Virginia Board of Medicine Changes Opioid Treatment Program Regulations

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In a surprising turn of events, last week the Virginia Board of Medicine passed regulations applying to the prescribing of buprenorphine not only in office-based settings, but also in opioid treatment programs.

At a time when many governmental agencies are trying to figure out ways to keep people from dying from opioid overdoses, the Virginia medical board is more concerned with diversion and misuse of the life-saving medicine, buprenorphine.

Last Thursday, the Virginia Board of Medicine outlawed opioid treatment programs from giving buprenorphine monoproduct take home doses. All patients on the buprenorphine monoproduct have to be dosed on- site at the opioid treatment program, with directly observed dosing. If patients are willing to switch to the combination product, buprenorphine/naloxone, they will be allowed to continue their earned take homes.

I know why the Virginia Board of Medicine restricted the monoproduct; they are convinced people are misusing this medication, injecting it and selling it on the black market. To be sure, this does happen, and I agree that we must do what we can – within reason – to prevent medication misuse and diversion. But I doubt the members of the Virginia Board of Medicine know that opioid treatment programs already have diversion control programs in place, both for buprenorphine and for methadone, a more powerful opioid.

It appears that rather than open a dialogue with opioid treatment programs and their physicians, to get a better idea of how to help patients, the Virginia Board of Medicine unilaterally issued an edit that will adversely affect these patients.

People on the front lines, working at opioid treatment programs in rural areas, know that the medical board ruing will cause considerable hardship for patients who are in good recovery.

Patients have several options, and all of them present some complications that will have to be overcome. Patients can either chose to stay on the monoproduct and dose daily at their opioid treatment program, switch to the combination product and continue to get take home doses, switch to methadone and get take home doses, or drop out of treatment altogether.

Let’s look at each option.

This medical board appears to assume patients could just switch to the combination product, with no problem. But there is a problem – a big financial problem. I’ve looked carefully at the costs of the generic monoproduct compared to the generic combination product. In my area, there’s about a $120 per month difference between the two, at a dose of sixteen milligrams per day. That’s a best-case scenario.

Let’s assuming the opioid treatment programs were able to pass on only their direct increased cost of medication to the patients. An extra $120 per month to stay in treatment doesn’t sound like much to some people, but to uninsured blue-collar workers who make up the majority of opioid treatment program patients in rural areas, that extra cost is prohibitive. It’s enough to force patients out of treatment.

People fortunate enough to have money and insurance can pooh-pooh this all they want, but an extra $120 per month is unaffordable for many patients enrolled in opioid treatment programs.

What about the small but significant number of patients who say they don’t feel as well on the combination product as the monoproduct? The medical board members exhibit a stigmatizing and biased attitude when they assume all patients who request the buprenorphine monoproduct are intent on injecting and/or selling their medication.

I’m convinced some patients do absorb more of the naloxone in the combination buprenorphine/naloxone tablets than they are “supposed” to. People do respond differently to medications, with no bad intent. These patients can recover nicely on the monoproduct, with careful monitoring, and they don’t have the headache and vomiting sometimes seen with the combination product.

While I agree physicians need to take extra measures when prescribing medication which have value on the black market, we should already be doing this, both at opioid treatment programs and office-based buprenorphine offices.

At opioid treatment programs, we have diversion control plans, including frequent bottle recalls to assess for diversion in all patients, on buprenorphine or methadone. We sometimes check patients’ arms for track marks, particularly if they have a previous history of intravenous drug use.

According to the Virginia Board of Medicine, if patients can’t tolerate the combination product buprenorphine/naloxone, or if they can’t afford it, they can just dose each day at their opioid treatment program.

That position overlooks our patients’ realities too.  In rural areas, patients may drive an hour and a half one-way to get to their opioid treatment program. For a person who is doing well and who has earned a week of take homes, the sudden imposition of dosing daily means three hours out of their day, plus the extra expense of travel. That can be a deal-breaker for financially fragile patients, too.

Think how insulting it would feel for patients who have done well in medication-assisted recovery. Think of patients who have done well for many months, have passed drug screens, passed all bottle recalls, and who have become employed. They have recovered into responsible and productive members of society…only to have legislators decide they can’t be trusted to have take home medication.

What would your response be? I’m afraid I might react very badly.

Since dosing every day at the opioid treatment program isn’t an appealing option, and for patients who can’t afford the extra cost of the combination product, or who can’t tolerate the side effects, methadone is a viable option. It works well, and it’s been proven over the last sixty years to be an effective treatment.

It does have some disadvantages, though. There’s still quite a stigma against methadone, and it is harder to taper off of at some point in the future, if indicated. It has more medication interactions and is more dangerous during the induction phase. It’s possibly less forgiving when mixed with alcohol or benzos than buprenorphine.

It also has street value and can be diverted, which is why all OTPs have diversion control plans, which brings us back to the original reason why the medical board wants to outlaw buprenorphine take homes. If they want to outlaw buprenorphine take homes today – a drug much less likely to kill people than methadone – will they outlaw methadone take homes tomorrow? I think that’s highly likely.

Because buprenorphine is so much safer than methadone, SAMHSA dropped the time in treatment requirement for buprenorphine take homes. Their purpose in doing this was, I thought, to encourage more people with opioid use disorder to get into treatment, and consider using the safer drug, buprenorphine.

Virginia’s new requirement puts an end to any take home doses for the monoproduct while ironically continuing to allow take home doses for patients on methadone, a much heavier opioid more likely to cause overdose death when misused.

The last, and worst, option for patients who will be faced with the decision of what to do when their buprenorphine take home doses are revoked by the Virginia Board of Medicine is to leave treatment.

I really hope this doesn’t happen. One study (Zanis et al, 1997) showed an eight-fold increase in overdose death for patients who left treatment at opioid treatment programs.

At a time when the rest of the world is trying to engage people in medication-assisted treatment of opioid use disorder, and make it more attractive to patients at risk for dying, the Virginia Board of Medicine is throwing up barriers to treatment.

I have a suggestion. Why not use some of those millions Virginia extracted from Purdue Pharma in their lawsuit settlement, and pay part of treatment costs for your Virginia citizens with no insurance?

If Virginia feels it’s imperative to offer the buprenorphine/naloxone tablets for patients with opioid use disorder who are able to tolerate that medication, help them pay for it.

For patients who don’t tolerate the combination tablet, let opioid treatment programs to continue to do what we do best…care for complicated patients with opioid use disorder.. Let us continue to do bottle recalls and arm checks to assess for continued IV drug use in patients who have that history.

I suspect, if diversion data could be examined, we will find what we found with methadone ten years ago. The diversion then was fueled by patients at pain clinics, who had little or no oversight, not the opioid treatment programs with active diversion control programs.

If we find some opioid treatment programs have lax diversion control, address that through the channels already in place, rather than trying to invent something new.

But please don’t erect new barriers for patients seeking to recover from opioid use disorder. It will – literally – kill people.

Happy, Joyous, and Free…

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Avid readers of my blog will recognize the following as a re-run, but I’m feeling under the weather this week, from a virus that’s been circulating in the community:

 

JB: Please tell me about your experience with pain pill addiction and your experiences with buprenorphine (Suboxone).

XYZ: For me, my opiate addiction got so bad, I was taking two hundred and forty to three hundred and twenty milligrams of OxyContin per day, just to stay normal. It had gotten really, really bad. And it started out with a reason. I had kidney stones, and I was in all this pain, but then it got to the point where it solved some other problems in my life and it got out of hand. I tried a lot of different things. I went to detox, and they helped me, but it was…it was almost like I never came out of withdrawal.

JB: How long were you off pain pills?

XYZ: Even after being clean for thirty or sixty days, I would still feel bad. Bowels, stomach…really all the time.

JB: Did it feel like acute withdrawal or just low grade withdrawal?

XYZ: No…I’d try to fix it myself, sometimes, and I would just put myself back where I was. It got to the point where I was making myself sicker and sicker and sicker. And then I got off of it, and stayed off of it for a hundred and twenty days, I guess…but still just sick. Just miserable, and not feeling right. I was miserable. I wouldn’t eat, I was losing weight…

It [buprenorphine] gave me something that replaced whatever was going on in my head physically, with the receptors. It took that [prolonged withdrawal] away, to the point that I felt well. All that energy I would spend getting pills…and I was going to the doctors almost daily. Because taking that much medicine, nobody would write me for that much, so I had to doctor shop.

My only life was going to the doctors, figuring out what pharmacy I could use. I had a whole system of how many days it could be between prescriptions, what pharmacy to go to. It was sick. I was just trying to not get sick.

JB: And you were working during that time?

XYZ: Yeah! I was working, if you want to call it that. I wasn’t a very good employee, but I held a job. I was a regional vice president for “X” company. I traveled a lot, so I had new states where I could see new doctors. That was bad. When I came off the road, I owed $50,000 in credit card bills.

JB: And your wife didn’t know about it?

XYZ: No. It all came tumbling down. And I had gotten into trouble, because they were company credit cards, and they wanted the money back! So, all of the sudden my wife found out that not only do I have a pain pill problem, but we’re $50,000 short, and I wasn’t very ethical in the way I got the money, because it really wasn’t my credit, it was my company’s credit card.

JB: So addiction made you do things you wouldn’t do otherwise?

XYZ: Absolutely. I lied to people, I took money from people, I ran up credit cards tens of thousands of dollars, and really put my family in serious jeopardy at that time. But buprenorphine took away that whole obsessive-compulsive need for pills, made me feel better, and took away all the withdrawal symptoms at the same time. I didn’t worry about it. To be honest, I was such a hypochondriac before. I haven’t been sick in years now. I haven’t had a backache or headache that ibuprofen didn’t cure [since starting recovery]. I was fortunate it was all in my head. I would milk any little thing. I had two knee operations that probably could have been healed through physical therapy, but I was all for surgery, because I knew I’d get pain pills.

JB: That’s the power of addiction!

XYZ:  Yes. Finally I did some research about buprenorphine, online. Actually, I had some good family members, who did some research and brought it to me, because they were concerned for me, and they brought it to me and said, “Hey, there’s a medicine that can help. Call this number,” and I found places out there that would do it [meaning Suboxone], but my concern was the speed that a lot of them were doing it. A lot of them said, OK come in, and we can evaluate you, and after a week you’ll be down to this, and after a month you’ll be down to this.

This was in 2005. And when I asked them what their success rate is, it wasn’t very high. It was something like twenty percent of the people who were doing it [succeeded]. So when I’d finally gotten a hold of “X,” [receptionist for Dr. H], she saved my life over the phone. Because she said, you can come tomorrow, and she said that whatever it takes, they’ll work with you. And I felt good about going to a place where it wasn’t already determined how long it would take. Because I already knew how I was feeling after I would come off of opiates. I didn’t want to do that again.

I saw Dr. H. and felt better within twenty-four hours, although it took a little while to get the dosage right. I think we started off at a lower dose, then we went up on the dose and it kept me so level. I had no symptoms. It cured my worst withdrawal symptoms, my stomach and my bowels.

There’s always a kind of stigma in the rooms [12-step recovery meetings] because I’d been in NA for a little bit of time then [he’s speaking of stigma against medication-assisted treatment]. You realize who [among addicts in NA] is die-hard, one way to do recovery, and who is willing to be educated about some things and understand that there’s more than one way to skin a cat. And I was fortunate that I had a sponsor at that time, and still do, who was willing to learn about what exactly it was, and not make me feel guilty about it. It wasn’t necessarily the way he would do it, but he was a cocaine addict, so he didn’t understand that whole part of it.

He said, “Your family’s involved, you’ve got a doctor that’s involved, your doctor knows your history. If all these people, who are intelligent, think this is an OK thing, then who am I to say it’s not going to work?” He was open-minded. And there are not a lot of people I would trust right off the bat [in recovery], that I would tell them. [that he’s taking Suboxone]. I’ve shared it with some people who’ve had a similar problem, and told them, here’s something that might help you. I always preface it with, [don’t do] one thing or another, you’ve got to do them together. You have to have a recovery program and take this medicine, because together it will work. Look at me. I’m a pretty good success story.

One of my best friends in Florida called me, and I got him to go see a doctor down there, and he’s doing well now. He’s been on it almost eleven months now and no relapses.

To me, it takes away the whole mental part of it, because you don’t feel bad. For me, it was the feeling bad that drove me back to taking something [opioids] again. Obviously, when you’re physically feeling bad, you’re mentally feeling bad, too. It makes you depressed, and all of that, so you avoid doing fun things, because you don’t feel good.

Once I trained myself with NA, how to get that portion of my life together, to use those tools, not having any kind of physical problems made it that much easier to not obsess.

JB: So, how has your life improved, as a result of being on buprenorphine?

XYZ: Well, the most important thing for me is that I’ve regained the trust of my family. I was the best liar and manipulator there was. I’d like to think of myself as a pretty ethical and honest person, in every aspect of my life, other than when it came to taking pills.

JB: So, you regained the trust of your family, felt physically better…

XYZ: I gained my life back! Fortunately, I had enough of a brain left to know it had to stop. Once I started on buprenorphine, it gave me back sixteen hours a day that I was wasting. That’s when I decided I really don’t want to jeopardize my recovery, by going out and looking for a job again [he means a job in corporate America, like he had in the past], because I’ve got this thing, this stigma…they’re going to check a reference and I’m screwed. I’m not going to get a job doing what I was doing for the same amount of money.

My brother had enough faith in me that it was worth the risk of starting this business [that he has now] together. My wife and I started on EBay, making and selling [his product], and slowly grew it to the point that, three years later, I’m going to do over two million dollars in sales this year, I’ve got [large company] as a client, I’ve got [large company] as a client, I’m doing stuff locally, in the community now, and can actually give things back to the community.

JB: And you employ people in recovery?

XYZ: Oh, yeah. I employ other recovering addicts I know I can trust. I’ve helped some people out who have been very, very successful and have stayed clean, and I’ve helped some people out who came and went, but at the same time, I gave them a chance. You can only do so much for somebody. They have to kind of want to do it themselves too, right?

JB: Have you ever had any bad experiences in the rooms of Narcotics Anonymous, as far as being on Suboxone, or do you just not talk to anybody about it?

XYZ: To be honest, I don’t broadcast it, obviously, and the only other people I would talk to about it would be somebody else who was an opioid addict, who was struggling, who was in utter misery. The whole withdrawal process…not only does it take a little while, but all that depression, the body [feels bad]. So I’ve shared with those I’ve known fairly well. I share my experience with them. I won’t necessarily tell people I don’t know well that I’m taking buprenorphine, but I will let them know about the medication. Even though the information is on the internet, a lot of it is contradictory.

It’s been great [speaking of Suboxone] for someone like me, who’s been able to put a life back together in recovery. I’d tell anybody, who’s even considering taking Suboxone, if they’re a true opioid pill addict, (I don’t know about heroin, I haven’t been there), once you get to the right level [meaning dose], it took away all of that withdrawal. And if you combine it with going to meetings, you’ll fix your head at the same time. Really. I didn’t have a job, unemployable, my family was…for a white collar guy, I was about as low as I could go, without being on the street. Fortunately I came from a family that probably wouldn’t let that happen, at that point, but who knows, down the road… I had gotten to my low. And that’s about it, that’s about as much as I could have taken.

It [Suboxone] truly and honestly gave me my entire life back, because it took that away.

JB: What do you say to treatment centers that say, if you’re still taking methadone or Suboxone, you’re not in “real” recovery? What would you say to those people?

XYZ: To me, I look at taking Suboxone like I look at taking high blood pressure medicine, OK? It’s not mind altering, it’s not giving me a buzz, it’s not making…it’s simply fixing something I broke in my body, by abusing the hell out of it, by taking all those pain pills.

I know it’s hard for an average person, who thinks about addicts, “You did it to yourself, too bad, you shouldn’t have done that in the first place,” to be open minded. But you would think the treatment centers, by now, have seen enough damage that people have done to themselves to say, “Here’s something that we have proof that works…..”

I function normally. I get up early in the morning. I have a relationship with my wife now, after all of this, and she trusts me again. Financially, I’ve fixed all my problems, and have gotten better. I have a relationship with my kids. My wife and I were talking about it the other day. If I had to do it all over again, would I do it the way I did it? And the answer is, absolutely yes. As much as it sucked and as bad as it was, I would have still been a nine to five drone out there in corporate America, and never had the chance to do what I do. I go to work…this is dressy for me [indicating that he’s dressed in shorts and a tee shirt]

JB: So life is better now than it was before the addiction?

XYZ: It really is. Tenfold! I’m home for my kids. I wouldn’t have had the courage to have left a hundred thousand dollar a year job to start up my own business. I had to do something. Fortunately, I was feeling good enough because of it [Suboxone], to work really hard at it, like I would have if I started it as a kid. At forty years old, to go out and do something like that…

JB: Like a second career.

XYZ: It’s almost like two lives for me. And if you’re happy, nothing else matters. I would have been a miserable, full time manager, out there working for other people and reaping the benefits for them and getting my little paycheck every week and traveling, and not seeing my wife and kids, and not living as well as I do now.

I joke, and say that I work part time now, because when I don’t want to work, I don’t have to work. And when I want to work, I do work. And there are weeks that I do a lot. But then, on Saturday, we’re going to the beach. I rented a beach house Monday through Saturday, with just me and my wife and our two kids. I can spend all my time with them. I could never have taken a vacation with them like that before.

JB: Do you have anything you’d like to tell the people who make drug addiction treatment policy decisions in this nation? Anything you want them to know?

XYZ: I think it’s a really good thing they increased the amount of patients you [meaning doctors prescribing Suboxone] can take on. I’d tell the people who make the laws to find out from the doctors…how did you come up with the one hundred patient limit? What should that number be? And get it to that number, so it could help more people. And if there’s a way to get it cheaper, because the average person can’t afford it.

The main thing I’d tell them is I know it works. I’m pretty proud of what I’ve achieved. And I wouldn’t have been able to do that, had I not had the help of Suboxone. It took me a little while to get over thinking it was a crutch. But at this point, knowing that I’ve got everybody in my corner, they’re understanding what’s going on…it’s a non-issue. It’s like I said, it’s like getting up and taking a high blood pressure medicine.

I originally interviewed this patient in 2009, for a book that I wrote. Since that time, he and his family have moved to the west coast, but I’ve stayed in contact with him. He’s been in relapse-free recovery for over eight years, he’s still on Suboxone, and still happy. He has excellent relationships with his wife and children, and his business has thrived and continues to grow.

He’s an excellent example of how a recovering addict’s life can change with the right treatment. For this person, Suboxone plus 12-step recovery worked great.

 

“We will not regret, nor wish to shut the door on it.”

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“We will not regret, nor wish to shut the door on it.”

This was a tough blog to write. I want to thread the needle; I want to relate some solid help from 12-step recovery sources without angering some of my faithful readers who become angry with any mention of 12 step recovery.

So you’ve been warned.

I know 12-step recovery isn’t for everyone. Some people tell of bad experiences with 12-step groups. And I know millions of people have been helped by these groups, too. So take what you like from this blog entry, leave the rest, and if you read something helpful, I’ll be happy. If not, try again next week because my topics fluctuate.

I talk to many recovering addicts who voice regrets about their past. The stories vary; the patients’ main theme is regret for behavior during active addiction. I understand those feelings, and feel tempted to tell patients how to deal with these feelings… but I don’t say anything, for fear that I’ll sound too “preachy.” Who am I to tell someone that they can examine past regrets, learn from previous mistakes, make amends when needed, and face the future with a clean slate? Isn’t that a conversation for a priest, imam, rabbi, or pastor?

Yes, it is. And yet, this person is in my office. Many times my patients tell me they feel unworthy to join or rejoin a religious community, and feel judged by such groups. Some of my patients’ perceptions could be colored by their own shame, but I fear many of them are accurate in their perceptions. Addiction is still regarded as a sin by some religious groups. Other groups know addiction isn’t a sin but a disease, which can cause us to do and say things we regret, which are contrary to our values

Twelve step groups like Alcoholics Anonymous and Narcotics Anonymous have mechanisms for dealing with past regrets and ruptured relationships. These groups didn’t invent anything new. They use the same approach as other spiritual and religious groups, which are also sound psychological advice. However, the twelve steps provide a handy framework for handling regrets.

First, in Step 4, the recovering person assesses past behavior, called a “moral inventory” in recovery parlance.  That inventory is shared with themselves (ending denial), another trusted person, and the god of their understanding. Patterns of behavior emerge, giving information to be used in steps 6 and 7, where the person becomes willing to give up old behavior and ask the god of their understanding for help with this.

In step 8, the recovering person lists the people he has harmed while in active addiction. With the aid of a sponsor or trusted spiritual advisor, in Step 9 the recovering person makes plans for how best to make up for past behavior.

Amends can be as simple as saying, “I’m sorry,” to someone for past bad behavior, or amends can be more extended, like resolving to be fully emotionally present for loved ones.

Sometimes direct amends aren’t possible, if the person has moved away, died, or unable to be located. A more general amends can be made instead. For example, if a person shoplifted to support their addiction, it may be impossible to remember where and what was stolen. Part of the amends process is not to repeat the old behavior, but a more general amends may involve volunteering in the same community to help society in some way, like donating to a food bank or giving time to help a child in need.

If the recovering person feels guilty about stealing money, amends may include apologizing for the past behavior, and making a plan of re-payment. For example, I know a person in recovery now for over 16 years who sends a check for $25 each month to a governmental agency to whom he owned money after a criminal conviction. He may never get the full amount paid off, but he’s taking action to fix what he broke.

Addiction taught harsh lessons that came at exorbitant prices, so we should learn from past mistakes. Recovering people can move forward by planning amends for past actions, but also should consult a sponsor or spiritual guide for help. For example, if an addict stole money from a drug dealer, it should not be paid back, especially if it puts the recovering addict at risk. In some situations, the best amends may mean having no contact with the other person.

Some recovering addicts have long lists of bad behavior to make amends for, and other recovering addicts’ lists may contain only a few people. Many addicts harmed only their immediate family, by not being completely emotionally available to their spouses or children during their addiction. Some recovering people feel just as bad about that as others feel about committing armed robbery for drug money.

The point of amends isn’t how bad the behavior was, but how the recovering person feels, and how he can leave behind guilt and shame and move forward.

Addiction, like some other diseases, affects behavior. Rather than living with regrets, recovery means facing regrets, learning from them, fixing what we can, and then moving on. It doesn’t matter what you call it: making amends, cleaning your side of the street, getting right with the god of your understanding, or some other term.

 

U-47700

Illicit U-47700

Illicit U-47700

 

 

 

My patients are sometimes my best teachers, so when one of them mentioned a new opioid drug, I searched for information online. This new drug is called Pink, or Pinky, but its chemical name is U 47700.

This drug was first developed in the 1970’s by a scientist at Upjohn, a pharmaceutical company. This drug has never been studied in humans, but produces a strong opioid-type effect due to its action at the mu opioid receptor. It’s quite powerful, with estimated potency at seven or eight times that of morphine.

Last year, forty to eighty overdose deaths in the U.S. were attributed to this drug, depending on which source you read. As a man-made research drug, it was legal to obtain until late last year, when the DEA placed U-47700 on Schedule 1 status. This means it is no longer legal to buy online, and that it has a high potential for causing addiction and harm.

Rolling Stone did an article on this drug last fall, saying it was one of the drugs that contributed to Prince’s death, found in his blood at autopsy along with fentanyl. When Rolling Stone published their article, it was still an unscheduled drug. According to that report, there had been around 80 deaths attributable to U 47700, which is usually combined with fentanyl or other drugs. [1]

In some areas, fake Norco tablets were peddled by drug dealers. These pills actually contained U-47700, or a combination of U-47700 and fentanyl. At least a dozen people died from these fake pills, because they believed they were buying hydrocodone, but actually ingested the much more powerful opioids U-47700 and/or fentanyl.

When I listened to an online lecture from last year’s American Society of Addiction Medicine’s fall conference, one of the speakers, Robert DuPont M.D., said the drugs of the future will be synthetics. We’ve already seen this in the rise of synthetic marijuana products, and now it appears we are seeing synthetic, novel opioids hit the streets.

These drugs are cheaper to make by the big drug labs in China and Mexico than traditional heroin, as I said in a former blog post.

It’s impossible to tell how big a problem U-47700 is at this time. Routine toxicology may not detect this substance, unless the lab is told to test for it specifically. It’s quite possible this drug could be a component of much of what is sold as heroin. We already know heroin is frequently mixed with fentanyl because it’s cheaper to manufacture. If U- 47700 is cheap to make, it’s also likely to become a common component.

Synthetic drugs present legal problems. A chemist who is experimenting may come up with a new psychoactive product, and it can hit the market before any law can be passed against its use.

These novel drugs aren’t illegal until after they appear on the streets and cause harm. Then governmental agencies like the DEA rush to change laws to cover these drugs.

There’s another big danger to synthetics. Sometimes the chemists making drugs aren’t that careful. Not all chemists are Walter White, the character on “Breaking Bad.” Walter was an educated chemist who wanted to make the purest product possible, in order to please his customers and maintain his reputation. I dare say most chemists aren’t as educated as Walter, and aren’t as meticulous with details.

There’s always the risk that these people will inadvertently make a similar drug with completely different properties and side effects.

MPTP is a great example of a drug manufacturing error.

MPTP, chemically known as 1-Methyl-4-phenyl-1,2,3,6-tetrahydrophyridine, can be accidently manufactured instead of MPPP, a closely related drug with opioid-like effects. In the 1980’s a handful of people injected what they thought was MPPP, and developed severe Parkinson’s disease. This happened because the chemist accidently made MPTP, which destroys cells in the brain that control movement of the body. MPTP caused Parkinson’s disease in these drug users. This error, though tragic for the people affected, led to useful information to better understands Parkinson’s disease and its treatments.

And some of what I read online seemed overblown. For example, one section of the Rolling Stone article said the drug could cause rectal bleeding. Upon closer reading of the article, the rectal bleeding was reported by people who had used the drug rectally. So yeah, that might cause problems down there.

In another online article, the police chief of Park City, Utah, is quoted as saying, “This stuff is so powerful that if you touch it, you could go into cardiac arrest.” [2]

I am skeptical about that statement. Unless there’s something in it allowing it to pass through the barrier of the skin, that’s doubtful.

Making speculative statements without proof can lead to hysteria, and can undermine the credibility of people who are trying to inform drug users of some very real dangers.

For me, the message is “buyer beware” with heroin. It may or may not be heroin. It could be fentanyl, it could be U-47700, and it could be a whole lot of other things.

This means it’s even more important for drug users to try “tester shots,” meaning use a fraction of drug to assess its potency. It’s important not to use alone, and to stagger injection times, so that there’s always someone able to call for help if needed. Drug users of opioids should have up-to-date naloxone kits on hand in case the worst happens and someone overdoses.

And above all, consider getting into opioid use disorder treatment: https://findtreatment.samhsa.gov/

  1. http://www.rollingstone.com/culture/news/u-47700-everything-you-need-to-know-about-deadly-new-drug-w443344
  2. http://www.inquisitr.com/3600359/new-drug-pink-causing-deaths-nationwide-opioid-u-47700-easily-purchased-online-despite-federal-ban/

Trump and the Opioid Grants: What Will Happen Next?

"Du-oh!"

“Du-oh!”

 

 

 

 

 

The front page article in the January 9, 2017 issue of Alcoholism and Drug Abuse Weekly is the jumping-off point for this blog entry. This excellent article outlines in plain language how the $ 1 billion Cures Act allocations were supposed to be used.

But on January 20, 2017, President Trump placed a sixty-day freeze on regulatory actions and executive orders that have been published but not yet taken effect. I scoured the internet to try to figure out if Obama’s Cures Act falls into this category. I’m still not certain it does.

The Cures Act, passed in late December as one of President Obama’s last actions had strong bipartisan support. Under this act, the Substance Abuse and Mental Health Services Administration (SAMHSA) is to administer funding for grants to each state. These grants are called State Targeted Response to the Opioid Crisis Grants, or Opioid STR for short.

The amount allotted to each state isn’t based on opioid overdose death rates, but rather on treatment gaps in each state. “Treatment gap” is a term for how many people need addiction treatment in a state compared to how many people are actually getting it. The bigger the gap, the more money that state will be allotted out of the $1 billion pot, to be disbursed over two years.

The states with the biggest treatment gaps are California, due to receive nearly $45 million, and Texas and Florida, both to receive around $27 million.

If dollars were spent based on per capita overdose death rates, the three top states would be West Virginia, New Hampshire, and Kentucky. This, of course, led to some criticism of the way money allocations were decided. Some people feel that the states that need money most desperately won’t get a big enough piece of the money pie.

As the ADAW article points out, some people feel the method of allocation is unfair to states where action has already been taken to treat substance use problems, out of their own state budget. By proactively treating problems, these states won’t qualify for as much of this federal money as states that ignored their opioid problem.

Other complaints are that states which decided not to expand Medicaid will now be awarded more than their share of this federal money, since their treatment gap is wider due to fewer citizens with substance use disorder who qualify for Medicaid to pay for substance use disorder treatment.

Probably no method of dividing the money can be perfectly fair to all states. I think the Cures Act does as good a job as is possible under the circumstances.

However, I am troubled by one aspect of this money distribution.

Each state can spend their federal money as they see fit.

In the ADAW article, H. Westley Clark, past director of SAMHSA’s Center for Substance Abuse Treatment, said, “State attitudes towards agonist medications will be a controlling factor.”

Oh dear. This could be bad.

States which have held a strong bias against methadone or buprenorphine as treatment for opioid use disorders may decide not to spend money on this evidence-based form of treatment.

But now, with President Trump’s sixty-day moratorium on new legislation, no one knows what will come to pass. There are so many uncertainties.

In the January 23, 2017 issue of ADAW, the front page article outlines how the repeal of the Affordable Care Act (ACA) could adversely affect the treatment of opioid use disorders. As we know, Trump campaigned on a promise to kill this healthcare Act. No one knows what he will decide to do, or how it will affect the 30 million people who have health insurance through the ACA now.

As the ADAW article points out, much of the gains in funding for treatment of substance abuse and mental health illnesses came from the ACA, and from the Mental Health Parity and Addiction Equity Act which preceded it. This last Act made it illegal for insurance companies to cover physical health problems while denying coverage for mental illness and substance abuse. Other laws made it illegal to refuse coverage for pre-existing illnesses. Denial of coverage for pre-existing conditions was common practice until relatively recently. When insurance companies could pick and choose who they wanted to insurance, patients who needed health insurance the most couldn’t get it.

Would canceling the ACA affect patients with substance use disorder who are already in treatment? Yes, of course, though I’m not sure to what degree. I know it would be more of an issue for my patients in office-based treatment with buprenorphine than for my patients enrolled at the opioid treatment program.

In the opioid treatment program setting, I don’t know of any patients with Obamacare who were able to get reimbursed for what they paid to our treatment program. These patients paid out of pocket even if they had insurance. I don’t know what the problem was, but I do know I had some bizarre conversations with physician reviewers. One physician said my patients with opioid use disorder, treated with methadone, needed to go a cheaper route, and get methadone prescribed in a doctor’s office. Of course, this is illegal, and has been since 1914, but that fact didn’t budge the reviewer.

Some of my office-based buprenorphine patients were able to enter treatment only because they got Obamacare. I would estimate I have eight to ten patients on Obamacare at present. They get reimbursed for the office visit and drug screening charges they pay to me, and get their medication paid for at the pharmacy, except for a co-pay.

Some of these patients have high deductibles, and still have to pay out of pocket for part of the year, but once they meet the deductible, have their opioid use disorder treatment paid for.

We’ve had the usual difficulties with prior authorizations with these patients, but it’s been no more difficult than patients with traditional insurance.

What would happen to my patients with Obamacare if it suddenly disappears? I assume most couldn’t afford treatment and would drop out. Data about patients who leave treatment for any reason shows relapse rates in the 85-90% range, so most of these people would go back to active addiction. I’ve become very attached to these patients, and this idea breaks my heart.

About a month ago, I was talking to Kristina Fiore, a reporter for the Wall Street Journal, who has done some outstanding reporting on the nation’s opioid use disorder epidemic. She called me for some background information for an article she was researching. Near the end of our conversation, she said something to the effect that everyone is always talking so negatively about our present opioid addiction situation, and she needed to know about reasons for optimism.

I thought about what she said for a few moments. Then I told her the only positive thing I saw was more money being released for desperately needed treatment.

Now, even this one positive aspect feels very uncertain.

 

 

Fentanyl is the New Heroin

aaaaoverdose-deaths

 

 

 

Big drug labs in China and Mexico have found it’s cheaper to manufacture the potent synthetic opioid fentanyl than it is to harvest and process opium into heroin. Therefore, much of what is sold as heroin is now mixed with fentanyl and its more potent analogues, sufentanil and carfentanil.

This is causing heroin overdose deaths in the U.S.  The National Institute on Drug Abuse issued a recent report saying that heroin overdose deaths increased over six-fold from 2002 to 2015. This is shown in the graphic at the beginning of this blog.

This problem is worse in some regions of our country than others; the Northeast has traditionally been plagued with heroin deaths at a high rates, but other areas of the country have higher rates of increase in heroin deaths.

There’s no way to know the potency of drugs sold as heroin, making it much easier to overdose and die.

There are some basic precautions that drug users can take to prevent overdose deaths. This is data all comes from the Harm Reduction Coalition:

  • Don’t use alone. Use with a friend, and stagger your injection times so that one person is alert enough to summon help if needed.
  • Have a naloxone kit available and know how to use it. You can get a free kit from many places, including harm reduction organizations. http://harmreduction.org/issues/overdose-prevention/tools-best-practices/od-kit-materials/
  • Do a test dose. This means instead of injecting your usual amount, try a tiny bit of the drug first, to help assess how strong it is.
  • Use new equipment, if possible. Some pharmacies are willing to sell new needles and syringes with no questions asked. Other drug users in your community may be able to tell you which pharmacies are willing to do this.
  • Remember that if you’ve had a period of time where you’ve been unable to use any drugs, your tolerance may be much lower. Highest overdose risk is seen in patients who have just been released from jail, from detox units, or from the hospital. Do NOT go back to the same amount you were using in the past.
  • Don’t mix drugs. Opioid overdose risk increases when other drugs are used too.
  • Consider getting into addiction treatment. https://findtreatment.samhsa.gov/

 

aaaaodpills

 

Skin Lesions from Injecting Buprenorphine: The Sign of the Cross

Skin lesions from injecting buprenorphine

Skin lesions from injecting buprenorphine

 

 

Trapped in my house due to nine inches of snow and a slick driveway, last weekend I worked to catch up on my medical journals. An article in the January 2017 issue of The American Journal of Medicine caught my eye.

The article was titled “Curious Crosses: Injection-Induced Lesions” and it described the clinical course of a patient on buprenorphine monoproduct who sought care for recurrent, painful nodules. These nodules would erupt, exuding bloody pus. The article’s author described a fairly extensive work up of these lesions.

This patient was checked for all sorts of exotic diseases which can lead to skin eruptions of this sort, including tuberculosis, sporotrichosis and other fungal diseases, Sweet’s syndrome and Behcet’s disease.

Finally, one of this patient’s blood cultures grew Pantoea species. This was an important clue, because this bacterium is thought to be the cause of “cotton fever,” a syndrome of severe body aches, fever, and intense fatigue.  Cotton fever occurs in some drug users because cotton used to filter injected drugs often harbors Pantoea bacteria. Once the bacteria are injected along with the drug, they release an endotoxin, which produces the symptoms of cotton fever.

With this information, the patient was again questioned about injection drug use. The physicians already knew the patient had a history of intravenous drug use, but this patient told them he was doing well in medication-assisted treatment on buprenorphine.  The patient denied any ongoing injection drug use.

All pills and tablets meant to be taken orally contain fillers. These are usually inert substances that stabilize the active drug, and help the pill or tablet keep its shape. Substances that are formed with the active drug and serve to stabilize it are called “excipients.”

Buprenorphine sublingual tablets contain an excipient called amidon. As near as I can tell by internet search, this is a starch-type substance. This amidon, when injected, causes skin reactions and gives a distinct finding under the microscope.

Under polarized light microscopy, some substances refract light in a distinct manner that can help identify the substance. This property is called birefringence. Amidon is birefringent. Under polarized light microscopy, amidon crystals have the distinct shape of a Maltese cross.

Physicians treating the patient described in the article obtained skin biopsies of some of the patient’s sores. Polarized light microscopy showed the Maltese crosses from the amidon filler in buprenorphine, which more or less confirmed the diagnosis. Other substances can also cause Maltese crosses in skin biopsies, but of course, the most obvious cause in this patient was injection use of the prescribed buprenorphine monoproduct.

I got interested in this finding, and looked online to see if this had been reported before. It has.

In France, where injection use of buprenorphine monoproduct has been problematic, doctors have reported this distinct finding under light microscopy.

In fact, I copied the picture at the beginning of this blog from one of those articles (Schneider et al, “Livedoid and Necrotic Skin Lesions Due to Intra-arterial Buprenorphine Injections Evidenced by Maltese Cross-Shaped Histologic Bodies,” Archives of Dermatology, 2010;145(2):208-209.) In this case report, the patient was injecting into an artery, which is much riskier than into a vein, but the appearance of the Maltese cross in the same.

At the end of the report I found in the American Journal of Medicine, the authors said the patient continued to deny injecting his buprenorphine. All of the lesions he had upon admission were in locations where track marks are usually seen. During his hospitalization, no new lesions appeared on his skin.

The article’s authors state they reported their findings to this patient’s buprenorphine prescriber, who planned to discontinue buprenorphine in favor of other treatment options.

This case was interesting, informative, and reminds me to monitor patients closely when prescribing the buprenorphine monoproduct, often better known under its past brand name, Subutex.

I do prescribe the monoproduct buprenorphine, mostly for patients at the opioid treatment program where I work. In that setting, we do observed daily dosing. After getting their dose, the patients sit and are observed for however long it takes to dissolve the medication, and must show a staff member under their tongue prior to leaving the facility. We do this to help reduce diversion and promote proper use of the medication. We don’t grant take home doses unless and until patients have a degree of stability.

I have also prescribed buprenorphine monoproduct for some of my long-term patients in my office-based practice. If one of these patients, doing well for years, loses their medical insurance, I will switch them to the cheapest form of medication, which is the buprenorphine generic monoproduct. I do this only because I know them so well, and don’t want them to relapse, or have to switch to methadone at an opioid treatment program.

In other words, I have to judge that the benefits far outweigh the risks.

Even with the medical problems illustrated in this interesting article, buprenorphine monoproduct has a place in the treatment of opioid use disorder. And this article reminds physicians we must use the monoproduct medication thoughtfully.

Many of the new patients I see entering treatment at the opioid treatment program have injected buprenorphine pills. I’ve seen some really terrible looking tracks, and now I suspect the scarring and inflammation may be due to these Maltese crosses from amidon crystals.