The American Association for the Treatment of Opioid Dependence (AATOD) on March 2 sent letters to the sponsors of proposals which would liberalize methadone regulations. While AATOD supports much of what is in the bills, it differs in particular on take-home prescribing of methadone through pharmacies. The two methadone reform bills, one in the Senate (S.3629, see https://atforum.com/2022/02/support-aatod-markey-paul-bill-nama/) and one in the House of Representatives (H.R. 6279, see https://atforum.com/2021/12/norcross-bill-modernize-methadone-treatment/AT Forum) contain identical language allowing pharmacies to dispense methadone.
Importantly, AATOD has changed its position on one issue: “stable” patients as defined by the Substance Abuse and Mental Health Services Administration (SAMHSA) should be able to receive their take-home medication through pharmacies, at the discretion of the opioid treatment program (OTP) director. “To be clear, this would involve methadone-maintained patients, who are currently enrolled in OTPs,” the letter, from AATOD president Mark Parrino, states. “We also recommend that the legislation include a requirement for an agreement between an OTP and a pharmacy to ensure electronic communication of prescriptions that cannot be duplicated or altered in any way and can require two-way communication such that the pharmacy is able to report to the OTP any problems with the dispensing of the medication.”
OTPs well know that their patients need their methadone. The average pharmacy may not understand that it’s not okay to say “we don’t have it in stock now, we need to order it, it will be here in a few days.”
AATOD continues to oppose the dispensing of methadone by pharmacies when the prescriptions come from physicians who are not affiliated with OTPs – something which is not currently allowed.
No self-induction, says AATOD
The bills suggests that prescribing should adhere to the 30-mg dose limit, but this does not mean induction should be done at home – and these bills would allow that. “Most methadone treatment related deaths occur in the first 3 to 10 days of treatment,” states the letter to the Senate and House sponsors, a copy of which was obtained by AT Forum. “OTPs can provide proper supervision during induction. Community prescribers and pharmacies cannot.”
In fact, there is no way to ensure that physician offices would adhere to any dose limits, AATOD notes.
This is not about protecting OTP turf. It’s about protecting the integrity of treating OUDs with methadone. If the trained providers are no longer guarding patient safety, it could mean that methadone quickly goes the way of many opioid pain medications. There are five federal reports linking methadone overdose deaths with primary care prescribing for pain.
The COVID-19 relaxations of take-home rules showed that many patients who are “unstable” are capable of managing take-home doses safely, but “the reality is that we do still serve a significant number of patients that would have a high likelihood of diverting their methadone.”
A monthly supply of methadone from community pharmacies could increase diversion, AATOD notes. And it’s not only AATOD. A January 10, 2022 letter from the American Academy of Addiction Psychiatry, also sent to the lawmakers, states that provisions of the methadone reform bills that “would allow certain providers to prescribe up to one month of take-home methadone doses to be dispensed from a community pharmacy may have unintended consequences.”
As for the five reports detailing the methadone overdoses from prescriptions for pain, AATOD states that “losing sight of the findings of these national reports is extremely dangerous.” Particularly now, when the opioid use epidemic is defined by illicit fentanyl, it could be harmful, not beneficial, “to have practitioners prescribe methadone to treat opioid use disorder outside of the scope of regulated OTPs, which use treatment teams and not individual practitioners, to treat patients.”
As for the other provisions of the bills, AATOD is completely supportive. These provisions include:
- Exemptions for treatment regulations during COVID-19 emergency
- The definition of stable patients under the COVID-19 emergency rules for takehomes
- completing a minimum of 60 days of treatment whose medical record documents
- the benefits of providing unsupervised doses outweigh the risks
- the individual demonstrates a total adherence per the OTP’s discretion with their treatment plan
- negative toxicology tests for 60 calendar days
- an absence of serious behavioral problems
- stability in living arrangements and social relationships
- absence of substance-misuse related behaviors
- absence of recent diversion activity, and
- assurance that the medication can be safely stored.