The 9th Annual Pain Care Skills Training taking place at SOUTHCOM Conference Center of the Americas in Miami, Florida, brings colleagues and subject matter experts together to learn more about optimizing care and integrative approaches to pain management within the Department of Defense (DoD). The focus will be in sharing best practices, conducting hands on training and learning integrative approaches. The overall goal of the Pain Care Skills Training will be to promote readiness, restoration of function and relief of pain while decreasing the use of opioids.
Transcript
Our next speaker today is Doctor Aram Mardian. Doctor Mardian comes to us today from Phoenix. He is a clinical associate professor, family and community preventative medicine, University of Arizona. Board certified family physician, also certified addiction medicine, pain medicine, medical acupuncture the founding chief of the chronic pain and wellness center of the Phoenix VA. I’ve known Doctor Mardian for many, many years now. His chapter on acupuncture is one of I highly recommend it, and the textbook I don’t know, because I pulled out the chapter, and is really amazing, and it is one of the most wonderful things that we have for our trainees, in explaining the science behind acupuncture. Doctor Mardian worked with me on our VA DOD Opioid Clinical practice guideline. Again Doctor Mardian is one that never says no. Whenever we from the military health system have a request Doctor Mardian always steps up to the plate, and is so generous with his time in doing that with us. Today he is giving us this fantastic presentation on something that’s very near and dear to us, something that he has pioneered in the VA, and really has led efforts in the VA, and that’s on opioid tapering. With that Doctor Mardian, we’re going to bring you up. (clapping)
Okay, can everyone hear me okay? I see maybe one, or two nods, I’ll assume yes. Very good. Well it’s an honor to be here, thank you. That was a wonderful first lecture, beautiful way to honor Doctor Hickey, and a wonderful way to start us out, with a lot of the underpinnings that I think we’ll see in our opioid talk, and really through the day, and the next few days. I usually have the lecture tech complain coming from Phoenix, and the pacific time zone of the time change, getting up early. But here I’m humbled by people coming from Japan, and all over the world. I think it’s time for me just to stop whining about that. (laughing) Okay, I have no disclosures, and these are my own views. Our objectives to start out, I’d like us to describe the characteristics of what I’ll call a collaborative opioid tapering process. I should be able to list the 3 Cs as a pneumonic to think about substance use disorders, and then identify evidence based treatment for opioid use disorders. Next slide. We’re very familiar with these converging, public health crisis. The opioid crisis, chronic pain crisis, I’ll spend just a few minutes talking about our current state, while we’re all well aware of that in the room here, but we’ll talk a little bit about the current state. Then we’ll talk just a bit about the background, some of the models of pain care, and our healthcare system that got us here, as a way to think of how we can transform those? How can we change those? Not only in opioid tapering, but in the larger context of chronic pain care. Next slide please. Again staggering numbers, almost 400,000 deaths from 1999 to 2017 from both prescription, and illicit opioids, next slide. This is a dramatic increase, a five fold increase from 1999 to 2016. Next slide. I think many of you have probably seen this slide. This is from the CDC. This essentially looks at the three waves of the opioid epidemic. On the far left side here, really the start of this epidemic was in the large increase in prescribing of prescription opioids, and the overdose deaths that were related to that. Then in about 2010, the deaths from heroin started to increase dramatically as our second wave. Both of those have started to level out, but unfortunately now those larger trends being overshadowed by the deaths from synthetic opioids primarily illicitly manufactured fentanyl, which are still increasing. Next slide please. Really our major adverse effects from opioids, overdose death, and addiction, so from 2016 numbers 1.8 million Americans having an opioid use disorder related to prescription opioids. Then some of these are overlapping, but 626,000 had a heroin related opioid use disorder. Next slide please. Chronic pain is the most common, the most costly, and the most disabling of chronic conditions. We have been spending a lot of money, over 600 billion dollars annually in both care, and lost productivity. We’re not doing very well. I’d like to talk about, and make a little bit of the connection between our current opioid situation, and how we got here based on models of pain care. Next slide please. Kind of staggering numbers. Looking at a trillion dollars up until 2016, and then additional 500 billion dollars projected. This is the cost of the opioid epidemic. Again both in the cost of care, and lost productivity. Next slide please. Again, so what we’re doing is not working very well. This shows the share of newly disabled workers from 1961 on the left hand side, over to 2011 on the right hand side. We see down on the left hand side, a little back pain, musculoskeletal disorders being quite low down on that list, and then coming up to the top, and the largest proportion of newly disabled workers in 2011. Next slide please. In response to this we’ve had many national guidelines, and recommendations, and policies. The CDC, and the National Pain Strategy in 2016. The VA DOD guidelines in 2017. Next slide please. Then in the two to three years since, we’ve seen some confusion around how to implement these guidelines. Such that the authors of the CDC guidelines in April published this New England Journal article, talking about policies and practices that are inconsistent with the CDC guidelines. Clearly, this is an area that requires a nuance approach, it’s an area that does not lend itself well to following a recipe. I think unfortunately that’s what many of us have maybe been wanting, and this article really shows us some of the unintended consequences. Looking at inflexible application of recommended doses, and duration thresholds, hard limits, and then abrupt tapering resulting in sudden opioid discontinuation, really are not what the CDC guidelines, the VA DOD clinical practice guidelines, or really any policies have really been recommending. Next slide. What are we looking at? Well really an individualized, and whole person pain care approach, and again the lecture by Doctor Louis really shows us some of the neurobiological underpinnings of this approach. Next slide please. Both in DOD and VA, looking at shifting from a model that focuses on disease, to a model that focuses on health, and health promotion. Next slide. Sedelther Mooker G is an American oncologist. On the left hand side here, he talked about this is his view of the bio medical model of pain. This is the model that really has allowed, and done some of the underpinning of both of these public health crisis. In his view he talks about this model that we can think of from the antibiotic era that has worked very well. Have a disease, take a pill, and kill something. That has worked phenomenally well in the areas of infectious disease, but when we take that model, and we apply it to something complex, like a chronic illness, as a chronic pain, or addiction. We in depth with high cost, and low value care. Looking at a biopsychosocial, or a resilience, or neuro prostisity approach over on the right hand side, we think of again using mind and body to change our brain, and our relationships. We think of retraining our brain, changing the relationship to the environment, both our internal, and … Sorry our external, and internal environment, that exteroceptive, and interoceptive environment, cultivating mindfulness, and positive affect. An area that we haven’t focused on very much over the last few decades, and engage in meaningful, and enjoyable activities. Next slide please. To implement this, we really need to think about pain differently. In the pain world, this biomedical model translates to finding the one pain generator, and really aiming to counter that through numbing destructional removal, and in some cases that can work well, particularly with more acute pain. But with chronic pain particularly when we’ve had major changes in the various brain networks that were described. We don’t do so well. That model focus again on passive treatments. Treatments that are done to me, pills, procedures, and surgeries. Switching over to this other model requires a major change. Again, a change to health base system, and this idea of changing relationships to our various sets of context, so interpersonal activities, and then interestingly how we approach challenge. Our next slide we look at how we approach challenge, and stress is a way we can think about resilience. Again, this shift of positive health, Alex Soutra from the Arizona State University had a three part definition of resilience, so I encourage you to think about as we think about our patients. The first part of that is recovery from adversity. When we have challenge, a stressor, adverse experience, how do we return to positive affect, and return to … Our second point here, sustainability of purpose. How do we return to our values, and our important goals in the face of adversity, and challenge. Our third definition here, looking at growth, so finding new insights form, or strengthen social bonds, and gain mastery in the face of challenge, and adversity. Next slide. Thinking now, starting to shift to looking at medications, and opioid tapering. It behooves us to take a step back, and think about where’s our therapeutic focus? Think about opioid tapering can be very enticing to focus on the medication. That can be pretty easy if we only focus on the medication. We might focus on pathology, or are we focusing on the whole person. When we’re focusing on medications, or disease, or the pathology, we’re doing a couple things. One we’re potentially jeopardizing the therapeutic relationship, and then two we may actually do more harm than good. Next slide. The goals of our treatment, again to shift to a long term focus, and pain we’ve often been focused on a very short term focus. If we do that with opioid tapering, we’re probably not going to get very far. Long term positive health focus, looking at minimizing adverse effects. We’re never going to eliminate them, and then supporting self efficacy and self management. Our psychologist, and our inter professional pain team has taught me this first bullet point here. So, rather than thinking about a pain treatment plan for a body part, we think about a plan for the person with pain. Again, so taking a step back, looking at the whole person. Looking at active treatments. The passive treatments that we use can be very powerful. We think of those as bridging treatments to help our patients gain that self ethicacy. Sometimes if we don’t have that focus, our passive treatments can have the opposite effect in pairing self ethicacy. Then finally making sure that we’re not just looking at a body part, but looking at medical, psychiatric, substance use comorbidities, and treating those as they come up. I’d like to introduce a concept of logical fallacies here. Treating patients with chronic pain, and particularly with opioids can be trigger emotional responses both in the clinician, and in our patients. That, if it’s unexamined can lead us to be vulnerable to these fallacies of reasoning, these errors in reasoning. I’d like to introduce a couple of these. These really can affect even the most experienced clinicians. When they’re present, what do they do? Well they reduce our flexibility, and they tend to point us in a more rigid application of our treatment plan. Our first one, I call the Now Forever Fallacy. This one really assumes that the plan I’m making today, and consciously as a forever plan. If I make a plan today to not taper a patient, sometimes that can more fend to the idea to keep the patient on opioids. In the past, three years ago, five years ago, 10 years ago, I would argue that really unconsciously we kind of put patients into these buckets. Do I keep the patient on opioids, or am I tapering? That can almost be a life plan, which I would argue is not in a patient’s best interest. Keeping in mind that the decision I’m making is an individual decision, at a certain point in time, and it will likely, very likely change as my patient changes, as our interaction changes over time. Our second one is the black, white fallacy. Again thinking of only binary treatment options, and binary treatment decisions. This can again kind of back us into corner, particularly in these emotional situations. (mumbles) for us to look at choice points. We have many of them, but sometimes we lose sight of that as we become under stress in these situations. We might make a decision to taper, but we can offer our patient many choice points, and that choice point may be would you … Today there’s a lot of fear, there’s a lot of emotion on the patient’s part, so maybe our decision is not to taper today. Our choice points are, would you like to start a small change in two weeks, in four weeks, or in six weeks. It might be something as simple as, if we’re on different formulations, would you like to look at this type of formulation to reduce first, or this type of opioid to reduce first. Trying to bring in as many choice points as possible. The next is our accept, fixed fallacy. This one is based on the idea that acceptance is similar to giving up. If we accept our current situation, that’s giving up, which would be antithetical to moving forward. Obviously not a choice that many of us would want to make. When we do this, we often are stuck in what we call the medical merry go round. An endless rotation of passive therapies, without helping us improve function, without helping us improve our quality of life. When we’re thinking about our treatment plan, recognizing that accepting our present reality, is often paradoxically necessary for us to move forward. Thinking about opioid naive, versus opioid exposed patients, it’s another very important way for us to think about these populations. Again thinking about some of the neurobiological changes, these are quite dramatic, and we’re learning more and more about those changes in an opioid exposed population. In the VA, DOD guidelines we’re very specific to call out these different populations, recommendation 1A is to recommend against initiation of opioid therapy for chronic pain. Much of the change in opioid prescribing the amount of opioid being prescribed, some of the low hanging fruit is really in this population is not starting long term opioid therapy for chronic pain. A much more complex situation in recommendation for teen, is recommending tapering when risks outweigh benefits. And again, we were somewhat present in this second (mumbles) should be avoided unless absolutely necessary. FDA issued an advisory about this in April of this year. Next slide please. So, again just this broad set of treatments, as we’re talking about opioid tapering, remembering that our foundational treatments for patients with chronic pain, are really our active therapies, and I put these in two large buckets. Our psychological therapies. We have multiple subtexts of that, cognitive behavioral therapy, acceptance, and commitment therapy, mindful space stress reduction, all have good evidence behind them. Then exercise, or movement therapy. Again, the way I think about this is, what’s an enjoyable way to move our bodies, and we have various disciplines that can help us. Yoga, Tai Chi, physical therapy, recreational therapy. In our clinic we look a lot at nutrition, so we have a dietician, who has created our anti inflammatory diet program, that is now available throughout our health system as an active treatment. Passive therapies again, looking at things like acupuncture, spinal manipulation as our bridging therapies to help support our patients, maybe as they’re tapering, when they’re doing something that’s particularly challenging for them to help them move forward in a more active direction. Highly recommend taking a look at this lancet low back pain series, summarizes as much of what I’ve talked about so far. This was published, there were three articles just last year for our world wide Lancet Collaborative. Again they talk about this notion of using positive health. They didn’t use the term resilience, but their definition here is ability to adapt, and self manage to challenging situations is really the definition of resilience. Then our bio psychosocial framework that we’ve talked about. Unfortunately we overuse low value treatments. So, treatments that are high cost, and have relatively little evidence of benefit. This collaborative recommending reducing the inappropriate high use of imaging, rest, opioid spinal injections, and surgery. All right, I’d like to switch gears just a little bit now, and we’ll be jumping into the, some of the meat of the opioid tapering section. It can be helpful to consider three groups when we think about opioid tapering. Our first group are those engaged, engaged, when I say engaged I mean engaged with us a treatment team, and open to tapering. Our next group are those diagnosed with opioid use disorder, and then our third group are those not engaged, and really not open to tapering. There are different levels of evidence for each of those. That first group open to tapering, we have some weak evidence, with opioid use disorder we have rather strong evidence of what to do, and then that last group we have very, very little evidence. So, this meta analysis published in 2017 in the Annals of Internal Medicine, does provide some low quality evidence, that when we’re looking at either tapering, or discontinuing opioid, the patients can actually improve function, pain, quality of life. That’s important to recognize that the majority of studies, included in this meta analysis, were interdisciplinary pain programs. These are programs where patients again are engaged. They’re engaging in intensive treatment. It’s important that we don’t extrapolate this data too far, also it’s important to recognize the caveat, this is very low quality evidence, but we do have some evidence to suggest in the right scenario with the right support, we can improve patients’ outcomes with opioid tapering. Next slide. Now, we do shift to really quite strong evidence, when we look at how to treat patients with opioid use disorder. Is this all patients on long term opioid therapy? No. What’s the percentage? Well we don’t really know. Does anyone remember what the percentage industry told us about 20 years ago? We were told that the incidents of addiction was less than 1%, when we’re using opioid for long term opioid therapy. We know that that’s not true now. We don’t know what the actual rate is, but anywhere from 10% one meta analysis showed, the CDC cites up to 25%. Bosco Reno at all, had demonstrated a lifetime prevalence for patients on long term opioid therapy of 41% of any opioid use disorder. That appears to be related to both the dose, and duration of therapy. Again, with a diagnosis of opioid use disorder, we have clear evidence that use of medication assisted treatment, these are two Cochran meta analysis. One for methadone, and one for Buprenorphine for the medication assisted treatment for opioid use disorder. Both showing good evidence that these reduced elicit opioid use, increased retention and treatment, and then other evidence, one 2018 article showing that we reduce both all cause, and opioid specific mortality when we use medication assisted treatment for opioid use disorder. So, again, we have quite strong evidence when we have diagnosed opioid use disorder. We’re going to jump in a little bit to this group of engaged, and open to tapering. So, it’s important to recognize that these groups are not fixed. Our patients may came in not at all, either engaged with therapy, or open to tapering. Until we start to talk about a more collaborative approach. So, again everything we talked about in the first 15 minutes or so, making sure that our patients know that we’re not focusing just on the pill that they’re coming in with. Hi Mr. Smith, we’re going to talk about your Vicodin today. Hi Mr. Smith, I’d like to get to know you. I’d like to understand the person with pain. Our first step is that therapeutic relationship, and a collaborative opioid tapering process, making sure our patients understand that our goal is to partner with them. Our goal is not to come in, and call all the shots. We need to make sure that what we’re doing is safe, and the treatment options that we offer to our patient are safe, and we’re comfortable with the safety of them. But beyond that, we really focus on a partnering with them. Identifying a whole person approach. The prescription factors we default to a gradual taper. There’s no specific taper pace that New England Journal of Medicine article from the CDC guideline authors, talk about as kind of a point in the middle of 10% reduction every month. That’s essentially what we default to in the VA, DOD guidelines, or even slower. 5%, 10% a month. Sometimes another just, real basic rule of thumb that I use is, as long as you can, it’s a type of pill that you can divide, so often a short acting, or immediate release. We think of starting with a half a pill reduction, and maybe a half a pill every month, making sure that we know that we can pause in there. There’s no predetermined set time that we’re thinking about. We need to be off in three months, or six months, or 12 months. This is really a process that we want to work together with our patients. Now, sometimes our patients come to us and say, “Doc I’m traveling out of the country in four months, I need to get off.” Great. We can move faster, but we want to do that in a patient centered sort of way. Using our routine risk mitigation strategies that we talk about in a variety of guidelines. We got to see our patient, routine visits, check urine drug screens, check our PDMP, our prescription drug monitoring program, and then opioid overdose education, and Aloxin distribution really should be universal in this population. Now, opioid use disorder may not be evident when we start a taper. It may only become evident after we’ve initiated a first dose reduction, or in our experience sometimes after we down below a certain threshold of opioid medication. So, we need to be extremely vigilant, and watchful for the emergence of opioid use disorder symptoms. Our experience, and others is that the context of the opioid taper, is really, these factors are much more important than the prescription factors. We have patients that are on very high doses, and we recommend reducing by half a pill, and they communicate that their life is going to fall apart. Conversely we have patients on low doses, or medium doses that again say, “Doc I need to be off in four months.” They make really significant reductions. They may have some physical symptoms, but they do quite well. Why is that? Well, Beth Darnell, a pain psychologist from Stanford University has written, and talked about the placebo, and the nocebo effects of opioid tapering. The way that we set up expectations about tapering is critically important. A patient who is starting an opioid taper, who is fearful, who is anxious, there’s already an antagonistic relationship, our therapeutic relationship. How are they going to do even with a very small dose? I think we’ve probably all experienced that that can go very wrong, and our patients don’t do well, versus if we have all of these other factors, commitment to a therapeutic relationship, whole person pain care, focus on health. Trying to increase our patient’s positive expectations from the beginning, we can make sometimes large reductions, and our patients do very well. Again, focusing on context, knowing some of the key factors about prescriptions, obviously important, but focusing on the context. Opioid use disorder, so, one of the best places to start here, is recognizing that this, both the condition of opioid use disorder, and the medication treatment that’s evidence based, and recommended for it, are both highly stigmatized in our culture still. I would argue, almost certainly, a pretty significant portion of us here, in a large healthcare setting. There’s a significant amount of stigma. Our idea to start with this is recognizing that, there are neurobiological changes, and the disease of addiction, opioid use disorder. This condition has strong behavioral components. So, much in the way we think of our patients with diabetes, there’s a biologic disorder with strong behavioral components. How often do we discharge a patient from practice with diabetes, who isn’t inherent to our lifestyle recommendations? Not very often I would argue. Yet this happens really quite frequently certainly in civilian medicine, the private sector. Recognizing the neurobiological underpinning, starting with this non stigmatizing approach is really a non judgemental approach is what will help our patients engage with us, and help us to be able to offer these evidence base, potentially life saving treatments. Again, in the context of whole person care, when someone we’ve diagnosed opioid use disorder, in a patient on long term opioid therapy, we certainly need to increase our risk mitigation strategies, and really look closely at a team based approach for medication assisted treatment. We’re going to shift gears here a little bit, to our most challenging group. This is our group that is not engaged, and not open to tapering. One of the reasons this is most challenging, is we have very little evidence to guide our approaches here. I want to encourage us to think about again this group is not a static group, but these are very dynamic. So, our patients are switching in these groups throughout the course of their illness, and their interactions with us. Looking at a team based approach, certainly in our VA, and DOD settings we know is critically important with not only this group of patients, but all of our patients, and we’re fortunate. In the VA we have what we call Primary Care Mental Health Integration. I think there’s something, a very similar analog in many DOD settings. In the private sector, this is largely absent. Unfortunately this schism, and siloing of care ends up not providing our patients with the most evidence based practice. If we can intensify treatment, and begin to recognize that, our patients coming in with low back pain may have untreated, or under treated anxiety, depression, PTSD, that in a setting that is only focused on pain procedures, we’re not going to get very far. If we start to bring our mental health colleagues, our movement colleagues, and look at it, now we can start applying some evidence based treatments, and begin to see this patient, who initially came in, in the non-engaged, now starting to engage, and may be more open to tapering in the future. It’s important to recognize that this group, really has a differential diagnosis. We can start to unpack it a little bit. One of the most common areas, again I just touched on briefly is this area of untreated, underlying mental health conditions. This might be a diagnosis, or it may just be sub-diagnostic emotional distress. We talk about chemical coping. Our patients may have, maybe medicating that emotional distress, and no one’s really talked to them about that before. Our patients that are coming in, not open to tapering, this can be a wonderful place to start, and it can begin to unpack, and show us more about that person coming in, and provide other ways for us to add support for that person, so that then they can shift over, hopefully to that area of engaging with treatment, and becoming more open to tapering. Sometimes we’ll say things like, to normalize the situation, we’ll say things like, “Mr. Smith I’d be surprised if you weren’t fearful “to make this change.” We say that before they’ve even expressed any anxiety, or any fear, since that is so common. We know that opioid reduce a sensory aspect of pain, but we know that they do much more than that. Some papers actually suggest that the interaction in the emotional parts of the brain for opioid is actually more robust, then in the sensory aspect. Bring attention to the emotional, the social, and the reward system aspects of opioids, again can open up kind of new horizons for us to engage with that treatment. To illustrate that, I’d like to read a quote from the Odyssey. It really does a wonderful job of describing some of these other effects. This is the TE Lawrence translation, and it says, but Helen of the line of Zeus called to mind another resource. In to the wine they were drinking she cast a drug, which melted sorrow, and sweetened gall, which made men forgetful of their pains. The next time that we recognize that opioids may be soothing someone’s loneliness, someone’s emotional distress, someone’s anger, someone’s sadness, or sorrow. We can take a new lens, and really shift towards helping them build skills to manage that, and often if we do that, since the opioid was the main thing that was helping them with that. Now that we give them other support, they can shift in to this group that’s engaged in therapy, and open to tapering. Next slide. We’re very comfortable with this idea of a risk benefit analysis. We do this all the time in medicine. When we read the CDC guidelines, other guidelines we’re talking about well who do we taper? We taper when the risks outweigh the benefits. This is a great place to start. First we look at the risks of opioid therapy, and we recognize that there’s converging evidence that opioids, again we talked about the overdose death, addiction risks, but have other risks, can increase the risk of depression, can increase the risk of disturbing sleep, endocrine immune function. We have this converging evidence about the risk side of the equation. What about the benefit side of the equation? Well, we certainly have a lack of evidence, we don’t have strong evidence showing benefit. The best way to determine benefit is looking at a pre treatment state, and our current state, and ideally multi dimensional, so we’re looking at emotional, social, vocational, and physical functioning, both before we started opioid therapy, and at our current state. Well how often do we have that? Unfortunately not very often. The benefit side of the equation, we’re often left with our next best proxy, which is well what’s our current functional state of our patient? Our current functional state, unfortunately what we often see is that our patients are not doing very well. We have a low often, this group we may see a low functional state, low improvement in pain, or quality of life. We know about risks. Now we shift to something we talk about as a risk, risk assessment. Now we look at what is the risk of staying the same, keeping our current prescription, versus the risk of making a change? Well now we’re wading in to some very murky waters that we have very little evidence to support. We’ve received very little training on how to address. We do very well to not take a one size fits all approach, to really, we need to be focusing on our patients as individualized as possible. Now, there is one interesting study, I wasn’t able to get it in to the slide deck, but came out just a few months ago, looking at dose variability, and opioid overdose death. This is published in The Jama Open Network by Glance at Ollies, researchers at Kaiser Permanente in Colorado, and they were looking at dose variability. So, both increasing, or decreasing dose, and they looked at the three months prior to an index date. Then they compared overdose, and the index cases were overdoses to controls. What they found was really fascinating. They found that the group with the highest variability, so that can be either an increase, or a decrease, and that highest dose variability was 27 milligrams of morphine, compared to the lowest variability which was zero to five variability. So, essentially not making a change. There was actually an increase in the risk of overdose. So it was actually greater than three times increase risk in overdose. This data really provides more questions, then it does answers, but I would strongly suggest that it gives us pause. It does appear that making that change, again likely in situations that they did not study this, but I suspect likely in situations for patients who are not engaged, not open, not involved in interdisciplinary care. Now, a caveat to this study, which interesting was kind of buried down in the middle of the study, wasn’t reported in the results, or inclusion is that, four patients who were achieved sustained discontinuation, which they described as having zero opioid for the three months prior to the index date. They actually had a 50% reduction in opioid overdose death. Again, this study I believe brings up more questions, then it does answers, but I strongly suggest that it gives us pause, particularly in this group. I think that gives us further impetus for looking at this risk, risk assessment, risk of staying the same, versus of making a change. That’s going to be a very, very individualized decision. It’s going to depend on the patient’s medical, their psychiatric substance comorbidities, in addition to the medication that they’re currently on. We can think of defaulting to give our patients more time. In this group, there’s certainly no rush. I think a very important message is that there are no guidelines, there no policies, there are no laws that say, at least not in our federal laws, or in the state jurisdiction that I know that say, we need to get everyone off opioids. It might have taken someone two years, five years, in our case in the VA 25 years to get to where they are. I think it certainly behooves us to recognize that this may take months, or years to make changes. So, erring on the side, when there is not acute danger. Erring on the side of giving our patients more time. Helping them engage in some of the other evidence based treatments, and investing in that therapeutic relationship, we do well with this group. One point I want to talk just briefly on is this idea of using Buprenorphine, in what we call the gray area. We’ll talk about that coming up in just a minute. Recognizing that Buprenorphine can be a useful tool sometimes, certainly we know it’s a useful tool when patients are diagnosed with opioid use disorder, can be life saving. For patients without opioid use disorder, it may be a useful tool to assist with the tapering process. Next slide here. I want to just talk briefly again, dive in a little here, so neuro biologic adaptations to opioids, we can think of two kind of major poles. We have simple physical dependence on one side, opioid use disorder on the other side, and we can think of these essentially as, the degree of neurobiological changes, we think correlating with these states. Simple dependence, we’re making this really in retrospect. Simple dependence being defined as, when we stop an opioid, or reduce significantly, there are withdrawal symptoms. The opponent affects of the opioids become prevalent, and they’ll last for a few days, or a couple of weeks. After that the patient basically feels back to normal. Simple dependence. Opioid use disorder on the other side, opioids may have been stopped years ago. They may not be using opioids. A cue in the environment can trigger an enormously, powerful craving to use opioids. Those brain changes certainly persists for decades it appears, and may be more permanent. We don’t know that yet. So, those are those two poles. In the middle this idea we talk about complex persistent opioid dependence. This is an emerging term, we don’t have strong data on it yet, but Jane Balentine has talked quite a bit about this. In this condition when opioids are stopped, after two, three, four weeks those opponent effects, worsening pain, poor sleep, labile mood, irritability persist. We have protracted withdrawal symptoms that may last for many months, or even years. Next slide please. This article, again is an excellent article, The Conundrum of Opioid Tapering, came out about a year after the CDC guidelines were published, highly recommend reading this, anyone that is involved in opioid tapering. Audrey Manhopkin, the VA Jane Balentine are the primary authors. They start recognizing that long term opioid therapy can worsen pain and function. Long standing dependence, meaning someone who’s been on long term opioid therapy for a long period of time, but not necessarily having DSM5 opioid use disorder, or addiction. This can interact in a complex, and bidirectional way, with underlying mental health conditions. If it actually causes significant lability of psychological distress, sleep disturbances, or an actual diagnosed mental health disorder. That can increase the perceived need for opioids. While it seems maybe the logical step in these cases would be stop the opioids. Well for someone with simple physical dependence, that is often helpful, but for someone with a complex dependence. This state that we’re beginning to understand, they may continue to describe worsening pain, worsening function, worsening mood, more irritability. It behooves us to look at this group more carefully. Next slide please. I don’t think we have a, let’s see a pointer up here. But if we look at the top row there, the downward arrows that are constant across the row, show that we kind of think of the beneficial effects of opioids being about the same over time. That increasing upward arrows, we get further to the right, are the opponent effects. These are all the opposite effects of opioids, which are what? Oh if opioids reduce pain, they can actually ramp up the pain systems in the body, increase sensitization. They can cause some anxiety. If opioids help calm, they can cause anxiety. These opponent effects appear to ramp up over time, such that on the next row here, the net effects over time start to weigh in, and become very small, though still highly salient to our patients. Our patients often come in saying, “Doc, I know this just “Takes the edge off “for a small period of time.” Sometimes it might even be just half an hour, but if you really start to dig in, and ask our patients, that have been on it for years. My experience it’s rarely more than 90 or 120 minutes, and then they do poorly after that for several hours, until their next dose. If we can begin to unpack that a little bit, and support some of these opponent processes in complex dependence, hopefully we can move our patients into the more engaged, and open to tapering group. Next slide here. These are some of the protracted opioid withdrawal symptoms. We’re going to move on to the next slide. Distinguishing between these groups, simple dependence, complex dependence, and opioid use disorder, requires that we know how to asses, and diagnose opioid use disorder. Unfortunately, in health professional education, we’ve done a rather terrible job of teaching about opioid use disorder, and substance use disorders. Now if I way that a group here, who knows how to prevent, treat, short term, and long term treatment of asthma? How many people raise their hands? Pretty common. If I say, who here can tell me the diagnostic criteria for opioid use disorder? Almost regardless of the specialist that I’m talking to, generally faces start to glaze over a little bit. Unfortunately that’s the state of our medical education. We need to do a better job at this. Doug Goylia a pain specialist said, that anyone that prescribes opioids needs to be a talented amateur in addiction. I actually think we need to go a step further. If we prescribe opioids, or are around patients who are prescribed opioids, we really need to have expertise in how to recognize, diagnose, and if we’re not going to treat it, then refer to treatment. I think about the 3 Cs here. Who’s heard about the 3 Cs? Excellent. Hopefully when we’re walking out of here, we’re all going to be really solid on these. This is a pneumonic for the diagnostic criteria. Our first C, let’s shout them out here is, loss of control. Our second one is cravings, and our last one is used by consequences. What’s our first one?
[Audience] Loss of control.
Excellent. Number two,
Cravings.
And number three?
Used by consequences.
Excellent. I really encourage you to commit this to memory, and use this as a primary way to screen our patients. Next slide please. This slide basically maps the 11 diagnostic criteria for substance use disorders. It maps nine of those on to the three Cs. Two at the bottom, we call physiologic criteria. Patients who are, according to DSM5, some think this may be, some are controversial, but according to DSM5, if you are on long term opioid therapy, and taking opioids as prescribed, the physiologic criteria don’t count. That leaves us four patients that are taking their opioids as prescribed, that leaves us with those nine criteria. You can see, each of those, the 3Cs maps to one of those nine criteria. I’d highly recommend for you to keep something like this up in your office, and to look at those criteria on a regular basis, but absolutely memorize those 3Cs. Two to three criteria, we have mild opioid use disorder, four to five moderate, and greater than six is severe. Next slide. There’s no universally accepted way to screen for opioid use disorder. We do have validated screening tools, so both the NIDA quick screen, and TAPS are validated tools. Now the challenge with these are there are two parts. The first part is very quick, that unfortunately if it’s positive, then the second part can be rather extensive. Certainly a primary care environment that can be challenging. I want to point out in particular the opioid risk tool the ORT, and SOAPP -R. I’ve seen these used much more frequently. I want to point out a couple of limitations. One, these are not screens for opioid use disorder. These were intended for a prior to starting opioid therapy, they were intended to predict, “Aberrant use, or high risk behaviors.” One of the other problematic part of the opioid risk tool, which is short, and it’s sort of seductive, because it’s easy to use in practice, is a low sensitivity. One study showed that if we look at taking the moderate to high risk. Either of those categories, the sensitivity was only 45%. Just some cautions there. The empower study led by Beth Darnell at Stanford, I’m a psych director at the Phoenix VA. This is a collaborative opioid tapering study. We had a consensus method, that essentially takes the three opioid questions from the TAPPS II. If any of those are positive, then we move to query for the presence of the diagnostic criteria. Main limitation, this has not been validated. This is a consensus method that we’re using for the study. I would suggest, and recommend that, we use our Clinical Gestalt, awareness of the 3Cs, identification of high risk behaviors, and then certainly having a list of the DSM5 criteria, very easily available, so that you can apply those. Sometimes it seems easier, when there are hard things to do to say, “Well the CDC guidelines are making me do this. “Well the VA Clinical Practice Guidelines, “the VA is making me do this.” That seems like it may be easier in certain situations, and it seems like it may deflect confrontation. In our experience, that can actually make things worse, it can actually increase resistance. It can increase that mistrust of the system, because you’re evoking something outside of your clinical judgment. Now, our patient is wondering, well what else are you doing that’s outside of your clinical judgment? Particularly in populations with a high degree of perceived injustice, or externalized blame, this can be very problematic. It encourages the opposite of what we’re trying to encourage. We’re trying to encourage self ethicacy, whereas this type of approach kind of encourages externalizing, well I don’t know, it’s not me, it’s someone else. Next slide. Let’s see I think, let’s go one next. Again, we talked about the FDA communication in April. We have that already, recommending against abrupt discontinuation, and our guidelines. Next slide. An alternative approach to new information is that’s more patient centered, entails spending some time with our patients, and talking about why these changes have happened. The fact that we have new knowledge about the risks, and harms of opioids. The fact that now non opioid, and non pharmacologic treatments are really the preferred treatments options. Thanks to Erin Crabs, and other researchers in the VA, we now have new evidence, showing that non-opioid therapy when used for over a year, long term treatment is actually slightly more effective with fewer side effects in opioid therapy. I’d like to finish just with a couple of cautions. Again, thinking about this whole person approach, really requires a keen attention to mental health and substance use comorbidities, because these factors are so significant in raising the overall risk on both sides of that risk, risk equation, we need to be particularly keen to recognizing, bringing in a team based approach when present. Assessing for suicidality should really be routine in our systems, and having approaches to manage that when present. Again erring on the side of giving time, as long as there’s no acute danger. Then lastly, an area that really hasn’t received a lot of attention, but during a taper, and in the time immediately after a taper, and the several months after, I highly recommend that we continue the same type of support, the same frequency of care for several months, three months, six months, we don’t know the exact time afterwards, because that time appears to be a particularly vulnerable time for patients. Again, we’re still learning about this, but it would behoove us to continue that same degree of support. Thank you very much. (clapping)
Can we ask some questions?
I’ll ask Doctor Speevak about that. Yes what we’re going to do is take a few questions now. Doctor Mardian will remain at the podium during our break, and then we’ll shift to a break. We’re open, Doctor Mardian, again I want to thank you. This has been an absolutely phenomenal presentation. Your ability to take the science, the neuroscience, our studies translated in a clinical practice, because you see patients every day of the week. It’s very helpful for us to get that perspective from you, and we’re all very appreciative. With that, we’ll take a few questions. If you can introduce yourself, where you’re from when you ask the question, that’d be great. We’ll start with Doctor Soto, our pain fellow from Walter Reed.
[Doctor Soto] Thanks for the introduction Doctor Speevak. My question is in regards to the CDC, and the DOD, VA guidelines about opioids, and it has to do with the medical, legal obligations, ramifications of continuing to prescribe, and stopping prescriptions, and then those patients who have a increased manifestation of behavioral health disease, and end up committing suicide for example. The physician who said, “I’m going to abide strictly by these guidelines, and we’re stopping opioids.” Even though that’s an incorrect interpretation of the guidelines, and the physicians who continues prescribing, and then finds their practice raided by the DEA, or some similar agency, for most likely an unrelated issue, but nevertheless two extremes of the spectrum.
Yeah, excellent, thank you. I guess first off, I think if we come back to the principles of the talk here, and really look at an individualized approach, we document well, we document the rationale for our decision making, whether that’s, really regardless of what that decision is, whether that’s a decision to continue a current dose, whether that’s a decision to change a current dose. If we’re documenting why we are doing that, and a concern for risks on either side. First of all we’d be doing better than most. So that unfortunately I think that degree of documentation is somewhat rare. I always talk about being the patients that we want to, whoever you’re going to document extensively on, these are the patients that we want to document extensively on. I would also say that, I think in the current environment there is fear about regulatory scrutiny, and I think it’s hard to avoid that. I am involved at the state level in Arizona, and really everything that policy makers are talking about is, in service of patient safety. As long as we are documenting that what we are doing is to serve patient safety, we’re going to be much better off, then if we document we’re doing X, Y, Z because of the CDC guidelines. Particularly since often when we’re doing that, the CDC guidelines are very, and our VA, DOD guidelines are very nuanced in how we describe this approach, because both groups did not want people to kind to take this out of context. Unfortunately that is happening, but yeah, so I think going back to individualized care, and documenting why you’re doing that is most important, thank you. Question?
[Cameron] Cameron Shaw of Pain Medicine of AMC. I’m just curious, when you initiate an opioid taper, do you have any adjunct medications that you like to add?
Yeah great question. Are there any adjunct medications that we uniformly add? I think the answer is yes, although there is no specific sort of cocktail that we use. I think just conceptually, we almost never start a taper without adding something else. Sometimes those passive treatments like a medication, patients feel most comfortable with adding something, so that might be a medication, and there is, I’m not aware of any good evidence to support really any of the medications. We can think about some of the medications that we use for alcohol, and opioid withdrawal, to sometimes help buffer some of those symptoms. Gabapentinoids can buffer some of those symptoms. I’m very careful since everyone is on Gabapentin now to say I may be using this not for the pain relieving effects, unless they have a neuropathic pain, but to help try to smooth out some of those withdrawal symptoms, particularly if they’ve had … Many of our patients have tried to taper on their own first, they’ve tried that, it’s failed, they have a lot of fear, trying to again to preempt that with some placebo effects can go a long way. Yes we use certainly a lot of those adjuncts, I think really that’s in a non (mumbles) approach, but we certainly feel like adding something psychology is often helpful, so we try to pick the least harmful thing to add.
[Seth] I am Seth, one follow up, I’m sorry. I keep seeing hand going up. Do you have any, familiar with the Lofexidine, the (mumbles) that’s specific for withdrawal symptoms?
Sure. Lofexidine recently approved. Certainly we, it’s very expensive. The evidence that I’ve seen is not superior to Clonidine. One very interesting protocol for withdrawal from some colleagues in Seattle, uses a combination of Gabapentin, Hydroxyzine, and Tizanidine. I often look at Tizanidine as, if I’m really about the blood pressure effects of Clonidine, I’ll often look at Tizanidine which has I think 1/10 to 1/50 of the effect of blood pressure, but can still have some of the alpha through agonist effects to assist. We’ll use that cocktail sometimes. We would certainly use that much before Lofexidine.
We’ll take one last question if you can introduce yourself.
Yes, please.
[Goburn] Captain Goburn from the Warrior Clinic at Walter Reed. Along the line of this questioning here, what’s your feeling on the utilization of cannabis to address the opioid addiction, such are Marinol, since that’s the only thing we can really use on the DOD side. I know a lot of the active duty personnel that retire, once they get out they’re falling back on the cannabis.
Yeah excellent question, excellent timing. I usually expect the last question in the last three minutes to be about cannabis. (laughing) I do appreciate that. Sorry? Yeah and that’s because it is, it’s a hot button issue, it’s very common. We have same restrictions obviously. My overall view, again this is me, (mumbles) speaking, but my overall view is that, really early in our evidence, some of the positive, it’s really fascinating if you look at, if it’s a Jamma, a meta analysis that was done a couple of years ago. If you dig down to the evidence of that, even just using for pain, not for reducing opioid use. There are some of the same limitations as some of our early meta analysis for opioids. When you look at the studies, many of those are in the two, three day, four day, five day, there were only two studies that were counted in weeks, or months. I think we’re very early in understanding the different components, certainly you probably struggle with the same thing we do. All of our patients coming in, and saying they’re on CBD oil, or some over the counter, unregulated product. At this point my main approach is one of caution, interest of additional research, but wanting, looking forward to that additional research. Thank you.
Doctor Mardian, thank you again. (clapping)
Doctor Mardian, and Doctor Lewis will be here at the podium during our break. Three quick announcements. First of all inside your badge, there is a listing of your workshops, and the sessions. All slides, if speakers have agreed to it, are available on Mill Suites, so you can get your slides on Mill Suite. Finally I am to say this exactly, bare with me, it’s here in red, bolded. The workshop rosters will be posted at the lunch and break. If you were unable, or want to change, if it’s available during the lunch break you can do that. Coffee is available at the A-Wall, very cute right next door, and we’ll see you back all at 10:15, thanks, so much.