Treatment for Opioid Use Disorder at the County Jail

I just got back from the NC Society of Addiction Medicine’s spring conference, and it was even better then I’d hoped. The presentations were informative and inspiring. Today I feel even more enthusiastic about helping our patients.

The sessions about providing care to incarcerated patients with opioid use disorder were particularly beneficial. We got to hear how Durham County is successfully providing all three FDA-approved evidence-based medications as treatments for opioid use disorder, as well as various counseling and other services. They can serve as a model for all one hundred North Carolina counties.

We had a presentation from a lawyer who reported all the cases around the country that have been settled in favor of patients who were denied medical care for opioid use disorder. It’s obvious from that information that all jails and prisons will ultimately make all three medications available– depot naltrexone, buprenorphine products, and methadone – to treat patients with opioid use disorder who are incarcerated. It’s no longer a matter of if…but how long it will take and how many lawsuits need to be brought before carceral facilities will offer these life-saving treatments.

The same is true for opioid withdrawal. It is no longer acceptable to give a few clonidine pills on day four and call it “withdrawal management.” Though most healthy adults don’t die from opioid withdrawal, medically more fragile patients certainly can and do die from withdrawal. Families who brought lawsuits for wrongful death have won giant awards, sometimes up to seven figure awards.

Last week I was excited to read this headline in our local paper last week: “$1.46 Million Awarded to Help Free Inmates from Addiction.”

Finally, I thought. All those letters I’ve been writing, begging the local jail to continue methadone and buprenorphine for our patients with opioid use disorder when they enter jail have worked. Someone is now interested in helping our patients with opioid use disorder.

Then I read the article.

It’s not bad news but it wasn’t as good as I’d hoped.

As it turns out, a grant was awarded for depot naltrexone injections for people with opioid use disorder, as well as alcohol use disorder. Jail inmates diagnosed with either disorder will be offered the injection, better known under the trade name Vivitrol. This monthly injection of naltrexone blocks opioid receptors and prevents any euphoria from illicit opioids. Some of the studies on Vivitrol also show it lessens cravings for opioids.

Then when the inmates are released, they will be referred to Project Lazarus, a local non-profit agency that will provide services for people with substance use disorders. At Project Lazarus, patients on Vivitrol will be assigned peer support specialists and group counseling sessions. Their Vivitrol injections will be continued for about six months, at an expected cost to the grant program of around $1500 per injection.

According to the newspaper article the sheriff’s office felt there was a need for a medication assisted treatment program at the Wilkes County Jail. However, this grant will not fund the two medications that are most heavily evidence-based for the treatment of opioid use disorders: buprenorphine or methadone. Apparently these two medications, deemed narcotics, are still not allowed in the jail.

I have such mixed feelings. This grant is a good thing, as far as it goes. Vivitrol is an evidence-based treatment that can help patients with opioid use disorder and alcohol use disorder. I suspect there may be as many or more people with the latter disorder who can be helped.

But to allow Vivitrol but not the more heavily evidence-based medications methadone and buprenorphine still violates the ADA and denies appropriate care to patients. It also means that the jailers and jail medical personnel will remain open to lawsuits from patients and action from the Department of Justice.

Years ago, I tried to talk to our county jail’s medical director, and it did not go well.  I tried to convince him to allow our patients on methadone or buprenorphine to stay on their medications while incarcerated. Not only did he refuse to consider my request, but he called me a legal drug dealer and I called him… I think I compared his intellect, unfavorably, to a sack of hair. It wasn’t a great interaction.

Vivitrol is a tricky drug to start. If one of our opioid treatment program patients ends up in the county jail, I hope the medical personnel – likely a nurse – giving the Vivitrol injection knows not to give the Vivitrol too early, before the patient has completed acute withdrawal from methadone or buprenorphine.

Vivitrol’s not an easy shot to give. It’s viscous and you have to give it slow enough to minimize pain but fast enough, so it doesn’t clot in the needle.

Patients can have bad reactions to Vivitrol even if they are not physically dependent on opioids when the shot is given. Many specialists make sure the patient can tolerate the medication by giving a few days of oral naltrexone before giving a month-long shot. Will providers know about this option? Or will they give tester doses of naloxone IV or IM?

Will patients be pressured into taking the shot, since they will be in an environment that expects them to follow orders? There’s tremendous danger of abuse of power in such a setting. Patients may feel like they must start Vivitrol in order not to get on the bad side of the legal system. I hope they will be able to consult their lawyers about this if they have misgivings.

Some patients considering Vivitrol fear what might happen if they get into an auto accident or other trauma. They worry they wouldn’t be able to get pain relief once given a Vivitrol shot. That is a legitimate concern, though the Vivitrol can be over-ridden by an infusion of fentanyl in a worst-case scenario. Naturally, patients fear the emergency department doctor that they see for trauma would not be willing to give fentanyl. The drug company that makes Vivitrol does includes a little wallet card in each dosing kit, intended to notify caregivers that the patient is on Vivitrol.

I’ve decided to see this Vivitrol grant as a good thing. It’s a first step. Hopefully as jail medical personnel get more comfortable helping patients with alcohol use disorder and opioid use disorder they will be more open to also allowing buprenorphine and methadone.

Maybe after the jail is using Vivitrol for a few months, I’ll call and try to mend the fences with their medical director.

Book Review: “Raising Lazarus: Hope, Justice, and the Future of America’s Overdose Crisis” by Beth Macy

This book, published in 2022, is a follow up to her best-selling book and Hulu series “Dopesick.”

The author followed people on the front lines who are helping people with opioid use disorder. She chronicles their experiences and emotions. She follows the dedicated individuals doing the hard and often discouraging work of harm reduction, mostly located in the foothills of Appalachia. The areas she described are familiar to me: Hickory, NC; Mt. Airy in Surry County, NC; Charleston, West Virginia; and Batesville, Indiana.

In the opening scene, the author describes the life and work of Tim Nolan, a nurse practitioner in the Hickory area. She follows him as he makes “house calls” to patients in parking lots and fast-food joints. He delivers harm reduction supplies and life-saving prescription medications, along with treatment for the infections that can be associated with patients who use drugs intravenously.

I know Tim. We talk every month or so, because I am – or was – his physician supervisor for his buprenorphine patients. In North Carolina, physician extenders like nurse practitioners and physician assistants had to be supervised by physicians with a waiver to prescribe buprenorphine, called an “X” waiver. His supervising physician didn’t have an “X” waiver, and Tim asked if I could serve as his supervising physician just for his buprenorphine patients. I knew him from a Project Echo, a three-year program through University of North Carolina that taught new providers how to prescribe buprenorphine to treat patients with opioid use disorder. I knew Tim was knowledgeable and enthusiastic about helping his patients, so I was happy to help.

Now of course, since the “X” waiver was eliminated earlier this year, he no longer needs me to be a supervising physician but I’m always eager to help if needed. He’s doing important work.

Anyway, by reading Beth Macy’s book, I got a better idea of how far Tim goes to help patients. I didn’t know he routinely made these house calls, for example. Transportation to and from treatment providers can be a barrier to treatment and Tim has found ways to surmount the obstacles to care for opioid use disorders and for Hepatitis C.

The author also talks about Olive Branch Ministries, a harm reduction outreach program based in Hickory, NC that serves about ten counties in North Carolina. They do counseling and addiction treatment triage in these counties, as well as syringe exchange. They were also key in getting Hickory police to carry naloxone to reverse overdoses. The author does a great job of describing the challenges workers at Olive Branch Ministries face every day, trying to do a whole lot with a little bit of money.

The author talks about Surry County, which is one county to the north of Wilkes, where I work and live.

We know things are bad in Surry County. It has one of the highest overdose death rates in the state. The systems of medical care in that county have not embraced patients with opioid use disorder or provided care for them, until very recently. Finally, a physician extender who works at the county’s Health Department plans to start prescribing buprenorphine products for patients who need this medication. EMS workers just started doing buprenorphine inductions there.

For years, patients have told me horror stories about the Surry County jail. Since it is only one county away, some have had the misfortune of being incarcerated there. The author took a tour of this jail and after reading her description of what she witnessed I’d say the only word to describe the jail would be “squalid.” She describes inmates lying on urine-soaked mats on bare cement, and people in opioid withdrawal vomiting into buckets, crammed too close together. When she asked about providing methadone or buprenorphine, jailers said there was no room for such services, despite the presence of a nurse’s office that to the author’s eyes would be adequate for services.

The author researched and wrote much of this book during the pandemic and had a front row seat to the spectacle of everything going from bad…to worse. Care was harder to get, illicit drugs like fentanyl and methamphetamine more plentiful, and overdoses were more common. The COVID pandemic took the misery of the opioid epidemic crisis and amplified it.

During COVID, our opioid treatment program saw the same distressing problems in some of our existing patients and in our new patients. We admitted sicker people to treatment, with more severe mental health and physical health disorders. More of them had co-occurring stimulant use disorder, using methamphetamine.

 Many of them would have been appropriate for inpatient care, were it available. The Western half of North Carolina competes for beds at one government-run inpatient detox/residential site that will keep or start patients on methadone or buprenorphine while addressing co-occurring treatment issues. There’s a lot of competition for those beds. Often it takes weeks to get a bed for a patient in need, and they won’t take some patients with complex medical needs. When all the stars aligned and a patient goes there for treatment, they do well, and it’s a good program.

Nearly all the other inpatient programs STILL won’t permit patients to continue or start on methadone or buprenorphine, despite those medications being the gold standard. Understandably, patients admitted to these programs don’t stay. They get sick, crave opioids, and leave.

Much of this book describes the grass roots efforts of concerned citizens working in small towns in the U.S. to reduce the harm to people with opioid use disorder. The author talks about people who initiated Narcan distribution systems, people who deliver low-barrier buprenorphine treatment, people who make sure needle exchange is available for those who want it, and people who provide food and shelter to people who have neither.

After reading this book the reader will see just a few of the largely silent army of workers on the front lines trying to fix an overwhelmingly broken system. I appreciate all of them. They are truly doing God’s work.

Part of that work illustrates the basic theme of harm reduction treatment. As the author says in this book, “The idea that drug users are worthy human beings – that they are, in fact, equals – is harm reduction in a nutshell.” She talks about the need to stop judging people who use drugs as bad.

The author writes about the legal battles to bring harm reduction measures to communities, with the familiar NIMBY (Not In My Back Yard) attitudes. The opposition faced by well-intentioned harm reduction workers is heart-breaking. It’s due mainly to lack of information in people who still believe that tired old lie, “Once an addict, always and addict.”

To make the stories of the people with opioid use disorder and their front line helpers more poignant, the author juxtapositions their lives with descriptions of what was going on at the Purdue Pharma bankruptcy trial. The trial was covered more thoroughly in the book “Unsettled,” by Ryan Hampton, which I’ve also reviewed, but its placement in Beth Macy’s book was effective.

Reading about how the truly poor people of Appalachia’s opioid epidemic are trying to get by each day, and then reading how Purdue Pharma, claiming to be bankrupt, hired lawyers for $1,800 per hour to defend their interests was distressing and enraging.

I appreciate Beth Macy’s coverage of this whole issue. I love she spent space in this book discussing how medications for opioid use disorder are the standard of care for treatment. I love how she talked about how the stigma against patients with opioid use disorder and against MOUD is strong and gets in the way of more patients getting their lives back.

Her book also reports on the people who are in recovery from opioid use disorder, giving hope to the reader.

Unflinchingly, she points the way out of our public health nightmare and asks if we are ready to treat people with opioid use disorder as people deserving of help. She asks if we are ready to lay aside dogma and biases and adopt treatment strategies that are proven to work.

Here in 2023, we have plenty of evidence to show how to treat the opioid epidemic. That isn’t a mystery. The bigger story, which Beth Macy beautifully illustrates, is the question of why our country isn’t embracing the changes that are proven to help people and reduce morbidity and mortality?

The front-line workers she describes don’t have great funding. They don’t have much support at all, yet they carry on, trying to raise the dead through quiet little programs that are deeply evidence-based and undoubtedly doing a great deal of good. Yet why are these workers the exception? Why isn’t our country carpeted with these programs in every tiny neighborhood with a need?

It’s That Time of Year: Conferences in Addiction Medicine

My favorite conferences are coming up soon: our state’s premier yearly Addiction Medicine meeting will be held in Asheville, NC, on March 24 and 25, 2023. The national American Society of Addiction Medicine meeting is in Washington D.C. this year, April 13 through April 16^th.

Here’s the link to our regional meeting:  https://addiction-medicine.org/

And here’s the link to ASAM’s national meeting: https://annualconference.asam.org/  

I missed our state meeting last year for the first time since it was first held in 2007 so that I could visit some ailing family members, so I’m particularly keen to be there this year. As an added bonus, it’s a hybrid event, meaning you can attend in person or virtually or both. That sounds nice. I prefer attending in person, but late in the day it might be nice to relax in the hotel room while watching a presentation.

The conference has planned presentations on important and timely topics. For example, on the first day, the plenary session will have speakers on emerging trends on overdose mortality, with attention to co-occurring use of fentanyl and methamphetamine. In our area, it feels like the use of both types of drugs has complicated treatment immeasurably.

Other planned topics include a substance use disorder epidemiology update, how drug usage trends affect urine drug screening, and the evolution of fentanyl use and the relevance of xylazine.

Later in the morning speakers will cover stimulant use disorder, alcohol use and misuse, harm reduction applied to controlled substance prescribing, and an update on CDC guidelines.

The afternoon of the first day will have the usual assortment of workshop sessions, and I am eager to go to our opioid treatment program open session, where experts will discuss how to get medications for opioid use disorder into jails and prisons.

This is a huge issue, and things are finally changing. Regular readers of my blog know that in some areas, patients on medication for opioid use disorder are treated poorly, denied their usual medication, and forced to go into withdrawal. Last year the Department of Justice issued a  statement that says it is a violation of the Americans With Disabilities Act for jails and prisons to deny patients these medications. This has helped make changes in some NC counties.

We want to hear how OTP providers in NC are working with personnel at jails and prisons to  avoid disruption of care.

Then on the second day there will be plenary sessions about MOUD in criminal justice settings. Shelly Weizman, JD, will be one of the speakers. I know her from her work at the Legal Action Center in New York. If you’ve never gone to their website, it’s full of good stuff: www.lac.org. This organization

I’m hopeful these sessions can help me work with our county’s jail, which thus far denies MOUD treatment to patients, unless they are pregnant. In the past I’ve talked to the medical director of the jail, and it didn’t go well. He called me a drug dealer and I retaliated by saying unkind things…not the best way to form a working relationship.

Maybe it’s time to try again.

Also on the second day, I’m eager to hear Robyn Jordan, MD, PhD, present on how physicians can take action regarding the opioid settlement funds. I’ve written about these funds in some previous blog posts. In North Carolina, each county’s commissioners have been given the task of deciding how to spend this pot of money. Who better to help these commissioners spend this money for evidence-based treatment than the physicians and other providers who work in the field of opioid use disorder treatment day in and day out? I’m eager to hear her suggestions because besides being knowledgeable, Dr. Jordan is practical, an excellent communicator, and has a great sense of humor.

The second day’s workshops present a problem, because I want to go to all four  but they are at the same time.

I want to hear about updates in the management of opioid use disorder in the age of fentanyl, but I also want to hear about perinatal systems of care in patients with substance use disorder, and about psychiatric comorbidity. The fourth workshop has an intriguing title: “Building Workforce Capacity to Address Diversity, Equality, and Inclusion: Developing a Shared Language.” I am hoping these workshops will be recorded so I can listen to the ones I can’t go to.

Then the afternoon of the second day is dedicated to “Hot Topics.” These diverse topics include advising patients about alcohol consumption: should we recommend complete abstinence or moderation? There’s a planned session about an update on the new fourth edition of the ASAM Criteria,  a presentation about treating comorbid ADHD in patients with substance use disorders, and a talk on urine drug screening. All the presenters are established and knowledgeable physicians.

The last sessions of the second day are about how to use peer support specialists to help our patients with substance use disorders. I suspect those sessions were scheduled last because organizers knew people will stay until the end not to miss them.

Our OTP doesn’t directly hire peer support specialists – yet – but we refer to several recovery agencies in our area who do great work with our patients. The needs of new patients have never been greater. Many are homeless, with no financial means and no family support. Often they have severe co-occurring mental health issues and physical health issues that need to be addressed urgently. Peer support specialists can help new and existing patients navigate our byzantine healthcare system while providing emotional support to these fragile patients.

I can’t say enough positive things about the important work peer support specialists do, and hope to see more such workers in our field.

I don’t know if I’ll be able to go to the national ASAM meeting in Washington D.C. this year. If I can’t, I’ll listen to all the sessions online, like I did last year, so I can stay current with what’s new at the national level. I love that ASAM records all sessions so they are accessible online.

Both our regional NC Society of Addiction Medicine meeting and the national ASAM meeting will be great opportunities to network with other providers who care passionately about our patient population. That’s a wonderful extra benefit, outside of the information that can be gained.

If you are a professional interested in this field, consider going to these conferences – virtually or in person.

I Get The COVID

Welp, after nearly three years of doing all I can to dodge it, the COVID virus caught up with me.

I have no idea where I contracted it. I met with a patient diagnosed with COVID just two days before I got sick but I don’t think transmission can occur that quickly. Besides, we both wore masks, sat more than six feet apart, and I wiped down my office right after I saw her.

Last week I felt an odd and persistent pain in my lower back. I attributed that to packing a twenty-five pound quartz rock I found in the woods to my lapidary a half mile away. But in retrospect that was likely the first symptom.

Then during the night I had shaking chills followed by sweats, both sure signs of fever. The next day I woke with a sore throat and a stuffy nose. I know what a head cold feels like, but this was different in its intensity, so I suspected “The COVID.”

My sweet husband ran to the drug store to get a COVID test kit. It was strongly and immediately positive.

I had patients scheduled at my office that morning, so we hurried to contact them and did telehealth appointments instead. I felt well enough to talk to patients and got through the morning. Later that day I felt worse but alternated Tylenol and Advil and was glad when the day was over.

I know some people say not to treat a fever. I know some say we have fevers for a reason, and higher body temperatures help fight viruses. I don’t care. I’m a complete wuss with the body aches that come with fevers and if I can get rid of them I will. I also soak in hot water in a bathtub to get rid of the body aches.

This COVID infection feels very like other viral upper respiratory infections I’ve had, except it’s more intense and severe. My nose was stuffy, but really stuffy, to the point my nose felt like a block of cement. This virus, I thought to myself, knows its way around the aerodigestive tract. When my nose wasn’t closed off, when I could still breathe through it, it felt like fire with any air movement. The sneezing was epic.

You would think that if my nose was clogged, it wouldn’t leak much fluid, but it still did. Sitting still, ten or so drops of clear water suddenly poured out of one nostril or another. I was trying to keep my virus and my secretions to myself and not infect my husband, but that was difficult.

The body aches felt like talons clutching at my shoulder and back muscles, but those eased some while sitting in a bathtub full of hot water.

I was probably at my most viremic and infective the day or so before I got sick, and I probably gave it to my husband during that time. He started getting sick with the same symptoms about four days after I did. He felt much worse, with severe sore throat and headache along with the nasal symptoms and fevers.

I feel let down by the vaccines I’ve taken. I took a total of five, with the last one in December of 2022. I expected NOT to get this sick. Of course,  I’d probably be even sicker had I NOT had five vaccines…but I’m disappointed.

It took four days before I felt like the antibodies made from those five vaccines got up off their lazy asses and started attacking the virus invader. I’m feeling much better, and was able to work this week, with a mask and other precautions, as per latest CDC recommendations. In fact, the CDC recommends isolating for only five days under most circumstances, and don’t require a negative test before going back to work.

That’s a good thing, since I’m still positive on the test I took this morning, day eleven after getting sick.

I’m grateful my husband and I are getting better. I’m grateful we weren’t sicker than we were. And I plan to be more careful about avoiding this virus in the future, because this virus is no joke.

What is Xylazine?

The drug xylazine has appeared in several news articles lately so it seemed appropriate to do a little digging and report what I find to my readers.

Xylazine is an animal sedative. Lately, it’s been found as an additive to the opioid fentanyl, because dealers of drugs say it extends and intensifies the effects of fentanyl. The trouble is that it makes overdose more likely.

Xylazine is not an opioid and is not reversed by Narcan. However, giving Narcan may still be life -saving in a xylazine overdose because it is usually used in combination with opioids. Narcan may reverse the opioid-induced portion of the overdose enough to get the person breathing again.

 Xylazine’s effects mimic other sedatives like benzodiazepines, though it’s not a benzodiazepine. It’s in the same class of medication as clonidine, though much more sedating. It is used by injecting, snorting, smoking, or swallowing.

Rather than coming from illicit drug manufacturing like the precursors to fentanyl, Xylazine appears to be diverted from veterinary suppliers to the black market to be added to fentanyl. It’s found more often in the Northeastern U.S., though incidence is rising in the South and West as well. According to data found on NIDA’s website, xylazine was found in 19% of all drug overdoses in Maryland in 2021, and Philadelphia has had high rates of xylazine contamination in their drug supply over the last few years.

Xylazine can cause a physical dependency and its main withdrawal symptom tends to be anxiety and depressed mood. The withdrawal can be mitigated with treatment with benzodiazepines.

Some specialists say repeated use of xylazine may cause skin ulcers ad cellulitis that are difficult to heal, though this property of the drug has only been confirmed in animal studies.

It’s difficult to get accurate data about this drug because many state toxicology labs don’t test for this substance, leading to possible underestimation of the incidence of its use.

Right now, xylazine isn’t on routine test panels, though it can be tested for specifically using gas chromatography/mass spectrophotometry methods.

Hopefully we will have more testing available soon for this drug. And I hope this drug threat disappears somehow. Treating fentanyl use is challenging enough without adding new sedatives to the mix.

Physician Liability at the Opioid Treatment Program

I’ve been thinking about writing this blog post for several years but hesitated because I fear it will make some people angry. But I want to write about all aspects of opioid use disorder and its treatment with medications, and liability concerns are part of treatment at OTPs.

In a way, it’s sad that physicians worry about anything but the well-being of the patient sitting in front of them. In another way, maybe accountability keeps providers from getting too far out of the mainstream.

This blog post is specifically about methadone induction and physician liability.

In 2001, when I first started working at an opioid treatment program, OxyContin had already established its reign of destruction. I worked for a non-profit program with satellite programs in seven small towns. All these programs were relatively new. What I saw at those programs was appalling. I was amazed at the extent of OxyContin use disorder in these locations. Patients were taking large amounts of oxycodone each day.

In one moderate-sized town, twenty to thirty patients would arrive early, hoping to get admitted to treatment with methadone. (That non-profit program didn’t offer buprenorphine until long after 2010.)

It was overwhelming.

I asked the administration to limit intake days to twenty intake patients per day, to have enough time to do an adequate job for each patient. My requests were not honored. Some weeks I worked 7am to 7pm and saw thirty or more patients. I left dog-tired and worried if I had done a good enough job.

Back then, physicians working to treat opioid use disorder talked about the unprecedented opioid firepower of extended- release oxycodone that was being used as an immediate-release drug. All our patients knew how to remove the time-release coating from OxyContin. They crushed it to snort and inject.

Because of the high prescription strength of OxyContin, which was sold as single doses as high as 160mg tablets, we all thought methadone starting doses would have to be adjusted upwards to account for the extreme physical opioid tolerance. Often, we started patients at 30mg and had them return later that first day for a second dose of 10mg, for a total of 40mg on the first day. Then we increased their dose by 5mg every day or every other day if they reported withdrawal symptoms. We justified this approach, saying these were special circumstances.

We harmed patients with this dosing strategy.

Some patients, probably slower metabolizers of methadone, could not handle that rapid methadone induction, despite their reports of using large amounts of OxyContin. Or they may have exaggerated about their opioid tolerances, to deadly effect.

Some of the families of deceased patients brought wrongful death lawsuits against the non-profit program and the physicians who had prescribed the methadone.

I wasn’t named in any lawsuits but the medical directors both before and after me were. This wasn’t because I was so smart, but rather because I heard an important ASAM (American Society of Addiction Medicine) lecture by Thomas Payte, M.D., that changed my prescribing habits and decreased the aggressiveness of my induction orders.

I bought the recordings from an ASAM conference sometime in the early 2000’s, maybe 2004 or 2005. During his presentation, Dr. Payte warned against starting methadone too high, or going up too fast. He said methadone induction deaths were rare and devastating. He said rapid inductions sooner or later result in overdoses. He used a term, “bubble-gum addict” which I think meant a patient who claimed to have severe opioid addiction but really only used occasionally or relatively small amounts. He said these “bubble-gum addicts” were at high risk because they exaggerated their tolerance to the physician.

After hearing that lecture, I stopped giving first-day total doses of 40mg, for the most part. I stopped giving orders for daily dose increases. And I watched as my colleagues went through malpractice cases brought by families of patients who died from methadone overdose.

Both the non-profit opioid treatment program and individual physicians had four wrongful death lawsuits filed against them. All the deceased patients had been started at more than 30mg on the first day, and their doses had been increased daily, faster than the prevailing guidelines. The medical examiner said the cause of death for all four patients was methadone intoxication. I felt that in two of the cases, there were clearly other factors, but that didn’t matter. The medical examiner’s pronouncements are final.

The families of the decedents had their worst nightmares come true: their loved ones with opioid use disorder passed away from their disease, and ironically, they were killed by people who said they were trying to help. I can only imagine the deep sense of betrayal and anger the families must have dealt with.

The lawsuits also troubled the lives of the physicians who were named. It was a long, drawn-out process for all four of the cases. I saw probably only a fraction of the emotional toll it took on these excellent providers who, with the best of intentions, wanted to take the methadone dose up quickly to prevent withdrawal and retain patients in treatment. The lawsuits took a toll on the administrators for this non-profit organization. Their reputation and the reputation of the organization was questioned in newspapers across the state. Indeed, the deaths made front-page news in the Charlotte Observer.

All four lawsuits were settled in favor of the families. I have no idea how much the settlements were and I’m sure there were non-disclosure agreements on the settlements. The two physicians named in these lawsuits both left the field of Addiction Medicine right after the lawsuits.

Lately, even at the recent conferences I’ve virtually attended, I’ve heard lecturers talk about how they recommend higher starting doses of methadone and faster rates of increase for methadone induction, due to the higher potency of fentanyl that patients are using. It’s exactly what I heard in the early 2000’s about induction in patients using high doses of OxyContin.

For sure, fentanyl is more potent than Oxycodone. Fentanyl and its analogues are dosed in micrograms, while oxycodone is dosed in milligrams. And we know that patients who are retained in treatment with an adequate dose are less likely to die from an opioid overdose.

And yet …I wonder if there’s an ultimate price to be paid by some patients if we go that fast on every patient. I haven’t forgotten lessons from the past.

Certainly, we know some factors can make induction more dangerous for some patients: current use of any sedating medications or drugs; health issues like sleep apnea or COPD; recent period of abstinence from opioids, and other factors. Those patients should be started at lower doses and increased more slowly.

But what about the new patient with no prior treatment history, healthy in other ways, who says he’s injecting a gram of heroin mixed with fentanyl per day? Is he going to be retained in treatment with a high starting dose and rapid rate of increase or is he born with the genes that make him a slow methadone metabolizer, likely to die on day five of his methadone induction?

Some tests exist that give genetic information about whether a patient might be a slow metabolizer. For now, I don’t have access to such tests. If I did, I would need that data before giving the first dose. If any readers are using these tests, I’d like to hear from them.

But here’s the thing that will anger people: it is not in the physicians’ best interest to start patients at high doses. Physicians aren’t usually blamed if the patient drops out of treatment and dies using fentanyl on the street. But physicians most certainly have been – and will be – blamed if the patient dies during induction, no matter what the cause. If were other drugs in the decedent’s system, it doesn’t matter, because malpractice lawyers say the physician should have taken that into account and started at a lower dose.

There’s one medical malpractice lawyer in our state who specializes in methadone overdose cases. She was the lawyer for all four families in the lawsuits I mentioned above.

Heeding advice from Sun Tzu (“Know thy enemy”), this lawyer was once invited to an addiction medicine conference to talk about what mistakes lawyers look for when suing a physician. Her talk was interesting to me but probably not for obvious reasons. As I listened to her talk, I realized lawyers look at only one side: the risk of giving a certain medicine, or dose of medicine, or treatment. She never talked about the risk of NOT giving medicine.

Medical professions who work in this field must take a much broader view. We know people with opioid use disorder who do not get treatment with medication die at a rate at least three times that of people who do get medications for treatment. Knowing this, it’s unconscionable not to do all we can to provide treatment, and to provide it quickly.

Providers will continue to try to thread a needle: we want to give enough methadone to ease our patients’ suffering but not enough to kill them. We will continue to make the best judgments that we can, with information from the patient, from collaterals, old records, urine drug screen results, the physical exam with any withdrawal signs, and any other data we can get.

More Info:

Here’s the email I got from the DEA last week:

“All DEA registrants should be aware of the following:

• A DATA-Waiver registration is no longer required to treat patients with buprenorphine for opioid use disorder.
• Going forward, all prescriptions for buprenorphine only require a standard DEA registration number. The previously used DATA-Waiver registration numbers are no longer needed for any prescription.
• There are no longer any limits or patient caps on the number of patients a prescriber may treat for opioid use disorder with buprenorphine.
• The Act does not impact existing state laws or regulations that may be applicable.

Separately, the Act also introduced new training requirements for all prescribers. These requirements will not go into effect until June 21, 2023. The DEA and SAMHSA are actively working to provide further guidance and DEA will follow up with additional information on these requirements shortly. Importantly, these new requirements do not impact the changes related to elimination of the DATA-Waiver Program described above.”

No more “X” number.

No more patient limits.

No more NADEAN required for CVS… but has anyone told the pharmacists yet?

I Did Not See This Coming…

I’m in an email chain with other Addiction Medicine physicians who alerted me to the news that the buprenorphine X-waiver is gone, eliminated by recent federal legislations.

Providers no longer need to get a buprenorphine X waiver to prescribe buprenorphine.

This happened per the MAT (Mainstreaming Addiction Treatment) Act, passed in December of 2022. Per this Act, the buprenorphine X-waiver no longer exists. Any provider with a DEA license can prescribe buprenorphine products for the treatment of opioid use disorder.

Also, providers who want to register to get a DEA license need to take the 8-hour course previously required to receive an X-waiver.

There are plenty of unanswered questions.

For example, will prescribers need to take the eight- hour course to get a DEA number for the first time, or for each renewal, required every three years? How will the DEA keep track of who has taken the course? Will there still be limits on the number of patients each prescriber can treat? Will there even be a DEA “X” number? What will become of CVS Pharmacy’s NADEAN?

When does the new law take effect? Is this Act finalized? Because on SAMHSA’s website there’s this message, implying more guidance is coming soon:

“Congress has taken action in the recent Consolidated Appropriations Act, 2023 that impacts federal requirements for Drug Enforcement Administration (DEA) registrants, including those involved in OUD treatment. SAMHSA and DEA are actively working to develop further guidance related to these changes. Please frequently check this webpage for further updates and guidance.”

The DEA, on its website, has a headline saying it applauds the repeal of the X-waiver.

For now, I have more questions than answers.

The intent of eliminating the requirement of an X-waiver is to eliminate a barrier to lifesaving treatment and get more patients with opioid use disorder into treatment.

But how many prospective buprenorphine prescribers have been deterred by the X-waiver requirement? Will its elimination in fact lead to more physicians being willing encourage more prescribers to treat opioid use disorder? Will eliminating the X-waiver reduce the stigma around opioid use disorder and its treatment? I have my doubts about this, but we will see what happens.

Already there are some negative comments from physicians on the internet. Some physicians wrote comments that if they are forced to take an “expensive” eight-hour course about substance use disorders, they just won’t renew their DEA number, and won’t prescribe any controlled substances. Several said they rarely prescribe controlled substances anyway, so it wouldn’t be a big loss. Others pointed out that without a DEA license, their patients may suffer.

For readers’ information, DEA numbers are required only to prescribe controlled substances, which are medications that have some degree of potential to cause substance use disorders. This includes opioids, of course, including buprenorphine. It also includes benzodiazepines and most sleeping pills, and stimulants like Adderall and phentermine. Physicians and other providers don’t need DEA numbers to prescribe non-controlled substances, like anti-hypertensives, antibiotics, diabetes medications, and the like.

However, it appears pharmacists on the front lines are not aware that the X-waiver is no longer required for the prescribing of buprenorphine products, because a pharmacist just called me yesterday to “confirm” that I had an X-number, even thought it was on the electronic prescription. She said she just had to call to verify it was a legitimate prescription.

I think providers will see elimination of the X-waiver requirement as a good thing, but as a practical matter it may be hard to implement quickly. It seems like this big change wasn’t well-coordinated with all interested parties (stakeholders, to use common lingo). After all, pharmacists need to know about this change or they, attempting to follow the law as they know it, might refuse to fill buprenorphine prescriptions from providers with no X-waiver. And that would defeat the change of the law.

So stay tuned and I’ll keep my ear to the ground, plus you can look at SAMHSA’s website for upcoming information: https://www.samhsa.gov/medication-assisted-treatment

Compassion, Again

I had such great intentions.

I had lofty goals for the twelve days I took off from work over the Christmas/New Year’s holidays. Among them, I was going to write two or three blog entries, to have new material for my blog this month.

That didn’t happen, for a variety of reasons.

I’ve been writing this blog since April of 2010, nearly thirteen years. It’s getting harder to find something new to say. I’ll think of a possible topic, then check my blog to see if I’ve written about it recently. Sometimes I recycled older blog posts since I have new readers and since my old readers, like me, forget what I’ve written in the past.

Sometimes I’ll read an old post and feel cringe-y at the language or at the outlook I had when I wrote it. That’s uncomfortable, but probably a good thing. It shows I’m still capable of change, and able to incorporate new ideas into my opinions and outlook, at least to some degree. This flexibility feels like a positive thing.

Today I’m recycling a post from several years ago, because it’s about compassion and that’s a topic that’s never old. It’s from two years ago so I updated it a little:

Maybe with all the suffering around us, it’s easier to feel compassion. I don’t think I’ve had a year when I felt more concerned about other people, to the point I pray more for them, have donated more to charitable organizations, and even started donating blood on a regular basis. I’m not bragging; I’m just happy I’ve felt more like doing these things. I’m at my best when I have that feeling of wanting to be helpful, and I tend to be happier with myself.

I am not, by nature, a very compassionate person. Left on my own, I can be judgmental, the opposite of compassionate. But I don’t want to be that kind of person. Thankfully, over the past twenty-plus years that I’ve been in recovery from substance use disorder, I’ve learned a few things. I’m better at recognizing my own negative attitudes and challenging them.

 It helps me to be around other compassionate people. I’m grateful I have such people in my life; my sister has natural compassion, as do many of my friends and my best friend of all, my husband. He is the love of my life and amazingly compassionate. Spending time with these people helps change my outlook.

 Prayer helps change me. I ask for compassion each day on my way to work. I pray to be able to see people as my Higher Power sees people and to treat them accordingly. I also read books that help me cultivate compassion. Alternatively, focusing on negative content in my conversations and reading can dampen my mood and tip me into more pessimistic attitudes.

Compassion doesn’t always look warm and fuzzy. Sometimes true compassion leads to difficult conversations, odd as that sounds. It can even lead to conflict, if I don’t remember to be respectful. If I didn’t feel compassion for patients, I wouldn’t take pains to talk to them about their lives and their desires for change.

No one is compassionate all the time. I have my early warnings that I’m slipping back into old patterns of thinking. For example, when I start making sarcastic jokes at other people’s expense…not good. I can justify by saying I’m blowing off steam and I’m only joking, but as a close friend pointed out to me, sarcasm is “flesh-eating” humor. It can be damaging to other people and corrosive to me.

When I start muttering negative things under my breath at work…not good.

So, what do I do when I start feeling negativity?

First, I don’t have to express it. Expression of negativity contaminates my workplace. It can make my home life feel heavy. I try to keep it to myself. It’s my issue and I don’t need to make it my co-workers, patients, or friends’ issues.

Next, I try to decide why I’m feeling what I’m feeling. Usually, it’s because I’ve decided other people aren’t acting like I want them to. I’ve slipped into a pattern of thinking that other people, organizations, politicians, whatever, need to conform to my ideas for them. Which brings up the real issue: such an attitude shows I haven’t accepted the basic truth that there are many things in the world that I can’t and shouldn’t try to control.

When I can accept people as they are, while still being willing to extend myself towards them when they request help, I’m in a good place.

Compassion helps me do my job better. Patients wanting help are more likely to engage in treatment when they sense their helpers are rooting for their success, and willing to go an extra mile to help them. Patients sense these things; a helper who is just going through the motions doesn’t inspire patients effectively.

I started to write this blog thinking that compassion is a difficult subject; the blog post could end up being a self-serving treatise extolling my virtue of compassion. Or it could reveal how much I struggle with compassion because at heart, I’m not a very nice person. I hope this blog post has threaded the middle ground by presenting the message that we can feel and act with more compassion by practicing, like any other habit. We can also refuse to cultivate more negative personality traits, like negative thinking and speaking. I’m not saying we should ignore problems when we see them, but rather try to focus on solutions.

Anyway, I hope 2023 is a better year for all of us. May we all feel more compassion for ourselves and others, and struggle less with negativity.

SAMHSA’s Proposed Update to Federal Rules to Expand Access to Opioid Use Treatment

Recently SAMHSA posted a “Notice of proposed rulemaking,” which means they would like to change current regulations pertaining to medications used to treat opioid use disorder. SAMHSA wants to revamp the rules to make it easier for people who need treatment to get it. SAMHSA hopes this will reduce the number of opioid overdose deaths, estimated at just over 100,000 in 2021. This was a 15% increase from 2020.

SAMHSA will post the proposed changes for sixty days, allowing anyone with input to post it to the site before February 14, 2022.

These proposed changes can be read in full at: https://public-inspection.federalregister.gov/2022-27193.pdf

The document is quite a read, at 135 pages, and I’ll summarize what I think are the most interesting parts of it.

The document starts by noting that standards haven’t been updated since 2001, and that many things have changed since then. They want to update language and use more person-centered, less stigmatizing wording, and they wanted to add evidence-based clinical practices. The Notice says it aims to reduce barriers to treatment.

SAHMSA permitted big changes in the number of take- home doses allowed starting in March of 2020, when the COVID 19 pandemic first started. This was meant to reduce transmission of COVID from one patient to another, and to healthcare workers at OTPs. Practically overnight, more take home doses for methadone were given at most (though not all) opioid treatment programs.

Studies of these patients over the last two years didn’t find any increase in overdose deaths and   found better patient retention and higher patient satisfaction rates with these more liberal take homes. Because of these benefits, the proposed new rules for methadone take home doses is relatively liberal.

The new criteria for take home doses includes absence of active substance use disorders, regular attendance, absence of behavioral problems, absence of diversion activity, the ability to store and transport medication safely, and any other criteria relevant to the patient’s health and safety. Essentially, SAMHSA has dropped the time-in-treatment requirements for take home doses of methadone.

Here are other proposed changes:

Methadone can be initiated at the OTP after an audiovisual telehealth visit with an approved provider. In the past, the initial visit had to be in-person, but the new rules allow for a telehealth admission, provided there is a visual component to the evaluation. Auditory-only evaluations are deemed insufficient for admission starting methadone, but still adequate for buprenorphine.

The audiovisual or in-person evaluation can be provided by an outside provider if an approved OTP provider sees the patient within seven days of admission.

OTPs must take measures to provide telehealth services to prospective patients with disabilities, including language barriers.

Patients no longer need to have a one-year use of opioids history to start at an opioid treatment program. In the past, only patients with a history of daily or near-daily use for one year could be admitted for MOUD at an OTP, unless an exception was obtained from SAMHSA and SOTA. This proposal would change that. Instead, the healthcare provider needs to diagnose the patient with either moderate or severe opioid use disorder to admit them to treatment. This is determined using DSM 5 criteria for the diagnosis of opioid use disorder.

Patients with an established history of moderate or severe opioid use disorder who are in remission but at high risk for “recurrence or overdose” can be admitted or re-admitted into treatment without an exception

These changes, if eventually approved, make good sense. The one-year requirement for use was arbitrary with no evidence to support it. Currently, we can admit a patient with less than a year’s use, if the provider feels it’s the best option for the patient, but we need to get an exception approved by SAMHSA and SOTA before giving the first dose. This sometimes delays admissions by a day, and the proposed change would eliminate this barrier.

Patients younger than 18 no longer need to have failed two attempts at inpatient treatment for their opioid use disorder. Parental consent is still necessary unless it is specifically NOT required by applicable state law.

The new proposed rules separate the medical exam into two parts: a screening exam to ensure the patient meets admission criteria and that no contraindications exist for treatment with MOUD, and then a full history and examination for broader health status, with lab testing.

The full exam can be completed up to 14 days after admission (and presumably dose initiation).

I’m a dinosaur in this field of medicine, but I can tell readers that I will not be giving any methadone orders for patients until I have done a full history and physical. I feel like if I have time for a screening exam, I can take time for a full exam. It doesn’t take much longer than a screening exam, and it can sure prevent a lot of problems.

I remember the new patient I was seeing, who answered “no” to questions about previous medical problems, surgeries, and specific questions about heart problems. I examined her and found a pacemaker device under the skin, high on her left chest. Curious, I asked her why she had a pacemaker if she didn’t have heart problems. She answered that she considered the heart problem to be resolved, since the device shocked her heart back into rhythm if she had an “episode.” So, the device was an AID and yes, she had long QT syndrome and methadone was relatively contraindicated.

This is anecdotal experience, which isn’t science-based like randomized controlled trials, so people could reasonably say my patient was rare and shouldn’t be considered evidence that a more thorough exam is best. They might say that the risk of an overdose death is much higher than the risk of finding a contraindication to starting methadone. And they would probably be right…but I still feel responsible for my patient’s well-being, and I think I can do a full exam without delaying admission. I do realize that not all OTPs are set up in the same way.

OTPs must provide “…adequate medical, counseling, vocational, educational, and other screening, assessment, and treatment services to meet patient needs…” and the document goes on to say that the program sponsor can enter into a documented agreement to provide these services with a private or public agency.

I feel like many OTPs will fall short on this one. If I’m reading this document correctly, it says these services should be provided on the primary site unless otherwise arranged. How can that be possible? How many OTPs can provide adequate medical services to meet patient needs, let alone vocational and educational needs? Perhaps things are different at OTPs in North Carolina than in other states.

The section about LAAM is proposed to be completely removed, since that treatment isn’t available in the U.S. anyway.

It appears that the proposed new rules no longer require an exception be submitted for split dosing pregnant patients, which seems more convenient.

The proposed regulation changes include sections on drug screening. This document requires testing for clinically relevant substances, at a frequency consistent with generally accepted clinical practice. The document does state there should be a minimum of eight drug screens per year.

Here’s where the proposed changes made me nervous:

The first day’s first dose should be no higher than 30mg, and the total on the first day shouldn’t be higher than 40mg. However, if 40mg is insufficient to suppress opioid withdrawal, the practitioner must document the rational that a higher dose is needed.

I don’t know what this would look like in real life. Since in most patients, methadone blood levels don’t peak until around three hours after a dose, it is prudent to wait at least two hours after giving a 30mg dose to consider giving 10 more milligrams. After that, the prescriber would have to wait at least more two hours to see how much effect the total 40mg is going to have. That’s a long time for a patient to stick around, though maybe some OTPs with extended hours could manage this.

I fear that providers, eager to get the new patient out of withdrawal, will give the second and subsequent doses too soon, before blood levels have a chance to peak. Methadone’s pharmacology is different from short-acting opioids like oxycodone and heroin, and it’s easy to give too much on day one, despite having the best of intentions.

The proposed update to the federal rules gets into details about take home doses. It says patients in the first 14 days of treatment should get no more than 7 days of take homes. Patients in treatment from 15 to 31 days of treatment can get no more than 14 days of take- home doses, and after 31 days in treatment, they can receive no more than 28 days of take homes.

Um, what??

This puzzles me. I know the new proposed regulations describe maximum number of take homes, and that the provider is free to give only as many as are medically appropriate, but I’m mystified how a provider would know what dose to authorize in a new patient for seven days at a time, unless he kept the patient at the same low dose, which is certainly not ideal.

Each day a new patient doses during induction, I want to know if they had any sedation three hours after dosing the day before, which is when the methadone blood level peaks. If the patient felt sedated, I want to know this and probably reduce the dose a bit. I suppose the feedback could be done by telehealth during the seven days of take homes, but the dose can’t be adjusted by telehealth.

I have no problem with these new regulations when doing an induction onto buprenorphine, given its much higher margin of safety. With buprenorphine, I could probably make an educated guess and give a week’s take home, as I do in my office-based practice, but methadone is a whole different breed of cat.

And then after two weeks of treatment, the patient can get up to two weeks of take homes? And after one month of treatment, give up to a month of take homes?

I think this is too much too soon, for a new patient with no prior treatment experience on methadone. It feels risky and I worry it sets patients up to fail in their treatment. The intentions were good, but why must the pendulum swing wildly from one side to the other?

Look at prescribing for opioid pain pills. Five to ten years ago, patients were still being given massive amounts of opioids for trivial reasons. Now a patient with a broken leg can barely squeeze one oxycodone 5mg out of an emergency room doctor in our county. A more measured response would have been more helpful.

Let’s not make the same mistake with methadone take homes. Demanding that patients dose every day for the first ninety days clearly was too strict, but isn’t there some reasonable ground between that and a week of take homes after a week of treatment?

Since COVID, I feel like we’ve found some middle ground. At our OTP, we have been starting new patients at daily dosing until they get up to 60mg or until they have been attending for three or four weeks. Then, if they are doing well otherwise, we can move them to every other day dosing. They only need to come three days per week, and we still see them often enough to get feedback about possible sedation.

I think that’s a more reasonable approach that still protects against overdose in the first two weeks, which is when most overdose deaths with methadone happen.

Well-trained and experienced physicians and other providers will disagree on the finer points of treatment of opioid use disorder with medications, but most will agree with the bulk of the proposed changes presented in this SAMHSA document.

Consider leaving written comments for SAMHSA at:  https://www.regulations.gov