Novel Idea for Buprenorphine Access

 

 

 

 

I still occasionally read medical journals with articles relating to general adult medicine; I consider it a task, not as enjoyable as reading medical journals about Addiction Medicine.

So, imagine my surprise and delight to read a thoughtful opinion piece in the most recent issue of the Journal of the American Medical Association (August 13, 2019, Vol. 322, No. 6, pp 501-502.)

This article, written by Payel Roy M.D. and Michael Stein M.D., both from Boston University School of Medicine, puts forth the idea of increasing access to life-saving buprenorphine by making it available behind the counter at pharmacies with no prescription required.

The article describes the scope of our problem in the U.S: we have around two million people with opioid use disorder, most of whom aren’t getting any treatment. We have around 130 people die from opioid overdose deaths each day. Though we have medication for opioid use disorder available, it’s often hard to access. The authors acknowledge the cumbersome process of prescribing buprenorphine, both for the patient and the provider. The provider must take a special course and get a special DEA license. Patients have difficulty locating and getting appointments with these rare providers, and then must wait for their appointment and be able to pay the provider.

The authors of this viewpoint piece say that having emergency buprenorphine available behind the counter at pharmacies would eliminate some of the problems with access to this life-saving medication.

They say that making buprenorphine available on an emergency basis makes sense, because we’ve done the same thing with other medications that are relatively safe and effective for the conditions they treat. They compared the use of emergency buprenorphine to that of emergency contraception medication, and to pseudoephedrine. The authors feel that a three-day supply of buprenorphine could encourage people with opioid use disorders an opportunity to try buprenorphine legally, and to follow up with a physician provider for long-term treatment.

They also say that uninsured patients could access this emergency treatment more easily than they can at present, since there wouldn’t be provider-based costs. They feel pharmacists could observe the dosing to watch for precipitated withdrawal symptoms.

The authors suggest we define in advance the conditions where emergency buprenorphine could be obtained, perhaps limited to situations where a patient has an upcoming appointment but has severe withdrawal symptoms prior to the appointment. Another indication for emergency use would be if a patient, previously on buprenorphine but tapered off, has a relapse or feels as if she may relapse and wants to get back on buprenorphine to prevent a serious event.

The authors realize this idea is bound to be controversial. They acknowledge that use of buprenorphine with other sedating agents could be harmful but say warning labels are already on buprenorphine medication fills. They also considered accidental pediatric exposure but say that limiting the medication to behind-the-counter would provide monitoring by pharmacists.

They also acknowledge the concerns for buprenorphine becoming a gateway drug. People without physical opioid dependence can experience euphoria with buprenorphine, but the authors say that since it tends to me only a modest euphoria, it’s unlikely to become a drug of choice. They point to literature suggesting that illicit use of buprenorphine is usually seen in people who already have an opioid use disorder, not people just starting to misuse opioids.

They argue that having buprenorphine available behind-the-counter without a prescription might reduce diversion. Rather than having people with opioid use disorder buy buprenorphine from people who already have prescriptions, they can buy their own legally, with the behind-the-counter arrangement.

They point out that having pharmacists monitor use of this emergency buprenorphine would switch some of the burden of safe initiation of treatment from physicians and onto the pharmacists. They say this would require pharmacists to become better education about buprenorphine and improve the counseling that patients receive from pharmacists

They conclude that their idea of emergency buprenorphine could benefit individual and the population overall, by treating withdrawal symptoms and preventing further illicit opioid use. They feel this could reduce health care costs and criminal activity related to obtaining illicit opioids. They also say it would reduce transmission of infectious diseases. They say the risks would be low, given buprenorphine’s safety relative to other illicit opioids, and people could access this medication at night and on weekends, when doctor’s offices are closed.

What do I think of this idea?

I like it.

I think we could define conditions under which buprenorphine could be provided. However, I think the biggest problem could be getting pharmacists to go along.

My patients see plenty of kind, helpful, and well-informed pharmacists, eager to help them with their recovery from opioid use disorder by using buprenorphine products. And other patients have pharmacists that…well…aren’t like that.

Last week, I had a pharmacist call me about a patient of mine who had tapered from 16mg to 8mg over a month. I didn’t recommend she do this; I thought it was a little too fast. But she was optimistic, and asked I write for only #30 films. That’s what I did, but I got a phone call from my patient on day 25 of her month, saying she’d taken more than 8mg per day and she was out of medication, and could I call in a few days of medication until she could see me at her scheduled appointment on day 28?

I didn’t see a problem with this. Yes, she had been overly optimistic about her ability to taper, but I saw no reason to let her go into withdrawal from day 25 to day 28. I called the pharmacist but couldn’t reach a live human. I left a message, saying it was fine with me for them to dispense enough medication for three days, since we had tried to taper, and it hadn’t gone as well as we’d hoped.

The patient called later in the day, crying, saying the pharmacist refused to fill any buprenorphine/naloxone films early, and that she intended to report me, the physician, presumably for careless prescribing.

Sheesh.

I tried again to call the pharmacist, to explain the situation and try to work it out. I was put on hold for eleven minutes, when it occurred to me that this pharmacist had no intention of coming to the phone. I hung up and called my patient back, telling her to go to a different pharmacy and I’d call in three days, which is what I did.

This emergency buprenorphine could be a wonderful thing, but some pharmacists in my area are extremely cautious about buprenorphine products. I think it’s weird that after practically throwing OxyContin and Xanax and Opana medications at patients for fifteen years, now pharmacists are worried about an established buprenorphine patient filling a prescription three days early.

Swallow a camel, strain at a gnat, as the biblical saying goes.

So yes, I’d like to see some pilot programs try this novel idea, but you’d better make sure the pharmacists are all on board first. Perhaps in Massachusetts, it would be easier than in rural North Carolina.

12 responses to this post.

  1. Posted by Chuck on August 19, 2019 at 1:08 am

    Probably won’t happen,it’s going to take years maybe another decade of people dying and it will have to be the right people dying , like a politicians kid for this to get done or methadone to be prescribed in a doctors office to people who have been on clinic years and proven themselves worthy to live among the perfect people! You know the people who drink and do other drugs and stick their nose up at people on medication assisted treatment. Bottom line is these politicians cry about socialism and keeping government out of healthcare and are responsible for the opiate epidemic but want to put insane rules in place for the cure , no drug addict looks for methadone or subs to get high , only to stop withdrawal and function. The discrimination is never going to end . Not in my backyard mentality and just ignorance it will take their kids dying of a overdose or getting addicted and seeing MMT help them for things to change .

    Reply

  2. Posted by william taylor, MD on August 19, 2019 at 1:25 am

    Instead of adding to the present cumbersome buprenorphine access system with another cumbersome window for emergency access, let’s chuck the whole tottering mess and let any prescriber approved for schedule III prescribe buprenorphine. People get sick at night or on the weekend? They can go to Urgent Care or the ED, where a drug screen, impairment assessment, precipitated withdrawal risk assessment, and maybe supervised administration of the first dose will enhance quality of care. Primary care physicians who encounter these patients can at least get them started right away until they can get enrolled with the practices that are set up to do long-term maintenance.

    There’s also an evolving literature on so-called “low-threshold buprenorphine programs” where the general idea is to make buprenorphine readily available without being too strict about the various other illicits that people seem to use.

    Reply

  3. Posted by Alan Wartenberg MD on August 19, 2019 at 1:37 am

    Another possibility is to approach the drug store chains that have “minute clinics” and see if we can garner interest in getting the NPs and PA’s that staff those programs interested in prescribing buprenorphine. They are in a large number of stores in a large number of neighborhoods and could be an effective bridge system, and for some the main prescriber.

    Reply

  4. Patients DESERVE more. I’m so sick of physicians coming up with novel ideas for their journals and not thinking through what actually facilitates improved quality of life for patients. I, for one, would have never found lasting recovery and improved quality of life being able to purchase medication at a pharmacy with no input from a physician or a multidisciplinary treatment team. I would have never processed the underlying childhood trauma I experienced without comprehensive services and access to a counselor. We know from multiple studies that opioid use disorder is a biopsychosocial disease. Throwing medication at it leaves 2/3 of the disease untreated. Patients DESERVE more. How quickly we forget the past and physicians who weren’t around in the 1960s don’t care to study history. We’ve tried such “low threshold access” before. And that’s exactly WHY we ended up with the OTP system. Methadone diversion was rampant and ER admission due to toxicity were on the rise. Enter the Drug Addict Treatment Act of 1974 and the establishment of the clinic system as a result. Despite buprenorphine’s higher safety profile, such low threshold measures would put it in the hands of folks where dual toxicity with other substances could be deadly. We are also seeing it on the increase as a drug of ABUSE for new treatment admissions. Their suggestion it’s “milder” euphoria won’t lead to abuse is naive and dangerous. So while physicians are writing from their Ivory Towers in the AMA journal, those of us in the trenches and with lived experience can see very clearly all the problems this could cause. Anyone who supports something like this is selling patients short. I deserved an approach that gave me access to comprehensive services and linkage to resources. I deserved more than a pharmacist giving me buprenorphine and hoping I could figure out the rest on my own.

    Data I now have access to suggests very poor retention and compliance even in an OBOT setting absent comprehensive services when the focus is primarily on the medication and without daily dosing during the induction phase of care. The approach suggested by the authors of this study is without evidence and without consideration of the complex biopsychosocial realities of substance use disorders.

    Zac Talbott
    President-Elect
    National Alliance for Medication Assisted Recovery

    Reply

    • Interesting response, Zac.
      Patients do deserve the very best quality of care with medications for opioid use disorder. But many patients don’t want comprehensive services. Some have no desire for counseling or other services, and want only the medication that makes them feel normal & allows them to function in life. What do we do with those patients? Do we insist they get the counseling we think they need, and deny medication if they don’t agree, or won’t/can’t comply with our assessment of their needs? And I think this 3-day supply would be meant only to get patients into some sort of treatment. That would be the problem – if the medication is more freely available, how can we make sure these patients access treatment.
      I know one of the authors, Michael Stein MD is not based solely in an ivory tower. He wrote a book titled “The Addict: One Patient, One Doctor, One Year,” that I read about nine years ago. It was about his office-based buprenorphine practice and treatment of a patient that he counseled. It got good reviews, though I didn’t care for it all that much.

      Reply

    • I agree. I myself am a “recovering addict” i put this in quotes because now i am addicted to the very medication i took to help me get off street opiates! If i had known 2 years ago that i would switch from being a heroin addict, to a suboxone addict… i dont know what to do now. Im so embarrassed to tell my prescribing doctor. “Hi Doc, im 2 weeks in on a 4 week script and im out! “

      Reply

  5. Posted by Don H on August 19, 2019 at 7:19 pm

    Well, Dr. Taylor beat me to it but I very much agree – let’s just be done with fooling ourselves about the regulations with buprenorphine prescribing. New drugs and new treatments come on the market all of the time yet the government doesn’t get involved in being mom or dad to licensed physicians. Why with this?

    OR – – – – how about we at least allow doctors without the waiver to prescribe to up to 30 patients? I have no doubt that the established patients who the doc has known for years could greatly benefit.

    OF COURSE – – – you are very correct that some pharmacists would not take advantage of it anyhow – just as I’m pretty sure any doc can write a three day emergency script even if they are not DATA2000 waivered – yet go to an ER or doc-in-the-box and rarely if ever are they even aware they can do this let alone willing to do so.

    We really need a support organization to lobby and educate on our behalf. We have the American Heart Association, Cancer Association, Diabetes Association and hosts of others who do great work educating for their causes. Yet the leading cause of death for anyone under 50 has no meaningful organization.

    Reply

  6. Posted by Martin on August 21, 2019 at 8:28 am

    I agree buprenorphine is probably not a common gateway opioid in the US currently (i.e. diverted buprenorphine is predominantly used for “self-treatment” by opioid tolerant people) but would worry it might be if it had OTC status. For people with limited tolerance, buprenorphine is really potent with strong reinforcing effects and there are examples where buprenorphine has become a popular street drug (e.g. Finland, France). It is hard to deny that availability is an important factor for abuse. What would happen if buprenorphine was the only highly potent opioid freely and legitimately available without a prescription? Increased recreational use with people developing opioid dependence from buprenorphine would cause harm for society and put legitimacy of buprenorphine treatment as a whole in question.

    Thus while I am a firm proponent of low threshold treatment and agree access should be improved, it appears difficult to get away from the prescription requirement to ensure that the drug is appropriately used by the correct patients.

    Reply

  7. Posted by Brent on August 21, 2019 at 3:53 pm

    I think it’s a great idea but the only thing I would have to disagree with, is the authors assertion that buprenorphine only causes “modest” euphoria in non-opioid tolerant individuals. This is absolutely false. I know from personal experience as well as from a lot of people (I’m in Ohio at the epicenter of the opioid epidemic) that buprenorphine takes by opioid naive individuals almost always cannot be distinguished from a full agonist opioid. It would be foolish to say that someone using the opioid buprenorphine for the first time wouldn’t receive euphoria and reinforcement from the drug. I’m not saying that making it more available behind the counter is a bad idea, but they definitely had that little bit of information wrong. I had a friend who had never used opioids get addicted to suboxone very easily and very quickly, and is still in it to this day years later. They shouldn’t be so naive when it comes to opioids. An opioid is an opioid, partial agonist or not.

    Reply

  8. Posted by Don H on August 21, 2019 at 5:44 pm

    I have to agree and put in another anecdotal report. Following an “intervention” of sorts I checked myself into a high dollar inpatient treatment center. I had no idea what I was doing and was convinced this was the way to go. I was there 5 days and my insurance paid nearly $10,000 grand to basically induct me on Suboxone. Anyhow, by this time I was self medicating with Tramadol to keep from going into withdrawals. I had not had a full agonist opiate in weeks. I stupidly stopped the Tramadol on Thursday morning, checked in Thursday afternoon already in mild withdrawals. By midnight I was in agonizing withdrawal. Still the one-size-fits-all, do the same with every patient doctor (who barely spoke to me) would not dose me until Saturday morning. I was now 48 hours since my last Tramadol (150 mg total). I actually slept some that Friday (second) night and my withdrawals were substantially less than the day prior. I was well over the hump. They dosed me with 8 mg of Suboxone before breakfast (on an empty stomach). It hit me nearly as hard as percocet used to. By 10 AM I could not keep my eyes open and had to lay in bed – fell asleep for a few hours. Clearly they waited too long and gave me too much for a first dose – but… that’s what we are talking about here. My second dose 12 hours later did next to nothing and I never “felt” my bup from that day on. But with somewhat clean receptors, it certainly knocked me on my butt.

    Reply

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