Welcome to the Provider Clinical Support System waiver training for medication assisted treatment. This is module 1. My name's Dr. Steven Wyatt. I'm an Addiction Psychiatrist at Atrium Health in Charlotte, North Carolina, and I'm also a clinical expert for the Provider Clinical Support System. The overreaching goal of the PCSS is to train a diverse range of health professionals in the safe and effective prescribing of opioid medications for the treatment of pain, as well as the treatment of substance use disorders, particularly opioid use disordes, with medication-assisted treatments. The objectives of this module is to describe the epidemiology of substance use disorders, and the related mortality and morbidity in the United States. We'll also be discussing the criteria in which substitutes disorders are made or used to diagnose and the pivotal milestones of the treatment of opioid use disorders. Lastly, I'll be describing the benefits of medication-assisted treatment. So within the United States, there's a significant number of people that suffer from substance use problems. Approximately 20 million people have suffered with this disease, and these are diagnosable substance use problems. About a third of those individuals have a concurrent mental illness. Within the mentally ill or those with behavioral health disorders, there's about close to 44 million individuals that have mental health problems, and about a fifth of that group has a concurrent substance use problems. So there's a significant overlay between these two populations. The problems with opioids has a been significantly rising over the last 20 years and really started in the early '90s, but has risen dramatically over the last 15 years. The initial problems that we were seeing were primarily around natural and synthetic opioids. So these were pharmaceutical opioids. As we have made inroads in reducing that to a degree, we've seen a significant rise in heroin and other synthetic opioids. Now one of the problems there has not just been the fact that we have in some ways lower the use of pharmaceuticals, but we've also unfortunately created more of an epidemic in the United States around the use of opioids. Consequently, there are now more initial initiatives of individuals that are starting with heroin compared to 10 years ago, let's say, when folks were more up to have used the first opioid as a pharmaceutical opioid. More recently, we've had worsening problems secondary to the increase of fentanyl in the United States. The problem with fentanyl has been in part that it's easy to produce. It has very little way in the way of odor. It can be mailed, it can be sent through the US mail or through FedEx or really any other way that's very difficult to identify. So consequently, it's gotten into the drug supplies. Significantly, we're now seeing a tainting marijuana and cocaine and methamphetamine. So it's creating more of a problem, not only in the fact that it's so potent and results in increased deaths, but also that it can be the introduction to an opioid through a different drug. If we look at the diagnosis of substance-use disorders in the Diagnostic Statistical Manual, the fifth edition, there are specific criteria to first recognize that addiction is really a chronic and relapsing brain disease, and it results in compulsive drug seeking and use, and that often then takes place and really it's part of the diagnosis that it results in people continuing to use even though they've had harmful consequences to the use. It is a brain disease. It does change the brain. We can see that on neuroimaging and recognition of various neurotransmitter composition within the brain. Consequently, it then changes the structure of how it works. People will often say to me like they have pain or a problem. "Doctor, why do you think this is all in my head?" I'll say, "Well, in fact, it really is." I mean, we see each other, we hear each other through neurochemistry and so the very idea that a drug can change how we think is not harder concept. When you think about alcohol and certain problems that occur in our society around alcohol, we recognize that it changes how we perceive things. Consequently, that has a huge factor in the development of substance use problems, but also the way in which they affect people's lives. So these brain changes, however, can be very long-lasting and lead to very harmful and often self-destructive behaviors. So Addiction is a primary chronic disease of the brain reward system, resulting in changes in motivation. What do I really want? What are my desires at this point in my life? Consequently, it lang down memory of previous experiences, and that is all tied together. So these areas of the brain, the amygdala, in terms of emotional understanding of the response to a certain drug, then changes that take place in the nucleus accumbens which is the reward center of the brain, and all of this is tied into our prefrontal cortex, our understanding of what the experience was like. Unfortunately, even though that motivation has increased dramatically with increased dopamine released within the prefrontal cortex, there's a significant down-regulation of any consideration for the risks that one might take in order to get that. I sometimes will describe that as needing a drink of water as you would be coming more and more thirsty. The thought of needing a drink of water increases and increases and increases until people would do just about anything to get a drink of water. The consequences and the ways in which they would care for themselves may change dramatically. They might take significant risk to get a drink of water to understand that that's what's taking place in people's brains that have substance use problems that it really is changing behavior. So addiction then results in this inability to consistently abstain. It results in an impairment of behavioral control and creating diminished recognition of significant problems with one's behavior and interpersonal relationships, and then this dysfunctional emotional response. So again, it changes the perception when we experience something we experience, it's what we know. So the example that I would give you is, a young guy is at a party and he's been drinking and he sees his girlfriend talking to some other guy and he's up punching him because he knows the guys coming onto her. That was what he experienced, even though he had no idea what they were talking about. But that's his reality. So this ties in somewhat with the difference of denial and lying. Lying is you know what happened, you're just not telling the truth. Denial is you're just not there, you haven't perceived it in the way that you normally would if you weren't drug-involved. The other aspect of this is that it is often a relapsing illness and there are periods of remission often. But then relapses to be honest. That's with or without treatment, engagement and recovery activities and addiction then results in progressive and can result in disability and premature death. So again, many times people will think of opioid and the drive to continue to use opioids as being so closely associated with withdrawal. They don't like feeling sick and sweats and nausea and achy joints, and that's what drives them to use again. But the reality is that's only part of it. We can get people through withdrawal quite easily. We can use medications to reduce those symptoms significantly. But the problem is, they continue to have these changes in their brain. They still have now that need for a drink of water, and in their case, the need for more opioid. A few days or almost immediately after this withdrawal takes place, they continue to get triggered for continued use. This is what we're trying to address with medications for the treatment of opioid use problems. So the criteria for substance use problems in general is this criteria. So it's a very similar criteria to alcohol and cocaine and marijuana, and that is people will lose control over their use, they'll have physiologic changes that take place, and then the big part that really sets them apart from just casual users is that they have significant consequences, that it starts to really affect their lives and sometimes dramatically negative effects on their lives that then they continue to use on top up. So in this regard, when we look at the diagnosis, it's really a progression of the disease. They're using larger amounts for longer periods of time, they have attempts to cut back that are unsuccessful. Pretty soon it is starting to impact their life in that they are using for longer periods of time. So instead of going to the gym after work, they're going to the bar after work, or they're meeting up with friends and using drugs. That consequently can eventually result in potential loss of job or changes in their family structure or physical problems. If they continue to use on top of those problems, they're in a place of really severe illness. Substance use disorder is defined by having two or more of these in the last year resulting in distress or impairment. Tolerance and withdrawal is seen in all individuals that are taking an opioid. So people that are taking pain medication for two weeks, will have some mild withdrawal symptoms and it's more the longer they take them. So we need to have other things than tolerance and withdrawal to make the diagnosis of an opiate use disorder. But the severity is related or rated by the number of symptoms present. Two or three is mild disorder, four or five is moderate and greater than six is severe. Again, the same criteria is used for all substance-use disorders. It's also important to recognize that this is on a continuum. So these are individuals. They got started differently, the pattern of use is different between them, and the severity can be along this continuum. So there can be some individuals where there's increasing amounts and higher risk of substance use problems starting to develop and then moving into that place where there's significant creating total loss of control and significant consequences. Again, tolerance and withdrawal can happen anywhere along this continuum. So if we look at some of the ways in which we've attempted to address this problem in the past, there's an interesting history. First of all, opioids have been available to mankind for thousands of years, and typically was always in the form of opium. So it was the poppy plant and ways in which we use the product from the poppy plant, the resin that's produced and it was typically smoked. In the 1800s , it was synthesized first to morphine and then later in the 1800s, we first were introduced to heroin. These were marketed commercially for pain, anxiety, and respiratory problems. Sometimes gastrointestinal problems. But anxiety was one of the very prominent ways in which it was proscribed. One of the important pieces there is that it did have the name of morphine and it actually had a pretty high incidence within females. Alcohol was the primary drug of males throughout the 1800s, but as these pharmaceuticals were made available and it was go to the doctor for anxiety or various difficulties with life, opioids were being prescribed. It was later in the 1800s that a hypodermic needle was first made available. It was actually in 1940. Unfortunately, the combination of the use of heroin and the injection drug use became quite popular and became even more of a problem. Just to point out, one of the aspects of the severity or potential severity of a particular drug in being addicted is how quickly it gets to the brain. So if we look at cocaine, the Peruvians that are chewing coca leaves, there's less addictive potential because it takes a certain process of chewing and the digestion and then the effect on the brain compared to turning it into cocaine hydrochloride and using it intranasally, which is less addictive because it doesn't get to the brain even as quickly as then turning it into cocaine, sodium bicarb, and crack cocaine. So smoking in cocaine literally gets to the brain as quickly as injecting cocaine. It's this speed, it's that connection with I take this drug, it has this effect that increases the addictive potential of a drug. So with the advent of the hypodermic needle, where now they could dissolve and inject heroin, it made heroin even more addictive and more of a problem. So when we look at the ways in which we've tried to help this problem, first of all, there was a law passed in 1914, Harrison Act, there was a tax act to reduce at that time the amount of opioids that were being prescribed by physicians. So similar to what we're experiencing now. But essentially they said that opioids cannot be prescribed for anything other than a bonafide disease and at that time there was no disease of opiate dependence. There was this idea of morphism as I mentioned earlier, but it wasn't thought of as a disease. So you couldn't prescribe an opioid to help reduce the symptoms of the up an opiate use disorder, which clearly there were a lot of people suffering from it. It wasn't until 1970 that methadone was actually approved for detoxification from opioids, but not for the long-term treatment of opioids. Actually in 1964 Nyswander and Dole at Einstein University had begun to look at this in terms of would methadone be an effective treatment in reducing the cravings for opioids and there were a variety of research studies that were done throughout the '60s and really identifying that we could actually have a significant impact in reducing this ongoing cravings that was well beyond the withdrawal period and improve people's lives. But it wasn't until 1973 that methadone was approved by the FDA for maintenance. But at that time, it was then established that this could only be prescribed in an opiate treatment program, an OTP. There still is significant oversight in terms of the criteria in which people can get started on a medication and what policies are involved in continued prescribing and administration of the medication. So it had to be done on site and there's various criteria that people need to go through including time and their behaviors, allowing them to eventually get to where they can start taking some take homes. Until that time, they have to go to the treatment center on a daily basis. This was difficult partly because of the impact that it would have on people's work and their lives. But it was also extremely successful. At the same time, there were many areas of the country that had no methadone treatment programs or OTPs, and some states even didn't have an OTP. So people would sometimes have to travel very long distances. Again, disruptive to their lives and really helping them get on with living a more fruitful and productive life. In 1984, oral naltrexone was approved by the FDA. Naltrexone is a opiate antagonist that we'll be going over later in subsequent modules. But this was only oral and it literally blocks the use of an opioid. But the problem was that people didn't take the medicine. All of you know that compliance with medications is often terrible and for someone to either think I don't have a problem anymore, I can stop the medicine, but then they're triggered by a person, a place, or a thing and they start using again, has been very prominent. I will say that when I first started this work, I thought, I mean I can just take this pill and I can't use for that day and yet the suspense were troubling in my life, that just seems like a no-brainer. But the truth is that the disease is just cunning and baffling and very insidious. It did not result in good compliance and, consequently, there was significant relapse and problems with oral administration of naltrexone. In the year 2000, the Drug Abuse Treatment Act was passed by the federal legislation that allowed qualified physicians to offer this modality of treatment that we're describing today and this is referred to as office-based opioid treatment. So this allowed physicians to get qualified and then certain medications to be used in this treatment. In 2002, buprenorphine was approved by the FDA. Now, I said that this slide should be qualified and that is buprenorphine is a part of a medication that we use often in combination, so buprenorphine with naltrexone. Only the sublingual formulation was approved by the FDA and specific products. So a product has to meet specific criteria which I'll go over in just a moment. In 2010, extended-release injectable naltrexone was made available so some of you may know this as Vivitrol and this is a 28-day depo-injection that then gets around this idea that people would not be compliant with the oral naltrexone and it became available for the treatment of opioid dependence. It was available for the treatment of alcohol use disorders earlier, but it was approved by the FDA for opioid dependence in 2010. Then in 2016, there was another change in the original DATA 2000 act which allowed for nurse practitioners and physicians assistants to become eligible to prescribe buprenorphine for the treatment of opioid dependence and there is a certain criteria in which they have to reach to gain that approval which I'll mention in a moment. So the data 2000 allowed physicians who met certain criteria to treat opioid use disorders in their office, they could only use specific medications and those had to be scheduled III, IV, V medications that were specifically approved for the treatment of opioid dependence. So note not all formulations of buprenorphine can you use to treat opioid use disorder, okay? Not all buprenorphine products and so just to be very clear about that, the injectable or the Butrans patch, or the transdermal buprenorphine, these are not products that one can use for the treatment of opioid use problems and they could be used also in methadone treatment programs, but initially they had to be used the same way as methadone was being used. Practitioners needed to meet certain criteria and that was, first of all, they have to have a DEA registration. They could be subspecialty trained in addiction doing a fellowship and gaining subspecialty training or to have grand further gains to the American Board of Addiction Medicine now through preventative medicine or, as you're doing, complete an eight-hour training and by far the majority of people with their waivers now have completed the training and in fact all subspecialty trained physicians have taken the course also. Then at the completion of the course, it is SAMHSA, the Service Abuse Mental Health Services Administration that's notified that you've completed the course and then they let the DEA know that you've completed the training and the DEA would then issue what's referred to as an x-number because it essentially is your DEA number minus the first letter and that letter is replaced by an x. The things that the physician also needs to establish is that they have, and this is the actual wording of the form that you would sign off on and that is the capacity to refer patients for appropriate counseling and ancillary services. Pretty open. It's not saying you have to have a behaviorist in your office or you have to have them signed up with a behaviorist. So to get your x-number or your waiver, this is all that you're stating that you will have done. At the same time, many states, many insurances will essentially establish or dictate that people need some element of behavioral health care or at least a good assessment for underlying psychiatric problems or just behavioral problems that should be addressed and we're going to spend some time talking about that in later modules. The first year a person can actually prescribe to 30 patients. That's been from the beginning of DATA 2000, we could only prescribed to 30 patients. It actually was an organization could only have 30 patients. It was changed just a few years after that to an individual practitioner could prescribe to 30 patients. A lot of this had to do with the fact that one of the goals of office-based opioid treatment, and it remains one of my strong points, is that we really are trying to bring people into the house of medicine. So often they have neglected either behavioral or social or physical problems over a long period of time and what we want to try to do is help with those problems and really get them into a stronger recovery because some of the problems that could have been exacerbating their disease would have been addressed and again this has resulted in people coming into medicine in a way that they do get Hep-C HIV testing, their pregnancies gets stabilized, there's more attention to psychiatric problems that they may be experiencing and other social problems that we can help them get to the right resources. So again, that was the goal and not only to increase access, but to increase access where people are really getting good health care and that's when it really makes a difference, and that's why I'm really delighted that you're taking this course and that as maybe a sub-specialties of various kinds because there are all kinds of physicians that are now getting waivered. How can you put it into your practice in a way that it can be most effective in helping a person move forward? A few years ago, the number was increased to 100, this is good 10 years ago now, and that you could apply to go up to a 100 after one year and there's no further testing, no more CME you need to do, you just need to say that you have done prescribing for a year and this is your intention to move up to 100. Two years ago, it became deadlock, changed once more and allowing people to go up to 275. They needed to be at a 100 for a year before they could apply for this. If you're a subspecialty boards certified addiction medicine specialist or psychiatrist, you can do this automatically. Otherwise, there's certain criteria that you need to meet including being available to take a patient under some form of insurance to have 24-hour coverage, that is having some way in which people could potentially get medication that's needed or have other problems addressed and having electronic health record in your office. So in 2013 then, Opioid Treatment Programs were made available to also be dispensing buprenorphine in a manner very similar to office-based practitioners. Up until that time, as I said earlier, they could only dispense it under the same criteria as methadone. The advantage of this was to provide structure to patients who need closer observation than office-based opioid treatment or that the practitioner could provide and may in fact offer additional services, counseling, sometimes mental-health and case management services. So those of you that don't know too much about your local Opioid Treatment Program, I would encourage you to give them a telephone call or just look it up and see what services are available there because one of the ways, and even as a specialist in this work and has been prescribing since it was available in early 2000s, I will have patients that I know need greater oversight than I can give them and an OTP is often a good opportunity for that. So we don't ever kick people out of treatment just as we wouldn't stop their insulin because they're not complying with their diet, but we would potentially get them into a higher level of care and that's essentially what an OTP can help establish. So the Comprehensive Addiction and Recovery Act was signed into law in 2016, as I said, a couple of years ago, and it did expand privileges to nurse practitioners, physician assistants for five years. So it's in a center trial period right now. These ACPs do need to complete 24 hours training before to be eligible for a waiver training, and all this training is available online or there's a variety of different ways in which people can get the training through different organizations that are now providing, and these are specialty addiction medicine or organizations. This was all in an attempt to decrease this gap between the number of people that need treatment and those that have treatment available. So about 22 million individuals in the country have a substance use problem and yet there's roughly 2.5 million substance use treatment places available for those individuals. Now, that's not saying all 20 million want treatment, but if they did, we are way short of that and the difficulties that people can experience in trying to get into treatment is something that we're really trying to work out in making it easier. So at the point where they have a motivation to make a change that we can get them into treatment more rapidly. That's really been a major goal of the physicians involved in this work but also certainly the federal and state governments. So what are the benefits? I've alluded to this in some of this introduction, but just to say a little bit more about the benefits of treatment. So there's a whole range of treatment goals that can take place and certainly, there's a reduction in the harms from continued use. So medication alone will reduce the impact and essentially establish a harm reduction status with any individual that's on medication. Then there is sustained recovery with abstinence from all substances. Those people that really engage in treatment get any other drug use out of their lives and move their lives forward in many ways, psychosocial and physical problems addressed and often resolved. So the treatment options are buprenorphine, which is a partial agonist on the mu-receptor. We're going to go through that pharmacology in a later module. Methadone is a full agonist and again will we view these later, and then there's naltrexone, a long acting antagonist, and noloxone, a short acting antagonists, both of which have really utility in working with these patients. On top of that, there's the behavioral-oriented treatments and can be used alone, but the efficacy of that has been very poor. So the ultimate goal is maintain long-term recovery with or without medication. So the amount of time, and we're going to discuss this, but it's very much patient-related and it should be patient-oriented, and that is how long they may be on medication. Ultimately, if they remain stable and they continue to move their lives forward whether they're on buprenorphine or methadone, really doesn't make a lot of different. It doesn't make a lot of difference in terms of how they're living their lives. I say that in that families when I've been confronted with struggles over this, I'll often say, do you see any difference in your son, daughter, husband, wife being on medication? Well, yeah, I see some tremendous differences in terms of them moving forward with their lives. Well, I can tell you when they come off the medication, often it's tapered down, they're at a low level for an extended period of time. Once again, up to them, when they come off it you won't see a change. So there's no significant change that cognitively, or motivation, or really there's not a change that people see. Once family members begin to recognize in that and really see the changes, they become much more comfortable with that and often are like, are you sure you're ready to get off? Because they so much want people to be able to maintain their recovery. So they've done a variety of studies. This one was done many years ago as you see in 1971, 45 years ago, but this was a naturalistic study prior to the use of medication treatment that followed people over time after they had successfully completed a program for substitutes. The study really found that most people treated for heroin use resumed heroin within the first three months. We still look at about 90 percent of people will relapse after an acute detox. We wouldn't accept that in any other area of medicine. So the idea that we can give a medication that boost that dramatically, and I'll show you that in a moment, it's just a good practice of medicine, it's very strongly evidence-based practice. So buprenorphine does promote retention, and I will tell you that retention to treatment as one of the variables that is pretty much always looked at in terms of the efficacy of a particular treatment, whether it be a behavioral treatment or medication treatment, if we can keep people in treatment, they do better and those who remain in treatment become more likely over time to abstain from other opioids. So as you see, both the Kakko and the Soeffing study showed that if we keep people in treatment, they continue to do better. Now, obviously there are people that dropout of treatment, but those that remain and treatment, there's continued improvement, continued reduction in the number of opioid positive tox screens. So in this way, it's looking at opioid negative have actually increased. The other is, and really this is the bottom line, and that is it's medication-assisted treatment actually still results in about twice the death rate of the general population, but untreated results in six times death rate compared to the general population. So there is a significant reduction in mortality having people on medication in the treatment of an opioid use disorder. Kakko did a study back in the early 2000s where there were 20 individuals that had been started on maintenance dose and the rest were buprenorphine was used to withdraw them. They were all made available a behavioral treatments. So they all have the same availability for behavioral treatment, but none of the individuals that went through withdrawals, stayed in treatment. Again, being on medications, these medications they do have their partial agonist or full agonist at rates they don't cause that's used appropriately any euphoria. As I described earlier, no changes significantly in behavior other than just getting the opioid use problem out of their lives, but they do come back because they want the medicine. So we're able to continue to reinforce the behavior changes, or looking at physical problems, or help them with social problems potentially, and they do really quite well. In that particular study, there were 20 individuals in each arm of the study and four of the individuals that were in the acute withdrawal phase arm at the study died of opioid use problems during that one year period that the study was done. This is a lethal disease and to really recognize that this does save lives and allows people to get their life together in a way that they're not overcome by this constant craving and really problems in terms of their motivation that can take place with continued drug use. So in summary, the rates of overdose deaths from opioids are at an all time high and are continuing to increase. Again, partly because of this introduction of fentanyl into the system. In the diagnostic statistical manual fifth edition, substitutes disorder is defined by having two or more symptoms that highlight a loss of control, physiologic effects, and harmful consequences. So when a person is meeting those criteria, they clearly have an opioid use disorder severe and would benefit from this treatment. A number of legislative initiatives have been passed to improve access to treatment for opioid use disorders, and medication-assisted treatment for opioid use disorders has several benefits including, decrease in the number of fatal overdoses, increase patients retention and treatment, and improve social functioning. That cures the references for much of what I talked about and these are all continually available to you, you can watch them, but that concludes Module 1. Thank you very much.