CDC Guideline for Prescribing Opioids for Chronic Pain

Coordinator: Good afternoon and thank you all for standing by. I'd like to inform all participants that your lines have been placed on a listen-only mode until the question and answer session of today's conference. Today's call is also being recorded. If anyone does have any objections you may disconnect at this time. And I would now like to turn the call over to Miss Loretta Jackson Brown. Thank you. You may begin.

Loretta Jackson Brown: Thank you Sue, good afternoon. I'm Loretta Jackson Brown and I'm representing the Clinician Outreach and Communication Activity, COCA, with the Emergency Risk and Communication Branch at the Centers for Disease Control and Prevention. I am delighted to welcome you to today's COCA call: CDC Guidelines for Prescribing Opioids for Chronic Pain.

You may participate in today's presentation by audio only, via Webinar or you may download the slides if you are unable to access the Webinar. The PowerPoint slide set and the Webinar link can be found on our COCA Web page at emergency.cdc.gov/coca. Click on June 22 COCA Calls. The slide set is located under Call Materials. Free continuing education is offered for this COCA Call. Instructions on how to earn continuing education will be provided at the end of the call.

CDC, our planners, presenters and their spouses / partners wish to disclose they have no financial interest or other relationship with the manufacturers of commercial products, supplies of commercial services or commercial supporters with the exception of Dr. David Tauben. Dr. Tauben would like to disclose that his employer, the University of Washington, received a contract payment from the Centers for Disease Control and Prevention. Planners have reviewed content to ensure there is no bias. This presentation will include discussion of the off label use of medications with evidence-based indications for pain.

At the end of the presentation you will have the opportunity to ask the presenters questions. On the phone dialing Star 1 will put you in the queue for questions. You may submit questions through the Webinar system at any time during the presentation by selecting the Q&A tab at the top of the Webinar screen and typing in your question. Questions are limited to clinicians who would like information on prescribing opioids for - opioids. And for those with media questions please contact CDC Media Relations at 404-639-3286 or send an email to media at cdc.gov. If you are a patient please refer your questions to your healthcare provider.

At the conclusion of today's session the participant will be able to describe what is known about effectiveness and risk of long-term opioid therapy for chronic pain, discuss how to determine when opioids should be initiated or continued for chronic pain and when they should be discontinued, discuss recommendations for opioid selection and dosage for chronic pain and describe the strategies that can be used to assess risk and address harm associated with opioid use. COCA is excited to partner with CDC's National Center for Injury Prevention and Control to offer this call series on CDC Guidelines for Prescribing Opioids for Chronic pain. Save the dates for upcoming calls scheduled for July 27, August 3 and August 17 and plan to join the discussion starting at 2:00 pm Eastern Time.

Today's first presenter is Dr. Tamara Haegerich. She is the Deputy Associate Director for Science in the Division of Unintentional Injury Prevention and Control at the Centers for Disease Control and Prevention. She provides leadership planning and guidance on scientific quality, research methodology, research priorities and guideline development. Her expertise lies in the area of prescription drug overdose prevention, motor vehicle injury prevention, evaluation, implementation science and evidence-based practice guidelines. Dr. Haegerich is co-author of the 2016 CDC Guidelines for Prescribing Opioids for Chronic Pain.

The second presenter Dr. Deborah Dowell is Senior Medical Advisor for the Division of Unintentional Injury Prevention at the Centers for Disease Control and Prevention. She previously led CDC's Prescription Drug Overdose Team and served as Advisor to New York City's Health Commissioner. Dr. Dowell is lead author for the 2016 CDC Guideline for Prescribing Opioids for Chronic Pain.

Today's third presenter Dr. David Tauben is Chief of the Division of Pain Medicine at the University of Washington. He has nearly 30 years of clinical practice experience in primary care internal medicine. He is board certified in both internal medicine and pain medicine. Dr. Tauben is a Director of Medical Student and Resident Education in Pain Medicine at the University of Washington. Jointly appointed in the Department of Medicine Anesthesia and Pain Medicine Dr. Tauben served as a reviewer for the 2016 CDC Guideline for Prescribing Opioids and Chronic Pain.

As a reminder the PowerPoint slide set and the Webinar link can be found on our COCA Webpage at emergency.cdc.gov/coca. Click on June 22 COCA Call. The slide set is located under Call Materials. At this time please welcome Dr. Haegerich.

Dr. Tamara Haegerich: Thank you. Thank you once again for joining us today. This is Dr. Tamara Haegerich and I'm a co-author of CDC Guidelines for Prescribing Opioids for Chronic Pain. I will start by providing an introduction to the purpose and development process for the guideline and then briefly summarize the evidence supporting the recommendations within the guideline.

Chronic pain is a serious public health issue. Recent national estimates indicate that 11% of Americans experience chronic pain. While there are other effective options for managing chronic pain, options that providers have used less and less over the past decade, opioids are frequently prescribed. Primary care providers commonly treat chronic non-cancer pain and account for at least half of all opioid pain medication prescriptions. At the same time, primary care providers report concern about opioids, their addiction potential in particular, and report a lack of sufficient training in pain management generally and opioid prescribing specifically.

From 1999 to 2014 the amount of opioids prescribed has quadrupled. However the pain that Americans report remains unchanged. And during the same time period of increased prescribing, we've seen parallel increases in overdose deaths. Since 1999 there have been more than 155,000 deaths from overdose related to prescription opioids leading us into the current opioid overdose epidemic.

Given this context, CDC believed that developing a guideline for opioid prescribing in primary care could both improve pain management and reduce misuse, abuse and overdose from opioid pain medication. The primary audience of the guideline is primary care providers typically including family medicine and internal medicine, although there are implications for other specialties as well. Providers include physicians, nurse practitioners and physician assistants. The focus is on patients 18 years of age or older with chronic pain. And we define chronic pain as lasting longer than three months or past the time of normal tissue healing. And the guideline is intended to apply to outpatient settings and does not include active cancer treatment, palliative care or end-of-life care.

CDC followed a scientifically rigorous and transparent process for developing the guideline. We began with a systematic literature review upon which we drafted recommendations. We consulted with a core group of experts on the initial recommendations and then drafted a full guideline. We obtained reviews of the full guideline from experts, stakeholders, federal partners and peer reviewers and shared the topline recommendations to constituents to obtain feedback during a Webinar. CDC then revised the guideline, posted it for public comment and the guideline underwent review by the National Center for Injury Prevention and Control Board of Scientific Counselors, a federal advisory committee. And finally after making revisions, we published the guideline in March of 2016.

To develop the guideline CDC used the Grading Recommendations, Assessment, Development and Evaluation method, otherwise known as GRADE. This method is a standard for guideline development used by over 100 organizations. It is a transparent approach for conducting systematic review, rating quality of evidence and determining strength of recommendation. And with this method recommendations are based on the quality of evidence, the balance between benefits and harms of specific clinical actions, values and preferences of providers and patients, and cost considerations.

Using GRADE, evidence was rated in the CDC guideline as four types ranging in rigor from randomized controlled trials to clinical experience. Recommendations were rated as Category A or B. Category A recommendations apply to all patients with most patients receiving the recommended course of action, while Category B recommendations require individual decision-making where providers help patients arrive at a decision consistent with values and preferences and the clinical situation.

The guideline was published on March 15, 2016 in the Morbidity and Mortality Weekly Report. We also prepared an abbreviated version of the guideline as a special communication in the Journal of the American Medical Association. These publications were accompanied by a patient page as well as a series of commentaries in JAMA as well as the New England Journal of Medicine. And there are also complementary publications appearing in American Family Physician.

Before I hand the presentation over to my colleague Dr. Dowell to present the recommendations I would also like to briefly provide a summary of the evidence supporting the recommendations. Importantly, we found that there were no long term studies in examining outcomes related to pain and function at one year or later, with most placebo-controlled trials of six weeks or less in duration.

In previous reviews of short-term trials, opioids were found to be moderately effective for pain relief in the short-term, with small benefits for functional outcomes, and a high percentage of patients discontinuing use because of a lack of efficacy and adverse events. In primary care settings, opioid dependence was found to range from 3% to 26%. There was a consistent dose dependent association with risk of overdose and harm at higher dosages. Inconsistent results were found for different dosing protocols but there was some evidence that initiation of opioid therapy with long acting/ extended release formulations increased risk for overdose. In particular, methadone was found to be associated with higher mortality risk. No differences in pain and function were found with dose escalation, however the range of dosages examined was small. Importantly, risk prediction instruments such as the SOAPP and ORT were found to have insufficient accuracy for classifying patients at risk for harm. And finally there was an increased likelihood of long-term use when opioids were used for acute pain.

Now to accompany the clinical evidence review focused on the effectiveness of opioid therapy, we conducted a contextual evidence review to better understand benefits and harms, values and preferences, and cost considerations. Existing systematic reviews in this review indicated that there are effective non-pharmacologic therapies for managing chronic pain including exercise, cognitive behavioral therapy, and interventional procedures. There are also effective non-opioid medications, some of which are over-the-counter, that include acetaminophen, nonsteroidal anti-inflammatory drugs, anticonvulsants and antidepressants. Again we found consistently that opioid-related overdose risk is dose-dependent with greater risk at higher dosages. And there were several factors identified that increased harm including pregnancy, older age, mental health disorder, substance use disorder and sleep disorder breathing.

In terms of values and preferences, we found that providers report a lack of confidence in their ability to describe safely and are concerned about opioid use disorder among patients. And finally patients were found to be ambivalent about the risks and benefits of opioid therapy and associate opioids with harm such as addiction.

So now that you have a foundation of the development process and scientific evidence, I'm going to pass the presentation over to my colleague Dr. Debbie Dowell who will talk with you about the recommendations within the guideline.

Dr. Deborah Dowell: Thank you Dr. Haegerich. The 12 recommendations are grouped into three conceptual areas: determining when to initiate or continue opioids for chronic pain; opioid selection, dosage, duration, follow-up and discontinuation; and assessing risk and addressing harms of opioid use.

The first three recommendations address determining when to initiate or continuing opioids for chronic pain.

Recommendation 1 states that non-pharmacologic therapy and non-opioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used they should be combined with non-pharmacologic therapy and non-opioid pharmacologic therapy as appropriate.

According to Recommendation 1, opioids should not be considered first-line or routine therapy for chronic pain outside of active cancer, palliative and end-of-life care. Note that this is not a fail first recommendation but a recommendation that expected benefits specific to the clinical context should be weighed against risks before initiating therapy. In some clinical contexts, for example headache or fibromyalgia, expected benefits of initiating opioids are unlikely to outweigh risks, regardless of previous non-pharmacologic and non-opioid pharmacologic therapies used.

In other situations such as serious illness in a patient with poor prognosis for return to previous level of function, contraindications to other therapies, and clinician and patient agreement that the overriding goal is patient comfort, opioids might be appropriate regardless of previous therapies used.

Recommendation 2: Before starting opioid therapy for chronic pain clinicians should establish treatment goals with all patients including realistic goals for pain and function and should consider how therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risk to patient safety. Clinicians can use validated instruments such as the three item Pain average, interference with Enjoyment of life and interference with General activity, or PEG assessment scale, to track patient outcomes. Clinically meaningful improvement has been defined as a 30% improvement in scores for both pain and function.

Recommendation 3: Before starting, and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. For example, in discussing opioid therapy, clinicians should be explicit and realistic about expected benefits explaining that while opioids can reduce pain during short-term use there is not good evidence that they improve pain or function with long term use and that complete relief of pain is unlikely.

Clinicians should discuss serious adverse effects of opioids including potentially fatal overdose, development of a potentially serious lifelong opioid use disorder, and increased risks at higher dosages or when opioids are taken with other drugs or alcohol. Clinicians should also discuss common adverse effects of opioids such as constipation, dry mouth, nausea, drowsiness, tolerance, physical dependence and withdrawal symptoms when stopping opioids.

The next four recommendations address opioid selection dosage, duration, follow-up, and discontinuation.

Recommendation 4, when starting opioid therapy for chronic pain, clinicians should describe prescribe immediate-release opioids instead of extended- release/ long-acting opioids. An important principle is to choose predictable pharmacokinetics and pharmacodynamics to minimize overdose risk.

For example, because of methadone's complicated pharmacodynamics, methadone should not be the first choice for any extended-release/long-acting opioid. Only clinicians who are familiar with methadone's unique risk profile and are prepared to educate and closely monitor their patients, including risk assessment for QT prolongation and consideration of electrocardiographic monitoring, should consider prescribing methadone for pain.

In addition, transdermal fentanyl's unique dosing and absorption properties are often misunderstood by both clinicians and patients. Consider prescribing fentanyl only if you are familiar with these properties and prepared to educate your patients. And in general clinicians should avoid the use of immediate- release opioids in combination with extended-release/long-acting opioids, although there are situations where concurrent use might be appropriate.

Recommendation 5: When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risk when increasing dosage to 50 or more morphine milligram equivalents, or MME, per day and should avoid increasing dosage to 90 or more MME per day or carefully justify a decision to titrate dosage to 90 or more MME per day.

Here are some practical considerations for implementation of Recommendation 5. Start opioids at the lowest effective dosage, increase dosage by the smallest practical amount and if total opioid dosage reaches 50 MME per day or more reassess pain, function and treatment, increase the frequency of follow-up, and considering offering naloxone. And if there are escalating dosage requirements, discuss other pain therapies with the patient, consider working with the patient to taper opioids down or off, and consider consulting a pain specialist.

What about when patients are already receiving high dosages? There is likely to be a different benefit to risk ratio for reducing opioids for patients already receiving high dosages than there is for not escalating to high dosages in the first place. The supporting text for this recommendation includes additional guidance, such as that established patients already taking high dosages of opioids, including patients transferring from other clinicians, should be offered the opportunity to reevaluate their continued use of opioids at high dosages in light of recent evidence regarding the association of opioid dosage and overdose risk. And for patients who agree to taper opioids to lower dosages, clinicians should collaborate with the patient on a tapering plan.

Recommendations 6: Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient. More than seven days will rarely be needed. Clinicians should not prescribe additional opioids just in case, but should reevaluate patients with severe pain that continues beyond the expected duration to confirm or advise the initial diagnosis and to adjust management accordingly.

Recommendation 7: Clinicians should evaluate benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or of dose escalation.

Clinicians should evaluate benefits and harms of continued therapy with patients every three months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. At follow-up, determine whether opioids continue to meet treatment goals, whether there are common or serious adverse events or early warning signs, whether benefits of opioids continue to outweigh risks, and whether opioid dosage can be reduced or opioids can be discontinued.

Here are some practical considerations to determine when and how to discontinue opioids. Work with patients to taper opioids down or off when there is no sustained clinically meaningful improvement in pain and function, when patients are on high risk regimens such as dosages of 50 MME per more or day or opioids combined with benzodiazepines without evidence of benefit, when patients believe benefits no longer outweigh risks or request dosage reduction or discontinuation, or when patients experience overdose or other serious adverse events or warning signs of serious adverse events. And when opioids are reduced or discontinued, tapers slow enough to minimize symptoms and signs of opioid withdrawal should be used.

A decrease of 10% of the original dose per week is a reasonable starting point. Tapering plans may be individualized based on patient goals and concerns. Make sure to access appropriate expertise when considering tapering opioids during pregnancy because of possible risk to the pregnant patient and to the fetus if the patient goes into withdrawal. And optimize non-opioid pain management as well as psychosocial support for anxiety related to the taper.

The last five recommendations focus on assessing risk and addressing harms of opioid use.

Recommendation 8: Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harm. Clinicians should incorporate into the management plan strategies to mitigate risks, including considering offering naloxone, when factors that increase risk for opioid overdose such as history of overdose, history of substance use disorder, higher opioid dosages greater than or equal to 50 MME or concurrent benzodiazepine use are present.

Certain risk factors increase susceptibility to opioid -related harms and are discussed further in the supporting text for this recommendation. For example, it's important to avoid prescribing opioids to patients with moderate or severe sleep-disordered breathing when possible. During pregnancy, carefully weigh risks and benefits with patients, use additional caution with renal or hepatic insufficiency and patients aged 55 or older, and ensure treatment for depression is optimized.

Recommendation 9: Clinicians should review the patient's history of controlled substance prescriptions using safe prescription drug monitoring program data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every three months. If the patient is receiving prescriptions from multiple sources, high dosages, or dangerous combinations, there are several actions that can protect patients. Discuss safety concerns with the patient including increased risk for overdose, considered tapering to a safer dosage and consider offering naloxone, discuss safety concerns with others prescribing to your patient, consider substance use disorder and discuss concerns with your patient. If patients might be sharing or selling opioids and not taking them, consider urine drug testing to assist in determining whether opioids can be discontinued without causing withdrawal. And finally, it's important not to dismiss patients from care based on PDMP information. Concerning information in the PDMP is an opportunity to provide potentially lifesaving information and intervention.

Recommendation 10: When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs.

Here are some tips for how to use urine drug testing to assess for prescribed opioids and other drugs that increase risk. First, be familiar with the urine drug testing panels used in your setting and how to interpret results. Do not test for substances that would not affect your patient management.

Before ordering urine drug testing, explain to patients that testing is intended to improve their safety, explain expected results, that is presence of prescribed medication and absence of unreported drugs, and ask patients whether there might be unexpected results. Discuss unexpected results with the local lab or toxicologist and with patients. Verify unexpected, unexplained results using specific testing. And finally, do not dismiss patients from care based on a urine drug test result.

Recommendation 11: Although there are circumstances when it might be appropriate to prescribe opioids to a patient receiving benzodiazepines, clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible. Remember to taper benzodiazepines gradually if discontinued, because abrupt withdrawal can be associated with rebound anxiety, hallucinations, seizures, delirium tremens and, in rare cases, death. Offer evidence-based psychotherapies such as cognitive behavioral therapy and/or specific antidepressants or other non-benzodiazepine medications approved for anxiety, and coordinate care with mental health professionals managing the patient.

Recommendation 12: Clinicians should offer or arrange evidence-based treatment, usually medication assisted treatment with buprenorphine or methadone in combination with behavioral therapies, for patients with opioid use disorder.

If you suspect opioid use disorder, discuss with your patient and provide an opportunity for the patient to disclose related concerns or problems. Assess for opioid use disorder using DSM-5 criteria, offer or arrange evidence-based treatment for patients with opioid use disorder -- either buprenorphine through an office-based buprenorphine treatment provider or opioid treatment program, methadone maintenance therapy from an opioid treatment program, or oral or long acting injectable formulations of naltrexone for non-pregnant adults, particularly for highly motivated persons. If your community lacks treatment capacity for opioid use disorder, strongly consider obtaining a waiver to prescribe buprenorphine for opioid use disorder.

This concludes our overview of the recommendations in CDC's Guideline for Prescribing Opioids for Chronic Pain. I also wanted to let you know about the availability of some user-friendly materials such as fact sheets, posters, brochures and pocket cards to help integrate these recommendations into practice and to communicate with patients about them. Here are some of the fact sheets available at cdc.gov\drugoverdose.

Another tool available from CDC is the checklist for prescribing opioids for chronic pain. We worked with Atul Gawande and his team of medical writers, editors and reviewers at Ariadne labs to develop this checklist outlining critical steps in providing safer more effective care for patients with chronic pain consistent with the CDC guidelines For example, set goals and set criteria for stopping or continuing opioids. The one-page checklist is available on cdc.gov\drugoverdose Web site. I'll now turn the floor over to Dr. David Tauben who will discuss the feasibility of implementing the CDC Guideline for Prescribing Opioids for Chronic Pain in primary care settings. Thank you.

Dr. Deborah Dowell: Thank you Debbie. And it's my privilege and pleasure to be able to address this very challenging topic. And speaking of feasibility I'd like to be certain that I share with the listening audience that my perspective comes from that of a primary care clinician 27 years in a nonacademic setting and well know that all the complications and challenges that this very daunting list of recommendations seems to put before us. So in the next ten minutes or so I hope to share my perspective as a primary care doc for many years. I know I will not convince you that it's feasible but I can share with you how I have experienced myself and why I'm a strong advocate of moving forward with these implementations.

So the first question, Is this possible? Wow! That was a lot of content with a lot of detail and remind the audience that the series of Webinars that are forthcoming that were listed early are going to go into more specific detail with case-based descriptions of the kinds of patients you're seeing in practice and a description of matching the challenges to responses that these recommendations bring forward.

So when it comes to feasibility I went to the Miriam Webster dictionary as my task would outline and identified several characteristics. And this is right out of the dictionary. It's "capable of being done", and I intend to demonstrate that it can be so. It's capable of being used. That's just not saying you're doing it but actually doing it. It's reasonable and on review of the guidelines as a reviewer I can state that it's difficult to find much of anything, if anything at all, that's out of line with reasonable clinical practice particularly as a primary care clinician, and it's likely because we really have no choice based on the data we have on the challenges we now face.

It's also an imperative. Those who've taken the Hippocratic Oath at graduation above all do no harm. And we do clearly know that the evidence of harm is overwhelming. And though there is evidence for some benefit, we really need to put that in balance with the perspective of do no harm. And most importantly, I would quote a great inventor Thomas Edison that vision, i.e., guidelines, without execution is a hallucination. And it's a great line but it's the reality of the situation that we have to be able to put this into our practice for it to be meaningful and effective.

So what have we done in Washington State? This is courtesy of Jennifer Sabel an epidemiologist here in the state charts. Our state experience and every state participants listening in from around the country have their own experience. And our work began in early 2000's when we recognized an escalating use of opioid dose and concurrent deaths. And our implementation of our Washington State guidelines which I will breeze very quickly past because they're largely in fact nearly identical to what the CDC has proposed demonstrated an immediate impact on the number of deaths and nonfatal hospitalizations -- so it works.

Key elements and courtesy of Dr. Melissa Weimer at Oregon Health Science University at a recent conference we were attending together described this as an approach for clinical practice, start with a team and identify a champion in your practice who understands pain and is familiar enough with the guidelines to be able to coach their colleagues, coach their staff, and most importantly explain that these guidelines make sense and that what we're offering by these recommendations is not a top-down, you must do this, but a bottom-up, that this makes sense that your best interest is the patient's best interest and you're doing this not because it's a rule but you're doing this because it's a matter of quality of care.

There should be an emphasis on multimodal treatment as identified. And on our next session Dr. Jim Robinson and I will be discussing multimodal strategies as we begin to move forward in the rest of the Webinar series. Don't be blind to substance abuse disorder. It's very prevalent in the practice of prescribing opioids and have referral options and a defined process that the whole system of care provides in that setting.

Patient self-management is the most important component. The patient needs to be engaged, variety of opportunities for classes and support that will be discussed in further webinars but again a key element. We may need longer visits. There are ways for coding for longer visits. It's time-based coding for counseling. We could discuss this later in terms of the challenges of introducing these recommendations into the busy primary care practices that most of the listeners are currently managing and not easily as it exists already.

Some kind of after visit care or case management is very, very helpful. It will be able to move your suggestions forward so the patient doesn't return without much having happened between visits. And then there's an enormous number of Web-based tools that are available and resources for e-consults that are currently in place. So have people done this? I've put ourselves at the bottom here the University of Washington are neighborhood clinics. Our neighborhood clinics in 2009 were disabled. They said they were not treating chronic pain. They were not prescribing pain medicine, the result of implementing the 2007 guidelines and the strategies that we've developed here they have moved to NCQA tier three medical home model competence in managing pain from being completely impaired to being expert and earning accommodation for that. There's 13 others and there's likely another 50 or even more that have accomplished the same. I've listed a number of them to simply to identify that this is possible.

We've heard certainly and you can't miss it if you read the newspapers that there is an epidemic of opioid overdose. It compares less fortunately than the influenza pandemic and HIV epidemic but 165,000 and counting since 1999 certainly is an urgent time to take action. Families and their communities, the leakage of our prescriptions from the prescriber, the unused prescriptions, the lack of disposal, the sharing of medications are leading to opioid -related accidental deaths and addictions in the patients to whom we don't even prescribe. But they by and large come from our prescriptions.

Healthcare expenses if we introduce multidisciplinary chronic pain care has been well documented many times. Bob Gatchel's work years ago and there's 30 references that can support this show reduced direct cost up to 70% of reduced disability cost of at least 40% by implementing multi-disciplinary care. So it's worthwhile, we get good results. So how do we accomplish this? An implementation strategy needs a way to understand safe and effective chronic pain treatments. So I've listed here three broad categories. For we clinicians - and I expect the bulk of the audience is people who are in the front line managing this, CDC guidelines. Most states now have some guidelines or recommendations. They're flowing out left and right. Most of them are now moving over to CDC guidelines based on the preeminence certainly of the Centers for Disease Control but also because they frankly my opinion and many others make good sense if only we can do it.

We at the University of Washington have an open training program. I've given the link here. You're welcome to dial into the Agency Medical Directors group here in Washington State online. You can get access to that.

I spoke about patient and family engagement. I've listed just a few. These are those that we recommend here and I've been very impressed by. The YouTube just Understand Pain you'll get to it. An excellent one Brain Man Stops His Opioids a cartoon. It's about five minutes long and it's a patient facing education that describes what we can also describe to our patients but, it's worthwhile looking at ourselves and then sharing it with our patients.

Stanford has a wonderful program for chronic pain self-management. This is lay-led so the people who have managed chronic pain themselves successfully help teach their colleagues. It's a tremendous self-help group. We've been implementing it here in one of our most challenging environments at County Hospital with a very high degree of co-occurring adverse conditions. And it's been received with fanfare and with great satisfaction by those patients. It's also very inexpensive for health systems to introduce this.

Dan Clauw's group University of Michigan, Dave Williams helped put together what's called fibroguide.com. It's basically 12 separate training modules for cognitive behavioral therapy. I'm sure like me you never were trained in what CBT is. It turns out to be the most effective evidence-based treatment we've got for chronic pain. You can take a look at these yourself and they're going to be substituting fibro for headache guide, low-back guide because the approach to cognitive behavioral therapy applies across the board and explain to your patients that this would apply to their condition and ignore the fibromyalgia component. And the American Chronic Pain Association for instance does a great job on patient facing education tools.

For those on the call and those who aren't on the call who you need to speak with your medical directors, your hospital support your local community if it's a community hospital based setting that you practice need to read the national pain strategy because this is a blueprint that was released timing it just within the release of CDC guidelines because if we're giving guidelines for us prescribers we're being told what to do. Our health systems absolutely need to be able to support that so that we can do it. It's just not fair to tell us to do something and not give us these resources. The national pain strategy offers specific tactical approaches to reach that strategy. And of course a seminal document the Institute of Medicine 2011 Report Relieving Pain in America fantastic read and really helped launch the move that has led to the development of these CDC guidelines as well.

So in quick summary and the Atul Gawande, I don't pretend to be a checklist master like he is but I would consider this a reasonable checklist to assess your practice to achieve guideline compliant care.

Do you use registries and regularly review your patients who are receiving opioids based on the morphine milligram equivalent dose? Patients on high dose 50 milligram morphine equivalent or above ought to be on your registry.

Do you measure and track functions? And we'll get into this in more detail, the guidelines and recommendations speak specifically for these tools.

Do you screen for misuse and addiction risk? And I recognize that the ORT, the SOAP, the DIRE based on evidence base grade review are not recommended at the highest degree because of poor predictive validity but they are widely used and if nothing else remind us when we implement this instrument that misuse and addiction is a problem perhaps 20% primary care practices.

Do you adhere to monitoring policies and procedures in your clinic setting, regularly check your prescription monitoring program regularly or periodically based on check urines for toxicology? Is your patient taking the meds? If they're not where are they going? If they're taking other drugs where are these coming from?

Do you enter care agreements and inform consent regarding benefits and harms?

Does your clinic setting routinely screen for medical risks such as sleep apnea and as we heard co-prescribing with benzodiazepines?

Do you and does your clinic follow protocols for opioid overdose high risk regularly prescribing naloxone for those patients? How many people in your clinical practice and more importantly do you have buprenorphine X licensing? Extraordinarily important and useful. And if you are licensed do you actually prescribe? Is it that hard to do? Well frankly it's not and it offers a tremendously useful tool to introduce into your practice.

Do you have a process for inter-professional referrals for behavioral health, cognitive behavioral therapy, for physical therapy, occupational therapy, rehab support, addiction support? Is there a regular process that you use that - and don't have to make it up every time you see your patient so it can fit into your workflow?

So who's going to put these guidelines into effect? Certainly we can hear from our top-down experts what you should do. But who's going to do it? Of course it's going to be you. And how are you going to do it? In my opinion if you're a primary care provider, you have phenomenal provider interpersonal relational skills. You have compassion and you certainly have the capacity to learn and deliver best practice pain care.

I think you have to be confident that you can do it. And you'd have to share that confidence with your patients. I frequently look my patient in the eye when I say I'm going to have to bring your dose down. And they say, "Oh no doc you can't do it, I'm never going to make it." And I use based on my gray hairs and years of doing this I say, "Have I ever in the years of my care ever done anything that was not in your best interest?" And the response is, "No, of course not." And my next line is, "I am not doing that now. I'm doing this in your best interest. This is not top-down. This is not legislated. This is what I now know is what's important to do.

Use your multidisciplinary inter-professional care team. You cannot do this alone. Pain medicine is a team activity and you need behavioral health, physical therapy. You need your nurses, your need your medical assistants. You need your scheduling people all on board with the same dialogue. You need to be enabled by your organization's medical administrative leadership. And I can't tell them how to do that but you can because you understand the importance of putting these in place and you need the help and resources to accomplish that. And your patients and families are ultimately the people who are going to be necessary.

When are you going to do this? It doesn't have to happen all at once. It's a transformation. I think we need to start with a sense of urgency. We have an epidemic on our hand. We need to identify your team and its champions. You need to engage and communicate your goals, prioritize them, identifying internal and external obstacles in your clinical practice and overcome the quick wins -- get them fast.

You need to build if you have an electronic health record in IT and introduce this with systems to support your change with .phrases, with PDFs that are readily available for patient distribution. And you need to regularly review to sustain your success. I've listed some references here and I believe now we're going to be ready to move to a question and answer time for the next ten minutes with our whole team here. So to ask a question directions and I think I'll turn this over to our CDC experts to move us forward into the question and answers. Thank you very much for participating and you'll be hearing more from me and my team and I look forward to continuing to walk step by step on a case-based team-based inter-professional basis. Now these guidelines are feasible. Thanks very much for your attention.

Loretta Jackson Brown: Thank you presenters for providing our COCA audience with such a wealth of information. We will now open up the lines for the question and answer session. Questions are limited to clinicians who would like information on prescribing opioids. For those who have media questions, please contact CDC Media Relations at 404-639-3286 or send an email to media@cdc.gov. If you are a patient please refer your questions to your healthcare provider. When asking a question please state your organization. And also remember you can submit questions through the Webinar system. Operator?

Coordinator: Thank you. One moment for the first question.

Loretta Jackson Brown: And while we're waiting for the first question from the phone I'll go ahead and present a question from the Webinar system to our presenters. So this question is related to the recommendations and comments about the type of evidence that was used in the recommendations and also the need for perhaps additional future research on topics. Would our CDC presenters like to comment?

Dr. Deborah Dowell: Thank you for that question. This is Debbie Dowell. And you are absolutely right. Clinicians would benefit, patients would benefit from much better research on opioid use and on risk mitigation strategies. The fact is we don't have great evidence to support current client prescribing practices and to be clear. The guidelines used a rating system, the GRADE framework categorizing evidence into four types from high to very low quality evidence. Low quality evidence does not mean there is no evidence but evidence usually consists of observational studies and there are - and means that there aren't well-designed randomized controlled trials.

So unfortunately there often aren't randomized controlled trials that directly address the decisions clinicians need to make every day. The GRADE process addresses the situation by providing a transparent framework to rate the evidence and to make recommendations based on factors including the evidence, but also based on benefits relative to risk and other factors. And we hope that the guideline provides a useful basis for clinicians to make decisions with their patients and to communicate with their patients about opioid use. We also agree that we need more research and we state this in the guideline.

Dr. Deborah Dowell: Yes this is Dave Tauben and may I step in? I know you asked for a CDC comment, but being at an academic institution where we are very involved in that front-line research I would respond to that question by saying there is lots of research ideas flowing out of national recognized prominent institutions. The Patient Centered Outcome Research Institute, the PCORI has now released at least three recent proposals to - that can give us more evidence on how to accomplish this. Many other foundations are supporting this.

This is also outlined in the national pain strategy, the specific research topics. And this includes education so that our new trainees, the future practice partners in the next few years that you'll be welcoming into your practices and as well as post-licensure trainees and the Pain Consortium at the National Institutes of Health as a Center of Excellence in Pain Education which is committing quite a considerable amount of resources to provide the training so that we can understand how to specifically implement non-drug and the non-opioid treatment strategies to manage pain.

It may be a bit overdue but it is happening. And I want to leave a message of confidence and hope in a positive end that next month's certainly within the few years they'll be continuing supportive evidence that the recommendations outlined not only makes sense but are proven to work.

Loretta Jackson Brown: Thank you presenters for those comments. Operator do we have a question on the phone?

Coordinator: We do. The first question comes from Dr. Fred Goldstein. You may go ahead with your question.

Dr. Fred Goldstein: Yes thank you folks for an interesting presentation. I'm at the Philadelphia College of Osteopathic Medicine and I have a colleague and I - and the question has to do with extended release long-acting opioids. And one of my colleagues when he prescribes methadone always prescribes an immediate release opioid. And so I believe I heard the comment that should be avoided unless under certain conditions. But based on the pharmacokinetics of the extended release and that we don't want patients to if they're prescribed one to take two of them that it's as far as I know it's pretty routine to say well we're giving you - you're on methadone or extended release once the transfer has been properly done. But we do provide immediate release so they don't take an extra extended release to manage the pain so I'd just like to hear some comments on that please.

Dr. Deborah Dowell: Yes so Dave Tauben here Fred. As having been on the front lines of this it's a great question. So I'm assuming this refers to a patient who's being converted from an immediate release agent to methadone which is a long-acting drug.

Dr. Fred Goldstein: Yes either methadone or some other extended release product.

Dr. Deborah Dowell: Okay. So you're going to do a transition rotation as it's called from an immediate release because I think the key point references recommendations that are outlined we don't want to start our patients...

Dr. Fred Goldstein: Right.

Dr. Deborah Dowell: ...on extended release.

Dr. Fred Goldstein: Right, no, no absolutely.

Dr. Deborah Dowell: So if you're introducing methadone in that setting this I believe would be an example of the unusual but real circumstances that Debbie mentioned was appropriate use for the interaction but the - as a review of these guidelines and having made the personal mistake of co-prescribing extended release/ long acting's with immediate release long term it's actually leads to problems in your patient management. So it would be a brief transition makes sense, done carefully, makes sense.

One of the future Webinars that our colleagues here are going to be discussing on how to accomplish this we'll pass the word along to address this specifically as well. But for short term makes sense. We're talking very short term. And once the patient's going to be on methadone it's really a commitment that they're going to be on chronic opioid therapy months to years and possibly lifelong.

Dr. Fred Goldstein: So I guess there's going to have to be some confidence established that the patient if they're in more pain to get back to the doc before they start changing, adding, increasing the dose themselves?

Dr. Deborah Dowell: Yes absolutely. And your point I want to just reinforce thanks Fred you're right on line with good care. Never use methadone as needed, only use it as directed. Start unbelievably low below the amount you're going to require and therefore an IR previous drug a taper down of that while you're bringing methadone up. And in my practice I have the patient seen every two to three days during this transition no longer than a week because its risky business initiating any extended relief long acting drug and methadone is particularly challenging. But it's doable and I agree with your practice partner there. Well done.

Dr. Fred Goldstein: Thank you.

Dr. Deborah Dowell: This is Debbie Dowell. Thank you for that question and thank you for your comments David. And I just wanted to underline that in supporting text for Recommendation 4 we do note that there are circumstances where combined use might be appropriate, including transition from - to a long acting opioid.

Loretta Jackson Brown: Thank you presenters for your comment. Operator...

Coordinator: Okay.

Loretta Jackson Brown: ...do we have another question on the phone?

Coordinator: We do yes. The next question comes from Steven Steinberg. You may go ahead with your question.

Steven Steinberg: Just a second. Hi. This is Steven Steinberg. Subject of great controversy is the use of Suboxone off-label for pain. We know the certification, the DEA certification's, not needed for Suboxone when you use it for chronic pain and not addiction. There's a lot of discussion about whether this is appropriate to use Suboxone for chronic pain, who should be prescribing the Suboxone, what about the issue that we're seeing that you tend to see a lot of prescribing of benzodiazepines or the opioids and the combination of benzodiazepines with Suboxone is problematic. What do you feel?

By the way, my feeling is that Suboxone, the problem with Suboxone is people that are given Suboxone tend to stay on it forever. Switching - using Suboxone for chronic pain will just result in a bunch of forever Suboxone chronic pain patients but that's my opinion and I'm asking you how you feel. Thanks.

Dr. Deborah Dowell: All right if I may step in again of this is a hot topic around the country. (Steve) you're identifying a very important question so I'll take just a couple minutes on this. You can prescribe buprenorphine naloxone off label. You can prescribe buprenorphine on label through a variety of products that are available as well. Suboxone just turns out to be safer than most other extended release/long-acting product because it's a partial mu agonist which means it's very, very difficult to overdose. So do - is it appropriate? I do it often. So using Suboxone off-label is a challenge for a couple of reasons.

First I would make a strong recommendation that every primary care provider in this country who prescribes a mu agonist also learns how to prescribe a partial mu agonist. And it's free eight hours online training and it's worth it. It's a great review of addiction and diagnosis. And it's every minute you spend is going to translate to improved care.

So that also keeps you out of trouble because it is a gray zone. And I know Dr. (Ballentyne) and (Sullivan) are going to speaking at length about this. There's a gray zone between people who are opioid dependent physiologically and who are patients who are truly addicted. So a question you ask is are you actually treating addiction? And if you've got that license when you make that determination later you're already in the proper place to be managing that in your office setting. It's a great resource because if you're treating addiction with a mu agonist you are out of compliance with federal regulations because only licensed buprenorphine or methadone prescribers can be using that.

So first get trained. Second if you're not trained, you can but you're a little bit exposed if again people slip on that slope. If you're using it for an addict, I would not allow co-prescription of benzodiazepines because that's such a risky prospect. And the concern about benzos and buprenorphine is that if you're using buprenorphine with addicts who were also on benzos they can overdose on the benzos and misuse the buprenorphine and overdose on that. And there have been a few deaths reported on - in that combination.

But if you're patient is not addicted, not misusing and there are some benzos in the background our practice at the University of Washington has been psychiatric and psychological co-treatment, bring the team in, be certain you have excluded all other opportunities to treat anxiety. Remember benzos are not approved for the use of anxiety long term they are a short term drug and highly dependency producing. But you can proceed in our opinion and there's no data, quality data on this. So the big caveat here the disclosure is this is what's happening in clinical practice right now and it's a safer alternative. The biggest problem is that insurers may not pay for if it doesn't have an addiction diagnosis. As I understand it there's work being done from the top to make this much less complicated for primary care providers. And as we learn more about that process we'll be happy to share it with you.

Loretta Jackson Brown: Thank you Dr. Tauben. I have another question for you. This is from a clinician through the Webinar system who states that when a state does not have a prescription drug medication database how should they proceed under this barrier?

Dr. Deborah Dowell: Was that - I'll weigh in on. I wasn't sure if that was to me or not. There's is only one state that doesn't have it. You must be from Missouri because there's an obstacle that's a political obstacle in that state. But if you don't have one you're handicapped. It is better than urine drug testing. It's immediately accessible. There may be errors but they're rare and they're much more reliable than urine drug testing and they are incredibly important.

But if the state doesn't have it this is an example where if you're system health system in your state access to treatments we're recommending are not there we should push at the state level to make that happen. Again giving us recommendations and not giving us the tools to implement it is not fair to us, it's not fair to our primary care practices and most importantly it's not fair to our patients. So I think this is a hot topic and whoever asked the question good job and I suspect you're from Missouri because I'm not aware of other states that don't - do not have some degree of a functioning prescription monitor.

Dr. Deborah Dowell: And this is Debbie Dowell and I'll just add to that if you're in the unfortunate position of being in a state without a well-functioning PDMP. It's not as good as PDMP but there's other things you can do like calling your patient's pharmacist to find out what other medications they're receiving there at least.

Loretta Jackson Brown: Operator, we have time for one more question from the phone.

Coordinator: Okay. That question comes from Dr. Marguerite McIntosh. You may go ahead with your question.

Dr. Marguerite McIntosh: Yes. I wanted to ask for some advice. I have - I inherited some chronic pain patients and I've been seeing them for 20 years now. And I know have to change my practice but I always get this, you know, like the Gabapentin or Pregabalin causes depression and edema, patients can't tolerate NSAIDs, physical therapy didn't work, et cetera, et cetera. That's one.

And the other thing is how do you incorporate naloxone, how do you give naloxone in somebody who's on high dose narcotics? Thank you.

Dr. Deborah Dowell: Marguerite, Dave Tauben here again. First it's a great question. We're going to take this up on our second Webinar. It's exactly the question we're going to be taking on and I suspect the patient that we're going culling through a few right now, Dr. (Jim Robinson) and I. It has failed, quote "failed" physical therapy. It has found intolerable side effects to other medications. And how they navigate this is beyond the frame of time that we're going to have for right now.

I think the key point here is you - these are inherent patients and the recommendations on dose limits are explicit that for patients who've been on these long-term, you don't have to immediately get to these levels. You just have to start the process of getting to these levels. So and the process means by first identifying and engaging the patient and we'll be discussing that in our later Webinars.

The issue of naloxone is easy. The purpose is if the patient is at high risk you've identified someone, ideally a sleeping partner, as someone in their house, someone nearby because a person cannot self-inject this when they're nodding out. So they're given that with the instruction that if you notice that your bed partner or your house partner or someone looking like they're stopping breathing you call 911 and you provide it nasally or via injection, don't delay.

We're doing this now at our clinic and it's an eye-opener. Patients say, Really, this much risk? You're giving me this overdose drug? And it changes the conversation that you have with the issues of risk that you're now realized that the risk is so high of dying that you're giving them the antidote. It reframes the safety and the harm and benefit conversation.

You just write the prescription. The pharmacist should have it and we could - we can cover this in one of our later Webinars. I'm a little worried about time. But Marguerite great question. It sounds like you're in the front lines. We'll look forward to hearing back from you at our future Webinars.

Dr. Marguerite McIntosh: Thank you.

Loretta Jackson Brown: On behalf of COCA we would like to thank everyone for joining us today with a special thank you to our presenters, Doctors Dowell, Haegerich, and Tauben. The recording of this call and the transcript will be posted to the COCA Web page at emergency.cdc.gov/coca within the next few days. Free continuing education is available for this call. All continuing education for COCA calls are issued online through TCE Online the CDC training and continuing education online system at www.cdc.gov/tceonline. Those who participated in today's COCA call and would like to receive continuing education should complete the online evaluation by July 21, 2016 and use course code WC2286.

Those who will review the call on demand and would like to receive continuing education should complete the online evaluation between July 22, 2016 and June 21, 2018. Use course code WD2286.

To receive information on upcoming COCA calls join the COCA mailing list by going to the COCA Web page emergency.cdc.gov/coca and clicking on COCA Mailing List. Mark your calendars for the next upcoming CDC Guideline for Prescribing Opioids for Chronic Pain COCA calls. Save the date for July 27, August 3 and August 17 from 2:00 pm to 3:00 pm Eastern Time.

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CDC launched a Facebook page for clinicians to receive COCA updates. Like our page at Facebook.com\cdcclinicianoutreachandcommunicationactivity. Thank you again for being a part of today's COCA call. Have a great day.

Coordinator: Thank you. That concludes today's conference. All participants may disconnect.

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