Posts Tagged ‘Virginia Board of Medicine’

Buprenorphine Regulations

Map is from vox.com

In response to the rise of opioid use disorders in this country, lawmakers in heavily affected states are passing laws they hope will help. But well-intentioned laws may have unintended consequences, requiring re-evaluation of those laws.

Nearly one year ago, The Virginia legislature asked the Virginia Board of Medicine to regulate prescribing of buprenorphine. Legislators were worried about the diversion of prescribed monoproduct buprenorphine to the streets. You can read about this in more detail in my blog entry dated February 24, 2017.

It’s been a year since that blog entry, and I have a little bit of data regarding some of the consequences of Virginia’s new rules.

Initially, the new Virginia Board of Medicine (VBOM) regulations said the buprenorphine monoproduct could only be prescribed for pregnant ladies and nursing mothers. They did this because the monoproduct, containing only buprenorphine and no naloxone, has a higher street value and is more likely to be injected and misused than the combination product.

The VBOM received so many complaint letters that they finally changed the regulations to say that each buprenorphine physician could prescribe buprenorphine monoproduct to up to three percent of their patients. Each of these patients must have documentation of their intolerance in their chart.

It was hoped that this compromise would limit the amount of buprenorphine monoproduct being prescribed, while still making allowances for some patents with intolerance to naloxone in the combination product.

The VBOM didn’t stop there. They passed regulations about care at opioid treatment programs (OTPs), which are already the most heavily regulated medical providers in the nation. The VBOM said if buprenorphine monoproduct was used, the patient had to consume it on site, with observed dosing, and that no take home doses could be allowed for the monoproduct.

To clarify, this meant that OTP patients dosing with buprenorphine monoproduct had to either switch to the combination product, buprenorphine/naloxone, to get their usual take homes, or dose daily at the OTP on the monoproduct and forfeit all the take homes they had earned.

Or they could switch to methadone, where take homes are still allowed, following standard guidelines.

This is the irony – methadone is a heavier and stronger opioid than buprenorphine, and more likely to cause overdose death if taken illicitly or diverted. Virginia patients can get methadone take home doses, after they have a period of stability and meet the guidelines which have been in place for decades.

OTPs must follow both state and federal guidelines, and must obey the stricter of the two. The federal guidelines dropped the time in treatment requirement for buprenorphine, meaning the federal agency decided to allow the admitting physician to decide how many take home doses were appropriate, from day one, for a buprenorphine patient.

Essentially, Virginia went the opposite direction, and eliminated take homes, at least for the monoproduct.

At the time the new regulations were implemented, there were 600 Virginia patients on buprenorphine at OTPs. Monoproduct was used because was about half the price of the combination product, and kept treatment more affordable for patients. Also, because OTPs already followed stricter regulations than office-based programs, the risk of diversion was felt to be lower than at office-based programs.

Of those 600 patients, 384 patients attended one of the four OTPs owned by Acadia Healthcare in Virginia. They collected data on what happened to their Virginia patients after these new regulations were implemented. Since I work for Acadia, that data was released to me for an upcoming presentation, but I’ll give my readers an early view.

Of those 384 patients, 260 made the switch to the combination product so that they could continue to get take home doses. In other words, two-thirds of the patients switched, and one-third did not.

The cost of medication doubled, but rather than pass this on to the patients, Acadia Healthcare absorbed all the extra cost. The patients paid the same as if they were getting the cheaper monoproduct. This was fortunate, since an overnight doubling of costs could have caused hundreds of patients to leave treatment.

To some lawmakers, an extra couple of hundred dollars per month might not seem like much. But to many patients, it’s the difference between being able to stay in treatment or having to leave and go back to illicit drug use.

So, what happened to the patients who didn’t make the switch?

  • 15 switched to methadone, and will be able to get take home doses once they meet criteria. It’s takes a while, but at least they can get take homes eventually.
  • 21 transferred to out-of-state opioid treatment programs because they had an intolerance to the combination product.
  • 24 (6%) patients dropped out of treatment.
  • 58 remained on the monoproduct and accepted that they will have to dose every single day that they are in treatment. Since all these clinics are in rural areas of Southwestern Virginia, I suspect some of these people are driving long distances daily, and incurring extra expenses for that travel.
  • 6 patients were lost to follow up, and couldn’t be contacted to see what happened.

Studies show the risk of death increases as much as eight-fold for patients who leave treatment, so those 24 people are at high risk. I suspect the 6 people who couldn’t be found are also in that risk group.

I have a little bit of data about what’s happened on the receiving end with patients on buprenorphine at Virginia OTPs. One OTP located in Boone, NC, received 12 patients in transfer from Virginia. Those patients could have been OTP patients or office-based patients; I don’t have that data.

I have my own office-based buprenorphine practice in the Lake Normal area of North Carolina, which is 73 miles from the North Carolina-Virginia border. My practice got around twenty phone calls last year, just after Virginia’s law changed. These patients were willing to drive from Virginia to my office if I would prescribe buprenorphine monoproduct. I declined to accept any of those patients, both because it is unworkable in the long run to come from such a distance, and because I was concerned about regulatory scrutiny in my own state.

You can draw your own conclusions based on this limited data. It appears that roughly two-thirds of patients, if forced to switch to the combination product, can do so and remain in treatment.

But remember, costs weren’t increased for those patients enrolled at Acadia OTPs.

That would not have been the case for office-based self-pay patients, who would have paid roughly double each month for their prescriptions for combo products at the pharmacy. Community pharmacies would not have absorbed the extra cost.

I combed the internet, trying to discover data on what happened to office-based patients in Virginia on the monoproduct. If data is out there, I haven’t found it. Or perhaps it’s still being collected and analyzed. I also looked to see if overdose death data changed much in 2017, but it’s likely too early for this.

The American Society of Addiction Medicine has written a public policy statement addressing regulations on office-based buprenorphine policy. This document outlines the most reasonable approach to assure appropriate care for patients while limiting onerous regulations for providers. State legislators would do well to read this policy and abide by its specific recommendations.

https://www.asam.org/docs/default-source/public-policy-statements/statement-on-regulation-of-obot.pdf?sfvrsn=df8540c2_2

I’m tempted to give a summary of ASAM’s statement, but ASAM warns against this, at least without their permission. They don’t want people to use just a section of their policy to justify a position; they want their statement to be read in full.

I think that’s smart of ASAM. I encourage interested readers to check it out.

Advertisements

Virginia Board of Medicine Changes Opioid Treatment Program Regulations

aaaaaafail

 

 

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.