Editor: Deborah K. Stephenson, MD, MPH
for the CSAM Committee on Treatment of Opioid Dependence
PREAMBLE
This monograph was developed by the Committee on Treatment of Opioid Dependence of the California Society of Addiction Medicine to provide an overview and discussion of the matters of clinical care that fall under the responsibility of the opioid treatment program (OTP) medical director and program physicians. It was prepared and distributed first in 1998 and updated once in 2004. This 2008 edition incorporates current information.
OTP is the term used by Federal and state regulating agencies to refer to clinics that are specially licensed to provide opioid pharmacotherapy for addiction treatment. OTPs are commonly known as methadone clinics. Both the Federal and state governments regulate OTPs. Federal regulations are found in 42 CFR Part 8, and California's regulations are found in Chapter 4, Division 4, Title 9 of the California Code. This document will reference these regulations, but it is not designed to summarize all of them. Rather, this monograph is meant to serve as a reference offering practical clinical information and suggestions for the physician working in an OTP. While this document is intended to assist physicians in making clinical decisions, it does not represent regulations or standards of care. Ultimately clinical decisions are made based on the patient's situation, the available resources and a physician's best clinical judgment.
Federal regulations require that OTPs be accredited by an agency approved by the Center for Substance Abuse Treatment (CSAT.) In California, in 2008, the approved agencies are the Joint Commission on Accreditation of Health Organizations (JCAHO) and the Commission on Accreditation of Rehabilitation Facilities (CARF.) The CARF standards say that each OTP must have a medical director who is responsible for:
- Administering or supervising all medical services.
- Ensuring that the program is in conformance with all applicable local, state, and Federal regulations regarding the medical treatment of opioid addiction.
CARF Standards go on to say that, in order to serve as the Medical Director of
an OTP, a physician must have either:
- Demonstrated experience in opioid treatment, or
- Developed a written plan to attain competence in opioid treatment within twelve months (to include continuing medical education in addiction medicine), and be monitored by the designated authority.
Although the Medical Director of an OTP has administrative responsibilities in addition to the medical/clinical ones, they are a separate issue. This monograph's focus is on the medical piece.
This monograph was circulated for review to interested parties, including representatives of these organizations and agencies:
- Center for Substance Abuse Treatment
- American Association on the Treatment of Opioid Dependence
- California Organization of Methadone Providers
- American Society of Addiction Medicine Sub-Work-Group on Opioid Agonist Treatment
- California Department of Alcohol and Drug Programs
The Committee considered all comments received and made additions and/or changes based on the information submitted in the comments.
Guidelines discussing clinical practice are subject to periodic review and revision to incorporate new developments. The CSAM Committee plans to review this document periodically to determine if revisions may be appropriate. If the document is revised, it will be circulated for comment and published with a new date. The latest revision is always available from the CSAM website: www.csam-asam.org
INTRODUCTION
The physician in an opioid treatment program (OTP) practices in a uniquely challenging medical environment, responding to a diverse array of medical, psychiatric, and social problems in a largely indigent population with limited access to health care. The past experiences of opioid dependent patients in medical settings often result in mistrust, and even hostility, toward mainstream medical providers, which discourages them from seeking even the limited care
available.
Characteristically, addicted patients receive high-cost crisis care in Emergency Departments and hospitals. After discharge, there is little to no follow-up.
The physician in the OTP is often the first medical provider with whom these patients establish a long‑term therapeutic relationship. The OTP physician can be an important, even lifesaving, resource for patients enrolled in treatment, identifying the multiple medical problems that characterize heroin and opioid addiction and providing treatment or referrals to address these problems. The OTP physician is also in a position to positively impact the public health of the
community by screening for and treating communicable disease and offering other preventive health services.
As of September 2008, there are two medications available and approved for use in opioid maintenance treatment: methadone and sublingual formulations of buprenorphine. This document focuses primarily on treatment with methadone and includes a brief review of treatment with buprenorphine in Appendix B.
Methadone maintenance treatment (MMT) in the United States is regulated, comprehensive treatment which requires observed dosing, random urine drug testing and participation in counseling. It offers major pharmacologic benefits, such as the alleviation of the symptoms of physical withdrawal, the reduction or elimination of opioid craving and partial or complete blockade of the euphoric effects of outside opioids. All of these benefits help to support patients' efforts to achieve and maintain abstinence. However the benefits of MMT extend beyond pharmacologic ones. Medical and counseling interventions help patients to reduce needle sharing and unprotected/risky sexual behaviors associated with drug use. Retention in treatment allows medical and psychosocial issues to be addressed. MMT allows patients to receive consistent and ongoing counseling to support the lifestyle changes necessary to progress in recovery. It is helpful for OTP personnel to have a basic understanding of 12 Step programs and of all elements of recovery to assist patients toward long-term goals. Ultimately, long term goals include improved family stability, decreased hospital admissions, regular medical and dental care, decreased criminal activity and incarceration, and vocational rehabilitation. Achieving these goals benefits society as well as the individual patient.
CSAM Committee on Treatment of Opioid Dependence:
- Karen Miotto, MD, Committee Chair, Medical Director, Substance Abuse Program, Los Angeles VA Ambulatory Care Center
- Peter Banys, MD, Director, Substance Abuse Programs, VA Medical Center, San Francisco
- Gail Jara, Consultant to CSAM, Staff to the Committee on Treatment of Opioid Dependence
- David Kan, MD, Head of the Opioid Replacement Team, VA Medical Center, San Francisco
- Lori Karan, MD, Drug Dependence Research Center, UCSF
- Walter Ling, MD, Chief of Substance Abuse Programs, UCLA
- Judith Martin, MD, Medical Director, Turk Street Clinic, Bay Area Addiction Research and Treatment, San Francisco
- John J. McCarthy, MD, Executive and Medical Director, Bi-Valley Medical Clinic, Sacramento
- Carolyn Shuman, MD, Medical Director, 14th Street Clinic, Bay Area Addiction Research and Treatment, Oakland and Medical Director, San Mateo Medical Center Methadone Treatment Program
- Stephen Ruh, MD, Medical Director, CRC Health Group, Inc., Wilmington, CA
- David Smith, MD, Medical Director, Centerpoint, San Rafael
- Laurene Spencer, MD, Medical Director, Geary Street Clinic, Bay Area Addiction Research and Treatment, San Francisco
- Deborah Stephenson, MD, MPH, Perinatal Substance Abuse Program/Central Valley Clinic, Santa Clara Valley Health and Hospital System, San Jose
- Charles W. Stewart-Carballo, MD, Private Practice, HIV Medicine, Oakland
- Matthew Torrington, MD, Integrated Substance Abuse Programs, UCLA
- Donald R. Wesson, MD, Consultant regarding CNS Medication Development
