be federally set and restrictive. There is good evidence from the regulation of alcohol that the less restrictive retail outlet density is, the more harms associated with alcohol use occur. Restrictions would also be placed on distances from schools, parks, playgrounds, colleges and universities, as well as on hours of sale. Regulations would lay out standards, including for the control of product sources, proof of minimum age required for purchase and restrictions on quantities sold. 3.2. To what extent is variation across provinces and territories in terms of distribution models acceptable? In the CMA’s survey of our members, there was not a consensus among respondents as to whether provincial and territorial governments should decide on their own distribution mechanisms. Many comments stated that a federal standard is warranted due to the need for initial close oversight and the ability to make effective changes more quickly. The CMA position is that there is an important role for the federal government to play in ensuring consistency across the country and avoiding provincial/territorial variation. 3.3. Are there other models worthy of consideration? The CMA recommends a phased in approach to the roll out of the system of distribution. Several pilot locations could be considered before going nationwide. Given the novelty and impact of this new legislation, particular caution is absolutely necessary from a regulatory and public health perspective. SECTION 3 RECOMMENDATIONS: The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive. The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions. The CMA recommends a phased implementation approach prior to national availability. 4. ENFORCING PUBLIC SAFETY AND PROTECTION 4.1. How should governments approach designing laws that will reduce, eliminate and punish those who operate outside the boundaries of the new legal system for marijuana? The severity of punishment for simple possession and personal use of marijuana should be eliminated with the removal of criminal sanctions. The CMA recommends that resources currently devoted to combating simple marijuana possession through the criminal law be diverted to public health and education strategies, particularly for youth. Having a criminal record limits employment prospects, and the impact on health status is profound, disproportionately among marginalized populations. Laws should include such things as the facilitation of access by individuals to services to address substance use, mental health and social stabilization. Laws should be drafted in a clear fashion to minimize ambiguity and provide as much guidance and direction to users, health care providers, enforcement authorities, producers, distributors and others. 4.2. What specific tools, training and guidelines will be most effective in supporting enforcement measures to protect public health and safety, particularly for impaired driving? The use of marijuana is associated with an increased risk of impairment, and is incompatible with the operation of vehicles and work in safety sensitive positions due to risk of injury to oneself, coworkers or the general public. Marijuana use is associated with an increased risk of motor vehicle crashes. Young people, particularly males, are more likely to drive after using marijuana. The Cross-Canada Report on Student Alcohol and Drug Use30 states that 14–21% of students in Grade 12 reported having driven within an hour of using marijuana, and more than 33% of Grade 12 students reported having been a passenger in a car where the driver had used the drug. Often, marijuana is associated with alcohol use, having an additive effect. A clear and reliable process for identifying, testing and imposing consequences on individuals who use marijuana and drive absolutely needs to be in place nationally prior to legalization. This will be complicated by the fact that a roadside test for marijuana use is not in widespread use; blood and urine testing also pose challenges. Another issue is the fact that recent use does not necessarily equate to impairment and no scientific standard for impairment exists in the literature. All individuals charged with impaired driving should have a specialist assessment to determine whether a substance use disorder is present. Individuals with substance use disorders should have immediate access to addiction treatment, mental health services and social stabilization. There is also a need for the development of guidelines for employers for the assessment and management of risk. 4.3. Should consumption of marijuana be allowed in any publicly-accessible spaces outside the home? Under what conditions and circumstances? No public smoking should be permitted, due to the risk of second hand smoke. Second hand marijuana smoke contains many of the same toxins, including carcinogens, found in directly inhaled marijuana smoke, in similar amounts, if not more. There is special concern for harmful health effects, especially among children. The CMA does not recommend the exposure of children to second hand smoke in public areas or in the home. The success in the reduction of tobacco use rates is significantly related to banning of smoking in public places. In the CMA’s survey of a sample of its members, 51.7% disagreed with consumption in designated public places, such as the Dutch model of coffee shops. SECTION 4 RECOMMENDATIONS: The CMA recommends that the federal government reallocate resources currently dedicated to the enforcement of marijuana infractions, to public health, education and treatment programs. The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana. The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places. 5. ACCESSING MARIJUANA FOR MEDICAL PURPOSES 5.1. What factors should the government consider in determining if appropriate access to medically authorized persons is provided once a system for legal access to marijuana is in place? The CMA recognizes that some individuals suffering from terminal illness or chronic disease for which conventional therapies have not been effective may obtain relief with marijuana used for medical purposes. However, clinical evidence of medical benefits is limited and there is very limited guidance for the therapeutic use, including indications, potency (levels of THC, CBD), interactions with medications and adverse effects. Health Canada does not approve of marijuana as a medicine, as it has not gone through the approvals required by the regulatory process to be a pharmaceutical. The present system poses a serious challenge for physicians in providing the best care to patients. The CMA has long called for more research to better understand potential therapeutic indications, as well as its risks. It is important that there be support for research of marijuana in order to develop products that can be held to pharmaceutical standards, as is the case with dronabinol (Marinol®), nabilone (Cesamet®) and THC/CBD (Sativex®). The present marijuana for medical purposes regime operates as an exception to a criminal prohibition for production, possession and trafficking of marijuana. It was developed in reaction to court challenges regarding the right to legal access of individuals to marijuana for medical purposes. With the new legal system for marijuana for non-medical use, the requirement to maintain a separate regulatory framework would not be necessary, given court-mandated access will be provided. As well, the experience of legalization for non-medical use in Colorado and Washington has shown that two separate regimes with distinct regulations can be very difficult to enforce given the dual standards (including different minimum ages, purchase quantities and taxation). Provisions would have to exist within the new system to attend to legitimate medical needs of individuals who are under the minimum age for purchase of marijuana, or for those with a requirement for a more potent product than that which is legally available. Consideration might also be given to affordable access for those with low incomes. As stated previously, the option of distribution through mail would have to continue, to facilitate access in remote areas. As well, patients or their families would be able to access marijuana through the distributors of marijuana for non-medical purposes, such as storefronts or liquor store-like entities, which would have employees trained to support patients and their needs. The use of marijuana products for medical indications, through this system, should preferably be done under research protocols. This framework would contribute to the provision of more robust scientific data. SECTION 5 RECOMMENDATION: The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available. 6. Summary of Recommendations The CMA appreciates the opportunity to provide feedback on this important matter to physicians and the public. Legalization of marijuana for non-medical purposes is a fundamental shift in the approach to drugs. The CMA’s position is that it is essential that the government consult with experts, key stakeholders and the general public not only at this phase in preparation for legislation on this matter, but throughout the process of the development of regulations and implementation. Recommendations: 1) The CMA recommends that the federal government take a broad public health policy approach in legalizing marijuana for non-medical purposes, and that it be held accountable to these public health objectives. Section 1 2) The CMA recommends that the federal government incorporate the following measures to support improved implementation of the legalization of marijuana: a) Ensure sufficient time to adequately prepare for the implementation of the legalized regime, including a phased-in approach and piloting legalization in smaller regions prior to national roll-out; b) Assess international experience with legalization and incorporate lessons-learned from other jurisdictions into Canada’s approach; c) Assess the domestic experience in the regulation of tobacco and alcohol against meeting the national objectives for each substance and incorporate lessons-learned from those experiences; and, d) Develop capacity for national surveillance to ensure rigorous national-level monitoring and evaluation. e) Support for a research agenda. 3) The CMA recommends that the federal government prohibit the marketing and advertising of marijuana and that packaging requirements include plain packaging, potency labelling and health warnings. The CMA further recommends that the federal government prohibit flavouring and shapes. 4) The CMA recommends that the federal government employ taxation and pricing levers to discourage consumption and that the revenues of this taxation be allocated to the provinces and territories and clearly allocated for health and social services. 5) The CMA recommends that the federal government establish potency restrictions to reduce the harms associated with higher potencies. 6) The CMA recommends that the federal government establish dosing restrictions on marijuana products, notably edibles. 7) The CMA recommends that the federal government establish maximum limits on quantities of marijuana that can be purchased. 8) The CMA recommends that the federal government employ effective public education tools, including skills-based training, to inform youth and families of the risks and harms of marijuana usage. 9) The CMA recommends that the federal government expand access and availability of substance use, mental health and social stabilization services simultaneously to the legalization of marijuana. 10) As part of this initiative, the CMA recommends that the federal government implement a plan to expand training programs in addiction medicine. 11) The CMA recommends that the federal government set the minimum age of purchase and consumption at 21 and that quantities and potency be restricted for those under the age of 25. 12) The CMA recommends that the federal government establish the minimum age at the national level to ensure consistency across all jurisdictions. Section 2 13) The CMA supports a tightly regulated competitive model wherein production and distribution is heavily regulated and includes strict oversight. 14) The CMA recommends that the federal government prohibit home cultivation in the legalized system for non-medical use. 15) The CMA recommends that the federal government evaluate the requirements established by the MMPR system for production, packaging, storage and distribution to introduce improvements for implementation in the new legalized system for non-medical use. Section 3 16) The CMA recommends that the distribution model should occur outside health care structures, for example, in liquor stores, and that storefront densities should be federally set and restrictive. 17) The CMA recommends that the distribution model should be established at the federal level and be consistent across jurisdictions. 18) The CMA recommends a phased implementation approach prior to national availability. Section 4 19) The CMA recommends that the federal government reallocate resources to the enforcement of marijuana infractions to public health, education and treatment programs. 20) The CMA recommends that the federal government ensure that a clear and reliable process for identifying, testing and imposing consequences on individuals who operate a motor vehicle under the influence of marijuana be in place nationally prior to the legalization of marijuana. 21) The CMA recommends that the federal government prohibit smoking of marijuana for non-medical purposes in public places. Section 5 22) The CMA recommends that there be only one regime for marijuana, following legalization of non-medical marijuana, with provisions for the medical needs of those who would not be able to acquire marijuana in a legal manner, e.g., those below the minimum age or those with a requirement for a more potent product than legally available. CMA Statement - Legalization of Marijuana Ottawa, September 9, 2016 - The CMA's submission to the Task Force on Marijuana Legalization and Regulation is framed by the fundamental position that the legalization of marijuana is a societal prerogative; the CMA is not weighing in on this decision as it has already been made. Keeping with our mandate as the national voice for the highest standards of health and health care, the CMA is squarely focused on minimizing the negative impact on individuals and public health. The CMA has longstanding concerns about the health risks associated with consuming marijuana, particularly in smoked form. Children and youth are particularly at risk for marijuana-related harms, given their brain is undergoing rapid, extensive development. As such, the CMA's submission is framed by the overarching recommendation that the government must take a broad public health policy approach in developing the legalization framework. Focusing on the legalization issue alone is inadequate to deal with the complexity of the situation. The CMA recommendations build on Canada's experience regulating alcohol and tobacco. The legalization framework must include:
Marketing and packaging restrictions
Restrictions on the types of products and their potency
Prohibiting home cultivation
Expanding access to support services such as mental health and substance use services
Expanding access to training programs in addiction medicine, and
Making extensive educational resources on the risks of harm to the user and others available We must recognize that the legalization of marijuana is a complex matter. Overall the CMA has submitted to the Task Force 22 evidence-based recommendations for a broad public health approach. For interviews: mediainquiries@cma.ca 613-806-1865
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National pharmacare in Canada: Getting there from here

https://policybase.cma.ca/en/permalink/policy11959
Date
2016-06-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2016-06-01
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
On behalf of 83,000 physician members, the Canadian Medical Association (CMA) welcomes this opportunity to provide input to the House of Commons Standing Committee on Health study on the Development of a National Pharmacare Program. Recognizing that the term “pharmacare” is used in different contexts, for the purposes of this brief, pharmacare is defined as a program whereby Canadians have comparable access to medically necessary prescription medications, irrespective of their ability to pay, wherever they live in Canada. The Canadian Medical Association (CMA) is the national voice of Canadian physicians. Founded in 1867, the CMA’s mission is helping physicians care for patients. On behalf of its more than 83,000 members and the Canadian public, the CMA performs a wide variety of functions. Key functions include advocating for health promotion and disease/injury prevention policies and strategies, advocating for access to quality health care, facilitating change within the medical profession, and providing leadership and guidance to physicians to help them influence, manage and adapt to changes in health care delivery. Key Facts According to the Canadian Institute for Health Information (CIHI), in 2014, of the estimated $28.8 billion spent in Canada on prescription medications (representing 13.4% of total health spending), governmentsi accounted for 42.0%, and private insurers and out-of-pocket (OOP) payment accounted for 35.8% and 22.2% respectively.1 The CMA is a voluntary professional organization representing the majority of Canada’s physicians and comprising 12 provincial and territorial divisions and over 60 national medical organizations. i Includes federal. Social security fund and provincial/territorial spending 1 Canadian Institute for Health Information. Prescribed drug spending in Canada, 2013: a focus on public drug programs. https://secure.cihi.ca/free_products/Prescribed%20Drug%20Spending%20in%20Canada_2014_EN.pdf. Accessed 05/15/16. 2 Royal Commission on Health Services. Report Volume One. Ottawa: Queen’s Printer, 1964. 3 Canadian Institute for Health Information. National Health Expenditure Database 1975 to 2015. Table D 3.1.1-D3.13.1 https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/08/16. 4 Statistics Canada. CANSIM Table 203-0022 Survey of household spending (SHS), household spending, Canada, regions and provinces, by household income quintile. Accessed 05/18/16. 5 Cancer Advocacy Coalition of Canada. 2014-15 Report Card on Cancer in Canada. http://www.canceradvocacy.ca/reportcard/2014/Report%20Card%20on%20Cancer%20in%20Canada%202014-2015.pdf. Accessed 05/08/16. 6 Canadian Cancer Society. Cancer drug access for Canadians. http://www.colorectal-cancer.ca/IMG/pdf/cancer_drug_access_report_en.pdf. Accessed 05/08/16. 7Schoen C, Osborn R, Squires D, Doty M. Access, affordability, and insurance complexity are often worse in the United States compared to ten other countries. Health Affairs 2013;32(12):2205-15. 8 Himmelstein D, Woolhandler S, Sarra J, Guyatt G. Health issues and health care expenses in Canadian bankruptices and insolvencies. International Journal of Health Services 2014;44(1):7-23. 9 Law M, Cheng L, Dhalla I, Heard D, Morgan S. The effect of cost on adherence to prescription medications in Canada. CMAJ 2012. 184)3):297-302. 10 Tamblyn R, Eguale T, Huang A, Winslade N, Doran P. The incidence and determinants of primary nonadherence with prescribed medication in primary care. Ann Inter Med 2014;160:441-50. Pharmacare is clearly part of the unfinished business of Medicare. Numerous authors have pointed out that Canada is the only developed country that does not include prescription medications as part of its universal health program. Table 1 below shows how Canada compares with the 22 member countries of the Organization for Economic Cooperation and Development (OECD) on the proportion of public spending for major categories of health expenditure in 2012. Table 1. Public spending as % of total spending: Major health spending categories, Canada and 22 OECD country average, 2012 % Public Spending Prescription Drugs Hospitals Doctors’ Offices Canada 42 91 99 OECD Average 70 88 72 Source: OECD.Stat, Doctors’ offices figure for Sweden is 2009 In the case of prescription medications, Canada was more than one-third (40%) below the OECD average. The Patchwork Quilt of Public-Private Coverage In 1964 the Hall Commission recommended 50/50 cost-sharing between the federal and provincial governments toward the establishment of a prescription drug program, with a $1.00 charge for each prescription. At the time, prescription medications represented 6.5% of spending on personal health services.2 This recommendation was not implemented. It might be further added that the Hall report contained 25 forward-looking recommendations on pharmaceuticals that remain current to this day, including bulk purchasing, generic substitution and a national formulary.2 As a result of the lack of inclusion of prescription medications in Medicare, there is wide variation today in public per capita spending on prescription drugs across the provinces. It may be seen in Table 2 that, for 2014, CIHI has estimated that public per capita expenditure ranged from $219 in British Columbia and $255 in Prince Edward Island (PE) to $369 in Saskatchewan and $437 in Quebec.3 CIHI does not provide estimates of private per capita prescription drug spending (private insurance plus OOP) below the national level. Table 2: Spending on prescription drugs: Selected indicators by province and territory, 2014 Province/ Territory Public spendinga ($ million) Public per capita spendinga ($ ) Private insuranceb ($ million) Average household out-of-pocketc $ NL 156.7 297 177 454 PE 37.3 255 32 516 NS 302.2 321 337 429 NB 210.8 280 284 477 QC 3,588.7 437 2,369 466 ON 4,730.4 346 4,626 324 MB 411.3 321 249 516 SK 415.4 369 192 514 AB 1,383.7 336 1,065 409 BC 1,015.8 219 894 456 YT 14.0 383 - - NT 17.5 400 - - NU 13.6 372 - - Territories 45.1 385 23 - Canada 12,297.4 334d 10,247 408 a CIHI, National Health Expenditure Database 1975-2015, includes all public funding sources b Canadian Life and Health Insurance Association c Statistics Canada, Survey of Household Spending, 2014 d Provincial/territorial average Table 2 also shows the significant role of private insurance in every region of Canada. Data provided by the Canadian Life and Health Insurance Association, shown in Column 3 of Table 2, show that private health insurance companies paid out $10.2 billion for prescription drug claims in 2014, representing 83% of the $12.3 billion paid for by governments. In three provinces — Newfoundland and Labrador, Nova Scotia and New Brunswick — the amount paid by private insurance exceeds that paid by governments. Table 2 also shows that there is wide variation in average household OOP spending on prescription drugs, according to Statistics Canada’s Survey of Household Spending (SHS). In 2014 this ranged from a low of $324 in Ontario to a high of $516 in PE and Manitoba.4 Even more striking variation is evident when looking at household out-of-pocket spending on prescription drugs by income quintile (detailed data not shown). According to the 2014 SHS the poorest one-fifth (lowest income quintile) of PE households spent more than twice as much ($645) OOP on prescription drugs than the poorest one-fifth in Ontario ($300).4 Aside from overall differences in public spending there are also differences in which medications are covered, particularly in the case of cancer drugs. The Cancer Advocacy Coalition of Canada reported in 2014 that four provinces have fully funded access to cancer medications taken at home. In Ontario and Atlantic Canada however, cancer drugs that must be taken in a hospital setting and are on the provincial formulary are fully funded by the provincial government; if the drug is taken outside of hospital (oral or injectable), the patient and family may have to pay significant costs out-of-pocket.5 More generally the Canadian Cancer Society has reported that persons moving from one province to another may find that a medication covered in their former province may not be covered in the new one. 6 Other sources confirm that prescription medication spending is an issue for many Canadians. On the Commonwealth Fund’s 2013 International Health Policy Survey, 8% of the Canadian respondents said that they had either not filled a prescription or skipped doses because of cost issues.7 Himmelstein et al. reported on a survey of Canadians who experienced bankruptcy between 2008 and 2010. They found that 74.5% of the respondents who had had a medical bill within the last two years reported that prescription drugs was their biggest medical expense.8 At least two Canadian studies have documented the impact that out-of-pocket costs, lack of insurance and low income have on non-adherenceii to prescription regimens. Law et al. examined cost-related non-adherence in the 2007 Canadian Community Health Survey and found that those without drug insurance were more than four times as likely to report non-adherence than those with insurance. The predicted rate of non-adherence among those with high household incomes and drug insurance was almost 10 times as high as that among those with low incomes and no insurance (35.6% vs. 3.6%).9 Based on a large-scale study of the incidence of primary non-adherence (defined as not filing a new prescription within nine months) in a group of some 70,000 Quebec patients, Tamblyn et al. reported that there was a 63% reduction in the odds of non-adherence among those with free medication over those with the maximum level of co-payment. They also reported that the odds of non-adherence increased with the cost of the medication prescribed.10 ii Non-adherence can be defined as doing something to make a medication last longer or failing to fill or renew a prescription. Previous Pharmacare Proposals In a recent monograph Katherine Boothe has contrasted the development of national prescription medication programs in Australia and the United Kingdom with the failure to do so in Canada.11 11 Boothe K. Ideas and the pace of change: national pharmaceutical insurance in Canada, Australia and the United Kingdom. Toronto: University of Toronto Press, 2015. 12 National Forum on Health. Directions for a pharmaceutical policy in Canada. http://www.hc-sc.gc.ca/hcs-sss/pubs/renewal-renouv/1997-nfoh-fnss-v2/index-eng.php. Accessed 05/18/16. 13 National Forum on Health. Canada health action: building on the legacy. Ottawa: Minister of Public Works and Government Services, 1997. 14 Bank of Canada. Inflation calculator. http://www.bankofcanada.ca/rates/related/inflation-calculator/?page_moved=1. Accessed 05/18/16. 15 Statistics Canada. Table 051-0001 Estimates of population, by age group and sex for July 1, Canada, provinces and territories. Accessed 05/15/16. 16 Canadian Institute for Health Information. National health expenditure database 1975 to 2015. Table C.3.1. Public health expenditure by use of funds, Canada, 1975 to 2015. https://www.cihi.ca/en/spending-and-health-workforce/spending/national-health-expenditure-trends. Accessed 05/25/16. 17 Berry C. Voluntary medical insurance and prepayment. Ottawa: Queen’s Printer, 1965. 18 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1969. Ottawa: Queen’s Printer for Canada, 1969. 19 Receiver General for Canada. Volume I Public Accounts of Canada for the fiscal year ended March 31, 1972. Ottawa: Information Canada, 1972. 20 Privy Council Office. Speech from the Throne to open the first session thirty-sixth Parliament of Canada. http://www.pco-bcp.gc.ca/index.asp?lang=eng&page=information&sub=publications&doc=aarchives/sft-ddt/1997-eng.htm. Accessed 05/18/16. 21 Standing Senate Committee on Social Affairs, Science and Technology. The health of Canadians – the federal role. Volume six: recommendations for reform. Ottawa, 2002. 22 Commission on the Future of Health Care in Canada. Building on values: the future of health care in Canada. Ottawa, 2002. 23 Canadian Intergovernmental Conference Secretariat. 2003 First Ministers’ accord on health care renewal. http://www.scics.gc.ca/CMFiles/800039004_e1GTC-352011-6102.pdf. Accessed 05/18/16. 24 Council of the Federation. Premiers’ action plan for better health care: resolving issues in the spirit of true federalism. Communiqué July 30, 2004. http://canadaspremiers.ca/phocadownload/newsroom-2004/healtheng.pdf. Accessed 05/18/16. 25 Canadian Intergovernmental Conference Centre. A 10-year plan to strengthen health care. http://www.scics.gc.ca/CMFiles/800042005_e1JXB-342011-6611.pdf. Accessed 05/18/16. 26 National Pharmaceuticals Strategy. National Pharmaceuticals Strategy progress report. http://www.hc-sc.gc.ca/hcs-sss/alt_formats/hpb-dgps/pdf/pubs/2006-nps-snpp/2006-nps-snpp-eng.pdf. Accessed 05/18/16. 27 Canadian Intergovernmental Conference Secretariat. Backgrounder: national pharmaceutical strategy decision points. http://www.scics.gc.ca/english/conferences.asp?a=viewdocument&id=112. Accessed 05/18/16. 28 Canada’s Premiers. The pan-Canadian Pharmaceutical Alliance: April 2016 Update. http://www.pmprovincesterritoires.ca/en/initiatives/358-pan-canadian-pharmaceutical-alliance. Accessed 05/18/16. 29 Canadian Medical Association. General Council Resolution GC15-C16, August 26, 2015. 30 Gagnon M. The economic case for universal pharmacare. 2010. https://s3.amazonaws.com/policyalternatives.ca/sites/default/files/uploads/publications/National%20Office/2010/09/Universal_Pharmacare.pdf. Accessed 05/18/16. 31 Gagnon M. A roadmap to a rational pharmacare policy in Canada. Ottawa: Canadian Federation of Nurses Unions, 2014. 32 Morgan S, Law M, Daw J, Abraham L, Martin D. Estimated cost of universal public coverage of prescription drugs in Canada. CMAJ. 2015 Apr 21;187(7):491-7. doi: 10.1503/cmaj.141564. 33 Morgan S, Martin D, Gagnon M, Mintzes B, Daw, J, Lexchin, J. Pharmacare 2020. The future of drug coverage in Canada. http://pharmacare2020.ca/assets/pdf/The_Future_of_Drug_Coverage_in_Canada.pdf. Accessed 05/18/16. 34 Canadian Medical Association. Policy resolution GC15-C19, August 26, 2015. 35 Conference Board of Canada. Federal policy action to support the health care needs of Canada’s aging population. https://www.cma.ca/Assets/assets-library/document/en/advocacy/conference-board-rep-sept-2015-embargo-en.pdf. Accessed 05/18/16. 36 Government of the United Kingdom. Written statement to Parliament NHS charges from April 2016. https://www.gov.uk/government/speeches/nhs-charges-from-april-2016. Accessed 05/18/16. 37 Appleby J. Prescription charges: are they worth it? BMJ 2014;348:g3944 doi: 10.1136/bmj.g3944. Among the several Canadian attempts that she describes, the most activity occurred in the decade following the National Forum on Health (NFH), which was struck in 1994 and reported in 1997. A NFH working group paper on pharmaceutical policy recommended first dollar coverage for prescription medications, but acknowledged that it could not occur overnight: “over time we propose to shift private funding on prescribed pharmaceuticals (estimated at $3.6 billion in 1994) to public funding”.12 The NFH included this recommendation in its final report, noting that “the absorption of currently operating plans by a public system may involve transfer of funding sources as well as administrative apparatus”.13 It is instructive to place the 1994 prescription drug expenditure cited by the NFH in today’s context. According to the Bank of Canada’s inflation calculator, the $6.5 billion in 1994 would have cost $9.5 billion in 2014.14 CIHI estimates that actual spending in 2014 was $28.7 billion1 – 203% above the level of 1994 spending, compared to population growth of 23% over the same time period.15 Annual prescription drug spending increases averaged 7.3% over the period, although they have averaged just over 1% since 2009. 16 A significant shift from private to public funding is not without precedent. A study prepared for the Hall Commission estimated that 9.6 million Canadians, representing 53% of the total population, had some form of not-for-profit or commercial insurance coverage for medical and/or surgical services in 1961.17 With the passage of the Medical Care Act in 1966 these plans were all displaced as the provinces joined Medicare. The funding shift did not occur overnight, although it did move quickly. In the first year, 1968/69, Ottawa paid out $33 million to the provinces pursuant to the Medical Care Act, which grew quickly to $181 million in 1969/70, and reaching $576.5 million in 1971/72.18,19 Since the 1997 NFH report the closest that the federal government has come to acting on pharmacare was a commitment in the 1997 Speech from the Throne to “develop a national plan, timetable and a fiscal framework for providing Canadians with better access to medically necessary drugs”, but nothing further was ever made public.20 Pharmacare was subsequently examined in two national studies, both of which recommended federal involvement in reimbursing “catastrophic” prescription drug expenditures above a threshold of household income. The Senate study on the State of the Health Care System in Canada, chaired by Michael Kirby, was authorized in March 2001 and the Commission on the Future of Health Care in Canada, headed by Roy Romanow, was approved in April 2001. Both issued their final reports in 2002. The Kirby plan was designed so as to avoid the necessity of eliminating existing private plans or the provincial/territorial public plans, not unlike the approach taken by Quebec in 1997. In the Kirby plan, in the case of public plans, personal prescription medication expenses for any family would be capped at 3% of total family income. The federal government would then pay 90% of prescription drug expenses in excess of $5,000. In the case of private plans, sponsors would have to agree to limit out-of-pocket costs to $1,500 per year, or 3% of family incomes, whichever was less. The federal government would then agree to pay 90% of drug costs in excess of $5,000 per year. Both public and private plans would be responsible for the difference between out-of-pocket costs and $5,000, and private plans would be encouraged to pool their risk. Kirby estimated that this plan would cost approximately $500 million per year.21 The Romanow Commission recommended a $1 billion Catastrophic Drug Transfer through which the federal government would reimburse 50% of the costs of provincial and territorial drug insurance plans above a threshold of $1,500 per person per year.22 The advantage of these proposals is that they are fully scalable. The federal government could adjust either the out-of-pocket household income threshold, the ceiling above which it would assume costs, or the percentage of costs that it would pay above the ceiling. Following the Kirby and Romanow reports there was a back and forth exchange between the federal and provincial-territorial (PT) governments on a plan for catastrophic coverage. In their February 2003 Accord, First Ministers agreed to ensure that Canadians would have reasonable access to catastrophic drug coverage by March 2006.23 At their annual summer meeting in 2004 the Premiers later called on the federal government to “assume full financial responsibility for a comprehensive drug program for all Canadians”, with compensation to Quebec for its drug program.24 In the September 2004 Health Accord, First Ministers directed health ministers to develop a nine-point National Pharmaceuticals Strategy (NPS), including costing options for catastrophic coverage.25 A federal-provincial-territorial Ministerial Task Force on the NPS was struck and a progress report was issued in June 2006. The estimates of catastrophic spending were markedly higher than those of the Kirby and Romanow reports. Using a variable percentage of income threshold it estimated that, based on public plan costs, only catastrophic spending represented 42% of total prescription drug spending. If private plan costs were also considered, catastrophic spending would represent 55% of total prescription drug spending. This report proposed four options for catastrophic coverage with estimates for new public funding ranging from $1.4 to $4.7 billion.26 Although no account of the methods was provided it is evident that a significant proportion of existing plan costs were included in the estimates of catastrophic expenditure. At their September 2008 meeting, the PT health ministers called for a national standard for drug coverage not to exceed 5% of net income and for the federal government to share 50/50 in the estimated $5.03 billion cost.27 The uncertainty about the projected cost of a pharmacare plan resulting from widely varying estimates has doubtless contributed to a reluctance of governments to engage on advancing this issue. Recent Developments At the PT level, there has been a concerted effort on price negotiations during the past few years through the pan-Canadian Pharmaceutical Alliance (pCPA) that was established in 2010. As of March 31, 2015, the pCPA reported that price reductions in generic and brand-name prescription medications result in annual savings of an estimated $490 million.28 The federal drug plans are now participating in the pCPA and the CMA has recommended that the pCPA should also invite the participation of private health insurance companies.29 The prospect of savings through lower prices has been foundational to two recent studies that have made the case that a single public payer pharmacare program with little or no co-payment is affordable. The first was by Marc-André Gagnon in 2010. The proposal was developed on the basis of a review of cross-provincial and international practices in pharmaceutical policy. The review formed the basis of a set of 11 assumptions that were used to develop four scenarios that resulted in estimates of prescription drug cost savings over the 2008 baseline expenditure of $25.1 billion that ranged to $2.7 billion to $10.7 billion.30 In a 2014 update Gagnon estimated that a first dollar coverage program would save 10% to 41% of prescription drug costs, representing savings of as much as $11.4 billion annually on a 2012-13 base of $27.7 billion.31 Steve Morgan and colleagues (2015) have estimated that a universal public plan with small co-payments could reduce prescription drug spending by $7.3 billion.32 Subsequently, in Pharmacare 2020 Morgan et al. set out five recommendations calling for the implementation of a single payer system with a publicly accountable management agency by 2020.33 Taking a First Step Forward At its 2015 annual meeting, the CMA adopted a policy resolution that supports the development of an equitable and comprehensive national pharmacare program.34 Reflecting on the experience of the past 40 years since the enactment of the Established Programs Financing Act in 1977 that eliminated 50:50 cost-sharing, it seems highly unlikely that the federal government would take on a new open-ended program in the health and social arena, cost-shared or not. However, notwithstanding the progress of the pCPA, we are unlikely to address the significant access gaps in prescription medication coverage without the involvement of the federal government. These are fiscally challenging times for both levels of government, with budget deficits expected for several years to come. As noted previously, the Kirby and Romanow proposals for a federal funding role in pharmacare are scalable. In 2015 the CMA commissioned the Conference Board of Canada to model the cost of covering prescription medication expenditure beyond a household spending threshold of $1,500 or 3% of gross household income, based on Statistics Canada’s 2013 Survey of Household Spending. The projected costs over the 2016 to 2020 are shown in Table 3 below. The cost to the federal government of covering the entire amount above the ($1,500 – 3%) threshold would be $1.6 billion in 2016.35 Recommendation 1: The Canadian Medical Association recommends that the House of Commons Standing Committee on Health request the Parliamentary Budget Officer to conduct a detailed examination of the financial burden of prescription medication coverage across Canada and to develop costing options for a federal contribution to a national pharmacare program. Recommendation 2: As a positive step toward comprehensive, universal coverage for prescription medications, the Canadian Medical Association recommends that the federal government establish a cost-shared program of coverage for prescription medications. First dollar coverage? The issue of co-payment arises in most discussions of pharmacare. Hall recommended a $1.00 prescription charge in 1964. In England, which does include prescription medications in the National Health Service (NHS), the current prescription charge is £8.40, although the government has previously noted that 90% of prescription items are provided free of charge.36 Appleby has noted however that the NHS’s in Wales, Northern Ireland and Scotland have eliminated prescription charges.37One observational study of dispensing rates in Wales found that the overall impact of removing prescription charges was minimal.38 Table 4 shows the total volume of prescriptions dispensed in Scotland over the period 2009-2015, which straddles the removal of prescription charges on April 1, 2011. It indicates that percentage increases in the annual dispensing volume diminished after 2012 and the increase observed in 2015 was just 1.4%. It should be added, however, that patient charges accounted for less than 4% of Scotland’s dispensing expenditures in 2010.39 It will be interesting to see the results of further studies in these jurisdictions. 38 Cohen D, Alam M, Dunstan F, Myles S, Hughes D, Routledge P. Abolition of prescription copayments in Wales: an observational study on dispensing rates. Value in Health 2010;13(5):675-80. 39 ISD Scotland. Prescribing and medicines. Data tables. http://www.isdscotland.scot.nhs.uk/Health-Topics/Prescribing-and-Medicines/Publications/data-tables.asp?Co=Y. Accessed 05/15/16. 40 Canadian Medical Association. A prescription for optimal prescribing. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD11-01.pdf. Accessed 05/18/16. 41 Canadian Medical Association. Vision for e-prescribing; a joint statement by the Canadian Medical Associaiton and the Canadian Pharmacists Association. http://policybase.cma.ca/dbtw-wpd/Policypdf/PD13-02.pdf. Accessed 05/18/16. 42 Department of Finance Canada. Growing the middle class. http://www.budget.gc.ca/2016/docs/plan/budget2016-en.pdf. Accessed 05/18/16. Table 4 Prescription Dispensing in Scotland, 2009 – 2015 Year Number of Prescriptions % increase from previous year (million) 2009 88.4 3.8 2010 91.0 3.0 2011 93.8 3.1 2012 96.6 3.0 2013 98.4 1.9 2014 100.6 2.2 2015 102.0 1.4 Source: annual tabulations - Remuneration and reimbursement details for all prescribing made in Scotland.39 Other Elements of a National Pharmaceuticals Strategy It was noted previously that the Hall Report contained 25 recommendations on pharmaceuticals, and the 2004 Health Accord called for a 9-point National Pharmaceuticals Strategy. Two of the NPS points that the CMA would emphasize are the need to influence prescribing behaviour and the need to advance electronic prescribing (e-prescribing). The CMA refers to the first of these points as “optimal prescribing” and defines it as the prescription of a medication 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 available to best meet the patient’s needs. Toward this end the CMA has identified principles and recommendations to promote optimal prescribing, including the need for current information on cost and cost-effectiveness.40 The CMA believes that e-prescribing has the potential to improve patient safety, to support clinical decision-making and medication management, and to increase awareness of cost and cost-effectiveness considerations. In 2012 the CMA and the Canadian Pharmacists Association adopted a joint vision statement calling for e-prescribing to be the means by which prescriptions are generated for Canadians by 2015.41 Clearly that date has come and gone and we are not there yet. The current state primarily consists of demonstration projects and “workarounds”. The CMA was pleased to see an amount of $50 million allocated to Canada Health Infoway in the 2016 federal budget to support the advancement of e-prescribing and telehomecare.42 Finally the CMA remains very concerned about ongoing shortages of prescription drugs. We would caution that whatever measures governments might take to implement a pharmacare program these must not exacerbate drug shortages. Recommendation 3: The Canadian Medical Association recommends that the Federal/Provincial/Territorial health Ministers direct their officials to convene a working group on a comprehensive National Pharmaceuticals Strategy that will consult widely with stakeholders representing patients, prescribers, and the health insurance and pharmaceutical industries to report with recommendations by spring 2017. Conclusion In conclusion, few would argue that prescription medications are less vital to the health and health care of Canadians than hospital and medical services. We would not have had the Medicare program that Canadians cherish today without the leadership and financial contribution of the federal government, and similarly without it now we will not have any form of a national pharmacare program.
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A Prescription for Optimal Prescribing

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