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1 Clinical Practice Approval Form Clinical Practice Title: Acute use of Buprenorphine for the Treatment of Opioid Dependence and Detoxification Type of Review: New Clinical Practice Revisions of Existing Clinical Practice Original Approval date: Care Management Council submission date: August 2013 Clinical Practice Owner / Author: (e.g., CCG and WG Lead(s) named) Behavioral Health CCG Contact Information Type of Clinical Expected Recommended Optional Practice: Brief Description of Clinical Practice Patients age with some physician discretion, presenting to a Banner Behavioral Health facilities as short-acting opioid dependent will be evaluated and assessed for the use of buprenorphine for the purposes of detoxification in acute withdrawal from short-acting opioids. Departments/Disciplines Affected Hospitalist Consult liaison team (Consult Service) Reviewed History Reviewed by (name/group): Buprenorphine (Subutex) WG June Behavioral Health CCG June P & T CCG July Hospital Medicine CCG June CMO July CNO July Clinical Practice Toolkit Link: Date: Upon Care Management Council Approval Clinical Practices enter DESIGN Phase in Care Management. Care Management Council Approval Returned to Author for Revision Date: Comments: X Approved by Care Management Council Date: August 22 nd 2013

2 TITLE: Number: Acute use of Buprenorphine for the treatment of opioid dependence and detoxification - Adult Date Posted: Type: Clinical Practice Contact: Approved Date: Implementation Date: Deactivation Date: Facilities: Approved by: Acute use of Buprenorphine for the treatment of Opioid Dependence and Detoxification Adult (16-65) PRACTICE APPROACH: Expected Clinical Practice PRACTICE STATEMENT: Patients age with some physician discretion, presenting to a Banner Behavioral Health facilities as short-acting opioid dependent will be evaluated and assessed for the use of buprenorphine for the purposes of detoxification in acute withdrawal from short-acting opioids. RATIONAL: Increasing hospital visits for emergency and detoxification treatment for heroin and short-acting prescription opioids has led to a need for more effective and safer pharmacological treatment options. Methadone has been demonstrated to be effective in decreasing opioid use, but the availability of treatment programs and ineffective short-term detoxification (Center for Substance Abuse Treatment, 2004; Oreskovich et al., 2005). Clonidine has been used as a common standard of acute detoxification for its ability to manage noradrenergic hyperactivity symptoms of withdrawal, but is limited of managing all symptomology and less effective with purer forms of heroin (Center for Substance Abuse Treatment, 2004; Oreskovich et al., 2005). Buprenorphine use for acute opioid detoxification in the acute inpatient has been well evaluated in the literature for both rapid withdrawal management and continued maintenance treatment (Center for Substance Abuse Treatment, 2004; Oreskovich et al., 2005). Buprenorphine is an opioid partial agonist/antagonist and available as a monotherapy Subutex or combination therapy Suboxone (buprenorphine plus naloxone (4:1)). When compared to full agonist opioids, it is a favorable choice for detox in the acute behavioral health setting due to a lower abuse potential; lower level of withdrawal symptoms, higher dose maximum effect (ceiling effect); and reduced overdose risk and respiratory depression. Banner Health Use of Buprenorphine Clinical Practice Page 2 of 5

3 Although not in itself directly life-threatening event, acute withdrawal from opioids presents a severe risk to patients experiencing it, including relapse to abusing short-acting opioids and co-morbid symptoms that can be a danger to the patient and to others. Inpatient treatment based on recognized standards provides for increased patient safety as well as comfort by controlling the acute withdrawal symptoms in a systematic manner. This allows for the prevention or control of co-morbid symptoms as well as providing for a higher rate of successful detoxification with reduced risk of harm or relapse to this patient population. Buprenorphine has emerged as a preferential treatment option for acute opioid detoxification in the acute inpatient setting due to its safety, demonstrated effectiveness in short withdrawal regimens, and lower abuse potential (Center for Substance Abuse Treatment, 2004; Oreskovich et al., 2005). The use of buprenorphine is indicated for use in supervised detoxification from opioid physical dependence, while at the same time promoting a transition to further rehabilitation and relapse prevention. While buprenorphine is effective as initial strategy towards being opioid-free, continued rehabilitation with opioid antagonist treatment or opioid abstinence is necessary to prevent relapse. Patients should be evaluated for their desire and ability to engage in an ongoing rehabilitation program with the goal of achieving a long-term opioid-free state. CLINICAL APPROACH: Patients requiring medically supervised withdrawal (detoxification) will undergo assessment/screening for shortacting opioid use and readiness to participate to treatment with a goal to become opioid-free. Upon entering opioid withdrawal, patients are initiated on an induction phase of buprenorphine followed by either a rapid tapering or maintenance phase dosing depending on individual needs and progress. Patients requiring ongoing maintenance beyond an inpatient admission will require a community referral for continued monitoring, dose management and rehabilitation therapy. Screening and Assessment for Buprenorphine Objectives of Screening and Assessment 1. Identify patients who are at risk or have developed drug or alcohol abuse problems. 2. Establish the diagnosis or diagnoses 3. Determine the biopsychosocial of the patient with addiction issues 4. Develop treatment plan that includes pharmacological and rehabilitation options 5. Identify and explore contraindications to buprenorphine treatments 6. Assess other medical problems or conditions that need to be addressed before or during buprenorphine treatments Inclusion Criteria for patient to use Buprenorphine 1. Diagnosis of opioid addiction/opioid dependence a) Patients meeting the criteria for opioid abuse may benefit from a short-period detoxification. 2. Between the ages of 16 and Patients initiated on buprenorphine should: a) Consent for treatment for opioid addiction b) Free of contraindications for buprenorphine c) Agree to buprenorphine treatment and compliant with safety precautions d) Understand the risk and benefits Exclusion/Caution Criteria Conditions and Circumstances That Preclude a Patient as a Candidate for Inpatient/Outpatient Buprenorphine treatment (as per SAMSHA Guidelines): Comorbid dependence on high doses of benzodiazepines or other central nervous system depressants (including alcohol and sedative/hypnotics) Banner Health Use of Buprenorphine Clinical Practice Page 3 of 5

4 Significant untreated psychiatric comorbidity Active or chronic suicidal or homicidal ideation or attempts Significant medical complications Conditions that are outside the area of the treating physician s expertise CLINICAL PRACTICE Conditions and Circumstances that requires further Psychiatric or Addiction Medicine Consult before buprenorphine initiation Multiple previous treatments for drug abuse with frequent relapses Methadone or levo-alpha-acetyl-methadol (LAAM) Acute ETOH Withdrawal Chronic Pain Seizures Unstable Psychiatric Condition The following medical conditions require evaluation of risk to-benefit of buprenorphine use and lower dosing maybe indicated. Pregnancy HIV treatment Impaired Hepatic Function ***Note: Buprenorphine/Naloxone combination is an absolute contraindicated for use in pregnant women and therefore only monotherapy buprenorphine be used. Management for Buprenorphine The goals of treatment: To stabilize the patient as rapidly as possible To minimize withdrawal symptoms Prevent further use of illicit opioids Initiation of withdrawal using buprenorphine will begin within hours after last known use of short-acting opioids and initial withdrawal symptoms present. Depending on the type of opioid (heroin vs prescription med), length of use (chronic) and amount of use/dosage levels, withdrawal symptoms may occur rapidly or delayed. Treatment should be initiated based on history of use and presence of withdrawal symptoms as early detoxification may precipitate opioid withdrawal syndrome. Tapering and Maintenance Treatment Course of Tapering and Maintenance Long-term reduction/maintenance treatment (12 months-lifetime) is preferable to shorter period detoxification. An opioid free state can be achieved over a day period in combination with rehabilitation. Patients in the acute hospital setting may desire and/or require rapid reduction to an opioid free state, including buprenorphine. Discontinuation of buprenorphine can be achieved over a 3 day period, however, relapse and successful outcomes from short-period reduction are unknown and a moderate period reduction should be employed when possible. 1. Long-Period tapering and maintenance 2. Moderate-Period tapering and maintenance 3. Short-Period tapering and maintenance Banner Health Use of Buprenorphine Clinical Practice Page 4 of 5

5 Waiver to Dispense According to the Drug Addiction Treatment Act of 2000 (DATA 2000), prescribers of buprenorphine have to obtain a waiver to prescribe/dispense buprenorphine for opioid detoxification without a primary medical problem. The waiver requires completing 8 hours of CE to obtain a Drug Addiction Treatment Act (DATA) waiver.[banner providers dispensing buprenorphine will have a DATA waiver] REFERENCES: Center for Substance Abuse Treatment. Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement Protocol (TIP) Series 40. DHHS Publication No. (SMA) Rockville, MD: Substance Abuse and Mental Health Services Administration, Oreskovich et al. (2005) A double-blind, double-dummy, randomized, prospective pilot study of the partial Mu opiate agonist, buprenorphine, for acute detoxification from heroin. Drug and Alcohol Dependence 77 (2005) KEYWORDS AND KEYWORD PHRASES: Clinical Practice Buprenorphine Subutex Opioid dependence Detoxification Banner Health Use of Buprenorphine Clinical Practice Page 5 of 5

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