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Home › Buprenorphine Interactive Treatment Agreement

Buprenorphine Interactive Treatment Agreement

Providers: Use this form as a guide to create your Buprenorphine Treatment Agreement. This form is in-development and in the future we hope to have it produce a printable agreement for you and your patient to sign.

Buprenorphine Practice Policies Building Engine For Medical Providers Data Entry Form

Step 1 of 7

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  • Introduction

  • Policies to guide patients toward behaviors that will improve buprenorphine treatment outcomes, result in better compliance and retention [1]. Treatment structure clarifies expectations of patients, which is often welcomed by the patient, in addition to supporting the operation of your clinic and helping to prevent diversion. Putting these policies in writing for patients is recommended recommended in expert developed guidelines [2,3,4] Instructions: Use this form to generate a list of office policies and a doctor-patient treatment agreement for your buprenorpine practice. The policies cover office, prescription, and treatment procedures and expectations of patients.
    View References
    1. Öhlin L, Fridell M, Nyhlén A. Buprenorphine maintenance program with contracted work/education and low tolerance for non-prescribed drug use: a cohort study of outcome for women and men after seven years. BMC Psychiatry. 2015; 15:56 (ISSN: 1471-244X). 2015; 15(56): ISSN: 1471-244X. Available at: http://www.medscape.com/medline/abstract/25881164 Accessed on: 2015-09-17.
    2. SAMHSA. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series, No. 40. Center for Substance Abuse Treatment. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Available at: http://www.ncbi.nlm.nih.gov/books/NBK64245/ Accessed on: 2015-09-23.
    3. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
    4. Farmer CM, Lindsay D, Williams J, Ayers A, Schuster J, Cilia A, Flaherty MT, Mandell T, Gordon AJ, Stein BD. Practice Guidelines for Burprenorphine for the Treatment of Opioid Use Disorders: Results of an Expert Panel Process. Substance Abuse Journal. 2015; 36(2): . Available at: http://www.tandfonline.com/doi/pdf/10.1080/08897077.2015.1012613 Accessed on: 2015-09-25.
  • Policy Sources

  • Policies described in this document are derived from several sources:
    • The original guide for prescribing buprenorphine, SAMHSA's Treatment Improvement Protocol (TIP) on the use of buprenorphine in the treatment of opioid addiction, TIP Number 40 [1]
    • The updated policies on buprenorpine treatment produced by the Federation of State Medical Boards' Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office [2]
    • An update and expansion of these guideline developed by an expert panel of expert consultants and intended to provide guidance based on accumulated experience and expert consensus based on 14 years since DATA 2000 was first enacted [3]
    • ASAM's National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use [4].
    View References
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
    2. SAMHSA. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series, No. 40. Center for Substance Abuse Treatment. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Available at: http://www.ncbi.nlm.nih.gov/books/NBK64245/ Accessed on: 2015-09-23.
    3. Farmer CM, Lindsay D, Williams J, Ayers A, Schuster J, Cilia A, Flaherty MT, Mandell T, Gordon AJ, Stein BD. Practice Guidelines for Burprenorphine for the Treatment of Opioid Use Disorders: Results of an Expert Panel Process. Substance Abuse Journal. 2015; 36(2): . Available at: http://www.tandfonline.com/doi/pdf/10.1080/08897077.2015.1012613 Accessed on: 2015-09-25.
    4. American Society of Addiction Medicine (ASAM). The ASAM National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use. June 1, 2015. Available at: http://www.asam.org/docs/default-source/default-document-library/asam-na... Accessed on: 2015-10-06.
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  • Introduction

  • Your office should have a set of policies by which your entire office operates to support smooth operation of your office-based opioid treatment practice and provide supportive structure that patients may need for successful treatment outcomes [1,2]. These will include:
    1. How to communicate with patients
    2. Policies for broken appointments
    3. Expectations regarding payment for treatment
    4. Responses to patient behaviors that could interfere with their treatment or your practice (such as referral to a higher level of care or dismissal from the practice)
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
    2. SAMHSA. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series, No. 40. Center for Substance Abuse Treatment. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Available at: http://www.ncbi.nlm.nih.gov/books/NBK64245/ Accessed on: 2015-09-23.
  • Describe your office policies for your office-based opioid treatment (OBOT) practice. Policies may need to differ from those for the rest of your practice, usually in the direction of providing more structure. Required fields are marked with an *. Skip questions for policies you do not wish to include.
  • Example: Steve Michael, MD, Anderson Health Center
  • Examples: Address, hours, doctor's names, specialty, appointment and emergency contact numbers, tag lines
  • MM slash DD slash YYYY
  • Office Policies

  • YesNo
    A list of policies, reviewed in person with patients
    A paper copy of policies given to patients
    A copy of policies emailed to patients
    Presenting policies as a written agreement between doctor and patient
    A written agreement that must be signed by patients
    A written agreement that must be signed by provider
  • Appointments

    Describe your policies regarding keeping appointments and the consequences for non-adherence.
  • Example: 20 minutes
  • Patient/Physician Contacts

  • Example: Patients may contact the prescribing doctor after hours by calling 555-555-5555 for urgent but non-emergency questions, such as what to do if a dose was forgotten or a concern about a troubling symptom that may be a side effect. For emergencies, patients should call 911.
  • Policy suggested by FSMB [1].
  • Payment of Fees for Buprenorphine Treatment

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  • Introduction

  • Buprenorpine practices need to determine a number of office policies that go beyond usual office policies [1, 2]. They should clearly state patient expectations, limits, and rules to follow to assure smooth practice, provide the structure a patient needs for successful treatment, or help prevent diversion. The policies you choose can be adapted to create a treatment agreement document to present to the patient so that they are aware of these expectations. In the following section, set policy and mechanisms for prescription renewals and consider not allowing early prescription renewals, as recommended by FSMB guidelines [1].
    View References
    Reference
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
    2. SAMHSA. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series, No. 40. Center for Substance Abuse Treatment. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); 2004. Available at: http://www.ncbi.nlm.nih.gov/books/NBK64245/ Accessed on: 2015-09-23.
  • Office Based Opioid Treatments Provided

  • YesNo
    Long term maintenance on buprenorphine
    Maintenance followed by taper
    Maintenance followed by taper with antagonist therapy
    Detoxification
    Detoxification followed by antagonist therapy
    On site counseling
  • Prescription Policies

  • Policy suggested by FSMB (2013).
  • Policy suggested by FSMB [1].
  • Policy suggested by FSMB [1].
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  • Introduction

  • Patients with opioid use disorder often have comorbid psychiatric or substance use disorders, which can affect treatment outcomes or determine whether to treat a patient in a primary care or more structured setting [1, 2, 3]. The most common of these comorbidities are Depression, Anxiety Disorders, and Personality Disorders. Active psychosis or suicidal or homicidal ideation, are contraindications to treatment. Therefore, screening for these conditions and disclosure of diagnosed disorders is important. Source: The FSMB Model Policy for buprenorphine treatment recommends that comorbid psychiatric conditions and disorders be identified and addressed [1].
    View References
    References:
    1. Substance Abuse and Mental Health Services Administration (SAMHSA). Use of Buprenorphine in the Pharmacologic Management of Opioid Dependence: A Curriculum for Physicians. Substance Abuse and Mental Health Services Administration. 2001. Available at:http://www.buprenorphine.samhsa.gov/Buprenorphine_Curriculum.pdf Accessed on: 2013-10-08.
    2. American Society of Addiction Medicine (ASAM). The ASAM National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use. June 1, 2015. Available at: http://www.asam.org/docs/default-source/default-document-library/asam-na... Accessed on: 2015-10-06.
    3. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
  • Mental Health Screening

  • Policy: Patients in buprenorphine treatment will be screened for comorbid psychiatric conditions prior to treatment and periodically throughout treatment.
  • Urine Drug Screening Policies

  • Patient Expectations:
    1. Patients are required to participate in urine drug tests. The FSMB model policy on buprenorphine treatment recommends that treatment agreements obtain permission from patients for drug screens.
    2. Patients are required to disclose the use of any psychoactive substance(s) to the physician. Use of psychoactive substances may be discovered through urine drug testing or review of the patients record in a Prescription Drug Monitoring Report and a policy is needed for when the patient did not disclose their use.
  • Substance Use Screening Questionnaires

  • You may elect to include a policy requiring patients completing substance use screening questionnaires periodicially during treatment.
  • Dose Changes Must Be Approved

  • Patient Expectation: Patient dose changes are not permitted without consulting the physician.
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  • Introduction

  • Policies that help assure that medications are taken safely will support the patient in meeting expectations that will result in a better treatment outcomes [1, 2]. Clear, consistent criteria are needed to determine when treatment needs to be changed or discontinued.
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
    2. American Society of Addiction Medicine (ASAM). The ASAM National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use. June 1, 2015. Available at: http://www.asam.org/docs/default-source/default-document-library/asam-na... Accessed on: 2015-10-06.<.li>
  • Mandatory Patient Expectations

  • The following policies regarding expectations of patients are essential in a buprenorphine practice [1]. The FSMB model policy on buprenorphine treatment recommends that treatment agreements specify the "conditions under which therapy will be continued or discontinued." They also recommend that patients be directed to stop taking other opioids unless specifically instructed to take them. Use the form to select how you will implement these essential policies and the consequences for non-compliance:
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
  • Avoiding the Use of Substance(s) with Potential Adverse Interactions or Poorer Outcomes

  • Patient Expectation: Patients are required to avoid use of substances that may cause an adverse interaction with prescribed medications. Use of benzodiazepines or other sedating patients is dangerous and so discontinuing office based care with referral to a higher level of care is indicated [1]. Use of marijuana or cocaine is not grounds for discontinuing treatment, however, it may be associated with poorer treatment outcomes and should be avoided. The FSMB model policy on buprenorphine states that patients should be told to stop taking all other opioids, unless told otherwise [2].
    View References
    References:
    1. American Society of Addiction Medicine (ASAM). The ASAM National Practice Guideline For the Use of Medications in the Treatment of Addiction Involving Opioid Use. June 1, 2015. Available at: http://www.asam.org/docs/default-source/default-document-library/asam-na... Accessed on: 2015-10-06.
    2. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
  • Taking Medication as Instructed

  • Patient Expectation: Patients are required to take medication as instructed by the physician.
  • Safe Storage & Disposal and Non-Sharing of Medications

  • Patient Expectation: Patients will agree to provide safe storage and to not share their medications. It is important to provide patients with instructions for safe storage and the reasons this is important [1]. This policy should also be reviewed with patients periodically throughout treatment. Example of guidelines that may be used: Safe storage of your medication is essential to safeguard against potentially dangerous use by others. Keep in mind that any visitor can steal from a medicine cabinet and so it is not a good storage place. A locked storage box is recommended. People who are not used to taking opioids or buprenorphine can overdose at a relatively low dose. Proper disposal of medications is also important.
    View References
    References:
    1. Farmer CM, Lindsay D, Williams J, Ayers A, Schuster J, Cilia A, Flaherty MT, Mandell T, Gordon AJ, Stein BD. Practice Guidelines for Burprenorphine for the Treatment of Opioid Use Disorders: Results of an Expert Panel Process. Substance Abuse Journal. 2015; 36(2): . Available at: http://www.tandfonline.com/doi/pdf/10.1080/08897077.2015.1012613 Accessed on: 2015-09-25.
  • Pregnancy Policy: Patients of childbearing age must disclose pregnancy or if they are planning to become pregnant.

  • This patient expectation is recommended for all doctor-patient treatment agreements for female patients of childbearing age [1].
    View References
    References:
    1. Farmer CM, Lindsay D, Williams J, Ayers A, Schuster J, Cilia A, Flaherty MT, Mandell T, Gordon AJ, Stein BD. Practice Guidelines for Burprenorphine for the Treatment of Opioid Use Disorders: Results of an Expert Panel Process. Substance Abuse Journal. 2015; 36(2): . Available at: http://www.tandfonline.com/doi/pdf/10.1080/08897077.2015.1012613 Accessed on: 2015-09-25.
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  • Introduction

  • Risks vs. benefits of a medication, which are part of informed consent, may also be included in treatment agreements. The benefits include treatment of opioid use disorder and risks include potential side effects as well as any interactions and long-term effects that may occur when going through treatment, including physical dependence on buprenorphine.
  • Optional Patient Expectations

  • Medication Supply Counts

  • The FSMB model policy on buprenorphine treatment recommends that treatment agreements include a description of how medication supply counts will be used "as indicated" [1]. This policy of counting the number of tablets or films in a patients prescription container works well for some practices to verify that patients are taking their medications as directed, but other clinics report low compliance with this step. You may elect to include a policy that patients are required to participate in medication supply counts.
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
  • Medication supply counts involve the patient bringing in all of their remaining medication in the prescription bottle and having a count to verify that they have been taking their medication as prescribed, no more and no less.
  • Practices may give 24-hour or 48-hour notice for a patient to complete a medication supply count call back.
  • Counseling and Other Treatments

  • The FSMB model policy for buprenorphine treatment [1] suggests that treatment agreements describe "other treatments or consultations in which the patient is expected to participate, including recovery activities" or "mutual support meetings of groups such as Narcotics Anonymous." You may elect to include a policy requiring patient participation in counseling, patient education, and/or mutual support programs..
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
  • Optional Treatment Policies

  • You may elect to include any of the following policies. They comprise policies that are advocated by some experts but either are not used with every patient, or are alternatives that may work better in some practices than others. If you select a policy in this section, further questions will ask how you wish it to be implemented and consequences for non-adherence.
  • Risks/Benefits

    You may elect to include the benefits and risks of buprenorphine in your treatment agreement, in addition to their mandatory presentation as a part of informed consent [1]. Examples:

    Potential Benefits:

    1. Control of withdrawal symptoms when quitting opioid use.
    2. Supports patients with opioid use disorder in quitting other opioid use.
    3. Compared to other treatments for opioid use disorder, allows more freedom to continue usual daily living routine.

    Potential Disadvantages and Risks:

    1. Patients become physically dependent on buprenorphine.
    2. May experience some opioid-related side effects including mild sedation or impairment of psychomotor function initially and after dose increases or constipation.
    3. Potential drug interactions with other substances, especially sedating drugs and alcohol.
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
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  • Introduction

  • The situation in which buprenorphine treatment is discontinued needs to be defined in advance and understood by staff, providers, and patients. This includes:
    1. Describing the criteria for treatment success
    2. Behaviors that may result in immediate dismissal from treatment
    3. Policy for relapse to opioid use
    These situations need to be outlined and well-understood both before treatment begins and throughout the process.
  • Criteria for Treatment Success

  • Treatment agreements for buprenorphine treatment should include the objectives that will be used to determine whether treatment is successful [1]. An example set of criteria includes the following:
    1. No intoxication from any substance use
    2. Physical, psychosocial, and work-related functioning improved
    3. No suffering from withdrawal
    4. No experience of drug cravings
    5. Following treatment protocol
    6. Adherence to treatment agreement and treatment plan
    View References
    References:
    1. FSMB. Model Policy on DATA 2000 and Treatment of Opioid Addiction in the Medical Office. Federation of State Medical Boards. http://www.fsmb.org. 2013. Available at: https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/2013_model_policy_t... Accessed on: 2015-09-23.
  • Relapse and Problematic Behaviors

  • It is often important to have a policy of what behaviors will not be tolerated in a buprenorphine practice.

    Patient Conduct

  • Relapse Policies

    Policy: Relapse to using opioids will not be grounds for stopping treatment, but treatment structure will be increased.
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Funding Information Development of this website was funded by grant #R44DA12066, contract #HHSN271200655304C, contracts #HHSN271200900003C and Grant #1R44DA027245-01, from the National Institute on Drug Abuse (NIDA) at the National Institutes of Health. The website contents are solely the responsibility of the authors and do not necessarily represent the official views of NIDA. Ongoing development and maintenance is funded by the training fee and Clinical Tools, Inc. No commercial support is received.
Clinical Tools is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

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