Introduction and Background1
Methadone is a Food and Drug Administration– (FDA-) approved synthetic opioid agonist that is widely used for treating both pain and opioid use disorder (OUD), a chronic brain disease defined as “a problematic pattern of opioid use leading to clinically significant impairment or distress” (APA, 2022). OUD affects more than 2.7 million people in the United States aged 12 and older (APA, 2022; SAMHSA, 2021). To address barriers associated with the use of methadone to treat OUD, on March 3 and 4, 2022, the National Academies of Sciences, Engineering, and Medicine (National Academies) hosted a workshop on “Methadone Treatment for Opioid Use Disorder: Examining Federal Regulations and Laws,”2 at the request of the Office of National Drug Control Policy (ONDCP) in the Executive Office of the President. The meeting was convened under the auspices of the National Academies boards on Health Sciences Policy and Health Care Services and the National Academy of Medicine’s Action Collaborative on Countering the U.S. Opioid Epidemic.
1 The planning committee’s role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop. Statements, recommendations, and opinions expressed are those of individual presenters and participants; have not been endorsed or verified by the National Academies of Sciences, Engineering, and Medicine; and should not be construed as reflecting any group consensus.
2 To learn more about the National Academies workshop, go to https://www.nationalacademies.org/event/03-03-2022/methadone-treatment-for-opioid-use-disorder-examining-federal-regulations-and-laws-a-workshop (accessed April 26, 2022).
In his introductory remarks, Rahul Gupta, director of ONDCP, said access to methadone is hindered by many unnecessary barriers. “Methadone is often viewed in a stigmatizing way, so we need to improve both how it’s viewed and how it’s utilized[used] and ask the right questions that would inform our policy decisions around it,” said Gupta. He noted that more than 100,000 Americans died from drug overdose in the most recent 12-month period for which data were available, and that opioids were involved in more than 78,000 of these deaths (Ahmad et al., 2021). “On average we’re losing an American to an overdose every 5 minutes,” he said. “These are sons and daughters, parents and grandparents, uncles and aunts, and we’re losing these folks around the clock. It is heartbreaking. It is staggering. And frankly, it’s unacceptable.”
The workshop, chaired by Alan Leshner, chief executive officer emeritus of the American Association for the Advancement of Science and a former director of the National Institute on Drug Abuse (NIDA) of the National Institutes of Health (NIH), built on a 2019 report by the National Academies entitled Medications for Opioid Use Disorder Save Lives (NASEM, 2019). This report concluded that treatment of OUD with methadone, buprenorphine, or extended-release naltrexone is effective and saves lives and that long-term treatment is associated with improved outcomes, yet the report also found inequitable access to treatment across population subgroups and treatment settings.
Of the three FDA-approved drugs, methadone is the subject to the most stringent regulations, including the requirement that it is provided only through opioid treatment programs (OTPs).3,4 Today there are about 1,900
3 An OTP is a federally accredited and certified treatment program that uses medication to treat individuals with OUD. They must meet the Substance Abuse and Mental Health Services Administration’s (SAMHSA’s) “opioid treatment standards and the accreditation standards of SAMHSA-approved accrediting bodies,” conform with federal regulations governing treatment of substance use disorders, be licensed by the state in which they operate, and be registered with the Drug Enforcement Administration. For more information, go to https://www.samhsa.gov/medication-assisted-treatment/become-accredited-opioid-treatment-program (accessed May 5, 2022).
4 Like the other approved medications (buprenorphine and naltrexone), methadone works by targeting the mu-opioid receptor within the endogenous opioid system, but does so via a different mechanism of action and has different pharmacologic, pharmacodynamic, and pharmacokinetic properties, according to the report. Methadone is a full opioid agonist, activating opioid receptors similarly to the action of illicit opioids, while buprenorphine is a partial opioid agonist. Naltrexone is not an opioid, but a full antagonist of the mu-opioid receptor. The National Academies report concluded that while all three of these medications are effective and save lives, the most appropriate medication varies by individual and may change over time (NASEM, 2019).
OTPs in the United States,5 with the number of OTPs expanding in the past few years despite the COVID-19 pandemic, which many policy makers predicted would result in the closure of many sites. However, despite the expansion in the number of OTPs, many individuals face substantial access barriers due to restrictive zoning ordinances, lack of third-party reimbursement, and highly regulated operating requirements at the state level, said Mark Parrino, president of the American Association for the Treatment of Opioid Dependence (AATOD). “We have to do better,” said Abby Coulter, methadone liaison for Urban Survivors Union. “This workshop must be the starting point for access to methadone beyond the walls of the clinic system,” she added.
Leshner predicted that the workshop would provide “landmark opportunities to seriously begin to address the longstanding issue of inadequate access to this life-saving medication…and to develop strategies to finally address a longstanding and pernicious health and social disparity.”
The workshop was designed to examine the current federal regulatory and legal landscape around the provision of and access to methadone for the treatment of OUD, said Leshner (see Box 1-1). Gupta added that he hoped the workshop would explore potential policy changes to address federal, state, and local barriers to the provision of methadone treatment and consider opportunities for implementing office-based methadone treatment.
ORGANIZATION OF PROCEEDINGS
Throughout the workshop, participants examined the history and current status of methadone treatment for OUD and were asked to consider potential next steps to address regulatory and legal barriers to improve access to methadone treatment. Workshop participants explored opportunities for innovation within the current system and in settings outside OTPs. Each chapter begins with a “highlights” box that summarizes key themes and, in many cases, concludes with bulleted lists of potential policy changes and next steps proposed by individual participants. The purpose of the workshop was not to reach consensus, so many individual ideas are presented. Given the interconnectedness of the issues discussed, many of these ideas arose in different sessions of the workshop and therefore appear in multiple parts of this proceedings. Throughout this proceedings, the
5 For more information, go to the Substance Abuse and Mental Health Services Administration’s opioid treatment program directory available at https://dpt2.samhsa.gov/treatment (accessed June 12, 2022).
rapporteurs aimed to use currently accepted terms that avoid perpetuating negative biases and stigma around addiction.6 However, in some instances, presenters used other terms with a particular intention, such as to report on historical usage or the stigma they faced, and these may be reported verbatim in quotation marks.
Chapter 2 highlights three individuals’ personal journeys through the methadone treatment system. A historical perspective on policies regarding methadone maintenance is presented in Chapter 3, along with discussions of how these policies create barriers to certain population groups. Chapter 4 provides an overview of the current regulatory landscape as well as flexibilities instituted in response to the COVID-19 pandemic. Improving access to treatment at OTPs through regulatory innovation is discussed in Chapter 5. Chapter 6 discusses the high prevalence of OUD in correctional facilities and opportunities for improving access to treatment at those facilities. Regulatory innovation outside of OTPs also has the potential to expand
6 To learn more about terms to use and avoid when talking about addiction, go to this National Institute on Drug Abuse resource: https://nida.nih.gov/nidamed-medicalhealth-professionals/health-professions-education/words-matter-terms-to-use-avoid-whentalking-about-addiction (accessed June 9, 2022).
access to methadone, including among racially minoritized populations, and is discussed in Chapter 7. Chapter 8 discusses regulatory changes and incentives that could be made under current laws to help ensure equitable access to methadone. Chapter 9 presents a policy analysis framework and an economic analysis framework that could be used to inform legal and regulatory changes. Chapter 10 provides a synthesis of potential next steps proposed by individual workshop participants to improve access to quality methadone treatment. References cited throughout these proceedings are listed in Appendix A, the workshop agenda is in Appendix B, and three commissioned papers serving as background to the workshop are provided in Appendix C.
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