The latest overdose mortality statistics are grim. Since 2021, more than 100,000 Americans have died of a drug-related overdose each year, and in Massachusetts overdose mortality rates reached an all-time high in 2022 with stark racial disparities. With so much public health attention on the overdose crisis, where are we going wrong? The issue is not that we don’t know what the solutions are – there are a range of well-established evidence-based approaches for reducing deaths and treating addiction, including naloxone distribution, provision of safe supplies, overdose prevention sites, contingency management, and medications for opioid use disorder (OUD). The issue is that there is a huge implementation gap in applying evidence-based approaches where they are needed. As Jeneen Interlandi put it in a recent New York Times opinion piece (an excellent, in-depth read), “a vast chasm exists between effective addiction medicine and the people who most need it.”
This chasm is especially prominent for methadone treatment, which has been approved for OUD in the United States since the 1970s and is the most effective treatment for opioid use disorder. However, access to methadone is highly restricted, and under federal regulation, this medication is only available for OUD treatment at facilities called opioid treatment programs (OTPs), commonly known as “methadone clinics”, which are certified by the Substance Abuse and Mental Health Services Administration (SAMHSA). Unlike medications for other medical or behavioral health conditions, methadone cannot be prescribed in outpatient medical offices and cannot be picked up at a pharmacy. In addition, there are limits on how many doses a patient can take home, meaning that patients have to visit the OTP frequently (sometimes multiple times a week) depending on the policies of a specific OTP. And there are a number of other state-specific regulations that impact access. Across the United States, there are also substantial geographic inequities in access to OTPs, with many parts of the country offering essentially zero access. In Massachusetts, there are 109 OTPs (though this includes correctional facilities that can also provide methadone), but they are concentrated in the eastern part of the state. Although we are in the midst of the worst overdose crisis in history, methadone policies continue to severely limit access for people who need this life-saving, evidence-based medicine. Something needs to change.
There have been some policy updates and innovations that have improved access that are worth highlighting. First, during the early part of the COVID-19 pandemic, SAMHSA increased the amount of methadone doses that patients can take home. Previously, patients had to come to the OTP almost daily, and SAMHSA changed this to allow patients to take home up to 28 days of medication (depending on time in treatment and stability). This has been positively received and does not appear to have resulted in negative impacts. Though this is a step in the right direction to reduce access barriers, it is still up to each OTP to determine how many take-homes they will allow, and there is substantial variation in program-specific practices. And even for patients receiving the maximum take-home amount, monthly visits can still be onerous, depending on the location and hours of the patient’s OTP.
Next, an exciting innovation in methadone treatment is mobile methadone programs. Some OTPs are now running mobile programs that travel to multiple locations to improve access, and this is happening here in Massachusetts. It is challenging and time-consuming to navigate the regulatory approvals needed to run a mobile methadone clinic, but the impact can be tremendous for those who have difficulty getting to brick-and-mortar locations.
In addition, the Modernizing Opioid Treatment Access Act was introduced in 2023, which proposes to significantly expand access by allowing qualified providers to prescribe methadone with pharmacy dispensing. Though it is by no means certain that this legislation will pass, the fact that it is on the table represents real progress. And even if it does pass, this does not automatically mean that benefits will be realized. Changes will have to be implemented very carefully, with attention to building provider and pharmacist capacity, addressing stigma, and monitoring and mitigating any unanticipated negative impacts. But we don’t need to reinvent the wheel – we can follow the lead of other countries that already do this, and learn from their experiences. OTPs can also still have a place in the treatment landscape for patients who prefer to get their medication under that structure.
So what role do researchers and evaluators play in this space? First, in the absence of major policy changes, we can study and document the impact of current policies and practices and the ways in which they present barriers or facilitators to access. This includes doing strong implementation research to understand the things some OTPs are currently doing that expand access (e.g., mobile services, offering drop-in hours, etc.) and examine associations with treatment engagement and retention, so that others can learn from best practices. When policies are being debated or developed we can do qualitative research to understand how methadone patients (current and potential future patients) and providers experience the current system, what they want and need in terms of policy changes, concerns they have with potential policy changes, and recommendations for how to implement new policies in the best way. It is essential that the intended beneficiaries have a voice in designing and implementing policies that will impact them significantly. And finally, when changes do happen, we need to evaluate them rigorously to inform continuous improvement and document the impact in a variety of settings with different populations. All of this will be instrumental as we work together with policymakers, program leaders, and practitioners to bridge the implementation gap and turn the tide of the overdose crisis.