Medications For Opioid Use Disorder - SAMHSA

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Medications for Opioid Use DisorderFor Healthcare and Addiction Professionals, Policymakers, Patients, and FamiliesUPDATED 2020TREATMENT IMPROVEMENT PROTOCOLTIP 63

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TIP 63MEDICATIONS FOR OPIOID USE DISORDERTreatment Improvement Protocol 63For Healthcare and Addiction Professionals, Policymakers, Patients, and FamiliesThis TIP reviews three Food and Drug Administration-approved medications for opioid usedisorder treatment—methadone, naltrexone, and buprenorphine—and the other strategies andservices needed to support people in recovery.TIP NavigationExecutive SummaryFor healthcare and addiction professionals, policymakers, patients, and familiesPart 1: Introduction to Medications for Opioid Use Disorder TreatmentFor healthcare and addiction professionals, policymakers, patients, and familiesPart 2: Addressing Opioid Use Disorder in General Medical SettingsFor healthcare professionalsPart 3: Pharmacotherapy for Opioid Use DisorderFor healthcare professionalsPart 4: Partnering Addiction Treatment Counselors With Clients and Healthcare ProfessionalsFor healthcare and addiction professionalsPart 5: Resources Related to Medications for Opioid Use DisorderFor healthcare and addiction professionals, policymakers, patients, and families

TIP 63MEDICATIONS FOR OPIOID USE DISORDERContentsEXECUTIVE SUMMARYForeword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-iiiTip 63 Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-iiiIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-1Overall Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-1Content Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-3Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-7TIP Development Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-9Publication Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-12PART 1: AN INTRODUCTION TO MEDICATIONS FOR THE TREATMENT OFOPIOID USE DISORDERThe Approach to OUD Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1Overview of Medications for OUD . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3Duration of Treatment With OUD Medication . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-8Treatment Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-9Challenges to Expanding Access to OUD Medication. . . . . . . . . . . . . . . . . . . 1-10Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11PART 2: ADDRESSING OPIOID USE DISORDER IN GENERAL MEDICALSETTINGSScope of the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Screening . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8Treatment Planning or Referral . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-17Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-28Appendix . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-32Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-39ii

MEDICATIONS FOR OPIOID USE DISORDERTIP 63PART 3: PHARMACOTHERAPY FOR OPIOID USE DISORDERScope of the Problem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1Chapter 3A: Overview of Pharmacotherapy for Opioid Use Disorder. . . . 3-5Chapter 3B: Methadone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-17Chapter 3C: Naltrexone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-37Chapter 3D: Buprenorphine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-51Chapter 3E: Medical Management Strategies for PatientsTaking OUD Medications in Office-Based Settings . . . . . . . . . . . . . . . . . . . . . . 3-83Chapter 3F: Medical Management of Patients Taking OUD Medications3-103in Hospital Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-109PART 4: PARTNERING ADDICTION TREATMENT COUNSELORS WITHCLIENTS AND HEALTHCARE PROFESSIONALSOverview and Context . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1Quick Guide to Medications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-12Counselor–Prescriber Communications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-18Creation of a Supportive Counseling Experience . . . . . . . . . . . . . . . . . . . . . . . 4-20Other Common Counseling Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-34Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-37PART 5: RESOURCES RELATED TO MEDICATIONS FOR OPIOID USE DISORDERGeneral Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1Resources for Counselors and Peer Providers . . . . . . . . . . . . . . . . . . . . . . . . . . 5-10Resources for Clients and Families . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12Provider Tools and Sample Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-16Glossary of TIP Terminology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-56Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-59iii

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TIP 63MEDICATIONS FOR OPIOID USE DISORDERExecutive SummaryFor Healthcare and Addiction Professionals, Policymakers, Patients, and FamiliesThe Executive Summary of this Treatment Improvement Protocol provides an overview on theuse of the three Food and Drug Administration-approved medications used to treat opioid usedisorder—methadone, naltrexone, and buprenorphine—and the other strategies and servicesneeded to support recovery.TIP NavigationExecutive SummaryFor healthcare and addiction professionals, policymakers, patients, and familiesPart 1: Introduction to Medications for Opioid Use Disorder TreatmentFor healthcare and addiction professionals, policymakers, patients, and familiesPart 2: Addressing Opioid Use Disorder in General Medical SettingsFor healthcare professionalsPart 3: Pharmacotherapy for Opioid Use DisorderFor healthcare professionalsPart 4: Partnering Addiction Treatment Counselors With Clients and Healthcare ProfessionalsFor healthcare and addiction professionalsPart 5: Resources Related to Medications for Opioid Use DisorderFor healthcare and addiction professionals, policymakers, patients, and familiesSubstance Abuse and Mental HealthServices Administration

TIP 63MEDICATIONS FOR OPIOID USE DISORDER—Executive SummaryContentsForeword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-iiiTIP 63 Update . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-iiiIntroduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-1Overall Key Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-1Content Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Part 1: Introduction to Medications for Opioid Use Disorder Treatment . . . . . . . . . . . . .Part 2: Addressing Opioid Use Disorder in General Medical Settings . . . . . . . . . . . . . . . .Part 3: Pharmacotherapy for Opioid Use Disorder . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Part 4: Partnering Addiction Treatment Counselors With Clients andHealthcare Professionals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .Part 5: Resources Related to Medications for Opioid Use Disorder . . . . . . . . . . . . . . . . . .ES-3ES-3ES-4ES-4ES-5ES-5Notes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-7TIP Development Participants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-9Expert Panelists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-9Scientific Reviewers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-10Field Reviewers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-10Publication Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ES-12ES-ii

TIP 63MEDICATIONS FOR OPIOID USE DISORDER—Executive SummaryForewordThe Substance Abuse and Mental Health Services Administration (SAMHSA) is the U.S. Department ofHealth and Human Services agency that leads public health efforts to reduce the impact of substanceabuse and mental illness on America’s communities. An important component of SAMHSA’s work isfocused on dissemination of evidence-based practices and providing training and technical assistanceto healthcare practitioners on implementation of these best practices.The Treatment Improvement Protocol (TIP) series contributes to SAMHSA’s mission by providingscience-based, best-practice guidance to the behavioral health field. TIPs reflect careful considerationof all relevant clinical and health services research, demonstrated experience, and implementationrequirements. Select nonfederal clinical researchers, service providers, program administrators, andpatient advocates comprising each TIP’s consensus panel discuss these factors, offering input on theTIP’s specific topics in their areas of expertise to reach consensus on best practices. Field reviewers thenassess draft content and the TIP is finalized.The talent, dedication, and hard work that TIP panelists and reviewers bring to this highly participatoryprocess have helped bridge the gap between the promise of research and the needs of practicingclinicians and administrators to serve, in the most scientifically sound and effective ways, people inneed of care and treatment of mental and substance use disorders. My sincere thanks to all who havecontributed their time and expertise to the development of this TIP. It is my hope that clinicians will findit useful and informative to their work.Elinore F. McCance-Katz, M.D., Ph.D.Assistant Secretary for Mental Health and Substance UseU.S. Department of Health and Human ServicesSubstance Abuse and Mental Health Services AdministrationTIP 63 UpdateTo ensure that the content of this TIP is as up to date and as useful to readers as possible, SAMHSA,in January 2020, revised certain areas of all five parts. These changes will help provide readers withthe latest information needed to understand medications for opioid use disorder. These changesincluded the following: Updating statistics from SAMHSA, the Centers for Disease Control and Prevention, and otherhealth authorities on opioid-related deaths, overdoses, accidents, and hospitalizations.Updating the expanded list of other qualifying practitioners who are eligible to apply for a waiverto prescribe buprenorphine (i.e., clinical nurse specialists, certified registered nurse anesthetists,and certified nurse midwives).Clarifying that buprenorphine is available in an extended-release injection formulation.Adding information about the use of subdermal formulations of buprenorphine (i.e., Probuphineand Sublocade).Adding information about possible clinical interactions between formulations of buprenorphineand naltrexone with various other medications and products.Improving the language to make clear the importance of testing for HIV and hepatitis C.Updating recommendations from the U.S. Preventive Services Task Force on performing drugscreening for adults in primary care settings.Removing or replacing broken hyperlinks to online resources.ES-iii

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TIP 63MEDICATIONS FOR OPIOID USE DISORDERExecutive SummaryThe goal of treatment for opioid addiction or opioid use disorder (OUD) is remission of thedisorder leading to lasting recovery. Recovery is a process of change through which individuals improve their health and wellness, live self-directed lives, and strive to reach their fullpotential.1 This Treatment Improvement Protocol (TIP) reviews the use of the three Foodand Drug Administration (FDA)-approved medications used to treat OUD—methadone,naltrexone, and buprenorphine—and the other strategies and services needed to supportrecovery for people with OUD.IntroductionOur nation faces a crisis of overdose deaths fromopioids, including heroin, illicit fentanyl, andprescription opioids. These deaths represent amere fraction of the total number of Americansharmed by opioid misuse and addiction. ManyAmericans now suffer daily from a chronicmedical illness called “opioid addiction” orOUD (see the Glossary in Part 5 of this TIP fordefinitions). Healthcare professionals, treatmentproviders, and policymakers have a responsibilityto expand access to evidence-based, effectivecare for people with OUD.Estimated costof the OPIOIDEPIDEMIC was 504BILLIONin 2015.2An expert panel developed the TIP’s contentbased on a review of the literature and on theirextensive experience in the field of addictiontreatment. Other professionals also generouslycontributed their time and commitment to thisproject.An estimated 1.7MAMERICANShave OUD related toopioid painkillers;526K have heroinrelated OUD.3The TIP is divided into parts so that readers caneasily find the material they need. Part 1 is ageneral introduction to providing medicationsfor OUD and issues related to providing thattreatment. Some readers may prefer to go directlyto those parts most relevant to their areas ofinterest, but everyone is encouraged to readPart 1 to establish a shared understanding ofkey facts and issues covered in detail in this TIP.Following is a summary of the TIP’s overall mainpoints and brief summaries of each of the fiveTIP parts.Overall Key MessagesAddiction is a chronic, treatable illness.Opioid addiction, which generally correspondswith moderate to severe forms of OUD, oftenrequires continuing care for effective treatmentrather than an episodic, acute-care treatmentapproach.ES-1

TIP 63Medications for Opioid Use DisorderOpioid overdose caused46,800 DEATHSnationwide in 2018—this exceeded the #caused by motor vehiclecrashes.4,5General principles of good care for chronicdiseases can guide OUD treatment.Approaching OUD as a chronic illness canhelp providers deliver care that helps patientsstabilize, achieve remission of symptoms, andestablish and maintain recovery.Patient-centered care empowers patientswith information that helps them make bettertreatment decisions with the healthcareprofessionals involved in their care. Patientsshould receive information from their healthcareteam that will help them understand OUD andthe options for treating it, including treatmentwith FDA-approved medication.Patients with OUD should have access tomental health services as needed, medicalcare, and addiction counseling, as well asrecovery support services, to supplementtreatment with medication.The words you use to describe OUD andan individual with OUD are powerful. ThisTIP defines, uses, and encourages providersto adopt terminology that will not reinforceprejudice, negative attitudes, or discrimination.There is no “one size fits all” approach toOUD treatment. Many people with OUD benefitfrom treatment with medication for varyinglengths of time, including lifelong treatment.Ongoing outpatient medication treatment forOUD is linked to better retention and outcomesES-2than treatment without medication. Even so,some people stop using opioids on their own;others recover through support groups orspecialty treatment with or without medication.The science demonstrating the effectivenessof medication for OUD is strong. For example,methadone, extended-release injectable naltrexone (XR-NTX), and buprenorphine were eachfound to be more effective in reducing illicitopioid use than no medication in randomizedclinical trials, which are the gold standard fordemonstrating efficacy in clinical medicine.6,7,8,9,10Methadone and buprenorphine treatmenthave also been associated with reduced risk ofoverdose death.11,12,13,14,15This doesn’t mean that remission and recoveryoccur only through medication. Some peopleachieve remission without OUD medication, justas some people can manage type 2 diabeteswith exercise and diet alone. But just as it isinadvisable to deny people with diabetes themedication they need to help manage theirillness, it is also not sound medical practice todeny people with OUD access to FDA-approvedmedications for their illness.Medication for OUD should be successfullyintegrated with outpatient and residentialtreatment. Some patients may benefit fromdifferent levels of care at different points in theirlives, such as outpatient counseling, intensiveoutpatient treatment, inpatient treatment, orlong-term therapeutic communities. Patientstreated in these settings should have access toOUD medications.2 MILLIONpeople in the U.S.,ages 12 and older,had OUD involvingPRESCRIPTIONOPIOIDS, HEROIN,or both in 2018.16

TIP 63Executive SummaryPatients treated with medications for OUDcan benefit from individualized psychosocialsupports. These can be offered by patients’healthcare providers in the form of medicationmanagement and supportive counseling and/orby other providers offering adjunctive addictioncounseling, recovery coaching, mental healthservices, and other services that may be neededby particular patients.Expanding access to OUD medications isan important public health strategy. 17 Thegap between the number of people needingopioid addiction treatment and the capacity totreat them with OUD medication is substantial.In 2012, the gap was estimated at nearly 1million people, with about 80 percent of opioidtreatment programs (OTPs) nationally operatingat 80 percent capac

MEDICATIONS FOR OPIOID USE DISORDER Executive Summary The goal of treatment for opioid addiction or opioid use disorder (OUD) is remission of the disorder leading to lasting recovery. Recovery is a process of change through which individ-

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2 Opioid Use Disorder Guide U.S. DEPARTMENT OF VETERANS AFFAIRS 3 Opioid Use Disorder (OUD) Opioid Use Disorder (OUD) is a brain disease that can develop after repeated opioid use.1 Just like other diseases (e.g. hypertension, diabetes), OUD typically requires chronic management.See Table 2 for OUD DSM-5 diagnostic criteria. Substance use disorders are more highly stigmatized than other health .

Opioid Use Disorder In 2017, 2.1 million Americans had an opioid use disorder and on average 130 people die every day from opioid overdose.1,2 Preventative measures for mitigation of risk in the face of this epidemic are essential. Harm reduction is a strategic set of policies, programs, and actions applied to

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Expanding access to effective treatment for opioid use disorder (OUD) is key to addressing high mortality and morbidity related to illicit opioid use across the United States. Medicaid coverage of medications to treat opioid use disorder (MOUD

4 Identifying and Managing Opioid Use Disorder (OUD) U.S. DEPARTMENT OF VETERANS AFFAIRS 5 Making the diagnosis: clarifying the terminology ICD-10 is the official diagnosis system used in VA medical records. The ICD-10 code “opioid dependence” is equivalent to the term “opioid use disorder” as defined in the

4 Post-op Opioid Use Study of 39,140 opioid-naïve patients having major surgery 49.2% D/C with opioid prescription 3.1% on opioids 90 days after surgery 5 Post-op Opioid Use Study of 391,139 opioid- naïve patients having short-stay surgery 7.7% were prescribed opioids 1 year after surgery

F41.1 Generalized anxiety disorder F40.1 Social phobia F41.2 Mixed anxiety and depressive disorder F33 Recurrent depressive disorder F43.1 Post-traumatic stress disorder F60.31 Borderline personality disorder F43.2 Adjustment disorder F41.0 Panic disorder F90 Hyperkinetic (attention deficit) disorder F42 Obsessive-compulsive disorder

Beste Freunde 2 - Kursbuch CD 1 Track 2 Lektion 19, 2 Anna: Laura? Hallo? Laura: Hi, Anna! Simon: Huhuuu! Kannst du uns sehen? Anna: Hey, Simon, ja, ich sehe euch. Super! Laura: Und? Wie ist es in Köln? Gefällt es dir? Anna: Na ja, eigentlich ist die Stadt ganz schön. Aber . ihr seid nicht da. Und München ist so weit weg . Laura: Du fehlst uns auch, Anna! Anna: Echt? Simon: Na klar .