Some support from AATOD in Markey-Paul bill, but NAMA-R supports it all
Wed, 23 Feb 2022 15:19:00 +0000
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Like the Norcross bill introduced in the House of Representatives last year (see https://atforum.com/2021/12/norcross-bill-modernize-methadone-treatment/) the Markey-Paul bill to allow pharmacy dispensing of methadone (see https://atforum.com/2022/02/bill-pharmacy-dispensing-methadone-senate/) was not endorsed by the American Association for the Treatment of Opioid Dependence (AATOD), because of the reduced role for opioid treatment program (OTP) prescribers.
Asked for a comment when the Norcross bill was introduced, Mark Parrino, AATOD president, told AT Forum that “In general, our Association supports a number of elements in Congressman Norcross’s bill,” adding that this “support is seen through our recently released policy paper.”
AATOD has advised the Congressman’s staff that a number of the proposed reforms have either been implemented by the Drug Enforcement Administration and SAMHSA or are in the process of being implemented, said Mr. Parrino.
However, AATOD does not support “physician prescribing of methadone to treat opioid use disorder so that such prescriptions can be filled by pharmacies,” said Mr. Parrino. “This is consistent with our Association’s ongoing recommendations.”
And it’s helpful to remember that methadone overdoses – mainly associated with pain prescriptions and always by non-OTPs – almost put methadone treatment for OUD out of business. “We are reminded of the five national methadone mortality reports, which were published between 2003 and 2010,” recalled Mr. Parrino. “All of these reports concluded that methadone mortality was the direct result of physicians in private practice prescribing methadone to treat pain and distribute it through pharmacy channels.”
With the current shifting opioid use epidemic, driven primarily by illicit fentanyl use, AATOD has “learned that treating such patients is very challenging in order to achieve stability in treatment,” said Mr. Parrino. “This requires a nuanced appreciation of how to treat opioid use disorder, especially when dealing with the combined challenge of methamphetamine/stimulant use.”
And there are great concerns about treatment being viewed as “medication only without the appropriate clinical support,” said Mr. Parrino. “In our judgment, treating opioid use disorder goes well beyond the prescribing of medication,” he said.
And none of this should be a surprise, coming from AATOD, which has steadfastly held to the principle of comprehensive treatment. “Once again, we have been consistent in promulgating such evidence-based policies from our inception,” said Mr. Parrino.
The AATOD legislative committee has vetted a letter responding to the Markey-Paul Senate bill, and that letter is now being reviewed by the whole board, Mr. Parrino told AT Forum Feb. 18. The letter with the board comments incorporated will be released to the House and Senate on Feb. 28. Mr. Parrino could not share the contents of the letter until it is approved, but he did tell us about some of its key points.
AATOD expresses support for sections two and three of the proposed bill.
AATOD focuses on the recent policy work of the Drug Enforcement Administration and mobile vans and letters from the Substance Abuse and Mental Health Services Administration (SAMHSA) clarifying this work in August, September, and November of 2021.
SAMHSA’s clarifying letters of August, September and November 2021.
Diversion and overdoses: “The problem comes with section four,” said Mr. Parrino. “We support OTP medical directors having the option to have stable patients receive take-home medication through pharmacies, which would be prearranged with the OTP and the pharmacy. We also explain in detail why we oppose having physicians with prescriptive authority for methadone. We cite the five methadone mortality reports and we believe that this would lead to more diversion and methadone related overdoses. We provide a detailed analysis.”
We will share the letter with AT Forum readers as soon as it is released.
More from NAMA-R
Meanwhile, Talbott, whose NAMA-R represents patients, had this to say:
Section IV of the bill, which allows for pharmacy dispensing of methadone by prescription from an OTP physician and/or physician who is Board Certified in addiction medicine or addiction psychiatry, is the shortest section of the bill. It does not make stipulations regarding “observed dosing” or address allowable methadone formulations. The bill does restrict consecutive unsupervised doses of medication to not more than two (2) in the first 30 days of treatment for a new patient, but that guardrail for patient safety is all that would be written into statute on these matters. Further, the bill does not define “supervised” versus “unsupervised” medication administration. Certainly, there are ways supervised self-administration could also be accomplished via technology and other means without requiring a patient to take medicine inside a community pharmacy.
NAMA Recovery’s hope in helping draft and support this legislation is to normalize methadone treatment for opioid use disorder, after all, and what other medications must be consumed in front of a pharmacist at a community pharmacy? Any stipulations around the definition of or restrictions around “supervised” versus “unsupervised” doses or formulations allowed, etc. will be handled by subsequent federal and state rulemaking, should the Opioid Treatment Access Act become statute.
NAMA Recovery’s greatest hope for the pharmacy provisions of the bill would be so that patients who are stable and no longer need or want comprehensive OTP services could be moved out of the OTP roles and into a more office-based setting. This would also make room for the thousands of untreated individuals to begin OTP services. Opioid overdose continues to increase, after all, not decrease. Our current system simply is not able to meet the demand. As fentanyl continues to drive up severity of illness, the need for methadone will only continue to grow, as well.
Without further definitions around formulations by rulemaking, my assumption would be that current FDA approvals would stand. These, as you know, allow for the dispensing of dispersible 40mg diskets to opioid use disorder patients but not pain patients. Without any other changes by the FDA or other relevant rulemaking, once would assume pharmacies that participate in this section of the bill would once again order and stock dispersible methadone diskets versus the additional complications of unit dose liquid preparations. Current federal OTP guidelines from March 2015 recommend 15 to 30 day supplies of methadone be dispensed as “dry medication” in one single bottle already, after all.
There was a focus throughout the drafting and collaborative process that statute should be kept as limited as possible while still being proscriptive enough to push rulemaking in the right direction. Any nuances, however, will be decided through NPRMs and public commenting periods from stakeholders and experts across the country, on both the federal and state levels.
Stay tuned as life appears poised to change for many patients in treatment for OUD with methadone, depending, of course, on the votes of federal lawmakers and then, the always unpredictable vagaries of state legislatures and statehouses, not to mention in pharmacies and prescribers themselves. These are particularly important measures for OTP patients who live far from their clinic but do receive 28-days of take-homes already.
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