Archive for the ‘Suboxone film’ Category

Media Maintains Methadone is Menacing Mountains

 

NEWS CAT

Last week, a colleague of mine directed my attention to local news coverage of the opioid use disorder epidemic. It’s a four-part series titled “Paths to Recovery.”

Anytime the press covers opioid use disorder and its treatments, I feel hope and dread. I hope the report will be fair and unbiased, and give the public much-needed information. And I dread the more likely stigmatization and perpetuation of tired stereotypes about methadone as a treatment for opioid use disorder.

Overall, the four segments of this news report had some good parts, and some biased parts. It was not a particularly well-done series, and could have benefitted from better editing. It was disjointed and contained non-sequiturs, which I suspect confused viewers.

In the introduction to the first segment, the report says their investigators have spent months digging into treatment options in the area. Their conclusion: there’s a variety of options and treatment is not one-size-fits-all. The report goes on to give statistics about how bad the opioid use disorder situation has become, and they interviewed a treatment worker who says we’re two years in to this, and the community doesn’t grasp the seriousness of the situation. They also interviewed some harm reduction workers, and discussed naloxone rescue for overdoses and needle exchange.

So far, so good, except that of course we are more like two decades into the opioid crisis, not two years.

Part two of this series was “Mountain methadone clinics.” As soon as I saw the dreadful alliteration, I cringed, fearing the content of the segment.

This report didn’t say good things about methadone. In fact, one physician, supposedly the medical director of a new opioid treatment program in the area, says on camera, “Methadone is very dangerous. It has some effects on the heart. The rhythm of the heart, it has some drug interactions.” He went on to say that at the right dose, people could feel normal, and that it replaced the endorphins that were lacking, but I worry people will remember only that a doctor said methadone was a very dangerous drug.

Methadone can be dangerous, if you don’t know how to prescribe it, or if you give a person with opioid use disorder unfettered access to methadone. But in the hands of a skilled and experienced physician, at an opioid treatment program with observed dosing, methadone can be life-saving.

The news report outlined the failings of existing methadone programs in the area, saying staff had inadequate training, and failed to provide enough counseling for patients. It said one program made a dosing error and killed a patient, while another program had excessive lab errors.

All of that sounds very bad.

No positive aspects were presented as a counterpoint to that bleak picture. I felt myself yearning for an interview with a patient on methadone who has gotten his family back, works every day, and is leading a happy and productive life. Of course, those people are hard to find, since they are at work and harder to find by the media, even reporters who have supposedly been “working for months” on this story.

And then…of course they interviewed patients who had misused methadone. One person criticized his opioid treatment program because they allowed him to increase his dose to 160mg per day, and he said “…that’s a lot. I didn’t need that much…” and goes on to admitting to selling his take home medication. Another patient said the methadone made him “sleep all the time.” Another patient said methadone made him “high all the time.”

There will always be such patients…ready to lie to treatment providers to get more medication than needed, break the law by selling that medication, and then blame it all on the people trying to help them. Unable to see their own errors, they blame it all on someone else, or on the evil drug methadone.

Every program has such patients. But these people can also be helped, if they can safely be retained in treatment long enough, and get enough counseling.

Even though these patients are few, they get far more media attention compared to the many patients who want help and are willing to abide by the multitude of rules and regulations laid on opioid treatment programs by state and federal authorities. These latter patients are why I love my job. I see them get their lives back while on methadone. They become the moms and dads that they want to be. They go back to school. They get good jobs and they live normal lives. They don’t “sleep all the time,” as the patients on this report said.

But not one such patient was interviewed for this report.

As I watched this segment, I thought back to an interview the A. T. Forum did with Dr. Vincent Dole, one of the original researchers to study methadone for the treatment of opioid use disorders. This was in 1996, before our present opioid crisis gained momentum.

A.T. FORUM: It seems that, over the years, methadone has been more thoroughly researched and written about than almost any other medication; yet, it’s still not completely accepted. How do you feel about that?

  1. VINCENT DOLE:It’s an extraordinary phenomenon and it has come to me as a surprise. From the beginning of our research with methadone we were able to rehabilitate otherwise hopeless addicts that had been through all of the other treatments available. I expected methadone would be taken up very carefully by the addiction treatment community, but with some enthusiasm. Instead of that, we’ve had endless moral and other types of objections which are really irrelevant to the scientific data.

I was surprised, because my background in research had led me to expect that the medical community was a very critical but nonetheless objective group that would respond to solid, reproducible data. Instead I find that we still get the anti-methadone argument of substituting one addictive drug for another.

This is ignoring the scientific data showing that, as a result of methadone treatment, people who have been hopelessly addicted and anti-social and excluded from any normal life or family, are in a wonderful way becoming responsive to social rehabilitation and today constitute a very large number of people who are living normal lives. The fact that people, especially medical practitioners, would dismiss that as unimportant simply staggers me!

[http://atforum.com/interview-dr-vincent-dole-methadone-next-30-years ]

 

What would Dr. Dole think now, twenty more years later, during a terrible wave of death from opioid use disorders, about the continued stigmatization of methadone?

Then next segment was about buprenorphine, and how it can be prescribed in a doctor’s office, making it a better choice for patients. It wasn’t a bad segment, and contained some useful information. Physicians who were interviewed had nothing but good things to say about buprenorphine.

Or rather, they had good things to say about Suboxone.

The brand Suboxone was heavily promoted by this piece. Not once did the reporter use the drug’s generic name, buprenorphine. Every time, the medication was called by its brand name, Suboxone, and every picture of the medication was of Suboxone film. No mention was made of the other brands: Zubsolv, Bunavail, Probuphine, or even that there are generic combination buprenorphine/naloxone equivalents for Suboxone film, for less than half the price.

I know buprenorphine is kind of a mouthful for non-medical reporters, but still, I thought it was odd to use only the name of one brand: Suboxone. It’s as if this was a commercial for that drug company. Indivior, the manufacturer of Suboxone, must be delighted with this coverage. To me, it felt like an advertisement rather than journalism.

Another segment was about sober recovery homes. The investigative reporter talked to owners of sober recovery houses and the tenants at those homes. She said NC has no regulations or standards for recovery homes. She talked on screen to a patient advocate who says patient brokering is going on in Asheville, as well as lab scams at recovery homes where the patients’ best interests aren’t at the heart of the way these homes function.

She talked to Josh Stein, NC Attorney General, about passing laws to better regulate these sober homes, and he agreed that if these laws were needed, they should be passed.

No controversy with that one.

There was a segment about how there’s not enough beds in residential facilities for patients with opioid use disorder who want help. I agree, though I’m not sure this is breaking news for anyone. I don’t think there’s ever been enough beds to meet the treatment need.

Overall, I was left with a bitter taste after this reportage. The news program missed an opportunity to educate viewers about all evidence-based treatments for opioid use disorder, but ended up doing an advertisement for Suboxone and denigrating methadone.

Buprenorphine and methadone both work under the same principle: they are long-acting opioids which, when dosed properly, prevent withdrawal and craving while also blocking illicit opioids. While buprenorphine is a safer drug with fewer drug interactions, it isn’t strong enough for everyone. Methadone has countless studies to support its use to treat opioid use disorder, showing it reduces death, increases employment, decreases crime… but why go on, since facts don’t seem to matter as much as sound bites.

In my opinion, WLOS bungled an opportunity.

Taper Off Suboxone: Using the Films

When my Suboxone patients are ready to taper off the medication, I prefer to use the film. Since the film is no longer crumbling, patients can take sharp scissors or a knife and cut the films into smaller pieces roughly equal in size, ideal for a taper. Yes, I know the manufacturer says we shouldn’t cut the film or the tabs, because they have not done studies to see if the medication is equally distributed throughout the entire film or tablet. But cutting is a great way to taper, it seems to work, and everybody’s been doing it since Suboxone came out in 2003.

Most of my patients who successfully tapered off were on Suboxone at least two years, and did the work of counseling before attempting a taper. Most recent studies show high relapse rates if tapered too soon, probably because it takes time to get the essential counseling and make life changes that support a new life without drugs.

How long should the ideal taper take? It depends on the patient’s tolerance of opioid withdrawal symptoms. I’ve been telling patients four to six months is an average taper. I’ve been decreasing the dose by 2 mg every 2 weeks, until the patient is at 8mg or less. Most patients tolerate that fairly well, though patients differ markedly in their tolerance of withdrawal. At any time in the taper, if the patient starts feeling more withdrawal than they can tolerate, we can go back up a little, or plateau at a dose for a month or so.

Below 8mg, I reduce the dose more slowly, since each milligram is a bigger percent of the whole dose. I’ve been trying to decrease patients by 2mg every 4 weeks. This way when I see them every month, we talk about how they’re feeling, and if they’ve had a relapse (With any relapse to opioids, we go back up on the dose and work more on relapse prevention). For an 8mg film, this can be accomplished easily, by cutting the film into fourths. That’s a 25% drop in a month, or around 6.25% drop per week, at least at first. It’s common to have to stay on 4 or 2 mg for longer than a month.

Once the patient is down to 2mg, I switch to the 2mg film, and again have the patient divide it into fourths. I still try to drop by one-quarter of the film per month, meaning a half of a milligram decrease each month.

Sometimes we seem to get stuck at a dose. For example, I have a patient on a 2mg tab, which can be cut in half but is too small to reliably cut into fourths. He’s been trying to drop to 1mg but can’t tolerate staying at that dose for more than a day or two. So at his last visit, we decided he would alternate 1mg per day with 2mg per day. He did better with that, and now we are trying two days of 1mg and one day of 2mg, in a cycle every three days.

Then today, in my latest issue of American Journal on Addictions, there’s an article that throws a monkey wrench into my ideas around tapering.

This article has case reports of four patients who stopped Suboxone suddenly, unplanned. They were on doses ranging from 12mg per day to 30mg per day, and all four had only one or two days of mild opioid withdrawal, then felt fine.  The author concluded that these patients, “Showed no objective signs of opiate withdrawal following abrupt discontinuation of chronic buprenorphine/naloxone treatment…” The authors postulated that a prolonged taper might actually be harder on patients than stopping suddenly at a higher dose, based on these four case studies and other doctors’ impressions. Three of the four patients returned to buprenorphine/naloxone treatment when they had the opportunity, for fears of relapse, and the fourth was felt not to be appropriate for continued treatment with buprenorphine.

Could this be true? Might it be easier for patients to stop at a higher dose, rather than taper to a lower dose? Intuitively, a taper seems to be the best way to avoid withdrawal symptoms, but what if buprenorphine is different? It is an unusual drug. It’s a partial opioid agonist at the mu receptors, but it also has action on other opioid receptors. Might the action at other types of receptors be responsible for what was seen in those case studies? What about the monoproduct, Subutex?

The article’s authors conclude by recommending further studies comparing intensity of opioid withdrawal in patients undergoing rapid taper or sudden discontinuation versus patients undergoing a slower 28-day taper.

I’m so intrigued by these case reports that I’d love to see a large randomized trial to answer these questions. I have seen a few patients stop taking medication suddenly at higher doses and they said they didn’t have bad withdrawals…but then I have had many others who stopped suddenly and had terrible withdrawals.

Patients on Suboxone or Subutex, what do you think?

  1. Westermeyer, Joseph MD, et. al. “Course and Treatment of Buprenorphine/naloxone Withdrawal: An Analysis of Case Reports,” American Journal on Addictions, 2012, Vol. 21 (5) pp. 401-403.

Update on Suboxone Films

In the past, I’ve blogged about how some of my patients were having problems with their Suboxone films. When they opened the foil packets, the films were broken into pieces or so fragile they broke when handled. But now over the last two or three months, my patients tell me the films are no longer breaking or fragile, making them easier to use.

I’m glad. The Reckitt Benckiser drug company, manufacturer of Suboxone, wants doctors to switch patients to film because it dissolves faster, is easier to use, is less dangerous to children because the package is so hard to open, and it’s less likely to be snorted. They also say it’s harder to divert and has less value on the black market. And they say tablets are more likely to trigger patients who were addicted to tablets.

There’s validity to much of that, but I believe the biggest reason they want patients to switch is because their patent on the film runs for at least seven more years. Call me cynical.

About half of my patients who tried the film didn’t like it. Nearly all were patients in good recovery, stable for months to years, and if they wanted to tablets rather than the film, I was OK with that. When the film became crumbly, a few more patients wanted to switch back to the tablets.

Now, I’m more enthusiastic about the films. I can prescribe the film with more confidence since they no longer crumble. I prefer to use the films for patients tapering off Suboxone. I know the drug company says the films (and tablets) shouldn’t be cut, but of course everyone has been cutting both. With sharp scissors, the films can be cut into equal and small portions, ideal for a gradual taper of the dose.

I have more success with tapers in patients taking the film. In my next blog, I’ll talk about some of the “recipes” for taper my patients and I have used.

New Health Care Laws: How Will They Affect Office-based Treatment with Suboxone?

Last week, one of my office-based buprenorphine patients asked me how I thought the new healthcare laws would affect my business. I’ve considered this question with a mix of anxiety and hope. Until we have more details, I’m not certain I’ll like the new changes. And of course since I’m a healthcare provider, I’ll look at changes differently than if I were an insurance executive.

I told my patient that it will be excellent for my patients in buprenorphine (Suboxone, Subutex) treatment who don’t have insurance now, and are paying out of pocket. My patient then remarked that I’ll be much busier, because more pain pill addicts will be able to afford treatment.

“No,” I said, “I can still only have one hundred Suboxone patients at any one time, so I can’t add any new patients.”

My patient was quiet for a moment and said, “So if an addict calls you because he just got insurance to pay for his treatment, you couldn’t see him anyway?”

“That’s right, unless I lost a patient for some reason, and had an open spot for him.”

“So even if addicts get insurance, they can’t use it? That’s crazy. Why does the government have that law?”

I explained to him about the newness of the DATA 2000 Act, and that some lawmakers were skittish about this program from the beginning. They were worried Suboxone “mills” would open, where hundreds of addicts were treated with little physician oversight or precautions.

Lifting that limit would be the easiest way to get more opioid addicts into treatment.

My private practice, where I treat opioid addicts with buprenorphine (Suboxone, Subutex), is a bare bones operation. Because of the one hundred patient limit, I have enough patients to keep me busy for one day per week. On the other days, I work at opioid treatment programs. I enjoy my own office practice because of the autonomy, and because I have some great patients that I’ve known for years. But at my own office, I make far less than half what I make at the opioid treatment programs.

I have the usual fixed overhead of rent, utilities, answering service, internet, etc., and most of the money I take in goes towards that. I have a part-time health care coordinator, who makes appointments for patients, calls them to remind them of appointments, does most of my office drug screens, screens my after-hours calls, handles the filing, copying and other record-keeping tasks, and deals with those pesky pre-authorization requests that insurance companies make. (She and the counselor have decided I ought not to be allowed to talk with the insurance companies, since I often erupt into profanity).Then I have the best LCAS (Licensed Clinical Addiction Specialist) counselor in the world who works with me on Fridays, doing individual counseling (he’s my fiancé). Since I don’t file insurance, but rather give the patient a receipt so they can file it themselves, I avoid that personnel expense.

And I don’t accept Medicaid or Medicare as payment for treatment. I feel guilty for admitting that, but I don’t think I could stay in practice if I accepted what these government programs pay for treatment. When I first opened my own office in 2010, I saw a handful of these patients for free, since trying to file and going through the necessary red tape isn’t worth the pittance these programs pay for an office visit.

So if my uninsured patients get Medicaid, I’ll have to decide how to deal with that problem.

It’s not legal for me to ask patients with Medicaid and/or Medicare to pay for treatment out of their pocket unless I opt out of those programs completely for a period of years. I can’t do that because some of the other treatment facilities that I work for do bill Medicaid.

So do I start taking Medicaid, with all its headaches, red tape and low re-imbursement? I don’t know. I don’t like the thought of it, but it will perhaps become a necessity. It will depend on reimbursement rates. Plus, I’ll be paid even less since I don’t have electronic medical records. Government programs have decreed that doctors without meaningful use electronic medical records will receive less money for Medicaid/Medicare patients than doctors with these programs.

I’m not against electronic medical records. I use them effectively at both of the opioid treatment programs. One program is completely paperless, and I like that much more than I ever thought. But in my small, one hundred patient office, I can’t afford any software for medical records. It’s not practical or feasible

Since I was trained and still am board-certified as an Internal Medicine doctor, I could fill my other days with primary care patients. I was talking to another doctor who was starting her own Suboxone practice, and she was wondering how to get by financially, only practicing Addiction Medicine. She too is a former Internal Medicine doctor. I suggested she could always do some primary care.

“Just shoot me in the head,” she said, summarizing my feeling exactly. I’ve never liked primary care as much as addiction medicine, to put it mildly.

Addicts are easier to deal with, and are often nicer people than the average soccer mom, demanding an antibiotic to treat her viral upper respiratory infection. But my biggest reason for preferring addiction medicine is that addicts get better. I never saw the big changes in health when I worked in primary care, like I do in people treated for addiction. Primary care feels like a step backwards. I don’t want to go back to treating non-compliant diabetics, and overweight people who won’t exercise. I’d prefer to keep my present patients, in whom I see an intense desire to get well.

I’m addicted to seeing the big changes that I see when I work in addiction medicine. I hope the new changes in healthcare will allow me to stay in the business of helping people change. Like the rest of the U.S., I’ll have to wait and see.