Posts Tagged ‘new regulations on buprenorphine’

Virginia Board of Medicine Changes Opioid Treatment Program Regulations

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In a surprising turn of events, last week the Virginia Board of Medicine passed regulations applying to the prescribing of buprenorphine not only in office-based settings, but also in opioid treatment programs.

At a time when many governmental agencies are trying to figure out ways to keep people from dying from opioid overdoses, the Virginia medical board is more concerned with diversion and misuse of the life-saving medicine, buprenorphine.

Last Thursday, the Virginia Board of Medicine outlawed opioid treatment programs from giving buprenorphine monoproduct take home doses. All patients on the buprenorphine monoproduct have to be dosed on- site at the opioid treatment program, with directly observed dosing. If patients are willing to switch to the combination product, buprenorphine/naloxone, they will be allowed to continue their earned take homes.

I know why the Virginia Board of Medicine restricted the monoproduct; they are convinced people are misusing this medication, injecting it and selling it on the black market. To be sure, this does happen, and I agree that we must do what we can – within reason – to prevent medication misuse and diversion. But I doubt the members of the Virginia Board of Medicine know that opioid treatment programs already have diversion control programs in place, both for buprenorphine and for methadone, a more powerful opioid.

It appears that rather than open a dialogue with opioid treatment programs and their physicians, to get a better idea of how to help patients, the Virginia Board of Medicine unilaterally issued an edit that will adversely affect these patients.

People on the front lines, working at opioid treatment programs in rural areas, know that the medical board ruing will cause considerable hardship for patients who are in good recovery.

Patients have several options, and all of them present some complications that will have to be overcome. Patients can either chose to stay on the monoproduct and dose daily at their opioid treatment program, switch to the combination product and continue to get take home doses, switch to methadone and get take home doses, or drop out of treatment altogether.

Let’s look at each option.

This medical board appears to assume patients could just switch to the combination product, with no problem. But there is a problem – a big financial problem. I’ve looked carefully at the costs of the generic monoproduct compared to the generic combination product. In my area, there’s about a $120 per month difference between the two, at a dose of sixteen milligrams per day. That’s a best-case scenario.

Let’s assuming the opioid treatment programs were able to pass on only their direct increased cost of medication to the patients. An extra $120 per month to stay in treatment doesn’t sound like much to some people, but to uninsured blue-collar workers who make up the majority of opioid treatment program patients in rural areas, that extra cost is prohibitive. It’s enough to force patients out of treatment.

People fortunate enough to have money and insurance can pooh-pooh this all they want, but an extra $120 per month is unaffordable for many patients enrolled in opioid treatment programs.

What about the small but significant number of patients who say they don’t feel as well on the combination product as the monoproduct? The medical board members exhibit a stigmatizing and biased attitude when they assume all patients who request the buprenorphine monoproduct are intent on injecting and/or selling their medication.

I’m convinced some patients do absorb more of the naloxone in the combination buprenorphine/naloxone tablets than they are “supposed” to. People do respond differently to medications, with no bad intent. These patients can recover nicely on the monoproduct, with careful monitoring, and they don’t have the headache and vomiting sometimes seen with the combination product.

While I agree physicians need to take extra measures when prescribing medication which have value on the black market, we should already be doing this, both at opioid treatment programs and office-based buprenorphine offices.

At opioid treatment programs, we have diversion control plans, including frequent bottle recalls to assess for diversion in all patients, on buprenorphine or methadone. We sometimes check patients’ arms for track marks, particularly if they have a previous history of intravenous drug use.

According to the Virginia Board of Medicine, if patients can’t tolerate the combination product buprenorphine/naloxone, or if they can’t afford it, they can just dose each day at their opioid treatment program.

That position overlooks our patients’ realities too.  In rural areas, patients may drive an hour and a half one-way to get to their opioid treatment program. For a person who is doing well and who has earned a week of take homes, the sudden imposition of dosing daily means three hours out of their day, plus the extra expense of travel. That can be a deal-breaker for financially fragile patients, too.

Think how insulting it would feel for patients who have done well in medication-assisted recovery. Think of patients who have done well for many months, have passed drug screens, passed all bottle recalls, and who have become employed. They have recovered into responsible and productive members of society…only to have legislators decide they can’t be trusted to have take home medication.

What would your response be? I’m afraid I might react very badly.

Since dosing every day at the opioid treatment program isn’t an appealing option, and for patients who can’t afford the extra cost of the combination product, or who can’t tolerate the side effects, methadone is a viable option. It works well, and it’s been proven over the last sixty years to be an effective treatment.

It does have some disadvantages, though. There’s still quite a stigma against methadone, and it is harder to taper off of at some point in the future, if indicated. It has more medication interactions and is more dangerous during the induction phase. It’s possibly less forgiving when mixed with alcohol or benzos than buprenorphine.

It also has street value and can be diverted, which is why all OTPs have diversion control plans, which brings us back to the original reason why the medical board wants to outlaw buprenorphine take homes. If they want to outlaw buprenorphine take homes today – a drug much less likely to kill people than methadone – will they outlaw methadone take homes tomorrow? I think that’s highly likely.

Because buprenorphine is so much safer than methadone, SAMHSA dropped the time in treatment requirement for buprenorphine take homes. Their purpose in doing this was, I thought, to encourage more people with opioid use disorder to get into treatment, and consider using the safer drug, buprenorphine.

Virginia’s new requirement puts an end to any take home doses for the monoproduct while ironically continuing to allow take home doses for patients on methadone, a much heavier opioid more likely to cause overdose death when misused.

The last, and worst, option for patients who will be faced with the decision of what to do when their buprenorphine take home doses are revoked by the Virginia Board of Medicine is to leave treatment.

I really hope this doesn’t happen. One study (Zanis et al, 1997) showed an eight-fold increase in overdose death for patients who left treatment at opioid treatment programs.

At a time when the rest of the world is trying to engage people in medication-assisted treatment of opioid use disorder, and make it more attractive to patients at risk for dying, the Virginia Board of Medicine is throwing up barriers to treatment.

I have a suggestion. Why not use some of those millions Virginia extracted from Purdue Pharma in their lawsuit settlement, and pay part of treatment costs for your Virginia citizens with no insurance?

If Virginia feels it’s imperative to offer the buprenorphine/naloxone tablets for patients with opioid use disorder who are able to tolerate that medication, help them pay for it.

For patients who don’t tolerate the combination tablet, let opioid treatment programs to continue to do what we do best…care for complicated patients with opioid use disorder.. Let us continue to do bottle recalls and arm checks to assess for continued IV drug use in patients who have that history.

I suspect, if diversion data could be examined, we will find what we found with methadone ten years ago. The diversion then was fueled by patients at pain clinics, who had little or no oversight, not the opioid treatment programs with active diversion control programs.

If we find some opioid treatment programs have lax diversion control, address that through the channels already in place, rather than trying to invent something new.

But please don’t erect new barriers for patients seeking to recover from opioid use disorder. It will – literally – kill people.

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