[MUSIC] So thank you all for joining us here. We're here today for a conversation with doctors Christina Mikosz and Jan Losby from the National Center for Injury Prevention and Control at the Centers for Disease Control and prevention. My name is Shannon Frattaroll, I'm on the faculty here at the Johns Hopkins Bloomberg School of Public Health. And I'm joined here today by my colleague. >> Caleb Alexander, I'm a practicing internist and pharmacoepidemiologist at Johns Hopkins. >> And we're very excited today for this conversation to talk with doctors Mikosz gets and Losby about the CDC guideline. It's been an important tool in the opioid epidemic. And were looking forward to learning more from them about CDC's vision for this, how it's rolling out, and the future of their work on this issue. >> Yeah, I mean, there have been so many efforts to try to improve the safe use of prescription opioids in clinical practice. And I've got to say when I think through a lot of the efforts over the past five to even ten years, the CDC guidelines really stand out as one of the most prominent. And this is a very rapidly changing epidemic and lots of different pieces to it. But the CDC guidelines are certainly worth some focus and attention. So maybe we could begin just with hearing a little bit more from you both about the guidelines and what the intention was as you set out to develop the guidelines. >> Sure, thank you. So the purpose of the CDC guideline for prescribing opioids for chronic pain is to provide recommendations for the prescribing of opioid pain medications for patients aged 18 and older in outpatient primary care settings. The guideline is not intended for use with active cancer treatment, palliative care, and of life care. And the primary audience is primary care providers, clinicians like family practitioners, and internists, and this group includes physicians, nurse practitioners, and physician assistant. We know the primary care providers are prescribing the most opioids, about 50%. Other specialties, like surgeons, pain specialists, and dentists prescribe opioids at higher rates, but they reach a smaller proportion of patients on opioids. When you consider the large number of primary care providers and the large number of patients seeing those primary care providers to treat their chronic pain diagnosis like their chronic low back pain or the chronic osteoarthritis pain. It turns out that the largest proportion of opioid prescriptions in the United States are coming out of primary care. And that's notable, because primary care providers report concern about opioid medication misuse. They've reported managing patients with chronic pain to be stressful. They've expressed concern about patient addiction and they've reported insufficient training in prescribing opioids. And collectively this prompted CDC to develop the guideline to better align opioid prescribing practices in primary care settings with the best available evidence to ensure safe, effective pain management. Now, the guideline is not a rule, it's not a regulation, and it's not a law,. And it doesn't deny access to opioid pain medication as an option for pain management. The guideline is intended to inform clinicians discussions with patients in their prescribing decisions based upon the best available evidence about benefits and risks of opioid use. I just want to take a moment to walk quickly through the guideline content. There's 12 recommendations in the guideline and they're grouped into three conceptual areas. The first area is determining when to initiate or continue of opioids for chronic pain. And this section includes guidance on the preference for non-opioid treatments when treating chronic pain. Including non-opioid pharmacologic treatment like ibuprofen and also non-pharmacologic ways of treating pain like exercise and cognitive behavioral therapy. There's also guidance on establishing treatment goals with patients and weighing risks and benefits of opioid therapy with individual patients. Both at the initiation of opioid therapy and periodically during opioid treatment. The second area is opioid selection, dosage, duration, fall off, and discontinuation. And here you can find guidance on selecting immediate release opioids instead of extended release or long-acting opioids. And also prescribing the lowest effective dosage when initiating opioid therapy. Also, when treating acute pain, using the lowest effective dose of immediate release opioids and prescribing no greater quantity than that expected to cover the duration of pain severe enough to require opioids. And also continuing to evaluate the benefits and harms of opioid use throughout treatment. And the last area is assessing risk in addressing harms of opioid use. This section has guidance on evaluating for evidence of opioid related harms and choosing strategies to mitigate that risk of ongoing opioid therapy. Such as the use of prescription drug monitoring programs or PDMPs, urine drug testing, avoiding concurrent use of benzodiazepines during opioid therapy. And also arranging for medication assisted treatment for opioid use disorder. >> That's super. Well, it's really helpful to hear the breath of the guidelines. What were clinicians using before the guidelines were issued? I mean, what were doctors and other prescribers using in 2010, 2011, 2012? >> There may have been individual state guidelines that were helping to inform practice. And then as well as various medical associations had guidelines as well that might have been informing prescribing decisions. >> It's great to hear that this was really a response to a need. It would be great to hear more about in brief, what was the process that you went through in developing the guideline? >> So to develop a guideline, CDC updated an agency for healthcare research and quality sponsored systematic literature review on the benefits and harms of opioids. It also conducted a supplemental evidence review to inform translation of that evidence into recommendations. CDC also used the grading of recommendations assessment, development, and evaluation or grade framework to rate the quality of evidence and strength of recommendations. And also got input from experts in pain management, primary care, opioid prescribing, substance use disorder treatment. As well as from medical organizations, advocacy groups, state agencies, national partners, and our Board of Scientific Counselors. CDC also got feedback from clinicians, patients, and the general public through webinars and by posting the draft guidelines in the Federal Register for public comment. And at each stage, we carefully reviewed, considered, and incorporated feedback. And ultimately the guideline was released in March 15th, 2016. The both the morbidity and mortality weekly report and in. >> Yeah, that's great and it's hard to believe that it's been, it was almost two years now. >> That's incredible, I mean, time passes so quickly. One of the challenges with this type of initiative is that there's a growing evidence base every day about opioids and the literature just seems like it's exploding. Guidelines ideally are sort of living breathing documents. And so how have you thought about that as you've produced the guidelines or thought about how they can best be used to inform clinical practice? >> You're exactly right, I mean, we really see the guideline as a living document. Of course, it reflects the evidence up to the release of the guideline and CDC is closely monitoring emerging science. And as you said, nearly every day, there's new science to attend to. So as new science warrants and also depending upon the type of evidence, we would either create additional supporting translation materials or perhaps look at updating the current guideline itself. >> So the guidelines were developed in 2016 or they were released in 2016. But the CDC does a lot in lots of different areas including to address the opioid epidemic. So how do the guidelines fit in with other activities taking place at the Centers for Disease Control and Prevention to try to reduce opioid related injuries and addiction and death? >> Sure, so CDC has five pillars of work that are guiding our response to the opioid overdose epidemic. And our work compliments the work of others across the federal government. So our five pillars are to improve data quality and track trends that monitor the epidemic, to strengthen state efforts by scaling up effective public health interventions. We have three funding mechanisms by which we support states in developing their own statewide overdose prevention programs. To enhance patient safety by supplying healthcare providers with data, tools, and guidance for evidence-based decision-making. Empowering consumers to make safe choices and coordinating with public safety and community-based partners to rapidly identify overdose threats, reverse overdoses, link people to treatment, and to reduce the harms associated with illicit opioids. And the guideline and its associated implementation activities fit squarely into that third pillar, enhancing patient safety by giving healthcare providers evidence-based tools. >> Is there a way that the CDC has considered how to best evaluate the effect of the guidelines? Is that a fair path of inquiry for the CDC? >> Yes, so I'll answer that question by first sort of setting a framework around how we're looking at dissemination and implementation of the guideline itself. And we've organized that into four quadrants. So the first quadrant is looking at translation or communication material. So it could be fact sheets or posters or checklists that are breaking down the science and the content of the guideline and making it more readily accessible and available to clinicians. The second area for dissemination is looking at clinician education. So we develop some trainings and some modules with the intent of helping clinicians earn CME or CEs to one, become familiar with the content of the guideline. But also they can walk through some hypothetical scenarios with patient case examples and really determine sort of those key points along the way in making those prescribing decisions. The third quadrant for our dissemination activities looks at health system interventions. So this has broadly as possible, thinking about what those systems levers are that could perhaps help support guideline concordant care on a broad scale. So a couple of examples is where we've been working with some stakeholders to help develop quality improvement measures that map onto the 12 recommendation statements that Christina highlighted in her overview of the guideline. And we're really thinking of these quality improvement measures as voluntary measures that are available to clinicians in the field or healthcare systems in the field. To implement these EHR based quality improvement measures to do a couple of things. One is they could try out whatever their implementation efforts are around the guideline. So perhaps it's implementing urine drug tests with a certain frequency. So that might be a quality improvement measure that the particular health system would be interested in tracking. So this looks at both the initiation of opioids and also for those patients who are on longer-term opioid therapy. And then the fourth quadrant in terms of our dissemination and implementation activity is related to payers. So both public payers such as Medicaid, Medicare or workers compensation and then commercial payers. To see what interventions they might be moving forward in that would be in support of guideline recommendations. So for example, coverage for evidence based non-pharmacologic therapy such as exercise therapy or cognitive behavioral therapy. Or reimbursement for time that a clinician spends, either through counseling, coordination of care, or the time it takes to actually check the PDMP or prescription drug monitoring program. So in terms of our evaluation, we're evaluating all four of those quadrants. So translation, clinical education, health systems as well as payers. And as you can imagine that the evaluation itself is comprehensive because of these four different areas that we're moving in. We released last summer a vital signs and MMWR that set the the baseline for prescribing rates that would lead up to the release of the guidelines. So those were national prescribing rates that went up to December of 2015. We're currently completing an evaluation that looks at pre-post guideline release, looking at some of those key indicators of prescribing as well. Longer term, we would look at morbidity and mortality for those evaluation outcomes. >> Great, that sounds really comprehensive. >> Yeah, and it's nice to hear about the deliberateness with which you've approached the translation process and the evaluation process. I'm sure that we're going to have a lot of good information coming out of all this four-quadrant approach that you've laid out. Could you talk to us a bit about what stakeholders are telling you about how they're using the guideline? And what kind of feedback you're getting from the communities that are using it. >> So we currently fund 45 states in addition to Washington DC. So we have a lot of great connections with those funded states. And we are hearing from them and various stakeholders within the states, how they're moving forward with the the guideline itself. And so one example is that we've heard that there are 34 state Medicaid programs that are implementing CDC's guideline or a portion of the guideline. For example, removing prior authorization for some non-opioids or having a prior authorization introduced when dosages are equaling or greater to 90 morphine milligram equivalents. We also know that commercial payers are sending letters to their top prescribes and then referencing both CDC's guideline and the training modules that we have available for free. And we heard when the guideline was released back in March of 2016, soon after we had medical societies that have issued statements of support as well. >> Have there been challenges? No doubt there have been challenges. So what have been the major challenges with developing and implementing the guidelines? I mean, this is a monumental task, so I can't imagine that it was totally smooth sailing. Were there challenges that you guys faced? >> I think one of the challenges in looking at the implementation of the guideline into the EHR, I mean, thinking about how best to help encourage that the science and the content of the guideline gets into the hands of clinicians within clinical workflow. I think that has been a challenge. So we've been working with stakeholders and physicians who are also informaticians. So that really specialized field of looking at the clinical workflow, but also understanding the role that the EHR systems play. So we've been really intentional and trying to develop clinical decision support tools or CDS that are not tied to a specific EHR vendor, but that would be available for any health system. To potentially look at the value sets and the artifacts and the code and then make adaptations to integrate those alerts or informational fields that would be brought to the attention of the clinician. That being said, the clinician only has so much time when he or she is engaging with the patient. And we certainly understand that adding alerts or adding more information that's in the EHR and is being pulled to the forefront to the clinician may not always be the answer. But I think in our dedication of working with physicians who are in field, they've been helping us to assure that the information that is is being brought forward is useful, is practical, and is actionable. So that's been helpful in terms of recognizing that there are certainly inherent challenges in translating the science into action. >> Sure, that makes a lot of sense. And maybe Caleb, what's been your experience working with a guideline in your practice? >> Well, gosh, it's a great question. And I think this issue of trying to be sure that clinicians have the information that would be most valuable to them and the patients they're treating in a timely fashion is really, to some degree, that's the Holy Grail. I think the sometimes when people are thinking about how health IT can be used to better address the opioid epidemic. There's an undue focus on simply trying to identify all of the various sources of a given patient's controlled substance prescribing. But there's really a lot more information that physicians can benefit from having at their fingertips such as better understanding patients who may be at greater than average risk for adverse events. Not necessarily because they're seeing lots of prescribers and getting opioids from lots of prescribers, but perhaps they have had an adverse event in the past. Or perhaps they are on a combination of opioids and non-opioid drugs such as benzodiazepines that may increase their risk. Or perhaps they have some other element of their history that increases their risk for opioids. And I think that one of the things that we've learned over the past few years is that the initial prescribing patterns, the initial prescriptions that patients receive from clinicians are important in determining the patient's long-term likelihood of being on prescription opioids. Some of that work has come from the CDC, but some has come from other researchers as well. So I think the guidelines help to promote prescribing, which we are learning actually has a significant contribution in reducing the likelihood that patients will be on long-term opioids. >> Yeah, really really important work, absolutely. I'd like to just move us, certainly the clinical applications of the guideline are our key and arguably central to why they were developed. But of course there's other uses for it. And I'd like to ask our guests to talk about, aside from those clinical applications, what roles do you see for public health researchers and practitioners in terms of facilitating improvements to prescribing practices and contributing generally to this issue? >> One area and looking at public health researchers. They really have an important role to continue conducting evaluations and studies and identifying effective practices. It's one of the goals of CDC in terms of our own research is that we're looking at studies and evaluations that we always have as a final goal really to determine what is the information that could be translated and provided to practitioners in the field. So what are those public health interventions or strategies that are most effective in addressing opioid use disorder or overdoses. And then urging public health researchers to then identify what are those key takeaway messages that could help transform interventions that are happening in the field? And hoping that public health practitioners would then have the tools to make those changes in the field. But we're really committed to ensuring that public health researchers are looking with a lens to their own research and how it can actually be used and acted upon by clinicians and public health practitioners in the field. >> Yeah, makes a lot of sense. Are there additional products that you have in the pipeline that we can look forward to hearing about from you guys in Atlanta? >> Sure, we have a few things in the pipeline. As Jan mentioned, earlier, one of our initiatives to address coalition training as a series of interactive training modules that have been sequentially released online. And thus far we've put out four modules, covering topics like the overview of the CDC guideline, treating chronic pain without opioids, communicating with patients, tips on how to have those difficult conversations around opioid initiation, continuation, and also tapering and discontinuation and also reducing the risks of opioid. In the pipeline, we've got some modules covering a few additional topics such as deciding whether to prescribe opioids at all, dosing and titrating opioids, and that includes guidance on tapering opioids when indicated, assessing and addressing opioid use disorder, and implementing the CDC guidelines on a practice level scale. >> Yeah, some of those are biggies. The issue of tapering was one that came to mind earlier insofar as, I don't know, I can't recall, you'll have to tell me how much the guidelines address that head on. But there's certainly lots of interest given that there are literally several million patients that may be on chronic opioids. Is that something that was in the guidelines? Or if not, what are your thoughts about those issues? >> It is in the guideline, and I'm glad you brought that up because it is an important topic to highlight and to provide guidance on. There is guidance on tapering in two sections of the CDC guideline for prescribing opioids. Also on our website, you can find a pocket card for clinicians that walks through the guidance on how to taper, from having how to have the conversations with patients, also to some guidelines on how to initiate that process. As well as the training module that I mentioned. >> Terrific, well, we just have a few minutes left. I was curious, have there been other initiatives of this scale that the CDC has developed in recent history focused on clinical guidelines? I just wonder, I mean, this feels to me as if within the scope of the opioid epidemic the guidelines have been so prominent and so frequently cited as an important contributor to shifting prescribing patterns. I just wondered if the CDC has similarly undertaken efforts to develop and disseminate clinical guidelines and other settings? >> Just thinking in terms of the agency as a whole, there's certainly been a number of initiatives addressing health issues from a larger perspective. One thing that comes to mind is the work that the division of healthcare quality and promotion is done in the area of antibiotic stewardship, addressing increasing rates of antibiotic resistance. That's one example that comes to mind. >> Yeah, now that you've mentioned that, I do recall some of those efforts, and certainly really big clinical challenges and public health challenges with antibiotic overuse. So I'm sure that those efforts have been well placed. >> Well, I think, maybe as we sort of look at the end of our time here together, and maybe we'll just leave with one last question. Which is there anything that you would like to share with us that we haven't covered today that you'd really like to share with our audience in this context? >> I could probably just mention briefly, I mean, with the shift in the epidemic itself, going to illicit drugs. So both heroin and illicitly made fentanyl, CDC has really felt it's important to partner with public safety and law enforcement. And we're really trying to identify what are those key collaborations and what that might look like between public health and public safety. And we've identified a few areas as top priorities. One is ensuring that first responders have access to the lock sound to reverse the overdoses. Also helping to refer people who are misusing or abusing opioids to treatment. So that continuum of care, looking between both prevention and leading into treatment. And then also using real time data to help identify hotspots in the communities that require immediate intervention. And those are some really important ways that there can be improved public health and public safety collaboration. >> Yeah, that's really vital. And I'm glad that you mentioned the shift in terms of the mortality from overdoses and the growing importance from about 2010, 2011 onward in heroin and illicit fentanyl, contributing to overdose, injuries, and deaths. >> Well, you have a minute left to get to your next meeting. Thank you so much for joining us today. This has been a great conversation. And I know that those who are tuning in are going to be very interested in knowing how this guideline came about and how they can best use it to advance their own work in their communities around the country. So thank you to you both for your time here today. >> Yeah, thank you so much. We appreciate it. >> Thanks very much for the opportunity. >> Yes, we appreciate it. [MUSIC]
