Federal Regulations Revised for Opioid Treatment Patients on Buprenorphine

Illustration of relative strength of methadone compared to buprenorphine

Illustration of relative strength of methadone compared to buprenorphine

[Please note: this post applies only to patients getting buprenorphine from opioid treatment programs and not to patients in office-based settings, where the doctor gives the patient a prescription to take to the pharmacy.]

As of January 7th of this year, the federal regulations regarding take home doses of buprenorphine (active ingredient in Subutex and Suboxone) in opioid treatment programs were relaxed. Instead of having to follow the same take home guidelines as patients on methadone, buprenorphine patients enrolled opioid treatment programs no longer have to meet the time in treatment requirements. This means a patient on buprenorphine who is doing well can get take home doses much earlier, at least in some states. These patients still must meet the other criteria, like no illicit drug use, stable home environment where medication can be stored safely, freedom from criminal activity, engagement in counseling, and the like.

To illustrate, if a new buprenorphine patient is doing very well, she can get some take home doses as early as a few weeks, instead of having to wait until ninety days of treatment, as is the regulation for methadone patients. The opioid treatment programs have discretion deciding how many take homes can be granted, and how soon. Theoretically, this patient could get up to 27 take home doses relatively early in treatment.

Only the federal regulations were revised. States like mine, North Carolina, have state regulations regarding take home doses for buprenorphine opioid treatment program patients, and programs still must still follow these state laws. Opioid treatment programs are governed by both federal and state regulations, and if they are different, the most restrictive regulations take precedence. North Carolina still has a time in treatment requirement, until/unless lawmakers change this to match the new federal regulations. So in my state, nothing changes because of the new federal ruling.

I have mixed feelings about the new federal ruling. It would be nice to have the freedom to grant take homes with less effort. However, I don’t see our state’s present regulations as a problem, since we have always had the ability to ask the state for exceptions to the time in treatment requirements for buprenorphine patients, and permission is nearly always granted by our state methadone authority. For example, if I have a buprenorphine patient who has been in treatment only a month, but who is doing exceptionally well in all areas, I can electronically submit a request asking for permission to give this patient four take home doses per week, and the state’s methadone authority usually approves it within 24 hours. This is because buprenorphine is so much safer than methadone, and less likely to kill someone who misuses it.

I like our present system, since it forces me and the treatment center staff to discuss all aspects of the patient’s progress before we submit a take home request. With the relaxed regulations, I worry some programs may make rushed decisions about early take homes, since the time in treatment criteria have been dropped. Our present system means a little more work for staff, but it also means we pay more attention to patient progress.

I can imagine a worst-case scenario where unconcerned clinics could grant twenty-seven take homes to a patient new to treatment. I can picture unscrupulous clinics using that as a marketing tool to lure addicts to their clinics, though it may not be in the addict’s best interest.

On the other hand, some people argue that doctors already give office-based patients monthly prescriptions. They do, but hopefully not until these patients are doing well and engaged in counseling. Until then, most are seen weekly or bi-weekly. Also, office-based treatment was originally meant for more stable patients: no or minimal other illicit drug use, stable home and work life, no or minimal mental health issues.

When issuing the new federal ruling, SAMHSA (Substance Abuse and Mental Health Services Administration) mentioned that in the past, people feared that increased take home for buprenorphine will mean more illicit intravenous use of the product. However, the five thousand patients already on buprenorphine in opioid treatment programs and already getting take homes don’t appear to be using buprenorphine intravenously.

Also importantly, SAMHSA re-iterates that in the opioid treatment program setting, physicians aren’t limited to only thirty or one hundred patients, as office based practices are. However, some states may require limits on the number of buprenorphine patients. Opioid treatment programs still need to adhere to the recommended drug testing, counseling, and other services described by the federal government.

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14 responses to this post.

  1. Posted by Benjamin K. Phelps on January 20, 2013 at 2:20 pm

    Wow, Dr Burson… Where to begin?? I have, like you, several feelings about this which go both ways. Naturally, with me being a methadone patient who has been compliant month after month, year after year – with the exception of the clinic giving me Lunesta for years & my beginning to abuse it, but now have been off for almost 2 years completely – it does stick in my craw that bupe patients are treated with preferential treatment by the government & others – as if they’ve achieved something MMT patients have not, simply b/c of the perception by outsiders that bupe is not abused & causes little withdrawal. While it may be safer, & may have somewhat less abuse in some aspects, it most certainly IS abused, & it most certainly DOES cause withdrawal, & there most certainly IS a black market that is very active & well. I won’t say that I believe methadone patients should be given the exact same latitude with methadone doses as bupe, but for folks in MMT to be forced to complete 4 years in every program I’ve encountered to get to 27 takehomes (I don’t know if NC’s law requires this or just the clinics’ policies do – but I know that federal guidelines only require 2 years for us to get “monthlies”/27 takehomes) is totally outrageous. That’s a VERY VERY LONG TIME when it’s your gas money, your car mileage, your time, your inconvenience, & your treatment fees (which I say b/c some clinics reduce fees when monthlies are achieved.) The disparity here is insulting when I (& here are more of my feelings on the article) keep reading on here (the blog “Who is snorting Suboxone/Subutex”) about all these people buying “Subs” on the street & injecting/snorting them, & all the patients who claim to be recovering WONDERFULLY with Suboxone……. by injecting just 1/2 (!) tablet a day!! That’s NOT recovery, nor is it compliance, nor is it safe. It may not be as quick to cause lethal respiratory depression, & is hence somewhat “safer” than methadone, however methadone in the present tablet formulation (wafers) are not injectable at all. Add water in a spoon to a wafer & you get a cake of soppy muck that you’d not get sucked up into a syringe if you spent a year trying. I know this not b/c I tried it, but b/c I had to add water to mine to take them (& then Tang mix – I had the white Mallinckrodt Methadose 40mg & 5mg dispersible tabs) & I saw what happens there, either with cold or hot water. No, I didn’t try burning it with a lighter as an addict would, but I wouldn’t have to – if you saw the muck it made, common sense would tell you as much. But no matter… the fact that respiratory depression occurs less intensely or less frequently with buprenorphine is not the entire story there – it may not kill you from that, but it will CERTAINLY kill you (or at the very LEAST, maim you) from injecting the fillers & binders in the tablets or the goo in the strips, either quickly or after some time. You will only get by for so long before you get lucky & swipe up a few bacteria with that needle you’re using & inject yourself with them & get a nice big dose of cellulitis or endocarditis. But I suppose that’s not what we’re worried about?? I don’t really get it. Every indication I see is that Suboxone abuse is rampant – even though it’s less frequently used for a high & more so for staving withdrawals by an already addicted addict. But don’t get it twisted – there are plenty of people getting high off them, as well, even if it is limited or dimmed. If you begin with using Suboxone, the high WILL be there. It’s only muted strongly when it’s started after using agonist opioids & switching. I’m not saying it’s the same as a heroin high or whatever, but it’s definitely there, & people definitely know this.

    I don’t like pointing these things out b/c bureaucrats will inevitably read this type of stuff & want to do away with it altogether (throw the baby out with the bathwater…) or restrict it to the point where people who would use it properly will no longer seek it out b/c it’s too restrictive (as MMT is now, causing many to refuse to tolerate it.) But these things are happening whether we acknowledge it or not. And I’m NOT advocating tighter restrictions on bupe, or equating it to methadone… I’m also NOT advocating loosening methadone to the level of bupe. But the current restrictions on MMT are WAY too tight in some ways, while bupe is too loose in some ways. I agree with Dr Burson that the patient’s progress needs to be scrutinized specifically before takehomes are just handed out like candy – which I’m afraid will begin happening, just like Dr Burson said, if the clinics can just sling them out without paying attention closely. What that will ultimately result in is that more Suboxone will end up abused & on the street by those abusing treatment & not recovering, & THAT will end up either causing the demise of office-based treatment & end the lower-level restrictions on bupe, or cause such a stigma to get attached to it from all the misuse & abuse that it will become just like methadone & MMT, being heralded as the “new Oxy-Contin” or the “new Methadone”, with everyone saying & thinking it’s trading one addiction for another, that it’s simply a monetary ploy by docs & drug companies to profit off addicts’ misery by keeping them addicted (we already deal with enough of that!), & all kinds of negative connotations we REALLY don’t want or need to see happen. I think I have to agree with Dr Burson’s evaluation of the situation by saying maybe we ARE better off with leaving things as they currently are. My only gripe with that is that clinics like the one I’m in won’t write to the SMA to ask for takehomes for bupe patients… at my current clinic, you must come dose at the window every single day, case closed. That’s wrong in EVERY way, & is unnecessary. But just as with everything else in the world that happens there, they are always scared to death that 1 patient will feel like s/he’s being treated differently than another patient b/c s/he didn’t get the exact same thing, & they’re petrified this will somehow bring the entire world to a halt. The way I see it, everything SHOULD BE case-by-case, not one-size-fits-all. I don’t sell my methadone, pop positives on my drug screens, I attend my counseling & groups, & I pay my bill on time every week. Why should I be treated equally as someone who doesn’t fit that description? But tell them that & see what they say about that notion… This is why I STILL don’t have my takehomes back from the bike-theft situation back in mid-November, & won’t until mid-May. According to them, this would’ve been done even if they’d been stolen the 3 takehomes in the lock box from a safe in my home with an alarm on it by an intruder, it’s done to any & everyone that loses or has takehomes stolen (why is loss treated the same as theft with a police report?? One implies carelessness, the other is uncontrollable in some/most ways), & I shouldn’t take it personally, b/c it’s simply “policy”. That I’ve been 100% compliant since beginning treatment does not matter or factor in. If I’d shot heroin, been drug tested, lied & claimed no drug use, & then been caught via the test, I’d have only lost 2 of the 5 takehomes I’d earned, & only for 2 months. You see, this type of treatment of methadone patients is what I’m talking about – it’s wrong, unfair (even if they’d taken them for a time, to assess that I am stable & likely didn’t take them – that would’ve been understandable – but not this…), & so very unnecessary. But they know – what are you gonna do? You can leave, but not if there’s not another place to go in this town. And they know I’d transfer without a single takehome to an out-of-town clinic, where I’d have to dose daily for 90 days before I’d possibly get 2 takehomes weekly. Then another 90 days to get 2 more. I can’t afford that in ANY way. The gas alone would do me in, not to mention the more expensive clinic ($4 more a DAY!!) This is what MMT patients are facing, without choices in whom we are treated by in many cases, while bupe patients are given choices galore in whom they get treated by; they’re given takehomes right off the bat in very decent numbers, even as things were; and they don’t face the stigma that we do. But bupe isn’t effective for some of us, so we don’t have the choice to switch to it. I’ve always needed a higher dose than 60mg of methadone, & thus, it would not be appropriate for me at all. Plus, I cannot afford it… I have no insurance. So while it may sound like I’m being partial &/or biased, I’m really not – I just think there should be a bit more balance between the treatments. I think they should be paying a little more attention to things on both sides of the fence – enough to know that people are NOT coming off bupe (as they claimed would be possible) without any suffering, or even minimal suffering; it is being abused, both IV & intranasally, & orally; it has killed people; & many other factors. I’m all for compliant patients doing well being given some latitude in how often they must do observed dosing. But that should apply to MMT, too, & I’m not sure where time in treatment has much of anything to do with that, after induction. And those given such latitude need to be done so with GREAT caution & full accountability. There are things that could be done to give some security there, which I won’t go into here. Just my thoughts. Sorry I wrote a book, but ya’ll know me by now on here!

    Reply

    • Posted by Lrm40 on January 21, 2013 at 11:36 am

      Drug addicts abuse all drugs.. Patients truly wanting sobriety do not abuse suboxone. We take it as recommended. Period.

      Reply

      • Posted by Benjamin K. Phelps on January 21, 2013 at 3:53 pm

        Lrm40, I’m not sure where your comment was directed… But I will reply with my thoughts. First, I don’t exactly agree. Many an addict has gotten on either methadone or Suboxone/Subutex wanting sobriety & then ended up abusing the maintenance medication unexpectedly or not intending to. As addicts, this CAN HAPPEN. Your comment makes it a very black-and-white thing, suggesting that it’s not possible for a person wishing to get clean to abuse these drugs. Unfortunately, history shows us otherwise. I wish you WERE completely correct, believe me! In which case, there’d be no need to earn takehomes at all for those who entered into treatment willingly on their own merits (not court-ordered.) Because those people sought treatment on their own, & as such, wanted to stop abusing illicit drugs. True, there are the ones that simply want harm reduction, but I dare say that the larger percentage INTEND at entry to stop drug use. But inadequate doses & other factors can make that impossible for some. Suppose I’m on Suboxone & really wanting sobriety, as you say. But this month, the doctor gave me only 30 (8mg) tablets. But to become stable, it turns out I actually am going to need 16 or 24mg/daily. True, in most cases I could probably make another appointment, but let’s say he’s now out of town until 2 weeks away, or can’t fit me in until then. In the meantime, my cravings are not suppressed & I could even be in some withdrawal each morning. You think in most cases, the patient (in this case, me) isn’t going to go ahead without permission of the doc & take extra? This is “using”, by definition – titrating narcotic dose w/out permission is the very epitome of addiction. And since I’ve not gotten out of my addictive behaviors yet, I am thinking I could probably get better efficacy out of my precious pills by injecting or snorting them. After all, if he finds out I’m taking more than I should, I might get kicked off the program! Or if I ask for another increase, he’ll think bad of me, so I should try to snort one each day, rather than ask for another increase… that way he’ll still think I’m doing okay. As you can see, MANY justifications & situations can come into play – along with just plain old addictive thinking & behaviors, which all of us are prone to, whether we like it or not, & whether we admit it or not. I’ve been clean for 10 years now using methadone. I don’t abuse it. But I have taken a takehome dose the night before I was due to take it in the morning a few years ago. A doc would’ve considered that using in a way. I’d have lost that takehome if I’d admitted it. I’ve been denied an increase when I needed one, & I’ve been put off for an increase when I was in withdrawal. This was all 10 years ago at the beginning of treatment, but I was not strong enough to stand on my own yet, & I did stupid things. Many people who’ve not ever had the chance to get stable & stay there for a time cannot handle such situations without relapsing or misusing/abusing the medicine they’ve got. And we addicts will oft times even attempt to abuse other meds we have in our possession that aren’t even controlled substances or have no abuse-liability. It’s a detestable part of our addiction. So you say those who want sobriety don’t abuse their medication, period. Sorry, but wrong answer. A better statement & one that I’d agree with is perhaps “Those wanting sobriety talk honestly to their doctor/counselor when an issue such as that starts or comes up for them”. That, I did when starting MMT – I went in & told on myself, knowing it would put off my takehomes being earned. But I wanted to get well & not continue in my old behaviors. But there are limits to what an addict can handle starting out, & sometimes even years later. I hope neither you nor I are confronted with anything strong enough to prove that statement in our lives, but I’ve seen it happen in others’ lives WAY too many times to think it can’t happen or doesn’t.

    • Posted by scott on July 15, 2015 at 5:06 pm

      Hi Benjamin, not sure if you are the Ben who recently lost your wife, but if so, I wanted to reach out to you, and tell you that you are not alone. I’m in Wilmington, and lost my wife two years ago, we have a 3 year old daughter, so I can certainly relate. If I can be of any help in any way, please reach out to me. Scott. beachsig @ hotmail.com

      Reply

  2. Posted by Benjamin K. Phelps on January 21, 2013 at 4:06 pm

    My BIGGEST point of all (since it wasn’t made clear – sorry) was that if your statement were true, Lrm40, there’d be little need for earning takehomes b/c we could all be trusted pretty much right away, once it was established we simply really wanted to get clean. That would be the only thing they’d need to be concerned with knowing! But in reality, there are M-A-N-Y other factors they must be concerned with when it comes to giving out opioids for home use. I’ll give you 1 example: a patient that REALLY wants to get clean & sober is given 30 takehome doses of Suboxone. He loses his job 2 weeks in. He’s now got no insurance & no income (& let’s assume no Medicaid from the beginning.) He knows an old “buddy” would give him enough to cover his next month’s treatment costs for just 5 of those tabs he’s got, & he starts calculating… “If I take a little less each day, I can stretch what I’ve got & be okay, & still have my treatment covered for next month & not worry about an administrative taper.” He doesn’t want to do this (sell his meds) by ANY means – he wants to do the right thing & be clean & sober & live according to the law. But he’s facing possible withdrawal & probably even a very uncomfortable one, since unlike a methadone clinic, they can’t taper you from bupe when you can’t pay – the pharmacy won’t give you a single tablet if you have no money! So this guy’s in a pretty darn BIG dilemma! Not one I’m saying justifies selling those meds. Not one I’m saying justifies breaking the law. But this guy has broken those laws scores of times in the past, & his “buddy” isn’t going to tell on him. What’s he going to do? Hopefully, he will not give in & go in the direction of selling his medication. But this is the diversion the docs & clinics have to consider every time they give takehomes to a patient. Nobody’s suggesting this guy’s a bad person, or that he doesn’t want to be clean & sober. But sometimes, life can back you into a corner & in your panic, you make the wrong decision! It happens every day of our lives to people around us. We are not immune from it b/c we want to do the right thing in any situation. That’s what my point was/is.

    Reply

    • Posted by Lrm40 on January 21, 2013 at 5:07 pm

      No you have a valid point. I understand what you’re saying. This medication should be dispensed to people with or without the means to pay for it, especially if the patient is committed to sobriety. The clinic I went through suboxone treatment at was state of the art and comprehensive. They issued urine screens no different than a probation department. They provided everything needed in return for my commitment to getting
      Sober. I think if you can prove you are sober treatment should continue regardless of payment ability.. I know we live in an imperfect world, and so
      Am I.. But I’m sober four years + and off suboxone for 22 days now

      Reply

      • Posted by Benjamin K. Phelps on January 22, 2013 at 1:43 pm

        Lrm40, that’s GREAT that you were successful in treatment, & if your ultimate goal was to come off the maintenance medication, I wish you continued success in pursuing recovery w/out it. That’s GREAT that you’ve been able to successfully taper – so many people get stuck at that point & can’t seem to get all the way off (I suspect a HUGE portion of this is more fear than actual physical symptoms… but I also don’t like to negate if someone says they are experiencing difficulties, b/c I don’t want others to negate me when I say that!) Anyway, I really do hope things continue to go well for you. Thanks for your reply & thoughts on this.

      • Do you think addiction should be treated for free as opposed to other medical conditions, which require payment? This country still regards health care as a priviledge, not as a right. Not saying i agree, but there are people with all kinds of medical problems who cannot afford to get help. should addiction be an exception? If so, who pays?

      • Posted by Lrm40 on January 24, 2013 at 3:42 pm

        I have always believed that medical treatment cannot be denied due to ones inability to pay. With exception to suboxone therapy. Unless we adopt a system like our neighbors the Canadians, who have universal healthcare, free, to everyone not just the indigent, it’s a tough fix. But then again Canada doesn’t have to pay for wars all over the world like the US does and has always done. So their people prosper and don’t have to suffer from medical neglect. Helping addicts with suboxone therapy and medication costs is a tiny pin prick when compared to this nations spending. I bet if a miracle pill existed that cured cancer within a couple years, it would not be prescribed to just those who can pay, and in return live. But then again maybe here in this country it would.

      • I don’t know why you think medical treatment can’t be denied due to inability to pay. It’s denied all of the time. I have patients in methadone and/or buprenorphine treatment who don’t have insurance, and if I try to get them in to see specialist for a pressing medical ailment, they can’t be seen unless they have cash up front to pay for the visit, if they don’t have insurance.

        I’m no better at my office – if a patient can’t pay, I can’t afford to keep him in my practice. Since I can only have 100 patients, I can’t cover overhead and have any left for me unless everyone pays. There are many weeks where I take nothing home after working an eight-hour day. I’m not complaining – it’s my choice to do this, and I love what I do. Once in a while I’ll temporarily reduce my fees for a long-term patient who is doing well if they have lost a job, but that’s the best I can do.
        That’s the reality in this country, at least at present. I’m not saying I agree with it, and in fact I do think we could be doing much better, but that’s a topic for another type of blog.

      • Posted by Benjamin K. Phelps on January 24, 2013 at 6:20 pm

        My problem with the state of the cost of addiction treatment & one’s ability (or inability) to pay for it is that we have places in most any city where people that are indigent can enroll for treatment, provided they do an intake & show proof of inability to pay. If they can’t go to one of these places (or even if they can, for that matter,) they can always go to the emergency room & be treated to some extent. States provide drug & alcohol treatment EVERY DAY at various places. But what they don’t provide are MMT (methadone) & Suboxone treatments, in most cases. In NC, I watch people at my clinic everyday who come in & have their medicine paid for in full by Medicaid, which yes, is the state. BUT, when I became unemployed & unable to find work for 11 months in 2008 (a place where I’ve just found my way to all over again 2 weeks ago,) I applied for Medicaid & was rejected b/c I’m not 65, don’t have a child, & am not considered “disabled” by the state. Nevermind that I don’t have the money for treatment – the ONLY treatment that’s EVER worked for me, & without it, I’m likely to AT LEAST end up in prison, if not dead, at worst. I have been diagnosed bi-polar II (2010 but have been treated for depression since 1996), have anxiety/panic disorder (diagnosed 1996), GERD since 1996 (I’ll grant you, that’s likely not going to be disabling, but I do have it chronically), & have opioid dependency since 1995, obviously. Without my methadone, I absolutely AM disabled & cannot work – first b/c I’ll be in withdrawal for over a month, & then after that, b/c I will be going out of my mind with opioid cravings night & day, probably falling back into dependency on heroin or pills, & finally, b/c I’ll be either jailed or dead. None of this makes an iota of difference to the disability people, evidently. Now I’ll admit I didn’t get an attorney for this, mostly b/c I ended up finding work before I could’ve gotten it to go through (even though that took 11 months), & once you’re working, you’re not going to be classified as disabled, period. Without being disabled, I won’t get Medicaid until I either have a baby or turn 65. And this is just the way it is. I have no alternatives if I lose my job, as I just have, to get treatment, & I see that as a problem. I’m NOT saying the tax-payers should just foot the bill for everyone on MAT – however, I DO believe there should be SOME system of help for at least a short time for those unable to pay… even if it’s just 90 days or 6 months while work is being sought out. This makes me have to feel under constant horrible duress the ENTIRE time I’m trying to focus on finding work, & unable to give ANY money to my roommate towards my half of the rent, b/c it all has to go to the clinic to avoid my getting sick & losing everything for good. Many have it worse than I do – paying $12-$15/day for treatment – I only pay $9. But that’s still harder than I can handle some weeks. I’ve had to practically beg casual friends to lend me money more times than a couple so I could make it one more week in the past, & now I face it again. In some counties such as New Hanover (Wilmington, NC), there’s help w/your bill – last time I talked to them, they had a sliding scale that dipped as low as $20/week! But I live 2 hours from there. If I were down to going 1 time a week, I’d drive it every week in a heartbeat if they’d take me, but they only take residents of NB County anyway. So what options do I have? This may not be a big deal to those out there doing well, but to me, it’s my entire LIFE & well-being. It’s my ability to continue to be a productive citizen & not go to prison. It’s my ability to stay away from ever passing fake prescriptions again (& thus, from breaking the law ever again.) I don’t EVER want to be the person that did those things again, & I NEVER EVER want to put a needle in my arm again. But will power alone is not enough. I’m VERY scared for my future – I can’t even describe how scared I am.

  3. I have recently become aware of methadone clinics and I just cant believe a pt has to come to the clinic everyday to get a pill. Who came up with such an absolute stupid ideal? I am a LPN. Most addicts are way down on their luck before they get treatment, then need a good working car , lots of gas money and $15 a day….how unrealistic. This system sets them up for failure right away. 3 for 3… 3 pills for 3 days. Fri, Sat, Sun, then 2 for 2 for Mon and Tues and 2 for2 for Wed and Thurs. That way 3 visits a week and you could cut out a day or 2 from the clinic being open…that is not unreasonable..I was looking up info about how the programs are run and I came across the info here. Your clinic takes in $40,000 a month. That is a lot. I think the United States government should make all fed and state laws to be the same and all clinics should be allowed subsidies. Id much rather my taxes pay for this instead of foreign aid. Can I ask what a methadone pill, say 24 mg, costs are and of the other drug too. I didn’t see the medication cost on this site. If a client pays daily, do they pay a fee and more for the pill, or is the pill covered by the fee?

    Reply

  4. Posted by Ell@ on March 8, 2017 at 5:56 am

    My spouse is mis-using methadone

    Reply

    • I’d advise telling his prescriber. His doctor can’t give you information without your husband’s permission, but you can give him information.

      Reply

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