Practices should develop and use systematic policies and protocols that, at a minimum, address intake, induction, stabilization, maintenance, medication management, diversion, and compliance with regulatory requirements for dispensing and administering medications to treat opioid use disorder.
The practice has well-designed protocols and systems for all issues related to medication management that are consistent with evidence-based practices and compliant with all legal and regulatory requirements. These protocols incorporate the principles of patient-centered care, including shared decisionmaking.
How Do You Do It?
Phase I: Evaluation and Induction
Upon intake into the program, patients undergo evaluation to help inform medication choices and treatment planning. How to conduct patient-centered Screening and Assessments will be discussed later in greater detail.
Medication Choice. Every patient is different and will have his or her own set of needs and preferences related to medication. When choosing medication, the goal should be to balance the risks and benefits of the medication, along with lifestyle factors that will encourage adherence to treatment.
The Substance Abuse and Mental Health Services Administration’s Treatment Improvement Protocol (TIP) 63: Medications for Opioid Use Disorder – Pharmacotherapy for Opioid Use Disorder, offers a comprehensive description of medications to treat opioid use disorder. The guidance document includes drug formulations and pharmacology, as well as considerations for dosing, potential drug interactions, risks and side effects, patient selection, treatment initiation, and duration of treatment. This information can help providers and patients make decisions about which medications to prescribe. Additional guidelines are in Exhibit 2.14: Comparison of OUD Medications To Guide Shared Decision Making (PDF—2.8 MB) on page 57-58 of the document.
The expert panel authoring TIP 63 notes “currently no empirical data indicate which patients will respond better to which opioid use disorder medications.”1 Decisions regarding medications to prescribe should take into account patient preferences, history (medical, psychiatric, and substance use), and treatment availability. Specifically, the guidelines recommend providers consider the following when deciding which treatment to provide1:
- Patient preference, including his or her prior history with and response to medications for opioid use disorder,
- Side effects associated with medications,
- Evidence base for the safety and effectiveness of the treatment,
- Patient’s use of other substances,
- Patient’s lifestyle factors (e.g., employment, scheduling limitations),
- Pregnancy status, and
- Patient’s physical dependence on opioids.
Informed Consent. Practices should ensure patients consent to treatment before beginning medications. This document should include the standard principles of consent common to other procedures and treatments. It should highlight the medication’s purpose, how it should be taken, its risks and side effects, alternatives to treatment with this medication, and what to expect during different phases of treatment. NIATx provides a sample patient informed consent (Word—81.5 KB) for buprenorphine.
Treatment Agreements. It is important that patients understand what will be expected of them during treatment. Treatment agreements are not meant to be punitive by nature but rather to create a set of expectations and understanding between the patients and the practice. With the goal of harm reduction and removing barriers to treatment, these agreements might include the following commitments:
- Attend treatment sessions and scheduled appointments.
- Stop using illicit opioids or other substances (depending on program policies).
- Take medications to treat opioid use disorder as prescribed and intended.
- Comply with urine drug screens.
- Do not sell, misuse, or divert medications.
- Do not ask for early medication refills.
- Inform the provider if the patient begins taking other medications.
- Provide payment for services.
- Meet expectations related to behavior and interactions with other patients and staff (such as acting in a respectful and courteous manner and respecting privacy and confidentiality of other patients).
- Adhere to any other program participation requirements or policies.
Induction. Providers often report fear or anxiety about conducting their first induction, although with experience inductions quickly become routine and straightforward. Boston Medical Center offers checklists to complete before induction for both buprenorphine-naloxone and naltrexone.
Medications may be taken in an observed, office-based setting or the patient may take the medication home. In the past, most clinical trials of buprenorphine included office-based inductions, which led to longstanding recommendations that medical settings were needed for induction to be safe and effective. However, recent evidence indicates that either approach can be successful,2 and many experts support home inductions.
- Office-based inductions: During an induction, providers should use the Clinical Opiate Withdrawal Scale (COWS) or another instrument to assess a patient’s withdrawal symptoms throughout the process.1 Inductions may last several days through a week or longer. Providers should only prescribe enough medications until the next visit to encourage continued attendance. Office-based inductions can be difficult to schedule and may require a significant amount of provider and staff time, which can create delays and barriers to treatment initiation. These are typically reserved for more complex inductions, such as those transitioning from methadone or other long-acting opioids or those who have had problems starting buprenorphine in the past.
- Home inductions: Logistically speaking, it may be advantageous for offices to support home inductions. Practices offering home-based inductions should be sure to implement strategies to support patients throughout the process, including followup during office visits, communication via phone or text message, and adequate education about what to expect. While home inductions are largely considered safe and appropriate for many patients, individuals who use fentanyl may be more likely to experience precipitated withdrawal (the rapid onset of withdrawal symptoms) when starting buprenorphine-naloxone. This risk may complicate a home induction.
For greater detail on how to conduct an induction, refer to SAMHSA’s guidance on Pharmacotherapy for Opioid Use Disorders (PDF—1.48 MB).
Phase II: Stabilization
Patients should be seen frequently during the first few weeks of treatment as they stabilize. They should be seen at least once per week, especially if they are struggling. Providers should review their State’s Medicaid guidelines for specific requirements regarding frequency of visits, as some State Medicaid guidelines require weekly visits for the first month. They also should try to address and manage any side effects during patient visits.
TIP 63 has a full explanation of side effects for each medication. Side effects may be related to the medication itself or to withdrawal, which may mean the dosage needs to be adjusted. These symptoms may include constipation, taste perversion, headache, nausea, vomiting, sweating, joint and muscle pain, sedation, increased liver enzymes, anxiety, symptoms of allergic reactions, insomnia, and decreased libido.
During this phase, ongoing efforts to promote engagement and retention in treatment can be critical. Providers and patients should work together to create a treatment plan both parties agree on. This treatment plan should specify the frequency of office visits, dosing schedule, and frequency of urine drug screens. It should also highlight the patient’s goals for treatment and adjustments that will be made if he or she fails to adhere to the plan (including the intensity of services or referrals to other providers).
If patients are ambivalent about decreasing opioid use or making other changes, motivational interviewing techniques can help them explore and understand their hesitation. Learn more in the section on Patient-Centered Care Plans.
Providers should also assess the patient’s willingness to engage in psychosocial support. Psychosocial support can help address co-occurring mental health conditions that may affect a patient’s ability to stabilize. If patients are hesitant, motivational interviewing techniques may help them understand their concerns and encourage participation in any available and appropriate form of counseling, therapy, or self-help group to address their needs. Learn more in Co-Occurring Behavioral Health Conditions.
Phase III: Maintenance
During the maintenance phase, if patients are doing well on their medication and treatment plan, the provider may consider decreasing frequency of medication management visits or may adjust the dosing schedule. Providers may continue to ask patients to submit both scheduled and random urine drug screens. State laws or payer requirements may mandate certain frequencies of urine drug screens of which providers should be aware. The following signs may indicate a patient is ready to decrease visit frequency1:
- Several weeks of no opioid use (based on self-report and results of urine drug screens),
- Continued attendance to scheduled appointments and adherence to the treatment plan, and
- Engagement in treatment to address co-occurring mental or physical health concerns.
Patients who are ready to decrease the frequency and intensity of treatment visits will also show no evidence of co-occurring substance use that may pose significant risk for patient safety; significant side effects from medication; or signs of diversion (e.g., early refill requests, unexpected prescriptions from other providers in the prescription drug monitoring program).
If the patient has not already started receiving counseling or other recovery support, providers should revisit this discussion with the patient and rescreen for mental health disorders, paying special attention to suicidal ideation.
Patients who stay on buprenorphine or methadone treatment have better outcomes than those who undergo medically supervised withdrawal.1 Medication-assisted treatment (MAT) has no standard length of treatment, although some experts have concluded that 1 year should be the minimum. The TIP 63 expert panel support “maintaining patients on opioid use disorder medication for years, decades, or even a lifetime if patients are benefitting.”1
When patients have met their treatment goals and have stability in their lives, they may want to taper off buprenorphine completely. They should be supported and monitored as they make this challenging and potentially dangerous transition. If a patient expresses interest in discontinuing his or her medications to treat opioid use disorder, the provider should use shared decisionmaking techniques to discuss this plan with the patient.
If patients ultimately decide to stop using their medication, it is important to slowly taper and monitor closely. Discontinuing medications is risky and should not be a hasty decision. Relapse prevention and response planning are needed to address the real risk of recurrence of use. Discontinuing medications can increase a patient’s risk of relapse, overdose, and death.1
Provide Medication Management
Followup medication management visits throughout the phases of treatment should be used to monitor the patient’s progress, functional status, appropriateness of the treatment plan, and risk of recurrence of use. Providers should use these visits to assess:
- Treatment adherence,
- Cravings and withdrawal symptoms,
- Self-reported substance use,
- Life and social stressors,
- Any other relevant medical or mental health issues,
- Engagement in counseling or psychosocial support, and
- Results of laboratory tests or urine drug screens.
Providers should use progress notes to capture observations of patients’ appearance, speech, mood, insight into their disease, and reported side effects of medication. With this information, the provider can determine any next steps or adjustments to the treatment plan.
If medication management visits indicate a patient has begun to or is at risk of using illicit opioids again, providers should take appropriate steps. Learn more in Prevention and Response to Recurrence of Use.
Testing and Screening. Practices should establish policies and protocols related to toxicology screens. These may specify expectations regarding frequency of tests and methods to be used (e.g., urine versus oral swab, point of care versus laboratory testing). Drug screens can help identify ongoing substance use patients may have not disclosed out of fear or shame. These tests are supposed to help assess patient progress toward treatment goals, not to serve as a basis for administering punishments or terminating treatment.
Urine drug screen results can be an important tool for providers as they can help reveal a return to use of illicit opioids, monitor continued use of other substances, and identify medication nonadherence that could increase risk of overdose.1 These results can help inform treatment plans and lead to adjustments such as1:
- Switching to a different medication or formulation,
- Changing dosing schedules or dosage prescribed,
- Implementing observed dosing,
- Encouraging more engagement in counseling and recovery support services, and
- Referring to more intensive levels of treatment.
There is no consensus around the frequency of drug testing. State Medicaid agencies may have specific guidelines around the frequency of testing. Random testing is typically preferred but hard to implement. See the American Society for Addiction Medicine report Appropriate Use of Drug Testing in Clinical Addiction Medicine for details.
Brief Supportive Counseling. Medication management visits also offer an opportunity for providers to provide brief supportive counseling, as they would with any other chronic disease. Providers may use the following strategies for brief counseling1:
- Help identify triggers and manage stressors.
- Listen empathetically and have discussions with patients in a nonjudgmental manner.
- Assess progress against treatment goals and revise these goals as needed using shared decisionmaking techniques.
- Provide medical care for co-occurring physical health conditions.
- Identify patient needs and refer to other providers as needed (including mental health treatment, substance use counseling case management, and community-based recovery support).
- Have patients invite family and friends to medication management visits to discuss how they can support the patents and to educate those who are reluctant to accept the use of medication to treat opioid use disorder.
- Advocate for patients if their retention in treatment is challenged by their employer, housing provider, insurance company, or the criminal justice system.
What Not To Do
- Don’t unilaterally decide which medication to prescribe for the patient. The patient should have input into this decision through a shared decisionmaking process between patient and provider.
- Don’t set an arbitrary limit on patients’ length of time in treatment or discontinue medications against their will.
- Don’t terminate treatment on the basis of urine screens that show continued substance use; instead consider the appropriateness of more intensive treatment.
Treatment Improvement Protocol (TIP) 63: Medications for Opioid Use Disorders
Reviews three FDA-approved medications for OUD treatment (methadone, naltrexone, and buprenorphine) and the other strategies and services needed to support people in recovery.
National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use
Provides information on evidence-based treatment of OUD. This guideline is the only document of its kind to include all Food and Drug Administration (FDA)-approved medications in one place.
Clinical Pathway for Buprenorphine
Clinical Tools (PCSS)
A set of sample tools including forms, treatment agreements, drug accountability records, followup appointment notes, and protocols.
A series of forms that serve as examples for programs implementing buprenorphine treatment.
Office-Based Addiction Treatment Clinical Guidelines
- Substance Abuse and Mental Health Services Administration. Treatment Improvement Protocol 63: For Healthcare and Addiction Professional, Policymakers, Patients, and Families. Rockville, MD: Substance Abuse and Mental Health Services Administration; updated 2020. Publication No. PEP20-02-01-006. https://store.samhsa.gov/sites/default/files/SAMHSA_Digital_Download/PEP21-02-01-002.pdfAccessed July 14, 2021.
- Martin SA, Chiodo LM, Bosse JD, et al. The next stage of buprenorphine care for opioid use disorder. Ann Intern Med. 2018;169:628-35.