Assessing Benefits and Harms of Opioid Therapy for Chronic Pain

NOTE: This transcript has not been reviewed by the presenters and is made available solely for your convenience. A final version of the transcript will be posted as soon as the presenter's review is complete. If you have any questions concerning this transcript, please send an email to coca@cdc.gov.

Moderator: Loretta Jackson-Brown

Presenters: Deborah Dowell, MD, MPH; Mark Sullivan, MD, PhD; Jane Ballantyne, MD, FRCA

Date/Time: August 3, 2016, 2:00 - 3:00 pm ET

---

Coordinator: Welcome and thank you for standing by. At this time all participants are in a listen only mode. During the Q and A session if you'd like to ask a question, you may press Star 1 on your phone.

Today's call is being recorded. If you have any objections, please disconnect at this time. I would now like to turn the meeting over to Doctor Loretta Jackson-Brown. You may begin.

Dr. Loretta Jackson Brown: Thank you Ted. I'm Dr. Loretta Jackson Brown, and I'm representing the Clinician Outreach and Communication Activity, COCA, with the Emergency Risk Communication Branch at the Centers for Disease Control and Prevention.

I'm delighted to welcome you to today's COCA Call, Assessing Benefits and Harms in Opioid Therapy 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 in the Webinar link can be found on our COCA Webpage at emergency.cdc.gov/coca.

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 relationships with the manufacturers of commercial products, supplies of commercial services or commercial supporters, with the exception of Dr. Mark Sullivan and Dr. Jane Ballantyne.

They would like to disclose that their employer, The University of Washington, received a contract payment from the Centers for Disease Control and Prevention. In addition, Dr. Sullivan would like to disclose that he is consulting with Chrono Therapeutics concerning development and testing of an opioid taper device.

At the end of the presentation you will have 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 and 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 those with 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 question to your healthcare provider.

At the conclusion of today's session, the participant will be able to describe the evidence for the benefits and harm of opioid therapy for chronic pain outside of active cancer treatment, palliative end of life care, review methods for setting goals for pain management with patients, summarize factors that increase risk for harm and how to assess four such factors and review methods for assessing patient's pain and function and for conducting appropriate follow up.

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 date for the next call schedule for August 17. Plan to join the discussion starting at 2:00 pm Eastern Time. Missed a call? No worries. View call recordings from the June 22 and July 27 calls on the COCA Webpage.

Today's first presenter is Dr. Deborah Dowell. Dr. Dowell is Senior Medical Advisor for the National Center for Injury Prevention and Control at the Centers for Disease Control and Prevention.

She previously led CDC's prescription drug overdose team and served as an advisor to New York City's Health Commissioner. Dr. Dowell is Lead Author for the 2016 CDC Guidelines for Prescribing Opioids for Chronic Pain.

Our second presenter, Dr. Mark Sullivan is a Professor of Psychiatry and Behavioral Sciences at the University of Washington. He is an Attending Physician at University of Washington Medical Center, Center for Pain Relief, and he provides tele medicine consultation for chronic pain management through the university's tele med program.

He has received research funding related to opioid therapy for chronic pain from several federal agencies. Dr. Sullivan helped to develop opioid guidelines for Washington State.

Today's third presenter, Dr. Jane Ballantyne, received her medical degree from the Royal Free Hospital of Medicine in London, England. She trained in anesthesiology at the John Radcliffe Hospital, Oxford, England before moving to the Massachusetts General Hospital, Harvard University, Boston in 1990.

Dr. Ballantyne joined the University of Washington in 2011 as a Medicine Professor of Education and Research and served as a Director of the Pain Fellowship. Dr. Ballantyne has editorial roles in several leading journals and textbooks and is a widely published author.

As a reminder, the PowerPoint slide set and the Webinar link can be found on the COCA Webpage at emergency.cdc.gov/coca. At this time, please welcome Dr. Dowell.

Dr. Deborah Dowell: Thank you Dr. Jackson Brown. Today's Webinar content on assessing benefits and harms of opioid therapy for chronic pain is based on the CDC guideline for prescribing opioid for chronic pain.

The guideline was released in March in both the morbidity and mortality weekly report and in JAMA. Here are key relevant findings from the evidence reviews for the guideline.

First, it's unclear whether there are long-term benefits of opioid therapy for chronic pain, given most randomized trials have lasted six weeks or less. Short-term benefits are small to moderate for pain and inconsistent for function.

Serious risks of opioid therapy include opioid use disorder and overdose. And risk assessment instruments do not consistently predict opioid abuse or misuse. Given these findings, it can be difficult to predict benefits and harms of long-term opioid use in individual patients.

CDC recommends the clinician should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient.

How do you determine whether expected benefits of long-term opioids will outweigh risks for your patient? This can be challenging. We'll devote most of today's webinar to discussing this determination.

We'll also discuss how to determine if opioids are started, whether or not benefits actually do outweigh risks. In order to do this, it's critical to establish goals at the outset so that progress can be measured.

CDC recommends that before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function. Because it can be difficult to discontinue opioids once started, CDC also recommends that before starting opioid therapy for chronic pain, clinicians should consider how opioid therapy will be discontinued if benefits do not outweigh risks.

Here are four practical steps to take before starting opioids for chronic pain. First, determine whether expected benefits for both pain and function are anticipated to outweigh risks to the patient.

Second, establish treatment goals, or for patients already receiving opioids, establish goals for continued treatment. Third, set criteria for stopping or continuing opioids and fourth, have an exit strategy for discontinuing therapy if opioids do not help or if they're harmful.

These are some key points to consider in assessing likely benefits of opioid therapy for individual patients. Consider the patient's diagnosis. There is insufficient evidence for long-term benefits of opioids in chronic headache, fibromyalgia and non-specific back pain.

Also consider the patient's goals. Opioids are more likely to be effective if the goals are to reduce pain in the short-term or to reduce intermittent exacerbations of pain. Opioids are less likely to be effective if the goals are to reduce pain over the long-term or to eliminate pain. In addition, we don't have evidence for long-term improvement in function with opioids.

CDC recommends that before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms, including moderate or severe sleep disorder breathing, concurrent benzodiazepine use, history of non-fatal overdose, mental health conditions such as anxiety, post-traumatic stress disorder or depression and substance use disorder.

Of note, a recent study found that treatment for depression may decrease the overdose risk when opioids are used. So it's possible that an inadequately treated mental health condition rather than the existence of a mental health condition is the more relevant risk factor for overdose.

Assess for anxiety, post-traumatic stress disorder and depression using validated tools. For example, the G87 PHQ9 or PHQ4. To assess for substance use disorder, ask patients about their drug and alcohol use. Single screening questions have been validated and can be used. For example, how many times in the past year have you used an illegal drug or used a prescription medication for non-medical reasons?

Validated screening tools can also be used. For example, the drug abuse screening test, or DAST, and the alcohol use disorders identification test, or AUDIT. Use prescription drug monitoring program data and urine drug testing to assess for concurrent substance use.

We've reviewed some of the factors that can help predict benefits and harm through opioids in specific clinical situations, including specific pain diagnosis, patient goals and comorbidities.

Later during this webinar, Drs. Sullivan and Ballantyne will discuss how to use some of these factors to weight benefits and harms for an individual patient.

Now I'll review how to establish treatment goals before starting opioids for chronic pain. It's important to include goals for both pain and function. Sometimes improvement in physical function might not be realistic, for example in catastrophic spinal injury. But remember, the function can include emotional and social, as well as physical dimensions.

Set realistic, meaningful functional goals. For example, walking around the block. Set goals for objective improvement. Use validated screening instruments such as the pain average, interference with enjoyment of life and interference with general activity, or PEG assessment scale.

This is the three-item PEG assessment scale. Clinically meaningful improvement has been defined as at least 30% improvement in pain and function.

Setting patient-specific and objective treatment goals at the outset makes it possible to evaluate benefits of opioid therapy during treatment. CDC recommends that clinicians should evaluate benefits and harms with patients within one to four weeks of starting opioid therapy for chronic pain or a 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 or continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids.

Patients should be reevaluated within one week when starting or increasing extended release, long-acting opioids, or when increasing total daily opioid dosage to 50 morphine milligram equivalents or MME or more per day. And within three days when starting or increasing the dosage of methadone.

Patients on stable dosages should be regularly reassessed at least every three months. Reassess patients exposed to greater risk more frequently. For example, patients with a history of substance use disorder or history of overdose, or patients taking 50 MME or more per day or taking other central nervous system depressants.

As follow up, before continuing long-term opioids for chronic pain, ask do opioids continue to meet treatment goals? Is there progress towards individual patient goals? Is there sustained, meaningful improvement in pain and function? Are there adverse events or early warning signs? Is there over-sedation or overdose risk? Are there signs of opioid use disorder? Do benefits continue to outweigh risk? Can the dosage be reduced? And can opioids be discontinued?

If harm outweighs benefits, work with your patient to reduce the dose or to taper and discontinue opioids. Optimize non-opioid pain management. And if the patient has opioid use disorder, offer a referral for medication assisted treatment.

I'll now turn the floor over to Doctors Mark Sullivan and Jane Ballantyne who will discuss how to apply these principles in the management of chronic pain.

Dr. Mark Sullivan: Thank you very much Dr. Dowell. Dr. Ballantyne and I will be jointly presenting our presentation on assessing benefits and harms of opioid therapy. If we could put the slide up with the case.

We're going to be discussing the case of Ms. (Christie), a 46-year-old woman who has had fibromyalgia for the past three years. She was sent by her primary care provider to a rheumatologist who diagnosed - hello?

Dr. Ballantyne: Hello. Okay, okay.

Dr. Mark Sullivan: Who diagnosed fibromyalgia after a physical exam and an extensive series of blood tests. Her primary care provider treated her with gabapentin, 300 milligrams in the morning and 600 milligrams at bedtime with moderately good results.

She continued to have moderate, about 5 out of 10 pain, but she was able to continue her job as a receptionist and her role as wife and mother to two high-school students.

So it's important to remember - actually I do now have - I'm on the live meeting and I can move the slides myself. So we'll be going with that.

So let me go to the next slide, which is the first of the guidelines we are to address today which is that opioids are not first line or routine therapy for chronic pain. And in fact, Ms. (Christie) was treated in a way consistent with this guideline. She was placed on gabapentin and had an incomplete but reasonable response.

Why that is appropriate? There has recently been a review under the Office of the National Institutes of Health Pathways to Prevention Workshop that documented quote, "Evidence is insufficient to determine the effectiveness of long-term opioid therapy for improving chronic pain and function. Evidence does support a dose-dependent risk of serious harm."

So we really don't have good evidence that there's long-term benefit from opioid therapy. But we do know that it creates some significant problems. When we look at fibromyalgia specifically, our guidelines are very clear that opioid analgesics are not recommended, despite widespread use.

Many professional organizations listed here on this slide have recommended against the use of long-term opioid therapy in fibromyalgia. The Cochrane Collaborative did a 2014 review and concluded specifically that there is quote, "no evidence at all," unquote of oxycodone efficacy in fibromyalgia.

The only opioid that has any evidence is tramadol. That has been shown to work short-term within RCT. And - but it's important to remember that tramadol is a weak mu opioid antagonist. But it's efficacy in fibromyalgia is more likely related to its action as a serotonin epinephrine reuptake inhibitor which is similar to duloxetine for example, which was FDA approved for the treatment of fibromyalgia.

So let's go back to the case. Yes?

Dr. Jane Ballantyne: Just ask you a question before we move on?

Dr. Mark Sullivan: Sure.

Dr. Jane Ballantyne: Are there any other conditions apart from fibromyalgia where you would say that the same thing applies? That opioids are just not recommended?

Dr. Mark Sullivan: Well I think that low back pain, headaches are a couple of other quite common conditions where we have no evidenced that there's long-term benefit from opioids.

There's the risks of rebound headaches that seem to be quite common with opioid treatment of chronic headaches. And we've also got no real evidence of long-term benefit in back pain. So those are a couple of quite common conditions where opioids should be avoided.

So back to the case here. Three months before today's visit, Ms. (Christie) was unfortunately rear ended when her car was stopped at a stop light. She suffered a significant exacerbation of her fibromyalgia pain.

In fact, she reported severe 8 out of 10 pain in the emergency department immediately after the crash. She had no fractures, but was diagnosed with neck and back sprain. At that time in the ED she was prescribed oxycodone, 5 milligrams every four hours as needed for pain.

Because she continued to complain of severe 7 out of 10 widespread pain despite taking 20 milligrams of oxycodone a day, when she saw her primary care provider after the crash. Furthermore, she said she was no longer able to do her job or fulfill her responsibilities at home due to this high level of pain.

So I want us to recall the second CDC recommendation at this point, which is that you need to establish a measured progress toward goals. So at this point we are not really meeting goals for opioid therapy because she is not getting adequate pain relief. She is not achieving functional goals. But it's confusing in this situation because we have a relatively recent acute injury that is now evolving. So let's see what happened with this case.

 

Ms. Christie asked her primary care provider to increase her oxycodone dose to improve her pain and function level. Her primary care provider wanted to help her keep her job. So he wrote for what was essentially double the original dose of oxycodone, now oxycodone extended release 20 milligrams twice a day.

And indeed, when he checked in with her a week later, she reported feeling better and was getting back to work. It is quite important to know that short-term response to opioids, even in chronic pain conditions, can be positive even when long-term response will not be positive.

And it's not uncommon that someone like Ms. (Christie) will feel better for matter of weeks after having her opioid dose doubled. Let me go through a few points before we get back to the case again.

Consistent with the second CDC guideline recommendation about establishing goals for opioid therapy for chronic pain. It is really advisable to do this before embarking on long-term opioid therapy, including criteria for success and failure of that therapy.

We had a therapy - I mean a training that was disseminated through the FDA REMS program. And I have the URL here, cop rems that talks in some detail about how to do that goal setting.

Very briefly, I believe that goal-setting should focus on the achievement of life goals. Do not accept a goal of no pain or even the goal of less pain if it's not framed in terms of the patient achieving their life goals because the point of opioid therapy is to improve the patient's life and let them get on with their life, not simply to drive down their pain score.

If the patient resists when you ask them for a goal other than pain reduction, you might ask instead, how would your life be different if you had significantly less pain? Then explain that this is the life you will aim for together, which may or may not involve significant pain reduction.

One of the uncomfortable but well replicated truths is that in chronic pain treatment, often times sleep, mood or function will improve first, and pain levels will improve later. So pain reduction is often not a leading indicator of improvement, even though that's often what patients are focused on.

So let's talk a little bit more about measuring progress in chronic pain care. Jane and I have both written about the fact that measuring pain intensity alone is not an adequate way to measure progress in chronic pain care.

First of all, this establishes the wrong goal for chronic pain care because pain intensity reduction is not sufficient. People can take a great deal of opioids and drive down their pain score, but be even less functional or sometimes we call it they have more couch time on the opioid therapy than they did before.

So this reduction in pain intensity is not sufficient by itself, nor is it actually necessary because many patients in pain rehabilitation programs will show substantial improvements in function and quality of life without a significant reduction in pain intensity. And they still think they're much better.

The second reason that measuring pain intensity is not adequate is that if we look at the patients with the highest levels of pain intensity, your classic patient who comes in reporting 10 out of 10 pain, who is completely overwhelmed.

Unfortunately that patient is very likely to have significant mental health and substance abuse comorbidities. And so we may be selecting the most high risk patients for opioid therapy if we just focus on those that are giving us the highest pain intensity score. We have to inquire more thoroughly than that.

And thirdly, by focusing on pain intensity we operate with the wrong understanding of chronic pain. It implies that chronic pain, like acute pain, is a fairly linear process with injury producing no compression, producing pain. But in fact, when pain becomes chronic, it become cyclical in nature with the consequences becoming causes.

So disability, produces disuse, produces more impairment in function, distress of a psychological kind reinforces pain intensity and all of those elements need to be assessed and addressed rather than a simple focus on the intensity of the pain.

To do that you really need a multi-dimensional assessment. You can't simply assess a pain score, but you need to be looking at function. Those physical enroll function.

And we also like to personalize that assessment with having the patient select a personally important activity. And we're going to track impairment to that during treatment to see if it's a success.

We also track sleep, depression and anxiety. Overall what we want to know, is life moving forward again? Is this person accomplishing things, enjoying things, having a life? That's what success is. The particular tool that we use at the UW is called pain tracker. And I've included that URL so that you can look at that if you would like.

The seventh CDC guideline that we are to cover today is reevaluate benefits and harms of opioids and continue therapy only as a deliberate decision. So this is complicated because I don't know that everybody is clear about how they should do this.

And there are a number of ways to get down some dead ends. I think it's very important that we remember that short-term and long-term opioid therapy are very different therapies, even though we may use the exact same medications.

You know, maybe its oxycodone short-term and long-term. But short-term opioid therapy has a fairly simple list of benefits and harms whereas long-term opioid therapy is much more complicated.

And for that reason, the often recommended treatment trial, which looks at short-term response to opioid therapy over a period of weeks to a month does not do a good job of predicting long-term response. That is how well the patient is going to do over months to years of therapy.

And the patients receiving opioids themselves tend to overestimate the benefit of therapy based on pretty persuasive experiences that they have right when they start therapy. And then when the often try to stop it abruptly.

So when they're starting, they get relief. And then if they stop, which is usually abruptly if they do it on their own, they have an increase in pain. And that convinces them that they need the meds even though in the middle of chronic opioid therapy there often not doing very well.

So I think it's important to indeed pay attention to patient's report of current level of pain and function. From epidemiologic studies we know that many patients on chronic opioid therapy are still having high levels of pain and high levels of functional impairment, but they qualify those reports by stating that they would be much worse without opioids.

And I think that's often based on their own experience. But I would not think it's a success if they're reporting 8 out of 10 pain and severe functional impairment even if they say I would be much worse without opioids.

So given the fact that we're talking about a longer-term therapy, it's important to evaluate not simply the benefits but do continuous and repeated assessment of opioid related harms. That's the eighth CDC guideline that we were to cover today.

So what are the sources of risk in long-term opioid therapy? First, they come from the medication regimen. We know that risks increase with the dose. We know that the risks of overdose and death specifically are higher for long-acting, extended release opioids. Methadone most markedly, but basically any long-acting or extended release opioids.

We also know that overdose and death risks are greatly magnified by concurrent sedative use. This includes benzodiazepines, muscle relaxants and Z-drugs. The best estimates are that the overdose risk is multiplied by a factor of about 10.

In addition to the risks associated with medication characteristics are the risks associated with patient characteristics. Most well documented and frequently mentioned are substance use disorders. Current substance use disorders are pretty much an absolute contraindication to long-term opioid therapy. Past substance use disorders do also increase risks, but don't preclude the therapy.

And I've inserted tobacco here in the parenthesis to remind me to mention that risks of chronic pain, risks of being put on long-term opioid therapy and risks of various adverse outcomes of long-term opioid therapy are elevated even in patients who smoke tobacco or use other tobacco products and certainly with other substance use disorders.

In addition to these substance use problems, inadequately treated mental health disorders also pose a risk. We talk about depression quite frequently. And that is in fact the most common mental health disorder in patients with chronic pain, but probably the disorder that has been shown to have the greatest effect on opioid use, misuse, and overdose is post-traumatic stress disorder where it appears that the opioids kind of retard recovery from PTSD. They greatly elevate the risk of opioid adverse effects.

Also young age. Patients who are younger are much more likely to have addiction problems, although older people are more prone to medical risks of opioids.

And then previous opioid overdose, perhaps that doesn't need to be stated, but we, in some of our epidemiologic studies have seen that many people having already had one opioid overdose get put back on opioids.

So in terms of the risks, what are the risks of long-term opioid therapy to patients? And there are quite a few of them. And I will go through them pretty quickly.

First of all we have all hoped that for example in injured workers, giving someone some opioids will help them go through rehab, do physical therapy, improve their function and return to work.

And although we don't have randomized trials of this, we do have multiple cohort studies, all of which show that early opioid prescription to injured workers reduces, not improves their chance of returning to work.

We know that from high dose opioid therapy in cancer patients or methadone clinics that long-term opioid exposure can have the paradoxical effect of opioid induced hyperalgesia as indicated often by people having all over body pain that needs to be addressed by stopping their opioids.

The role of opioid tolerance is also likely significant, though complicated because it can be invisible. People on long-term opioids often are reporting high pain levels. Tolerance is complicated because it develops to different opioid effects at different times.

Patients on opioid therapy, particularly high dose therapy for a long time, years, can become quite dependent on these opioids. And in fact we have seen multiple patients in Washington who don't meet addiction criteria, have never sought illicit drugs or done any antisocial behaviors we normally associate with addiction, and yet are pretty much stuck on opioids for the rest of their lives.

We really can't get them off. So there is the potential for life long dependence. We don't know how frequently that occurs, partly because there is this development of tolerance and dependence, misuse is a risk.

There are patients who have reported to me that they can't feel their 80 milligrams of methadone a day, and so they save it up and will use extra on days where they're going to active so that they can actually feel the effect. Of course, that's risky and increases the risk of overdose.

Our best estimates, these are conservative estimates, but consensus estimates are now that about 25% of patients with long-term opioid therapy will show evidence of abuse of the opioids and full-fledged addiction or opioid use disorder may develop in 10% or even more.

There are other risks I won't go into as much, but long-term opioid exposure does increase your risk of hypogonadism. It affects infertility. It lowers your libido. It can mask psychiatric disorders. We frequently will see patients with quite severe depression or PTSD somewhat masked by their chronic opioid therapy.

There is now fairly good evidence that opioid therapy, rather than relieving depression, as many patients hope and claim, has a clear risk of inducing depression. And this seems to be more related to opioid therapy duration than dose per se.

And of course, the CDC has very well documented risks of overdose and death associated with opioids, but also we need to remember that many more events occur that are non-lethal. And in fact there were estimated to be over 700,000 emergency department visits in 2012 associated with prescription opioids.

Prescription opioids are also associated with motor vehicle crashes, and particularly in older individuals -- falls, fractures, sedation and delirium.

It's important to remember that it's not just patients that have risks associated with long-term opioid therapy, but also their family and friends. Rates of abuse of opioids among 12th graders have luckily been coming down since 2010, but still 6% reported in 2014 is still too high.

We also are now seeing ripples of the prescription opioid epidemic showing up in heroin deaths, which doubled between 2010 and 2012. And you can get addiction in non-patients, particularly family members.

So let's go back now to our case of Ms. (Christie), the 46-year-old female with fibromyalgia. So remember, she was initially managed on gabapentin. And she began opioids in the emergency department after her motor vehicle crash.

And these were continued because she continued to report severe pain and dysfunction that was interfering with her ability to work. So what essentially happened is that opioid therapy slipped from a short-term strategy to a longer-term strategy without any explicit examination of goals, risks or benefits of long-term opioid therapy.

And I selected this case because I think this is an increasingly common situation that primary care providers face where they are not increasing the doses, but doses of opioids increase elsewhere, in specialty care or in emergency departments when patients have acute events.

And what is happening is not so much that these are being increased by primary care providers, but that they're increased by others and the primary care are not getting the doses down.

So I think the lessons to be learned from our case with Ms. (Christie) is that she should not have been given more than three to seven days of opioids for her back strain - back and neck strain from the motor vehicle crash.

When she saw her primary care provider two weeks later, her opioid therapy was really not treating her acute back and neck strain anymore, but was now treating her fibromyalgia.

And her improvement a week after her primary care provider doubled her OxyContin dose sounds promising but really is not a good indicator of the likelihood of her benefit from opioid therapy.

So I think I've said enough. I was going to invite Dr. Ballantyne to make some comments or questions about my presentation at this point.

Dr. Jane Ballantyne: So thank you Dr. Sullivan. I think one of the difficulties we all face with cases like this is when exactly does the treatment cross over from being...

Dr. Mark Sullivan: Hello?

Dr. Loretta Jackson Brown: Dr. Sullivan, I think we may have lost Dr. Ballantyne.

Dr. Mark Sullivan: Oh I'm sorry about that. Well I'll fill in with what I think she was going to say. Jane and I have done this before. So I think what she was going to focus on is when the therapy crosses over into a more chronic therapy and a more acute therapy.

And I think the CDC guideline does highlight three to seven days of opioids for acute pain problems. And I think that in some ways the cutting edge of policy about opioid use because we don't want to be giving patients a month or multiple refills of med - of opioids for acute pain problems because that's where long-term opioid therapy gets started. It's difficult to discontinue.

And like I said, it can slide pretty easily from one to the other. And in this case it was, you know, confusing because she had had the neck strain. But if we note, when she was back to her primary care doctor, she was talking about widespread pain.

So that I think is a hint that she's really been now bothered by fibromyalgia rather than just an extreme. And we do need to remain vigilant about getting opioid doses back down after acute events rather than letting them go on and on. Even if the patient is continuing to have pain, the therapy and the risks of the therapy are changing. And we need to have different criteria for continuing the therapy.

 

Is Dr. Ballantyne back on? I guess not. How would you like to proceed at this point?

Dr. Loretta Jackson Brown: I would like to begin the question and answer session. So thank you all so much presenters for providing our audience with such a wealth of information. So 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. So again, if you are media, please contact CDC media at 404-639-3286. And if you are a patient, please contact your healthcare provider.

When asking a question, remember to state your organization as well. And remember, you can submit questions through our Webinar system by clicking on the Q and A tab at the top. Let's hear from our coordinator, (Ted).

Coordinator: Just a reminder, to ask a question over the phone please press Star 1 and record your name. If you'd like to withdraw your question, press Star 2. Thank you.

Dr. Loretta Jackson Brown: And while we're waiting for the first question from the phone. So for University of Washington staff we do have a participant who wants to know if your pain tracker tool can be used at other clinics.

Dr. Mark Sullivan: We do have a paper version, excuse me. There's a paper version up there on the Website that you can use. We have other online versions that you can email us about using, but the basic paper version that we have up there on the Website is free for you to use.

Dr. Loretta Jackson Brown: Thank you. Coordinator do we have anyone on the phone with a question?

Coordinator: Yes we do have a question in the queue from (Amanda Ryan). Your line is now open.

Amanda Ryan: Hi, this is Amanda Ryan. I am a Pharmacist with Adam Alliance Cream QIO. I had a question about potentially applying the CDC guidelines, especially this risk versus benefit assessment, to patients who are in a long-term care facility, not palliative care, end-of-life or cancer patients.

But I wanted to see if you could speak to that a little bit and see if these guidelines are intended for that use at all. And if so, how we might be able to utilize them in that setting.

Dr. Deborah Dowell: This is Debbie Dowell from CDC. And I think that these guidelines, although they were primarily intended for use in primary care settings, I think the principles still apply to long-term care settings, especially if you're treating somebody that is not at the end of life and has substantial expected life expectancy.

I think, you know, it's - they're intended to be individualized. And the way that you would do that is work with the patient to establish treatment goals that makes sense for them. And to use those to measure benefits of opioid therapy.

And view it off of - you know, there may be a different benefit risk equation in terms of the harm. There are certain risks that are more likely in older adults, including constipation, including in some patients there may be issues with dementia and inability to report on adverse effects.

So I think the principles of the guidelines can be used in long-term care. And that like anywhere else where you're applying these guidelines, you're going to make individualized decisions based on the patient's circumstances.

Dr. Loretta Jackson Brown: Thank you Dr. Dowell. Coordinator do we have another question from the phone?

Coordinator: Yes there is another question in the queue from (Felix Van). Your line is now open.

Felix Van: Hi, my name is Felix Van, Torrance Memorial Medical Center. In patients being treated for post-operative care, we find often that there are patients who would require high doses of opiates, especially if they've had a history of opiate use.

With regards to the two sources of risk for long-term opiate care, can you - on the slide that you provided, you said that long-acting extended release opiates would increase your risk of a potential harm to patient. How do we approach providing or I guess opiate care to those patients that might benefit from a short regimen of long-acting opiates?

Dr. Jane Ballantyne: This is Dr. Ballantyne. Maybe I should answer the question because I'm an anesthesiologist. I think the CDC guideline makes a very clear distinction between patients who have never received opiates before and patients who have been on opiates for a long time.

And I think you're describing a patient who's been receiving chronic opioids. In which case, managing their acute pain particularly over the surgical period will be tough. And they probably will require high doses.

What we're recommending now is that as quickly as possible you get patients back to their pre-surgical regime. So the three to seven day recommendation applies to those patients as well.

Every effort should be made to get them off the high doses that they require to the acute pain in the surgical period, but get them back to the regime that they were on before surgery, which often is, particularly since the recommendations of the last two decades have been rather focused on using long-acting opiates may be that they're already on long-acting opiates.

In which case you will consider that as part of your taper plan if your plan is to taper. And it's on very high doses, nowadays we would recommend that there is a taper plan in place. But it's acceptable to use long-acting opiates if they've already been on long-acting opiates. If they haven't, then it's generally advised not to use long-acting opiates.

Dr. Loretta Jackson Brown: Dr. Ballantyne, I'm going to ask you to delve a little deeper. We have a comment on the webinar about chronic opioid therapy. And they want to know about addressing assessing function and starting a taper for someone who has been on it chronically.

Dr. Jane Ballantyne: Well as Dr. Sullivan touched upon, when people have been taking opiates for a long time, they inevitably become dependent on the opiate, which means that they have adapted in such a way that when you start to come off the dose that they've been on for a long time, quite often pain does get worse. It's part of withdrawal, which is why we recommend very slow taper to try and avoid that affect.

But it's so easy to someone who's been on opiates for a long time to believe that they need the opiate because if they stop taking it, the pain gets worse. But our experience is that if you can succeed with a taper, get to the end of the taper and get them on back to baseline where they're not on any opiates at all, in fact the pain improves.

So it is a challenge because people are frightened of going back to the pain they remember. And they're frightened of going back to the pain they experience if they taper too quickly. But generally the experience is that a successful taper makes a patient much better able to function. And generally their experience is the pain level either doesn't change or is actually increased.

Dr. Loretta Jackson Brown: Thank you so much. Coordinator do we have another call from the phone?

Coordinator: I'm showing no further questions at this time.

Dr. Mark Sullivan: So this is Dr. Sullivan. I'll just add in to Dr. Ballantyne's comment about taper, because we just finished a taper trial. And I do have to agree, although patients are very afraid of dramatically increased pain levels with taper, if the taper is done gradually, we do this in combination with pain self-management training.

And we also pay attention to psychiatric comorbidity with the tapering. And so if you address both of those issues, then taper can go quite well. Obviously each patient is individual. And we find that it does take a fair bit of time for patients to adapt to lower opioid doses.

So I think one good watch word for opioid taper is no rush. As long as the dose is going down, it doesn't matter too much what the pace of the reduction is. We don't let people go back up, but we do let people pause the taper for a breather before they go back down.

Obviously that needs to be adjusted in situations where patients are at great risk. But on the whole, a slow opioid taper is pretty well tolerated.

Dr. Deborah Dowell: And this is Debbie Dowell from CDC. I just wanted to put in a plug for our next Webinar is going to be on dosing and titration of opioids, including tapering. So we'll get into the specifics of taper in more detail on that Webinar as well.

Dr. Loretta Jackson Brown: That's great Dr. Dowell because one of our participants does want a better idea of what goal is instead of less pain. And so you all will be able to discuss that in more detail in two weeks. Is that correct?

Dr. Deborah Dowell: Yes. I think we can address that now as well, if there's no other questions waiting. But some of the other goals that would be important would be function, enjoyment of life. For some patients it's sleeping better.

And as Dr. Sullivan talked about in his presentation, it really gets back to that question of how would your life be better if you had no pain? And it may, you know, it may be a very different answer for different patients.

It may be being able to walk around the block. Being able to grocery shop and prepare a meal, being able to pick up grandkids. But so we emphasize in the guideline both choosing patient-specific goals that relate to their function and quality of life. And also looking at objective improvement using validated tools like the PEG. I don't know if Dr. Sullivan or Dr. Ballantyne want to add anything to that.

Dr. Mark Sullivan: Yeah I would say that somewhat paradoxically life may improve before pain improves. But the fact that life has improved, meaning that they've gotten back to some things that they really love doing. That can bring along with it pain reduction.

So it's not true that pain reduction is necessarily irrelevant. It's just not front and center. Not first and foremost in terms of treatment of chronic pain. Once you get people living more, doing more, they often find that their pain levels become less important and even reduce.

Dr. Loretta Jackson Brown: Thank you. I remember that being illustrated during the last call in this series where the case study kind of focused on the individual being able to work more often and how they were so fulfilled with that. And for those who missed that call that recording can be found on the COCA Webpage.

Coordinator do we have any other questions on the phone?

Coordinator: I'm showing no questions in the queue at this time.

Dr. Loretta Jackson Brown: So on behalf of COCA, I would like to thank everyone for joining us today, with a special thank you to our presenters, Dr. Dowell, Dr. Sullivan and Dr. Ballantyne.

The recording of this call and the transcript will be posted to the COCA Webpage 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 September 2, 2016. Use course code WC2286.

If you will listen to this as a recorded Webinar, you will use course code WD2286 and should complete your evaluation between September 3, 2016 and August 22, 2018.

To receive information on upcoming COCA calls, join the COCA mailing list by going to the COCA Webpage, emergency.cdc.gov/coca and click on COCA mailing list.

Mark your calendar for the upcoming CDC guidelines for prescribing opioids for chronic pain. The next call will be August 17 from 2 to 3 pm Eastern Time.

Tuesday, August 9 at 2 pm Eastern Time join COCA for call titled, Updated Interim Zika Clinical Guidance for Pregnant Women and Data on Contraceptive Use to Decrease Zika Affected Pregnancies. During this COCA call, clinicians will hear from CDC subject matter experts and learn about the updated CDC interim guideline for caring for pregnant women with possible Zika virus exposure. Get detailed information about this call by visiting the COCA Webpage.

CDC has a Facebook page for clinicians. 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: This concludes today's call. Thank you for your participation. You may disconnect at this time.

END