Thank you for being here with us. My name is Adele Schaefer. I'm currently a forensic psychiatry fellow at Case Western Reserve University in Cleveland. I'm also trained in addiction psychiatry. I will let everyone else introduce themselves as we go on, and today we'll be talking about avoiding legal trouble with medications for opioid use disorder. We do not have any commercial relationships to disclose, and this presentation is not supposed to be any type of legal advice, and the views that we're expressing here are ours and are not our employers. So we'll get started by just briefly going over the opioid epidemic. We're all very familiar with this. There's so much to say here that this could be an entire talk on its own. A huge number of Americans are impacted by the opioid epidemic, so just to put things into perspective, it's estimated that six to seven million Americans have an opioid use disorder, and 136 Americans die each day from overdoses, and you can see here opioid use disorder in, I believe, 2017 cost the United States 1.2 trillion dollars, and that number represented the combined costs of health care expenses, criminal justice proceedings, loss productivity, and of that 1.2 trillion, close to half of it was attributed to the value of life lost from fatal overdoses. And so opioid overdose deaths continue to rise in the United States. So you can see here how the rise in opioid overdose deaths did not happen overnight. It came in three distinct waves, which you can see outlined here. The first wave began in the 1990s when the prescribing of opioids greatly increased. So you can see here that's represented by the teal line, the commonly prescribed opioids. And then the second wave began around 2010 with rapid increases in overdose deaths involving heroin, which is the like navy blue line that you see. A lot of people in this time period were began switching to heroin because there were crackdowns on these sort of like pill mills, and people did not have access to the prescription pills they were now dependent on, so a lot of people began to switch to heroin. And the third wave of deaths began in 2013 when we began to see more overdoses from these very potent synthetic opioids, and particularly fentanyl. And you can see here on the very far right, so the the deaths from synthetic opioids are skyrocketing. This graph cuts off at 2020, and unfortunately I was not able to find a more recent graph, but you can see here that the majority of opioid overdose deaths today are involving fentanyl, and they continue to rise. So we'll now discuss the commonly used medications for opioid use disorder. There's three FDA approved medications that are typically used to treat opioid use disorder. The first that I will briefly go over is methadone. So methadone is a full agonist at the mu opioid receptor that is found naturally in our bodies, and methadone works because it binds to that receptor, and by doing so it eliminates symptoms of opioid withdrawal and reduces cravings to use opioids. There's some things with methadone. It has a variable in long half-life, so it can be difficult to dose sometimes for people. There's also some side effects that come with it, such as sedation, respiratory depression. It prolongs the QTC interval, and it's actually metabolized by the CYP3A4 enzymes, if we kind of go back to med school here. So due to that, it has many drug-drug interactions. Methadone is heavily regulated by the U.S. government. When it's used to treat chronic pain and other like medical conditions, you can actually be prescribed it, but when it's being used to treat opioid use disorder, you have to obtain it from an opioid treatment program or an OTP. So receiving treatment at these OTPs is very cumbersome. They have limited hours. Sometimes people line up outside of them at like 6 in the morning. You know, you're penalized for missing doses. You're kind of married to that clinic, unfortunately, if you're, you know, on methadone for your opioid use disorder. So whenever I have patients that are sort of coming to me describing their experience at these clinics, it makes me sad because I just think about how hard it would be to have a full-time job taking care of your kids if you have to present to this clinic every day and wait in line to receive your medication. The next medication for opioid use disorder is buprenorphine. Buprenorphine is a partial agonist at the mu-opioid receptor, meaning that it binds to the receptor, but it only partially stimulates that receptor, and it also produces some blocking effects at the receptor. But even though buprenorphine is only a partial agonist, it has a very high affinity for the opioid receptor, and it actually blocks other opioids from binding to that receptor. So if somebody uses opioids while they are on buprenorphine, they won't experience either as much or any euphoric effect, depending on what they actually used, because buprenorphine is already bound to that receptor very tightly and is essentially blocking the other opioid from binding. And so when people are on buprenorphine, for instance, for like surgery, you have to use very high doses of very high potency opioids to overcome the block from buprenorphine. So buprenorphine, it treats withdrawal symptoms and cravings, but it's less likely than methadone to cause intoxication, sedation, or serious side effects, and this is due to the fact that it's only a partial agonist. Buprenorphine is marketed under various brand names. Some of the brand names are Suboxone and Subutex, and a lot of the time buprenorphine comes in a film formulation, and there's a demonstration film shown on the right here, but the film formulation is typically a combination product that contains both buprenorphine and naloxone, and naloxone is the opioid reversal medication, and so it's kind of like, well, why is that in there? It actually reduces concerns for diversion of the combination buprenorphine product. So the naloxone, naloxone itself has a very low oral bioavailability, so if you're taking it in the film version with buprenorphine, that part of the medication, the blocker, the naloxone, is not going to be active, so you're just going to get the effect of the buprenorphine, but if somebody takes Suboxone, you know, if they dissolve it in a liquid and inject it in any form, that naloxone will be active and immediately send that person into withdrawal, so that's kind of the rationale between by having both of those products in there. And a huge benefit of buprenorphine is that, unlike methadone, you don't have to go to a clinic daily. We actually prescribe this to people, and they can just go pick it up from the pharmacy. We will go much into this much more in detail, but it used to be that to prescribe buprenorphine, you had to have a special extension of your DEA license called an X-Waiver, but they actually, the government just did away with the X-Waiver requirement as of January of this year, so we will kind of discuss the implications that eliminating the X-Waiver might have and how that will play into the opioid epidemic. The last medication I will go over is naltrexone. Naltrexone is a full antagonist medication that binds preferentially to opioid receptors, but it doesn't stimulate them, so it essentially just binds to the receptor and occupies it and prevents other opioids from binding to it. It doesn't, since you're not stimulating the receptor, it doesn't cause any dependence, intoxication side effects, and since it's not an agonist at the receptor, it's not alleviating withdrawal symptoms, and it is not causing the side effects that would be typical of an opioid medication. It's available in an extended release injectable called Vivitrol that you give every 28 days via a gluteal injection. The thing with naltrexone, I think I go into this more in some of the coming slides, but it has a pretty high treatment dropout rate, and I will discuss that more in a minute. So how effective are these medications? So when looking at treatment with the agonist therapy, so methadone and buprenorphine, people are less likely to die when they are in treatment with the agonist medications versus when they're not treated. So studies have shown that there's a 50% reduction in mortality both all cause and overdose related when people with opioid use disorder are on agonist medications, and that's huge, right? Studies also show that people in treatment with the agonist therapies have reduced rates of other opioid use and reduced cravings. They have reduced injection drug use, which is important because then therefore they would have a reduced risk of infectious diseases like HIV and hepatitis C, and these people have improved social functioning and a better quality of life overall. Interestingly, methadone has also, there's mixed, some mixed evidence, but it has been associated with reduced levels of criminality. Part of the reasoning for that might be that these individuals are engaging in daily care of some form at the OTP clinic, and being more involved in care in general might be associated with reduced criminality. So it's interesting. So this is where I was getting at with the naltrexone. So naltrexone may be associated with reduced opioid use, but there's really not been a long-term benefit in mortality, and this is mainly because of the very high treatment dropout rate. People really do not stay on either oral naltrexone or the long-acting injectable medication. A 2018 meta-analysis of 34 studies examined the long-acting injectable form and showed that half of patients had discontinued their treatment after only receiving one injection, so after one month, and only about 10% of patients were adherent to the long-acting injectable after six months. So the best medication just in general to treat somebody, I know we say this in psychiatry probably a lot more than other professions, but the best medication to treat somebody is going to be the one that they actually want to take, and there's really better data at this point for methadone and buprenorphine, but naltrexone and the long-acting injectable form of it are useful in treating patients with opioid use disorder. Perhaps the long-acting naltrexone might be more useful in populations that are at high risk for relapse or fatal overdose, such as the post-incarceration population. When people are just released from jails or prisons, they have an exponentially higher rate of opioid overdose, so something like a long-acting shot of naltrexone could be useful there. So yeah, data suggests that use of the agonist medication should continue as long as they're beneficial to the patient without adverse effects. So despite all the benefits of medications for opioid use disorder that we've just gone over, these medications are largely underutilized. A 2019 study estimated that one out of four people who needed a medication for opioid use disorder actually received it. So despite increasing opioid overdose deaths, these medications are not being used in the people that really need them, and certain groups of people consistently have even lower access to these medications. Some of these groups include just younger people in general, people involved with the criminal justice system, pregnant women, racial and ethnic minority individuals, and people that live in rural areas of the country. There's a lot of barriers to receiving these medications for people. Stigma plays a huge role, lack of providers willing to prescribe, insurance or financial issues. Yeah, so to go over some of the barriers to receiving these medications. So I was talking before briefly about how you used to be required to have an X waiver to prescribe buprenorphine. The X waiver was a special extension of your DEA license. In order to get an X waiver, you would need to complete like an eight hour, I believe it was around eight hour training course, and you had to like apply for the specific X waiver. But data looking at people that had X waivers and if they were using them wasn't that great. So a 2018 study estimated that 40% of US counties had no wavered buprenorphine prescribers, and only 5% of US physicians in total had an X waiver. And then also 56% of the counties with the greatest needs for buprenorphine likely had an inadequate capacity to prescribe. So a lot of these, a lot of people that did have X waivers weren't using them. The training requirements were loosened in light of the COVID-19 pandemic. In April 2021, the US government, I believe they made it so that you could treat up to 30 patients without actually having an X waiver or taking the course or doing anything. And then in January 2023, the X waiver was completely eliminated as part of the Consolidated Appropriations Act, which is also known as the Omnibus Bill. So yeah, highlights of this bill. So now to prescribe buprenorphine, you only need a regular DEA number. The X-Waiver number no longer required. There's not caps on how many patients you can treat. So another thing with the X-Waiver is there was sort of a stepwise progression of how many patients you could treat with your waiver. It would go, like you could treat up to 30 and then for certain requirements, you could treat up to 100. There's no longer any patient caps. And states may oppose their own additional requirements if they choose to do so. And there's some new training requirements to get a DEA license in general. So this is going to go into effect June of this year. So in order to either renew or get a new DEA license, you will need to complete eight hours of training from an approved organization on opioid or other substance use disorders, or be board certified in either addiction medicine or addiction psychiatry, or if you graduated within five years from a medical school that basically as part of your training already had curriculum about opioid or other substance use disorder. So why are providers hesitant to prescribe buprenorphine? So I was already mentioning that even after receiving X waivers, not all waivered prescribers were prescribing buprenorphine. A 2022 study that looked at 2020 data from VA hospitals showed that nine months after actually receiving the X waiver training, only two thirds obtained the X waiver and of those who did, only half of those prescribers were providing buprenorphine to patients. So it's interesting to think about, right? Because removing the requirement to have an X waiver might not have the intended policy effect that one would naturally assume would happen, you know, if we eliminate the requirement for an X waiver, you know, people must have more access to buprenorphine, right? And while that might be true, this data is kind of worrisome because removing the X waiver, clearly the X waiver wasn't all of the problem. It's just a concern if there are waivered prescribers that aren't providing buprenorphine and there's other barriers to receiving this medication. So some of the reasons providers that can don't provide buprenorphine, so either misinformation or lack of information. Some providers, you know, despite the fact that they had to do a training course to get the X waiver, some providers really just don't, they report that they don't have a good understanding of the mechanisms of action of these medications and the need for them and how they specifically work. Some providers unfortunately still view these medications as replacing one addiction for another or that these medications aren't part of living like a clean or sober lifestyle. Providers, yeah, might have limited knowledge about managing opioid use disorder. It's a lot different to sit in a class for eight hours and maybe half listen to what's going on versus sitting in your office and actually prescribing this to somebody. You know, and we don't want to cause harm to patients. So if you're not feeling confident about prescribing it, it makes sense why you would be fearful of causing someone harm. There are concerns for diversion. Buprenorphine does have a street value and people do obtain it illicitly. However, the abuse potential for buprenorphine is much lower than that of other opioids. And there's actually been some studies looking at this. So in one study of patients who had abused opioids over the past month, 97% reported that they preferred to use other opioids that were intended for pain relief, like fentanyl, hydromorphone, morphine, over buprenorphine. And the concern for diversion of buprenorphine can be reduced by doing various like evidence-based diversion practices. So random urine drug screens, random medication counts, things like this. And another huge hesitancy which Dr. Morris will discuss in much more detail is a fear of legal precautions from prescribing these medications. So providers are hesitant to provide bup because they either don't want to get in trouble for providing it or not providing it. And finally, stigma. So throughout psychiatry in general, stigma is huge. In addiction psychiatry, even more so. The stigma comes from all angles. It comes from peers in the addiction community. It comes from medical providers. As I mentioned before, with the agonist therapies, being on them can be viewed erroneously as not being clean. Some support groups won't allow people in them if they are on one of these agonist therapies because they're not clean and sober. So it's just things to consider in regards to why providers aren't providing buprenorphine and other medications for opioid use disorder to patients. And with that, I will turn it over to Dr. Morris to discuss the legal consequences of inappropriate prescribing practices for these medication. Morning, everybody. My name's Ned Morris. I'm an assistant professor of psychiatry at UCSF. I'm one of the physicians who works in the San Francisco jails taking care of patients there. I'm glad to see you all here this morning, bright and early, 8 a.m. on Wednesday. So we're gonna be going through examples of what are some legal situations that can arise with medications for opioid use disorder. All of us up here take care of plenty of patients with addiction. I imagine many people in the audience as well. And it's something we've come across frequently is reasons why our colleagues in the field often do not wanna use these medications, take care of these patients, or even think about addiction in their clinical practice is concerns about what are the legal ramifications of doing so. So one of the main legal issues that comes up with these medications is often in criminal justice settings. This is an article by attorneys where they're talking about the ways in which the legal system treats people with substance use disorders, particularly the medications for them, differently than other conditions. So let's take an example. In many places across the country, if you are diverted from jail and you go into a drug court or other treatment court, you might have a judge, a prosecutor, or the treatment team in that court telling you you cannot take buprenorphine or you have to come off of methadone, right? And this is a quote from that article. Imagine a judge ordering an individual to alter the dose of physician-prescribed heart or blood pressure medication. No one would tolerate such conduct. I don't know if anyone here in the audience has heard of a judge telling you to change your dose of amlodipine. I personally have never heard that. But for some reason, buprenorphine, methadone, naltrexone, those are things that the legal system often tells patients what they can and cannot use. So this has been kind of the front lines of some of the legal arguments, and we're gonna get, I imagine not everyone here works in criminal justice settings, but we'll talk about community settings as well in terms of broader clinics and hospital settings. But a lot of the front lines of the litigation over medications for opioid use disorder have been in criminal justice settings. So you can see here on the left, federal prisons were told to provide addiction medications. Instead, they punish people who use them. California prison doctors fear drug treatment program could create, quote-unquote, new addicts. That's about expanding access to MOUD in California prisons. Opioid users are filling jails. Why don't jails treat them? And so this is an article from 2017. Fewer than 1% of jails and prisons allow these types of medications. And so this is, again, one of the most glaring and striking examples of the need for these medications, and yet the lack of use of them in legal concerns. So this is from a Vox article from a few years ago. So it's not fully up to date, given that there's been, we'll talk about some of the litigation and some expansion, actually, in the use of these meds. But just a few years ago, this is what the landscape of prison settings across the United States looked like. And so if you see, most of the gray ones means literally none of these medications are available if you were to be incarcerated in their prison system. Rhode Island is the one dark blue one, which offers all three. And they've kind of generated a lot of press and a lot of attention by offering all three very early, several years ago. And then you can see kind of the light blue ones. They might offer naltrexone. One reason why jails, prisons, other criminal justice settings sometimes are more open to naltrexone is it's not a controlled substance. And so it can't, quote unquote, be diverted. As Dr. Schaefer mentioned, there's a lot of stigma surrounding these medications and, quote, substituting one addiction for another. And so that's one reason why, in a lot of these settings, you actually see openness to naltrexone, but not the other ones, because those are not actually opioid-like medications. All right, so what's going on in terms of some of this litigation, some of the legal action? How does this apply to you, particularly if you don't work in criminal justice settings? And so what we see over the last few years is not only with the opioid crisis that Dr. Schaefer showed, but in terms of these lawsuits. And here's one quote. This is a recent article in the Journal of American Academy of Psychiatry and Law. The evolving medical legal precedent for MOUD in jails and prisons, but this is now kind of emanating out into the community. With evolving clinical evidence and a national dialogue, a shift in judicial and societal standards of what constitutes appropriate medical care for OUD appears to be underway. And I'll talk in a few slides about what that means for community settings as well, but essentially it's becoming increasingly recognized in court legal systems and in broader settings that these treatments are part of the standard of care. Rather than I'm just referring to this person to detox, or I'm just gonna basically manage their withdrawal, more and more that's becoming, how do I phrase it, less and less acceptable when facing scrutiny in court systems. How did these challenges emerge? And part of the reason you might be wondering, well, why are jails and prisons such a frontline? Not only, one, there's such a high prevalence of people with substance use disorders in these settings, but also it's kind of the front lines of determining people's access to care because they are trapped there, right? And so theoretically, someone in the community, if you have a psychiatry clinic and somebody has opioid use disorder and they come to you and you say, I don't treat that, good luck. I don't recommend that. I think that's inhumane and not evidence-based care. However, if you were to do that, you could tell the person, here's a handout of other places you can go, right? And that person might be able to go there. And so it's harder to make a case against you as the psychiatrist turning that person away because they have other options, right? Jails and prisons, they don't. You are literally confined and trapped. And if that provider tells you, I'm not offering this, you are trapped, right? And so that is where a lot of these legal challenges come out of. Some of the frameworks from a legal standpoint that also apply in some context to, particularly the last one to the community settings. So the Eighth Amendment, less so, that's prohibition on cruel and unusual punishment. That's typically used for people who have been sentenced for crimes already. So that's often in prison populations. The 14th Amendment is usually how the Eighth Amendment is actually applied to pretrial detainees. And so that's equal protection or due process. And the due process clause is what's usually used there. And the Americans with Disabilities Act where substance use disorders are typically considered to be a disability in terms of people's ability to access public entities and public accommodations. And so that's one that has huge ramifications. We'll talk about in a bit for broader community settings as well. This has become such a major issue. This is actually from the US Department of Justice. They've released this basically, like frequently asked questions about medications for opioid use disorder and treating people with opioid use disorder related to the Americans with Disabilities Act. And this applies not just to jails and prisons, but all different settings. And they give various examples of acts that they would consider to be illegal and that would not qualify. And we'll go through some of those examples. But essentially going through all of the different protections that the ADA offers for people with these medications. So here is one famous example. There's many different kind of quote unquote landmark cases you might find online about people with opioid use disorder. This was a woman who was in the state of Maine who was sentenced to jail. I believe it was like for 40 days. And essentially she had been taking medications for opioid use disorder and finding them to be beneficial. She hadn't relapsed for years. And then was essentially told that she had to be tapered off of buprenorphine during that jail sentence. And essentially sued for access to medication during that time. This went through various courts. So here you can see the District Court of Maine right here. And so she sued the county, went through the Federal District Court, went up to the Appellate Court for the First Circuit. And actually the courts agreed with her, literally ordering the facility to provide that medication to her. And so this is one example where historical practice, as Dr. Schaefer mentioned, in many places across this country, in jails, prisons, but to be honest, in hospitals, clinics, nursing facilities, is to say, sorry, we don't do that. And increasingly that's being recognized as not only poor medical practice, but also in some situations, illegal. And so now we see lawsuits across the country. So Massachusetts prisons agree to extend medication for addiction treatment after a lawsuit. Lawsuit may compel opioid treatment in New Mexico prisons. A person incarcerated in Kansas will be allowed opioid addiction drugs. And so you see, this is generating lots of attention across the country, the ACLU getting involved. And this is basically states across the country are facing lawsuits over access to these medications in jails and prisons and elsewhere. This is a research letter that came out in the JAMA network. And what you see here mainly is in the bottom right part of that figure, but is essentially the massive increase in the use of buprenorphine. It still is far, far, far underutilized as Dr. Schaefer mentioned compared to what it should be. But not only do you do increasing attention to the opioid crisis litigation across the country, they are becoming more available in these types of settings. And so again, you might be sitting here saying, well, okay, I don't work in a jail or prison. Like how does this apply to me? This is actually occurring. And again, this entire sequence of slides here is about under prescribing, not providing a treatment that you should be providing to patients who need it. This also applies outside of carceral settings. So here's an example is skilled nursing facilities. Many folks I imagine here in the audience, but also us on this stage have had situations where we have patients who are hospitalized. They're benefiting from buprenorphine or methadone or whatever. And we have that call from social work who says, hi, they're going to insert a skilled nursing facility. They have a policy that people cannot be on that medication. What do you wanna do? And that becomes the nightmare of trying to figure out how do we place this person and how do we get them out of the hospital when the one place they're supposed to go is gonna take away a lifesaving medication. And that is common practice in many skilled nursing facilities. You can see here on the right, this Annals of Internal Medicine article, which they've described as medical complicity with discrimination. And actually now there's been massive lawsuits and settlements here on the left. I believe that's the nation's largest nursing facility system. And then also the US Attorney's Office there in Massachusetts, so federal attorneys are essentially going after facilities when they do things like this. And not only with skilled nursing facilities, what I showed earlier with that ADA, Department of Justice kind of advisory they released, they have released ways for reporting when people come across these things. So for example, if you are in your hospital and you are taking care of a patient and a skilled nursing facility is refusing to accept a patient because they're on one of these medications, that is one of the ways that leads to these settlements is when clinicians and health professionals raise concern about that and actually report that for investigation. Okay, so that's under prescribing. Sure. Sure. So I think we're being recorded. I'm supposed to repeat it, right? It was a great question from the audience about seeing the validity of lawsuits for like a one month or 40 day sentence or something. But what about 20 years, right, if somebody's behind bars? Is there a reason to keep someone on medication for that amount of time? Do they have legal arguments? Obviously, not being a federal judge overseeing these cases and just as a clinician, my suspicion is you would still have a very, very valid legal case because we don't deny people access to transplants. We don't deny them access to surgery. We don't deny them access to asthma treatment, even when they're in prison for 20 years. And having worked in jail and prison settings, substance use does not stop when people are behind bars. There is a significant amount of substance use that happens when people are incarcerated, and so even overdoses, even deaths. And so if people are craving, if they still meet opioid use disorder criteria that they're craving, they could potentially use, they could die from overdoses, that's a situation where a treatment is beneficial to that person. And so it's a great question of, well, different timespans, different contexts, obviously, affects how people think about this. In California, there actually, even in the prison system, was administrative debate going back and forth about access to medication for opioid use disorder for people on death row, which starts getting into very confusing legal arguments there. But essentially, my response and point there would be, if it's medically indicated, whether you're there for 40 days or 20 years, people deserve access to the same quality of care behind bars. Does that make sense? Any other questions before I go on to the next part? OK. So the next part we're going to talk about is overprescribing. And this is, so we've gone through underprescribing. You have people who need help. They are not getting the medications that they need. We've talked about a little bit in this presentation and other talks that we've done as a group where, unfortunately, the field of psychiatry often ignores people's substance use, doesn't talk to people about them. In our clinic visits, in our hospitals, even in our, at least in my training, did not have a lot of exposure to medications for opioid use disorder. And people who present with what we think is depression, insomnia, suicidality, things like that, is often actually acute manifestations of withdrawal. Sometimes even people leaving the hospital before medically advised is due to nicotine withdrawal that we don't talk about. And so I think it's very important for us as a field to look at the ways in which we all underprescribe. Overprescribing is the opposite problem, handing these medications out left and right without appropriate controls. And so the top is a schedule three controlled substance. That's buprenorphine. I should have included methadone, which is schedule two. But yeah, you have to think. If you are prescribing these medications, it's like prescribing any controlled substance, right? Benzodiazepines, other types of opioids for pain relief. You have a variety of legal bodies that are overseeing what you're doing. The DEA, they're going to be monitoring, do you have a DEA license? Are you prescribing in normal amounts? Are you checking, at least in California, we call them cures reports. But other states is your, basically, state database of where people are picking up controlled substances. Medicare, Medicaid regulations on how you're using these medications. Also, just basic malpractice concerns, right? Are you actually following the standard of care? If you are prescribing 1,000 milligrams of buprenorphine to somebody, that would probably not be the standard of care. I don't know anyone who would do that. So these are all different concerns that, again, people tend to magnify on medications for opioid use disorder for some reason, but they apply to any substance that you use. If you're prescribing lorazepam, alprazolam, any of these medications, you need to think about all of these things, right? OK, so there's some really out there examples that I would hope would be fairly obvious if you're prescribing these medications. This is a lawsuit filed in eastern Kentucky about different clinics providing medications for opioid use disorder. And essentially, what the attorney general in that state alleged is this is one example where they monitored at least one of these clinics on a business day in 2017. The owners wrote 136 buprenorphine prescriptions to Medicaid recipients. All of the 136 prescriptions were for the exact same dosage, according to the lawsuit. And the concern here is not actually practicing medicine, right, not actually meeting with patients, checking in on how they're doing, conducting an assessment, developing a personalized plan. As Dr. Schaefer mentioned, thinking about every medication. Tylenol has side effects, right? But these medications do as well. Thinking about what is the appropriate dose for someone. And so it's very, I don't, I was not involved in this case and don't know who these clinicians or even the attorney general were, but it's very concerning if they were to be identifying 136 people in a row who seem to be getting the exact same treatment. That's very odd when you're prescribing a controlled substance, particularly to people receiving Medicaid. And that's an example of federal oversight. Here's another example. DEA raids clinics, arrests four doctors. This is from 2014. And so in charging documents, authorities accused the doctors of illegally providing patient prescriptions for buprenorphine in exchange for cash. And so this is what at least the police task force kind of alleges. There were no physical or mental exams. Patients walked in, paid their cash, and walked out with prescriptions. And so again, this gets attention because with the opioid crisis, pill mills, and particularly as clinicians, I remember when I was first prescribing medications for opioid use disorder being kind of stressed out about, man, what are the regulations I have to follow? But again, you could apply this to any controlled substance. If you were doing this with morphine, with benzodiazepines, any medication, if you have people who are walking in, you're not doing an exam, if this is true, and you are just taking cash, with any controlled substance, that's a concerning thing to be doing. And so these are potential consequences. This is a Supreme Court case that literally just came out within the last year. And essentially, it was a group of health professionals who, I'm blanking on the dates, it was over a couple of years, had prescribed over 400,000 opioids in their local community. And what happened is the federal government went after them essentially for negligently prescribing all these medications. And what this court case was, and went up all the way to the Supreme Court, Ron v. United States, and essentially clarified what is the degree to which a clinician or health professional must know that their conduct is contributing to unauthorized practices. Is it simply that, from an objective standard, someone could look at that and say, oh, wow, that's kind of sketchy? Or did the person actually have to know that what they were doing was illegal? And so it's kind of this subtle legal nuance. But this generated a lot of attention in the medical community, because it applies to using these types of medications, as well as many others that we use in psychiatry. And so what the Supreme Court said is, after a defendant produces evidence that he or she was authorized to dispense controlled substances, so essentially, if you have a DEA license, and you're a licensed clinician, if you're prescribing these medications somehow without those, then that's probably not great, the government must prove, beyond a reasonable doubt, that the defendant knew that he or she was acting in an unauthorized manner or intended to do so. And so this actually was met with relief by many in the medical community, because it essentially was, rather than someone else can look at your prescribing practices and say, whoa, that's not what I would do, and that's concerning, that should be illegal. It instead is that you, as the health professional, they have to demonstrate that you knew or intentionally knew that what you were doing was unauthorized or was wrong. And so the reason that this is a subtle difference that's important is because with the opioid epidemic, some of the standards of practice are changing very, very rapidly. I can give you one example. When I was a resident, we used to do very, very slow, cautious up titrations when we were starting people on buprenorphine. They would come in and withdraw. We would give them two milligrams. We would repeat a cow's. We'd give them another two. This would be like an all-day thing in clinic. Fast forward just four or five years now that I'm in practice, and given fentanyl, there are local practices where people are started on 16 milligrams immediately. And they start at 16 high-dose buprenorphine tapers. And that's been published from Highland Hospital and other places. And so this Supreme Court case here is very reassuring in some situations where if you were to do something like that, someone can't point at you and say, that's not the standard of care. They would have to show that you were intentionally or knowingly doing something that was either illegal or unauthorized, such as people coming into your practice without medical exams and accepting cash just for buprenorphine. And so this JAMA article summarized the Supreme Court decision. In other words, rather than simply showing that a physician's prescriptions did not conform to professional standards, prosecutors must prove that the physician intentionally wrote prescriptions without any legitimate medical purpose. And so that is a very, very different standard, which many in the medical community were reassured by. The last thing that I'm going to go through is, we've focused a lot on the big three that are approved and typically used by the FDA, so methadone, buprenorphine, naltrexone. But we forget that there are other medications that are often used surrounding opioid use disorder that are just as important and for all of you to think about in your own practice as well from a legal standpoint. So naloxone. And historically, naloxone has faced a lot of resistance in terms of its distribution in the United States. Here on the left is a news article about Governor Paul LePage in Maine. They had passed a bill to increase access to naloxone, and he vetoed it. In writing in his veto, he said, you can see this little quote in the subheader there, naloxone does not truly save lives. It merely extends them until the next overdose. Similarly, you can see here on the right, this is an Ohio sheriff, and he generated a lot of buzz because he said that his officers would not carry naloxone. He was basically saying, we're not going to do that. And he was quoted by NBC News as saying, quote, all we're doing is reviving them. We're not curing them. One person we know has been revived 20 separate times. And so you can see massive resistance. This is several years ago to even considering using naloxone. What are we even doing here? To go further, this was a bill that was proposed in Maryland, and it would enable penalties if you received naloxone three times or more. So essentially, if they identified you as somebody who had already received naloxone in the community like three times or more, you would either be ordered into a treatment program, or you would face a fine to help recoup public losses. And so this representative who had authored this said, quote, keeping someone alive should not be confused with saving someone's life. And so this may sound like kind of very specific egregious examples of kind of the stigma and misunderstanding of how these medications work, but the broader public feel quite similarly. This is from 2019, it's a survey from earlier, but an online survey, and 400 US adults, and more than half of US adults who are surveyed here believe that having naloxone enabled people to misuse opioids. And so again, this is not just particular representatives or sheriffs or governors, this is the broader public has concerns about this as well. And this is a paper that Dr. Kleiman and I worked on a couple years ago. And I'd say ours is more a symptom than a cause of changing attitudes towards these things. And so seeing how do these medications work and the importance of them, and I'll get to the legal implications of some of these changes and attitudes, but it's essentially that these are lifesaving medications where you can literally save someone's life, and rather than saying we're extending it until the next overdose, these need to be available, and that's what we're gonna get to. So one comparison we made is in recent decades, public policies have promoted the distribution of automated external defibrillators across the United States, including in schools, gyms, and state buildings to prevent mortality from cardiac arrest, and yet you don't see sheriffs, governors, representatives arguing that AEDs just extend life until the next cardiac arrest or propose penalties if somebody's been defibrillated multiple times, right? Why are there different standards for the different medical interventions that we use for people? And so fortunately over the last few years, there actually has been a dramatic expansion in distribution of naloxone across the United States. And so this is just one paper looking at literature on naloxone access in the US, but essentially this is the number of states with naloxone access laws expanding access to this medication, and the kind of fun, various-looking colors is the different regions, and essentially you can see different ways in which states are now expanding access to this medication. So third-party prescribing, better distribution by pharmacies, decriminalizing possession, dispenser immunity, prescriber immunity, and so all of these different ways to allow people better access to this medication. Here's just one example giving numbers at how rapidly this is all changing. In 2018, this is the California prison system. They had over 34,000 people released from California prisons. Two of them, so 0.005% were given naloxone when they left the prison system. Just cut to a couple years later, so this is last year, over 20,000 people received naloxone out of 24,000 releases, so 84%. So that is a massive shift in terms of availability of these medications, and we're talking about from a prison system, and this is just reflecting broader societal changes around access to these meds. And the reason why I think this is important is for you all as clinicians, whether you work in a hospital, if you work in a clinic, if you have a private practice, I think you should think about, do I have access to naloxone? Is that something that I carry? And there's several reasons for this. One, the FDA just approved naloxone for over-the-counter sales, so it's becoming much more widely available, which is great. There's concerns about price and other access concerns, including if it's kind of put behind glass shelves and whether that still stigmatizes people. But over-the-counter sales is hoped to dramatically increase access. And this part on the right is what I'm pointing out that's also happening across the country is legislation or proposals to actually require public places to have access to these. So if you remember the AED example I was bringing up, increasingly, places are requiring having naloxone in first aid kits. So we're thinking on, is this gonna be expanded on airplanes, at the VA, at restaurants, at bars? And this next part is, there's a very interesting episode of The Daily, the New York Times podcast, if any of you listen. And essentially, they talked about the dramatic expansion of access to naloxone and what are the legal implications. And so this is one part of that conversation. And frankly, I think the more people use it, the more it gets packed into a first aid kit on an airplane, at a restaurant, in your house, I think it just becomes normalized. And you know what I think is going to make a huge change? The first time someone files a lawsuit against an airline, a restaurant, or an office building because they didn't carry Narcan or naloxone and could have saved someone's life. And so this is something for the medical community that we think about where if you are holding yourself out to be some sort of substance treatment facility and yet you do not have access to naloxone there, that is something that could potentially raise legal implications. Similarly, as a psychiatric clinic, this is all hypothesizing in the future, but looking at existing case law and how rapidly this is changing, if you are holding yourself out to be a mental health professional who takes care of people's mental health and yet do not talk to patients about their substance use, about treating their substance use, which is a key determinant of mental health, that would be something from a clinical standpoint I'd be concerned about. But we're seeing here already rapidly if a restaurant would be required to have naloxone, why wouldn't a psychiatric unit? Or why wouldn't a psychiatric clinic? And again, these are things that could or could not happen in the future, but I think are important things for us as a field to think about given how rapidly this landscape is changing. Alrighty, so I'm gonna stop rambling. I'm gonna hand it over to our colleagues here who are gonna be doing a case vignette. Dr. Klyman, you have now? Yeah, so hand it over to Dr. Klyman, thank you. Thank you, Dr. Morris. My name's Robert Klyman, I'm an addiction psychiatrist at the University of Toronto. And as we go through these case discussions, nothing that I say in these case discussions is intended to be legal advice within the United States or clinical guidance within the United States. We do have fairly different legal frameworks in Canada. So the first case that we're gonna be talking about is a patient experiencing opioid withdrawal in an emergency department. So imagine that you have a 38-year-old male who presents to the emergency department with forearm cellulitis and a forearm abscess. He has a history of opioid use disorder that's been well-documented in the charts. And he tells you that he has injected opioids and that's probably the cause of the cellulitis and the abscess. He has no other medical conditions. And he's previously taken buprenorphine naloxone. And when he's taken this in the past, he has experienced precipitated withdrawal or an increase in the withdrawal symptoms that he's experienced. And this can often happen or can happen when someone is exposed to a full agonist opioid like fentanyl and buprenorphine naloxone has started. Buprenorphine is a partial agonist to the mu opioid receptor. And so the displacement of the full agonist by the partial agonist can sometimes exacerbate withdrawal symptoms. He is not at all interested in taking buprenorphine naloxone again. He prefers not to take any medication for opioid use disorder rather than restart it. His emergency department team has determined that he has to be admitted to the hospital or at least remain in the emergency room. His abscess is drained and he started on IV antibiotics. And because they're not sure whether he's gonna need a prolonged admission, he's brought to the short stay unit of the emergency department for IV antibiotics. You're either the psychiatry consult liaison team or the addiction consult service within the hospital. And you're asked to come and assess this patient. This patient has a history of opioid use disorder and they're currently in opioid withdrawal. They have a COWS or a clinical opiate withdrawal scale score of 12, suggesting that they're in mild to moderate withdrawal according to the scale, but they're actually in quite a lot of discomfort. As a service, as a team, you recommend that this patient would benefit from methadone and the patient is eager to start methadone and interested in starting methadone. And so, he's given a first dose of methadone, 30 milligrams, within the emergency department. This patient experiences, sorry, yes. So I'll just repeat that for the recording. So the question was, in Canada, can you start methadone for opioid use disorder? You potentially can't do that in the United States, given that you're starting it for opioid use disorder. We'll actually talk about both the Canadian and the American context just on the next slide. No, not a problem, but we'll definitely come to that. So the patient experiences partial resolution of their opioid withdrawal symptoms with the methadone of 30 milligrams. Their cellulitis rapidly improves after the abscess has been drained and with the IV antibiotics that they've received over the next two days. They are transitioned to oral antibiotics by the primary team that's looking after them. And in discussions with the primary team, they've informed you that this patient is actually ready for discharge with outpatient follow-up from an infection standpoint. They are provided with a prescription for oral antibiotics and a three-day supply of methadone, 30 milligrams PO daily with an instruction to follow up at an opioid treatment program. As you're thinking about this case, I'd like you to think about it in two separate streams. The first is, is this care clinically reasonable that this patient has received from an addiction standpoint? And then is this care legally permissible within the United States from a legal standpoint? And to try to separate those two concepts, is the care clinically reasonable and is this care legally permissible? So in terms of the first point, is this care clinically reasonable? Methadone is an excellent treatment for opioid use disorder. It's considered a first-line treatment, at least in Canada, that is equivalent to buprenorphine or it's an alternative first-line treatment for opioid use disorder. It has some advantages over buprenorphine and some disadvantages, but some of the advantages include that it has likely increased treatment retention over buprenorphine. It can be started while patients are, after patients have recently used fentanyl without the risk of precipitated withdrawal. And patients don't have to be experiencing the same level of withdrawal in order to start methadone because it's not a partial agonist. Importantly, it's an option for patients who are not interested in taking buprenorphine. That, as Dr. Schaffer mentioned, the best medication for opioid use disorder between methadone and buprenorphine is really the medication that a patient is going to want to take, is going to be adherent with, and is going to find benefits to their symptoms. And so in terms of is this a clinically reasonable practice, starting methadone within an emergency room, aside from the legal framework, is actually something that's very reasonable to do. There are some questions as to whether 30 milligrams of methadone is a sufficient dose to relieve the withdrawal symptoms and maybe you may have started at a different dose, maybe you may have increased the dose. But the actual practice of providing methadone within an emergency room and having someone take methadone afterwards is actually a fairly reasonable practice and it's one that we do in Canada frequently in our practice. But what is the legality of this practice in the United States? So back to your question, sir. There is something in the United States called the three-day rule. And this is an exemption to the broader question that was asked about earlier. So first, broadly speaking in the United States, methadone cannot be prescribed for the treatment of an opioid use disorder. It has to be provided through opioid treatment programs that are registered through the DEA, accredited and certified through SAMHSA as well. But there is a three-day rule, which the DEA has promulgated, that is an exception to some of those practices. And so what this rule is is that this rule is not supposed to prevent individuals who are in opioid withdrawal from receiving emergent treatment for their opioid withdrawal. And the way the rule was previously described, individuals could receive a narcotic drug for the relief of withdrawal symptoms for a period of not more than three days by someone who was not registered as an opioid treatment program. And an individual could only receive a single day at a time. And so this system permitted some emergency rooms and some clinics to provide and initiate methadone for the purpose of relieving withdrawal symptoms while the referral was being made to an opioid treatment program. And the DEA has actually changed this rule recently, or they've modified some of the aspects of this rule. And so just over the past year, the DEA has said that they're going to be creating exceptions to this three-day rule. So the three-day rule in itself is an exception to the standard opioid treatment program framework. But one of the aspects of the three-day rule is that you can only provide a single-day supply to the patient. And in fact, you're not allowed to provide a prescription, but you're only allowed to administer the medication to the patient. And so this exception to the three-day rule is that a DEA-registered practitioner can apply to the DEA for an exception in order to be able to provide up to a three-day supply of the medication in certain circumstances. This is not going to be a blanket exception that everyone can receive, but an individual would have to make an application to the DEA in order to receive this exception. And again, just as was described earlier, methadone cannot be prescribed, and so these medications would not be able to be prescribed under this exemption, but could be dismissed. And these exceptions have actually been put into practice. So this is an abstract from a paper at the Boston Medical Center where they have a rapid access clinic or a bridge clinic for individuals with substance use disorders. And what they've done at the Boston Medical Center is that they have used the three-day rule in order to provide a first dose of methadone for individuals experiencing opioid withdrawal and then made referrals to treatment. They provided their first, they started this program, I believe, in 2021. And here they describe the outcomes for over the first 100 patients that they've used this for. And as you can see, there were 150 episodes of care, 142 unique individuals who were treated, and there was actually a quite high retention rate. So among the people who received at least one dose of methadone in their rapid access addiction medicine clinic, ultimately 87% were linked with care and 58% of those individuals remained receiving methadone treatment at one month. And these outcomes suggest that this type of care can be provided within the United States framework so that individuals presenting to rapid access clinics or low threshold clinics can be presented with the option of whether they are interested in taking methadone or buprenorphine. And this provides substantial advantages. You can imagine that a patient is experiencing, is suffering from opioid withdrawal symptoms and they present seeking help and asking for care. And now they have, under this framework, they have the option to receive either methadone or buprenorphine, which is a really powerful way to increase their autonomy and increase engagement within the healthcare system. With that, I wanna see if anyone has any questions about that case before we move on to the second case. Okay, thank you very much, everyone. And I'd like to introduce Dr. Dill. All right, thank you. My name is Andrew Dill, by the way. I'm an addiction psychiatry fellow at Mount Sinai Beth Israel in New York. And we'll be going over a quick telemedicine case that kind of illustrates some of the difficulties or questions you might run into while prescribing buprenorphine via telemedicine. And this will be the last case, and then we'll go into any questions. Okay, so for the recording, your colleague is in a group practice and has been prescribing buprenorphine for a patient with opioid use disorder. They've had regular in-person appointments every one to two weeks. Your colleague was away on vacation, and as the covering physician, you renewed the prescription for a four-week supply with no refills after a quick phone visit with the patient. Unexpectedly, your colleague is required to take a further leave of absence for medical reasons. And for the next month, you're also asked to refill the prescription for another four-week supply. So in normal non-COVID times, what would govern the situation is the Ryan-Haite Act. This is from 2008. To prescribe a controlled substance, such as buprenorphine, a previous in-person exam by the practitioner is required. And after that, further in-person visits are not required by this specific act. So in this case, continuing telemedicine would be okay. And there's also the question of what to do if there's a covering practitioner. The act provides that you may prescribe without a previous in-person exam if you are this covering practitioner. And the specific definition is that you're prescribing on behalf of a practitioner who is temporarily unavailable. And the original practitioner must have evaluated the patient within the last two years. But this act did not apply during the COVID pandemic. With the public health emergency, this was essentially an exception to the act. And just to point out, there are other possible restrictions besides the Ryan-Haite Act. For example, state law, very state by state. Your state might be more restrictive in this respect. There is this website I found pointing out some of the relevant state laws. But again, this isn't legal advice. You should do your own diligence before prescribing like this. As one other example, let's say that you go on vacation, whether it's Canada, Europe, wherever. And you want to refill your patient's buprenorphine. Your malpractice insurance might have an issue with this. Possibly the DEA as well, that's unclear. And finally, just use your clinical judgment. Even if you could do something legally, it might be best in certain situations to have the patient come in in person. For example, if they're not doing well psychiatrically, if they've relapsed, things along these lines. And that brings us to the relaxation of the in-person requirement during the COVID public health emergency. There are some guidelines where they specifically mention buprenorphine. This is from their frequently asked questions list. Can a practitioner with a data 2000 waiver, an ex-waiver, and working outside the context of an OTP, treat new and existing patients with buprenorphine via telehealth, including use of telephone if needed? And the answer that they had was yes. If a practitioner has a data 2000 waiver, the practitioner may prescribe buprenorphine under the practitioner's data 2000 waiver while complying with all applicable standards of care. And just as a reminder, we have done away with the ex-waiver at this point. And there is a lot of uncertainty around this situation. It's something that seems to change month by month at this point, and we've ended up changing some of these slides as these announcements have been released. There was a proposed rule in February earlier this year where buprenorphine might continue to be an exception to the Ryan Haight Act in order to get it out to treat people who have opioid use disorder. According to this rule, they had suggested a 30-day supply for the treatment of opioid use disorder. That would be okay without an in-person evaluation or a referral from a medical practitioner that has conducted an in-person evaluation as long as it's consistent with other laws. So they received many comments on these rules, over 38,000. So that's something they're still trying to finalize. And the absolute latest from the DEA, they released something saying that a patient and a practitioner have established a telemedicine relationship on or before November 11th, 2023. The same telemedicine flexibilities that have governed the relationship to that point are permitted for an additional year until November 11th, 2024. So basically, you can keep getting new patients through November this year and treating them the same way that you would have during the pandemic. And then there's an additional grace period year after that. And in these announcements, there has been some language from the DEA really suggesting that they want to continue these flexibilities for the prescription of buprenorphine. We have this statement from the DEA administrator. Medication for opioid use disorder helps those who are fighting to overcome substance use disorder by helping people achieve and sustain recovery and also prevent drug poisonings. The telemedicine regulations would continue to expand access to buprenorphine for patients with opioid use disorder. And we have another statement here. They strongly support policies that promote access to effective and safe treatment for opioid use disorder, including through telemedicine platforms and ensuring continued access to necessary controlled medications past the COVID emergency. So I can't predict the future, but I think that they really will continue these flexibilities. And that brings us back to the case. So as a covering practitioner under the Ryan Haight Act, you may prescribe on behalf of your colleague who is temporarily unavailable, even without an in-person exam, because the colleague had done the in-person exam. But due to the extension of flexibilities that began during the pandemic, no in-person exam is required. However, consider whether this patient would benefit from an in-person visit. For example, in the situation here, the patient was being seen every one to two weeks, and probably the first psychiatrist in this situation had a reason to keep seeing him that often as someone new seeing the patient, it might be a good idea to have him come in to increase the engagement of care, for example. So this brings us to the key points, which we'll review quickly, and then we'll open it up for any questions. Medications for opioid use disorder are life-saving medications, but they're widely underutilized. As with any medication, medications for opioid use disorder can be under-prescribed and over-prescribed, but as long as you use common sense while prescribing buprenorphine, the DEA is not going to come after you. Recent policy reforms have brought use of medications for opioid use disorder closer to that of other controlled substances. Regulations are changing rapidly, and amid the COVID-19 pandemic, shifting legal precedents and evolving public opinion. Thank you. Thank you for such an excellent presentation. I have a private practice in Frisco, Texas. I see a lot of patients coming to my office for Suboxone, but they're also taking Adderall and Xanax and the benzos. So what are the, I want to help these patients. I want, so what is the best standard of care in this polypharmacy? I do treat a lot of VA patients, so VA has a very strict policy of no benzos. So they are willing to prescribe opioids, but for benzos, they will say go to your community provider. So I'm in a bind how to treat these patients in the most effective way and also in an ethical manner. Thank you. So I know that, and I'll see what everyone else thinks about this too. I know that it can often be very complicated when there's multiple prescribers in the mix. It can often be easier if there is one central prescriber for all of the psychiatric medications or the medications that are given for psychiatric indications. So if there were one prescriber for all three of those problematic medications, you could have a lot to work with and would not have to worry about another provider adding something in or what have you. It can be very difficult, especially with opioids and benzos because we know that often together those are a really bad combination for overdoses as well. A lot of the time, at least in my clinical experience, the patient would, in order to prescribe their medication for opioid use disorder, there would be terms such as reducing polypharmacy and getting on a better medication regimen to target inattention, anxiety, what have you with non-controlled substances. Does anyone else have thoughts? And I would maybe try to get collateral from other prescribers. And someone with opioid use disorder is really likely to relapse without suboxone. And in cases where I have had patients who are taking suboxone and then receiving medications like Xanax from other prescribers, it is a dangerous situation, but it's also dangerous to take away the suboxone. So you could just document the risks and benefits of continuing the suboxone. Thanks for that question. Those are really challenging situations for everyone involved, I think both for prescribers and then also for patients who can often feel like they're not heard or that their treatment requirements aren't being met. I can certainly speak more from the Canadian perspective. In our product monograph for suboxone, which is similar to the product label for suboxone in the U.S., does caution about the risks with combined benzodiazepine prescribing and the receipt of buprenorphine naloxone. That being said, it's really an individual determination with each patient based on their risk, what is going to be most likely to reduce their risk from harms. And for many individuals, the risk from opioid use disorder, as Dr. Dill mentioned, is going to overweigh the risks associated with combined suboxone or buprenorphine naloxone and benzodiazepine prescribing. So while engagement with patients and trying to address the benzodiazepine use, if in fact it is a use disorder, is important, trying to mitigate the overdose risk is going to be really important as well. And so we certainly do have patients who are co-prescribed buprenorphine naloxone and benzodiazepines. And it's thought that for those patients, that the risk of overdose from continued use of unregulated opioids surpasses the potential risks associated with buprenorphine naloxone in combination with prescribed benzodiazepines. But you can certainly in those cases reach out to colleagues, reach out to addiction medicine consult services, even for a one-time consult about the risks, and that's certainly an option as well. Almost all of my addiction colleagues would be happy to help with cases like that. And so reaching out is always an option in those cases. The last thing I'll just add is I completed training in forensic psychiatry, and throwing that hat on is documentation, I would say, is very important in this situation. Obviously, as with most answers in medicine, it depends on the case you're describing, right? If somebody comes to your clinic, well, I use opioid pills, risky, once or twice a month or something, and I'm worried about it, can I start buprenorphine, and I'm also on stimulants, I'm on benzos, I'm on all of the gabapentin, all of these things, right? You might say, well, let's figure out ways to reduce those risks, or is naltrexone a better option, or whatever, versus, as to Dr. Dill and Dr. Kleiman's points, if you have somebody who is injecting fentanyl every single day, that is probably a far bigger risk to that person's well-being and livelihood than the risks of being off of a stimulant or potentially, I mean, obviously, benzodiazepine withdrawal is different. But yeah, if you are having an open conversation with that patient, explaining the risks, these are risky combinations, but I think it's important, the risks outweigh, or the benefits outweigh the risks in this situation of keeping you alive, and we're gonna work on polypharmacy, I've looked through the state database to make sure that you're not going to multiple doctors, I've given you naloxone, I've explained the risks to the patient, that is very different than someone who walks into a clinic with benzos, stimulants, walks out with buprenorphine, like that would be more concerning. And so, yes, I mean, obviously, those kind of polypharm examples are, whether for medications for opioid use disorder or not, are stressful, but I would tend to agree of what is going to be the thing that's going to kill this person, and it's probably in most of those situations, the opioid use disorder, not the panic disorder, or the, you know, ADH, not to say that those aren't, you know, serious as well, yeah. Hi, Alexander Butrins, I work in addiction in Sweden. Very interesting to hear the similarities and the differences between how we work. I have a short question just regarding long-acting injectables. You didn't mention them, are they not available in the States, or do you just not use them? Yes, so we do have long-acting buprenorphine injectables. The brand name we have is Sublocade. It's a subcutaneous injection. It's monthly. It's true that it's not used as often, but I'm not sure how long it's been on the market. I'm not sure if maybe people have insurance issues with it, but hopefully it will become more commonplace. Yeah, so there's currently two FDA-approved long-acting injectables. There's the long-acting, or the extended-release buprenorphine, which is a subcutaneous formulation, and then there's extended-release naltrexone as well, which are both available in the United States. Interestingly, in Canada, only the subcutaneous buprenorphine is available, and we don't have the long-acting injectable formulation of naltrexone. Those two are available here. There is another agent that is currently undergoing the FDA approval process, which has been used in clinical trials. This is going to be another formulation of extended-release buprenorphine, which is currently available in some international jurisdictions. This has been used in clinical trials and has a new drug application with the FDA. It's been a game-changer in Sweden. It's done wonders, the long-acting buprenorphine, in order to include a lot more patients faster and get them into a stable regime. We've anecdotally noticed similar things in Canada as well with extended-release buprenorphine. We're waiting on the effectiveness data and some real-world outcome analyses, but those will hopefully be available shortly. Another benefit of it is that a person in our outpatient rehab had gotten that on their discharge, so that just provides another month of protection while they're settling into their next providers. I'll just add, in the U.S., even naltrexone injectable, which has been around for a while, these injectables are prohibitively expensive. I think on this stage, we all think it's very important to have as many formulations as possible to keep people well and to treat them, but on the other hand, if you have someone who is living on the sidewalk with no food, no shelter, no supports, and they are eligible for a $5,000 injection, but there's no housing, there's nowhere for them to eat, there's nothing else, it's a kind of sad reflection of our medical system. That's, in my view, has been the biggest factor precluding their use, is the expense. So I've worked in jails and prisons, and many patients, to Dr. Dill's point, would benefit going out the door with shots like this, but they are so expensive that you often can't even administer them, just because the pure cost, and so hopefully that's something that would come down in the future. I guess in prescribing buprenorphine in particular, I wonder, well, am I going to fall across red lines that I really don't, the DAA is going to find, I mean, you have a patient who really does have a, has not been able to control, be able to control an ordinary narcotics, doesn't really recognize it, you know, an older patient, I can give you an example, but just take my word for it. So then you'll never get them to agree that they actually have that condition. So obviously they're not going to go to meetings, and they'll even tell you, if you tell me I have to go to meetings, I'm not going to do it, I'd just rather not have anything. Well, that's not really good for them. And also people that, well, I don't like to go to meetings, I haven't gone to meetings yet, well, and I will get the blood, I will get the toxicology, are there some red lines I should be aware of that I might trip over? I mean, what you're, if I heard the question right, I think what you're getting at is that at the heart of addiction care and some of the debates across this country is to what degree should it be voluntary or coercive, where some people lack insight into what's going on in their lives as part of their illness, right, or are at certain stages in their life where immediately cutting off all use is not, they're not able to, and at least in my experience, and I'll let my colleagues speak here, oftentimes people who are really getting to the point of care in a lot of our clinics or in a lot of our clinical settings are often so sick when they can't access these substances that they are desperate for treatment. And so it's not, I at least don't, given I work in carceral settings, I can let them speak from their addiction expertise as well, but yes, there are obviously situations where people who have substance use disorders may not want to participate in certain aspects of treatment. To your point, different people respond very well to different treatments. There are people who go to 12-step programs, it completely changes their life, there are people who go and the first day they walk out and say that's not for me, right. Very similarly to the medications, some people buprenorphine, methadone, naltrexone, it depends on the person. But I think that's another sad reflection of how dramatic or awful this drug overdose crisis and drug-related crisis across the country has gotten is when people are so sick and so ill that that's when they're seeking treatment is literally to feel normal, to feel well, where they're not in a constant state of withdrawal. And so I think that's an important aspect of these medications as well, is helping people not only avoid the risks of death and overdose that we all talk about, but that daily struggle for survival and quality of life and feeling like a human being. And I think that's a really important part as well. I think when we were first fighting the opioid epidemic, I mean obviously the dream would to have somebody on, you know, an agonist therapy or an injectable or something along with doing therapy and all the other things, you know. But in terms of real world, if we can get them on a medication that can potentially save their life even if they're not engaging in some of the other very helpful, you know, specific modalities, we'll take what we can get. Hi there. Thank you for the wonderful presentation. I learned a lot here. As an early career psychiatrist just coming out of residency, I actually fall into the category of that you presented about having an ex-waiver and like not using it. One of my biggest concerns always is like trying to avoid the precipitated withdrawal. So I don't know if you have any clinical pearls for somebody about how to start that, how to avoid it. If you do run into precipitated withdrawal, what should you do from there? Thanks so much for the questions. The question was about precipitated withdrawal. And the concerns around precipitated withdrawal, so it's the idea that providing a partial agonist which is buprenorphine is going to exacerbate withdrawal symptoms that people are already experiencing by displacing a full agonist from the mu opioid receptor. The concerns around this have become magnified as fentanyl has spread across North America with the idea that there is something that's different qualitatively about fentanyl withdrawal and there's something different about the pharmacodynamics of fentanyl such that anecdotally patients are reporting higher rates of precipitated withdrawal when starting buprenorphine. In retrospective data, this is certainly the case. This has actually become more controversial as of late. Just in the last few weeks, there's been a larger prospective study of the initiation of buprenorphine among individuals exposed to fentanyl, and there were actually quite low rates of precipitated withdrawal. This was an observational study that was embedded within an IDA-funded clinical trial. You know, the guidance around initiating buprenorphine in the era of fentanyl or among patients who are exposed to fentanyl is that we generally wait for a higher COWS threshold, and so COWS is that Clinical Opioid Withdrawal Scale. Often we wait until a COWS of 13 before providing the first dose of buprenorphine if we're going to be providing a standard buprenorphine initiation. And then different hospitals or different settings have different protocols about sometimes waiting 24 hours since the last use of fentanyl or 48 hours since the last use of fentanyl. That can be really hard for patients to wait that long because you can experience quite severe withdrawal even if the COWS suggests that a score of 13 is in the mild to moderate range. You know, patients are really suffering by the point they have a COWS of 13. And so there's a lot of different approaches that have been tried and are being developed and have been proposed. One approach is something called microdosing or the microinitiation of buprenorphine, and so this involves providing small doses of buprenorphine or even smaller doses than the standard 2 milligram sublingual that's provided initially. The challenge with this is that someone has to continue receiving a full agonist opioid while they are using that microinitiation process. And so patients have to continue in an outpatient setting if they want to avoid withdrawal and they're just receiving half a milligram or 1 milligram of buprenorphine daily, they have to continue using fentanyl in order to avoid the withdrawal symptoms. So other approaches that have been tried are this macroinitiation or macrodosing. There's less data about that specifically in the fentanyl era, but people have proposed that. This is an approach that we use locally. So we have the advantage of we can offer patients the option to stay in a short stay unit that's attached to our emergency room. And so we can sometimes provide a bridge by using short-acting opioids, so providing hydromorphone to patients while they're in that setting. Again, this is Canada. This is a different setting than the U.S. But by providing hydromorphone, we can create that space so that people have 24 to 48 hours after their last fentanyl use while remaining comfortable and the fentanyl is metabolized and then do a standard initiation, which would be from a short-acting opioid to buprenorphine naloxone, which is more similar to the older buprenorphine naloxone initiations during the prescription opioid era. So there's a lot of different strategies that have been proposed. There's not a lot of comparative data between those. All of the strategies that I've just described are off-label in the United States and in Canada. And presumably would be in other jurisdictions as well. It's something that's really hard to do. And it's something that's hard to do in an outpatient setting. And so the concern is very reasonable. »» One thing I would just add is you mentioned being out of residency now. And I think this is an important reason for expanding this kind of training while you're in a supervised setting, right? It's a lot more anxiety-provoking and stressful to deal with medications, whether they're medications for opioid use disorder or not, if you've never seen them before. What's the likelihood you're going to be starting people on Clozapine all the time if you've never seen how to use it and never done blood draws and don't know the ANC levels? Probably not likely, right? Or to do electroconvulsive therapy or long-acting injectables. I think this is an important point, why expanding the degree to which our residency training programs, medical schools are training people about how to use these types of medications. And so it's great having interest once you go out and that's like an amazing next step. But yeah, to Dr. Kleinman's point, I mean, yeah, that anxiety if you've never used those medications and never seen it in training, totally makes sense. And that's one of the reasons we definitely advocate for people doing that while they're in a supervised training setting just because they can be more comfortable once they leave practice or go out into practice. »» When Dr. Schaefer was talking about the hesitancy that people have after completing the X waiver but then not prescribing, one thing that did come up with those studies, the people who did go on to prescribe, they cited things like mentorship, support from more experienced practitioners. Those were really important factors. »» Time for one more. So with the removal of the X waiver, have we heard anything about whether the DEA will still do inspections of prescribers of buprenorphine? Is that something that's going to go away or is that going to continue? I haven't seen anything on it. I just didn't know if you guys had seen anything in that area. »» Yeah. I don't know the specifics. We've all been talking about even during this, as we put this presentation together, as some of you in the audience, we keep getting emails from the DEA with new updates about what the latest prescribing guidelines are. The first thing I would say is my understanding is inspections by the DEA are very, very rare for clinicians in this situation. And we've been using medications for opioid use disorder for years and never faced one of these. Can they happen? Sure. But I think that's a big fear that people have is when they start using these meds, the feds are going to kick their door in and start going through their medical records. But it's a great question whether the recent changes affect how they're conducting those audits. My sense is that some of it would be more lenient given that the X waiver is gone, patient caps are gone, those types of things. But that doesn't mean, as we talked about up here, you shouldn't still follow the basic standards of care of conducting exams, you know, having regular record-keeping, documentation of your visits, prescribing within typical guidelines. But I don't know if anyone else here. Not that I know of. Thank you.

opioid use disorder

MOUD

methadone

buprenorphine

naltrexone

Adele Schaefer

Ned Morris

opioid epidemic

X-waiver

legal landscape

prison systems

telemedicine