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Policies that advocate for the medical profession and Canadians


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Opioid overdose prevention supplies available in publicly accessible locations

https://policybase.cma.ca/en/permalink/policy13703
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-06
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Policy Type
Policy resolution
Date
2017-08-23
Topics
Health care and patient safety
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Resolution
GC17-06
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Text
The Canadian Medical Association supports making naloxone and other opioid overdose prevention supplies available in publicly accessible locations.
Less detail

CMA submission to the study of Bill C-37

https://policybase.cma.ca/en/permalink/policy13617
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Parliamentary submission
Date
2017-04-06
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
The Canadian Medical Association (CMA) provides this brief for consideration as part of the Senate Committee on Legal and Constitutional Affairs’ study of Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts.1 1 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 The CMA is deeply concerned with the opioid crisis in Canada, with unprecedented levels of harms, including overdose deaths. The crisis is taking a toll on individuals, families and communities, as well as first responders and health professionals at the front lines. The most recent BC Coroner’s Report indicates there were about 3.6 illicit drug overdose deaths per day in February 2017, an increase of 72.9% over the number of deaths in February of last year.2 Other provinces are also facing critical situations. The CMA welcomes the introduction of Bill C-37, proposed by the Minister of Health to address various portions of the Controlled Drugs and Substances Act (CDSA), among other changes. * We are particularly appreciative, given that this is part of a new federal strategy that promises to “replace the existing National Anti-Drug Strategy with a more balanced approach (…) and restores harm reduction as a core pillar of Canada’s drug policy, alongside prevention, treatment and enforcement and supports all pillars with a strong evidence base.3 This is necessary to ensure a public health approach to drug use and addiction. * For further discussion of CMA’s position on addiction, harm reduction and supervised consumption sites, as well as terminology, such as supervised consumption sites or supervised injection sites, see CMA’s submission to the Senate Standing Committee on Legal and Constitutional Affairs. Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf This proposed legislation includes various objectives, including “to prohibit the unregistered import of pill presses, and remove the exception currently placed on border officers to only open mail weighing more than 30 grams,” (…) to “make it a crime to possess or transport anything intended to be used to produce controlled substances, allow for temporary scheduling of new psychoactive substances, and support faster and safer disposal of seized chemicals and other dangerous substances.”4 CMA is supportive of actions by the federal government that advance the work at national, provincial and local levels to address the opioid crisis. Application for a Supervised Consumption Site The objective of Bill C-37 that CMA would like to provide recommendations for is the one that seeks to “simplify the process of applying for an exemption that would allow certain activities to take place at a supervised consumption site, as well as the process of applying for subsequent exemptions.5 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 The Bill proposes to repeal the 26 requirements to apply for an exemption to the CDSA, in Section 56.1, established by the Respect for Communities Act (former Bill C-26). The CMA supports the repeal, as we have repeatedly called for the withdrawal of the amendments made by former Bill C-2, and their replacement with “legislation that recognizes the unequivocal evidence of benefits of supervised consumption sites, that was accepted by the Supreme Court. Legislation would enhance access to health services, which include prevention, harm reduction and treatment services in communities where the evidence has shown they would benefit from such health services.”7 Bill C-37 proposes to replace those 26 requirements with the five elements cited in the 2011 Supreme Court of Canada unanimous ruling on Insite8, Vancouver’s supervised injection site. These elements are, “evidence, if any, on: . the impact of such a facility on crime rates, . the local conditions indicating a need for such a supervised injection site, . the regulatory structure in place to support the facility, . the resources available to support its maintenance and . expressions of community support or opposition.”9 These elements are proposed to reduce the unnecessary obstacles and burdens on local health departments and community organizations that would deter the creation of new supervised consumption sites, even when the health and safety benefits have been clearly established. Because of this cumbersome process, the BC Ministry of Health recently authorized the creation of “overdose prevention sites” in various locations where there are concerning numbers of overdose deaths, while the ministry “wait(s) for Health Canada approval of supervised consumption services”.10 This was after the creation of unsanctioned popup sites by community groups in the downtown eastside.11 Only Insite and the Dr Peter Centre operate with approved exemptions to date, with Montreal having recently received approval for three sites.12 Many other applications have been submitted for sites in Vancouver, Victoria, Toronto and Ottawa, and others are in preparation. Although a welcome reduction to only five elements, the CMA believes that these elements require more clarity, as they can be subject to interpretation, and undue influence, and could still demand unnecessary and significant time and resources on the part of provincial and local agencies. As well, the present crisis would require an expedited process that would not delay local responses to the crisis. Hence, our first recommendation is that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. Further, CMA recommends that the elements required for an application for opening a supervised consumption site proposed in Bill C-37 be more clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. The central element to be considered is that of “the local conditions indicating a need for such a supervised injection site”. Local health authorities and community organizations struggle with the issues related to drug use, including rising rates of infections, overdoses and deaths, and this is the fundamental reason to open a supervised consumption site. The regulatory structure and the resources available to support a supervised consumption site’s maintenance are issues that local health authorities deal with regularly for any health service, given the need to provide care with reduced risk of liability. The impact of a facility on crime rates is difficult to quantify before such a site is created. Further, the government must consider the experience of the many sites both in Canada and internationally, where law and order have improved in the areas surrounding those sites. The Supreme Court stated that there has been “no discernible negative impact on the public safety and health objectives of Canada during its [Insite’s] eight years of operation.”13 As well, the crime rate is not only influenced by the existence or not of a site, but by many other factors, such as unemployment and enforcement resources. A site would necessarily be located where there are high rates of drug use, for the very purpose of offering people who use drugs much needed harm reduction and support services. The last element, expressions of community support or opposition, should not represent a burden to applicants. As stated in our brief on Bill C-2, “although public opinion might initially be against the introduction of such facilities, public acceptance of supervised consumption sites is considerably high in most of the locations where they have been established, in both Vancouver sites and in European countries.”14 Communities, neighbourhoods and local authorities are usually involved in the good functioning of the facilities through cooperation and communication.15 Bill C-2 is an example of how this element could be interpreted. There was an extensive list of letters of opinion required, including from representatives of local police and local and provincial governments (ministers of health and public safety), chief public health officer, professional licensing authorities for physicians and for nurses, as well as reports from community consultations.16 Such a requirement represented a cumbersome and unnecessary burden. The CMA looks forward to continued collaboration with the federal government and other organizations in the development of further action as part of the much needed comprehensive approach to address the opioid crisis. Recommendations 1. The CMA recommends that there be provisions for an expedited review, at the request of provincial or territorial ministries of health, for situations in which there is an immediate need for such sites. 2. The CMA recommends that the elements required for an exemption application to the CDSA to open a supervised consumption site, proposed in Bill C-37, be clearly defined and simplified in order not to require unnecessary and extensive resources and funding by local public health authorities and community agencies. Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Retrieved from: http://www.parl.gc.ca/HousePublications/Publication.aspx?Language=E&Mode=1&DocId=8769825 2 British Columbia Coroners Service. Coroners Report. Illicit Drug Overdose Deaths in BC: January 1, 2007 – February 28, 2017. Retrieved from: http://www2.gov.bc.ca/assets/gov/public-safety-and-emergency-services/death-investigation/statistical/illicit-drug.pdf 3 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 4 Health Canada “Government of Canada announces new comprehensive drug strategy supported by proposed legislative changes”. News release. December 12, 2016. Retrieved from: http://news.gc.ca/web/article-en.do?nid=1168519 7 5 Bill C-37, An Act to amend the Controlled Drugs and Substances Act and to make related amendments to other Acts. Legislative Summary. Retrieved from: http://www.parl.gc.ca/LegisInfo/BillDetails.aspx?billId=8689350&Language=E&Mode=1&View=8 6 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1 7 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 8 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. Retrieved from: http://scc-csc.lexum.com/scc-csc/scc-csc/en/item/7960/index.do 9 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 10 Vancouver Coastal Health. News release. Further overdose response action to include BC Mobile Medical Unit and new overdose prevention sites. December 8, 2016. Retrieved from: http://www.vch.ca/about-us/news/news-releases/further-overdose-response-action-to-include-bc-mobile-medical-unit-and-new-overdose-prevention-sites 11 CTV. ‘Pop–up’ injection sites aim to combat overdoses in Vancouver. November 20, 2016. Retrieved from: http://www.ctvnews.ca/health/pop-up-injection-sites-aim-to-combat-overdoses-in-vancouver-1.3169397 12 Woo, A. & Perreaux, L. Health Canada approves three supervised consumption sites for Montreal. Globe and Mail. February 6, 2017. Retrieved from: http://www.theglobeandmail.com/news/politics/federal-government-approves-three-supervised-injection-sites-in-montreal/article33914459/ 13 Supreme Court of Canada (2011) Canada (A.G.) v. PHS Comm. Serv. Soc. supra. p.192-3 14 Bill C-2 An Act to amend the Controlled Drugs and Substances Act (Respect for Communities Act). CMA submission to the Senate Standing Committee on Legal and Constitutional Affairs. May 14, 2015. Retrieved from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/cma-brief-c2-respect-for-communities-act-senate-committee-may-14-2015-english.pdf 15 Schatz, E. & Nougier, M. (2012) Drug consumption rooms: evidence and practice. International Drug Policy Consortium Briefing Paper. (p.20) Retrieved from: http://www.drugsandalcohol.ie/17898/1/IDPC-Briefing-Paper_Drug-consumption-rooms.pdf 16 Bill C-2, An Act to amend the Controlled Drugs and Substances Act. http://www.parl.gc.ca/HousePublications/Publication.aspx?DocId=8056955&Language=E&Mode=1&File=24#1
Documents
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Statement to the House of Commons Committee on Health addressing the opioid crisis in Canada

https://policybase.cma.ca/en/permalink/policy13936
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
  1 document  
Policy Type
Parliamentary submission
Date
2016-10-18
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Population health/ health equity/ public health
Health care and patient safety
Text
Thank you Mr. Chair. I am Dr. Jeff Blackmer, the Vice-President of Medical Professionalism for the Canadian Medical Association. On behalf of the CMA, let me first commend the committee for initiating an emergency study on this public health crisis in Canada. As the national organization representing over 83,000 Canadian physicians, the CMA has an instrumental role in collaborating with other health stakeholders, governments and patient organizations in addressing the opioid crisis in Canada. On behalf of Canada’s doctors, the CMA is deeply concerned with the escalating public health crisis related to problematic opioid and fentanyl use. Physicians are on the front lines in many respects. Doctors are responsible for supporting patients with the management of acute and chronic pain. Policy makers must recognize that prescription opioids are an essential tool in the alleviation of pain and suffering, particularly in palliative and cancer care. The CMA has long been concerned with the harms associated with opioid use. In fact, we appeared before this committee as part of its 2013 study on the government’s role in addressing prescription drug abuse. At that time, we made a number of recommendations on the government’s role – some of which I will reiterate today. Since then, the CMA has taken numerous actions to contribute to Canada’s response to the opioid crisis. These actions have included advancing the physician perspective in all active government consultations. In addition to the 2013 study by the health committee, we have also participated in the 2014 ministerial roundtable and recent regulatory consultations led by Health Canada — specifically, on tamper resistant technology for drugs and delisting of naloxone for the prevention of overdose deaths in the community. 3 Our other actions have included: · Undertaking physician polling to better understand physician experiences with prescribing opioids; · Developing and disseminating new policy on addressing the harms associated with opioids; · Supporting the development of continuing medical education resources and tools for physicians; · Supporting the national prescription drug drop off days; and, · Hosting a physician education session as part of our annual meeting in 2015. Further, I’m pleased to report that the CMA has recently joined the Executive Council of the First Do No Harm strategy, coordinated by the Canadian Centre on Substance Abuse. In addition, we have joined 7 leading stakeholders as part of a consortium formed this year to collaborate on addressing the issue from a medical standpoint. I will now turn to the CMA’s recommendations for the committee’s consideration. These are grouped in four major theme areas. 1) Harm Reduction The first of them is harm reduction. Addiction should be recognized and treated as a serious, chronic and relapsing medical condition for which there are effective treatments. Despite the fact that there is broad recognition that we are in a public health crisis, the focus of the federal National Anti-Drug Strategy is heavily skewed towards a criminal justice approach rather than a public health approach. In its current form, this strategy does not significantly address the determinants of drug use, treat addictions, or reduce the harms associated with drug use. The CMA strongly recommends that the federal government review the National Anti-Drug Strategy to reinstate harm reduction as a core pillar. Supervised consumption sites are an important part of a harm reduction program that must be considered in an overall strategy to address harms from opioids. The availability of supervised consumption sites is still highly limited in Canada. The CMA maintains its concerns that the new criteria established by the Respect for Communities Act are overly burdensome and deter the establishment of new sites. 4 As such, the CMA continues to recommend that the act be repealed or at the least, significantly amended. 2) Expanding Pain Management and Addiction Treatment The second theme area I will raise is the need to expand treatment options and services. Treatment options and services for both addiction as well as pain management are woefully under-resourced in Canada. This includes substitution treatments such as buprenorphine-naloxone as well as services that help patients taper off opioids or counsel them with cognitive behavioural therapy. Availability and access of these critical resources varies by jurisdiction and region. The federal government should prioritize the expansion of these services. The CMA recommends that the federal government deliver additional funding on an emergency basis to significantly expand the availability and access to addiction treatment and pain management services. 3) Investing in Prescriber and Patient Education The third theme I will raise for the committee’s consideration is the need for greater investment in both prescriber as well as patient education resources. For prescribers, this includes continuing education modules as well as training curricula. We need to ensure the availability of unbiased and evidenced-based educational programs in opioid prescribing, pain management and in the management of addictions. Further, support for the development of educational tools and resources based on the new clinical guidelines to be released in early 2017 will have an important role. Finally, patient and public education on the harms associated with opioid usage is critical. As such, the CMA recommends that the federal government deliver new funding to support the availability and provision of education and training resources for prescribers, patients and the public. 4) Establishing a Real-time Prescription Monitoring Program Finally, to support optimal prescribing, it is critical that prescribers be provided with access to a real-time prescription monitoring program. 5 Such a program would allow physicians to review a patient’s prescription history from multiple health services prior to prescribing. Real-time prescription monitoring is currently only available in two jurisdictions in Canada. Before closing, I must emphasize that the negative impacts associated with prescription opioids represent a complex issue that will require a multi-faceted, multi-stakeholder response. A key challenge for public policy makers and prescribers is to mitigate the harms associated with prescription opioid use, without negatively affecting patient access to the appropriate treatment for their clinical conditions. To quote a past CMA president: “the unfortunate reality is that there is no silver bullet solution and no one group or government can address this issue alone”. The CMA is committed to being part of the solution. Thank you.
Documents
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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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Consultation on the prescription drug list: Naloxone

https://policybase.cma.ca/en/permalink/policy11847
Date
2016-03-17
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Association. Policy Document PD15-06 - Harms associated with opioids and other psychoactive prescriptions
  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).
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Non-prescription availability of low-dose codeine products

https://policybase.cma.ca/en/permalink/policy13734
Date
2017-11-7
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
  1 document  
Policy Type
Response to consultation
Date
2017-11-7
Topics
Pharmaceuticals/ prescribing/ cannabis/ marijuana/ drugs
Text
Submission to the Health Canada consultation on the potential risks, benefits and impacts of changes to the regulations to the Controlled Drugs and Substances Act that would require all products containing codeine to be sold by prescription only The Canadian Medical Association (CMA) is pleased to provide this submission in response to Health Canada's notice as published in the Canada Gazette, Part I1 for interested stakeholders to provide comments on the potential risks, benefits, and impacts of changes to the regulations to the Controlled Drugs and Substances Act that would require all products containing codeine to be sold by prescription only. Codeine is a widely used narcotic analgesic in Canada - low dose formulations are currently sold without a prescription, when in combination with at least two other medications. It is not available for self-selection, but kept behind the counter in pharmacies. However, serious concerns have been raised about the safety of this practice in recent years.2,3,4 A literature review examining over the counter medicine abuse in several countries found that "there is a recognized problem internationally involving a range of medicines and potential harms," including codeine-based medicines.5 Doctors support patients in the management of acute and chronic pain, as well as addictions, and as such we have long been concerned about the harms associated with opioid use, including codeine. Codeine is considered to be "a poor analgesic in its own right," for which there are more suitable alternatives.6 In addition, genetic factors can substantially affect the metabolism of codeine into morphine, resulting in concentrations that vary from person to person. This can lead to potentially serious consequences, even at conventional doses, particularly in children.2 Codeine has the potential for dependence. Studies show an increase in non-therapeutic use of codeine, including over the counter formulations, leading to increases in morbidity and mortality as well as social costs. 7,8,9 An Australian study noted that "codeine-related deaths (with and without other drug toxicity) are increasing as the consumption of codeine-based products increases."10 Ontario data shows that over 500 people began methadone treatment for non-prescription codeine, between 2011 and 2014.3 In addition, over the counter codeine is often combined with acetaminophen or ASA, which also present concerns in terms of toxicity, particularly in higher doses. A review of the process examining the problems related to codeine-based over the counter formulations in Australia, New Zealand, and the United Kingdom found that each of their respective committees had decided, based on the existing evidence, "to minimize harm by using regulatory levers to restrict availability."11 Many European countries have also implemented a prescription-only status for products containing codeine, as well as some U.S. States. Some Canadian hospitals have removed codeine from their formularies, and Manitoba ended the over the counter sales last year12. Given this reality and, as part of the CMA's advocacy to reduce the harms related to opioid use, the CMA supports the requirement that all products containing codeine be sold by prescription only, as this is both a public health and a patient safety issue. Moving codeine to prescription-only will enable limiting its use and closer monitoring of patients with the view of preventing harms.10 A challenge for policy makers and prescribers is to ensure patients still have access to treatments that are appropriate for their clinical conditions.13 At the same time, we recognize that there could be unintended consequences when moving low-dose codeine to prescription-only status, particularly for those who have come to depend on its availability over-the-counter. Some may choose to seek out illicit markets for these products or purchase other, more powerful, narcotics as a substitute. Authorities must develop educational tools to inform people about less-harmful pain-relief options. As well, a reasonable timeframe for implementation of this measure should be given to allow for patients to find appropriate alternatives. The CMA continues to urge governments to increase access to services and treatment options for addiction and pain management, as well as harm reduction.14 1 Controlled Drugs and Substances Act: Notice to interested parties - Non-prescription availability of low-dose codeine products. Canada Gazette Part I. 2017 Sep 09, 151(36). Available: http://www.gazette.gc.ca/rp-pr/p1/2017/2017-09-09/html/notice-avis-eng.php#ne3 (accessed 2017 Nov 07). 2 MacDonald N, MacLeod SM. Has the time come to phase out codeine? Can Med Assoc J 2010;182(17):1825. Available: https://doi.org/10.1503/cmaj.101411 (accessed 2017 Nov 07). 3 Yang J, Zlomislic D. Star investigation: Canada's invisible codeine problem. The Toronto Star. Jan. 17, 2015. Available: https://www.thestar.com/news/canada/2015/01/17/star-investigation-canadas-invisible-codeine-problem.html (accessed: 2017 Nov 7). 4 MacKinnon, JIJ. Tighter regulations needed for over-the-counter codeine in Canada. Can Pharm J Rev Pharm Can, 2016;149(6):322-4. Available: http://www.cmaj.ca/content/182/17/1825 (accessed 2017 Nov 07). 5 Cooper RJ. Over-the-counter medicine abuse - a review of the literature. J Subst Use, 2013 Apr;18(2):82-107. Available: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3603170/pdf/JSU-18-82.pdf (accessed: 2017 Oct 23). 6 Vagg M. Four reasons why codeine should not be sold without a prescription. The Conversation. Apr. 30, 2015. Available: http://theconversation.com/four-reasons-why-codeine-should-not-be-sold-without-prescription-41025 (accessed: 2017 Oct 23). 7 Nielsen S, Cameron J, Pahoki S . Over the counter codeine dependence final report 2010. Victoria: Turning Point, 2010. Available: http://atdc.org.au/wp-content/uploads/2011/02/OTC_CODEINE_REPORT.pdf (accessed 2017 Nov 07). 8 Fischer B, Ialomiteanu A, Boak A, et al. Prevalence and key covariates of non-medical prescription opioid use among the general secondary student and adult populations in Ontario, Canada. Drug Alcohol Rev 2013;32(3):276-87. 9 Compton WM, Volkow ND. Major increases in opioid analgesic abuse in the United States: concerns and strategies. Drug Alcohol Depend 2006 Feb 01;81(2):103-7. 10Roxburgh A. et. al. Trends and characteristics of accidental and intentional codeine overdose deaths in Australia. Med J Aust 2015; 203(7): 299 11 Tobin CL, Dobbin M, McAvoy B. Regulatory responses to over-the-counter codeine analgesic misuse in Australia, New Zealand and the United Kingdom. N Z J Public Health 2013 Oct. 37(5): 483-488. Available: http://onlinelibrary.wiley.com/doi/10.1111/1753-6405.12099/abstract (accessed: 2017 Nov 7). 12 Zlomislic, D. & Yang, J. The Toronto Star. Jan 12, 2016. Available: https://www.thestar.com/life/health_wellness/2016/01/13/manitoba-sets-new-rule-limiting-codeine.html (accessed: 2017 Nov 7). 13 Canadian Medical Association. Opening Statement addressing the opioid crisis to the House of Commons Standing Committee on Health. Ottawa: The Association; 2016 Oct. Available: https://www.cma.ca/Assets/assets-library/document/en/advocacy/submissions/hesa-opioid-study-opening-remarks-oct-18-2016-e.pdf (accessed: 2017 Nov 7). 14 Canadian Medical Association. Harms Associated with Opioids and Other Psychoactive Prescription Drugs. CMA Policy, 2015. Ottawa: The Association; 2015. Available: https://www.cma.ca/Assets/assets-library/document/en/policies/cma_policy_harms_associated_with_opioids_and_other_psychoactive_prescription_drugs_pd15-06-e.pdf (accessed: 2017 Nov 7).
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