The surprise speaker was Mark W. Parrino, MPA, president of the American Association for the Treatment of Opioid Dependence (AATOD). And he was standing in for Rep. Paul Tonko (D-New York), who couldn’t make it to the New York Society of Addiction Medicine (NYSAM) meeting on February 7.
It was surprising for this reason: the two men are on opposite poles when it comes to deregulating buprenorphine. Representative Tonko is sponsoring a bill that would eliminate the special Drug Enforcement Administration (DEA) waiver for prescribing buprenorphine. This bill (Mainstreaming Addiction Treatment Act) is endorsed by NYSAM and its parent association, the American Society of Addiction Medicine (for more on that, see https://atforum.com/2019/08/add-asam-to-x-the-x-waiver-movement/ ). Mr. Parrino, representing AATOD, is completely opposed to the bill.
Mr. Parrino is no stranger to speaking in hostile territory, and is always diplomatic. In this situation, many of the physicians present seemed unfamiliar with OTPs, but liked the idea of being able to prescribe buprenorphine without any interference from the DEA or anyone else.
“I’m sure some of you will agree with me and some will disagree,” said Mr. Parrino, opening his speech with his usual charm.
Mr. Parrino has always taken issue with the claim that there is no harm coming from buprenorphine diversion—that diverted buprenorphine is being used to stave off withdrawal, it’s intended purpose, even by people who buy it in the street. “These people say, ‘why should you be concerned about buprenorphine diversion?’” he said. “But that depends on where you sit.” He noted that abuse of buprenorphine pain-relievers is higher than abuse of any other opioid pain relievers, based on the Substance Abuse and Mental Health Services Administration (SAMHSA) data from 2018 to 2019.
Not Enough OTPs, Especially Rural
One of the problems for OTPs is that there aren’t enough of them, especially in rural areas. “We have good data showing that 16% of patients travel to another state” for treatment, said Mr. Parrino, noting that there are now about 450,000 OTP patients in the United States.
The number of qualifying practitioners for buprenorphine prescribing is increasing, but this is mainly due to more nurse practitioners and physician assistants, said Mr. Parrino. These mid-level practitioners have to take a 24-hour course, rather than the 8-hour course that is required for MDs and DOs.
8-hour Training: Is It Enough?
The 8-hour training requirement would be removed by the Tonko bill. Mr. Parrino was involved in this as early as 1998, when the question was how to determine whether eight hours of training was sufficient. At the time, H. Westley Clark, MD, then director of SAMHSA’s Center for Substance Abuse Treatment, which has authority over OTPs, wanted to testify that training should be at least 16 hours. There was disagreement in higher levels of government, and he did not prevail, Mr. Parrino recalled.
Now the question, for Mr. Parrino and for regulators, is how to measure what the buprenorphine prescriber does—who tracks it? How do you measure what the physician does? Who tracks that? Who follows it?
When CSAT approved up to 275 patients for that group, the requirement was for the prescriber to report the retention rate, the result of drug tests if any were done, and more. But a small percentage of the physicians who prescribe for up to 275 patients have completed that review, said Mr. Parrino. “SAMSHA is not following this even though it is a federal requirement based on a published Federal Register Notice.
There have also been reports uncoupling the use of medication-assisted treatment (MAT) with counseling and other clinical support services, among them articles that dismiss the need for any counseling. But this can be confusing, because of the unclear definition of counseling. It’s not psychotherapy, in the context of MAT. It can be as simple as the prescribing doctor asking the patient how he or she is doing, and titrating the dose to make the patient comfortable.
Counseling Requirements
The World Health Organization will release new international standards stating that clinical support services are necessary for MAT to be effective, said Mr. Parrino. At a recent corrections meeting, Mr. Parrino heard the sheriff of Middlesex County in Massachusetts, who started the state’s first treatment program that included all three OUD medications in the jail, also point to the need for clinical services. The sheriff said that without them, the effectiveness of the medication is diminished. The other people in the room—other law enforcement officials and judges—agreed with him. “So, my question is, how do you engage justice people in MAT if you don’t listen to them?” In other words, corrections doesn’t want medication-only.
There is always criticism of programs that “require” counseling, and that do not let patients stay on medication if they don’t participate. “If the patient is doing well and is stable, mandating counseling is questionable,” conceded Mr. Parrino. “Sometimes counseling is not good. As I have said repeatedly, if the clinician doesn’t have good training, or lacks in compassion, or is overwhelmingly negative in dealing with the patient, then it’s not good.”
Fortunately, NYSAM members are supportive of patients with addiction; many spent decades working with heroin users in New York City. How they all fare in the controversy over what is widely seen as a turf war between OTPs and OBOTs is hoped not to affect patient welfare.
Buprenorphine’s labeling states that prescribers must have the ability to refer patients to counseling. It does not say that it is required.
For Mr. Parrino’s slide presentation at NYSAM, go to https://nysam-asam.org/wp-content/uploads/1.-1pm-Mark-Parrino.pdf