By Christopher Johnston, MD ABPM-ADM, Chief Medical Officer, Pinnacle Treatment Centers
The Dilemma: Expanding Access While Maintaining Essential Care
Two public health crises over the past decade changed the way we think about treatment for people with opioid use disorder (OUD). The first public health crisis – the opioid epidemic – led the White House to declare a national health emergency and implement a three-point plan to address the crisis:
- Reduce demand, reduce over-prescription, and educate citizens about the dangers of opioid misuse.
- Disrupt the supply of illicit opioids through increased domestic and international law enforcement efforts.
- Expand evidence-based treatment and access to recovery support services for all citizens.
That plan showed promise. Prescriptions for opioids decreased, overdose deaths decreased, and addiction professionals saw a ray of hope, because it appeared the tide had turned. Despite a spike in addiction deaths caused by fentanyl, the doctors, psychiatrists, and addiction counselors were optimistic that we were headed in the right direction.
Then the second public health crisis arrived: the COVID-19 pandemic.
We all know what happened then – but many of us may not understand that the public health rules and regulations implemented to flatten the curve and protect our citizens from COVID-19 had an adverse effect on people in treatment for opioid addiction. Therefore, local, state, and federal policymakers enacted a new set of changes to address the new situation:
- New federal policies allowed patients to begin treatment with buprenorphine via telemedicine. Several states eased buprenorphine restrictions beyond those federal changes.
- New federal policies allowed opioid treatment programs to dispense additional take-home doses of methadone. Several states eased rules that govern methadone dispensing and take-home dose limits.
- In some cases, new policies terminated prior authorization requirements for medications for opioid use disorder (MOUD).
In this article, we’ll focus on another change policymakers are considering: further expansion of how the medication methadone is prescribed and delivered.
What is Medication-Assisted Treatment (MAT)?
The Substance Abuse and Mental Health Services Administration defines MAT as follows:
“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.”
There are three medications approved by the FDA for the treatment of OUD:
- Methadone: Reduces withdrawal symptoms and cravings and blocks the action of other opioids/opiates
- Buprenorphine: Reduces withdrawal symptoms and blocks the action of other opioids/opiates
- Naltrexone: Blocks opioids and reduces cravings but cannot treat withdrawal symptoms
MAT is universally accepted as the gold-standard treatment for the treatment of OUD/opioid addiction. Decades of research show that MAT can:
- Reduce overdose rates
- Increase time-in-treatment
- Decrease drug use
- Decrease involvement with the criminal justice system
- Improve prognosis for pregnant women with OUD
- Increase ability to gain and maintain employment
- Improve family and social function
This article will focus on one medication in particular: methadone.
Methadone: The Original MAT
The most widely researched drug – among the three approved for MAT – is methadone. Clinicians tested the effectiveness of methadone clinics in the 1960s, and by the 1970s, methadone treatment was in use around the country. Methadone is effective: there’s no doubt about that.
Methadone is effective and methadone is the most extensively researched medication for MAT, but it’s also the most highly controlled drug used for MAT. Currently, the only way an individual can receive methadone for MAT is through a specialized clinic called an Opioid Treatment Program (OTP). Until the pandemic, regulations required most people in methadone treatment to visit the clinic every day to receive their medication. As patients accrued time-in-treatment, they were allowed to take home doses, according to a tightly controlled schedule.
With the arrival of the pandemic, some of the rules around MAT changed to accommodate the COVID-19 mitigation strategies. The rule changes that affected methadone included:
- States were permitted to request a blanket exemption for stable methadone patients to take home 28 days of medication
- States were permitted to request a blanket exemption for less stable methadone patients to take home 14 days of medication
- OTPs were permitted to continue to treat existing MAT patients via telehealth
- OTPs were permitted to continue to prescribe methadone to existing patients via telehealth
- OTPs were permitted to offer addiction counseling services via telehealth
- OTPs were permitted to deliver methadone to patients in quarantine or otherwise unable to travel
Those changes saved lives during the pandemic. They helped people:
- Access treatment while under shelter-in-place guidelines
- Reduce potential exposure to COVID-19 by allowing take-home doses
- Access drug counseling while under shelter-in-place guidelines
- At high-risk of COVID-19 infection (immunocompromised individuals and those with medical conditions that increase risk of severe complications) access treatment without increasing likelihood of contracting COVID-19
We’ll now address two new ideas we’ve noticed in research on methadone treatment: a further expansion of methadone prescribing and distribution policies.
Methadone in Primary Care, Methadone in Pharmacies
This topic is a little bit tricky.
It typically wouldn’t be, because it involves the expansion of methadone treatment, which means increasing access, which means, overall, an increase in harm-reduction. We’re harm-reduction advocates. We support policies that make it easier for people with OUD to access medication, counseling, and any type of evidence-based treatments that help them heal and recover from opioid addiction. That means we’re tempted to give a blanket yes to anything that increases access to MAT.
The new ideas around expanding methadone access include:
- Permitting prescription of methadone in primary care (general practitioner) office settings
- Permitting dispensing methadone in primary care office settings
- Allowing pharmacies to dispense methadone
A study published last year offers preliminary evidence for implementing these changes. Methadone treatment in general practice, and methadone dispensing by pharmacies, is common abroad. Researchers cite studies from France and Australia that indicate similar outcomes for people who receive methadone in primary care settings compared to people who receive methadone in specialized clinics like the OTPs in the U.S. They also offer data from four studies in the U.S. that show parallel results.
Here’s how the researchers describe the data:
“Limited research suggests that office-based methadone treatment and pharmacy dispensing could enhance access to methadone treatment for patients with opioid use disorder without adversely affecting patient outcomes and, potentially, inform modifications to federal regulations.”
In addition, the following disclaimer accompanies the study:
Limitations included small sample sizes and lack of generalizability of outcomes of studies conducted over 20 years ago.
There’s another thing that we’d like to address, with regards to these ideas about expansion: the role of addiction treatment and counseling in MAT.
That’s a big deal to us – and we think it should also be a big deal to anyone considering this type of expansion for methadone treatment.
Why?
Because MAT – for us, at least – has never been just about the medication.
What’s It About, Then?
The answer is in the clinical definition of MAT. We provided it above, but let’s revisit it now:
“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.”
We highlighted the aspects of expanding methadone access that concern us: the counseling, therapy, and whole-person aspects. One thing the studies from France and Australia do not indicate is whether patients received the counseling and behavioral therapy currently required for anyone participating in a methadone program in the U.S. The studies from the U.S. likewise do not include information on the presence or absence of counseling for the participants.
That’s information we need. We think of recovery as a process which, in order to be successful, engages the whole person. For people with OUD, medication is important. However, to achieve recovery in a manner consistent with a whole person approach, more than medication is required.
Consider this definition of recovery published by the American Society of Addiction Medicine (ASAM).
“Recovery is a process of sustained action that addresses the biological, psychological, social, and spiritual disturbances inherent in addiction. Recovery aims to improve the quality of life by seeking balance and healing in all aspects of health and wellness, while addressing an individual’s consistent pursuit of abstinence, impairment in behavioral control, dealing with cravings, recognizing problems in one’s behavior and interpersonal relationships, and dealing more effectively with emotional responses.”
Methadone addresses important biological aspects of recovery. However, methadone alone does not address the “psychological, social, and spiritual disturbances” mentioned above. That’s where counseling comes in. Nor does methadone alone address “problems in one’s behavior and interpersonal relationships, and dealing more effectively with emotional responses.” Again, those areas are where counseling comes in.
When an individual enters treatment at an OTP, they also participate in:
- Individual, group, and family counseling
- Addiction counseling
- General medical services
- Family support
- Addiction education
- Vocational counseling
- Legal counseling
Those supports are essential for an individual seeking to rebuild their lives in recovery. They’re also required by federal law for all OTPs: if they don’t meet the standards, they can lose their license. That’s why we say for us, treatment in OTPs has never been just about the methadone.
Expanded Access for Methadone: Yes, And…
We know from firsthand experience that methadone can:
- Normalize brain chemistry
- Relieve physiological cravings
- Stabilize physiological functioning
- Enable a person to engage in treatment
Those four things are very, very important. That’s why methadone is very, very important. That’s why, when we read studies about expanding methadone access by allowing initiation in a primary care office setting and dispensing in pharmacies – and read persuasive letters like this one from physicians about these ideas – we feel the need to say this:
Yes, expand access to methadone.
And.
And require the elements needed to achieve full recovery. Law requires OTPs to provide psychological counseling, addiction counseling, legal counseling, and vocational support because those things are necessary for an individual to achieve overall long-term recovery. Long-term recovery means a person thrives on all levels: biological, psychological, and social. It means a person lives in a state of health as defined by the World Health Organization (WHO):
“Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.”
Methadone can help a person take the first steps toward recovery and keep them stable as they learn how to live without opioids. Treatment and therapeutic services that address the whole person help them take the next step and learn to live the life they create for themselves. For that, they need the support of counselors, recovery peers, and a compassionate community – not just expanded access to a single component of a complete treatment and recovery plan.