Archive for the ‘American Society of Addiction Medicine’ Category

Tidbits

 

 

 

 

 

 

As I promised several weeks ago, in this blog I’m writing about some of the studies published in the latest issue of the Journal of Addiction Medicine, the journal published by ASAM (American Society of Addiction Medicine). All of the following articles were in the last issue, May/June of 2017.

The opioid situation in the U.S. has temporarily claimed a big chunk of our attention, but elsewhere in the world, amphetamine and methamphetamine use disorders are more common than heroin and cocaine use disorders combined. In fact, amphetamine and methamphetamine are second only to marijuana worldwide as the most commonly used illicit drug.

Many scientists have been working to find a medication that will help in the treatment of patients with this disorder. Thus far, only psychosocial treatments have been helpful, including individual and group therapies using motivational interviewing, cognitive behavioral therapy, 12-step therapy, relapse prevention, and contingency management strategies. These treatments do improve outcomes, but are at best only moderately effective.

In Runarsdottir et al., extended-release injectable naltrexone was studied in 100 subjects with amphetamine use disorder in a randomized, placebo-controlled study done in Iceland.

This authors of this study postulated that the opioid blocker naltrexone could block the opioid receptors and thus the pleasurable effects on any endorphin-mediated dopamine release resulting from methamphetamine use. Preliminary studies in rats, primates, and healthy human volunteers suggested naltrexone could be effective, so this study on human subjects with methamphetamine use disorders was undertaken.

Subjects in one arm of the study were randomized to the usual psychosocial treatments plus placebo injection, and the other arm got the same psychosocial treatments plus active extended-release naltrexone injections.

Unfortunately, in this study, extended-release naltrexone did not show any statistically significant benefit over placebo. Both groups had high rates of drop-out at around 50%, which hampered the study results. However, the study’s authors postulated that their selection criteria for the study may have pre-chosen subjects with more severe use disorders.

This study’s results were disappointing. We would love to have a new and effective was treatment for amphetamine and methamphetamine use disorders, but this study didn’t show benefit from extended-release naltrexone for use in this disorder.

 

Another article was about a newer product containing buprenorphine: the rapidly-dissolving buprenorphine/naloxone sublingual tablet (brand name Zubsolv). It’s been on the market for a few years, and previous studies showed it works as well as other sublingual buprenorphine products on the market.

This study took patients from the previous studies and extended their treatment with this product for twenty-four more weeks, to evaluate the safety of longer-term treatment. As a secondary goal, study subjects were evaluated for their quality of life, opioid cravings, and their addiction severity.

Of the 665 patients who entered this second-stage study, only 44% completed the 24 week extension study. So that’s not great – we would like to see patients retained in treatment. The authors say patients withdrew due to being lost to follow-up, patient nonadherence to medication, and patient request for discontinuation.

But of the 44% of patients who finished the 24 week extension study, improvements were seen in their addiction severity, in their quality of life, in their employment status, and other measures. This means that the rapidly-dissolving buprenorphine tablet was found to be as safe as other similar products on the market, and the benefits of continued treatment persisted throughout this prolonged study period.

The high rate of discontinuation is concerning, but certainly not unusual. In fact, this drop- out rate was similar to studies done on other sublingual buprenorphine products.

I see this at my work. We use both buprenorphine and methadone at the OTP where I work, and drop-out rates are higher for patients on buprenorphine. They tend to bounce in & out of treatment more often than methadone patients do. I believe, but can’t prove, that the milder withdrawal gives patients less incentive to make sure they dose daily.

Patient drop-out is undesirable for all concerned. When a patient drops out of treatment at an MAT, relapse rates are very high, and risk of death may increase as much as eight-fold.

From that point of view, I might be tempted to regard methadone as a superior treatment. However, I know some of our buprenorphine patients would never consider starting methadone, often citing the difficulty of tapering off methadone as the reason. So offering buprenorphine attracts patients who may not enter treatment otherwise.

 

 

Another article in this copy of the journal, titled, “Methadone-Induced Hyperhidrosis Treated with Oxybutynin, by Hong et al., was a case study of a patient with pronounced sweating caused by methadone.

Pronounced sweating from any cause is termed “hyperhidrosis.” All opioids can cause this, including methadone. As the author points out, we think this may be caused by muscarinic receptor activity in the part of the brain that controls body temperature.

This case study is of a patient who stabilized on methadone 100mg for the treatment of his opioid use disorder, but had severe sweating, to the point he had to change clothes multiple times per day. This patient went to his internist, who prescribed oxybutynin, a medication also known under the brand name Ditropan. It’s used for overactive bladder disorders, and works through its anti-muscarinic activity.

The patient had resolution of his excessive sweating within two days, so the treatment was a success in this case.

I think I will start recommending to my patients with excessive sweating see their primary care providers for a trial of oxybutynin.

There are some pitfalls…it can lead to urinary retention, of course, and that’s always vexing when we ask patients to give urine drug screens.

 

 

What’s a Doctor To Do?

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Above, you will see two documents which illustrate the problem.

The second is a letter sent to North Carolina opioid treatment program (OTP) physicians from the preeminent OB/GYN group at the University of Tennessee. The first is a letter sent last month to obstetrical providers and opioid use disorder treatment providers from the Center for Substance Abuse Treatment, an arm of SAMHSA (Substance Abuse and Mental Health Services Administration).

You will note they recommend polar opposite approaches to the management of opioid use disorder in pregnant women. The obstetricians at University of Tennessee recommend that pregnant women with “chronic narcotic use” be offered the option of taper from opioids, to avoid neonatal abstinence syndrome and to avoid microcephaly.

In contrast, the letter to providers from CSAT division of SAMHSA recommends, “Pregnant women with opioid use disorder should be advised that medically supervised withdrawal from opioids is associated with high rates of relapse and is not the recommended course of treatment during pregnancy.”

That mention of microcephaly in the U of T letter baffles me. The resources cited in their letter referred to one study of head circumference in babies with neonatal abstinence syndrome (NAS). There’s no mention whether the moms are on illicit opioids or MAT. The second study looked at head circumference in babies born to moms with polysubstance use. None of the studies looked at head circumference of infants born to moms on MAT and compared them with controls. Using microcephaly as an argument against MAT is a misuse of data.

Why on earth would Tennessee obstetricians send their letter to NC opioid treatment program providers? Because, as I have ranted about so often in the past, there are no opioid treatment programs in Eastern Tennessee. Because that portion of Tennessee still has no methadone programs, patients are forced to drive across the border to get the gold standard of treatment for opioid use disorder. True, there are some buprenorphine prescribers in that area, and that’s a great thing as far as it goes, but as we know, not all patients do well with buprenorphine, and we have around six decades worth of data about methadone in pregnancy.

So not only does Tennessee refuse to allow the most evidence-based treatment for opioid use disorder to exist in that part of their state, but their physicians seek to control the actions of opioid treatment physicians in North Carolina, and ask us to adopt treatment approaches discouraged by all other expert organizations.

The study touted by Dr. Towers in their above letter was published by Bell, Towers, et al. in September 2016 issue of the American Journal of Obstetrics and Gynecology: http://www.ajog.org/article/S0002-9378(16)00477-4/abstract

After reading this study in some detail, I’m surprised by the authors’ conclusions. I find their conclusions to be based on some very thin evidence.

This study was a retrospective analysis of four groups of pregnant women with opioid use disorder. The first group consisted of incarcerated women, allowed to go through opioid withdrawal without the standard of care, buprenorphine or methadone. How this is even legal is beyond me.

The study says that jail programs in east Tennessee have “no ability to provide opiates to prevent or perform an opiate-assisted withdrawal medical withdrawal.” It went on to say that the jail doctor can treat symptoms with anti-nausea meds, clonidine, and anti-diarrheal meds. They also lack the ability to perform fetal monitoring while incarcerated.

Of the 108 women in group 1, two suffered intrauterine fetal death, one at 34 weeks and one at 18 weeks. The authors don’t say what the expected rate of fetal death would be, and I don’t know either. Apparently the authors didn’t consider these two deaths to be outside the range of normal.

Group 2 consisted of 23 pregnant women with opioid use disorder who were sent to inpatient opioid detoxification followed by long-term follow-up behavioral health programs. These women did well, with only 17% relapsing while in treatment. This group had a 17% rate of neonatal abstinence syndrome in the newborns.

I guess that means all of the four women who relapsed had babies with NAS. That’s 100%, much higher than the 50% rate nationwide. That seems odd to me.

Group 3 did the worst. These 77 women had inpatient detoxification but then did not have the long-term treatment that group 2 were given. Of the infants born to these women, 22% needed admission to the neonatal intensive care unit. Of these 77 women, 74% relapsed, and NAS was present in 70% of those infants. Again, this gives a NAS rate of 95%, which is a great deal higher than most other studies of NAS in babies born to moms using opioids of any kind. Even with methadone, studies give estimates of 50% to 80% at the highest.

Group 4 consisted of 93 women on buprenorphine prescribed by office-based physicians who agreed to taper the women’s doses during pregnancy. The rate of relapse in this group was noted to be 22%, and 17% of all the babies had NAS. Again, this gives a relatively higher NAS rate than has been found in other studies. In this Bell study, NAS occurred in 76% of the women who relapsed, up from 50% of women on buprenorphine in the MOTHER trial who were not tapered.

A little sentence in the articles table of demographics and outcomes gives the clue to why their NAS rates were so high. The way this study determined relapse was by drug screen at the time of admission to the hospital for delivery, or an admission by the pregnant woman, or positive meconium screen, or treatment of NAS in the newborn.

I think relapses could have gone undetected very easily, so that only the women with a relapse close enough to the time of delivery were detected to have used opioids.

Other problems with this study have been pointed out by much smarter people than me. Dr. Hendree Jones, author of the landmark MOTHER trial comparing methadone and buprenorphine during pregnancy, commented in the Journal of Addiction Medicine in the March/April 2017 issue: Her conclusions after a review of the Bell article plus a handful of other similar studies is: “Evidence of fetal safety to support the equivalence of medically assisted withdrawal to opioid agonist pharmacotherapy is insufficient.”

Of course, pregnant patients have one big concern: “What can I do to keep my baby from having withdrawal?” and that’s what they focus on. They are willing to do anything, including coming off methadone or buprenorphine or other opioids, if it will keep their baby from withdrawal. As Doctor Jones cogently points out in the above referenced article, there’s lack of data to show medically-supervised withdrawal from opioids results in less risk of NAS.

In other words, if prevention of NAS is our only goal, there’s not enough evidence to show that reducing opioids during pregnancy will achieve this. In part, that’s due to the high risk of relapse in the mother, and in part due to other factors.

This is the state of the situation right now. Things could change in the future. We do need new studies, done with closer attention to fetal monitoring and drug testing throughout pregnancy to help us determine the ideal treatment of pregnant women with opioid use disorder.

But for right now, maintenance on buprenorphine or methadone is still the treatment of choice.

It’s not only SAMHSA that’s recommending MAT as the treatment of choice for pregnant patients with opioid use disorder. Even the American College of Obstetrics & Gynecology (ACOG), the professional organization of OB/GYNs in the U.S., in a position statement from 2012, says:

  • “The current standard of care for pregnant women with opioid dependence is referral for opioid-assisted therapy with methadone, but emerging evidence suggests that buprenorphine also should be considered.”
  • “Medically supervised tapered doses of opioids during pregnancy often result in relapse to former use.”
  • “The rationale for opioid-assisted therapy during pregnancy is to prevent complications of illicit opioid use and narcotic withdrawal, encourage prenatal care and drug treatment, reduce criminal activity, and avoid risks to the patient of associating with a drug culture.”

The World Health Organization says, in its guidelines from 2014:

  • “Pregnant women dependent on opioids should be encouraged to use opioid maintenance treatment whenever available rather than to attempt opioid detoxification. Opioid maintenance treatment in this context refers to either methadone maintenance treatment or buprenorphine maintenance treatment.”

A new statement from the American Society of Addiction Medicine earlier this year, titled, “Substance Use, Misuse, and Use Disorders During and Following Pregnancy, with an Emphasis on Opioids” said:

  • “For pregnant women with opioid use disorder, opioid agonist pharmacotherapy is the standard of care; the ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use recommends that pregnant women who are physically dependent on opioids receive treatment using methadone or buprenorphine monoproduct rather than withdrawal management to abstinence.

So the experts agree. Medication-assisted treatment is the gold standard for pregnant women with opioid use disorder.

Why are some OB/GYNs in Tennessee and other areas recommending the opposite, based on evidence that most of us consider preliminary at best, and flimsy at worst?

I don’t know for sure, but I think these physicians suffer from the same biases as other non-medical people. I would like for these physicians to base their actions on the best scientific data, but that’s not happening in some areas. I believe these doctors, with the best of intentions, have been swayed by the political climates of their areas. Rather than challenge long-held beliefs about medication-assisted therapies that have been based on ideology rather than fact, they have stayed inside the comfort zone of believing pregnant women shouldn’t be on methadone or buprenorphine.

This leaves addiction medicine physicians in the middle. We know what the standard of care is, but our patients are told we are wrong, and that they should taper off maintenance medication, or not start it in the first place.

I’ve tried, one OB at a time, to educate gently about what I see as the standard of care. I’ve sent studies and position papers and other data to the OBs with whom I share patients. I’ve blogged about the negative experiences I’ve had. In short, many of these obstetricians say something to the effect of: “Who are you to tell me how to care for this pregnant patient?” After all, I’m not an obstetrician. But I do read, and I do keep my fund of knowledge up to date in the field of addiction medicine, which overlaps with obstetrics at times.

I’m terribly frustrated by the situation, and I know my colleagues at other opioid treatment programs feel the same way. I’m fortunate that there is one group of OBs who are somewhat supportive of my pregnant patients on MAT, and I appreciate that. But often these pregnant ladies using opioids are already going to one of the anti-MAT OBs, and that creates real problems.

If it’s difficult for physicians, just think how the pregnant patients feel. They are given polar opposite recommendations by their OB and their physician at the OTP. They sought help in order to do the best thing for their babies, wanting to be good mothers. In most situations, they have tried desperately to quit opioid on their own, and couldn’t. Now the OB is telling them they must taper off their medication during pregnancy, and the OTP physician is recommending they stay on it, even recommending they increase their dose if needed.

At a difficult time in their lives, these mothers-to-be aren’t sure if they are doing the right thing by being in treatment with MAT or not. They second guess themselves, and their families also recommend, with the best of intentions, that they follow the OB’s directions.

I think this won’t change unless professional organizations like ACOG reach out more directly to obstetricians in the field. Perhaps SAMHSA can organize educational lectures, given by obstetricians who know the data and know the best practice recommendations. Perhaps state medical societies or state medical boards can contact these obstetricians with statements of best practices, if more are needed. With WHO, ACOG, SAMHSA, and ASAM all recommending MAT for opioid-dependent pregnant women, you wouldn’t think further statements of best practice would be needed…yet they are.

All I know is that I don’t seem to be making any headway at all. I need help, and my patients need help.

 

 

 

Cutting Edge Addiction Medicine Information

 

 

 

The last issue of Journal of Addiction Medicine, the official journal of the American Society of Addiction Medicine (ASAM), was full of interesting articles, and I plan to blog about some of them in upcoming entries.

I’m pleased to be a member of ASAM, recognized as the premier professional society dealing with substance use disorders and their treatments. This organization has members with great enthusiasm, and hosts the best conferences I’ve ever attended in my career as a physician. The journal ASAM publishes is also top-notch. They publish articles pertinent to issues addiction medicine physicians face daily. They are practical for my everyday use.

Today I’m blogging about their drug testing recommendations.

Recently there’s been an upsurge of laboratories offering fantastic deals to physicians and patients which in the long run may turn out to be not so fantastic. ASAM published a document giving evidence for the most appropriate way to use drug testing in the setting of addiction medicine practices.

This document underwent extensive evaluation by experts in the field, using a data search for the highest quality of evidence, and then, using the RAND/UCLA appropriateness method, decided the importance of all of the data gleaned. Then an expert panel judged the ratings of all statements concerning drug tests. IRETA (Institute for Research, Education and Training in the Addictions), the prestigious group in Pennsylvania, also contributed to the document.

ASAM mailed a copy of the entire document, titled, “The Appropriate Use of Drug Testing in Clinical Addiction Medicine,” along with the latest issue of the Journal of Addiction Medicine.

I recommend every physician working with patients with substance use disorder read this document and use its information. The document isn’t meant for federally mandated workplace forensic testing, only for addition medicine practice.

In this blog, I’m going to point out a few of the ideas in the document and comment on them.

The ASAM document points out that drug testing technology is useful only when the technology is used appropriately. This reminds providers that we must understand the underlying principles of drug testing, know the limits of this technology, and remember it’s only one tool in our toolbox of patient evaluation.

They remind us that there’s only limited evidence to show that drug testing improves patient outcomes. More recent studies suggested that when drug testing is used correctly and integrated into making treatment decisions, outcomes may be improved.

Physicians shouldn’t use drug tests in a punitive, confrontational way. Rather, if we get an unexpected result on a drug test, it should be the beginning of a conversation with our patient about the result, not the end of treatment for the patient.

Some patient advocates point out that if patients have no adverse consequences for positive drug screens, self-report of drug use would be sufficient. That’s probably true, but if a patient continues to use drugs while in treatment, a change in treatment may be needed. Patients view intensification of counseling as an adverse consequence, so there we have a dilemma. As a physician, I may feel that positive urine drug screens indicate a need for more intensive treatment, but my patient doesn’t want that, and feels that I’m being punitive for insisting on more intense treatment.

That’s not unique to addiction medicine. In primary care, I often recommended patients participate in more intense treatment for a chronic disease. Sometimes they felt like I was making a fuss about nothing.

For example, I had a patient with extremely high blood pressure. He ran 220/130 on a regular basis, and refused hospitalization saying, “That’s normal for me. That’s just what my blood pressure runs.” OK, maybe that’s true, but it’s still dangerously high. When my patient refused to take a second medication for blood pressure, refused to get necessary lab tests done, and missed follow up appointments, I had to decide whether to continue to see him as a patient or dismiss him for non-compliance. He was a time bomb, at high risk for a stroke or heart attack. If I kept seeing him, maybe I could gradually convince him to take more blood pressure medicine. By continuing to prescribe blood pressure medication, I was doing something to reduce the possible harm to him. But if he had a large stroke and died under my care, am I partly liable because I kept seeing him despite his non-compliance?

I eventually decided I couldn’t keep seeing him since I was more worried about his health than he was. He did view my dismissal of him as a patient as punitive. I guess it was, in a way, yet I hoped he’d find a doctor better able to convince him to take care of his disease.

Drug testing should be therapeutic. This means that that the drug test should be used as a tool, but not a club. A positive test can serve as a starting point for a discussion about denial, motivation, and about the actual substances used. A positive test can become a starting point that leads to helping patients understand some of their triggers for use.

For example, when I talk to a patient about an unexpected drug test, I say something along the line of, “Tell me about the cocaine (or whatever drug).” I want my patient to talk through how the drug use occurred, especially about what was going on just before they decided to use the drug. Who were they with, what were they doing, what was their mood and attitude like, how was their stress level…all of these things can lead to helpful information. Often, before the actual drug use, there’s a sequence of events leading up to the use. I tell patients that relapses often contain valuable information they can use in the future, and since they didn’t die from the relapse, they should mine the experience for all data that can be helpful in the future.

This should be a collaborative process, assuming the patient sees the drug use as change-worthy behavior. If the patient sees no problem with using a drug, a completely different approach is needed, because you’re trying to sell a dog to someone who prefers cats.

ASAM’s document us that the intent of the test is to discover whether a substance has been used within a particular window of time.

That would seem obvious, but sometimes providers expect the test to tell them more than that, or less than that. For example, if a patient sample tells us whether a substance has been used over the past 4-5 days, it will not tell us if the patient is impaired or under the influence of that substance at one particular time over the past 4-5 days.

A test can’t give us information outside of the test’s expected window of detection. That should be obvious, but it bears repeating, because some providers can get confused.

For example, a non-medical acquaintance who claimed to be an expert in toxicology recently told me his organization planned to use hair testing for buprenorphine patients. That made no sense to me. The window of detection for hair is great for weeks to months, depending on the length of the hair sample, but it won’t tell me if my patient has used drugs over the past few days or week. That data won’t be part of the hair follicle record until more than a week from now. I would regard that as stale data, not as helpful to me clinically.

The ASAM document agrees, saying that hair drug testing is not appropriate for most addiction medicine treatment settings. Also, I would add that it’s costly, not timely, and possibly discriminatory, since dark hair concentrates drugs more than pale hair.

The ASAM document made a few points I had not considered. One would expect that any patient in treatment for substance use disorder would know what her urine drug screen would show. That’s not always the case. For example, with heroin, the person using the drug may have no idea that it’s been mixed with fentanyl, a much more powerful opioid that heroin. That’s a common practice now, since drug cartels have discovered it’s cheaper to make fentanyl than harvest opium and process it into heroin.

That’s some valuable information for a patient who thinks he’s using heroin. If fentanyl, a much more powerful opioid than heroin, is contained in the product he’s using, he may be more likely to do “tester” shots to avoid overdose.

I’ve had patients who use marijuana suddenly test positive for both THC and methamphetamine. Was the marijuana mixed with methamphetamine? If the patient knows for sure she hadn’t intentionally used methamphetamine, it must have been mixed with the marijuana, possibly to give the user a different effect. This gives this person information about the contents of the drug she’s buying, which can be useful information for her.

Of course, when patients use pharmaceutical-grade drugs like oxymorphone, oxycodone, and the like, users know what they are getting. Obviously that different with street drugs.

This guide about drug testing also reminds us that drug tests can help physicians decide if mental health symptoms can be due to mental illness or drug use. For example, patients who have used methamphetamine often have psychotic symptoms. They can be paranoid and have visual and auditory hallucinations.

In the past, when I’ve seen patients with these findings, I’m often relieved to find methamphetamine on their drug screens, because there’s a good chance the clinical signs are all drug-induced, and not a devastating mental disorder like schizophrenia.

These are only a few of the helpful, more big-picture ideas in the ASAM document. I’d like to encourage any physician or provider treating substance use disorder to get and read a copy of the document.

De-stigmatize the Doctors

 

 

 

 

As our opioid addiction epidemic rumbles on, carrying an avalanche of overdose deaths, people are asking why doctors who are authorized to prescribe buprenorphine are not doing so. Many of these physicians, interested enough to take an eight-hour course in how to prescribe buprenorphine in an office-based setting, don’t implement buprenorphine prescribing into their practices.

My last blog entry was about the obstacles identified by scientific studies as reasons why physicians don’t prescribing buprenorphine for their patients with opioid use disorders.

This blog entry is about my opinion, not about hard data. I think there are unspoken reasons why doctors don’t treat patients with this disease, the biggest being stigma.

Stigma keeps physicians from treating substance use disorders.

Starting in 1914, it was illegal for physicians to prescribe any opioid for the purpose of treating opioid addiction. Doctors went to jail for doing this. Since then, physicians have absorbed the same cultural messages as the rest of the U.S. population: addicts are bad, and doctors who want to treat addicts are probably unscrupulous. It’s difficult to reverse the attitudes of generations of physicians over a few years.

I don’t blame physicians for thinking that way, since I carried that same attitude, until I knew more about medication-assisted treatment for substance use disorders.

Most physicians don’t know about the proven, extensive benefits not only to patients but also to families and communities when addiction is treated. They must be educated, if treatment of substance use disorders is to become mainstream in primary care.

Physicians need to know that addiction medicine is now a recognized medical subspecialty, with a specialized body of knowledge, with specialized training and a board certification exam. Addiction medicine became recognized only last year, long after other specialties like allergy & immunology, preventive medicine, nuclear medicine, and genetics had recognition as specialties. I don’t point out those areas of medicine out to demean them, but to illustrate that substance use disorders affects many more patients and their families than these, yet it took many more years for recognition. I think the reason for the delay was stigma.

Physicians who want to work with patients with substance use disorders need to know they will be supported, not judged, for working in this field. At many conferences, we hear from experts from DHHS, SAMHSA, and CDC about how important it is to recruit good providers to treat patients with substance use disorders. This is helpful and encouraging, but it’s not enough.

I think it’s going to take public statements of support from state licensing boards and professional organizations for office-based treatment of opioid use disorder for physicians to be reassured that they aren’t doing something wrong or shady by treating opioid use disorders with buprenorphine.

Physicians must feel they won’t be under unfair scrutiny because they treat people with opioid use disorder.

Many physicians who might like to treat opioid use disorder with buprenorphine worry about being judged, and feel like they don’t need that kind of stress when there are so many perfectly “normal” patients with chronic disease that they can help. When I talk to them, some of them say things like, “I don’t need the extra hassle,” viewing this type of medical care as more trouble than it’s worth.

Doctors already feel a little wary. Mind you, not twenty years ago, doctors were scolded for under-treatment of pain. We were told to regard pain level as the “fifth vital sign.” We were told the risk of addition from being prescribed opioids for months to years was only about one percent. We were told by pain management experts that due to tolerance, high doses of opioids are often required, and are safe. Physicians were told they should believe what a patient said about their level of pain, and were told they had an obligation to get rid of pain.

Some of that was wrong, as it turns out. Now we know the risk of creating opioid use disorder from long-term prescribing of opioids is somewhere in the range of nine to forty-eight percent. We know that patients on higher doses of opioids are at higher risk for death.

Some doctors now find themselves reprimanded by their licensing boards for over-prescribing opioids. These doctors feel they’ve been prescribing in the exact manner recommended by the so-called pain management experts of fifteen to twenty years ago. Now they are told opioids should rarely be prescribed for chronic non-cancer pain, and that prescribing opioids at high doses isn’t good medical practice.

You can’t fault doctors for being a bit wary about any new attitude or practice that isn’t steeped in medical tradition.

You also can’t fault physicians for worrying about extra regulatory scrutiny when treating substance use disorder because there is some extra scrutiny for physicians who treat substance use disorders.

Yesterday I completed the latest form that I must submit yearly to register with my state’s department of health and human services in order to prescribe buprenorphine. I don’t think any physicians have to do that when prescribing opioids for any other disorder. Physicians with no “X” DEA number who prescribe buprenorphine “for pain,” with a wink and a nod, don’t have to submit this form.

Office-based providers of care for opioid addiction can be inspected by the DEA at any time, and we have to register with the national Department of Human Services every three years. I’m not saying this is wrong, but it is a level of scrutiny not required when physicians use controlled substances to treat other diseases.

Hassles don’t always take the form of licensing boards. Let’s not forget the phone calls from

hostile and uneducated pharmacists.

I respect pharmacists. Most are my allies, and most want to do the best thing for their patients. But I’ve received the nuttiest phone calls from pharmacists about buprenorphine prescriptions. Some pharmacists insisted I tell them exactly how long I planned to prescribe buprenorphine for a particular patient. Others say I have to put a diagnosis code on the prescription. Others won’t fill a half- day early.

My latest weird call was from a CVS pharmacist, who questioned whether my patient actually had opioid use disorder. She was worried the patient was lying to me, since the patient had never filled an opioid prescription before, per data on our state’s prescription monitoring program data.

I told the pharmacist that opioid use disorder can occur with opioids obtained from sources other than prescribed for the patient in question. Sometimes these patients use other people’s medication, or buy it on the black market. Then the pharmacist said she just had to make sure I wasn’t prescribing this buprenorphine product for pain. I said that since I used the “X” DEA number, that confirmed I was prescribing for opioid use disorder, and the “X” number was the only DEA number I wrote on this patient’s prescription.

Then the pharmacist told me I didn’t need to get an attitude with her, and that she was just trying to do her job…

I’m guilty of bad attitudes sometimes, but this wasn’t one of those times. I didn’t have a derisive tone, and was genuinely trying to educate her (so I wouldn’t get another phone call from her in the future asking these same questions). So I think she was the one with a bad attitude, towards me and my patient.

People who treat people with opioid use disorders with MAT sometimes need thick skins, much like the people with the actual disorder.

Dozens of times, when asked by another doctor what kind of medicine I practiced, I’d say “Addiction Medicine” and get a blank look. “What, you treat drug addicts?” would be the doubtful reply. Often the next question is something like, “So are you a real doctor, an M.D.?” and I have to assure them that I am.

One physician in my area tells our shared patients that I’m a legal drug dealer. I’d be tempted to discount one such report, but dozens tell me the same thing about the same doctor, so I tend to believe it’s true. Yet the few times we’ve met face-to-face, this physician says nothing to me. Sometimes I wish he would – it could open a dialogue. I have information he needs.

I’ve been judged very harshly by a few people in the 12-step community. I’ve had ex-patients, for whom I’ve prescribed methadone or buprenorphine, come up to me after they’ve entered 12-step recovery and tell me what an awful thing I did by treating them with medication. On a few occasions, those people returned to my practice to re-enter medication-assisted treatment. I do the right thing, and admit them, but it makes me feel twitchy.

Some physicians have ideas about what people with opioid use disorders are like, and worry they will bring a criminal element in their practice. In fact, recently, when I asked one doctor why he didn’t use his “X” number to treat patients with opioid use disorder, he answered that the first two patients he attempted to treat threatened his life, and he felt it was too dangerous.

I thought to myself that either this was the unluckiest doctor on the planet, or he had a terrible bedside manner. I’ve treated thousands of patients with opioid use disorders over the past fifteen years, and none have threatened my life. (I can’t say the same of my years in primary care. One soccer mom threatened bodily harm when I refused to prescribe a Z-pack for her viral respiratory infection of one day’s duration.)

I love my work because it is so rewarding. Patients actually get better, and some get better really quickly. It’s thrilling to be even a small part of their success. And they are nice people, nearly without exception. I wish I could show other physicians and providers how much fun working with people with substance use disorders can be.

Even considering the occasional hassle from pharmacists and other professionals, it’s worth it. Maybe I do have to fill out a few extra forms every year or so, and I need to be prepared for a DEA inspection at any time. Yet that’s a slight inconvenience when I see the progress my brave patients make.

Last week, a patient I’ve followed for years described his honeymoon to me. He found a well-paying job that he loves, met and married the woman of his dreams, and is working on starting a family. When I asked my usual question about his biggest source of stress, he said, “I don’t have stress. When I look back on how big a mess my life was six years ago, I have nothing at all to stress about now. I’m so blessed.”

That kind of thing makes my day.

 

Buprenorphine in the Primary Care Setting

 

 

 

 

 

I was asked to participate in a project to help primary care doctors provide buprenorphine in office-based settings. This grant, awarded to some very smart people at the University of North Carolina, uses the ECHO model to help physicians in the community become more comfortable with treating patients with opioid use disorder in their offices.

This ECHO model, originally conceptualized at the University of New Mexico, uses a hub-and-spoke model to connect experts at UNC and other locations with primary care doctors at their North Carolina locations. The ECHO model can help not only the physicians and physician extenders, but also nurses, social workers and other staff members who are a part of patients’ treatments, using teleconferencing.

Other hub-and-spoke models have placed physicians and the hub and patients at the spokes, so this is a little different. It’s also different from telemedicine, since the participants at the hub and spoke are all care providers, not providers and patients.

It’s a great program, and gives free continuing medical education hours to the physicians who participate, at the same time they get help with problematic situations in their practice.

Our group is prepared. We’ve done practice sessions and we’ve gotten comfortable with the technology (no small achievement for me!).

Now all we need are providers to participate.

We’ve had some interest, but of course would like to reach as many providers as possible. We had some brainstorming sessions about how to get more participants. We would like to reach primary care providers who have a waiver to prescribe buprenorphine, or who may be interested in prescribing.

As it turns out, many physicians who get the waiver to prescribe buprenorphine don’t end up prescribing, or only prescribe to a few patients. These providers could see more patients with opioid use disorder, and help our nation’s situation with the treatment gap.

This treatment gap is the number of people who need treatment compared to the number of people who are able to receive it. At present, experts estimate that only about 20% of people who need treatment for opioid use disorder actually get it. Of course, some of the remaining 80% aren’t yet interested in treatment, but many are desperate for help, and can’t access it.

Due to changes in the DATA 2000 law, physician extenders like nurse practitioners and physicians assistants will be allowed to prescribe buprenorphine to treat opioid use disorder, after they take a 24-hour course. Of course…many extenders in my area have been prescribing buprenorphine for years, off-label “for pain” with a wink and a nod, but the new law will allow them to be legitimate prescribers. This may expand the number of prescribers a great deal, and help to close the treatment gap.

So why do providers, after getting the training to be able to prescribe buprenorphine, not end up prescribing?

A study done by Walley et al., published in the Journal of Internal Medicine, 2008, surveyed all 356 physicians in Massachusetts who were waivered to prescribe buprenorphine. The study was done in 2005, so that was relatively early in the history of office-based treatment. Out of that total, 235 responded to the survey. Of the 235 that answered the survey, 66% had prescribed at least once, and 34% had never prescribed buprenorphine.

Of the non-prescribers, around half said they would prescribe if some barriers were removed. Nearly a third of these doctors felt like they had insufficient office support. Other barriers, in rank of descending importance, were insufficient nursing support, lack of institutional support, insufficient staff knowledge, low demand for services, and payment issues. So this study showed physicians didn’t feel like they had the support staff that they needed.

Of the physicians who were already prescribing buprenorphine in their office-based practices, the biggest barriers, in descending order of importance, were payment issues, insufficient nursing support, insufficient office support, insufficient institutional support, and pharmacy issues.

Some additional tidbits of data emerged from this study. For example, psychiatrists were less likely to prescribe buprenorphine than were primary care physicians, and physicians in solo practice were more likely to prescribe than those in group practices.

I suspect it’s easier to implement changes to medical practice when you are the boss and the lone provider. In groups of physicians, it’s probably harder to change the status quo to take on new projects and ideas, even when more support staff are presumably available.

This trend, where many of the physicians waivered to prescribe buprenorphine don’t end up prescribing, or prescribe for very few patients, has continued through the last fifteen years.

A study from 2014 by Hutchinson et al., published in the Annals of Family Medicine, looked at 120 physicians in Washington State who received training in 2010 and 2011, to prescribe buprenorphine for opioid use disorder. Out of the 120 providers trained, 92 participated in the post-training survey. Of those providers, some were excluded because they were still in their residencies, or were prescribing buprenorphine before they took the course, leaving 78 physicians newly qualified to receive a waiver to start prescribing buprenorphine for opioid use disorder

Of these 78 physicians, only 64% actually applied for the waiver. Of these 50 physicians, only 22 actually ended up treating at least one patient with buprenorphine. In other words, only about a fourth of physicians who could start prescribing to treat opioid use disorder actually did so. Of these 22 physicians, half prescribed for only three or fewer patients.

Physicians in a practice where there was already another physician prescribing buprenorphine were significantly more likely to actually start prescribing than physician in practices where no other physicians prescribed. Younger physicians were more likely to prescribe buprenorphine than older physicians. Fewer than half of these physicians were willing to have their names listed on SAMHSA’s buprenorphine treatment locator site. (http://buprenorphine.samhsa.gov)

Another study by DeFlavio et al., Rural Remote Health, 2015, was done with an anonymous survey of all of Vermont’s primary care doctors. As it turns out, 10% were buprenorphine prescribers, while 80% said they saw patients addicted to opioids. The barriers that these physicians saw for buprenorphine treatment were inadequately trained staff, insufficient time, insufficient office space, and cumbersome regulations.

Interestingly, Vermont also used a “hub and spoke” model, where experts at the hub stabilize patients newly starting buprenorphine, and after stabilization they transfer to the “spokes” which are primary care providers who continue the prescribing for these patients. This model seemed to work well for the patients and physicians who participated.

As of today, SAMHSA’s website (https://www.samhsa.gov/programs-campaigns/medication-assisted-treatment/physician-program-data accessed 6/6/17) says there are almost 38,000 physicians with waivers to prescribe buprenorphine from an office setting to treat opioid use disorder. Around 3200 have permission to treat up to 275 patients; nearly 9000 can treat up to 100 patients, and around 26,000 can treat up to thirty patients.

In other words, if all of these physicians were prescribing to their maximum, and were located in areas with the highest rates of opioid use disorder, we’d have enough manpower to treat all patients who wanted help.

But these providers aren’t at their maximum.

How can we convince these doctors to prescribe for more people? How can we recruit new providers, who will follow through with a commitment to treat people with opioid use disorder? How can we remove the barriers, which largely appear to fall under the category of insufficient support to give good care?

Some smart people have been working on this for some time, and we now have several models available to assist buprenorphine providers help patients with opioid use disorders.

“Collaborative Care Model,” also known as the Massachusetts model, uses nurse care managers to expand access to treatment. This model is based on how patients with other difficult chronic diseases are managed, such as diabetes and HIV infection. In other chronic illnesses, nurse care managers help the patient with day-to-day care management. This helps the physician know what is going on with the patient and gives the doctor much-needed support to manage the health of these patients.

Studies done on this model showed that patients did as well or better than patients managed only by physicians. This program expanded into community health centers, and the numbers of waivered physicians participating increased by 375%, though this was at a time when buprenorphine was first taking off anyway. The patients treated under this model also had significantly fewer hospital stays.

In this model, nurse managers were doing much of the medical management: doing inductions, doing follow-up on patients, and troubleshooting any problems the patients were having. Providers participating in the model mentioned that RNs can’t charge as much for the care they provide as physician extenders or physicians, so that’s a possible problem.

This year at the American Society of Addiction Medicine’s annual conference, Dr. Andrew Saxon spoke during a session which addressed how to engage practitioners to treat opioid use disorders. He treats patients in the Veterans Administration system, and describing an intriguing method that he called “academic detailing” that they use at the VA.

He said that pharmaceutical companies have already found a model that works, when it comes to getting doctors to prescribe new medications. These companies hire charming people to go to doctors’ offices to spend time talking with the physicians and physician extenders, explaining the new medication and giving them brochures with information.

Dr. Saxon started doing the same thing with VA doctors. Experienced providers make an appointment to speak with a doctor, and bring him or her information, perhaps bring lunch, and generally talk about the process and pleasures of treating opioid use disorders in an office setting. This one-on-one approach appears to work well, and the VA increased treatment availability a great deal using this approach.

The VA made a slick brochure, called “Opioid Use Disorder Provider Guide” which is a pretty good summary of information needed by providers starting to prescribe buprenorphine. Since it’s in the public domain, you can access this document at: https://www.pbm.va.gov/PBM/AcademicDetailingService/Documents/Opioid_Use_Disorder_Educational_Guide.pdf

I think this academic detailing idea is a winner. It makes sense – pharmaceutical companies wouldn’t have used this method for years if it didn’t work.

To veer off-topic for a moment…it strikes me that I’ve been trying to “detail” local providers for five years, not to get them to prescribe, but just to get them to stop telling patients to get off buprenorphine and methadone. It would be a huge relief if local doctors encouraged these patients, rather than belittling them.

I exaggerate, of course. There are many physicians in my area who are great to work with, but I guess the more difficult doctors tend to stand out in my mind.

Maybe local doctors need detailing from a physician with credentials and/or clout. Perhaps I lack the credibility or personal charisma that makes other doctors listen to me. I’d like to enlist that kind of doctor to “detail” in my area.

Back to the topic at hand.

The VA isn’t the only agency that’s created guidelines.

The American Society of Addiction Medicine (ASAM) has had a similar document, composed by experts as a guide for prescribers: https://www.asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf

There’s also information published by SAMSHA (Substance Abuse and Mental Health Services Administration):

https://store.samhsa.gov/product/Medication-Assisted-Treatment-of-Opioid-Use-Disorder-Pocket-Guide/SMA16-4892PG

However, the last time I tried to download this one, there seemed to be a glitch.

So there’s plenty of information available for new prescribers, and there’s a nationwide support network called PCSS MAT, for Providers’ Clinical Support System. It’s an organization dedicated to training and mentoring medical providers in the treatment of opioid use disorders with medication-assisted therapies.

If you go to their website, (http://pcssmat.org/) you can access archived trainings about various topics relating to MAT. They have online modules, podcasts, and basic information. It’s possible to be connected with a one-on-one mentor with experience treating the disease. This helps the provider feel connected and supported, particularly with difficult issues that often arise.

So currently, there’s a ton of data and support for providers who want to treat patients with opioid use disorders, more than there’s ever been before.

With our ECHO UNC launch, providers can get specific recommendations for managing complex patients (with patient privacy protected, of course). Their staff can learn how to support the prescriber, and it’s all free, paid for under grant money. The prescriber can even earn continuing education credit hours, so it’s a win-win-win prospect for them.

I’ll keep my readers updated about how it’s going.

If you are a provider or know a provider who’d like to take advantage of this opportunity to learn, get help with issues that are vexing you, and get free credit hours for doing so, send me an email so I can connect you with the ECHO UNC hub. The technology is free and easy to use.

ASAM Conference

 

Twenty-one hundred people registered to come to this meeting, the biggest yearly event of the American Society of Addiction Medicine. In the vast grand ballroom, row after row of chairs, in section after section, are occupied with medical professionals eager to learn more about their chosen field. Leaders in the field are scheduled to speak.

On this first morning, distinguished and learned people are ready to speak.

But first…a poet spoke to us.

Joseph Greene is a spoken word artist. I didn’t know what that was until he started, but then I discovered I liked it.

He performed his poetry. First, he reminded us to shed our cynicism and pessimism, symptoms of burnout. He reminded us to remember the people we have already helped, and to allow their energy to revitalizes us. Right away, I felt a wave of enthusiasm.

I admired the positivity his poetry evoked in his audience. We are not so easily moved, we doctors who toil on the front lines in the war on the people who use drugs. We can become cynical, and he moved us out of our pessimistic ruts.

The plenary speakers who came after him presented information and had mixed news.

Patrice Harris, MD, MA, Chair of the American Medical Association Board of Trustees, gave us alarming updated information: ninety-one people die from opioid overdose each day in the U.S., according to data from 2015, the last year for which we have data. That’s up from seventy-eight opioid overdose deaths per day in the previous year. That’s depressing news, especially since the amount of opioids prescribed in this country has been dropping since 2014, a little before the American Medical Society’s call to action. From 2013 to 2015, the total amount of opioids prescribed dropped by about 10%.

Mortality grew despite many more physicians signed up to use their states’ prescription monitoring programs, pushes to prescribe more naloxone to reverse overdoses, more medication drop-off so controlled substances don’t fall into unintended hands, and a push to increase treatment availability.

Despite an eighty-one percent increase in physicians trained to prescribe medication-assisted therapies in the years 2012 to 2016, still only twenty percent of U.S. citizens with opioid use disorder got treatment.

Dr. Barbara Mason, PhD, winner of the R. Brinkley Smithers Distinguished Scientist award, spoke next. She reminded us that despite all the attention paid to opioid use disorder, alcohol still causes many more deaths per year. In the U.S., about eighty-eight thousand deaths per year are attributable to alcohol. Alcohol is the fourth leading cause of preventable death in the U.S. Dr. Mason gave us information about new studies on medications which may be approved for use in alcohol use disorder treatment.

At present, we have only three medications approved by the FDA: disulfiram (Antabuse, acamprosate (Campral), and naltrexone (Revia, Vivitrol). Only around ten percent of people with alcohol use disorders are prescribed any of these three medications.

Next we heard from Vivek Murthy, MD, MBA, Surgeon General of the U.S. He planned to talk to us in person but due to airplane delays, had to join us via internet. We also had plenary sessions with talks from George Koob, PhD, Director of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), and from Wilson Compton, MD, MPE, Deputy Director of the National Institute on Drug Abuse (NIDA).

All of the speakers were good, and most of them were great.

I’ve learned much, socialized a little, ate some great food, and relaxed.

Being around this many people who are all excited about helping people with substance use disorders change their lives is exhilarating. Even better than the data I learned is the enthusiasm I’ve re-discovered.

Thank you, American Society of Addiction Medicine, for another great conference!

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/