National consultation on the Section 56 exemption requirement for methadone prescribing
Table of Contents
- Acknowledgements
- Executive Summary
- Background
- Current Regulatory Processes
- Monitoring and Diversion
- Consultation Process
- Results
- Recommendation and additional considerations
- Summary
- Appendix 1: Provincial educational and training requirements to prescribe methadone and buprenorphine for opioid use disorder
- Appendix 2: List of organizations contacted
- References
Acknowledgements
This consultation was conducted by Nirupa Goel, PhD (Project Lead), with assistance from Denise Adams, PhD; Farihah Ali, MA; Athena Hyunh; Kamagaju Karekezi, MPH; Alice Lam, MA; Aïssata Sako, MSc, CRP; and Pam Sabioni, PhD.
Guidance and support were provided by the CRISM Nominated Principal Investigators: Julie Bruneau, MD, MSc; Benedikt Fischer, PhD; T. Cameron Wild, PhD; and Evan Wood, MD, PhD.
Consultation design and objectives were informed by Bobby Chauhan, Kirsten Mattison, and Neelam Merchant (Health Canada, Controlled Substances Directorate).
Executive Summary
Background and rationale. Canada has seen an extensive rise in opioid use and related morbidity (including opioid use disorders) and mortality. As a result, there is an urgent need to increase availability of and access to treatment options for opioid use disorder, including opioid agonist therapy. A potential barrier to the provision of opioid agonist therapy is the current regulatory requirement for a federal exemption for practitioners (i.e., physicians and nurse practitioners) to prescribe methadone maintenance treatment (MMT) under Section 56(1) (s.56) of the Controlled Drugs and Substances Act. Health Canada requested that a national consultation be conducted in order to assess, through expert opinion, the utility, advantages, and disadvantages of the s.56 requirement, to inform future Federal policy options regarding this regulatory requirement.
Methods. On this premise, and in close collaboration with Health Canada, the Canadian Research Initiative in Substance Misuse (CRISM) conducted a consultation, reaching out to over 250 stakeholders, including clinical leaders and other health service providers; representatives from provincial/territorial regulatory bodies, provincial/territorial and federal governments and regional health authorities; and people with lived and living experience with substance use (including family members). Respondents were located in all provinces and territories in Canada, and local, regional, and federal perspectives were represented. Stakeholders provided initial input through a web-based survey that included 3 open-ended questions jointly formulated by Health Canada and CRISM. Responses were analyzed for frequency of recurring themes. Further input was subsequently gathered through structured questions and open discussion, informed by the initial responses, through a series of 12 regional meetings held via group teleconferences. These follow-up discussions provided additional context on experiences with and perspectives on opioid agonist treatment.
Results. About three quarters of survey participants identified the s.56 exemption process as a barrier to care. At the same time, approximately one-third of the participants mentioned the importance of safety and education. These participants stated that the training currently required for methadone prescribing is needed and should continue, due to both the vulnerability of patients with opioid addiction as well as the unique characteristics and risks of methadone treatment (e.g., overdose). In most provinces and territories, teleconference participants supported the removal of the s.56 exemption due its administrative burden and lack of added value, on the condition that training and monitoring systems remain in place through regional authorities. Thus, the main recommendation from this consultation is to consider eliminating the s.56 exemption requirement, while also ensuring that strategies are in place to maintain appropriate training and monitoring for methadone treatment delivery.
In addition to the s.56 exemption, participants raised concerns about other challenges and barriers to opioid agonist treatment resulting from provincial and federal regulations. Suggestions and considerations for Health Canada were provided on how to address these barriers, which are described in more detail in the report. These include support for evidence-based training and guidelines; improving access to other forms of evidence-based opioid agonist therapies; addressing barriers to treatment access in rural and remote communities; and supporting or providing resources for prescribers and patients, to allow for improved access to high-quality care.
Background
Methadone, a medication primarily used to treat chronic pain and opioid use disorder, is a controlled substance under the Controlled Drugs and Substances Act (CDSA), and activities with it are regulated under the Narcotic Control Regulations (NCR). The NCR require practitionersEndnote * (e.g., physicians and nurse practitioners) to obtain an exemption under section 56(1) (s.56) of the CDSA before they can prescribe, administer, sell or provide methadone. This special exemption requirement is unique to methadone and does not apply to other opioid medications, including buprenorphine, a drug also used to treat opioid use disorder, or those approved for pain management, such as controlled-release oxycodone, morphine, and fentanyl.
The regulatory and administrative context for methadone treatment in Canada has evolved since it was introduced in 1964Footnote 1. As the use of methadone increased, the federal Department of Health and Welfare observed growing reports of dependence, overdoses, and the improper prescribing of methadone. Consequently, the Department created a clinical guideline for the use of methadone and amended the NCR to require all methadone prescribers to receive authorization issued by the federal Minister of Health. Physicians who were authorized to treat patients with methadone were required to follow federal guidelines for methadone treatment, register all patients with the Department, and submit monthly statistics to the Department. After the guidelines and restrictions were introduced, the number of patients receiving methadone treatment in Canada declined. However, this number has risen substantially since the 1980’s, due to increased awareness of opioid use disorder and the changing medical, social, and legislative contexts.Footnote 1
In 1995, oversight of the physician practice aspects for methadone treatment was transferred from Health Canada to the provinces and territories (P/T). Although not mandated by federal legislation, P/T licensing authorities developed or adopted guidelines, training requirements, audit processes and other mechanisms aimed at ensuring that physicians were knowledgeable and qualified to prescribe methadone for the treatment of opioid use disorder.Footnote 2 The NCR were amended in 1999 to replace the previous authorization requirement with the exemption under s.56 of the CDSA.
Section 53(3) CDSA’s Narcotic Control Regulations (NCR) states that “No practitioner shall administer methadone to a person or animal, or prescribe, sell or provide methadone for a person or animal, unless the practitioner is exempted under section 56 of the Act with respect to methadone.”Endnote **
Subsequently, P/T created oversight mechanisms and regulations to support the administration of Health Canada’s s.56 exemption process. Practitioners either apply directly to Health Canada (Saskatchewan, Nova Scotia, New Brunswick, Newfoundland and Labrador, Prince Edward Island, the Northwest Territories, Nunavut and Yukon) or via their respective P/T licensing authority (British Columbia, Alberta, Manitoba, Québec and Ontario), which in turn makes a recommendation to Health Canada regarding the issuance of a s.56 exemption on behalf of the practitioner. Data from individual provinces suggest that a limited number of physicians in Canada have applied for and hold a valid s.56 exemption.Footnote 3 Footnote 4
Current Regulatory Processes
Each P/T, through their respective licensing authorities, have developed application procedures and educational requirements that providers must complete in order to be granted a s.56 exemption. As well, each P/T has issued or adopted clinical standards and guidelines for methadone prescription. The requirements for obtaining the exemption vary from province to province, but common requirements include:
- completion of an approved methadone workshop or course;
- a preceptorship (length varies between 1-2 days across jurisdictions); and
- a review of the physician’s prescribing profile
Some provinces have additional requirements which can include:
- mentorship in the first years of practice;
- an interview with registrar staff;
- making efforts to provide non-pharmacological supports to patients;
- continuing education in addiction medicine (required hours vary across jurisdictions);
- undergoing a practice assessment;
- access to laboratory services and a pharmacy; and/or
- access and use of prescription monitoring programs (i.e., duplicate/triplicate forms, prescribing databases)
In Alberta and Saskatchewan, physicians must meet a different set of requirements depending on whether they wish to initiate methadone treatment, maintain methadone treatment, or provide temporary prescriptions. In Manitoba, New Brunswick, and Nova Scotia, nurse practitioners may apply for a s.56 exemption to prescribe methadone. Requirements for Yukon, Nunavut, and the Northwest Territories are not publicly available. Details of the specific requirements in each province are fully described in the forthcoming CRISM National Guideline for the Clinical Management of Opioid Use Disorder and are shown in Appendix 1 of this report.
Previously in hospital settings, practitioners who attended to patients already on methadone were required to obtain a temporary s.56 exemption. In March 2017, Health Canada issued a s.56 class exemption for all practitioners maintaining inpatients on methadone in hospitals, thereby removing the requirement for individual exemptions.
Changes have recently been made or are in process for treatment standards and s.56 exemption requirements in various provinces. For example, in British Columbia, the management of the methadone program has shifted from the College of Physicians and Surgeons of British Columbia to the British Columbia Centre on Substance Use, which has issued a new provincial guideline for opioid use disorder treatment and has dramatically scaled up and increased access to education and training. Alberta is in the process of developing a more consistent and structured preceptorship which can be accessed online (e-preceptorship), with an anticipated roll-out in early 2018. Saskatchewan recently updated their treatment standards and guidelines to include buprenorphine/naloxone. The treatment guideline for Québec is under revision by the Collège des médecins du Québec and the Ordre des pharmaciens du Québec and will include buprenorphine/naloxone in the new version. In addition, practitioners in Newfoundland have built a new education platform for methadone and buprenorphine/naloxone and are working with their regulatory College to classify it as an approved course option for fulfilling the provincial requirements.
Several provinces are developing regulatory pathways to authorize nurse practitioners to prescribe opioid agonist treatments. In British Columbia, standards for training and conditions for nurse practitioners to prescribe methadone have been developed, and these will come into effect in the near future. Similarly, Alberta plans to publish their methadone treatment guidelines for nurse practitioners in early 2018.
Monitoring and Diversion
Most provinces utilize some form of prescription drug monitoring, which is able to track if a patient is accessing the same medication from more than one prescriber or more than one pharmacy.5,6 Some systems are designed with alert messaging features and are able to send real-time warnings to providers about potential misuse of controlled substances. Methadone and buprenorphine/naloxone prescriptions are currently monitored in British Columbia, Alberta, Saskatchewan, Ontario, New Brunswick, Nova Scotia, and Yukon, and by the Non-Insured Health Benefits program. Methadone, but not buprenorphine/naloxone, is tracked in Manitoba as well. Québec has an alert system, Programme Alerte, that is able to identify patients who are visiting multiple physicians or multiple pharmacies. Though not available in real-time, targeted and neighbouring pharmacies will receive a warning message about that patient. Other provinces have mandatory duplicate or triplicate prescription pads for controlled substances which are aimed at preventing diversion, forgeries, and alterations, though these activities are not equivalent to a prescription monitoring program. Prince Edward Island and Newfoundland and Labrador have recently committed to implementing provincial prescription monitoring programs, and stakeholders in Quebec have called for it as well.
In addition to prescription drug monitoring, many provinces have policies that are able to restrict certain patients to using a single pharmacy and/or a single prescriber for specific medications (e.g., opioids, benzodiazepines, and stimulants). Further details on these programs and policies can be found in recent environmental scans.Footnote 5 Footnote 6
Data on diversion of methadone into the illegal market is difficult to collect, though some inferences can be made through toxicology reports for overdose-related deaths. Several provinces now conduct regular surveillance and tracking of overdoses and overdose-related deaths and perform toxicology analyses to identify the substances involved. The presence of methadone is reported in closed and certified cases in British Columbia, Saskatchewan, Manitoba, and Ontario. The most recent data available from these provinces indicate that methadone was detected in 9 - 24% of overdose deaths.Footnote 7 Footnote 8 Footnote 9 Footnote 10 Reports from Alberta and New Brunswick do not isolate methadone in the toxicology results and data were not available for Québec, Nova Scotia, Newfoundland and Labrador, Prince Edward Island, and Yukon.
Consultation Process
Overview. In light of the current opioid crisis, the Minister of Health committed to engaging stakeholders to identify barriers to accessing treatment options for opioid use disorder. Health Canada enlisted the Canadian Research Initiative in Substance Misuse (CRISM), through its four regional Nodes, to lead a national consultation to determine whether the current exemption requirement for methadone prescribers poses an unnecessary barrier to methadone treatment provision and access. The recommendations resulting from this consultation process will inform Health Canada’s future activities related to federal regulations for methadone and other steps to improve access to care.
Participants. Health Canada and CRISM jointly developed a stakeholder list, ensuring that regulatory bodies, P/T health departments or ministries, service providers, and people with lived experience were included. See Appendix 2 for the list of organizations that were contacted. Each of the four CRISM Nodes invited stakeholders from their respective regions to participate in the consultation via email. Of the 267 individuals that were contacted, a total of 145 participated in the consultation. Participants were located in all 13 P/T in Canada, and included federal-level stakeholders (Figure 1). Multiple types of participants provided input, with health practitioners making up the majority of the respondents (Figure 2). Those who selected the “Other” designation were academic researchers, advocates, consultants or advisors, and other types of health service staff.
Figure 1. Number of respondents by Province/Territory
Figure 1 - Text Equivalent
| Answer Choices | Responses | |
| British Columbia | 19.26% | 26 |
| Yukon | 1.48% | 2 |
| Northwest Territories | 2.96% | 4 |
| Nunavut | 0.74% | 1 |
| Alberta | 23.70% | 32 |
| Saskatchewan | 5.19% | 7 |
| Manitoba | 9.63% | 13 |
| Ontario | 17.04% | 23 |
| Quebec | 2.22% | 13 |
| Prince Edward Island | 0.74% | 1 |
| Newfoundland and Labrador | 2.96% | 4 |
| New Brunswick | 5.19% | 7 |
| Nova Scotia | 4.44% | 6 |
| Federal | 4.44% | 6 |
Figure 2. Number of respondents by type of profession or representation (multiple selections allowed)
Figure 2 - Text Equivalent
| Answer Choices | Responses | |
| Health Practitioner | 53.33% | 80 |
| Professional association | 5.93% | 8 |
| Regulatory body | 19.26% | 29 |
| Federal government | 3.70% | 6 |
| Provincial/Territorial government | 14.81% | 21 |
| Regional/local programming, policy or administration | 10.37% | 15 |
| Person with lived experience of substance use | 8.89% | 12 |
| Other | 18.52% | 21 |
Online survey. Health Canada and CRISM jointly developed an online survey, available in French and English, consisting of the following questions:
- Do the Section 56 exemption requirements pose an administrative obstacle or barrier to treatment access for opioid use disorder in your jurisdiction? Please explain.
- Please describe the potential benefits and repercussions of removing the federal requirement for methadone prescribing in your jurisdiction.
- Do you have any other comments regarding the role of the federal government in barriers to access to medication-assisted treatments for opioid use disorder in your jurisdiction?
Survey responses were submitted as freeform text. The survey also asked participants for their name (optional), their region or jurisdiction, and their professional role. The survey was open to invited consultation participants from August 16 to October 23, 2017.
Analysis of online surveys. The content survey responses were analyzed manually by sorting freeform text into themes using a standardized coding structure. For question 1, responses were categorized as “yes”, “no”, or “undetermined.” For question 2, responses were categorized as “benefits” or “repercussions.” The accompanying explanations were categorized by identifying broad themes that appeared at least five times throughout all survey responses (e.g., insufficient number of prescribers). All responses were then coded independently by two research analysts. Codes were not mutually exclusive; response statements could be assigned to multiple codes as necessary. The analyses were merged and individual responses with discrepancies were re-coded by one of the analysts. The summary below describes the number of responses in each of the broad themes, along with explanatory statements. Codes that received less than eight responses (<5% of participants) were not included in this summary.
Follow-up teleconferences. Following the survey, each CRISM Node hosted one or more teleconference-based discussions with stakeholders in their regions. During these meetings, participants were given opportunities to provide additional feedback and comments about the s.56 process, discuss consequences that would result from maintaining or removing the s.56 exemption, and identify other regulatory challenges and barriers in their jurisdictions. Participants were asked directly if they would support the removal of the s.56 exemption requirement from federal legislation and to provide other recommendations for Health Canada related to access to care. Between September 12 and November 28, 2017, 12 teleconference discussions were held; these included 80 participants from most P/T in Canada (except for Yukon and Prince Edward Island). Each teleconference was attended by one or two CRISM staff who took comprehensive notes of the meeting.
Analysis of follow-up teleconferences. Teleconference discussion notes were compared with survey responses to identify themes that overlapped as well as new information. Overall, these discussions provided additional examples and context but did not identify new thematic categories. These examples, if mentioned by more than one province, are described below to provide clarity on experiences with methadone provision, but they were not quantified.
The most frequent types of suggestions or requests for moving forward with methadone regulation and access were consolidated into a main recommendation regarding the s.56 exemption and additional considerations to address barriers to care. Exemplary responses encompassing many of the recurring statements from the survey were selected and quoted below.
Results
Barriers posed by the s.56 exemption requirement
A substantial majority (110 responses) of respondents characterized the s.56 exemption process as a barrier or obstacle. Conversely, 31 participants did not view the s.56 exemption process as a barrier overall.
The most commonly cited (45 responses) type of barrier to methadone treatment was an insufficient number of care providers. Respondents explained that the existence of the exemption itself discourages many family physicians and general practitioners from applying, which limits the availability of methadone treatment to a relatively small number of qualified physicians. As a further consequence, methadone treatment is not well-integrated into primary care, which prevents access. The insufficient number of nurse practitioners who are licensed to prescribe methadone was also cited as a barrier by 10 survey responses and on seven of the regional teleconferences.
Methadone treatment access was characterized as particularly challenging in rural, remote, and Indigenous communities (18 responses). Within the wider context that these areas are under-resourced for health services, respondents explained that the lack of licensed prescribers and pharmacies located in or near these communities forces patients to travel long distances or relocate to receive their daily witnessed doses of methadone and to attend frequent follow-up appointments. The time and transportation logistics for patients living in rural and remote communities were described as being almost impossible to manage.
Nine survey respondents were concerned about the stigma that is caused or perpetuated by placing methadone treatment into a separate category that is outside of the general scope of practice. This stigma impacts both the providers, by identifying them as a methadone treatment provider, and the patients, who must seek a licensed provider instead of being able to receive care from their family physician.
Other barriers to treatment access that were frequently mentioned related to the administrative burden of applying for the exemption (33 responses) and the resulting delays to the patient for receiving care (18 responses). Participants described the bureaucratic requirements associated with the application as “rigid” and “discouraging” and commented that they needed administrative support to help manage the multiple application steps. Participants also expressed concern over the lag time between sending the application to Health Canada and receiving the exemption, stating that this wait causes an unnecessary delay for patients. A few responses (10) indicated dissatisfaction with the training requirements, noting the expense, burden, and time commitment required for completion, which can cause physicians to miss their normal clinic hours.
An additional finding from the online survey was that some participants (19 responses) equated the federal s.56 exemption process with the provincial requirements created by the regulatory Colleges. However, the majority of respondents seemed to understand the distinction between the provincial programs and the federal mandate. Acknowledging that the federal exemption is an administrative step, some responses (13) described s.56 as having “no added value” and simply a “rubber stamp.” Despite the understanding of the s.56 mandate, it was difficult to determine whether the barriers identified (e.g., paperwork and delays) were caused by the provincial or federal process, as the two are inextricably linked in their current form.
“I have not observed any value in the federal regulation. It is void of purpose; aside from being an artificial impediment to access. Governance of professional practices should be deferred to provincial Colleges mandated to govern regulated health professionals.” -Survey respondent
Benefits to removal of s.56 exemption
Corresponding with the barriers and challenges described above, almost 70% of participants (100) viewed the removal of the s.56 exemption requirement as a beneficial step. A majority of participants (73) believed that the major benefit would be expanded access to methadone treatment due to an increased number of prescribers. Several of these comments highlighted the benefits of methadone treatment being provided in primary care; family physicians are abundant and accessible, thereby potentially decreasing wait times and increasing ease of access for patients. Moreover, a growing number of provinces allow nurses to prescribe methadone, which may be particularly impactful in rural areas where licensed methadone providers are sparse. Along the same lines, some respondents indicated that removing the s.56 exemption would “normalize” methadone and treat it similarly to other treatments for opioid use disorder (12 responses) and would serve to decrease the stigma attached to substance use treatment (21 responses).
“BENEFITS: I think that there would be less concern for practitioners to become involved in Opiate Agonist Therapy, that addiction management would have less stigma and be seen as more a part of mainstream medicine (just as depression and anxiety management are). It may be more easy to engage primary care physicians in this area of medicine, and the current crisis needs all physicians to be of some help.” -Survey respondent
In addition, 20 survey respondents felt that reducing the administrative burdens and paperwork would be beneficial for both providers and patients, as this would lead to simplification of the process and remove the delays in providing treatment. Consistent with this suggestion, several provincial regulatory Colleges have already resolved the issue of the delay between the time the provider’s application is sent to Health Canada and the receipt of the exemption certificate by authorizing the provider to prescribe methadone as soon as requirements are completed.
Confirming evidence for the results reported above was obtained during the follow-up teleconference meetings. Specifically, meeting participants from several provinces described the s.56 exemption as an unneeded step and stated that they intended to keep training requirements and regulatory mechanisms in place if the s.56 exemption was eliminated (only the Northwest Territories anticipated that they may recommend, but not require, prescribers to obtain education). In this scenario, education, monitoring, and prescribing regulations may still be controlled by the P/T Colleges or other regional authorities in the provinces where such mechanisms already exist. Teleconference participants from most P/T supported the elimination of the s.56 exemption requirement, while some were indifferent, on their interpretation that this would not impact current oversight practices.
Participants from Ontario were an exception, highlighting that the regulatory College does not monitor or oversee prescribing physicians. Thus, if s.56 did not exist, the College of Physicians and Surgeons would have difficulty enforcing the educational requirements and would need to establish new mechanisms to regulate methadone prescribing. As such, most Ontario teleconference participants did not support the removal of the s.56 exemption without additional mechanisms to provide training and ensure safety due to the potential risks of inappropriate prescribing and patient harms that may occur if untrained physicians gain access to methadone provision. Furthermore, participants from Québec explained that regulatory bodies do not currently have a surveillance and monitoring system for methadone prescribers but they would encourage this development if s.56 was eliminated.
“Methadone is a highly dangerous medication, and its use by those who are not well-versed with its risks and benefits poses enormous risks to patients and the population in general. The federal requirement is unhelpful and redundant, BUT a local authorization (through the College of Physicians and Surgeons or similar bodies) is definitely necessary.” -Survey respondent
Potential repercussions from removal of s.56 exemption
Several of the participants (32) noted the potential for both benefits and negative repercussions, while an additional 20 people commented only on the possible negative outcomes following removal of the s.56 exemption requirement. The most common repercussions identified by these responses were the risks of diversion and harms such as overdose and death (26) and the potential for lower quality of care and providers not adhering to guidelines and standards of practice for methadone treatment (22). These participants noted that the negative outcomes could result if a large number of providers begin prescribing methadone without adequate training and a proper understanding of its pharmacodynamics and common patient care challenges. However, concerns about inappropriate prescribing and monitoring would be mitigated if training and oversight remained mandatory. Indeed, given the potential to improve training and oversight, the removal of the s.56 requirement could be accompanied by federal guidance and support for provincial efforts in this area. As mentioned above, representatives of P/T Colleges from many provinces stated that they would retain the existing regulatory procedures for methadone through the ability to authorize prescribers and therefore, these increased risks are not likely to occur.
“The only argument to keeping the exemption is the recognition that methadone is a toxic drug that is a leading cause of opioid overdose death in [redacted]. However, provincial oversight of all opioid prescribing over a certain threshold would mitigate this potential harm, along with the requirement that, like all prescribing, the methadone provider should ensure competency to prescribe the medication.” -Survey respondent
Additional barriers to methadone treatment
Through the survey and teleconferences, participants highlighted other barriers to methadone treatment that are not directly related to the s.56 exemption. The rigid structure for daily witnessing and allowance of take-home carries was cited by ten survey participants and by teleconference participants in six jurisdictions as a major impediment for patients. As noted earlier, the requirement to travel to a pharmacy daily places a large burden on patients, especially in rural and remote communities. Alternative delivery and witnessing models were suggested, including allowing delegates or nurse practitioners to deliver the methadone dose and/or witness the dose. This would require changes to the existing federal and provincial regulations that currently limit who can provide these services (i.e., only physicians and pharmacists). Moreover, ten survey participants noted particularly large challenges that Indigenous communities face in accessing treatment, which result from the distance between the community and a pharmacy or physician, the insufficient support for daily travel, the disconnect between the physician and the community’s governance, lack of cultural safety training, and inadequate facilities for the safe storage of take-home doses. Some called for the federal government to address these types of barriers to methadone treatment delivery and work to improve access in rural, remote, and First Nations communities, as current regulations create impediments to providing appropriate and accessible services for these patients. Furthermore, participants noted that buprenorphine is less stringent in the requirements for take-home dosing; greater access to and uptake of this medication would ease some of the barriers to treatment.
In addition, 13 survey responses and additional teleconference participants mentioned that sufficient resources and funding to provide opioid agonist treatment services are not available. Examples of needed improvements include: physician billing codes that allow the physician to spend an adequate amount of time with each patient and to administer screenings and other tests; support and mentorship through a prescriber network or consultation service; resources and staffing to provide comprehensive, wrap-around care; financial support for taking the required methadone courses and additional training in non-pharmacological approaches; and funding or coverage for the medications.
Other considerations
One-third of survey participants (48) agreed that training and education on the safe provision of methadone treatment are needed before a provider begins prescribing, due to its unique pharmacodynamics and vulnerabilities that are common in patients with opioid use disorder. Specifically, the long half-life creates challenges for titration to an effective dose and therefore, methadone must be initiated and monitored carefully to avoid the relatively high risk of overdose and death during the induction phase. The narrow therapeutic window conveys high risks for patients and opioid-naïve persons, leading many to feel that prescriber training, regulation, and oversight are necessary for patient safety. Participants recommended that regulatory authority remain with the P/T Colleges, rather than the federal government, as the P/T bodies are best positioned to manage and respond to their own regional needs.
Eighteen survey responses and participants in five regional teleconferences suggested that the federal government could have a role in ensuring that the training, education, and standards and guidelines for practice are consistent across Canada. Currently, the training requirements vary considerably by P/T, as do the standards for dosing and take-home scheduling. Participants felt that physicians and patients would benefit from standardization of these practices, though these efforts would need to be led by P/T regulatory bodies.
Another theme identified from the data sources was the illogical and hypocritical nature of having a federal exemption for methadone, while similar policies do not exist for other opioid medications (24 responses). Some of these responses explained further that singling out methadone treatment in this way “perpetuates stereotypes around patients” and “sets an expectation that patients requiring methadone are of greater complexity.” Survey and teleconference participants explained that other available medications can be dangerous to patients and do not require training or education in order to prescribe them. However, while the standard education received during the stages of general medical training presumably covers the safe use and management of such medications, education on opioids and other treatments for substance use is particularly lacking. Some called for more comprehensive addiction medicine training to be included in medical curricula, which could be included in residency training programs and through the development of interdisciplinary fellowships.
“It remains unclear at this time what benefit comes from having the exemption requirement in place especially when it only involves methadone and is not required for other OAT options.” -Survey respondent
Lastly, participants suggested that the federal government address barriers to accessing other treatments for opioid use disorder (21), including buprenorphine and injectable forms of opioid agonist treatment, such as diacetylmorphine and hydromorphone. For buprenorphine, one barrier to access in certain provinces is the requirement to obtain a methadone exemption in order to prescribe buprenorphine.
Recommendation and additional considerations
Based on the input received from the survey and the teleconferences, the following suggestions for Health Canada were developed to increase access to methadone and other forms of treatment for opioid use disorder:
Main Recommendation
Consider eliminating the requirement for practitioners to obtain a s.56 exemption and support regional authorities in regulating authorization and monitoring prescriptions.
At the federal level, this would normalize the regulation of methadone, treating it similarly (from a regulatory perspective) to other opioid medications. As some P/T do not have a robust regulatory oversight system in place already, Health Canada could support those jurisdictions by providing guidance around surveillance and monitoring systems.
Additional considerations to improve access to high-quality care:
Support P/T in adopting evidence-based and accessible training, guidelines, and standards of practice for methadone prescribing.
Health Canada could support P/T in setting a minimum standard for training and education to prescribe methadone, help ensure that training is evidence-based, and promote accessibility of educational resources. Health Canada could support or help facilitate consultations with P/T stakeholders to discuss improving consistency in the required coursework and prescribing guidelines across Canada.
Support increased access to all evidence-based opioid agonist therapies.
Some provinces (Saskatchewan and Manitoba) require a s.56 exemption in order to prescribe buprenorphine, an opioid agonist therapy with a superior safety profile compared to methadone, allowing take-home dosing for buprenorphine to be more flexible and started earlier than methadone. Removing the restrictions on buprenorphine would increase access to treatment by allowing a greater number of primary care physicians to prescribe this medication and by easing the travel and witnessing burdens on patients. As a major step towards increasing treatment access and improving safety, the forthcoming CRISM National Guideline for the Clinical Management of Opioid Use Disorder recommends buprenorphine as the preferred first-line therapy. In addition, barriers to access and restrictions on other forms of opioid agonist therapies (including diacetylmorphine and hydromorphone) has led to major gaps in care, especially for patients who were not successful with methadone or buprenorphine. Health Canada could support the removal of such barriers in order to make these treatments more widely available.
Support the development of education and regulatory pathways to allow nurse practitioners to prescribe methadone.
Health Canada could encourage and help facilitate the nursing regulatory bodies and relevant educational structures to develop application processes and evidence-based education for nurses to prescribe opioid agonist therapies. Increasing the scope of practice for nurses with the appropriate training and competencies would greatly improve access to treatment for patients with opioid use disorder.
Address barriers to access in rural, remote, and Indigenous communities.
While the s.56 exemption may pose some barriers to potential methadone prescribers (contributing to limited access to methadone), the lack of resources and services present major challenges in rural and remote areas, including Indigenous communities. Access to opioid agonist treatment in these areas can be facilitated through alternative delivery models. Health Canada should facilitate policy changes federally and in each P/T to allow for safe delivery and witnessing models, performed by nurses or delegates that can improve access while also limiting the potential for diversion. In Ontario, a delivery model where the pharmacist may transfer custody of individual doses to a physician delegate for subsequent administration to the patient is being piloted, and would serve to benefit other regions if similar programs were adopted. In addition, support for telehealth and mobile services would alleviate time and cost burdens associated with traveling great distances to the nearest prescriber. Finally, supports for the safe storage and handling of methadone and buprenorphine in Indigenous communities are needed in order to facilitate take-home dosing.
Support access to high-quality care by providing resources for prescribers and patients.
Providers urged Health Canada to support the development of provincial networks to improve access to knowledge for those providing care to patients with substance use disorder. These networks are critical for mentorship and providing consultation for challenging activities (e.g., buprenorphine induction) or cases. Building a community of practice promotes consistency and elevates standards of care. Further, resources and staffing are needed to promote medication coverage for patients, to allow comprehensive, wrap-around care, and to participate in training.
Summary
With the growing numbers of persons with opioid disorder in Canada, the demand for evidence-based treatment and access to services is increasing. Thus, all jurisdictions need to expand access to evidence-based treatments for opioid use disorder and address barriers faced by health care providers and patients. Historically, methadone treatment has been subject to federal regulation since the 1960’s and is currently restricted to prescribers who hold a section 56 exemption under the Controlled Drugs and Substances Act. Canadian provinces and territories are responsible for the oversight and monitoring of methadone treatment and have either developed or adopted educational modules and training requirements to support prescribers in the safe use and delivery of methadone treatment. Many consultation participants from all regions felt that appropriate and accessible training is invaluable in order to prevent harms from unsafe prescribing such as overdose and death. Participants stated that the potential for diversion and misuse of methadone should be balanced with the need to provide effective and accessible treatment. Thus, participants from most provinces and territories supported the removal of the section 56 exemption due its administrative burden and lack of added value, under the conditions that the mandate for training, monitoring, and surveillance programs remain or be created through regional authorities.
Through this consultation, participants recommended additional steps for removing barriers and improving access to high-quality opioid addiction care. Supporting evidence-based education and prescribing standards would improve quality of care and promote consistency in practice. In addition, regulations that create barriers to all opioid agonist therapies should be reviewed, including the requirement in certain provinces for a s.56 exemption to prescribe buprenorphine and restrictions on providing diacetylmorphine and hydromorphone. Support for nurses to provide addiction care through the development of training resources and regulatory pathways to authorize prescribing would increase the number of care providers accessible to the patient population. Furthermore, residents of under-resourced areas, such as rural, remote, and Indigenous communities, face substantial challenges in obtaining methadone treatment. Alternative delivery and administration models, through nurses or other delegates, would serve to ease the burdens of these patients who are located far from physicians and pharmacies. Finally, providers expressed the need for increased support for providing comprehensive care and for mentorship from experienced prescribers, through staffing, funding for training, and consult services, in order to improve their own practices and ensure patient safety. Overall, the suggestions provided by participants across Canada are designed to balance the need for patient safety and the need for accessibility.
Appendix 1: Provincial educational and training requirements to prescribe methadone and buprenorphine for opioid use disorder
Methadone
For all provinces, the requirements to obtain and maintain authorization to prescribe
methadone for opioid use disorder are:
- Licensed to practice medicine and in good standing with the provincial regulatory college
- Where applicable, licensed as nurse practitioner and in good standing with the provincial regulatory college
- Obtained a Section 56 methadone exemption from Health Canada, and have the exemption endorsed by the provincial regulatory college
- In Quebec, British Columbia, Alberta, Manitoba, and Ontario, practitioners may obtain a methadone exemption by contacting their provincial licensing authority directly
- The initial exemption is issued for one year, with subsequent exemptions issued every three years
| ProvinceFootnote * | Education and Practice Requirements |
|---|---|
British |
|
Alberta |
|
Saskatchewan |
Similar to education and practice requirements for Alberta, with the following distinctions:
|
Manitoba |
Note: in Manitoba, nurse practitioners may also obtain an exemption to prescribe methadone if they fulfill the requirements below:
Before the Section 56 exemption period expires, practitioners must submit a renewal application specifying education and practice completed to maintain methadone prescribing competency |
Ontario |
Nurse practitioners must complete approved education for controlled substances and may only prescribe methadone on a continuation basis, only in hospital settings |
Quebec |
|
New |
Nurse practitioners:
|
Nova Scotia |
Nurse practitioners:
|
Prince |
|
Newfoundland and Labrador |
|
| ProvinceFootnote * | Education and Practice Requirements |
|---|---|
British |
Nurse practitioners:
|
Alberta |
Nurse practitioners:
|
Saskatchewan |
|
Manitoba |
Nurse practitioners:
|
Ontario |
Nurse practitioners:
|
Quebec |
|
New |
Nurse practitioners:
|
Nova Scotia |
Nurse practitioners:
|
Prince |
|
Newfoundland and Labrador |
|
Appendix 2: List of organizations contacted
| Organization | Region |
|---|---|
| ACT Medical Clinics | Alberta |
| Alberta Addicts Who Educate And Advocate Responsibly | Alberta |
| Alberta College of Pharmacists | Alberta |
| Alberta Dental Association and College | Alberta |
| Alberta Health | Alberta |
| Alberta Health Services | Alberta |
| Alberta Medical Association | Alberta |
| Boyle McCauley Health Centre | Alberta |
| Calgary Urban Project Society | Alberta |
| College and Association of Registered Nurses of Alberta | Alberta |
| College of Physicians and Surgeons of Alberta | Alberta |
| Health Upwardly Mobile | Alberta |
| HIV Community Link | Alberta |
| Inner City Health and Wellness Program | Alberta |
| Opioid Dependency Program | Alberta |
| Safeworks | Alberta |
| Streetworks | Alberta |
| The Addiction Recovery & Community Health Team | Alberta |
| University of Alberta | Alberta |
| AIDS Network Kootenay Outreach and Support Society / Rural Empowered Drug Users Network | British Columbia |
| BC Association of People on Methadone | British Columbia |
| British Columbia Centre on Substance Use | British Columbia |
| British Columbia Ministry of Health | British Columbia |
| British Columbia Nurse Practitioner Association | British Columbia |
| British Columbia Pharmacy Association | British Columbia |
| Centre for Addictions Research of British Columbia | British Columbia |
| College of Pharmacists of British Columbia | British Columbia |
| College of Physicians and Surgeons of British Columbia | British Columbia |
| College of Registered Nurses of British Columbia | British Columbia |
| Doctors of British Columbia | British Columbia |
| First Nations Health Authority | British Columbia |
| Fraser Health Authority | British Columbia |
| Interior Health Authority | British Columbia |
| Island Health Authority | British Columbia |
| Northern Health Authority | British Columbia |
| Portland Hotel Society | British Columbia |
| Providence Health Care | British Columbia |
| Surrey Area Network of Drug Users | British Columbia |
| Vancouver Area Network of Drug Users | British Columbia |
| Vancouver Coastal Health Authority | British Columbia |
| Western Aboriginal Harm Reduction Society | British Columbia |
| 595 Prevention Team / Manitoba Harm Reduction Network | Manitoba |
| Addictions Foundation of Manitoba | Manitoba |
| College of Pharmacists of Manitoba | Manitoba |
| College of Physicians and Surgeons of Manitoba | Manitoba |
| College of Registered Nurses of Manitoba | Manitoba |
| Manitoba Area Network of Drug Users | Manitoba |
| Manitoba Dental Association | Manitoba |
| Manitoba Health, Seniors and Active Living | Manitoba |
| Northern Region Health Authority | Manitoba |
| Winnipeg Regional Health Authority | Manitoba |
| Assembly of First Nations | National |
| Canadian Association of People Who Use Drugs | National |
| Canadian Indigenous Nurses Association | National |
| Correctional Service Canada | National |
| Department of National Defense | National |
| Health Canada, First Nations and Inuit Health Branch | National |
| Indigenous Physician Association of Canada | National |
| Inuit Tapiriit Kanatami | National |
| Moms Stop the Harm | National |
| moms united and mandated to saving Drug Users | National |
| Thunderbird Partnership Foundation | National |
| Veterans Affairs Canada | National |
| College of Physicians and Surgeons of New Brunswick | New Brunswick |
| Department of Health | New Brunswick |
| New Brunswick College of Pharmacists | New Brunswick |
| Nurses Association of New Brunswick | New Brunswick |
| St. John Regional Hospital | New Brunswick |
| College of Physicians and Surgeons of Newfoundland | Newfoundland and Labrador |
| Department of Health and Community Services | Newfoundland and Labrador |
| Eastern Health Authority | Newfoundland and Labrador |
| Newfoundland and Labrador Pharmacy Board | Newfoundland and Labrador |
| Government of Northwest Territories, Health and Social Services | Northwest Territories |
| Yellowknife Primary Care Clinic | Northwest Territories |
| College of Physicians and Surgeons of Nova Scotia | Nova Scotia |
| College of Registered Nurses of Nova Scotia | Nova Scotia |
| Halifax Area Network of Drug Using People | Nova Scotia |
| Nova Scotia College of Pharmacists | Nova Scotia |
| Nova Scotia Department of Health and Wellness | Nova Scotia |
| Nova Scotia Health Authority | Nova Scotia |
| Government of Nunavut, Department of Health | Nunavut |
| Addictions and Mental Health Ontario | Ontario |
| Centre for Addiction and Mental Health | Ontario |
| Centre for Addiction and Mental Health: Strengthening Your Voice | Ontario |
| College of Nurses of Ontario | Ontario |
| College of Physicians and Surgeons of Ontario | Ontario |
| Drug User Advocacy League | Ontario |
| Health Quality Ontario | Ontario |
| Nurse Practitioners’ Association of Ontario | Ontario |
| Ontario College of Family Physicians (OCFP) | Ontario |
| Ontario College of Pharmacists | Ontario |
| Ontario Drug Policy Research Centre | Ontario |
| Ontario Medical Association | Ontario |
| Ontario Ministry of Health and Long-Term Care | Ontario |
| Participatory Research in Ottawa: Understanding Drugs | Ontario |
| Public Health Ontario | Ontario |
| Registered Nurses Association of Ontario | Ontario |
| Royal College of Dental Surgeons of Ontario | Ontario |
| Sandy Hill Community Health Centre | Ontario |
| Sioux Lookout Meno Ya Win Health Centre | Ontario |
| St. Joseph’s Health Centre | Ontario |
| St. Michael’s Hospital | Ontario |
| Toronto Drug Users Union | Ontario |
| University of Toronto | Ontario |
| Women’s College Hospital | Ontario |
| Health Prince Edward Island | Prince Edward Island |
| Prince Edward Island College of Pharmacists | Prince Edward Island |
| Association québécoise de la douleur chronique | Quebec |
| Association québécoise pour la promotion de la santé des personnes utilisatrices de drogues | Quebec |
| Collège des médecins du Québec | Quebec |
| Comité des usagers du Centre de réadaptation en dépendance de Montréal - Institut universitaire | Quebec |
| Direction régionale de santé publique du Centre-Sud-de-l'Île-de-Montréal | Quebec |
| Meta d’Ame | Quebec |
| Ministère de la Santé et des Services sociaux du Québec | Quebec |
| Ordre des dentistes du Québec | Quebec |
| Ordre des infirmières et des infirmiers du Québec | Quebec |
| Ordre des pharmaciens du Québec | Quebec |
| Université de Montréal | Quebec |
| College of Dental Surgeons of Saskatchewan | Saskatchewan |
| College of Physicians and Surgeons of Saskatchewan | Saskatchewan |
| Saskatchewan College of Pharmacy Professionals | Saskatchewan |
| Saskatchewan Ministry of Health | Saskatchewan |
| Saskatchewan Registered Nurses Association | Saskatchewan |
| Saskatoon Health Region | Saskatchewan |
| Substance Abuse Services Center | Saskatchewan |
| University of Saskatchewan | Saskatchewan |
| Government of Yukon, Health and Social Services | Yukon |
| Government of Yukon, Tourism and Culture | Yukon |
| Government of Yukon, Yukon Medical Council | Yukon |
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