California Society of Addiction Medicine California Department of Health Care Services Guidelines for Physicians Working in California Opioid Treatment Programs Editors: Walter Ling, MD Deborah Stephenson, MD, MPH Ernest Vasti, MD This publication made possible through a SAMHSA Opioid State Targeted Response Grant © 2019 California Society of Addiction Medicine (CSAM) 575 Market Street, Ste 2125 San Francisco, CA 94105 www.csam-asam.org California Society of Addiction Medicine California Department of Health Care Services 2019 Guidelines for Physicians Working in California Opioid Treatment Programs Editors: Walter Ling, MD Deborah Stephenson, MD, MPH Ernest Vasti, MD This publication made possible through a SAMHSA Opioid State Targeted Response Grant © 2019 California Society of Addiction Medicine (CSAM) 575 Market Street, Ste 2125 San Francisco, CA 94105 www.csam-asam.org 2 Guidelines for Physicians Working in California Opioid Treatment Programs TABLE OF CONTENTS Preface ........................................................................................................5 Introduction .................................................................................................5 Objective .....................................................................................................6 Chapter 1 Patient Assessment and Diagnosis ..........................................................7 Chapter 2.1 Medication-Assisted Treatment: Methadone ........................................... 15 Chapter 2.2 Medication-Assisted Treatment: Buprenorphine ..................................... 34 Chapter 2.3 Medication-Assisted Treatment: Naltrexone ........................................... 40 Chapter 3 Managing Pain in Patients with Opioid Use Disorder .........................................................................44 Chapter 4 Pregnancy and Neonatal Withdrawal .....................................................47 Chapter 5 Comorbid Polysubstance Use .................................................................64 Chapter 6 Concurrent Medical Conditions ..............................................................71 Chapter 7 Comorbid Psychiatric Illness ..................................................................86 Chapter 8 Laboratory Data ........................................................................................92 Appendix I Use of California’s CURES Database by OTPs ....................................100 Appendix II Hub and Spoke Model in California ......................................................102 Glossary of Terms .................................................................................104 References ..............................................................................................105 www.csam-asam.org 3 AUTHORS AND CONTRIBUTORS Anthony Albanese, MD, FACP, Rachel McLean, MPH DFASAM David Mee-Lee, MD Soraya Azari, MD Yulsi Fernandez Montero, MD, Peter Banys, MD, MSc MPH Timmen Cermack, MD Erica Murdock-Waters Diana Coffa, MD Kerry Parker, CAE Peggy Compton, RN, PhD, FAAN Richard Rawson, PhD Hilary S. Connery, MD, PhD Alessandra Ross Jeffrey DeVido, MD, MTS Kenneth A. Saffier, MD, FASAM Douglas Gourlay, MD, MSc, Andrew J. Saxon, MD FRCPC, FASAM Peter Selby, MBBS, CCFP, FCFP, Joseph Graas, PhD MHSc, DipABAM, DFASAM Gail Jara Brad Shapiro, MD, FASAM David Kan, MD, DFASAM Steven J. Shoptaw, PhD SueAnn Kim, MD Claire Anne Simeone, DNP, MSN, FNP, RN Michael Li, PhD, MPH Hannah Snyder, MD Michelle Ling, Masters in Journalism Scott Steiger, MD, FACP, FASAM Walter Ling, MD Deborah K. Stephenson, MD, MPH Paula J. Lum, MD, MPH Matthew A. Torrington, MD John J. McCarthy, MD Ernest J. Vasti, MD 4 Guidelines for Physicians Working in California Opioid Treatment Programs PREFACE By Jara, G. & Ling, W. These guidelines were developed by the Committee on highlighted in an overview of the “Hub and Spoke” model. Opioids of the California Society of Addiction Medicine to provide an overview and discussion of the matters of Equally as notable, however, is how little our treatment clinical care that fall under the responsibility of the Opioid protocols, policies, and procedures have advanced — Treatment Program (OTP) Medical Director and Program particularly with methadone — since their introduction in the Physicians. They were prepared and distributed first in 1998 1960s, despite advances in pharmacological and behavioral and updated first in 2004, and again in 2008. We are now sciences. Therefore, the reason for the limited change pleased to publish the newest update for 2019 . in practices is likely unrelated to scientific knowledge, but rather a myopic cultural attitude towards addiction. In the past decade, much has changed in opioid We continue to wage war on patients with substance pharmacotherapy – indeed, even the title for these use disorders that we call a “war on drugs” and although guidelines required updating to “OTP” (vs. Narcotic we study addiction as a serious illness, too often people Treatment Program). Notably, there are an increasing afflicted with it are treated more like criminals than patients. number of patients receiving buprenorphine treatment Therefore, in addition to providing guidelines based on the and, to a lesser extent, naltrexone. In 2013, DSM-5 was most recent evidence in pharmacology, we also hope to published, replacing DSM IV-TR. Accordingly, this update inspire introspective change within ourselves as physicians includes sections on buprenorphine, naltrexone, and and healers in our communities. To this end, we have management of pain in patients maintained on opioid included guidance on general approaches to patients, pharmacotherapy. We have expanded the section on ethical considerations, and the importance of using non- pregnancy and urine toxicology testing; we have updated stigmatizing language. advancements in treating co-occurring medical illnesses, especially hepatitis, HIV and other infectious diseases, We thank all the authors who took responsibility for various and co-occurring psychiatric disorders. The recent interest Chapters. in expanding access to difficult-to-reach patients is INTRODUCTION By Stephenson, D., & Ling, W. The physician in an opioid treatment program (OTP) can also improve community safety and public health practices in a uniquely challenging medical environment, through screening for and treating communicable diseases, responding to a diverse array of medical, psychiatric, and offering other preventive health services. and social problems. The past experiences of patients with Substance Use Disorder (SUD) in medical settings often result in mistrust and even aversion to mainstream opioid treatment Program (otP) medical providers, which discourages them from even definition, Accreditation and seeking what limited care may be available. In recent Management years, OTPs are seeing a growing number of patients who are addicted to prescription opioids rather than, or in addition to, heroin. Many of these patients have chronic Federal regulations require that OTPs be accredited by pain issues as well as SUD. an agency approved by the Center for Substance Abuse Treatment (CSAT). At this time, in California, the approved Characteristically, people with SUD receive high-cost agencies are the Joint Commission on Accreditation of crisis care in emergency departments and hospitals. After Health Organizations (JCAHO) and the Commission on discharge from the hospital there is little to no follow-up, and Accreditation of Rehabilitation Facilities (CARF.) The CARF there is rarely any continuity of care for patients with frequent standards say that each OTP must have a medical director emergency room visits. The physician in the OTP is often the who is responsible for: first medical provider with whom these patients establish a a. Administering or supervising all medical services. long term therapeutic relationship. The OTP physician can be an important, even lifesaving, resource for patients enrolled b. Ensuring that the program is in conformance with in treatment, identifying the multiple medical problems that all applicable local, state, and federal regulations characterize chemical dependence and providing treatment regarding the medical treatment of opioid addiction. or referrals to address these problems. The OTP physician www.csam-asam.org 5 CARF Standards go on to say that, in order to serve as the in the Code of Federal Regulations Titles 21 and 42; medical director of an OTP, a physician must have either: California’s regulations are found in Title 9 of the California Code. This document refers to these regulations, but it is a. Demonstrated experience in opioid treatment, or not designed to summarize all of them. Rather, this guide b. Developed a written plan to attain competence in offers practical clinical information and suggestions for opioid treatment within twelve months (to include the physician working in an OTP. While this document is continuing medical education in addiction medicine), intended to assist physicians in making clinical decisions, and be monitored by the designated authority. it does not represent regulations or standards of care. Ultimately clinical decisions are made based on the Although the Medical Director of an OTP has administrative patient’s situation, the available resources and a physician’s responsibilities in addition to the medical/clinical ones, best clinical judgment. they are separate issues; this guide focuses on the medical piece.