Novel Idea for Buprenorphine Access

 

 

 

 

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

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

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

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

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

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

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

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

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

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

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

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

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

What do I think of this idea?

I like it.

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

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

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

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

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

Sheesh.

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

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

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

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

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Book Review: Out of the Wreck I Rise: A Literary Companion to Recovery

 

 

This book, written and edited by Neil Steinberg and Sara Bader and published by the University of Chicago Press in 2016, will appeal to intellectual and thoughtful people in recovery.

The book is a compilation of writings from famous and non-famous people throughout history regarding aspects of substance use disorder and recovery from this disorder. It’s an impressive effort. The book is composed of essays, statements, prose or poetry relating to the topic of each chapter.

The book is organized by sections. It’s easy to miss the topic of each chapter unless you read the lead-in writings by the authors at the beginning of each chapter. For example, I started one chapter in the middle, and was unsure of the topic until I started at the beginning of the chapter and found it was about going to Alcoholics Anonymous.

The nine chapters cover the topics of drug use and the negative experiences that lead people to recovery. Chapters cover the experience of early recovery, maintenance of recovery, and 12-step meetings. The last chapters cover the experience of the family and friends of people with substance use disorders, the possibility of relapse, and the blessings of a rich life in recovery.

Some of the cited excerpts are tangentially related to drinking, drug use, and recovery. For around ten percent of the book, I have a hard time seeing how it’s relevant to the topic. But then, over the years my scientific brain has become stronger than my poetic brain, so it could be me and my limited, linear thinking. And that’s a benefit of the book – it got me thinking just a little more outside the box about substance use disorders and things related.

For example, there are three excerpts from Khaled Hosseini’s The Kite Runner, a book that is not about substance use disorders at all, unless I very much misread that whole book too. The excerpts are lyrical, and I appreciate them…but they are not about addiction or recovery. This compares to the same number of entries, three, from William Burroughs, who wrote exclusively about substance use disorders.

Surprises lurk in this book; would you have expected to read something from Dickens’ A Christmas Carol in such a book? Would you have expected only three excerpts from Keith Richards? No to both.

Yet as extensive as it is, there are obvious quotes that the authors neglected. What about Lenny Bruce’s famous quote about using intravenous opioids: “I’ll die young, but it’s like kissing God.” What about Drew Gates: “Heroin gave me wings but took away the sky.”? There’s nothing from Augusten Burroughs, one of my favorite authors, (“I myself am made entirely of flaws, stitched together with good intentions.”) and only one entry from the Big Book of Alcoholics Anonymous.

So, while I enjoyed this book, I did find it to be uneven in its selections for inclusions.

This isn’t a book you’ll sit down and read through. It’s a book to be picked through, read in sections and pondered. It’s great for the ADD readers like me, who tend to read several books at once because I need different books like different foods. Sometimes I want meat, sometimes a good carbohydrate, and often a light and fluffy dessert.

This book is a sophisticated French dish that’s tasty but rich.

Here are a few of my favorites that I had not read before: “How many people thought you’d never change? But here you have. It’s beautiful. It’s strange.” From Kate Light in “There Comes the Strangest Moment,” a poem from her book Open Slowly. I think I will have to read this book of hers.

Most of the quotes I’d never heard before, and I consider myself very well-read on this topic. Many quotes are from very old writing, from Seneca or Ovid, for example, but the quotes still hold up over time. The age of the quotes gives more perspective about how this illness isn’t new, and substance use disorders have been with use since man has been alive.

This book is well-annotated, with extensive source notes, a list of permissions, and an index, making it easy to find a reading.

Maybe I lack appreciation for the poetry of this body of work. I would give the book a solid 4 stars – interesting and appealing to most people interested in substance use disorders and recovery from substance use disorders.

I suspect this book will be most appetizing to people in recovery who are avid readers, no only because readers like books, but because this anthology points towards other authors and other books that might interest us. With the tidbits in this book we are pointed toward potential feasts with other authors who understand the peculiarities of addiction and recovery from addictions of all sorts.

I know I now have a list of other books I’d like to read. Some are old and some new; some may be out of print and others will be at my local library. I’m thankful to the authors of “Out of the Wreck I Rise” for pointing me towards these resources for the soul.

And I’d like to offer my readers my very favorite quote, not found in any books but uttered by a stranger at a 12-step meeting: “If I could drink like normal people, I’d do it all the time.”

That’s the dilemma, perfectly.

Where Did All the Pills Go?

On the left, number of pills per capita by county
On the right, opioid overdose death rates by county

 

The Washington Post has written some amazing stories this month about our present opioid epidemic. One of their articles described how they accessed data about the distribution of all the prescription opioid pills manufactured and consumed in the U.S. https://www.washingtonpost.com/graphics/2019/investigations/dea-pain-pill-database/?utm_term=.f9fb5fdb26b7

This data is amazing. There’s a box where you can enter your state or county and learn how many pain pills were sold, how many that averages per person, and which pharmacy sold the most.

For my state of North Carolina, around 2.5 billion pills were sold from 2006 until 2012. Most of these pills were distributed by Cardinal Health. Omnicare Pharmacy of Hickory, NC sold the most pills of any pharmacy, at over 9 million pills.

In my county, 26 million pills were prescribed from 2006 until 2012, enough for 55 pills per person. SpecGx pharmaceutical company manufactured the most pills sold in our county. (They make Roxicodone, called “roxies” by the patients I admit to treatment.)

The data, while interesting, needs to be interpreted with caution. For example, we could jump to the conclusion that Omnicare Pharmacy of Hickory, NC, which sold more pain pills than any other pharmacy in NC, is doing something wrong or inappropriate. But this pharmacy doesn’t sell directly to the public. It supplies opioid pain medications to assisted and skilled nursing facilities. This means the pharmacy may supply pain pill to facilities where patients stay to recuperate after orthopedic surgeries, for example. For such patients, opioid pain pills may be not only appropriate but necessary. The data is also seven years old, but that’s the way data is obtained; it takes time to collect and process information.

But the data gives overall trends and shows the staggering numbers of opioid pain pills consumed by residents of certain areas.

The Washington Post website also published two maps: one shows the number of opioid pills sold, and the other shows opioid deaths by county. The overlap, though not absolute, is striking.

The Washington Post’s recent articles contain valuable information for us, if we chose to learn from them and act on them. To me, they have given us maps of where to concentrate opioid use disorder treatment programs. Unfortunately, some of the most severely affected counties are rural, with few providers who know how to treat opioid use disorder. We’ve got to continue to focus resources on these areas.

The Washington Post also published an article about which pharmaceutical companies made the most opioid pills, which corporations distributed the most prescription opioid pills, and which pharmacy chains sold the most pills. Right now, lawsuits are proceeding against all these participants in the opioid epidemic.

The biggest manufacturers include Janssen Pharmaceutical, Purdue Pharma, Endo Health Solutions, Teva Pharmaceuticals, Allergan, and Mallinckrodt. Some of the biggest distributors were AmerisourceBergen, Cardinal Health, and McKesson Corp. The biggest pharmacy chains are CVS, Rite Aid Corp., Walgreen’s, and Walmart Inc.

The lawsuits against these companies allege that they should have notified the DEA of suspicious orders for large amounts of opioids, and that they violated the Controlled Substances Act by failing to report. Some lawsuits against pharmacies allege the pharmacies had to know that medications were being diverted to the street.

Other than that, I’m not sure I understand the basis of these lawsuits.

For sure, if a company mislead physicians in its marketing, as many people feel that Purdue Pharma did, I understand that as a crime.

But I don’t know enough about what manufacturers and distributors and pharmacies are supposed to do when supplying opioids. This must be driven by physicians’ prescriptions, I would think. I doubt drug companies would manufacture opioids unless there was a demand, or that distributors would distribute and pharmacies would sell, unless there are legitimate physicians’ prescriptions.

I don’t understand how we can expect manufacturers, distributors and pharmacies to know more about good prescribing than physicians should. And physicians surely did underestimate the dangers of these medications, thanks in part to the so-called experts, who downplayed the risks of long-term opioid prescribing for chronic pain. Also, the “under-treatment of pain” movement accused doctors of being callous to suffering and encouraged them to view pain as the “fifth vital sign.”

At any rate, Washington Posts’ series of articles bring some facets of the opioid epidemic to light.

 

 

 

Pharmaceutical Companies Still Behaving Badly

 

 

 

 

Reckitt Benckiser, the drug company that used to make the brands Suboxone and Subutex forms of buprenorphine, is now owned by a company named Indivior. Earlier this month, the company was fined a whopping $1.4 billion for fraudulent marketing of their brand Suboxone.

To put this in perspective, Purdue Pharma paid $600 million in 2007 for criminally misleading marketing of the drug OxyContin.

The suit against Indivior claimed that Reckitt Benckiser made false claims to physicians, saying their Suboxone film was safer and better than competitor’s tablet versions of the medication buprenorphine, and the risk of pediatric exposure was lower with the film than the tablet.

I blogged about this issue in May of 2012, saying that I thought the RB drug representatives were pressuring me to prescribe the films, and I felt their arguments lacked credibility. Here’s that blog post from seven years ago:

 

Pharmaceutical Companies Behaving Badly

I’ve been relatively supportive of the Reckitt-Benckiser pharmaceutical company until now. I’m impressed this drug company was willing to market a medication to treat opioid addiction. Other companies may not have wanted the stigma of producing a medication to treat addicts, and Reckitt has done a great many beneficial things for opioids addicts. In the past they sponsored eight-hour training sessions that doctors needed to get the special license to prescribe Suboxone/Subutex. They have a patient-assistance program that can help up to two patients out of a hundred get free medication, which a generous program. And their target patient population often lacks both money and insurance to pay for treatment.

But now they are starting to irritate me. At the ASAM conference last month, I heard doctors say how the Suboxone drug reps are starting to pressure them in to prescribing only the name-brand Suboxone film. I’ve encountered similar pressure, and it makes me cranky.

I know the score. Reckitt’s patent on the Suboxone and Subutex tablets has run out, and there are a few Subutex-equivalents now on the market, selling for about half the cost of the name-brand. Reckitt waited until both tablet’s patents were ready to expire to release the film, because the film will be protected under patent for years to come. From a business point of view, all that makes good sense. And of course, now Reckitt wants doctors to switch to the new and improved film.

But if the drug company salesperson starts telling me how harmful Suboxone tablets are to get me to switch patients to the film…they will lose credibility. Am I to believe the same medication, Suboxone tablets, which you were pushing so hard two years ago now is dangerous and must be replaced by films?? No. If the company believed this, why did they release the tablets in the first place? And why wait until the tablet patent expires to release their new “safer” form?

I like the Reckitt-Benckiser drug rep who comes to my office. Let’s call her Mary. Mary is intelligent and personable, as drug reps tend to be. She’s been helpful, and listened to my concerns about the film when patients reported it was flaking and crumbling, a problem that does seem to have resolved

But now, she’s annoying me. She goes into her company’s song and dance and I can’t help needling her. Here’s a reproduction of a portion of one of our latest conversations as I remember it.

“Doctor, are you at all concerned about the pediatric overdoses with the tablets?” Mary said.

“No I don’t often prescribe them to toddlers.”

Mary’s eyes get a little wide until I start to laugh.

“I’m not sure the films are safer than the tablets when it comes to pediatric overdoses.” I say. “I think it’s all about making sure the patient knows how to store them safely. I had a comment to my blog say the films were harder to keep track of than the tablets.”

“There have been pediatric overdose deaths with the tablets and none so far with the film.” Mary tells me in what I hear as a slightly accusatory tone.

“And the tablets have been on the market longer.” I counter, just to be contrary. I do think the films are less likely to cause accidental overdoses, because those packages are so hard to get open.

“And don’t you think the tablets are a relapse trigger? Nearly all patients had been addicted to opioid tablets and using them to get high. Now if you prescribe a tablet to treat the addiction…the sound of pills rattling in a bottle is a trigger for many addicts. If the patient has snorted pills, they may misuse the tablets and crush them into a powder to snort.”

What gall, I thought. “Mary, why didn’t you tell me all of this two years ago when you were encouraging me to prescribe more Suboxone tablets? Why didn’t you tell me then I was triggering my patients to snort pills and endangering their children?” She and I both know she was touting the healing properties of Suboxone tablets two years ago, right up until the film was released onto the market in the fall on 2010.

Mary was silent for a long moment, apparently at a loss for words. This is a rare thing to see in a drug rep. finally, she said with a laugh, “It’s hard to try to sell against yourself.”

The drug company says the film is less divertible than the tablets because of the unique ten-digit number on each pouch. This number can be traced back to the patient for whom it was prescribed. If a patient sells his medication and it’s eventually confiscated by police, the authorities can tell who it came from. Plus, if the doctor wants to do a film count, the patient won’t have the correct numbers on the foil pouches if he’s sold them. All of that’s true but doesn’t give the average addict/dealer much credit for intelligence. It’s likely the person wishing to sell Suboxone films would just open the pouch and remove the film, saving the pouch in case it’s needed later. The numbering of the pouches is a good idea, and according to some information I heard at the ASAM conference, it probably is a little less likely to be diverted. But pill and film counts don’t work unless doctors do them.

As far as the “snortability” of a tablet, I don’t know. I’ve been surprised by the number of blog commenters who snort their Suboxone tablets, so there’s some validity to the argument that the tablets are snortable and the films not snortable. But then I have had commenters say the film is easier to inject, so what do I make of that?

I must cautiously evaluate each patient. I have patients that I am certain would never even think of selling their prescription. I have had patients I think could possibly be selling. I’ve done pill counts on them and for the most part was pleasantly surprised their count was correct. Then I’ve had patients fail pill counts, and I will no longer prescribe for them.

Risks of medications must be balanced. I do agree the film is somewhat better because it dissolves faster, and early reports show it’s less desirable on the black market than the tablets are. But for some patients, that name brand is unaffordable. If they have no insurance and will have to drop out of treatment unless a cheaper alternative can be found, I feel it’s OK to use the generic tablets. I take more precautions with those patients and check their arms for track marks at office visits. I do more frequent pill counts. I do frequent urine drug screens. I don’t use generic buprenorphine in patients with a history of IV drug use.

Addiction treatment is expensive. If I can use caution and prescribe the generic to save a previously stable patient from dropping out of treatment because of the cost, I may do it, if the patient agrees to the above safeguards.

 

So now the chickens are coming home to roost in Indivior/Reckitt Benckiser’s coop…

I read the court document filed by prosecutors of the U.S. District Court in the Western District of Virginia (https://www.justice.gov/opa/press-release/file/1153066/download ). It’s an interesting read.

In this document filed in Abingdon, Virginia, the government says Indivior deceived health care providers and healthcare programs by saying that the film was safer and less susceptible to diversion. The document also says the drug company established a telephone program for patients to be connected to physicians who, in some cases, they knew were prescribing their product in a careless manner. The drug company also trained their representatives to tell providers that the films carried a lower risk of child exposure, despite a lack of evidence for that claim. In fact, some authorities at the FDA worried the films might be more dangerous and difficult to remove from a child’s mouth than a tablet, because they dissolve more quickly

In the end, Indivior/Reckitt Benckiser agreed to a negotiated fine of $1.4 billion, but admitted no wrongdoing, stating they had “acted lawfully at all times and expressly denies all allegations that it engaged in any wrongful conduct.” Thus far, it’s the biggest fine paid by a drug company related to the opioid epidemic.

As for me, I haven’t seen an Indivior/Reckitt Benckiser drug representative since 2012. After I posted the blog above, the RB representative for my area saw me one more time. She told me she was disappointed I had chosen to blog about our interaction in a public forum.

I hate I offended her, because she was a nice lady, but I think time has proven my criticisms about RB’s behavior to be well-founded.

Opioid Use Disorder: Then and Now

 

 

 

 

I started working at an opioid treatment program in 2001, by accident. It’s a long story that I’ve told elsewhere, but once I saw data about the improvements for patients who start medications to treat opioid use disorder, I knew this was the field for me.

After a few weeks working in an opioid treatment program (OTP), I could help patients make huge and productive changes to their lives. Prescribing medications to treat opioid use disorder can have tremendous impact on the lives of people with this illness. Medications like methadone and buprenorphine reduce the risk of dying from an overdose at least three-fold, according to a recent study. [1] Methadone and buprenorphine used for opioid use disorders are also associated with improvements in physical and mental health, reduced risk of suicide, improvement in employment status, reduction in criminal activities, and increased life satisfaction for patients.

I started as a physician at a not-for-profit program in a southern city. I saw mostly patients using heroin, but also pain pills. We had patients drive from hours from more rural areas, and eventually this program expanded into seven additional programs, mostly located in the western part of the state.

By 2004, on Wednesdays I worked at a town of around 40,000 people. I saw patients who drove an hour or more for help. Some patients drove several hours from Tennessee. At this time, methadone was the only medication this OTP used. DATA 2000 had passed, and a few Suboxone providers prescribed in cities, but buprenorphine products weren’t widely available in smaller towns and rural areas.

Wednesdays were busy. We had dozens of people show up seeking admission, but because I was the only physician, I asked that we admit no more than 20 people per day. My requests were not honored, and I worked many long days, admitting up to 25 to 30 people on these days.

These were complicated patients, and it took time to unravel their medical, psychiatric, and drug use histories. We had limited staff, who already had more than fifty patients on their caseload. This exceeded state limits on the number of patients assigned per counselor and kept us under scrutiny by state authorities. It felt like the wild west.

I knew it wasn’t safe to admit so many people, but what was the alternative? There were no other opioid treatment programs around. That small city had one or two inpatient detoxification units, but as we know, the relapse rate is very high, as is the overdose death risk, for patients leaving these five -to -seven-day programs. Inpatient residential programs were difficult to access and weren’t acceptable to most patients anyway. If these patients didn’t get help with us, they probably couldn’t get any help. So, I worked long hours and did my best.

I felt a continued tension between trying to get people into treatment and taking good care of them once they were in treatment.

These people did not get the attention they deserved, but I’m comforted by data from “low threshold” methadone programs. These are programs that don’t require that patients participate in counseling services, and that don’t dismiss patients for positive drug screens. Data shows that patients entered in these programs do relatively well, despite receiving treatment that lacks the usual counseling requirements. [2]

That Wednesday waiting room was packed with urgency and misery. Imagine twenty or thirty people, in various stages of opioid withdrawal, impatient to see the doctor and get a dose of methadone that will help ease their suffering. I hated making people wait, but had to spend enough time with each of these complicated patients. Hiring additional physicians or physician extenders would have helped, but this program had a hard time keeping providers.

Almost all these patients were using OxyContin brand of pain pills. Patients described how easy it was to file off the time-release coating from “oxys,” as they were called, freeing the entire 20mg, 40mg, 80mg, (and for a time, 160mg) pill to be used at once. Most patients crushed the pill and either snorted it or injected it. Apparently, it easily dissolved in water, making it easy to shoot.

That’s a lot of opioid firepower to release all at once, and misused OxyContin killed many people. Sometimes people, not aware of how harmful this medication could be, thought that since it was prescription medication, it couldn’t hurt them.

Patients couldn’t be expected to know what their doctors didn’t even know. OxyContin was prescribed freely in most communities at this time. Some of it was prescribed by pain management physicians, but mostly it was prescribed by small-town physicians with little training in pain management. These physicians had been told by the so-called pain management experts that the risk of developing addiction was low, less than 1%. How wrong they were…

Our opioid treatment program never advertised services. We didn’t need to. Patients showed up because they were referred by friends or relatives. We had whole families in treatment. We might admit a husband and wife one week, only to admit their adult children the next week, plus cousins, an uncle, or a grandparent. Sometimes we would have three generations of a family in treatment.

Whole neighborhoods seemed to come for help. Addiction appeared to be part of the social fabric of the region, binding people together like a fondness for playing cards or baseball.

I remember in 2004, I admitted so many people from Gray, Tennessee, that I asked the rhetorical question, “What is going on in Gray, Tennessee? It looks like everyone in that town must have opioid use disorder.” As it turns out, the first opioid treatment program in Eastern Tennessee was opened in Gray, Tennessee…in 2017.

Benzodiazepines were freely prescribed back then, and we had patients overdose and die while on methadone. I struggled then, as now, trying to decide if a patient using benzodiazepines heavily can safely be admitted to treatmen. Current recommendations say we shouldn’t limit access to methadone and buprenorphine for patients with co-occurring benzodiazepine use disorder, but I’ve had such patients die, and remain wary. Each patient’s risk must be carefully assessed. If patients have taken benzodiazepines regularly for years, a taper could take weeks or months, and sometimes can be done in an outpatient setting, while the patient is getting treatment with medications for opioid use disorder. Other patients can’t control their use of benzodiazepines in an outpatient setting and must be admitted to an inpatient medical detox unit. They must be monitored carefully while reducing or stopping benzodiazepines. Patients can have seizures during withdrawal, just like patients withdrawing from alcohol

Back in 2004, we didn’t have a prescription monitoring program in North Carolina. Our program didn’t become functional until 2007. By then, I was medical director for this program that had around 3100 patients scattered over their eight opioid treatment programs. In December of 2007, when I got authorized to use our PMP, I spent most nights and weekends looking at patients on the system. In the end, around twenty-three percent of all our patients were filling another major controlled substance. Those medications varied from methadone, OxyContin, Xanax, and clonazepam.

I was asked to submit a narrative of my experience to Brandeis’ Center of Excellence. This narrative was later sent to OTP prescribers in a SAMHSA “Dear Colleague” letter and can be read here: https://www.pdmpassist.org/pdf/Resources/methadone_treatment_nff_%203_2_11.pdf

Once we could see what other medications patients were taking, our overdose death rates came down rapidly. I will always believe PMPs are life-saving.

Now I check all entering patients on our state’s prescription monitoring program and check all established patients once per quarter. I don’t get very many surprises these days on the PMP.

Compared to 2004, patients have more options for treatment for opioid use disorders. Still, financial barriers are considerable, especially in office-based setting prescribing buprenorphine products, and far too few people who need treatment can get it.

Many more OTPs in this state now take Medicaid, helping more patients get treatment. We also have grant programs for patients with no Medicaid or other insurance, funded through the CURES program in the past, and now by the state opioid response grants. Most new patients can get started in treatment even if they have no money, thanks to these grants.

Our OTP was lucky to be asked to participate in a MAT PDOA grant. I forget what the initials stands for, but this grant pays for treatment for patients on probation or parole who have opioid use disorder. This grant, which lasted three years, is ending soon, and we’ve treated hundreds of patients with it. For many, it was their first treatment experience. Some did very well, and some not so well, but the recovery seed has been planted. Some patients need a few tries at treatment before they get traction into recovery.

In the OTP where I work now, I have tons more contact with established patients and know them much better than I did at the OTP where I worked in 2004. There’s still much room for improvement, but today I do more than just admit patients. I also have time to talk with the staff, which I think helps all of us understand our patients better and provide better care.

Now, almost no patient mentions the brand name OxyContin. Some patients are using oxycodone, but not one brand. There’s still some Opana use, and certainly heroin is used by many entering patients. Some patients come for help because they prefer using illicit buprenorphine over heroin or other opioids, because buprenorphine can keep them out of withdrawal for a day or longer. Instead of paying $30 for one 8-milligram tablet on the street, they come to treatment programs to get cheaper, legal help. Most, though not all, patients are also happy they receive counseling.

I’ve change since 2004. I’m much more tolerant of continued drug use by patients. I cringe to remember that in the past, I tapered patients off medications to treat opioid use disorder because they wouldn’t stop using marijuana. I don’t do that now. I tell patients that though I’m not happy about their use of an illicit (in my state) drug, it’s not a deal-breaker for treatment. I still stress over patients’ use of benzodiazepines and alcohol, especially if they are on methadone.

Things change quickly in this field, and our OTP may look very different in the future than it does now. I pray that we continue to improve the quality of care for our patients and continue to reach ever more of the people who need help. I love my job, and after eighteen years, still believe I can do more to help people in one day at my OTP than I did in a week doing primary care.

1. Sordo et al., “Mortality risk during and after opioid substitution treatment: systematic review and meta-analysis of cohort studies,” British Medical Journal, 2017.
2. Christie et al., 2013

Driving on Methadone

 

 

 

 

“How can you let those people get behind the wheel and drive after you shoot ‘em up with methadone?”

This question, frequently asked by law enforcement and other people, reveals key misunderstandings about the pharmacology of methadone. That’s OK; I don’t expect laypeople to know methadone pharmacologic principles. Oh, and we don’t “shoot them up.” We give them controlled oral doses of methadone measured to the nearest milligram of liquid, and observe our patients consume this medication on site.

While laypeople may not have a reason to understand medication-assisted treatment, I think it’s essential for law enforcement officers to understand. They need to know why our patients are not impaired when they leave our parking lots after dosing.

When patients on methadone (or buprenorphine) are dosing every day, they have a tolerance to the drowsiness that opioids cause opioid-naïve people. Our patients, assuming they have reached a stable dose and aren’t using any other drugs, have blood levels of medication that don’t fluctuate much through the day. Because methadone is such a long-acting medication, the blood level doesn’t even reach its peak until around three hours after dosing.

Because of the frequent misunderstandings and assumptions of law enforcement personnel, I’ve composed a sample letter that opioid treatment programs may forward to the law enforcement officer of their choice.

Dear Officer Zealous:

First of all, thank you for patrolling our streets and highways and for your efforts to keep them safe. I know you have a difficult job and I deeply appreciate your willingness to take on this responsibility.

However, please stop arresting my patients for whom I’ve prescribed methadone and buprenorphine (better known under the brand names Suboxone, Subutex, or Zubsolv). You mistakenly think all people taking these medications have no right to be driving, and you are wrong. I’m writing this letter to give you better information, so you can do your job more efficiently.

Our nation is in the middle of a crisis. Opioid use disorder is an epidemic, and too often its sufferers die of overdoses. Treatment of this disease with methadone and buprenorphine works very well to prevent overdose deaths, and it’s been proven to help patients have a better quality of life in recovery.

I doubt you’ve been provided any information about this type of treatment, so I want to offer data to you.

Methadone has been around for fifty years and has a proven track record. It’s been studied more than perhaps any other medication, and we know it does a great job of treating opioid use disorder. Buprenorphine has only been available in the U.S. for about 17 years, but has been used in Europe for decades with success.

With both methadone and buprenorphine, the proper dose of medication should make the patients feel normal. Patients should not feel intoxicated or high, and should not feel withdrawal symptoms as the day wears on. Methadone and buprenorphine are both very long-acting opioids, and can be dosed once per day. They both can provide our patients with a relatively steady level of medication, compared to short-acting opioids usually used for intoxication. Therefore, using methadone to treat opioid addiction is not “like giving whiskey to an alcoholic,” as has incorrectly been asserted. The valid difference lies in the unique pharmacology of methadone. Opioid addicts can lead normal lives on this medication, when it is properly dosed.

In addition, both of these medications block other opioids at the opioid receptor. When a patient is on an adequate dose of methadone or buprenorphine, if she relapses and uses an illicit opioid, the medication blocks the effects of the illicit opioid. The patient feels no euphoria, which reduces the urge to use illicit opioids in the future. Both methadone and buprenorphine work in this way to deter use of other opioids for the purpose of getting high.

Treatment of opioid addiction with methadone and buprenorphine is endorsed by the CSAT (Center for Substance Abuse Treatment) branch of SAMHSA, by the U.S.’s Institute of Medicine, by ASAM (American Society of Addiction Medicine), by AAAP (American Association of Addiction Psychiatry), and by NIDA (National Institute of Drug Addiction. In study after study, methadone has been shown to reduce the risk of overdose death, reduce days spent in criminal activities, reduce transmission rates of HIV, reduce the use of illicit opioids, reduce the use of other illicit drugs, produce higher rates of employment, reduce commercial sex work, and reduce needle sharing. Medication-assisted therapy is also high cost effective.

Indeed, the current debate of government officials at the highest levels has been how best to expand medication-assisted treatment with methadone and buprenorphine, not to make it less available. So please don’t do anything which may discourage opioid addicts from receiving life-saving treatment.

Over the years, many studies have been done on methadone and buprenorphine to see if patients are able to drive safely on either of them. In study after study, data show patients on stable doses of both medications can safely drive cars, operate heavy equipment, and perform complex tasks. Please see the list of references at the bottom of this letter if you wish to investigate for yourself.

I’m not saying, however, that patients on methadone or buprenorphine can’t become impaired. Impairment can occur if patients are given too high a dose of methadone or buprenorphine, which most often occurs during the first two weeks of treatment. For that reason, patients are warned not to drive if they ever feel sedated or drowsy.

Patients on medication-assisted treatment can also become impaired if they mix other drugs or medications with their methadone or buprenorphine. In fact, benzodiazepines (like Xanax, Valium, Klonopin) and alcohol act synergistically with maintenance opioids. They can cause impairment with smaller amounts of alcohol or benzos than expected. And of course, patients can still become impaired with other drugs, such as marijuana.

As you probably know, a urine drug screen won’t detect impairment. The urine screen only tells you if a person has taken a given drug or medication over the last few days to weeks. Drugs are detectable in the urine long after the impairing effect wears off.

You can do blood tests, but these aren’t useful for patients on methadone. The dose required to stabilize one of my patients would impair or even kill a person who’s never taken opioids, so the meaning of the blood level depends on the patient’s experience and history.

My family and I drive these roads too, and I don’t want impaired drivers on our highways any more than anyone else. However, due to your desire to do a good job, you have mistakenly targeted patients on medication-assisted treatment for the disease of opioid addiction.

I know you have formed bad opinions about methadone and buprenorphine patients from seeing both drugs misused on the street. I hate that, because you probably rarely get to see our more typical patients on medication-assisted treatments.

The vast majority of my patients have jobs, families, and responsibilities that they meet, despite having this potentially fatal illness of opioid addiction. If you are fortunate enough to encounter one of my patients on a random traffic stop, please don’t give them a hard time. Please congratulate them on having the courage to find recovery from addiction, and tell them to do what works for them. In some patients, that means medication-assisted treatment.

Thanks for reading this long letter and thanks for all you do in the name of keeping our roads safe. If you want to know more about how we treat opioid use disorder at our facility, please call our program manager at xxx-xxx-xxxx and we would be happy to provide you with an after- hours tour and lots of information.

Sincerely,

 

Jana Burson M.D.

Member of the American Society of Addition Medicine

Board certified in Internal Medicine

Certified by the American Board of Addiction Medicine

P.S. And please don’t attempt to intimidate patients from coming to get help for this fatal illness of opioid use disorder by parking your squad car just outside our facility’s entrance. Some of these patients may have old warrants, but by stalking them where they come for help, you discourage people who want to escape addiction and want to better their lives. If you do park near us, you should expect a staff member to approach you with a smile, a cup of coffee, and a pile of information about opioid addiction and its treatment.

 

Methadone and Driving Article Abstracts

Brief Literature Review

Institute for Metropolitan Affairs

Roosevelt University 2/14/08

1. DRIVING RECORD OF METHADONE MAINTENANCE PATIENTS IN NEW YORK STATE

BABST, D., NEWMAN, S., & State, N. (1973). DRIVING RECORD OF METHADONE MAINTENANCE PATIENTS IN NEW YORK STATE. DRIVING RECORD OF METHADONE MAINTENANCE PATIENTS IN NEW YORK STATE,

When a comparison was made within specific age groups, it was learned that the accident and conviction rates were about the same for methadone maintenance clients as for a sample of New York City male drivers within the same period. The findings from other related studies discussed in this booklet are consistent with the results in this study.

2. The effects of the opioid pharmacotherapies methadone, LAAM and buprenorphine, alone and in combination with alcohol, on simulated driving.

Lenné, M., Dietze, P., Rumbold, G., Redman, J., & Triggs, T. (2003, December). Drug & Alcohol Dependence, 72(3), 271.

These findings suggest that typical community standards around driving safety should be applied to clients stabilized in methadone, LAAM and buprenorphine treatment.

3. Maintenance Therapy with Synthetic Opioids and Driving Aptitude.

Schindler, S., Ortner, R., Peternell, A., Eder, H., Opgenoorth, E., & Fischer, G. (2004). Maintenance Therapy with Synthetic Opioids and Driving Aptitude. European Addiction Research, 10(2), 80-87

Conclusion: The synthetic opioid-maintained subjects investigated in the current study did not differ significantly in comparison to healthy controls in the majority.

4. Methadone-substitution and driving ability
Forensic Science International, Volume 62, Issues 1-2, November 1993, Pages 63-66
H. Rössler, H. J. Battista, F. Deisenhammer, V. Günther, P. Pohl, L. Prokop and Y. Riemer

The formal assertion that addiction equals driving-inability, which is largely practiced at present, is inadmissible and therefore harmful to the therapeutic efforts for rehabilitation.

5. Methadone substitution and ability to drive. Results of an experimental study.

Dittert, S., Naber, D., & Soyka, M. (1999, May).

It is concluded that methadone substitution did not implicate driving inability.

6. Functional potential of the methadone-maintenance person.

Gordon, N., & Appel, P. (1995, January). Functional potential of the methadone-maintenance person. Alcohol, Drugs & Driving, 11(1), 31-37.

Surveys on employability and driving behavior of MTSs revealed no significant differences when compared to normal population. It is concluded that MM at appropriate dosage levels, as part of treatment for heroin addiction, has no adverse effects on an individual’s ability to function.

7. Influence of Peak and Trough Levels of Opioid Maintenance Therapy on Driving Aptitude. Baewert, A., Gombas, W., Schindler, S., Peternell-Moelzer, A., Eder, H., Jagsch, R., et al. (2007). European Addiction Research, 13(3), 127-135.

This investigation indicates that opioid-maintained patients did not differ significantly at peak vs. trough level in the majority of the investigated items and that both substances do not appear to affect traffic-relevant performance dimensions when given as a maintenance therapy in a population where concomitant consumption would be excluded.

8. The influence of analgesic drugs in road crashes.

Chesher, G. (1985, August). The influence of analgesic drugs in road crashes. Accident Analysis & Prevention, 17(4), 303-309.

Methadone, as used in treatment schedules for narcotic dependence, produces no significant effect on measures of human-skills performance.

9. Influence of narcotic drugs on highway safety.

Gordon, N. (1976, February). Influence of narcotic drugs on highway safety. Accident Analysis & Prevention, 8(1), 3-7.

A review of the literature on narcotic drug use and driver safety indicates that narcotic users do not have driving safety records that differ from age-matched individuals in the general population. Maintenance on methadone also does not appear to increase driving risk.

The Sacklers: Rich People Problems and a Possible Solution

Heroin Spoon sculpture left outside Purdue Pharma

 

 

The Sackler family is having rich- people problems. No, let me correct that: they are having ultra-rich -people problems. They can’t find museums to accept their financial donations.

This family made its fortune, estimated into the billions, by making and promoting sales of OxyContin, the drug that started the opioid epidemic in North American.

I know some readers will quibble about that statement and tell me there are other reasons for our opioid epidemic. I know there were other factors: an FDA that was perhaps too cozy with drug companies, a nationwide push to do a better job of treating pain, so-called pain experts who used shaky data to support their safety claims for long-term opioid prescribing, and few prescription monitoring programs that could identify patients who were developing opioid use disorders by doctor-shopping. These were factors. But the opioid firepower in OxyContin tablets, easily available by removing a coating, fueled our opioid epidemic for more than ten years.

In April 2019, the New York Times ran an article about the Sackler family, their wealth, and their legal problems. [1]

Purdue Pharma, the drug company owned by the Sacklers, has been sued by various entities claiming OxyContin caused harm. As I’ve written about in previous blog posts, Virginia won a $600 million award against the drug company and its three top executives in 2007, after the company and executives pled guilty to criminal charges of misbranding. It’s a big verdict, but perhaps not so big, given the wealth of the Sackler family, estimated by Forbes to be about $13 billion.

In the past, the Sackler family distanced itself from the problems of their pharmaceutical company. Now, individual family members are being sued for their part in pushing OxyContin inappropriately. New York, Massachusetts, Utah, Connecticut and Rhode Island have all filed suits against members of the Sackler family. The New York Times says more than 500 cities, counties, and tribes have coalesced to sue members of the Sackler family.

These agencies claim some of the Sacklers are more involved in sales decisions that they would like the courts to believe. For example, according to the NYT, two years after the Virginia guilty plea, Mortimer Sackler, who was on Purdue Pharma’s board, wrote a memo inquiring why Purdue’s sales force wasn’t selling more opioids.

Either this man either didn’t understand his company’s guilty plea two years earlier, which is unlikely, given all he’s achieved in life, or he didn’t care. He wanted to make more money, at any cost.

The family, well-known for their philanthropy, has made big donations to various cultural and educational institutions. They’ve donated large sums to the Metropolitan Museum of Art, where they financed an entire wing: The Temple of Dendur. They’ve donated to the Louvre in Paris, the Guggenheim, and to colleges and universities.

Earlier this year, activists targeted several of these locations as protest sites, and asked museums to refuse money from the Sacklers, tainted as it is by association with the opioid epidemic. In February, protesters at the Guggenheim dropped paper slips made to resemble prescriptions from upper floors of that museum to protest acceptance of the Sackler’s money. Protesters also staged a “die-in” to represent the lives lost to opioid use disorder, and the Sackler family’s role in those deaths.

Last year, sculptor Domenic Esposito placed an 800-lb sculpture of a bent spoon containing heroin outside Purdue Pharma’s headquarters in Stamford, Connecticut, to protest the Sackler’s role in the opioid epidemic. The spoon was confiscated by police and eventually returned to its creator.

Because of the political pressure from protesters, this summer, the Metropolitan Museum of Art decided not to accept further money from the Sackler family, as did the Guggenheim and the National Portrait Gallery in London.

Thus the ultra-rich problem of having no outlet to make charitable contributions.

The Sacklers defend their actions in manufacturing and promoting sales of OxyContin, saying they were mislead like everyone else into thinking that prescription opioid pain pills, when prescribed for pain, put patients at very low risk for developing opioid use disorder. They say they were taken in with the bad science of the age like other health agencies, and that it’s not fair to blame them for the opioid epidemic.

I find the Sackler’s proclamations of ignorance to be implausible, for several reasons. I can remember attending a course called “Pain and Addiction: Common Threads,” around 2004. At that course, a physician associated with Purdue Pharma chided physicians in the meeting who were trying to tell the presenters about how easy it was to inject or snort OxyContin. My memory may be inaccurate, but I know those meetings were recorded. I think I once possessed cassette tapes of a 2003 meeting, made by a company working for the American Society of Addiction Medicine. I surely wish I hadn’t discarded these old tapes; it would make for some interesting listening, given all that has happened since.

In Barry Meier’s prescient book, “Pain Killer,” he described how small-town physician Dr. Art Van Zee tried very hard to tell Purdue Pharma representatives about the devastation he was seeing and treating in opioid-addicted patients. Meier’s book was published in 2005, so Dr. Van Zee’s efforts had to be taking place around 2003.

In 2003, a Purdue Pharma representative testified before Congress that the company knew people were misusing their medication, and that they were re-formulating their medication to make it more abuse-resistant. But Purdue Pharma didn’t make that change until 2010, seven years of profit later.

Richard Sackler, once Purdue Pharma’s CEO, called people who misused OxyContin “scum of the earth,” “criminals,” and “victimizers,” in an article in the New York Daily News published in May of this year. Sackler has since said he made those uninformed statements decades ago, and that he understands more about opioid use disorder now and recognizes his lack of sensitivity to people suffering with opioid use disorder. [2]

This evidence indicates Purdue Pharma knew about the problem of misuse. The Sackler’s claim they had no knowledge of the death and destruction associated with their medication just isn’t credible. If the Sackler family didn’t know about the destruction their medication was causing, they’d have to be stupid or living under a rock. You don’t get to be billionaires by being stupid.

However, the Sacklers may be politically tone-deaf. In one of the biggest shows of chutzpah in the world, Purdue Pharma at one point considered getting into the opioid use disorder treatment market by manufacturing buprenorphine products to sell.

Yes, that’s right. In a full circle of greed, Richard Sackler got a patent in 2018 for a new form of buprenorphine in a wafer form. Since it dissolves in only a few seconds, it claims an advantage over tablet and film forms of the product now on the market.

This incredible development leads to the point of this blog: I have a solution for the unfortunate Sacklers, who have a bunch of money they want to give away but can’t. They say they want to help fix this opioid epidemic, and they now have a patented form of the product.

I say let the Sacklers, through Purdue Pharma, manufacture buprenorphine for the treatment of opioid use disorder and provide it free of charge to any patient who needs treatment. All the patient would have to do is see a physician, who prescribes Purdue’s buprenorphine product. The patient takes this prescription to any pharmacy to receive free treatment medication. Purdue could pay the small pharmacy fee for stocking and dispensing the medication. More patients could access treatment this way.

Everyone wins with my idea. The Sacklers get to give away money in a method that provides direct amends to the very patients they have harmed. Physicians no longer have to agonize over which form of buprenorphine to prescribe so that the patient can afford it. Patients get treatment that saves lives.

My idea has the advantage of removing middle-men. If Purdue Pharma and/or the Sackler family are found guilty in future lawsuits, they could pay their fine in the form of free treatment medication. This method avoids pitfalls with money gathered from civil fines that must be filtered through layers of government. Sometimes such money gets spent well, and sometimes not. With my method, it all goes to benefit the patients.

I love my idea, both for its practicality and for its poetic justice.

What do you think?

 

1. https://www.nytimes.com/2019/04/01/health/sacklers-oxycontin-lawsuits.html
2. http://www.nydailynews.com/news/national/ny-news-richard-sackler-opioid-addicts-scum-criminals-emails-20190507-ujfmvpphqjc77icemxafbjhlai-story.html