While conducting research for articles to write and share on our blog, we found a report with a title that resonates with us:
“Methadone Saves Lives. So Why Don’t More Patients With Opioid Use Disorder Take It?”
Published by the renowned, well-respected organization Pew Charitable Trusts, this is a question we ask ourselves every day.
For people with opioid use disorder (OUD), we know the statement in the title of the report is true: methadone saves lives.
We know because we support people on medication-assisted treatment (MAT) for OUD with methadone every day. We see the positive effects with our own eyes. Our patients on methadone tell us it works – but there are complications involved in MAT with methadone that make treatment challenging for many people.
That’s what this article is about: the steps we need to take to make methadone more accessible, allow us to treat more people, and ultimately, save more lives.
Before we get into those details, however, we’ll offer a brief history and overview of methadone for those of you who’ve never heard of methadone, or have heard of methadone, but don’t know much about it.
What is Methadone?
Methadone is a synthetic opioid pain-relieving medication developed during the second world war when the standard opioid pain-relieving medication, morphine, was in short supply. A decade later, physicians initiated clinical trials using an oral methadone formulation to treat people with heroin and morphine use disorder. These initial trials led to a landmark moment in the history of opioid addiction treatment: the opening of the first methadone clinic in the country in 1964.
Since then – over the ensuing four and a half decades – extensive research on methadone has verified it as a safe and effective treatment for all types of opioid use disorder (OUD), including the disordered use of prescription opioids such as oxycontin and illicit opioids such as heroin and fentanyl.
In short, methadone is a medication for opioid use disorder (MOUD) that saves lives, as we mention above.
The need for effective treatment for OUD is more urgent now than at any time in our history.
Why?
The opioid crisis.
The Opioid Crisis in the U.S.
We’re sure you’ve heard of the opioid crisis – but if you haven’t, we’ll offer the latest information now. It’s a decades-long public health crisis that was eclipsed temporarily by COVID-19, but didn’t go away.
In fact, it got worse.
Here’s a summary of the current situation, and how we got here.
Between 1999 and 2021, over a million people in the U.S. died from a drug overdose. Seven out of ten of those overdose deaths involved opioids. Despite an organized, nationwide effort to reduce this disturbing and destructive phenomenon, the death toll continues to rise. Between 2019 and 2020, opioid related overdose deaths increased by close to 40 percent, and overdose deaths involving synthetic opioids increased by over 50 percent.
Here are the latest raw numbers:
- In 2019:
- 67,697 people died of drug overdose
- 50,178 of those deaths involved opioids
- In 2020:
- 78,056 died of drug overdose
- 69,061 of those deaths involved opioids
- In 2021:
- 107,622 people died of drug overdose
- Data on fatal opioid overdose unavailable
Now let’s look at a set of data from the 2020 National Survey on Drug Use and Health (2020 NSDUH). This information will explain why one of our responsibilities as treatment professionals is continuously work to raise awareness about OUD and treatment for OUD. In the year 2020:
- 2.7 million people – about 1% of the adult population of the U.S. – had a clinical diagnosis for opioid use disorder
- About 275,000 of those diagnosed with OUD received medication-assisted treatment (MAT) – that’s about 11%
- That means almost 90% of people with OUD did not get the treatment they need
That’s what we call the treatment gap, and it’s far too large. When we consider the fact that effective treatment is available, a gap of this size is unacceptable.
Medication-Assisted Treatment: The Gold Standard for OUD
Here’s how the Substance Abuse and Mental Health Services Administration (SAMHSA) define MAT:
“MAT is the use of medications, in combination with counseling and behavioral therapies, to provide a ‘whole-patient’ approach to the treatment of substance use disorders.”
The Food and Drug Administration (FDA) has approved three medications for opioid use disorder (MOUD): buprenorphine, methadone, and naltrexone. We’ll limit our discussion to methadone. Research shows that methadone can do the following:
- Reduce withdrawal symptoms
- Reduce cravings for opioids
- Prevent other opioids from affecting the brain, i.e. in the presence of methadone, other opioids will not work to reduce pain or induce euphoria
Research also shows that, in general, methadone and MAT treatment can:
- Prevent overdose
- Reduce mortality
- Increase treatment adherence, i.e. keep people with OUD in treatment
- Reduce us of illicit drugs
- Reduce criminal activity associated with opioid use
- Improve outcomes for women with OUD who are pregnant
- Improve ability to find and keep gainful employment
- Restore ability to maintain positive relationships with family and peers
When we read those benefits, MAT appears like the obvious first choice treatment for a person with OUD. Among the three MAT medications, people with OUD report that methadone is the most effective. That’s why the statistic we shared above is cause for legitimate concern:
In 2020, just 11% of the 2.7 million people with OUD in the U.S. received medication for opioid use disorder (MOUD).
Again, that means 90 percent of people with OUD did not get the gold-standard level of care they needed – and among the three medications used to treat OUD, methadone is the least used, even though for many people, it’s the most effective.
Why?
The federal rules and regulations for methadone are a significant barrier to access.
We’ll explain.
Methadone Only Available in Federally Licensed Opioid Treatment Programs
The current restrictions on methadone have their roots in a late 1960s and early 1970s mindset that was the origin of what we now know as The War on Drugs. At the time methadone was approved for OUD and physicians began treating patients with the medication, the Drug Enforcement Agency (DEA) and federal government were primarily concerned with reducing criminal activity associated with heroin use, and preventing the diversion of methadone from therapeutic clinics to illicit street use.
Here are the rules created then, which remained in place until the COVID-19 pandemic.
Federal Guidelines: Methadone
- Requiring patients to show up, in-person, six days a week, to receive medication
- Restricting methadone dispensation to Opioid Treatment Programs (OTPs):
- There were only 1700 OTPs operating in the U.S. before COVID
- OTPs are uncommon in rural and suburban areas
- There are no OTPs in the state of Wyoming
- OTPs are more common in Black and Hispanic areas than in White areas
- Preventing take-home doses for the first 90 days of treatment
- Requiring monitored urine screening:
- Methadone patients were mandated to provide urine samples under the observation of clinicians
- Restricting the initiation of treatment to in-person visits with specifically licensed and trained physicians
During the COVID-19 public health emergency, the federal government eased restrictions on methadone. Here’s how the rules changed.
Federal Guideline During COVID-19: Methadone
- State authorities were allowed to request a blanket exemption for stable methadone patients to take home 28 days of medication, previously only available after 90 days
- States authorities were allowed to request a blanket exemption for less stable methadone patients to take home 14 days of medication, previously only available after 90 days
- Clinicians in OTPs were permitted to continue to treat existing methadone patients via telehealth
- Clinicians in OTPS were permitted to continue to prescribe methadone to existing patients via telehealth
- Clinicians were permitted to offer counseling services via telehealth
- OTPs were permitted to deliver methadone via mobile MAT units to patients in quarantine or patients unable to travel for health reasons
Those rule changes saved lives.
Now, experts recommend keeping those rules in place – and making them permanent – after the COVID-19 crisis.
Improving Access to MAT and Methadone
We’ll circle back to the report we mention at the beginning of this article:
“Methadone Saves Lives. So Why Don’t More Patients With Opioid Use Disorder Take It?”
That report features extended interviews with two people with direct experience with methadone and MAT: Dr. Rachel Simon, a physician at the New York University Grossman School of Medicine, and Abby Coulter, a special projects coordinator with the North Carolina Survivors Union. Dr. Simon treats patients in the MAT clinic in Bellevue Hospital in New York City, and Abby Coulter has used methadone in MAT programs for 20 years.
Here’s an observation made by Abby Coulter:
“I hate to say it, but had COVID not happened, we wouldn’t be talking about making methadone easier to access. The federal regulations governing OTPs and how patients get methadone haven’t changed in years.”
Even now – after COVID-19 – OTPs operate under severe restrictions, because many states did not request the exemptions allowed under COVID-19. Here’s the current situation, according to Coulter and Dr. Simon:
- Most patients must travel to their OTP every day for medication
- OTPs are often difficult to get to, even those located in urban areas
- Accessing OTPs in rural areas is so difficult it’s almost impossible
- Most OTPs require government-issued identification
- Patients wait in long lines in public for medication
- There’s a heavy police/security presence at almost all OTPs
- Patients are still required to participate in observed urine drug screens
That begs the question:
What can we do to improve this situation?
First, according to Simon and Coulter, we can make the changes allowed under COVID permanent, as we mention above. Next, we can move to make MAT – and methadone treatment in particular – more like treatment for other chronic medical conditions.
We’ll explain how that can happen.
Reducing Harm and Increasing Access to Treatment: The Next Step for Methadone and MAT
The basic idea is what we just mentioned: making treatment for OUD more like treatment for typical chronic medical conditions. In other words, create a patient-centered model that follows these three principles:
- Offer all patient with OUD a choice between all FDA-approved medications for OUD.
- Initiate treatment with clinically effective dose
- Create Low-barrier, flexible treatment options that do not restrict access beyond existing federal regulations
In order to follow these three principles, experts recommend that federal guidelines mandate the following changes.
How to Expand Methadone and MAT Access: Practical Solutions
- Prohibit OTPs from discharging patients from care for continued drug use
- No urine drug screens in excess of the federally mandated eight times per year
- No observed urine screens
- Data from an OTP in NEW York with 3600 patients that suspended urine drug screenings during COVID-19 showed no overdoses
- Do not require a government ID to receive treatment. This creates barriers for:
- Patients experiencing homelessness
- Patients recently released from jail/prison
- Transgender patients with ID that may not match their gender
- Require OTPs to offer counseling on a schedule created in collaboration with the patient, rather than on an arbitrary, predetermined timeline
- Do not force patient to discontinue MAT
- Rushing patients off MAT can have negative consequences
- Long-term participation in treatment can lead to better treatment outcomes
- Ease barriers to take-home doses, rather than increase them
- Research indicates that methadone diversion during COVID-19 – when these rules were relaxed – did not increase
- Allow patients flexibility as to when and where they receive their medication.
- OTPs should operate on weekends
- OTPs should operate outside of regular business hours
- OTPs should expand rules around creating rules around guest dosing, which allows a patient from one OTP to arrange to pick up medication at a different location, as needed or travel or other reasons
In addition, OTPs can offer specific treatment – including counseling – for the needs of diverse populations, including pregnant women, veterans, and members of the LGBTQIA+ community.
How These Changes Can Help
People on MAT want respectful and compassionate treatment. They want to live lives with dignity. They want their lifesaving medication – and how they get it – to be no different than lifesaving medications people use for other conditions, such as diabetes, hypertension, or cancer.
Let’s go back to that first report, and conclude this article with the words or Dr. Simon and long-time advocate Abby Coulter.
First, Abby Coulter:
“In a perfect world, there would be no OTPs. I could go to my doctor for a drug I need, just like anybody else goes to their doctor for the medications they need. But OTPs aren’t going away, so parity between methadone and buprenorphine is the goal.”
Now, Dr. Simon:
“Expanding access would change lives. It would increase access to care by reducing long commutes and transportation costs to treatment, especially for people living in rural areas. It would also reduce stigma, because office-based treatment would increase patient privacy, compared with the communal setting of an OTP. And it would address issues of racial equity, because Black and Latinx people with OUD are disproportionally harmed by oppressive methadone regulations.”
Research conducted during the COVID-19 pandemic, which we cite in the links above, proves that reducing barriers to care for people on MAT who receive methadone does not increase rates of overdose, does not increase the diversion of methadone, and does not increase criminal activity related to OUD.
Since those are the reasons the stringent guidelines were implemented initially – almost 50 years ago – it follows, therefore, that we can now eliminate those restrictions in a measured, logical, and practical manner that ensures the health and safety of individuals in all communities.
The evidence shows we can reduce harm, save lives, and help people with OUD move forward to a better life.
That’s our life’s work.
That’s why we hope these proposed changes become a reality as soon as possible.