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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29 responses to this post.

  1. Posted by Theodore D Fifer MD FACS on February 24, 2017 at 1:49 am

    Bravo. Right on.

    Paragraph 5: ? edict ?

    Reply

  2. This is so unfortunate. I feel awful for the patients who this will affect.

    Reply

  3. It seems that the medical boards of both VA and TN are now practicing medicine, not just maintaining quality. I hope that NC remains sane.

    Reply

    • Posted by axegrinder300 on February 24, 2017 at 8:05 am

      You mean the first state to come up with an LGBT bathroom bill? I don’t think NC will live that down for a while. Changed my whole image of the state, I thought you guys were more liberal than that.

      Reply

  4. Posted by axegrinder300 on February 24, 2017 at 7:49 am

    OMG. This is the pharmacological equivilent of trying to keep Aspirin off the streets, except Bupe actually saves lives (even if diverted). It doesn’t get you ‘high’, which these people will never understand apparently, and a person wanting to go get high can huff gasoline. Someone must be lobbying against Buprenorphine use. Politicians don’t just ‘do things’, unless it’s part of their hard-core ideology. Who?

    Reply

    • That is the irony. Even though we do our best to interdict diversion, those of us working in OTP and OBOT settings see many intake patients who tell us they have been using illicit buprenorphine rather than the “harder” products. They actually come into the program asking for bupe instead of methadone. I don’t minimize the potential dangers of bupe, but compared to methadone it is ridiculously safe. It has taken me a couple years to realize that.

      Reply

  5. This is stupid because once you are dependent on the combination product, you can inject it with no ill effects, due to bupe’s binding affinity. As usual, the powers that be are motivated by 2 things: bad information and greed.

    Reply

  6. Posted by Kyle on February 24, 2017 at 2:12 pm

    Thank you so much for this write up, I have been trying to get people to see this is a problem. I keep up with your work, you truly do help stand up for people. Here is a petition for it if anyone is interested in signing we need all the signatures we can get before the governor makes a decision and he has to by sunday or it goes into law. These patients need to be thought of, and it’s patient discrimination. I have a DOCUMENTED SIGNED hypersensitivity to Naloxone. I have been in maintenance treatment for 2 years now now failed urines, counts, all the counseling I was required to do. I earned my take homes, and then I switched to a prescription program because it was just easier to keep up with, but it was at the same clinic. I don’t have the methadone option as I have bad asthma and it restricts my breathing to much. It is far less safe, also abuse-able. Believe me I wish I could switch to something else I do. Here is a link to a petition that needs signatures before the governors deadline.

    Reply

  7. Posted by Nancy Friel on February 24, 2017 at 4:24 pm

    In addition to the negative outcomes from this new regulation that you outline, this increases the stigma and the disinformation about the treatment of opioid dependence. People on treatment are stigmatized as “those addicts” who are not to be trusted; this regulation cements and amplifies that attitude. It also amplifies the disinformation that there is a difference in the disease of dependence between those “good pain patients” who are maintained on high doses of opioid painkillers, and those “bad addicts” who “can’t get clean”. This is scary and disgusting repressive medical politics, and I fear we are in for much more of this in our new political climate. I too am very afraid that more of our patients will die, because of unilateral, uninformed and biased decision making by the powers that be.

    Reply

  8. Posted by Alan Wartenberg MD on February 24, 2017 at 7:10 pm

    Jana, I understand that this particular horse has already left the barn, but what is the process by which the legislature reached this decision, and where were the interested stakeholders during the hearings? The Massachusetts ASAM chapter is part of the Mass Medical Society, which has a full-time lobbyist in its employ. Part of his job is to search out EVERY bill with medical consequences and to notify people within the MMS. Do you have something like this in Virginia, and if you don’t, when are you going to get one? Such bills are not passed in a vacuum, and somewhere an opportunity may have been missed to make a difference by educating the legislators and (perhaps more importantly) their staff.

    Reply

    • Hi Alan, Good questions all.
      I’m in North Carolina, and don’t know the particulars about lobbyists in Virginia, or even in my own state, for that matter.
      I found out about it one week before that meeting, and I know much hard work was attempted by some very good people in my own company, which owns clinics in the rural parts of Southwestern Virginia.
      No body else seemed to get too excited about it, which puzzled me.

      Reply

  9. Posted by Kyle on February 25, 2017 at 4:53 am

    The horse hasn’t left the barn yet, it all depends on the governors decision on HB 2163 he has until sunday to make a decision or veto. If he doesn’t sign it into law it won’t go into effect. It can still be fought, there are lawyers out here from california fighting for our rights but everyone we can get doesn’t hurt.

    Reply

  10. Posted by Karen brown on February 26, 2017 at 4:22 am

    in Tennessee where they are cracking down so hard on doctors they are scared to do there job correctlyand without fear my husband is on the combination medication suboxzone and he was riding his motorcycle down there road when a car pulled out in front of him and he broke his elbow which is his right one he broke his left elbow a few years back and on suboxzone, using same doctor and doing same as last time he had emergency surgery well, they orthopedic said a few years back that these were then most painfull breaks u could get other than your Sturm well, he had emergency surgery with both, 5 years ago no problem with going off suboxzone for a month and using oxycotin/oxycodone with them same doctor who writes his medicine suboxzone with ghis break of his other elbow he told the doctor what had happened right after even before the doctors appointment to get his suboxzone on both times. Well, this time when he went to doctor (and stating to her that he did not want the suboxzone appointment to just see him as a regular physicianappointment to come up with a plan on treatment after his elbow did not hurt extremely bad and go back to suboxzone because of filling it she discharged him he had only had their surgery 9 days prior to his appointment not to mention I am his wife and get suboxzone from her also and she discharged me which I never have been dirty of oxys or opiates or any other drug than what I was supposed to in the last year of seeing her and I felt she discriminated against me because of him and through out there because we did not want to go down (me basically) on my 2 a day is why I was been in discharged but she did let me make one last appointment cause I asked her why are u dischargin me that was her response that I didn’t want to go down so I asked if I could still stay in treatment even if not my husband was not if I go down on myin so she wrote me for one and 3 quarters instead of 2 which I have temptation around and she said she felt she was not helping when I have been doing fine and he also was not dirty prior to his brake in their last year. and she could never explain to us what we were to do in a emergency case of been hurt badly and we let both doctors know he was taking suboxzone and both knew about their opiates I asked her where did I fall in his boat to be discharged should I seek a lawyer on my behalf I just think I should of not been discharged because of him and if you know about what we are to do in emergency situations please help me out to understand and he did get pain relief from their other opiates after bout 2 days of no suboxzone but his tolerance was where he had to take a little more than most non opiate users but hewas discharged because of using 2 pharmacy cause our rx. we had used for years was changing owner they could not fill narcotics till dea. finished with them so it flagged me of going to another rx. which they doctor also knew cause he had to get her to call in his remaining last month because dea. would not let him transfer his med so she knows we we had to change rx. I only have had used wall greens since change but wall greens at different locations because one wall greens didn’t have enough of my med. on had that I had to go down there street and last thing she kept throwing up was none of her other patients was on 2 a day just us but we had explained to her we had been on this for over 7 years and why change something that’s working from my understanding 2 a day is their normal management plan and because of him riding motor cycles and dirt bikes he gets hurt a lot and he also used it for managing his elbow pain and me my knee on top of using it for them normal I had been hit by a car walking down their road at 22 which started my issues and him almost dying of perdonal abecess ov the tonicells where he about died at 27 PLEASE HELP!

    Reply

    • Posted by Karen brown on February 26, 2017 at 4:26 am

      p.s. I have always gotten migraines for suboxzone and they are way more expensive here in Tennessee I can get 60 subutex for 200 dollars where 60 suboxzones cost 450 dollars with a discount card but doctor would only write me combo not subutex but now since I am discharged I will look for a do tor who will write subutex.

      Reply

  11. Posted by Kyle on February 26, 2017 at 2:55 pm

    If this petition can get signatures, I can pay to have it promoted to extend to 1000 possible signers. I need around 30 signatures to hit that mark. It doesn’t matter if you live in Virginia or not. The governor has until monday midnight to sign or veto. I have contacted literally everyone in the the virginia goverment, 101 delegates, 32 senate, 2 senators, and the governor. I other people are trying to do whatever can be done, but im fighting for the area im in, this bill have consequences to these families that are dealing with it first hand. If these patients turn to the streets they cannot have Narcan if they overdose. There shouldn’t be as many restrictions as there are but if there has to be it needs to include patients such as myself that cannot have Suboxone, and I know Buprenorphine is MUCH safer than methadone. They act like methadone and suboxone can’t be abused but thats just a straight lie. I hope one day I don’t need a surgery, but have to use a auto mechanic to get it done. These politicians should do the research first hand and let doctors make the right choice if the doctor goes through the correct protocol. What I find weird is HB 2163 has a sunset date of July 1st 2022, almost like they made a deal with a big pharma company.

    https://www.change.org/p/virginia-general-assembly-virginia-buprenorphine-treatment?recruiter=19915210&utm_source=share_for_starters&utm_medium=copyLink

    Reply

  12. Posted by Kyle on February 26, 2017 at 5:36 pm

    I just wanted to post I accidentally put some miss information in my last posts. I thought Governor had until February 27th, because in WV they Governor has 5 Days to respond with most bills. I was wrong he has unti March 27th to respond, I guess the bad news is the news could come anytime from now until then. The good news is I have time to help the petition hit 40 signatures so I can pay to promote it to others instantly. I feel everyone that cares and has seen firsthand what addiction and opioid dependency can do it a person and their family to sign it. I would hate to see methadone patients fighting this same fight next year. The patients that earned their take homes did everything necessary to earn them. The have many more restrictions than pain patients do. Multiple urines, more counts, checks, and counseling. These people will have their lives torn apart. Seeking treatment in another close by state may be an option for some people but for most it isn’t.

    Reply

  13. Posted by Kyle on February 27, 2017 at 3:56 pm

    I don’t know if anyone else is still keeping up with this conversation. It doesn’t look like it but just in case someone sees it I have updated the petition with statistical facts to help back up these patients. The petition now has 21 signatures it has enough now to where i can pay to have it promoted thanks to a couple signatures from here. I won’t ever ask any signer to promote it but if any person feels like it and/or are being effected by it go write on ahead. I will paying later tonight as soon as I get a chance to promote it. I appreciate the few people here that did sign it.

    https://www.change.org/p/terry-mcauliffe-virginia-opioid-treatment

    Reply

  14. Posted by Whit on February 28, 2017 at 4:06 pm

    You keep talking about the impact that this will have on rural clinics. It’s important to remember that the current government of Virginia is from Northern Virginia, and makes policy with this in mind. I.e. they assume that Virginia is an urban and suburban state where a clinic will be 20 minutes away at most.

    Reply

  15. Posted by Kyle on March 3, 2017 at 5:40 am

    That is true too, but even just 20 minutes away is often to far for a everyday travel. Most patients in treatment often have to carpool because they don’t have a ride everyday. The petition is taking off, and hopefully the message will be heard. It isn’t such a bad compromise that if they have to prohibt prescriptions to also include patients that are hypersensitive to Naloxone. They also need to allow otp clinics to dispense it in take homes. I have contacted SAMHSA, AATOD, and NAMA. The President of AATOD is in contact with the Virginia government. None of this will go into effect if the Governor decides to have it amended or vetoes it. It will go into effect if he doesnt make a decision by march 28th. I don’t know if the regulations will go into affect on July 1st or that very day.

    Reply

  16. Posted by Mary Aldred-Crouch on March 6, 2017 at 5:54 pm

    I completely agree that the VA Board of Medicine is tripping over mole hills (diversion) and ignoring the mountains (opiate addiction and the deadly nature of that disease if not treated using best practices).

    Reply

  17. Posted by Kyle Miles on March 7, 2017 at 11:22 am

    https://www.richmondsunlight.com/bill/2017/hb2163/

    This is the link to comment on the bill, the other one may not work but this one will.

    Reply

  18. Posted by Kyle Miles on March 8, 2017 at 5:29 pm

    Dr Burson, what are the SAMHSA regulations for buprenorphine take homes. I cannot find that information. I can only find the information pertaining to methadone. I know when I started I was eligible for 1 take home after 30 days had passed after my first clean urine but I would like to look at the information so I know myself.

    Reply

    • The SAMHSA regulations are the same as for methadone, except they did drop the time in treatment criteria.

      Reply

      • Posted by Kyle Miles on March 12, 2017 at 10:05 am

        Dr, Burson I didn’t know you were employed by CRC. I was talking at my clinic about your work, and was told about it. I know they are in federal court trying to get it pushed back because no where in the bill did it say otps couldnt dispense it in take homes. The argument has basis, because all the bill said is would leave it up to the medical board as far as prescriptions go. So hopefully this federal judge gives us patients some justice, because these politicians are killing people for no reason. I don’t see how they get a good nights rest.

  19. Posted by Brittany on March 17, 2017 at 5:01 pm

    I am scared to death about my recovery now! I was put on subutex due to anaphylaxis to Naloxone during my dosing 2 years ago. They made no clause for patients who actually do have an allergy. I will NOT go to methadone since I tried it and it wasn’t for me. I’ve been doing well with my revivers and have never had any issues with my recovery. Why now? Why and what do patients do that CAN NOT have the Suboxone. It’s an hour commute for me to see a doctor and it’s expensive for me since I have Medicaid paying for my treatment to have to travel that far everyday to be dosed. I’m confused as to what options I do have?!

    Reply

    • Posted by Kyle Miles on March 20, 2017 at 2:28 am

      We have absolutely zero options, and the politicians could give a shit less. The medical board said they are thinking of adding a clause but need more feedback so call them. We don’t have any options and its sucking to think if I didn’t have this hypersensitivity to Naloxone and 10 other medications that I could have Suboxone treatment, Its disheartening to see everyone else gets to keep theirs but we are out of luck. They enacted these regulations anyway, The Board of Medicine went over the governors head and added a regulation that hasn’t even been signed into law yet. That is illegal.

      8043674558

      Reply

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