Update: Getting CDL on Buprenorphine

Sweet revenge

Since I posted last week about my patient on MAT getting turned down for a commercial driver’s license, some interesting things have developed.

Colleagues gave me suggestions for places where I could refer my patients on medication-assisted treatment to get their commercial driver’s license. As it turns out, several colleagues who work in addiction medicine also work in offices where DOT exams are done. Those doctors suggested I send my patients who need DOT exams to them. I can send a letter of support, describing their progress in recovery, and if everything else checks out, the CDL will be granted. Of course there can be no guarantees, but those offices won’t reject a person for a CDL only because they are being treatment for opioid addiction with medication-assisted treatment.

Problem solved. I thank my fellow physicians who offered that solution!

Additionally, some smart people in NC state government read my post, and contacted me. They suggested that our state’s prescription monitoring program does not permit use of its data for the purpose of denying a person their commercial driver’s license. My patient wasn’t seeing this doctor to get medical treatment, and did not give his permission for his records to be checked. Penalties for misuse of the NC Controlled Substance Reporting System can potentially be $10,000 per offense.

My patient is now deciding if he wants to pursue this issue by filing a complaint with the state. Outwardly, I told him it’s his decision.

Inwardly, I’m thinking, “Oh pleasepleaseplease file a complaint!!”

 

Tramadol and Tapentadol: Ultram and Nucynta

aaanucynta

Tramadol, the generic for the brand name Ultram, is a pain reliever that has actions on several types of brain receptors: the mu opioid, serotonin, norepinephrine, NMDA, and other receptors.

Because it stimulates the mu opioid receptors, it can cause feelings of pleasure as well as pain relief. Tramadol is a pared-down version of codeine, and it is far less active at the mu opioid receptors than its metabolite. Because it takes time for the tramadol to be metabolized in the liver to its first metabolite, some experts thought it wouldn’t appeal to addicts, who prefer an immediate high. Overall this is probably true, and tramadol has a much lower rate of addiction than other opioids, but it still causes addiction in some patients.

Some of tramadol’s pain relieving properties may also be produced by its actions on serotonin and norepinephrine receptors, since tramadol’s pain relieving capability is only partially reversed by a pure opioid antagonist like naloxone.

When this medication was first released, it wasn’t a controlled substance. That is, the DEA didn’t control it strictly like medications that can cause addiction. Now, it’s a Schedule IV drug, in some states. It does have some benefit for pain relief, but also some risk of addiction, though lower than that of hydrocodone, for example.

Tramadol is usually dosed in 50mg pills, one or two every six hours, giving the maximum dose of 400mg per day. Recreational use of this medication (to get high) is dangerous, since it causes seizures at doses higher than 400mg. In susceptible patients, it can even cause seizures at lower prescribed doses.

I’ve seen patients in tramadol withdrawal who were so sick it frightened me. This drug can produce a severe withdrawal. If a patient taking high doses stops taking tramadol suddenly, some patients have opioid withdrawal symptoms like sweating, nausea, diarrhea, high blood pressure and heart rate, and severe muscle and joint pains. The sickest patient I’ve ever seen in opioid withdrawal had been using only tramadol, in doses of around 600mg per day. She had fever to 103 degrees, and dehydration from the diarrhea and vomiting. That patient needed hospitalization.

Besides the opioid-withdrawal symptoms, some of these patients also have withdrawal symptoms similar to those seen when certain serotonin-affecting antidepressants, like Paxil and Celexa, are stopped suddenly. They can have fairly severe anxiety, depression, mood swings, and restlessness. Many times they have weird sensory experiences, often called “brain zaps,” or the sensation of electric shocks throughout the body. They can have seizures during this withdrawal.

If the patient had only physical dependency and no addiction, the dose of tramadol can usually be tapered slowly over a few weeks to months, as an outpatient. But if the patient has not only physical dependency but also the disease of addiction, the obsession and craving for the medication will usually prevent a successful outpatient taper, unless a dependable non-addict holds the pill bottle, and dispenses it as prescribed.

Traditional treatment for tramadol addiction starts with detoxification. As above, that can rarely be done as an outpatient, so medical inpatient detoxification admissions for five to seven days can be helpful. However, since tramadol acts so much like an opioid, patients ready to leave detox probably need to go on to an inpatient residential treatment center for at least thirty days. Intensive outpatient treatment probably isn’t enough support for these addicts. But that’s only my opinion, since I haven’t found any studies describing success rates with tramadol addicts.

Opioid maintenance medications like methadone and buprenorphine do stop the opioid-type withdrawal symptoms from tramadol, but there’s no information about the use of maintenance medications in these patients. Most doctors working in clinics won’t start a patient on maintenance medications unless the patient is also using other opioids.

Often, methadone patients at the opioid treatment centers where I work are given tramadol by their primary care doctors who think it’s a low risk medication for opioid addicts. It probably is lower in its risk for abuse, but it can cause withdrawal in patients on stable, blocking doses of methadone. [1]

Tapentadol, sold under the brand name Nucynta, is becoming a drug of abuse in my area. It is a schedule II drug, presumably because it has a higher abuse potential than tramadol. Tapentadol stimulates opioid mu receptors, and also acts as a norepinephrine re-uptake inhibitor, like some antidepressants.

Unlike tramadol, tapentadol is not a prodrug; that is, it doesn’t have to be metabolized to be active at the opioid receptor. For that reason, pain relief starts within thirty minutes of swallowing the drug. Also unlike tramadol, it has little action at the serotonin receptor. It’s marketed for use in patients with moderate to severe pain, and can be useful in patients who don’t respond to more traditional opioid medications.

If you check various drug use forums, some people clearly are able to inject the tapentadol, and even the extended-release formulation, which was manufactured to be more abuse-resistant.

I saw my first patient who was addicted to Nucynta a few years ago, and have seen other patients similarly afflicted since then. Usually, Nucynta isn’t the only drug that’s being misused, but one of many.

The bottom line is this: if you are in recovery from addiction (alcohol or drugs), this medication should be used with caution. Let your doctor know that you’re in recovery from addiction. If you must take a potentially addicting medication, be careful, and let all of your doctors know about all of your medications. Let a dependable non-addict hold the pill bottle and dispense as prescribed.

  1. Leavitt, MA, PhD, “Methadone-Drug Interactions,” Pain Treatment Topics, Addiction Treatment Forum, January 2006

 

Can Patients on Buprenorphine Get a Commercial Driver’s License?

CDL

I’ve been seeking an answer for some months now, and it appears to be: “It depends.”

One of my most successful office-based buprenorphine patients was due to renew his commercial driver’s license (CDL). He’s had his CDL for years, and has never had a serious accident. He’s been a stable patient of mine for around four years, and his last illicit opioid use was ten years ago. He started his recovery at a methadone clinic, and then transitioned to another buprenorphine doctor’s office-based practice before he transferred to me four years ago.

He’s held a commercial driver’s license (CDL) all of those years.

Since he has done so well, we’ve discussed the pros and cons of starting a slow taper off buprenorphine. Due to recurring pain issues, he would probably require intermittent opioid medication if he tapered off buprenorphine. Ultimately, we decided he would have a better quality of life and a lower risk of a relapse to uncontrolled opioid use if he remains on buprenorphine indefinitely.

Like so many of my patients, once his addiction was treated, he excelled at his job, and he’s received several promotions over the past few years. However, even though he doesn’t drive a truck every day, he’s still required to keep a CDL in order to keep his job.

When he went for his usual Department of Transportation driver’s exam this year, he was turned down for his CDL. He was told that people on narcotics can’t get a commercial driver’s license.

The Department of Transportation has undergone some changes over the past few years. Back when I was in primary care, any doctor could fill out the DOT form for a patient to get a CDL. Some doctors were rather slap-dash in their efforts, and I suppose that’s why doctors now have to quality to do these CDL exams. Starting a few years ago, doctors must take a training course and pass a test in order to register to do DOT exams. All such doctors are listed on the National Registry of Certified Medical Examiners.

When he was asked about his medications, he lied and told them he wasn’t on any medications. He was conflicted about this; he wanted to tell the truth, but was afraid that if he did so, his livelihood would be in danger. We discussed this issue at one of his visits, and I told him what I knew at the time. Patients maintained on methadone can’t get a CDL if they reveal that to the medical examiner, and I doubted buprenorphine would be viewed any differently. I also told him the DOT doesn’t test for buprenorphine. He passed all DOT exams in the past because the examiner didn’t know he was on maintenance medication. DOT doesn’t test for anything but marijuana, cocaine, opiates, amphetamines, and PCP. (Yes, you read that right. PCP.)

The DOT test will detect opiates, that is, substances derived from the opium poppy, but won’t detect synthetic opioids like methadone, buprenorphine, fentanyl, and the like.

I also told my patient that I did not feel he was impaired from the buprenorphine I prescribed, as he had a tolerance to any sedating effect it could have. I told him I’m much rather meet him on the road than a driver who took Ambien the night before. And I told him it was ultimately up to him to decide what to tell the DOT examiner.

So my patient didn’t tell the DOT examiner that he was on buprenorphine. He was afraid if he did tell the examining doctor, his employer would find out and he would be fired. He was also afraid he wouldn’t be able to get his CDL if he told the truth. As it turns out, he was correct.

As expected, my patient’s DOT drug screen was negative for all substances. However, this examiner checked the state prescription monitoring program, where he saw my patient’s prescriptions for Suboxone. So the examiner denied my patient his CDL.

I felt so badly for my patient. Here he was, as successful as a person can be in recovery, being turned down both because he is taking buprenorphine, and also because he didn’t tell the DOT examining doctor that he was taking buprenorphine.

I wanted to advocate for my patient, and in a misguided effort, wrote a letter to my state’s DOT. It was a great letter, emphatically worded, with data references, but I sent it to the wrong place. Eventually, my patient got a letter from the state DOT saying it was fine with them that he keep driving, but that suitability for a CDL wasn’t under their purview. When I called for more information, they told me I needed to contact the Federal Motor Carriers Safety Administration (FMCSA).

It took repeated calls (six) to this government agency before I was able to talk to someone, but finally I reached a person who gave me the scoop. Her name was Angela, and she told me that if my patient was on methadone, there was no way he could get a CDL. She also said that with buprenorphine, it was decided on a case-by-case basis, and that I would need to talk to the physician doing my patient’s DOT exam, and that the decision was ultimately up to this person. She also said my patient had the right to seek a second opinion about his CDL.

OK, I thought. Now we’re getting somewhere. Before my patient spent time and money talking to a doctor for a second opinion, I thought I should try talking to the first doctor who had turned him down. This doctor was on staff at the same teaching hospital where I did my residency in Internal Medicine about a billion years ago, so I hoped he would be educated and open to the facts I wanted to present.

After all, I thought, science was on my side. Studies have not shown differences of reaction times and driving abilities between patients maintained on buprenorphine and normal controls. There is no evidence that I’m aware of that shows maintained patients shouldn’t be behind the wheel. That fact, plus my patient’s successful recovery should convince this doctor.

It did not.

I’ll spare my readers painful details, but this doctor was not open to what I had to say. I felt like this doctor was so hung up on the fact that my patient had lied that he couldn’t hear anything else I was saying. Yes, I told him, my patient did lie, but he did so out of fear that his boss would find out about his substance use disorder, and that he would lose his job. He has a wife and kids to support, and I think many people would lie in similar circumstances.

After I had harped on that for some time, this doctor said that people prescribed narcotics can’t get a CDL, that was that, case closed.

When doctors say things like that, I get confused. I hate the term “narcotic,” because it means different things to different people. To some, it means opioids. To others, it means illicit drugs. If we look at the root of the word, “narco,” which means sleep, a narcotic is a substance that puts people to sleep.

So what does the FMCSA mean when they use the word “narcotic?”

For the purposes of my conversation with this doctor, it meant my patient would not be getting his CDL.

I went to the website of the FMCSA to see exactly the wording of their statement. Here it is:

If a driver uses a drug identified in 21 CFR 1308.11 (391.42(b)(12)) or any other substance such as amphetamine, a narcotic, or any other habit forming drug, The driver is medically unqualified. There is an exception: the prescribing doctor can write that the driver is safe to be a commercial driver while taking the medication. In this case, the Medical Examiner may, but does not have to certify the driver.”

I thought 21 CFR 1308 would give me more exact information, but when I found it on the internet, it does not. It’s just the law that categorizes potentially addicting drugs into Schedules 1-5.

Does this mean that any person filling a controlled substance can’t get a commercial driver’s license? Really? Will there be any people left to drive trucks if everyone prescribed a controlled substance is excluded from driving?

Or will this unfairly apply only to patients on medication-assisted treatment? I don’t know.

Anyway, my patient took a copy of the letter I had written for him to another DOT examining physician, for a second opinion. This doctor granted him a time-limited CDL, and my patient is OK for now.

For now. He’s still worried about his job security in the future, and so am I. Several of my patients are on buprenorphine, and I worry if they will also be denied. I’m happy to advocate for them – assuming they are doing well – but it feels a bit unfair to me.

I have patients on methadone and buprenorphine through our opioid treatment program (OTP). They can get CDLs without problem, because their data is more protected than my office-based patients. OTP data is not posted on the prescription monitoring program in my state because privacy laws prevent this. There has been talk recently about changing this law. But for now, a patient attending the OTP, on the same medication as my office-based patient who was initially denied his CDL, can be granted a CDL because OTP records are held to a higher standard of confidentiality.

The Veterans Administration, where large quantities of controlled substances are prescribed, does not (yet) report to the state prescription monitoring program, so those patients’ medications also would not be revealed to a DOT medical examiner.

It’s a weird world.

If my patient is turned down in the future for his CDL, would he qualify for disability? It seems like that should be the case, and that’s another question I have.

But my patient wants to work. He doesn’t want to go on disability.

I understand that driving commercially is a safety-sensitive job, and people doing those kinds of jobs aren’t granted the same confidentiality about drug use and addiction as people doing other jobs. It’s the same in other safety-sensitive jobs, like medical professionals, pilots, and the like. I drive frequently, and I do want all drivers to be safe.

But I would like for decisions about who can drive and who cannot to be made on the basis of science and fairness, not on persona bias or happenstance.

Raising the Patient Limit on Buprenorphine Physicians: HHS’s New Proposed Rule

Expanding access

Last month, the Health and Human Services (HHS) department of the U.S. government posted new proposed regulations for doctors who prescribe buprenorphine (better known as Suboxone, Subutex, or Zubsolv) from office-based practices. This rule proposes to raise the number of patients that physicians can treat in their office practice from one hundred to two hundred. They did this to make more treatment available for people with opioid addiction, to combat opioid overdose deaths in our country,

This new proposed rule is now posted online at: https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders#h-63

Anyone can submit a comment about this proposed rule, until May 31, 2016.

I studied this proposed rule at length, and thought I’d give my blog readers my interpretation and my opinion of it.

First of all, I approve of the idea behind the proposed regulation. Too many people with opioid use disorder want treatment and can’t get it. Many doctors are at their one hundred patient limit and have been for some time.

I haven’t taken a new patient in months. And as I’ve grumbled about in previous posts, several practitioners in my area already have well over one hundred buprenorphine office patients. Rogue doctors are going to do what they do no matter what, but us law-abiding doctors would like permission to treat more patients.

This new proposed rule would allow physicians who have had a one hundred patient limit for at least one year to request permission to treat up to two hundred patients at one time.

However, this proposed rule is a little more complicated than it would appear on the surface. Medical practitioners have to meet certain criteria to get approval to treat up to two hundred patients.

First of all, as the regulation is written now, some physicians believe that physicians who are board-certified by the American Board of Addiction Medicine won’t qualify for approval to treat up to two hundred patients. The proposed new regulation says the physician must have “subspecialty board certification.” Apparently, some physicians feel that an exact interpretation of this means only psychiatrists with subspecialty certification in addiction medicine would qualify. I read on the American Society of Addiction Medicine’s website that they want members to protest this wording to allow ABAM-certified doctors to qualify too. Thirty-six hundred doctors, including me, are board certified by ABAM, while only about a thousand psychiatrists have subspecialty board certification in Addiction Psychiatry in this country.

I read the entire DHHS document online, but the way I read it, I thought ABAM certified doctors would definitely qualify, but then maybe I’m a little fuzzy about what, exactly, “subspecialty” means. I think HHS’s intention was to include ASAM/ABAM doctors.

Practitioners seeking approval to treat up to two hundred patients must meet other criteria. In simplified terms, they need to, among other things:

  1. Have professional coverage for after-hours emergencies.
  2. Provide case management services
  3. Have electronic medical records
  4. Use that practitioner’s state prescription monitoring program
  5. Accept third-party insurance
  6. Have a plan to address possible diversion of prescribed buprenorphine medication
  7. Re-apply for permission to treat up to two hundred patients every three years
  8. Supply yearly reports about their practice and their buprenorphine patients

Several of these requirements are fairly obvious and should be standard of care anyway. For example, coverage after hours should be provided no matter if the practitioner has one patient, two-hundred, or a thousand. And I can’t imagine any doctor would prescribe buprenorphine for a patient with opioid use disorder without checking the state prescription monitoring program.

Personally, every night before I see my office-based patients, I look at their data on the prescription monitoring program. That way, if I get any surprises, I can discuss this with my patient at their visit.

All practices should have a plan to detect diversion. In my patient agreement, patients understand they may be asked to do a pill count at any time. I’ve lost some patients who failed pill counts.

Yearly reporting requirements seem reasonable, depending on what the government intends to do with this data. I assume DHH intends to monitor the quality of the care that a buprenorphine physician is delivering, and monitor the results of this care. Such monitoring is to include: average monthly case load of the physician, percentage of patients who are receiving either psychosocial counseling or case management services; number of patients being checked on the state prescription monitoring program; sending year-end reports about the number of patients who have completed treatment, number who have been referred elsewhere, and the number of patients who no longer want this form of treatment.

Physicians can collect that data without too much problem, I think.

However, I worry about how this information could be misinterpreted. For example, if the people who will review these reports expect patients to “complete” treatment for a chronic disease such as opioid addiction, they may mistakenly conclude that doctors with higher numbers of patients who complete treatment provide better care than doctors with lower numbers of patients who complete treatment. In reality, the opposite may well be true, since the standard of care with medication-assisted treatment is maintenance, not detox.

I’m also concerned about submitting the number of patients getting counseling. For maintenance patients, how long should they receive counseling? To me, the answer should be “as long as they need it.” This should be highly individualized.

If patients have been stable on buprenorphine for more than three years, with relapse-free recovery, do they still need counseling? Some of my patients are in relapse-free recovery for longer than that, and they have productive jobs, happy home lives, and no mental health issues. Should I still insist they still go to counseling? I don’t think so, unless counseling can improve the quality of their lives.

I’m not talking about new patients, fresh into treatment. Nearly all of those patients need counseling. But what if they have no insurance, and can’t afford “official” counseling? Is 12-step attendance good enough to meet counseling requirements?

There’s no way to know how people evaluating yearly physician reports will view such topics.

Now let’s talk about some of the requirements which may be deal-breakers for me.

When I read about practitioners having to accept third-party payers, I thought nope, not gonna do it.

My practice is bare-bones. I have three employees: me, my fiancé, and a man who works my front desk for about six hours per week. It’s kind of a mom-and-pop practice. Patients pay me, and I give them receipts with the needed codes to fill with their insurance company so they can be paid back. Since I don’t mess with insurance, I can keep my office costs down, because I don’t have to pay for another person to file insurance. Technically it is not a cash-only practice, since I’m set up to take credit and debit cards, but I am cautious about accepting checks. I have learned the hard way not to accept a check from a new patient.

My fiancé, who is a licensed professional counselor and also a licensed clinical addiction specialist, does the counseling for some of my office patients. He also answers the 24-hour phone, and since we are together most of the time, it’s easy for him to talk to me about whatever is going on. He screens new patients and does scheduling. He also handles most of the prior authorizations for buprenorphine medications (since I tend to get angry and swear).

My other employee, Daniel, works in my office on the one day per week that I’m open. He is terribly overqualified for his job, since he is just finishing his Master’s degree in addiction counseling. He checks patients in, performs drug screens, records the results, checks patients out and takes their money, and schedules their next visit. Besides being smart and savvy, he also knows my patients are sick people getting well.

I have few expenses. My fiancé does all the computer work that I need, and the only bills I have are rent, electricity, and various office expenses.

If I decided to accept third party insurance, I’d have to add another employee. I’ve seen the nightmares that come with billing insurance, having worked in primary care for ten years. Insurance companies deny claims for frivolous and stupid reasons, and take their time paying doctors. I heard this year from a few colleagues that BlueCross/BlueShield, the primary payer in my state, in some cases waits longer than six months to pay doctors, and still denies many claims. I’d have to raise my rates to make up for this, making it more difficult for my patients with no insurance.

Right now I charge $85 to $100 per 20-minute visit. I feel strongly that people with addiction shouldn’t have to pay more to see their doctor than people with other chronic illnesses, so I keep my rates low, relative to other providers. About half of my patients are the working poor, who don’t qualify for Medicaid in my state, and also don’t qualify for Obamacare. They can still afford treatment, because I’m also willing to prescribe generic buprenorphine/naloxone, which is quite a bit cheaper than name brand medication.

Am I willing to take on the headache of accepting insurance in order to be able to treat a hundred more patients? I don’t know if I am. I plan to investigate it further, maybe talk to some other doctors who take insurance currently, to see how big a hassle it is to get paid.

Next let’s talk about electronic medical records (EMRs). EMRs sound better in theory than they work in practice. My doctor friends complain that they cost much money, are not designed to be physician-friendly, and take up more time than they save. They aren’t interoperable, so each practice has a different electronic record. To coordinate care with a provider outside of one specific system means the record still has to be printed out on paper to be faxed or mailed.

Do electronic records provide better care? I have my doubts. I’ve bitched about EMRs in prior blogs, describing how I’ve requested records on my patients from the local hospital. Those records show on the front page, without fail, that the patient has been screened for Ebola. But I have to look at many pages to try to find a final diagnosis and treatment plan from the emergency department physician. Sometimes I find it… and sometimes not.

Privacy is a big issue to some of my patients. I treat several people, prominent in their communities, who see me specifically because I don’t have electronic medical records. They are willing to travel more than an hour one-way to see me, both because they know their records aren’t computerized, and because my office is very private, in the back on a non-descript realty building. Some of these patients may be a little paranoid about their records, but maybe not.

If I worked in an office owned by a big hospital system, how many people could get access to read my records? We all know stigma against substance use disorders and mental health diagnoses exist. It could cause damage to patients with substance abuse issues if details about addiction treatment were leaked. Ironically, my patients who work in healthcare are the ones most concerned about their privacy, and maybe for good reason.

Besides, EMRs are expensive, and probably I couldn’t afford one for my small practice.

Those are my specific objections to the proposed rule. I understand why the authors of the rule included these requirements. HHS doesn’t want bad doctors, running buprenorphine pill-mills, to be able to qualify to treat more patients. But as I’ve complained about at length and repeatedly in my blog…those doctors already thumb their nose at patient limits. So this proposed rule is likely to be followed only by the doctors who are already conscientious about following rules and guidelines.

I’m glad and grateful the HHS proposed this new rule. But I’m not yet sure I will want to increase my patient limit, for the reasons described.

Probuphine Implants: Impractical?

Probuphine

The more I learn about Probuphine, the less I think it will be practical for use in the average office-based opioid use disorder treatment setting. I predict it will be a specialty medication implanted by a few practitioners who take referrals from other doctors.

Braeburn Pharmaceuticals is sponsoring conferences for doctors to learn how to insert Probuphine, the form of buprenorphine that’s implanted under the skin like Norplant, the birth control medication. This medication is marketed by Titan Pharmaceuticals. Probuphine consists of four slender rods that are inserted just under the skin at the upper arm. These rods release buprenorphine over six months, when they have to be removed, and new rods implanted.

I wasn’t sure I wanted to do Probuphine implants, but I liked the idea of being able to do it, so I asked to attend one of their conferences to learn the procedure.

Alas, the company says only doctors who have performed minor surgical procedures over the past ninety days are eligible to learn to be an implanter of Probuphine. I can still prescribe it if I take the course, their letter says, but I’d have to refer to someone else to implant Probuphine.

Huh? I thought I could prescribe it already, since I have an “X” number. Maybe not.

If I can prescribe it but I can’t administer it, why would the patient see me at all? Why not just go directly to the doctor who can prescribe and implant?

I looked around the room during my recent addiction medicine conference and tried to imagine how many of these specialists had done surgical procedures over the past three months. There was one surgeon, and a few obstetricians, so I decided three out of sixty or so of the doctors who presently prescribe buprenorphine.

Even if the FDA approves Probuphine in May, I have a hard time imagining how Probuphine could be used in a typical office-based buprenorphine practice.

Because besides the implantation conundrum, who pays for it? Drug company representatives were unable to answer questions about the cost.

And how does the implant, the implanting physician, and the patient all arrive at the appointment time? Is the doctor expected to order the implant, store it in her office, and hope the patient shows up for the implantation? Surely we couldn’t give a prescription to the patient to take to a pharmacy for the implant, so I’m not sure how that’s going to work.

Won’t this medication need prior approval? Representatives from the drug’s manufacturer say “no,” but I have a hard time believing that.

I picture one or two sites in North Carolina that will have the resources to do the implants and probably keep them in stock, perhaps at a hospital pharmacy. Maybe the teaching hospitals will have the resources to do this.

Also, the Probuphine delivers drug levels equivalent to six to eight milligrams of sublingual buprenorphine, so patients at higher probably won’t be considered.

I’m starting to doubt the practicality of Probuphine at an average addiction medicine physician’s office.

Buprenorphine: Current Practices

NCSAM

I just got back from the NC Society of Addiction Medicine annual conference. (Yes, I’ve been to several conferences lately.) One of the sessions I attended was a lively discussion of the current practices in office-based prescribing of buprenorphine, for opioid addiction.

The session was run by two experienced, knowledgeable addictionologists, who mediated topics and shepherded the dialogue. One physician works in North Carolina and the other in Tennessee. The room was packed with at least fifty people, most of us doctors who prescribe buprenorphine for addiction.

Deliberations were collegial but we didn’t agree on all issues, of course. Dissenting opinions were respected and debated.

The first topic I can recall was about how often buprenorphine patients need to be seen. Most practitioners agreed that new patients needed to be seen at least weekly initially. As stability develops, we gradually extend the time between visits to one month. One doctor opined that no patient should be allowed to go any more than one month between physician visits. When the moderator asked if anyone disagreed, I raised my hand, and the moderator asked me to explain.

With some trepidation, I told the audience that I had a super-stable group of patients in my practice. I inherited most of them from another physician who was one of the first in the area to prescribe buprenorphine. This group of patients all have over five years of stable and relapse-free recovery. A few have been in stable recovery for nearly ten years. These people work, and have happy and productive lives.

So yes, I do allow these patients to go two months between visits.

No one booed or hissed me, but I got the feeling I’m doing something with my patients outside the realm of normal for most doctors prescribing buprenorphine. Thankfully, the moderator made the point that we should use our clinical judgment and adjust treatment to best fit each situation, which made me feel better.

I was mulling this over later, and maybe I do have an unusual group of patients, who have been stable on MAT for so long. Some of these patients elected to stay on sublingual buprenorphine because they are doing so well on it, and they fear relapse if they taper off of it. Others plan to stay on buprenorphine because they developed addiction as a complication of chronic pain treatment. Happily, the buprenorphine works as well for their pain as it does for their addiction, so we get the two birds with the one stone.

There’s another unusual thing about these super-stable patients: almost all of them are deeply involved in 12-step recovery. Many were in Alcoholics Anonymous prior to their opioid addiction. They developed addiction to opioid pain pills after receiving prescription opioids for an acute or chronic pain condition. Once they started on buprenorphine to treat the opioid addiction, they continued going to Alcoholics Anonymous (a few go to Narcotics Anonymous).. Other patients didn’t start going to AA until after they entered MAT on buprenorphine.

I’ve had many people write comments to my blog, furious when I even mention 12-step recovery and MAT in the same sentence. But I have living proof in my practice of multiple patients on medication-assisted treatment of opioid addiction who have been able to make 12-step programs work for them.

Getting back to the conference…we spent much time discussing the monoproduct buprenorphine versus the combination product buprenorphine/naloxone. All of us agreed there’s a need for caution with prospective patients who insist they can take only the monoproduct (this is the equivalent of the brand name Subutex), because it does have a higher street value than the combination product.

Of course, there are people who inject the combination product (Suboxone film, Zubsolv, etc.), but overall, people seeking to inject buprenorphine are much more likely to prefer plain buprenorphine. Black market prices are higher for the monoproduct than the combination product, underscoring the preference for monoproduct.

One outspoken doctor said the monoproduct should rarely if ever be prescribed. Another doctor echoed my feelings on the matter when he said something to the effect that some patients really do have a bad reaction to the naloxone in the combination products, and if we are cautious, we can prescribe the monoproduct. However, the general opinion was that financial reasons weren’t sufficient to take the risk of prescribing the monoproduct.

I disagree with that, but kept quiet, already feeling like maybe I’m a bit too liberal.

I have had patients, stable on a buprenorphine combination product (usually brand name Suboxone films), who suddenly lost their health insurance. If such patients had negative drug screens for years, and no history of intravenous use, I switched them to the generic monoproduct because it’s the cheapest buprenorphine product on the market. These patients could not have stayed in treatment if I’d made them stay on the much more expensive brand names. Most of those patients prefer the films, and when they got new insurance, asked to switch back to the films.

I did not suspect these patients would sell their medication for profit. You have to know them, but these patients had stable jobs and no leanings toward criminality. And I am by no means a gullible person.

Since then, a generic combination product came onto the market. Still more expensive than the monoproduct, it’s less expensive than all the name brands.

Next we discussed how to deal with patients who say they are allergic to naloxone, and thus can’t take the combination product (Suboxone, Zubsolv) but only the monoproduct (Subutex).. Patients usually don’t mean an actual allergy, but rather intolerance to naloxone. These patients report headache, nausea, etc. when they ask their physician to prescribe the monoproduct. Of course, this raises suspicion with physicians that such patients plan to misuse the medication by injecting or snorting.

Should physicians just accept what patients say at face value, or should we say sorry, I only prescribe buprenorphine in combination with naloxone? After all, there’s no way to “prove” a headache or nausea. There’s no test we can order that will give any useful information. One doctor said he sent such patients to a neurologist for evaluation of the headache, or to a gastroenterologist to decide the cause of nausea. He says most patients fail to follow through, and so he weeds such prospective patients out of his practice that way.

An audience member suitably questioned this habit, asking how could a specialist be expected to determine if a medication caused headache or nausea? I think it’s kind of a sneaky way to get rid of patients who want buprenorphine monoproduct.

I have the same fears when fielding new calls from prospective patients. I’ve instructed my patient contact representative (who is also my office’s licensed professional counselor, after-hours contact person, pharmacy liaison, licensed clinical addiction specialist, prior approval wrangler, and fiancé) to tell these people that I do not prescribe the monoproduct to new patients. I have no problems saying “no” upfront to these patients, and try to explain why I’ve made this decision for my private practice (even though, as above, I have prescribed it for patients I know very well).

I use the monoproduct in the opioid treatment program where I work, because those patients dose with us every day until they have a period of stability. The dosing nurses roughly chop the tablets, to minimize diversion, and patients stay on-premises until the medication has dissolved, also to make diversion more difficult. These patients don’t get any take home doses until we feel they have stabilized.

We also discussed how long to keep patients on buprenorphine. The bottom line is that no one knows. Best outcomes are seen in patients who stay on buprenorphine, since there’s still a high relapse rate back to opioids in patients who stop buprenorphine. I ask my patients periodically if they wish to start a slow taper, if they’ve been stable for over a year. I don’t push them to taper if they’re not ready, but if they are, I recommend they taper slowly. From the discussion at this meeting, it sounds like most of my colleagues do the same.

We discussed the maximum daily dose of buprenorphine. According to studies, a daily dose of 16mg saturates most of a patient’s opioid receptors, and increasing the dose to 24mg only gives about a 4% increase in the number of covered opioid receptors. Some doctors say this shows buprenorphine should never be dosed more than 16mg per day.

However, about a third of the doctors in the room raised their hands when the moderator asked if they had any patients who seemed to require 24mg per day to stabilize.

I didn’t interject anything into the discussion, but I just went to a session at the national ASAM meeting where this same topic was discussed. While it’s true that basic pharmacology would indicate 16mg is probably the just as effective as 24mg in most patients, several studies have shown better patient retention in treatment when higher doses (24-32mg per day) are used.

It’s possible this isn’t a physiologic effect, but more of a mental process. We can’t be sure. But for whatever reason, if my patient does best at 24mg, I’ll allow her to stay on that dose.

For patients on higher doses, we need to make sure they aren’t diverting some of their medication. Patients sometimes ask for a higher dose than they need, in order to get enough medication to treat a friend, family member, or significant other. Some doctors call this “piggy-backing.” Even though it means a suffering addict is getting treatment, the piggy-backer won’t get any counseling. Also, law enforcement types use examples of diversion to demonstrate that buprenorphine is a bad street drug, contributing to the stigma against patients doing well in their treatment. Diversion threatens the whole concept of office-based treatment program.

All in all, we had two hours of lively interaction on the finer points of office-based prescribing of buprenorphine. I don’t think all doctors will agree about everything, but it’s nice to hear what other physicians are doing, to make sure I am not too far out of line with the standard of care.

Conference

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I just got back from the yearly American Society of Addiction Medicine conference. As always, it was a treat. It’s so refreshing to be surrounding by other physicians who know addiction is a treatable illness and not a moral shortcoming. I feel revitalized from being around people who also love treating people with substance use disorders, and who also love seeing people get well and get back to being themselves.

This conference was huge. Over 1800 people attended. When I went to my first ASAM meeting in 2004, I think there were around 300 attendees. What a difference!

This year, I sensed even more hopefulness and enthusiasm than in past years. Last month, Addiction Medicine was finally recognized as a legitimate specialty of medicine. Finally, we got recognition that we have a substantial body of science with data that supports the work we do.

Recently, there’s more conversation about treating people with opioid addiction. We see television shows, online articles, and blog posts about the opioid addiction epidemic and the death toll it’s exacting on our nation. Even President Obama recently emphasized the importance of treating people with opioid addiction, and the obligation of incorporating medication-assisted treatment. More federal and state grants are available to start programs to help people with substance use disorders.

All of these recent changes encouraged me, but the speakers at the ASAM conference pushed my enthusiasm further.

On the first session of the first day, Dr. Nora Volkow, director of NIDA (National Institute on Drug Abuse), spoke. She was her usual brilliant self, giving a concise summary of this nation’s present opioid addiction situation. She discussed many of the same studies I’ve highlighted in my blog over this past year, so I felt good about that.

Next to speak was Dr. William Miller, the “father” of Motivational Interviewing. His lecture, titled “The Power of Empathy in Addiction Treatment,” was a gift. It reminded me of why I love what I do, and how I can continue to improve as a clinician.

I also went to his ninety-minute session about the basics of Motivational Interviewing. I’ve read all three editions of his book, “Motivational Interviewing,” and I’ve seen videos of therapists using MI as a counseling technique. Motivational Interviewing is an evidence-based method of counseling people in order to help them change.

MI sounds much easier than it is. It also looks easy when I watch other people do it, but it’s much more difficult than it looks. Fortunately, my fiancé is a “MINTee,” meaning he’s one of the Motivational Interviewing Network of Trainers for Motivational Interviewing. I figure that can’t help but rub off on me. Plus, he helps train the counselors at our local opioid treatment program. In my obviously biased opinion, he’s helped our counselors become much better at their jobs, which ultimately benefits our patients.

I went to many other ASAM sessions – from a lecture on contingency management techniques to a discussion about buprenorphine doses above 16mg. All were excellent. Even though it’s impossible to attend all the sessions, since many times there were four of five going on at the same time in different rooms, I plan to listen to the recordings of them all on ASAM’s website when they become available.

And I will return to work a better, more enthusiastic doctor.

 

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