Take-home dosing (carries) of OAT may increase motivation to participate in opioid agonist treatment, improve treatment retention, facilitate virtual care, and enhance quality of life by increasing patient autonomy and flexibility and decreasing treatment burden. Carries also decrease costs related to daily witnessed ingestion. However, these benefits must be balanced against patient and public safety considerations. See Take-home OAT Dosing for a review of evidence informing take-home dosing guidelines.
The criteria and limitations for take home dosing of each medication should be discussed with patients prior to treatment initiation, as this information may impact treatment selection.
Considerations for individuals in rural and remote areas
Early and flexible provision of take-home dosing is a particularly important consideration for individuals who live in rural and remote communities, as daily travel to pharmacy may not be a feasible or sustainable requirement for this population. When determining the individualized criteria for take-home dosing in this population, prescribers should weigh medication safety concerns against the risks associated with loss of patient to care and their continued reliance on the unregulated drug supply.
Considerations for patients who use other CNS depressants
Due to the increased risk of overdose when full opioid agonists are combined with other CNS depressants, benzodiazepines and other sedative medications should generally not be prescribed concurrently with opioid agonist treatment, particularly when take-home doses are being considered. Clinicians should ask patients whether they are using any CNS depressants, and offer information on the risks of combining these with opioid agonists.
As per CSPBC guidance, PharmaNet should also be reviewed at each clinical visit to confirm that another care provider has not prescribed these medications.
A6.1 Buprenorphine/naloxone
Take-home dosing should be considered for all patients who meet the following criteria:
- Clinical and psychosocial stability
- Generally, the indications of clinical and psychosocial stability include:
- Ability to attend appointments
- Absence of unstable psychiatric comorbidities (e.g., psychosis, suicidality)
- Absence of severe behavioural issues at the clinic
- Absence of severe sedation
- Absence of high-risk or uncontrolled substance use patterns that cause frequent overdoses or blackouts
- Point-of-care assessment of stability is patient-specific, depending on each patient’s circumstances and needs and how they change over time.
- Generally, the indications of clinical and psychosocial stability include:
- Ability to safely store medication (access to a secure lockbox or cabinet)
Take-home doses may be considered immediately for patients who meet the above criteria, as quick transition to take-home dosing is associated with improved treatment adherence and retention.248,249 In a study of commercial claims data (n=17,159) in the US, receiving fewer (i.e., ≤15) days of take-home doses in the initial prescription was associated with increased odds of discontinuing treatment (adjusted odds ratio=1.32, p<0.01) as well as increased odds of opioid-related adverse events (suggesting relapse or overdose), the majority of which occurred after treatment discontinuation. The increased odds of opioid-related events remained even after treatment discontinuation was controlled for.497
If concerns exist around the appropriateness of take-home dosing, the impact of providing or limiting take-home dosing on treatment adherence or loss to care should be considered. If take-home doses are determined to not be clinically appropriate, the rationale for not prescribing take-home doses should be carefully documented in the medical record and explained to the patient.
Individuals experiencing homelessness may especially benefit from immediate take-home dosing, as they may not be able to return to the same pharmacy each day due to the realities of homelessness and the requirement for frequent moves (e.g., from one shelter to another). Co-occurring substance use should not be considered an absolute contraindication for take-home dosing. Patients should receive education on the risks associated with co-occurring substance use and the option to initiate treatment for co-occurring substance use disorders.
A6.1.i Considerations for Safely Maintaining a Patient on Take-home Buprenorphine/naloxone
- Buprenorphine/naloxone can be initially prescribed as a 1- to 2-week supply. This is for the purpose of following up to establish the effectiveness of dosage; longer prescription intervals may be appropriate once a stable dose has been established.
- Clinicians should monitor patient for signs of increase in unregulated opioid use and new use of sedating agents (e.g., alcohol, benzodiazepines), other signs of instability, and/or diversion.
- When clinically indicated, urine drug tests (UDTs) may be requested to confirm medication adherence.
- If UDT is indicated, assure the patient that this test is intended to confirm the presence of buprenorphine, and that the results will not be used punitively.
- When appropriate, clarify to the patient that the presence of other unregulated substances is not necessarily grounds for discontinuation of carries.
A6.1.ii Monitoring of Take-home Buprenorphine/naloxone Dosing
Patients receiving take-home buprenorphine/naloxone should be seen at least monthly to assess progress and stability. Once the patient is stable, intervals between planned visits may be prolonged (e.g., to 8 weeks) at the prescriber’s discretion, provided that the patient is able to reach the prescriber remotely or in person if urgent support is needed.
Prescribers should be vigilant in monitoring for signs of increased unregulated opioid use, alcohol and other (non-opioid) substance use, psychosocial instability, and diversion. The following are considerations for follow-up and reassessment:
- Self-reported or other indication of increase in unregulated opioid use
- Missed appointments or doses, or repeated reports of lost, stolen, or vomited doses
- Requests to increase a previously effective dose
- Other evidence of diversion (e.g., tampering with blister packs, UDT negative for buprenorphine, repeated inability to provide urine samples)
Before take-home prescriptions are reduced or discontinued, the prescriber must balance the risks of destabilizing patients by enforcing daily dispensation of medication. Daily witnessing of this medication has not been shown to improve outcomes and is a recognized barrier for treatment engagement.247 In addition, the buprenorphine/naloxone formulation was created to facilitate take-home dosing and make treatment more attractive to patients due to its safety profile and lower risk of diversion.
For patients prescribed take-home buprenorphine/naloxone showing signs of major clinical or psychosocial instability, individual patient circumstances should be considered when reducing the number of take-home doses of buprenorphine/naloxone, as limiting take-home dosing may result in loss to care. Following discussion with the patient about any underlying issues contributing to treatment instability, clinicians can consider:
- Increasing the frequency of clinical appointments in order to provide more intensive support, monitoring and assessment
- Providing referrals to adjunct psychosocial and community-based supports, as appropriate
If treatment intensification does not adequately address clinical or psychosocial instability, clinicians and patients can consider transitioning from buprenorphine/naloxone- to full agonist treatment.
Evidence of diversion should prompt a reassessment of the treatment plan, and, in some cases, reduction or discontinuation of take-home dosing with consideration of dose reduction if doses have been missed.
- A negative UDT result for buprenorphine suggests that the patient has not taken this medication for many days. In this case, discuss reasons why and, if appropriate, consider discontinuing buprenorphine/naloxone and transition to another OAT medication with the patient.
- Evidence of falsified UDT sample should prompt a supportive, non-judgmental discussion with the patient regarding whether the current treatment plan is helping them achieve their goals. A new sample should be requested to help make modifications to the treatment plan. Patients should not be asked to leave treatment.
A6.2 Methadone and Slow-release Oral Morphine
Due to their inferior safety profile, more restrictive considerations are advised for the provision of take-home methadone doses of full agonist OAT options in comparison to buprenorphine/naloxone, in order to minimize individual and public safety risks. Past guidelines set very strict criteria for access to methadone take-home doses, and discouraged any take-home SROM doses. More recent data, however, has suggested that increased access to carries can be safe for many patients who are stable on their medication, and can potentially improve treatment retention for select patients. Ontario’s META-PHI has recently developed A New Framework for Methadone Carries: A Person-centred Evidence-informed Approach to Take-home “Carry” Dosing, outlining criteria and considerations for starting and extending take-home methadone doses in the interest of reducing barriers to the sustainability of methadone care for patients. The guidance provided below for methadone and SROM take-home doses has been developed in reference to these considerations.
The decision to initiate take-home doses can only be made by the prescribing clinician in collaboration with the patient and with case-by-case consideration of risks and benefits. Particular caution should be exercised when considering take-home doses for patients who are still in the titration phase; for these patients, frequent pharmacy visits may be a safety necessity.
Rationale for decisions regarding take-home doses, including confirmation that criteria listed below have been met, should be clearly documented. Clinicians must ensure that take-home doses are safe for both patients and the public, as unsafe storage, non-prescribed use, and diversion of methadone or SROM may result in lethal consequences.
A6.2.i Patient Criteria for Methadone and SROM Take-home Doses
Prior to prescribing take-home methadone or SROM doses, the following patient criteria should be met:
- Appropriate UDT results (e.g., evidence of medication adherence) for a minimum of 4 weeks
- Ability to safely store OAT medication (e.g., locked containers or cabinets)
- Clinical and psychosocial stability (i.e., ability to keep appointments and manage medication; no severe psychiatric issues, such as psychosis or acute suicidality, at the point of assessment; no high-risk substance use patterns that cause frequent overdoses, blackouts, or hospitalizations)
Take-home methadone and SROM dosing schedules for patients who meet the above criteria should start as a single take-home dose per week. The number of take-home doses per week can be increased gradually (e.g., every 1–2 weeks). The patient will progress from 1–3 non-consecutive take-home doses, then to 4–6 consecutive take-home doses. However, clinical discretion may dictate a faster increase in the number of take-home doses in consideration of patient-specific circumstances, (e.g., wok schedules, rural or remote location, pharmacy hours, or previous successful experience with tak-home doses).
Beyond the time frames specified in Table 30, additional take-home doses can continue to be offered gradually (e.g., every 2 weeks) to patients who have consistently been able to manage previous take-home doses, sustain medication adherence, and experience improving clinical and psychosocial stability including reduction in substance use in alignment with patient’s treatment goals.
Table 30. Suggested Protocol for Methadone and SROM Take-home Doses
| Number of take-home doses per week | Minimum time on methadone/SROM | Conditions/Criteria |
|
0 (Not a candidate for take-home doses) |
- |
|
| 1–3 (non-consecutive take-home doses) | 4 weeks |
|
| 4–6 (consecutive take-home doses) | 12 weeks |
All of:
|
Adapted from META-PHI’s A New Framework for Methadone Carries: A Person-centred Evidence-informed Approach to Take-home “Carry” Dosing.
It is advised that the first dose be provided as DWI in the pharmacy on the day the prescription is picked up. Prior to dispensation of take-home doses, patients should be informed of the risks of infection associated with injection use of medications intended for oral use. This discussion may be particularly relevant for SROM, as methadone and buprenorphine/naloxone have properties that reduce the risk of injection use (i.e., presence of naloxone, and high liquid volume, respectively).
Take-home doses should be dispensed in individual, appropriately sized, child-resistant containers. Containers with tamper-proof seals may also be available at some pharmacies, and should be requested if available.
A6.2.ii Monitoring of Take-home Dosing for Full Agonist OAT Medications
Patients receiving take-home methadone or SROM dosing should be seen at least monthly to assess progress and stability. Prescribing clinicians should be vigilant in monitoring for signs of increased unregulated opioid use, alcohol and other (non-opioid) substance use, psychosocial instability, and diversion.
When clinically indicated, UDT may be requested to confirm medication adherence, or in collaboration with a patient to gain clinically relevant information about self-reported unregulated substance use. Prior to conducting the test, clearly explain to the patient that the test is intended to confirm the presence of OAT medication, and that the results will not be used punitively. When appropriate, clarify that the presence of other unregulated substances is not necessarily grounds for discontinuation of carries.
The following are considerations for follow-up and reassessment:
- Self-reported or other indication of increased use of unregulated opioids and other CNS depressants
- Missed appointments or doses, or repeated reports of lost, spilled, stolen, or vomited doses
- Requests to increase a previously stable dose
- Unable to attend the clinic or lab for UDTs
For patients prescribed take-home methadone or SROM showing signs of instability, prescribing clinicians should consider reduced take-home dosing days per week or complete return to DWI if appropriate, following discussion with the patient. Clinicians should also increase the frequency of clinical appointments and provide referrals to adjunct psychosocial treatment and community-based supports. If treatment intensification and adjunct support does not address issues underlying instability, clinicians and patients can consider transitioning to an alternative opioid agonist treatment.
Evidence of diversion (e.g., UDT results negative for OAT) warrants return to prescribing witnessed doses following a discussion with the patient to ensure that the medication is appropriately meeting their needs. Transition to another medication may be collaboratively considered where appropriate. In the case of negative UDT results for OAT, prescribers should assess loss of tolerance and consider restarting or resuming OAT at a lower dose, as needed, to minimize risk of overdose.
The above appendix was developed to support clinical practice using a different methodology from the process utilized for the main body of the guideline.
The clinical guidance provided in the appendix has been derived through guideline committee consensus following iterative discussions in reference to existing evidence and national and international evidence-based clinical practice guidelines.
The content presented in the appendix is also informed by the opinion of expert reviewers, personal communication with study authors, and a review of position papers and practice bulletins issued by recognized addiction medicine professional organizations and authorities. In addition, where appropriate, Health Canada-approved drug product monographs, and previous and current guidance from the College of Physicians and Surgeons of BC (CPSBC) and Health Canada were consulted to ensure compliance with provincial and national safety regulations and standards for practice.