Guidance on Opioid Use Disorder (OAT) Program: August 16, 2021

This document outlines best practices consistent with the Canadian Research Initiative in Substance Misuse (CRISM) National Guideline for the Clinical Management of Opioid Use Disorder^{Footnote 1}. The goals of this document will be supported by an Implementation Plan addressing the resources to meet the clinical standards; an educational plan for the healthcare and operational teams; and an organization wide education initiative to address stigma related to substance use disorders. In addition, Correctional Service Canada (CSC) will actively work to cultivate partnerships with community organizations and providers to facilitate transitions into the community.

CSC introduced methadone over 20 years ago, and since that time, there have been several revisions to the guideline. This review and revision, is occurring in the context of a Canadian opioid crisis.

Opioid use disorder (OUD) is a recognised disease requiring therapeutic intervention. There is strong evidence that Opioid Agonist Treatment (OAT) (with buprenorphine-naloxone as the preferred first-line treatment for OUD) leads to reduction or cessation of illicit opioid use and can allow for patients to achieve sustained long-term remission. OAT is also effective in reducing the risk of HIV and hepatitis C infections among people who inject drugs and decreasing the harm associated with opioid use in prison and the likelihood of substance use upon return to the community.

Improvements in psychosocial stability and reduced use of illicit opioids and associated drug-related harms tend to occur after at least three months of OAT, with maximum benefits gained after at least one year of continuous OAT^{Footnote 2}. Longer-term OAT (longer than one year) is associated with better sustained outcomes, including an increased likelihood of abstinence from illicit opioids and increased stability, compared to shorter time receiving OAT^{Footnote 3}. A 30-year follow up of participants in a community methadone program found that participants who had achieved abstinence from illicit opioids had been receiving OAT for an average of five to eight years^{Footnote 4}.

This Guidance document provides policy direction for OAT in CSC.

Effective OAT incorporates physical and mental health care and harm reduction delivered in an integrated fashion (not provided sequentially). For example, care includes provider-led counselling, substance use monitoring, provision of comprehensive primary care, harm reduction, the assessment and monitoring of emotional and mental health, and offering of psychosocial treatment interventions and supports. In addition, there are several contextual factors essential to an OAT program in a correctional setting that will be adopted by all health care staff:

Ongoing OAT prescribing will be based on evidence of the patient benefiting from the medication itself. This can manifest as a reduction in illicit opioid use, improved engagement in addiction treatment or other markers of stability (e.g., re-establishing contact with family/friends, employment, etc.). The priority is to keep patients engaged in care.

The 4 pillars of the Canadian drug and substances strategy^{Footnote 5} recognize the importance of Prevention, Treatment, Harm reduction and Enforcement. Enforcement includes addressing illicit drug production, supply and distribution. An effective response to substance use requires valuing and respecting the co-existence of the strategies of treatment / harm reduction and enforcement.

The operationalization of treatment, harm reduction, and enforcement must take into consideration the challenge of dual loyalties for health care professionals^{Footnote 6} (See Appendix I). The United Nations Standard Minimum Rules for the Treatment of Prisoners^{Footnote 7} (the Nelson Mandela Rules), which CSC healthcare providers will follow, clarify the issue of dual loyalty by stating that "Health-care personnel shall not have any role in the imposition of disciplinary sanctions or other restrictive measures," and require "confidentiality of medical information, unless maintaining such confidentiality would result in a real and imminent threat to the patient or to others." The Mandela Rules also state that "Clinical decisions may only be taken by the responsible health-care professionals and may not be over-ruled or ignored by non-medical prison staff."

Maintaining clinical independence (undivided loyalty to the patient's care) is critical to the provision of effective health care. Revisions to the Corrections and Conditional Release Act (CCRA), Bill C-83^{Footnote 8} mandate and support professional autonomy and clinical independence. In particular, Section 86.1 of the CCRA states "when health care is provided to inmates, the Service Shall (a) support the professional autonomy and the clinical independence of registered health care professionals and their freedom to exercise, without undue influence, their professional judgment in the care and treatment of inmates; (b) support those registered health care professionals in their promotion, in accordance with their respective professional code of ethics, of patient-centred care and patient advocacy; and (c) promote decision-making that is based on the appropriate medical care, dental care and mental health care criteria."

A recovery orientation recognizes that recovery is a non-linear process, and as such, individuals receiving OAT are not "fired" or penalized for not achieving treatment goals or for relapsing to substance use^{Footnote 9}. OAT is an effective treatment for OUD with literature evidence demonstrating its success in reducing the use of illicit opioids and improving retention in addiction treatment.

One of the barriers to treating OUD, other substances use disorders, and accepting and adopting a harm reduction approach is the stigma associated with substance use. Stigma, negative attitudes and beliefs, prejudices, about a group of people due to their circumstances in life, leads to discrimination, judging, labeling, isolating and stereotyping can prevent people from seeking help for their addiction. Stigma can impact care on three levels:

1. Structural: e.g. withholding health or other services until substance use is better managed;
2. Social: e.g. negative attitudes, labels, language used pertaining to people who have a substance use disorder; and
3. Self: e.g. the individual takes the negative messages people ascribe to those who use drugs and apply them to themselves.

The language that we use everyday shapes our understanding of the world around us. It influences how people feel about themselves as well as how they are perceived by others. Using certain words, even in ways that are well-intentioned, can lead to stigma and further health disparities. Changing our language can lead to more autonomy, respect, understanding, and empathy.^{Footnote 10} For CSC, reducing stigma means changing how we talk about substance use and adopting a model where individuals feel supported and safe to receive harm reduction and/or addiction treatment and are provided with ongoing hope and support.

Trauma informed care^{Footnote 11} acknowledges the interconnections between traumas (e.g., adverse childhood experiences, violence and exposure to violence, abuse, neglect, etc.), mental health concerns and substance use disorder and the need for these factors to be addressed in an integrated manner. According to the Canadian Centre on Substance Use and Addictions (2014), trauma informed services "create a treatment culture of nonviolence, learning and collaboration…"Services are provided in ways that recognize needs for physical and emotional safety, as well as choice and control in decisions affecting one's treatment. In trauma-informed services, there is attention in policies, practices and staff relational approaches to safety and empowerment for the service user. Safety is created in every interaction and confrontational approaches are avoided."

Care providers should be aware of the historical context of the lives of Indigenous people in Canada and be sensitive to the impacts of intergenerational trauma and the physical, mental, emotional, and social harms experienced by Indigenous people¹¹. Similarly, culturally appropriate care requires an awareness of the experience of other racialized groups.^{Footnote 12}

1. Opioid use disorder is a chronic medical condition and patients often struggle in reducing illicit opioid or other drug use or re-occurrence during treatment.
2. People with opioid use disorder should receive services that are respectful of their rights and dignity.
3. A focus on treatment and development of holistic care plan.
4. Patients with an opioid use disorder often have a history of trauma or co-occurring mental health concerns and therefore require trauma-informed care.
5. Adherence to treatment increases and illicit opioid use decreases when patients are involved in setting goals for treatment (person centred care).
6. OAT plays an important role in reducing illicit opioid use and improving retention in addiction treatment
7. OAT plays an important role in managing the spread of infectious diseases.
8. Psychosocial treatment interventions and supports should be routinely offered.
9. The program should include planned follow-up meetings with a team.
10. The treatment team should provide culturally safe care.

To be eligible for OAT, patients must meet DSM-5 criteria for opioid use disorder. The processes described in this document do not replace the CRISM National Guideline for the Clinical Management of Opioid Use Disorder, but rather provide additional specification for its application in CSC settings.

Physicians and nurse practitioners are expected to follow the clinical practice guidance described in the CRISM National Guideline for the Clinical Management of Opioid Use Disorder.

1. Clients admitted to Correctional Service Canada in opioid withdrawal should start OAT on the day of admission. Of greatest risk are clients admitted to Temporary Detention directly from the community. Overdose risk is highest within the first 48 hours of intake
2. Once the nurse has confirmed the client:
   1. has an opioid use disorder, which can be assessed using the OAT Medical Assessment Form (eForm);
   2. has completed a urine drug test
      1. please note: a positive opioid urine drug test is not required to start a patient on OAT.
      2. in some cases, a client may not be able to provide a urine sample. Starting OAT in these cases will be a clinical decision.
   3. has consented to OAT.
3. The intake nurse should call the Institutional Physician/Physician On-Call to initiate buprenorphine/naloxone on the day of admission:
   1. Methadone is considered second line for OAT and cannot be inducted without physician/nurse practitioner examination. Pregnant clients who are currently using opioids or were previously using opioids and are at high risk of relapse should start OAT as soon as possible. Pregnant clients in opioid withdrawal should start OAT to prevent harm to the fetus.
   2. Buprenorphine/naloxone and methadone are both considered first line for OAT in pregnancy. Pregnant clients in opioid withdrawal can be inducted on methadone without physician/nurse practitioner examination if there is a risk of precipitated withdrawal with buprenorphine/naloxone or the client prefers methadone.
      • British Columbia Centre on Substance Use (BCCSU) Guideline for the Clinical Management of Opioid Use Disorder: Pregnancy Guideline Supplement^{Endnote i}.
   3. Clients who are currently using opioids or who were previously using opioids and are at high risk of relapse should start OAT as soon as possible.
   4. Clients with a history of non-fatal opioid overdose in the past 30 days recent history of non-fatal opioid overdose or medical/psychiatric complications of opioid use disorder should be seen in person or by telemedicine by the physician/nurse practitioner as soon as possible and no later than 3 days.
4. Patient with urgent criteria for OAT will be seen by the physician/nurse practitioner in person or by telemedicine as soon as possible and no later than 3 days.

1. In consultation with a physician or nurse practitioner, unless specifically directed otherwise, individuals already on OAT will be continued on OAT, without interruption.
2. The individual must be seen and assessed by the nurse within 24 hours of arrival:
   1. The nurse completes the medication-reconciliation process;
   2. Consults the physician/nurse practitioner who reviews the patient's OAT medication and authorizes continuation of the OAT treatment and other medications based on available transfer documents & the nurse's assessment.
3. The individual will be seen by a physician/nurse practitioner in person or by telemedicine at the next available clinic but no later than 7 days after arrival.
4. All individuals will be offered holistic integrated primary health care, psychosocial^{Footnote 13} support, OAT and other treatment interventions if necessary, within 15 days of a nursing assessment.

1. A nursing assessment will be conducted within 7 days of receiving a request. The OAT Medical Assessment Form (eForm) will be completed by the Nurse.
2. The institutional physician or nurse practitioner will assess individuals, within 7 days, after the nursing assessment is completed.
3. Medication will be initiated after the individual has been assessed by the institutional physician/nurse practitioner and approved for OAT.
   1. Buprenorphine/naloxone will be initiated within a day of being assessed.
   2. Methadone will be initiated on the next business day from being assessed.
4. All individuals will be offered psychosocial support, OAT and other treatment interventions if necessary, within 15 days of a nursing assessment.

1. Practitioners should follow the provincial protocols as indicated in the Canadian Research Initiative in Substance Misuse (CRISM), National Guideline for the Clinical Management of Opioid Use Disorder.

1. The Treatment Team will consist of the patient, OAT Nurse, OAT prescriber, and related health care professionals (e.g. clinic nurse, mental health provider, etc.) involved in the patient's care. The OAT Prescriber is the team lead. The OAT Nurse coordinates with the team to develop the treatment plan and communicate any changes. This team exists virtually but can meet in person as needed to review significant issues or concerns. If the patient consents the Treatment Team will also include the Institutional Parole Officer, Social Program Officer (as required), Aboriginal Liaison Officer (as required), and consultation with the Elder (as required).
2. The most responsible nurse provider (OAT nurse) will support an individualized integrated treatment plan developed by the members of the team, in collaboration with the patient. The integrated individualized treatment plan will outline all relevant aspects of the patients needs and specify the role of each member of the team and the role of the patient in addressing the plan.
3. Role of the Parole Officer:
   1. The provision of OAT is a health care function and confidential. The patient, on their own initiative, may inform the Parole Officer of their wish to discuss their opioid agonist treatment.
   2. If the patient consents, the Parole Officer may be involved in OAT discharge planning.
4. The most responsible nurse will coordinate Treatment Team meetings.
5. Treatment Team meetings will be scheduled as follows:
   1. For all individuals, within 30 days of being prescribed OAT within CSC;
   2. When a significant issue or concern has arisen for the patient on OAT;
   3. To discuss complex cases monthly, or as defined in the treatment plan;
   4. For all participants in the program, 6 months prior to their release or as soon as a release notification is received for those in custody less than 6 months;
   5. Any member of the team, including the patient may request a team meeting.

• Providers are expected to be aware of the requirements of their provincial regulatory body. If the provincial regulatory body requirements are more stringent than the requirements in this document, the provider is expected to follow the directions of their provincial regulatory body.
• The physician/nurse practitioner assessment and induction including history, examination, investigation and documentation, including the treatment contract with the patient, should comply with the provincial regulatory body requirements and the National Guideline for Clinical Management of Opioid Use Disorder. It is important during the assessment to review the mental health history, screen for mental health symptoms and evaluate suicide risk, including requesting psychiatric or psychological consultation if indicated.

• The nurse will schedule follow-up appointments and tests at the direction of the primary care physician / nurse practitioner. These appointments/tests will be scheduled based on the prescriber's provincial regulatory body requirements

• The nurse will schedule follow-up appointments and tests at the direction of the institutional physician / nurse practitioner. These appointments/tests will be scheduled based on the prescriber's provincial regulatory body requirements.

• CSC offers methadone, buprenorphine/naloxone (tablet and film) and buprenorphine extended-release, a monthly injection. The Canadian Research Initiative in Substance Misuse (CRISM), National Guideline for the clinical management of opioid use disorder strongly endorses opioid agonist treatment (OAT) with buprenorphine/naloxone or buprenorphine extended-release (Sublocade) as the preferred first-line treatment when possible. "This is in view of buprenorphine considerable advantages, including a safety profile that is superior to that of methadone. However, this guideline recommends the use of methadone as a first-line therapy when buprenorphine/naloxone or buprenorphine extended-release are contraindicated, and supports the use of methadone as a second-line option when buprenorphine/naloxone or buprenorphine extended–release treatment proves to have limitations or is ineffective.
• Admissions from provincial corrections or the community who are on intravenous opioid agonist treatment (iOAT) should be discussed with the physician/nurse practitioner involved in care before transfer to CSC. A plan to transition the patient from iOAT to methadone should be developed in conjunction with a specialist in addiction medicine. Refer to the BCCSU Guidance for Injectable Opioid Agonist Treatment for Opioid Use Disorder: Conversion Table^{Footnote 14}. See Appendix V
• The efficacy of Slow release oral morphine (SROM) is similar to methadone, and evidence for SROM as OAT still emerging. Admissions from provincial corrections or the community who are on slow release oral morphine opioid agonist treatment should be discussed with the physician/nurse practitioner involved in care before transfer to CSC and collateral information on OAT history provided. The decision to transition a patient from SROM to methadone or buprenorphine/naloxone, taking into account the benefits and risks, will be developed on a case by case basis in conjunction with a specialist in addiction medicine. Refer to the BCCSU Guidance for Injectable Opioid Agonist Treatment for Opioid Use Disorder: Conversion Table. See Appendix V

• The administration of OAT medication is a health care clinical activity while post-administration observation to prevent the diversion of medication is a security activity that falls under the responsibility and direction of the Institutional Head.
• Administration process (observed dosing) for methadone: To verify the ingestion of methadone, the nurse must:
  1. Ensure that the patient ingests the entire dose of methadone.
  2. Provide the patient with either a cup of water or several ounces of water to be poured into the bottle of methadone.
  3. Observe the patient drinking the water and then require them to speak with you.
  4. Ensure that the patient returns empty methadone bottles to the nurse.
• Administration process for buprenorphine/naloxone tablet: To verify the ingestion of buprenorphine/naloxone, the nurse must:
  1. Ensure the patient drinks a glass of water (at room temperature) to humidify the mouth immediately before the buprenorphine/naloxone administration.
  2. Provide tablet(s) to the patient in a medication cup.
  3. Ensure the individual places the tablet(s) under their tongue.
  4. The manufacturer does not recommend crushing buprenorphine/naloxone tablets. If the prescriber chooses to crush the tablets, the decision should be made on an individual patient basis and the medical reason should be documented in the clinical record.
• Administration process for buprenorphine/naloxone film: To verify the ingestion of buprenorphine/naloxone, the nurse must:
  1. Ensure the patient drinks a glass of warm water to humidify the mouth immediately before the buprenorphine/naloxone administration.
  2. Give the envelope to the patient and observe them tear the envelope on the dotted line.
  3. Observe the patient placing the film on one side under their tongue, close to the base either to the left or right of centre.
  4. The patient should press and hold the film in place for 5 seconds.^{Footnote 15}
  5. Any additional film must be placed on the opposite side.
  6. No two films should be overlapping.
• Administration process for slow release oral morphine: To verify ingestion of SROM, the nurse must:
  1. open the capsule(s) and sprinkle it on apple sauce at the time of administration
  2. the patient ingests the contents of SROM and apple sauce, do not chew or crush beads.
  3. direct patient to rinse mouth with water and then swish and swallow water.

All post-administration security observation by correctional officers, in order to prevent diversion, will be as directed by the Institutional Head. The minimum observation period for methadone and slow release oral morphine is 20 minutes. The minimum observation period for buprenorphine/naloxone film and tablet is 5 minutes.

Medication non-adherence refers to medication not being taken as prescribed. It is important to understand the reasons for this while being supportive, therapeutic, and non-stigmatizing. Any non-intended or non-medical use of the prescribed OAT, or use by any individual other than the individual for whom it was prescribed is considered misuse.

The effectiveness of the OAT program requires that each partner (Health and Security) operate according to their expertise and role. For example, the following table illustrates the different approaches and tools used by Health Services and Security in considering "treatment and harm reduction" and "enforcement," respectively.

1. Health care professionals will follow the United Nations Standard Minimum Rules for the Treatment of Prisoners (the Nelson Mandela Rules), Rule 46 (1) such that "Health-care personnel shall not have any role in the imposition of disciplinary sanctions or other restrictive measures…" Health-care professionals are responsible for managing non-adherence to treatment in the context of a patient-provider supportive relationship.
2. Clinicians who are aware of misuse should continue to protect the confidentiality of patients, and should not breach confidentiality unless clear legislative criteria regarding harm to self or others are met. Management and the consequences of diversion are the responsibility of Security.
3. "Adherence" rather than "compliance" is used because it "… puts the therapeutic relationship in its proper perspective, by focusing on patient participation in deciding treatment choices, and being non-judgmental about patients' medication taking behaviour.^{Footnote 16}
4. Adherence to treatment will be evaluated through regular follow-up and assessment, scheduled and random urine drug tests that is used clinically and not used punitively.
5. Health care professionals will operate with the understanding that a substance use disorder is a chronic, recurring health condition, and it is not unusual for patients to experience challenges in reducing illicit opioid use during treatment.^{Footnote 17} In circumstances where the patient is not following their treatment plan, the approach is prompt reassessment and engagement of the patient in their treatment plan, for example, review and adjust dose, increase the frequency of clinical appointments, liaise with psychosocial supports, provide counselling on the risks of non-adherence to treatment and the limitations of continuing to prescribe medications that are not taken as prescribed. Canadian Academy of Psychiatry and the Law (CAPL) Practice Resource for Prescribing in Corrections
6. Involuntary discontinuation of OAT should be considered only after other attempts to engage and maintain adherence to treatment have been unsuccessful (dose adjustments, trial on alternative OAT medication, increasing psychosocial support etc.). Involuntary discontinuation, if required, must be gradual, humane, and specific to the clinical situation. Opioid withdrawal symptoms can be addressed with medications like clonidine, ibuprofen, dimenhydrinate, and loperamide. Before involuntarily discontinuing OAT, the expected practice within CSC is for the patient to be seen in person (or by telemedicine) by the physician/nurse practitioner. Involuntary discontinuation should be considered temporary (subject to medical contraindications) and in all instances, the patient will be offered continued harm reduction education, counselling, and interventions to mitigate possible overdose related to discontinuation. See Appendix IV, Process for Involuntary Discontinuation.
7. Where adherence to treatment cannot be maintained, the reasons for voluntary or involuntary tapering of treatment must be clearly documented. Continuing support should be offered and the patient informed of any actions the person should undertake over what period of time before they would be considered again for OAT.
8. Urine drug screens, ordered by healthcare, is for healthcare purposes only and is subject to healthcare confidentiality provisions.

1. Security observation is within the "enforcement" pillar of the Canadian drug and substances strategy and one component of addressing illicit drug production, supply and distribution.
2. Security personnel is responsible for observation, seizure and control of diverted medication. Diverted medications are "contraband" and managed according to existing policy (i.e. CD 568-5 Management of Seized Items). Security personnel is responsible for managing diversion through the application of administrative consequences and/or disciplinary sanctions, in accordance with the procedures and policies in place at the institution: for example, cell searches, urine drug screen, etc. The decision on which tool(s) to use will be driven by analysis, security expertise, and the judgement of security professionals.
   
   Security may inform Health Services with respect to general or specific diversion, but healthcare will not participate in the application of any sanction.

1. Psychosocial treatment interventions and supports should be routinely offered to patients in OAT.
2. Concurrent disorders with substance use are common (e.g. depression, anxiety, bipolar disorder, posttraumatic stress disorder etc.), and people should be offered treatment as indicated.
3. Participation in psychosocial interventions is not a requirement in order to receive OAT.
4. Psychosocial interventions should not be limited to people receiving OAT, but should be available to individuals on the OAT waiting list and for those with non-opioid related substance use disorders.
5. Psychosocial interventions may include psychoeducation, motivational interviewing, individual psychotherapy and group interventions, e.g. InsideOut, SMART Recovery Peer Recovery, SMART Recovery for Co-Occurring Disorders and other programs.

1. Effective discharge planning is essential for those on OAT and planning must reflect the functional roles of Health Services and Case Management each having clear accountabilities.
2. A meeting of the Treatment Team will take place 6 months prior to release to develop a transition plan for the individual's return to the community. If the discharge is sudden or insufficient time for the Treatment Team to meet, then the responsible nurse will develop a transition plan and if possible seek to include feedback from other members of the Treatment Team. The aspects include provincial/territorial coverage, continuity of care, availability of medication/prescription on release, take home naloxone kit, harm reduction education/counselling, connection to harm reduction resources such as needle exchange programs/safe consumption sites, housing and other psycho-social supports as required. Psychosocial supports could include formal in person or virtual substance use counselling (individual or group, residential or outpatient), peer support (e.g. SMART Recovery, 12 step), psychotherapy/counselling, cultural-spiritual support, vocational support, leisure activities, reconnection with family and friends, etc. Of note, psychosocial supports should be pursued collaboratively with the person that are relevant to their specific needs and responsivity factors. There are self management tools through a Health Canada Wellness Program^{Footnote 18} that can be offered to patients with OUD.
3. Health care, with the consent of the patient, will complete and send a GIST report (CSC-1371, available as an e-form in the OHIS-EMR Oscar) to the Institutional Parole Officer six months prior to release, in order to communicate brief, non-confidential information on a patient's ongoing treatment plan, including whether the patient:
   1. is receiving ongoing health care services which will likely continue after release to the community;
   2. requires appointments to be made with health specialists in the community prior to release in order to facilitate access to community health care in a timely manner;
   3. Has specific disability accommodation needs.

Institutional Parole Officer Responsibilities include:

1. Confirming the availability of identification documentation that will enable the individual to obtain a provincial health card;
2. Providing early notification to Health Services and Community Correctional Programming of an individual's release date to create links with the community and facilitate a seamless transition of health care and other services;
3. Facilitating (for example, via volunteers) and assisting individuals on OAT in filing an income tax declaration while in CSC to remove this as a barrier to receiving provincial /territorial health and social services.

Mike Kekewich and Dr. Jacky Parke

Originally developed by Norman Daniels, the "Accountability for Reasonableness" ("A4R") framework has been applied to a wide variety of priority setting, resource allocation, and triage scenarios. The most notable uses of A4R have been in pandemic planning activities related to SARS and H1N1, but it can also be applied to broader public and private health system issues. The A4R framework is generally characterized by four procedural values: relevance, publicity, revisions/appeals, and enforcement.

As a decision-making framework, A4R is premised on the notion that individuals are more likely to agree on these types of 'procedural values', rather than particular outcomes themselves, or the substantive principles that would generate those particular outcomes. In using the A4R framework, the goal is for users to satisfy the requirements imposed by each procedural value, thus strengthening the ethical credibility and legitimacy of the ultimate conclusion reached. It is also possible that various outcomes could be compatible with A4R, which allows for reasonable disagreement to occur. For this reason, A4R has been described as a type of threshold test for fairness, in that it encourages ethical scrutiny in decision-making without being overly-prescriptive.

In this respect, A4R acts as a guide to ethical reflection in the decision-making process by connecting "decision-making in healthcare institutions to broader, more fundamental democratic deliberative processes". Users should raise questions related to each value and consider whether the current decision-making process is ethically justifiable in light of that question. Doing this will build resistance to arbitrary or otherwise ad hoc decision-making.

With respect to practical application, Kapiriri et al surveyed 184 decision-makers at various levels of health care leadership in 2009. Participants in this study identified the following as "elements of fairness" in relation to the A4R framework. While this is not an exhaustive list, it does provide good examples of how the procedural values contained in A4R can be further specified and applied by decision-makers.

Correctional Service of Canada has an Opioid Agonist Therapy (OAT) Program that includes prescription and administration of medications (methadone, buprenorphine/naloxone (oral), buprenorphine (injectable)), the monitoring of symptoms and supportive counselling. Diversion of medications (particularly Suboxone) has been identified as an ethical concern, both for health service providers and operational staff. From the health services perspective, diversion creates challenges in terms of the clinical or therapeutic management of patients. Clinicians must consider whether the treatment is providing a benefit to patients, and whether alternative approaches would be more appropriate. Solutions to clinical problems should be guided by relevant and well-established principles, including harm reduction, respect for autonomy, beneficence and non-maleficence.

It is also critical that clinicians be compliant with the United Nations Standard Minimum Rules for the Treatment of Prisoners (Mandela Rules). In the context of managing diversion, clinicians should never be involved in the administration of discipline or punishment of an offender. In this respect, clinicians should only be managing the health care of their patients, and not be guided by operational concerns. For offenders who are diverting, the primary clinical concern becomes non-adherence to a treatment plan that must be dealt with clinically. The response to this could include adaptation of the treatment plan, which may involve change, reduction or discontinuation of a specific medication in reference to the offender's medical interests, and not as a disciplinary tactic. Similarly, clinicians who are aware of diversion should continue to protect the confidentiality of patients, and should not breach confidentiality unless clear legislative criteria regarding harm to self or others are met.

Operationally, diversion creates different challenges that require solutions that would not be appropriately imposed in a therapeutic relationship. Examples of these solutions might include institutional charges, loss of certain privileges, searches, or other options available to security. Diversion of medications requires an institutional response because of the harms arising from it. Within an institution, for example, diversion can be harmful to individuals by compromising security, spreading infectious diseases, causing new addictions, and contributing to violence (i.e. in relation to transactions, debts, "muscling"). As a result, disincentives to diversion should exist and be clearly communicated. At the same time, the method by which diversion is dis-incentivized must be fair, reasonable, and ethically grounded.

The following ethical considerations are specific to the operational approach to diversion of OAT medications (clinical response must be separate, as noted above), and are premised on the following assumptions:

• Diversion of OAT medications cause identifiable and significant harms within institutions;
• These harms are not an acceptable or necessary by-product of the OAT program;
• The organization has an ethical responsibility to be responsive to, and to disincentivize these harms;
• The organization should be able to clearly articulate its position with respect to diversion.

The organization's approach to diversion and the consequences thereof needs to be reasonable, and it will only be reasonable if discussions and formulation of policy include relevant stakeholders. This means that the organization must identify those impacted by this issue, gather information about the responsibility to protect the safety, security and well-being of inmates, and weigh the risks of diversion. A good example of inclusiveness in this context could include the national OAT Working Group meetings in March, 2019. These discussions, which addressed diversion, included health, security, leadership and administrative staff. CSC may also wish to consider soliciting the feedback of patients who have or are currently using the OAT program to ensure that their voice is represented. Currently, the only formal feedback from patients is obtained through external organizations such as Prisoners Legal Services, and it would likely be of benefit to both CSC and patients to create internal mechanisms for feedback (e.g. focus groups, patient advisors, surveys) that could inform these types of policy decisions.

Any position taken by the organization also needs to be fair (i.e. similar cases should be treated similarly). If the organization imposes certain punishments, sanctions, or other consequences in relation to diverted medications, this should be applied fairly both within and between institutions. This also requires a relatively standardized approach to implementing the OAT program, which was also the focus of the March 2019 OAT Working Group meetings. It is also important to note that "reasonableness" is not the same as "consensus". While consensus and complete standardization may be desirable, there may be some reasonable degree of variation based on institutional circumstances, resources or needs. For example, the implementation may be somewhat different in a minimum security institution than it is in maximum security. The principles, however, should remain the same, and should always be clearly justifiable.

The approach to diversion should be transparent in at least two different ways. The organization should be transparent as a whole with respect to the position (i.e. outwardly, publicly, or from a policy perspective). This would also require that the organization have a clear justification for that position in the event that scrutiny is raised. It will likely be important in this context to differentiate the correctional environment from "community standard" with respect to the issue of diversion. Although there is an expectation of equivalence to community standard in terms of health services, CSC may reasonably have a different administrative approach to preventing diversion given the unique circumstances of the correctional environment and the high prevalence of diverted OAT medications.

The organization also needs to be transparent to all inmates, and those who are part of the OAT program in particular, about the consequences of diversion. These consequences should be clear, reasonable and fair. Inmates should not be uncertain about the consequences of diversion if the organization has identified clear and significant harms that require mitigation. During the March 2019 OAT Working Group meetings, it was noted that all offenders should receive information on medication management, including diversion. This would be a reasonable time to present the expectations regarding taking one's own medication, as well as the consequences of trafficking diverted medications.

In the context of treatment, clinicians can also clearly emphasize the importance of adherence to treatment without compromising the Mandela Rules or the therapeutic relationship. This could be formalized through a standard patient agreement document that is reviewed with a health care professional prior to initiation of treatment. Although clinicians should not prima facie share patient-level information regarding diversion, they may nevertheless receive that information through reports from security or participation in intervention team meetings that include security. This may also provide clinicians an opportunity to ensure ongoing treatment is medically appropriate.

The organization must be willing to revise any approach to diversion in light of new challenges, evidence, or complaints. Decisions are rarely perfect, or completely fair, and this requires a commitment to revisiting historical agreements.

Clinically, there would always be an opportunity to revisit treatment plans, or for patients to voice their concerns to members of their care teams. In the context of treatment adherence issues, clinicians should emphasize that care planning decisions are rarely permanent, and that decisions and circumstances can change over time. Although a formal "appeals process" may not be necessary with respect to health care services, clinicians should make this clear when initiating treatment, and the patient agreement form can include reference to the fact that treatment may be tapered, modified or stopped if medically indicated and appropriate. It should be clear that this is not a form of punishment in response to diversion, but is part of a care plan for the patient. If patients are for some reason discharged from the OAT program for medical reasons, this should also not preclude the possibility of being re-admitted for treatment if necessary.

Operationally, it is clear that offenders already have mechanisms by which to contest or appeal sanctions or discipline. In the context of diversion, these tools would continue to be of relevance to offenders who are sanctioned for trafficking diverted medications. If these internal tools are not seen as effective, it may be necessary to enhance them. Offenders also have access to external advocacy groups such as Prisoner's Legal Services and the Office of the Correctional Investigator. While these are not formal "appeals mechanisms", they do provide an additional avenue through which concerns can be raised.

The OAT Working Group should also consider data collection and period evaluations to ensure the program is performing as intended. This could include data on diversion, and whether CSC's approach is achieving an impact.

This procedural value is perhaps the most relevant in discussing an organizational approach to diversion. Enforcement, including addressing diversion, is also a key pillar in the Canadian Drugs and Substances Strategy. Even if the first three conditions are met, the approach will not be successful or ethically credible without meaningful enforcement. This requires that consequences of diversion actually occur in a relatively consistent fashion. In this context, the difficulty is enforcement without negatively impacting the health care of patients who require OAT. This is a real and significant challenge, but it would be difficult to justify a position that accepts diversion as necessary consequence of the OAT program. This means that some strategy needs to be put in place and enforced to mitigate harms.

Given aforementioned concerns regarding the Mandela Rules and integrity of therapeutic relationships, enforcement of sanctions or discipline should be fully the responsibility of security. This also means that security should be responsible for observation of offenders to identify cases of diversion. This could include direct observation during DOT lines, video surveillance, or mouth checks. These activities are not therapeutic and should not be the responsibility of clinicians if the objective is to identify and remediate cases of diversion. Healthcare staff should only be observing offenders during administration of treatment to ensure that the treatment is delivered appropriately and is adhered to, as per the guidelines.

I understand that I am being prescribed _, which has a high potential for physical or psychological dependence and misuse.

I recognize that appropriate use of medication is very important for my health.

I understand that following this agreement is essential to building and maintaining trust in the doctor/nurse/patient relationship.

I will take my medication as prescribed, and will not use it or other medication in any manner other than as directed by my doctor/nurse practitioner (e.g. I will not take medication in larger amounts, more frequently or through a route other than prescribed, or take drugs not prescribed for me).

I will participate constructively in other recommended non-medication treatment for my condition.

I agree to cooperate with mouth checks, and provide random urine, saliva, nasal swabs or blood samples for testing if requested by my doctor/nurse practitioner (note: this is for health care purposes only, and results of any drug screens will not be shared with others outside of my Treatment Team).

I understand that my doctor/nurse practitioner may consider stopping or tapering my medication(s) with high abuse potential if I am not following this agreement. If this occurs, my doctor/nurse practitioner will meet with me in person to discuss the concerns, including those related to my health or the health of others, and why it is happening. If warranted, they will also explain other possible treatments, or what I need to do over what period of time before consideration is given to reinstating the medication(s).

Patient Name and FPS# _
Date _
Signature _

Physician/Nurse Practitioner Name _
Date _
Signature _

Two important aspects amongst others need to be reflected on when considering involuntary termination of OAT due to a patient not adhering to the agreed treatment plan. These are addressed in the Opioid Agonist Treatment Working Group Interim Guidance document.

There are several contextual factors integral to an OAT program in a correctional setting:

• Dual loyalties: The United Nations Standard Minimum Rules for the Treatment of Prisoners (the Nelson Mandela Rules), clarifies the issue of dual loyalty by stating that "Health-care personnel shall not have any role in the imposition of disciplinary sanctions or other restrictive measures."
• Harm reduction: OAT is both a treatment and harm reduction initiative, where harm reduction aims to reduce the harms associated with the use of psychoactive drugs in people unable or unwilling to stop. It focuses on keeping people safe and minimizing death, disease and injury associated with high-risk behaviours, while recognizing that the behaviour may continue despite the risks. In a harm reduction context, patient accountability recognizes that recovery is a non-linear process and as such, OAT participants are not "fired" for not achieving goals or penalized for backward movement.

The physician in making decisions on involuntary tapering must come to a decision based on medical reasons and not include any aspect of punishment or deterrence. Observation or reports of diversion, or other aspects of substance misuse should prompt discussion of why this is occurring and focus on supporting the patient to adhere to the treatment plan. At some point with continued failure to adhere to the treatment plan, or if there is a real concern for others safety, e.g. diverting methadone, then involuntary tapering would be appropriate. If the patient has OAT tapered then the patient should continue to be offered support, informed of any actions he should undertake over what period of time before he would be considered again for OAT.

Patients who are bullied or muscled for their OAT can be supported by the correctional team. Security has various options to pursue with patients who are diverting their OAT medication willingly. Abuse or threats to staff should be reported to the correctional team who should be expected to follow their usual practice in such instances.

Physicians and the healthcare team in supporting and treating patients with a substance use disorder should focus solely on medical care and not be influenced or pressured to discontinue OAT by the correctional staff.

Change or discontinuation of medication (due to non-adherence to the treatment plan) is made by the prescriber based on repeated episodes of documented non adherence. Discontinuation must be gradual and humane and may include non-opioid medications to treat opioid withdrawal.

Process to follow

The Treatment Team would meet with the patient either in person or virtually & address the biopsychosocial and spiritual needs of the patient taking in to account the patient's treatment plan.

Give the patient an opportunity to explain his/her concerns and description of any occurrences of misuse, and document the explanation in EMR.

Consider the following when contemplating medication discontinuation:

• Scope, composition and appropriateness of the patient's treatment plan, including medication dosage;
  1. Consider potentially changing to a medication that mitigates the risk of misuse;
  2. Suitability of the patient for a particular program;
  3. Safety of the patient involved;
  4. Safety of other individuals within the institution;
  5. Alteration of the patient's treatment agreement;
  6. Providing a humane taper for medications that require one (e.g. Methadone, Buprenorphine/Naloxone)
• Continue to offer harm reduction education and counselling;
• Advise the patient about potential for overdose if using non prescribed medications, and
• Inform the patient that he/she may re-enter the program at a future time that will be based individually for each patient in discussion with the prescriber.

The Treatment Team discussion in the meeting with the patient must be documented in the EMR, including the reasons if the patient had the OAT involuntary discontinued.

(Reference page 46, Appendix 5: Conversion Table in the BCCSU Guidance document)

The following conversion table can be used to determine an equivalent dosage for the purpose of travel (for example, converting to witnessed ingestion of SROM for travel to a funeral) or longer term (for example, if someone is entering the corrections system or hospitalized in a facility where iOAT is not feasible or clinically contraindicated). Ideally, travel is planned in advance, allowing for a slow titration from iOAT to oral OAT following the BCCSU's A Guideline for the Clinical Management of Opioid Use Disorder. It is recognized, however, that emergency travel (e.g., a funeral or family emergency) is at times required. In these cases, the below table can be used along with patient education to minimize safety risks. Although there is more evidence supporting the use of methadone for travel, the authors of this document favour the use of slow-release oral morphine for its improved safety profile, including significantly less variability in required dosage.

Important safety note: All doses must be reduced by 25% from the figure given in the table due to incomplete cross-tolerance. Patient safety must be prioritized in converting from iOAT to oral OAT. If a patient has been injecting intramuscularly the bioavailable dose may be less, requiring a larger dose reduction.

Patients should be provided with take-home naloxone kits, training on how to administer naloxone, and be advised to make sure family or friends can observe them for sedation or respiratory depression. Dose conversion should be calculated cautiously, and multiple-day prescriptions of oral OAT should be prescribed with recognition of the cumulative effects of dosing. Maximum doses of 1200mg slow-release oral morphine and 100mg methadone are recommended to ensure patient safety.

The DAM-methadone conversion was established by two DAM treatment centres in Switzerland, which has been refined and used in other settings, including the NAOMI trial. The HDM doses were calculated using the DAM: HDM ratio of 2:1. The SROM doses were calculated using the HDM: SROM ratio of 1:5. Doses reflect total daily dose.