Speaker 1: You are listening to Your Practice Made Perfect; support, protection and advice for practicing medical professionals. Brought to you by SVMIC.


Laws are constantly changing, so please make sure you refer to the most current laws where you practice medicine prior to prescribing. We've provided some resources in the show notes for this episode to help guide you.


Brian: Hello, and welcome to today's podcast. I'm Brian Fortenberry and with us today is Dr. Rhett Blake: Welcome Dr. Blake.


Dr. Blake: Thanks Brian.


Brian: We're going to be discussing some treating of pain and really getting into the guidelines and the regulations around treating pain. This is something that you're certainly familiar with. Tell us a little bit about yourself Dr. Blake.


Dr. Blake: I'm a pain medicine physician. I have a multi-disciplinary practice in Chattanooga and we've been there for about 10 years. I did an anesthesiology residency followed by a pain medicine fellowship prior to starting that practice.


Brian: In the wake of this opioid epidemic that is out there facing the country right now, everyone is weighing in on it from anybody running for office to any political figure, you can't get away from it. On the news as well. Many different groups out there really taking action to try to get this problem under control. Can you speak a little bit about what is being done about this, what they're doing to try to get this in hand?


Dr. Blake: Certainly, and there is a lot that's being done. As we all know, the opioid overdose deaths have quadrupled over the past decade. I think 64,000 in the US last year, 1,600 just in the state of Tennessee last year, so this is a major issue that's...


Brian: Sure.


Dr. Blake: ...affecting the nation and Tennessee, as well as a lot of other Southeastern and Appalachian states have been hit particularly hard with this. And so, there have been multiple different efforts. There has been a federal task force, there are multiple federal agencies that are looking into the opioid epidemic, the pain epidemic, which is a kind of, in some ways, goes hand in hand with that.


Brian: Okay.


Dr. Blake: There are legislative task force, several different legislative task force with elected officials and community task force throughout Tennessee. They all look at making recommendations about legislation, which laws should be passed to address this problem, education both for medical professionals as well as the general public, and what to do about the law enforcement side of this because as we know, almost all the increase in opioid overdose deaths is now not coming from prescription opioids, but from illicit opioids like carfentanil and heroin. All of these things have to work in concert and all of these separate issues need to be dealt with, but it's important to process and a lot of this has already been done.We've come a really long way in the state of Tennessee just over the past five years because Tennessee again, like we said, has been hit particularly hard, so it makes us a Petri dish if you will for looking at the best ways to improve the opioid epidemic and to move forward from it because we had so much work to do. I think other states are going to be looking at us and possibly following suit on our heels in terms of ways to fix problems in their states as well.


Brian: I want to continue down that road of when all of this really got started. Obviously, it is a nationwide issue, I don't think we would disagree with that, but are there certain areas of the country that are worse than others and if so, where?


Dr. Blake: There definitely are. When we look at rates of opioid prescriptions per capita and rates of opioid abuse and overdose deaths, it tends to be the Appalachians and the Southeast, so Tennessee, Kentucky, West Virginia, Alabama, Mississippi, as well as certain areas in the northwest and the Midwest, so certain areas have been spared somewhat. I'm not sure exactly all the reasons behind that. A lot of different socioeconomic differences between those areas, but there are certain areas of the country that have been hit worse than others. Just in the state of Tennessee, there are pre-marked geographic distance between Western Tennessee and Eastern Tennessee...


Brian: Really?


Dr. Blake: ...with Eastern Tennessee seemed to be hit much harder than the western half of the state.


Brian: When we're talking about this, to your point about Tennessee being kind of the Petri dish, we're right in the hotbed of where this issue is. And so, a lot of the efforts are going to be focused here then to really be able to use as a guideline for other places.


Dr. Blake: Right. When the Surgeon General came to some of the hardest hit areas, last year we came to Knoxville, so obviously, that's one of the areas that has had a significant problem as well.


Brian: When did these efforts to start trying to reign this in, when did it really begin? When did it really start ramping up?


Dr. Blake: It's been more in the public eye just for the past two to three years.


Brian: Right. That's the perception. Yeah.


Dr. Blake: In Tennessee, it started back as far as 2002 when the Controlled Substance Monitoring Act was passed.


Brian: Okay.


Dr. Blake: That created the CSMD or the Prescription Database.


Brian: Yes.


Dr. Blake: That was in response to issues where we were seeing the initial increase in opioid overdose deaths. That was from both prescription opioids as well as heroin even back in the late 90s. That created the database, so the CSMD. That became active and started collecting data back in 2006, so these are not new. Again, this has been going on for 15 some odd years where we've been taking action about this problem. Back in 2012, there was a pain clinic bill that created a certificate requiring pain clinics to follow certain protocols and meet certain requirements.


Brian: So, not just anybody can go and hang a shingle and start a pain clinic without going through a process then. Correct?


Dr. Blake: There was a process. I don't think it was nearly as stringent as it should have been, but at least it was a start in the right direction. And so, that started back in 2012 and it's been gradually increasing since then.


Brian: Okay.


Dr. Blake: And, it was recently revised just last year. The other bill was the Prescription Safety Act that was also passed in 2012. That required everyone with a medical license in Tennessee to register in this database, meaning you have to go, you have to enter, and you have to give your email address. It also required you to check that database anytime you wrote a prescription for opioids for more than seven days. That was to make sure that if you were going to write a prescription for opioids for a patient, to make sure that you knew what other sources he was receiving opioids from...


Brian: Sure.


Dr. Blake:...you wanted to minimize the doctor shopping, if you will.


Brian: I got you.


Dr. Blake: It also required the Department of Health to create guidelines for how opioids should be prescribed. That was the Chronic Pain Guidelines that the Department of Health started to work on over the next several years after that.


Brian: So, you talk about there're guidelines in place for prescribing opioids. There's a process I'm assuming for doing this. How did that get started and what does that look like on a big picture?


Dr. Blake: It was a fairly involved process. The reason that that got started was because we could clearly see data where both nationally, but specifically in the state of Tennessee, we were prescribing a lot of opioids and the number of opioids we were prescribing was climbing dramatically. Along with the number of opioids that were being prescribed, we would see the number of addiction treatment admissions into addiction treatment centers and opioid overdose deaths. Those numbers all climbed gradually, so we had to do something to talk about, okay, the prescribing of these opioids is part of this problem and we have to address that. We wanted to establish guidelines of if you are going to prescribe opioids for chronic pain, how should that be done?


And so, the Department of Health gathered multiple different stakeholders, which were pain physicians, primary care physicians, law enforcement representatives, insurance representatives from commercial insurers and Medicare.


Brian:  A lot of people had a seat at the table then, right?


Dr. Blake: A lot of people, and addiction medicine specialists, so they tried to get everyone that had any interest in this issue to be able to come and be able to say, "Here's the problem, here's what we know about it, and here's what we have to offer in terms of addressing it."


Brian: So, when everyone got together and you have all these minds going we obviously have an issue, it's a big issue, we have to come up with some guidelines, everybody put their input, what did the guidelines include at this point?


Dr. Blake: I thought they came out with fairly reasonable guidelines, but when you look back on it, it seemed to be fairly common-sense type recommendations. If you're going to write opioids, you should make a legitimate diagnosis of a painful condition. If you're going to treat pain, you should diagnose it's something that would cause pain. What would you see in a lot of these little pill mills that we talked about earlier was that someone would come in with chronic pain syndrome and they would pay cash, and they would be given a ton of pills for chronic pain syndrome whatever that is.


Brian: Whatever that is. Right.


Dr. Blake: We said, "Okay, you need to be able to diagnose a specific or multiple specific conditions that would cause chronic pain." We also have to at least assess the risk of abuse and misuse of these opioids. It is a possible problem. It doesn't happen to everybody. It only happens to about 10% of people that take chronic opioids.


Brian: It's only about 10%.


Dr. Blake: Depending on the study that you read, yeah.


Brian: Really?


Dr. Blake: 10% is a fairly large number, but you have to establish again, and at least assess for the risk of abuse and misuse and do what you can to minimize that. Then, monitor for the compliance, how these patients are using their medications, what they should be doing, what they shouldn't be doing, and then what you should do about that. There are also some specific recommendations about using more than one different short-acting opioid, recommendations about avoiding opioids and benzodiazepines because that's a particularly dangerous combination.


Brian: Combination.


Dr. Blake: Obviously, they can combine to have a synergistic effect that can lead to overdose more frequently.


Brian: Mm-hmm.


Dr. Blake: Some recommendations about avoiding methadone because it has a particularly long half-life and it accounts for a disproportionate number of deaths compared to the number of prescriptions that it represents. Also, there were some recommendations regarding neonatal abstinence syndrome, which is where as soon as a baby is born, it starts withdrawing from the opioids that it was getting in utero during the pregnancy. Obviously, Tennessee is again leading the nation in a very unfavorable statistic in that regard, which is something that is really tragic that we need to address and have already done a lot to address.


And then, in terms of dosing, we made some recommendations that for patients that are on high doses of opioids, you should refer those to a pain specialist. Maybe that's not something that should be treated in the office of a primary care physician and those were, again, seemingly common-sense recommendations.


Brian: As you say them and as you go through them you think, "Well, yeah." I mean, it does make a lot of sense, but it is always good to get together and set them down as guidelines. Is that the only set of guidelines out there that really oversee opioids?


Dr. Blake: No. Those were the first recommendations that came out of Tennessee. Since that time, the CDC has created their own set of opioid guidelines. Those came out in 2016. I think the Tennessee version was finalized in 2014 or thereabouts, and the CDC guidelines were specifically geared towards primary care physicians. Again, they're similar in a lot of ways. You have to establish goals for treating with opioids. If you're going to treat a patient with opioids, establish those goals. Where are you trying to go? More importantly, if you're not achieving those goals, then should you continue those medications? If they aren't working, why do you continue to use them? You should make sure we discuss the risk of addiction and abuse and overdose, as well as the potential benefit of that medication. They lay out clearly that opioids are not the first line of treatment in most, if not almost all circumstances. They recommend that you treat with the lowest dose and for the lowest amount of time possible for acute pain, which again seems common-sense.


Brian: Sure.


Dr. Blake:  They recommend checking the database or the CSMD. They recommend using urine drug screens for monitoring compliance. They recommend evaluating a patient for opioid related harm, such as abuse or addiction, and again, avoiding opioids and Benzos as we discussed earlier. Arranging for addiction treatment if that's present. Those all seem fairly reasonable. They chose a different mark for what they consider high dose than the Tennessee guidelines did, but again, that was two years later, so they recommended using caution for doses of opioids over 50 morphine equivalents and then avoiding or very, very carefully justifying doses of opioids over 90 morphine equivalents.


Brian: Wow.


Dr. Blake: Which again, considering that these are primary care physicians specific guidelines, fairly reasonable.


Brian: Sure. What was the overall impression of these CDC guidelines that came out compared certainly to the ones that had come out earlier?


Dr. Blake: I think they were fairly well received overall. Since these come from such a large and well-known organization as the CDC, they were very impactful. When the CDC says something, everyone listens. There were some problems because I think there was a little bit of misconception about some of the things that the CDC guidelines said. They said that when opioids are initiated, they should not be initiated with the long-acting formulation.


Brian: Right.


Dr. Blake: I think a lot of people perceived that as that long-acting formulations should never be used, which ruffled some feathers a little bit, but really, they said if initiating opioids, you shouldn't start with long-acting, which again makes sense most of the time. They are guidelines and guidelines are not law. They are not set in stone. These are rules that should be followed most of the time, but since they're guidelines, by definition almost, you recognize that there are people and there are patients that are going to fall outside of those guidelines.


Overall, I think they were fairly well received and I think they've shed a lot of light on the fact that every physician in the country needs to pay a little bit more attention to this than we have previously and we should drill down on that. It kind of makes you look at your own practice when you see a guideline and then if you notice, wow, I'm routinely falling outside of these guidelines, then you need to be a little bit introspective and figure out, well, why is that? Why am I not following the guidelines that the CDC says every physician should follow? If there's a really good reason, then fine. If there was a problem with the CDC guidelines, I would say that there was very little input from pain physicians and there was a little bit of discussion about the inclusion and exclusions criteria about some of the data that was used to create those guidelines, but overall, I think they have had a very good positive impact.


Brian: As a physician, when you start hearing, okay, we've come up with our own set of guidelines, then the CDC gets involved, they're coming up with a set of guidelines, at that point you know, okay, they may be guidelines, but there are people out there that are really starting to look closely at this now. Even though they aren't laws, we probably need to get within those guidelines just to stay compliant to some extent because things are going to start ramping up. To that point, are there other... not guidelines, but rules or laws out there regarding opioids and pain?


Dr. Blake: Specifically, if you are going to prescribe Buprenorphine, you can use that on label for the treatment of opioid addiction, but you cannot use that off label for the treatment of pain. Now, there are some FDA approved formulations of that, which are FDA approved for pain, but you can't use Suboxone for the treatment of chronic pain. That's a law. Then, of course, there's some other ones where pain clinics cannot dispense controlled substance and pain clinics cannot take cash for payment, except for co-pays and some other things. Those are the laws that are associated with that. Again, in Tennessee there are the other pain clinic license rules. That's a very, very long list of different rules and regulations and very specific requirements that pain clinics have to follow.


At this point, pain clinics are extremely tightly regulated and very, very closely monitored and that has helped because again, I think five to 10 years ago we did have a lot of the pill mills that were causing some of these problems. There are still some that need a little bit more scrutiny, but we've made a lot of progress in that regard.


Brian: It certainly sounds like this is a problem that when responsible physicians solve the problems out there, probably you can see the down the road this is coming.


Dr. Blake: For pain physicians, and frankly one of the reasons that we started passing these laws back in 2012 was because the legitimate pain physicians that were there were seeing these problems and we were the one calling the legislatures and saying, "Hey, you guys got to do something about this." We were calling our colleagues in the Department of Health and saying "We see this problem and it's getting worse. You guys have to do something about this." The pain community has been closely involved with the Department of Health and possibly even being the driving force behind some of this legislation to say we have to address this because we had a front row seat for it.


Brian: Sure.


Dr. Blake:  We would see a lot of the negative impact from the pill mills and obviously, it gave us a little bit of a black eye because we were getting a bad reputation.


Brian: It's a negative reflection on anybody associated with pain at that point.


Dr. Blake: Absolutely. Yeah.


Brian: So, are these rules and guidelines, although important and although necessary, do they create a liability climate for physicians out there because it's kind of a necessary evil? What is your impression of that?


Dr. Blake: I think they quite possibly can because again, what you don't want to see is the pendulum swinging too far in the wrong direction. There was clearly an over-utilization of opioids over the late 90s and the early 2000s and some of that was in response to a long history of under-treating chronic pain problems. And just saying you got chronic pain, tough, deal with it. Of course, that's not good medical care either.


Brian: No.


Dr. Blake: We developed a problem where opioids seemed to be the fastest and easiest way to treat pain, not necessarily the best, but insurance companies have a long history of not covering things like physical therapy and injection therapy and cognitive behavioral therapy and other types of ways to treat chronic pain. The only thing they would cover was opioids because that's cheap for the insurance company.


Brian: That's where you had to go for the patient. Right?


Dr. Blake: Yeah, so you're left with very few options other than using what might be the most dangerous way to treat pain, but I think we're in real danger of creating access to care problems for the patients that do have chronic painful conditions that can't get their pain treated in any other way. Where nobody's willing to write any opioids, even for low-risk patients, so there may be problems where physicians don't want to treat pain at all. We've seen a lot of primary care physicians refuse to write opioids at all even for low-risk patients.


Brian: This is really how it could affect the patients as well. Right?


Dr. Blake: Yeah, and we've seen multiple different physicians and pain providers leave the state because of what is viewed as over-regulation of what I consider a very, very legitimate noble profession. When done correctly it is. Now, obviously there are some elements that need to be dealt with and more carefully regulated, but we have seen physicians and other pain providers leave the state because it was viewed as a hostile climate. Certain patients have also said that. There was a survey done on I think about 3,000 chronic pain patients and 71% of those patients said that they had their opioids either discontinued or decreased because of the CDC guidelines. Now, whether that was right or wrong is a different study, but a lot of those patients reported decreased quality of life because of that.


So, the guidelines, again, they are very, very well intentioned and in fact I do think they are absolutely necessary in terms of addressing a problem that we clearly have and that has gotten worse. They've had a very positive impact on educating the healthcare providers in the US about general habits that were probably overly liberal when looking at opioids, but at the same time, I still think we need to take other actions in terms of we still have an epidemic of under-treated pain. We also have an opioid overdose and abuse epidemic, but we still have the epidemic of chronic pain in the United States. We've got figure out ways to treat it and then ways for patients to have access to chronic pain care in a way that treats them compassionately and treats them well, but minimizes some of the unintended consequences of using too many opioids, which again, unfortunately, they're the cheapest way and the most easily covered way for insurance companies to treat that.


Brian: So, as we wrap up our discussion here on the guidelines and regulations of treating pain, I'm now going to ask you to do something almost impossible and that's look into the crystal ball of the future. In your opinion, where do you see this moving forward? I guess the easy answer is we're going to continue to see more regulation, we're going to continue to see more laws. If so, how stringent do you think this is going to become and how much is it going to affect pain physicians like yourself?


Dr. Blake: I think from the medical side of things we have done what needs to be done, almost. There are still some things and some loose ends that we need to tie up. Those loose ends may seem insignificant, I think they will have very, very important and long-lasting effect. We have to find a way, again, to balance the compassionate treatment of the chronic pain patient with minimizing the unintended consequence. This is just on the medical field, so I do think we will see some more regulations and some more changes. I think the best way to go about this problem is to educate, not legislate. Now, if you want to legislate education, I think that's fine and I think that's a very good idea.


That's what I would like to see in this coming legislative session is where we say, okay, we have to educate people on how to do the right thing. Most importantly, we have to give them the right tools to do this. It's one thing to say, "Okay, I'm going to give you a hammer and a bunch of screws and I want you to screw in all these screws with a hammer." It's not going to work, so you have to give the physicians the right tools to do the job that they need to do. If we don't have coverage for non-opioid pain treatment, such as injections and physical therapy and cognitive behavioral therapy, then we're going to continue to see this problem. If you continue to allow anyone, regardless of their training or their board certification to open and own and run a pain clinic, we're going to continue to see this problem.


There are some changes that I think need to be made, but I think we need to be cautious... I guess I would say we need to use a scalpel rather than an ax at this point, but as we have changed and done so much over the past five years, some of these changes take a little bit of time and we have to give them some time to adjust because if you don't do that and if you don't do this in a controlled and thoughtful manner, what you're going to see is a lot of chronic pain patients using illicit drugs like heroin and illicit fentanyl that are being shipped in from China and Mexico. Then, you're going to see the overdose dose continue to spike up as we have over the past two years.


Brian: Sure.


Dr. Blake: It's kind of an interesting story. The past two years have seen a fairly dramatic decrease in the number of opioid prescriptions that have been prescribed, so doctors are writing fewer opioids, fewer prescription opioids, but the number of opioid deaths has spiked and increased dramatically. Again, that's because of the presence of the illicit drugs like carfentanil and heroin. That brings up the law enforcement side of this equation, which is certainly outside of my wheelhouse, but that's going to take funding and that's going to take law enforcement agents on the street doing what they do well. At this point, that's a major part of this equation and that's, I think, some of the things that you're going to see in the upcoming legislative session with how this goes in the future.


Brian: This is so broad reaching. I mean, there are so many different areas that do have to come together to really get a handle on that. Even, like you were saying earlier, the specialties within medicine having to come together to do this. This has been fantastic and very informative. Dr. Blake, thank you for joining us today.


Dr. Blake: Thank you.


Speaker 1: Laws are constantly changing, so please make sure you refer to the most current laws where you practice medicine prior to prescribing. We've provided some resources in the show notes for this episode to help guide you. Thank you for listening to this episode of Your Practice Made Perfect, with your host, Brian Fortenberry. Listen to more episodes, subscribe to the podcast, and find show notes at SVMIC.com/podcast. The contents of this podcast are intended for informational purposes only and do not constitute legal advice. Policyholders are urged to consult with their personal attorney for legal advice as specific legal requirements may vary from state to state and change over time.