SAMHSA’s Absurd Criteria for Identifying “Stable” Methadone Patients

3 months

For decades, methadone reform advocates have tried to loosen or remove the highly restrictive take-home dose regulations promulgated by the Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The answer from both was always an unequivocal no.

It didn’t matter that study after study has shown that traveling to a clinic on a daily basis and other barriers lead to poor engagement and retention rates. It didn’t matter that there is an ongoing opioid-related overdose crisis that killed more than 67,000 people in 2018. Of those deaths, 70 percent involved an illicit or prescription opioid.

But now, these federal agencies are finally saying yes to a temporary change in take-home dose policy. What changed? COVID-19.

In a hot minute, SAMHSA issued temporary guidelines allowing opioid treatment programs to give “stable” patients 28 days’ of take-home doses, and “patients who are less stable but who the OTP believes can safely handle this” 14 days’ take-homes. For methadone patients quarantined at home, the DEA authorized clinic employees, law enforcement and National Guard personnel to do doorstep delivery.

Seriously? The National Guard would be deployed to deliver methadone? What a difference a national, viral pandemic makes!

But there is a catch in the loosening of restrictions. How will people be assessed as “stable” or “less stable” by methadone providers? These SAMHSA guidelines provide the answer:

1. Absence of recent abuse of drugs (opioid or nonnarcotic), including alcohol

2. Regularity of clinic attendance

3. Absence of serious behavioral problems at the clinic

4. Absence of known recent criminal activity, e.g., drug dealing

5. Stability of the patient’s home environment and social relationships

6. Length of time in comprehensive maintenance treatment

7. Assurance that take-home medication can be safely stored within the patient’s home

8. Whether the rehabilitative benefit the patient derived from decreasing the frequency of clinic attendance outweighs the potential risks of diversion

The criteria are absurd. The bar is set so high that for many, it is unachievable. In fact, could any person who takes a medication daily comply with all eight? And it isn’t hard to guess which populations fare worse than others in such determinations.

The first benchmark—”absence of recent abuse of drugs”doesn’t spell out that not all drug use is “abuse.” This failure of SAMHSA’s criteria allows for the widespread drug-testing of methadone patients, who are subjected to punishments for positives, regardless of the extent of any risk of methadone interactions. Moreover, alcohol is legal, as is medical and recreational cannabis in numerous states.

The criterion of “regular” clinic attendance to get take-home doses is also problematic. The reality is, cars break down, gas money runs out, trains and buses are delayed, people get sick and lack childcare, employers are inflexible about work hours. Most of these factors disproportionately affect poorer people—making them less likely to get the take-homes that might save their lives.

The stipulation about the absence of crime “e.g., drug dealing” raises the old canard of the risk of “diversion” of methadone. The DEA is obsessed with diversion and rejected the idea of mailing methadone to patients, stating, “…the potential for diversion and abuse of methadone for maintenance and detoxification treatment of narcotic dependent persons is too high to extend the waiver further to permit dispensing via the US Postal Service or other common carriers.” Actually, postal workers or UPS delivering methadone would probably be safer for everyone in terms of limiting the transmission of COVID-19 rather than using hundreds of clinic staff or law enforcement officers.

But who buys diverted methadone? Most likely opioid users, to avoid withdrawal or to manage drug use. Those who raise the alarm about diverted methadone seem not to consider that fentanyl-adulterated heroin is already widely available in every community—often the only choice for opioid-dependent people who can’t get methadone or buprenorphine.

SAMHSA’s criteria focus on an individual’s ability to comply with rules and norms, not whether take-home methadone would make them safer.

The demand that a person have a stable home environment similarly discriminates against those who have no home or are marginally housed. And how does having “stable relationships”—whatever that means and however it is determined—impact a person’s ability to swallow their medication every day?

The requirement that medication must be safely stored at home is patronizing. Methadone bottles have child-proof caps. But this rule presents yet another barrier. What if a person doesn’t have a home? Does that mean they can’t get any take-home doses?

SAMHSA’s eight criteria will hinder methadone access amid COVID-19. They focus on an individual’s ability to comply with rules and norms, not whether take-home methadone would make them safer or stay alive! And they ignore the structural drivers of inequality, racism and poverty that set up methadone patients to be denied take-home doses.

It’s not just drug policy reform advocates who see these benchmarks as problematic. Allegra Schorr, the president of the Coalition of Medication-Assisted Treatment Providers and Advocates and the owner of a methadone clinic in Manhattan, told Addiction Treatment Forum, “Few people meet those criteria. It’s just not human, it’s so cut and dried.”

The COVID-19 pandemic has exposed how controlling, punitive and outdated federal methadone regulations are. The time has never been more urgent to transition to a flexible and humane system of pharmacy pick-up and home delivery.


Photo by Helen Redmond

Helen Redmond

Helen is the senior editor of Filter. She has written about nicotine, mental health and drug policy for publications including Al Jazeera, AlterNet, Harper’s and The Influence. As an LCSW, she works with drug users in medical and community mental health settings. An expert on tobacco harm reduction, she provides training and consultation on mental health, nicotine use and THR, and in 2016 organized the first Tobacco Harm Reduction Conference in the US. Helen is also a documentary filmmaker.

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