This week I interviewed Andrew Friedman, MD a member of the expert committee who authored the latest revision of the AMDG Guideline, that addresses the management of pain, particularly the evidence related to the use of opioids.

Dr. Friedman is a Physical Medicine and Rehabilitation Specialist at Virginia Mason Medical Center in Seattle.

We discussed how the new Washington Agency Medical Directors’ Group (AMDG) Opioid dosing guideline is scheduled to be released today, and is a whopping 80 pages with over 300 references.

How will it change the standard of care?

How do the standards set forth to document a 30% functional improvement during acute titration, apply to the thousands of patients on chronic therapy?

What new tools and resources will be needed in primary care to provide safe and reasonable care to patients at high risk for complications from exposure to pain treatments?

Thanks to Andrew Friedman, MD for his perspectives.

The first AMDG Guideline for opioid dosing in chronic pain was published in 2007. The Guideline was first revised in 2010. The Latest revision of the guideline was published June 5, 2015.

Read the 5 Keys to Adopting a New Guideline in Primary Care

The following is a transcript of the audio podcast recorded June 5, 2015:

For A Leader s Guide – Michael Schiesser MD

I m excited to have my friend and colleague Andrew Friedman on the Podcast today. Can you tell listeners a little bit about yourself?

Andrew Friedman MD:  Thank you Michael. Most of my practice is focused on musculoskeletal disorders chronic pain and I ve been doing that for 20 years, since the initiation of the opioid treatment paradigm. I have recently seen the rapid change towards a more balanced approach. I am board-certified in physical medicine as well as pain management and about 80% of my practice is in evaluating patients with chronic pain and musculoskeletal disorders.

Andrew Friedman, MD

Dr. Michael Schiesser: We first crossed paths at Virginia Mason when I was in my residency in primary care internal medicine there finishing in 1997. Pain medicine was not really a focus of my training or even a focus of primary care at all at that time. Obviously you were focused more on that but really in the rehabilitation of injuries. Then you and I worked together 2009-2010 on this Agency Medical Directors Group Guideline, sometimes called the “AMDG Guideline” which we will talk more about that today.

Dr. Andrew Friedman: Yes I want to spend some time talking about that, this guideline is much different than the prior guidelines its more than 80 pages with over 300 references, and has a lot of new sections that help clinicians to understand how to treat and the acute, sub-acute the chronic phase of pain. It also has a new section on perioperative pain management and expanded into dependencies. So there s a lot of new material here that s evidence-based it s very exciting to get it out I would strongly agree with you about the fact that there needs to the methods for clinicians to incorporate this material into their clinical practice. This is a big document ,one really important thing is that even though  this is now a guideline as opposed to a clinical standard, prior AMDG guideline versions have turned out to form the core foundation for law so that may come from some of this material as well.

Dr. Michael Schiesser:  One of the things that I ve noticed in the past, is the lack of available information that codified a standard or even a guideline. I was asked to look at a case involving a death about seven years ago where a physician was being investigated by the State licensing commission. The question was whether the care was consistent with professional standards. At the time I thought it might look for published guidelines of care as an objective starting point to compare against. It was interesting because there were really weren t any published guidelines of the time other than the AMDG guideline (the original one, two revisions ago). There was some reference material in there but not a lot to go on. Of course in the civil environment, the standard is really what s reasonable and prudent; this is one standard that s commonly referenced. This was a regulatory situation, which incidentally is going to rely on state licensing commission rules to slice the boundary between a definable violation in the face of alleged charges. This was prior to the licensing commission updating its rule on the use of opioids in chronic pain care. As far as a theme for today s conversation, one of the things I think that is striking is the changing standard of care, the evolving standard of care, the more-defined-than-before standard of care, the rapidly changing standard of care; The complexity of issues, many of which used to be ignored; or seen by clinicians as overly complex, is now starting to get unwound.

For example you mentioned peri-operative, right? That s a whole separate issue where we can take a patient who s on some medications that are high risk and then turn them around into a surgery environment. We probably won t talk about that much today, but I understand that is new in the guideline.

I think it is important to ask, what s the difference between a patient initiating on meds versus a patient who might have the same underlying condition,  but somehow has been on meds for five years with accumulated issues of dependency? How does pain care with opioids play out in the real world? A lot of these things have been very confusing for doctors and care environments. Hopefully some of this is getting unwound.

So give us some of your big thoughts on what makes you excited, or what makes you concerned, when it comes to how this new AMDG guideline? How do you see it affecting pain care, in both primary care and the larger world of medicine?

Dr. Andrew Friedman: Sure so I think it s useful to go back to the beginning of liberal use of opioids for chronic nonmalignant pain state and that really started in the mid-1990s to 1996. Around that time, there was an article published that suggested that we were under treating pain and that opioids should be used much more liberally. The associated changes were probably not that great. There was no ceiling dose on opioids. We saw over the ensuing decade were lots more use promoted by drug companies and promoted by natural national pain societies. We started to see there were problems now which are questions of efficacy and lots of adverse effects and public health concerns. So in 2007 the Washington State Agency Medical Directors Group came out with what were the first guidelines, which was primarily the dosing threshold of 120 morphine equivalents; suggesting that at that threshold you get a pain specialist involved, or at least stop and take a minute to think about whether these things are effective or problematic. That was revised in 2010 in expanded guidelines, and now in 2015 and it s been expanded quite a bit because there is a lot more science around what is the risk and what is the benefit. As I said this document has more than 300 references so there are new sections here. One of the most important is that in order to judge the efficacy of opioids one must consider functional improvement. Just relying on pain and patient s report of reduction in pain at some phase is no longer considered by this guideline to be adequate to say that you had a successful trial of opioids. It s defined as clinically meaningful improvement in function, or CMI, have which basically means that a person needs to have at least a 30% improvement in function as documented by a validated instrument to suggest a beneficial trial of opioids to continue opioids beyond the acute phase into subacute phase for three or more months into the chronic phase.

Dr. Michael Schiesser: Wow 30% is kind of a round number but I guess you have some experts who say this is what s reasonable. Being addiction specialist, I see a lot of referrals from Primary Care for patients not necessarily diagnosed with addiction, and these patients are receiving opioids for chronic pain, sent to me for an overall evaluation. Is the care appropriate, is the medication regimen safe, are there underlying issues of dependence, addiction or both. Many of these patients have been on opioids for 10 to 15 years and I m just meeting them for the first time trying to make the judgment call for whether or not there is a reasonable risk/benefit. Since you re talking about that acute response as a critical component to define efficacy, how does that work when a primary care doc is inheriting a patient that moves into town from far away, and claims to have been on opioids for seven years, and the patient is saying Hey doc, these meds work for me ? How do docs apply a 30% clinically meaningful improvement in function without a baseline? How does that apply if you had not had an opportunity to see what the response was acutely?

Dr. Andrew Friedman: I think that s a great question and I encounter that myself with my own patients because they don t have baseline functional data on these patients, and there was a lot debate about how good are these skills for defining function. The two scales that are recommended are PEG which is a three item scale which talks about 1) Pain intensity, 2) Enjoyment in life and 3) Interference with General activities. This is similar to the two-item rated chronic pain scale which is pain intensity and interference with activities. These are supposed to be the validated tools, but the question is: Are they really good surrogates for talking to family, getting the patient estimate in terms of what they re actually doing, are they able to go back to work? Those are also valid ways to assess function for those people we don t have any baseline information. Talking about those issues and documenting that in the note is can be important going forward.

Dr. Michael Schiesser: When you see your patients in your practice, especially since you been working on this guideline committee, and you encounter them one-by-one on opioids; What is your gut impression on how well primary care docs, who each may be only managing 10 or 20 total patients on opioids, how well are they going to be able to have this precision standard in operation as far as the treatment of the patient?

Dr. Andrew Friedman: Well I think it s a big challenge to get it right and as you said earlier in our conversation, making available the proper tools that are going to help clinicians be able to do this is can be critical. Any time you provide guideline that is evidence based, as brilliant as it might be, translating that into clinical practice is a challenge. So you know at Virginia Mason, the primary care doctors have already started to make templates for their encounters with their patients, for building these tools and that s one good way to do it. Every practice is different, so it solutions can be a little different.

Dr. Michael Schiesser: Do you tend to have the patient fellow periodic questionnaires every six months to track longitudinally? Are some of these measures something you re rolling out now in response to some of these the newer tools that are recommended?

Dr. Andrew Friedman: In our specialty area, physical medicine, We have for years been tracking function as well as pain and then once a year we would do much deeper dives and look at more data and more information about possible adverse effects, as well as benefits but the recommendation now coming from this guideline is that every visit in which an opioid is prescribed,  function is measured and compared to the baseline. I think that learning to do that in clinical practice is important but it will also take some practice change

Dr. Michael Schiesser: Will that s an interesting point right there because it seems like it is pervasive in the primary care environment for patients to call-in and say I couldn t get into the schedule etc, and ask for a refill. I insist on not doing that, in other words I don t refill medications without an appointment. Part of the reason is because these other care elements can get ignored, and the writing of the prescription becomes the reminder for the clinician to actively monitor the patient in my opinion.

It seems like the act of writing of the prescription is often a short-circuiting of care that happens where there are a lot of things that ought to happen, but the prescription gets written and nothing else happens.

Dr. Andrew Friedman: Right, and the answer to your question of how often you see the patient depends on their risk and their dose. A patient with low risk on a very low dose of opioids might need to see the clinician every six months so but probably most of the people that were concerned about need to be seen more frequently. These are patients who are at higher doses and a moderate amount of risk; they need to be seen more frequently. We have a practice of seeing people for the most part a minimum of every three months because I think they probably need to be reassessed more regularly. Part of what s coming out in the literature now is the incidence of substance use disorder, and the incidence of physical dependence is much higher than we previously thought based on the literature

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Dr. Michael Schiesser: What would you say the incidence of dependence and/or addiction for a given patient over 50mg of a morphine equivalent dose (MED) per day for more than a year?

Dr. Andrew Friedman: I would say that most of those patients are on high enough dosages to have physical dependence and withdrawal phenomenon if they stop their meds. We used to the original studies that describe this for very small patient populations and we think their estimates of 3 to 5% of patients that you to worry addiction. In a newer study that just came out this year from Australia, they have estimated dependence for these patients and addiction rates are closer to the 20 to 40% range, and there are probably dose dependencies if you use a DSM-V criteria for opioid use disorder. The likelihood of developing an opioid use disorder on low dose opioids is probably threefold increase compared to the general population but as people get over 120 morphine equivalents daily a recent publication suggested that there is more than 100 fold increase risk for opioid use disorders. So dependency and addiction do occur more commonly than we thought before.

Dr. Michael Schiesser: That squares with my experience, especially the people whose consumption behavior has obvious signs. But patients I am otherwise not so concerned about, I do urinalysis and find alcohol patterns that were unrecognized, or don t square with their disclosure. It just keeps going and going from there.

Let s talk a little bit about what the guideline recommends when things are not going so well. Suppose you identify a patient for whom care appears counterproductive or their urine suggests something that s not right, or the patients is taking their grandma s medication. Whenever encountering a situation where the patient does have physical dependence, what is the guidance emerging out of this guideline that would direct physicians as to what to do next?

Dr. Andrew Friedman: Well I think this is opening a new area of conversation that hasn t been adequately addressed in the field. Previous guidelines have said if the patient is stable regardless of how they are functioning, there s no need to taper the patient. The current guideline says patients who have not benefited from therapy functionally, or if is aberrant use patterns, then the patient should be tapered. There is another whole section how to taper patients on an outpatient basis and recommendations for when a pain specialist needs to be involved in taper. We all know this is a difficult thing to do. Most of the time patients do not want to taper. If they have dependence, they may be concerned that they are going to be separated from their source of medication. If they have a chronic pain issue, they, may be concerned about the fact that their chronic pain can get worse. So my impression that this cohort of patients we have seen for years, maybe they have been treated like we treat opioid dependence, but with agonist therapies, but the agonist therapies aren t the ones that we consider to be used as therapies for dependence. The line between dependence and addiction chronic pain treatment has always been difficult when understand. I wonder as we try to taper larger amounts of patients with are working to find the transition into more of more opioid agonist therapy in the way we otherwise manage traditional opiate dependency model. But I don t know if we have resources available to treat large number of patients in that way.

Dr. Michael Schiesser: yeah so I think if I was in the say the same thing you said, but differently, is that the more we prompt patients towards a taper the more we uncover the issues of dependence in that population. Maybe even the notion that we been treating them for opioid dependence for many years with agents that are intended for opioid dependence, or treating dependence under the diagnosis of pain .

Dr. Andrew Friedman: Yeah it is a difficult area because clearly doctors are not trained in maintaining patients on opioid dependency, and legally can t do that. It is often difficult to tell whether the patient has benefited but when we try to taper them… we have a lot of difficulty. My understanding of the addiction world is that patients with opiate dependency do much better in terms of avoiding relapse and avoiding dangerous behaviors,  when they are maintained on opioid agonists. It just begs the question as to whether this group of patients may not have severe aberrant behaviors but maybe opiate dependence, and may benefit from similar kinds of treatment models.

Dr. Michael Schiesser: The authority to prescribe Suboxone is a handy thing in my toolkit because I could try to taper patients and then after having trouble then we can just switch to Suboxone. Typically they are really grateful because they are like wow, I was on a whipsaw with that hydrocodone up and down and up and down every day, I had no idea how badly it was affecting my quality of life but now that I m on Suboxone I am much better This med has a really stable serum level, and the resulting experience leaves patients often really grateful to be on the Suboxone,  although not one-hundred percent. I think it s an important thing that Rick Reiss and Andy Saxon and and Dave back were all on this committee to stack the AMDG guideline committee with a lot of addiction folks.  Cindy Grande is going to be an upcoming interviewee and while she is not addiction specialist, she understands these issues and will be an upcoming guest on this podcast as well.  Access to Suboxone therapy is a must-have in my opinion, when you treating pain patients with opioids. This is where I d like to see the world go, it s just a resource that you need to have around especially primary care.  What you think about that?

Dr. Andrew Friedman: I think you re probably right and I don t have a lot of experience with Suboxone, I haven t prescribed it myself but I probably should learn more about it and start prescribing it because again the up-and-down nature of the medicines the difficulty patients have  tapering, plus the fact that Suboxone does provide analgesia… I think all those together. I d rely more on you than my own experience to say how well it works but there are a lot more patients that find themselves in the gray area between being opioid dependent and having a pain problem that we need to look at this carefully .

Dr. Michael Schiesser:  So let s go back then to the tapering because I do  a good amount tapering as well. One of the things I learned is the slower I go, the more sustainable the effort is. With a lot of these patients, we are making an arbitrary call, that is, we have been saying to them for years that all of this is appropriate therapy, because you are treated by a doctor, and giving you this medication. Now all of a sudden were saying this is not appropriate, because we ve changed our own minds , and maybe for good reason. It seems like a little bit unfair to upend the patient s life and introduce a lot of post-acute withdrawal symptoms or acute withdrawal symptoms when they have become accustomed to large dosages of agonist therapy. For example if I have a patient on one-hundred milligrams of methadone or 150 mg of morphine, I might set out a 8 to 12 month taper schedule for those. Every month is just baby steps and an opportunity to review them why it is in their best interest to move away from these therapies. At the same time were not trying to wreck their Saturday . Have you had any experience with a slow taper?

Dr. Andrew Friedman I have. A few things to consider: There have been a number of studies to show the patient on high dosages greater than 120 morphine equivalents , that a taper down to lower doses has actually had improvement in their pain and function. That not universal but something comes a time, so there is good reason to think that it might be the right thing to do for a lot of patients. Then there are the circumstances under which you decided to initiate the taper. A situation like a patient diverting or they are have an impending adverse outcome; like they re having falls or confusion, or they had an overdose, then you do a relatively rapid taper over couple weeks. Perhaps those patients who don t have those sorts of concerns, then I think it s a balance between how long do you drag this thing out, how much discomfort does that bring versus something more rapid. The recommendation in the guideline is 10% of the original dose per week, or say taper over three months, but slow is okay if there are not problems that would force you to go quickly.

Dr. Michael Schiesser: I want to shift a little bit here to the whole idea standard of care. What you think is the outcome like three years down the road? Is this guideline going to have a big impact on how we approach opioids and pain?

Dr. Andrew Friedman: I think it will. I think there is now a pretty broad realization that the efficacy of these medicines for long-term pain in many of these circumstances is quite low. Not better than other sorts of interventions. I think that notion is something will be more widely understood in the future. In 2007, when Washington published the first guideline it was quickly taken up by other states and other agencies. So much of the country is looking to Washington to inform their decisions. The scope is important moving forward, as with the other issues, the harms with opioids are actually  pretty significant and the data on that is just growing at this point. That s not to say that nobody can benefit from opioids. We have to be careful not to say that because I may say something in the guideline committee, and make statements in broad terms, and then go back to my practice and I see example after example, of people who do seem to benefit. So to answer your question I think this guideline will be broadly looked at and will influence the standard of care.

Dr. Michael Schiesser Andy you pointed out that this phenomenon of using opioids broadly and liberally for chronic pain, maybe it s over 20 years old;  but as far as mainstream it s over 20 years old. This guideline first came out in 2007. You and I participated in a revision 2010 and today (June 5, 2015) the latest revision is being published in your part of the committee.

How many other experts are on that committee?

Dr. Andrew Friedman–  Might have to count them but we probably had say 30 from clinical pain experts to academics the government on the committee. The agencies represented would be the Department of Corrections, The Department of Labor and Industries, the Department of Health, and Medicaid. Many people both in the pain management and the addiction medicine world, both from academia and private practice.

Dr. Michael Schiesser– one of the things I noticed when I look that the committee members, most of which I know, some of my don t;  but it seems like there are not a lot of primary care docs. I think that s a reflection that primary care docs are often not really experts in this area. But the two things that I m wondering is: 1) to what extent can we apply the standard to primary care when it s really was really boiled down from pain experts? 2) The other question is how many of these experts on the committee get their hands dirty with patient care versus just reading the evidence?

Dr. Andrew Friedman: Right, it s a fair question. I would say that there was certainly an emphasis to try to make sure that this made sense from a primary care perspective. One of the most influential leaders was Malcom Butler, who has been a leader for a long time in primary care, and was quite outspoken. Then we had a number of nurse practitioners both from primary and specialty care and so whenever we met as a group we did try to understand the impact on primary care and how well this could be translated. Then your question about about the academic versus in the trenches issue is also important one. It s one thing to translate the evidence when we re thinking about a population of patients. It s another thing to be dealing with patients in the office that have unique characteristics and needs. So I think this guideline does provide some guidance as to how to talk to patients, on how to deal with cognitive issues, the emotional issues as well. It s a big document and I think there s a lot ask all doctors to read it but to the extent that some are interested in sitting down and reading it.

Dr. Michael Schiesser: I imagine it is. One of the things I ve learned in my own journey with patients and physicians being a teacher of doctors in a physician for my patients, is that doctors are often worried hurried, frustrated, or scared; they want to know what the right thing to do is. They say I just want to do the right thing . Sometimes that comes into direct conflict with patients in terms of what the patient wants. I found that the more I can focus in on what is in the patient s long-term interests, and orient the patient towards the idea that my intent is to help them, the better the result. The idea that 10 years from now I want them to look back and say I didn t necessarily always agree with Dr. Schiesser at the time, but I realize now that he was looking out for my future health . Patients can t always see that immediately, but as long as a maintain that posture in my communications and my actions, that I m not just trying to follow some medication Nazi guide to how to manage the pain patient thing. Rather, it s more like: How do we do a good job with patient care? How do I be the best doctor for my patients? That s really the place where I recommend clinicians try to line up, because otherwise it s can be a battle with the patient, just because everything s changing now. Do you have thoughts on how to get patient engagement when it comes to taking step in directions they don t immediately want to have happen ?

Dr. Andrew Friedman: Being a witness to a person s suffering, and to be there with them, to do some old-fashioned doctoring to try and do the best for the patient… as simple as that sounds it s actually our main job in these circumstances. Finding ways to do that, the time to do that, ways to reimburse doctors to do that …that s an important change that we need to all figure out together. I completely agree with you. We are focused on patient satisfaction as one of the main performance indices now. At least in the short term, some of these things are not very satisfying to patients, but doing the right thing is ultimately what we all promise to do, so we need to think about how to do that.

Dr. Michael Schiesser: Do you have a success story in your own head that you can share before we wrap up today about maybe something that felt like it wasn t going to be super popular but ended up turning out better than you thought

Dr. Andrew Friedman: I ve been doing this for 20 years and has spent as much time tapering off opioids as I have treating them with opioids I would just reassure clinicians that people often do get better when they taper down to lower doses or off of opioids. Rarely does pain get worse and their cognitive function improves and then their function improves. Just knowing that, and helping patients to understand that is really critical… and believing that. So I guess I wouldn t point out one single-story but there have been many my experience. So telling them to just hang in there, going slow and addressing fears, telling patients that despite what they re asking for…which might be a dose increase or some other similar kind of modification of the opioid program; you have to do what you know is right in the long term for the patient. Sometimes that is tapering off.

Dr. Michael Schiesser: Andrew thanks for joining me today on A Leader s Guide audio companion as a physician expert, who has worked on the Agency Medical directors group opioid dosing guideline panel that is being published today June 5, 2015 and I really want to thank you for coming on the podcast today.

 

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