The Role of Clinicians in Addressing the Opioid Overdose Epidemic
Moderators:Loretta Jackson Brown
Presenters:Christopher M. Jones, PharmD, MPH, Gary M. Franklin, MD, MPH, and Melinda Campopiano von Klimo, MD
Date/Time:September 24, 2015 2:00 pm ET
Welcome and thank you all for standing by. At this time I would like to inform all participants that you will be on a listen-only mode until the question and answer session of today’s conference call. Today’s conference call is being recorded. If you have any objections, you may disconnect at this time. During the call if you would like to ask a question, please press star, one on your touchtone phone. You will be prompted to record your name prior to asking your question.I would now like to turn the call over to Ms. Loretta Jackson Brown. Thank you, ma’am. You may begin.
Loretta Jackson Brown:
Thank you (Lisa). Good afternoon. I’m Loretta Jackson Brown and I’m representing the Clinician Outreach and Communication Activity -- COCA -- with the Emergency Risk Communications Branch at the Centers for Disease Control and Prevention. I’m delighted to welcome you to today’s COCA call, “The Role of Clinicians in Addressing the Opioid Overdose Epidemic.”
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 September 24 COCA call. 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 relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. Planners have reviewed content to ensure there is no bias. This presentation will not include any discussion of the unlabeled use of a product or products under investigational use.
At the end of the presentation, you will have the opportunity to ask the presenters questions. On the phone, dialing star, one 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 managing patients with pain conditions and who want to learn steps that can be taken to improve opioid analgesic prescriptions for the treatment of pain. 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’re a patient, please refer your questions to your healthcare provider.
At the conclusions of today’s session, the participant will be able to review the epidemiology of opioid-related morbidity and mortality; describe the challenges of managing patients with pain conditions as well as patients who have opioid use disorders; discuss the FDA approved treatment for opioid use disorders; discuss the steps that can be taken to improve opioid analgesic prescription for the treatment of pain; and identify the steps that can be taken to incorporate opioid use disorder treatment into clinical practice.
Today’s first presenter is Dr. Chris Jones. Dr. Jones is a pharmacist, and Director of Division of Science Policy in the Office of the Assistant Secretary for Planning and Evaluation for the US Department of Health and Human Services. A public health researcher with a focus on drug abuse and overdose, Dr. Jones is a former lead for CDC’s Prescription Drug Overdose Team.
Our second presenter is Dr. Gary Franklin. Dr. Franklin is a research professor in the Department of Environmental Health, Serology, and Health Services at the University of Washington, and medical director at Washington State Department of Labor and Industries. A board certified serologist, his major research interests include use of administrative databases to conduct epidemiologic research.
Our third presenter is Melinda Campopiano. Dr. Campopiano is a medical officer in the Centers for Substance Abuse Treatment with the Substance Abuse and Mental Health Services Administration for the US Department of Health and Human Services. She is board-certified in family medicine with additional credentialing in addiction medicine. Dr. Campopiano has worked in both primary care and addiction medicine, including managing programs and patients using methadone and buprenorphine.
At this time, please welcome Dr. Jones.
Dr. Chris Jones:
Thank you Loretta, and thanks for those who have joined the webinar, and to my co-presenters as well. We’ve already gone through the leaning objectives, so I’ll skip through those.
In the overview today -- just the structure -- I’ll be briefly talking about the epidemiology of the issue and then Dr. Franklin will talk around the pain management side. And then Dr. Campopiano will talk about the opioid use disorder treatment.
So looking at prescription opioid trends and understanding the epidemiology of where we are currently in the US, this slide presents data from SAMHSA’s National Survey on Drug Use and Health, which the 2014 data was just released a week or so ago. And what we see here is that we have a slight declining trend for past-year nonmedical use of prescription opioids. And we also see a decline in initiation of nonmedical use. So that’s people using prescription opioids non-medically for the first time. That’s been declining for the last several years.
So certainly those are positive signs. However, when you look at the number of people who have - meet diagnostic criteria for past-year dependence or abuse, we see a different trend where we continue to see an increasing trend for the number of people. So right around two million people in 2014 reported past-year abuse or dependency out of a universe of probably more than ten million people who reported nonmedical use of pain relievers.
And the next slide looks at heroin trends. And certainly from the federal perspective with the Department of Health and Human Services, we really see these intertwined problems in addressing one - and policies to address one need to coincide with policies to address the other. And that’s how we’ve formatted this webinar for today.
So when we look at heroin trends we see a more consistent trend where initiation, past-year use, and past-year dependence or abuse one heroin have all been increasing in parallel in the last several years. And 2014 probably more than 900,000 people in the US reported past-year use of heroin. And you could see a little bit less than 600,000 reported abuse or dependence; and slightly less than 200,000 reported past-year initiation. The numbers certainly are lower than we see for prescription opioids, but they have been increasing year over year since at least 2006, 2007.
When we look at deaths, again, we see an increase in heroin-related deaths in the last couple of years -- slightly more than 8,000 overdose deaths involving heroin in 2013. And you compare that with the trend for prescription opioids, which you did see a slight stabilization through 2013, but a little bit more than 16,200 deaths involved prescription opioids. There’s still two times as many deaths involving prescription opioids than heroin. If you look at this line combined, it’s just opioids generally -- whether they be prescription opioids or heroin -- you would see that we had year over year increases since 1999 continuing through 2013.
And there’s been a great deal of focus around heroin use, especially because of the recent increases in heroin-related deaths. And the discussions around prescription opioid policies and their impact on heroin use. And this comes from the National Survey on Drug Use and Health from a Vital Signs that was put out by CDC this past summer. And when we look at who is using heroin, we really see an almost across-the-board increase across sex, age groups, race/ethnicity, annual household income, and health insurance status.
But we tend to see increases - most significant increases in the female population, the eighteen to twenty-five year old population, and the non-Hispanic white population. And when we look at the demographics of heroin use now and where we’ve seen high rates of nonmedical use of prescription opioids, demographics are starting to line up. So that certainly underscores the intersection between prescription opioids and heroin.
We also know from prior research that the current group of people who are using heroin - about 75% of them report nonmedical use of prescription opioids prior to initiating heroin use. But it’s not a black and white issue where there’s actually a lot of gray because we know that about seven out of ten people who use heroin in the past year also non-medically use prescription opioids. So there is back and forth depending on availability of what particular drugs are around.
And when we look at who is in the population of nonmedical users of prescription opioids, are most at risk for heroin initiation, what we find is that people who are more frequent nonmedical users -- and that would be defined as 200 days or more of nonmedical use of prescription opioids in the past year -- as well as those with prescription opioid abuse or dependence -- are really the high risk population for initiating heroin use. And that certainly has implications for availability of treatment, for the initial decision to prescribe and monitor patients who are receiving opioids.
But the data are pretty consistent that those particular populations are at highest risk. And when we look at what’s underlying the drive in the increase in heroin-related deaths, we see a very tight correlation between heroin abuse and dependence and heroin-related overdose deaths. And this, again, comes from the vital signs that CDC put out in July. And you can see here starting in 2007 a pretty consistent increase in abuse or dependence that tracks closely with the increase that we’ve seen in heroin-related overdose deaths. And again, this has implications when we think about at-risk populations, access to treatment.
In the same vital signs, we also looked at other substance use problems in addition to prescription opioids. And we found that people who have abuse or dependence on alcohol, marijuana, and cocaine, as well as prescription opioids, are all at greater risk for heroin abuse or dependence. Certainly, the risk for alcohol and marijuana, as you can see here - two times higher for alcohol abuse or dependence; three times for marijuana abuse or dependence. Cocaine - fifteen times, and then prescription opioids in the modeling came out as the strongest risk factor for heroin abuse or dependence.
So what do we do about this particular issue? And I think this really lends itself to what you’ll hear from my other two speakers - is a three-pronged approach. First, we have to prevent people from starting heroin, and there is a clear connection between prior exposures and nonmedical use to prescription opioids and people who are currently using heroin. So fundamentally, we have to change how prescription opioids are being prescribed and identify early high risk individuals prior to prescribing.
Second, we have to ensure access to medication-assisted treatment. WE know that for both prescription opioids as well as heroin addiction, medication-assisted treatment for opioid use disorders is the most effective treatment modality. And combining that with counseling and behavioral therapies is an important factor in the provision of that treatment. And then lastly, expanding access to naloxone as an emergency countermeasure for the populations who are at very high risk. Again, we’ve seen a pretty quick spike in heroin-related deaths and access to naloxone is certainly an important component of the overall strategy to reduce mortality related to opioids.
And just two quick slides around medication-assisted treatment. And I know Dr. Campopiano will talk more about this from a clinical perspective, but fundamentally we have a significant gap in the US in capacity to provide medication-assisted treatment -- specifically opioid agonist medication-assisted treatment with methadone or buprenorphine -- compared to the need for treatment. And we estimate around a gap of a million persons in 2012 between who might meet criteria for treatment and the actual ability to provide that treatment. And that’s under best case scenario where all providers who have a certification to prescribe buprenorphine are actually doing it at their clinics.
And consistent to many other areas such as drug overdose and opioid prescribing patterns, there’s wide variation across states in their rate of opioid abuse or dependence and their capacity for opioid agonist medication-assisted treatment. And you can see here the states that are darker colored have higher abuse and dependence rates, and the states that have larger circles have higher capacity for opioid agonist based medication- assisted treatment. And you can see here that many of the states that are darker in color -- so have higher abuse and dependence rates -- have - they’re in the lowest quartile for capacity for medication-assisted treatment. So certainly there’s a need for the medical profession to engage in the provision of this treatment. And clearly there are many opportunities to improve that.
So that’s a brief overview of the epidemiology, hopefully setting up both the importance of the upstream changes in prescribing patterns that need to occur as well as some more downstream provisions in clinical offering of medication-assisted treatment for people with opioid use disorder. I’ll now turn it over to Dr. Gary Franklin.
Dr. Gary Franklin:
Thanks very much, Chris, and thank you all for joining us. This has been an extremely serious epidemic and I give a lot of talks to primary care groups and specialty groups. And I know that taking care of these patients in your practices is not an easy thing to do.
It’s been said that it’s sometimes easier to give somebody a prescription than it is to have a fifteen-minute conversation about the complexities of their pain. I wanted to talk today mostly about ways that we have figured out, I believe, to reverse the trends and to reduce the overdose deaths and overdose admissions to hospitals.
I believe this is the worst manmade epidemic in modern medical history, that is made by - when I say manmade epidemic, I mean made by modern medicine. This included, in the late 1990’s, teachings by certain clinicians, and behind that, quite a bit of drug company money. There have been over 200,000 deaths. Only 58,000 people died in Vietnam.
Many more hundreds of thousands of overdose admissions and millions addicted or dependent from prescription opioids. A recent article in Lancet Psychiatry - if you include severe dependence and opioid use disorder, it’s as high as 30% in the patients that are sitting in your office.
I’ll talk a little bit later about how some of these patients might not meet the classic definition of opioid use disorder. And then finally, I believe there’s been a huge spillover effect, especially from using opioids for nonspecific musculoskeletal disorders, headaches, and the like - people with those disorders on chronic opioids. Those opioids are not proven to be beneficial in those patients and they have become disabled. And in fact, are spilling over to the social security disability and the SSI disability systems.
As to the issue of whether chronic opioid analgesic therapy is actually even useful in terms of being effective, the Agency for Healthcare Research and Quality in the past year completed a report which was ultimately published in the Annals of Internal Medicine in January of this year. That concluded that there was insufficient data on long term effectiveness to reach any conclusion on effectiveness of opioids for chronic pain, but evidence on the other hand supports a dose-dependent risk for serious harms.
This is not what we were taught in the late 1990s. It is just the opposite of what we were taught in the late 1990’s. This imbalance of potential harm versus no proven benefit led the American Academy of Neurology to publish a position paper– I was the lead author on this, but it was submitted by multiple committees of the American Academy of Neurology -- to show a risk/benefit scale which is totally imbalanced: mortality at the top and overdose morbidity next, serious adverse events -- but bigger and bigger swaths of patients in terms of dependence and addiction, lifelong disability, and loss of family and community. This is an extremely serious problem
One of the things that the American Academy of Neurology and agreed on in which Washington State has agreed on is that opioids should in general not be used routinely for the treatment of routine musculoskeletal conditions, headaches, or fibromyalgia. Not only is there no evidence for that, there is actually quite a bit of evidence against doing that. And these are probably the most routine patients that are on chronic opioids who have become dependent and addicted in our country.
Why not prescribe opioids for chronic lower back pain, aside from the fact that it is not proven to be of benefit? Number one, the alternative treatments -- particularly programs that take a psychosocial approach -- have a stronger evidence base. Secondly, opioids are generally deactivating and not activating. Third, reducing prescribing for nonspecific low back pain would significantly reduce the overall prescribing and availability of opioids, for example, sitting in one’s medicine cabinet. This would reduce other outlets for those unused opioids. And finally, eliminating prescribing for common indications that have failed would be a step towards identifying cases that do derive benefit for which there is very little published evidence at this time in terms of identifying who might benefit and not be harmed.
We published this study in 2008. I think it’s important in the sense that this is a large prospective study, a Level I population-based prospective study of injured workers with acute low back injury with at least four days of time lost from work. And we looked at what the relationship was between receiving opioids early -- that is in the first six weeks -- and whether these workers were disabled one year later. We found that 14% of these workers were disabled at one year, and that receiving at least seven days, or two prescriptions, or a cumulative dose of 150 milligrams MED of opioids doubled the risk of those workers being on disability one year later, even after adjusting for baseline reported pain and function and injury severity, which we had information on from chart review.
Now, Jane Ballantyne has been an internationally known pain leader and we’ve all learned a lot from her. She has been very strong on the fact that case definitions of tolerance, dependence, and opioid use disorder are starting to blur. It is getting to be much more difficult to differentiate the pain patient who’s receiving opioids in a doctor’s office as to whether or not they have developed opioid use disorder. For the illicit drug user, it’s very easy for them to exhibit procurement behaviors that are apparent. But for the pain patient who comes to your office who’s saying, “Doc, my pain is an eight now and it was a six last week,” to get more pain medication, they don’t need to exhibit the behaviors that illicit drug users would exhibit.
So I would caution you to pay a lot of attention and to talk to your patients you believe to be dependent, and caution you to actually try to talk to their families as well to see exactly what those patients are doing in their life, how much they’re accomplishing, and whether they are basically totally disabled or not.
I want to talk for a minute about an extremely important issue, which is the evidence relating the daily morphine equivalent dose (MED) to the risk of an overdose event, either a hospitalization or a death. And it is very clear that the level of dose that is associated with a dramatic increase in overdose risk is at 100 milligrams morphine equivalents per day. You can see that on the last data points on the right side of this curve. But, the risk of overdose is two to fivefold at doses between fifty and ninety-nine milligrams MED, and a lot of states are moving towards a yellow flag/red flag approach. You don’t want to go over 100 milligrams in most cases (red flag), but you should also be paying a lot of attention at lower doses, say at fifty or sixty or seventy milligrams (yellow flag). And a number of states have implemented lower dosing thresholds- for example, the Ohio and California Medical Boards have both implemented an eighty milligram MED lower bound threshold to pay attention to.
This would be particularly important in patients that are getting combinations of opioids with benzodiazepines or muscle relaxants, which can dramatically add to the risk even at lower doses. I’m not including tricyclic antidepressants in that and muscle relaxants, which can dramatically add to the risk even at lower doses.
This is a more complete list of the opioid dosing policies since 2007. Washington was the first state to come up with a threshold at 120 MED. That was probably the upper bound of where most places should be on this issue.
Our first guideline in Washington, which was done by all of the public agencies in 2007, laid out a scheme for doctors that if you followed these best practices, and if you had someone on - if you were thinking about putting someone on opioids for chronic pain, these are minimum best practices: establishing an opioid treatment agreement, screening for prior or current substance abuse or definitely depression, using random urine drug screening judiciously, not using concomitant benzodiazepines or muscle relaxants, tracking pain and function so you know where you’re at at every single visit at which you’re prescribing an opioid, and then seeking help if you get into that danger territory definitely over 100 MED but now more data shows that you should be paying much more attention at much lower doses.
And then finally, using your state prescription drug monitoring program both with any first prescription and for ongoing monitoring to look for multiple prescribers and other sources that the patient may be using to receive controlled substances. It’s also very important to use all the open source tools that are free and available in numerous guidelines. This is the one from the Washington Agency Medical Directors Group guideline. All of the tools and all of the screening issues that I just talked about are all present in this guideline. In addition, it is very important to have an easy way to calculate the opioid dose in your patient. We have an online or a phone ready app opioid dose calculator. So you can put in all sources of opioids and immediately calculate the morphine equivalent dose to be able to pay attention to where you’re at at every visit.
So combining this with a brief questionnaire for tracking pain and function - if you know where pain and function is at every visit, and you know what your dose is at every visit, then you’ll be in much better shape.
We also just completed a new study in Washington Medicaid, and we found that quite a few of the overdose admissions in Washington Medicaid were doses that were lower than 100 and in patients who were not on chronic opioids, so that intermittent opioid use and lower opioid doses can also have - be dangerous in certain people. The interagency guideline on prescribing opioids in Washington State just completed a new and completely comprehensive update. You’d be very interested in looking at some of the things that are in here that I think would be one of the most comprehensive guidelines that has been done. I think that I am extremely excited as well about the new CDC guidelines which will be coming out at the beginning of the year, which also are quite comprehensive and very forward-looking.
These guidelines in Washington basically make the same point that, because there’s little evidence to support long term efficacy of opioids in improving function and pain, and ample evidence of risk, that you should proceed with caution when initiating opioids or transitioning to chronic opioids. And although opioids benefit some patients if they’re prescribed and managed properly for appropriate conditions, from a public health perspective, preventing the next group of your patients -- or in our case, Washington residents -- from developing chronic dependence or chronic disability due to unnecessary, ineffective, and potentially harmful chronic opioid therapy would be a key objective in Washington and in your practice.
It is very important to pay attention when you’re tracking pain and function to make sure that there is a clinically meaningful improvement in pain and function whenever you use something that is as potentially dangerous as opioids. In Washington State, we’re saying that at least 30% improvement in pain and 30% improvement in function is what is required. We want to avoid chronic opioid therapy if there’s any FDA contraindications. Then use great caution if the patient has any of the associated risk factors.
There are a lot of nonpharmacologic alternatives that all have extremely strong evidence bases, and I want to point out particularly graded exercise as opposed to modality-based physical therapy, cognitive-behavioral therapy, mindfulness-based stress reduction, and various forms of meditation and yoga or spinal manipulation in patients especially with low back pain. Also, it’s extremely important to address sleep disturbances, but the greatest risk lies in prescribing benzodiazepines or muscle relaxants rather than, say, tricyclic antidepressants or doing other things to improve sleep hygiene, even at lower doses of opioids.
There are a lot of pharmacological alternatives; I don’t have time to go through all of them here. But antidepressants are very useful in chronic pain, especially in people with sleep disturbances. And you should definitely avoid carisoprodol because of its risk of misuse and abuse related to its metabolism to meprobamate.
Prescription drug monitoring programs - I mentioned you should check it with any first prescription and if you’re tracking people with chronic opioid use. It is very important to stop inappropriate chronic opioid use, and the way to start that is by looking at how you’re using opioids in the acute pain situation. For example, if a patient comes into the dentist for extracted wisdom teeth, one or two days of an opioid is all the patient usually needs. Do not give them thirty days of an opioid. The use of opioids, again, for nonspecific low back pain, headaches, and fibromyalgia is not supported by the evidence. So you really probably shouldn’t even get started in those patients with days or weeks of opioids.
And then we have new information in our guideline on the use of opioids for perioperative pain. The most important thing here is that the patient, if they’re on opioids when they come in for an elective surgical procedure, should be back to their preoperative dose by six weeks after surgery. And if they came to elective surgery without being on opioids, they should be off of all opioids within six weeks.
And then you should be doing all of the best practices to track these patients as we went over previously to monitor patients on chronic opioid analgesic therapy. If patients are not improving, if they request a taper, if clinically meaningful improvement in function has not occurred using validated instruments during the time of chronic opioid therapy or during an acute or subacute trial, if the ongoing risk from continued treatment outweighs the benefit, if there are severe adverse outcomes, or a reported overdose event, if there is noncompliance with your state’s guidelines or best practices, if urine drug tests show aberrancy or if there’s drug seeking aberrant or diversion behaviors -- these patients should be discontinued and their opioids tapered to zero.
The new guideline has clear-cut guidance as to how to taper opioids: 10% per week with or without cognitive-behavioral therapy. And then inpatient detox plus or minus a four week intensive pain clinic if the 10%/week taper fails.
These patients are losing their lives in our system and we need to do everything possible to reverse this epidemic and save these lives. What we’ve learned in Washington is that collaboration among state agencies at the highest levels is what’s important. It is important for you as clinicians to contribute to these efforts both in regard to your public agencies as well as your state medical societies:
*Reverse the permissive laws that occurred in the late 1990’s that did not represent evidence that allowed no ceiling on dose, and allowed unfettered prescription of opioids.
*Set opioid dosing thresholds and best practice guidelines and rules for acute, subacute, and chronic non-cancer pain.
*Establish metrics for tracking progress.
*Implement an effective prescription monitoring program.
*Incent the use of best practices, including web-based MED calculators and use of state PDMP’s.
*Do not pay for office-dispensed opioids. We think this is a bad practice
*Identify high risk prescribers and offer assistance through academic detailing and telehealth.
*And most importantly, from the standpoint of a payer, to incentivize community-based treatment alternatives including activity coaching, graded exercise, opioid taper, and medication-assisted treatment.
Thank you very much. We have been able to reverse the trends in Washington State. I’m very proud to say that our efforts have led to a 30% sustained decline in deaths in Washington and, in Worker’s Compensation, a dramatic decline in the proportion of injured workers going on opioids chronically. This is the most important thing to do. We went over everything that you need to do to be successful in treating chronic pain and I want to thank you for your attention.
I’d like to introduce the next speaker who will speak to you from SAMHSA -- Melinda Campopiano from SAMHSA who will talk to you about medication-assisted treatment.
Dr. Melinda Campopiano:
Hi and thank you. I am going to very quickly talk about the basics of what you need to know to begin devising strategy to include medication-assisted treatment in your clinical services. There are a number of slides in here that have resources on them, so I may go past them fairly quickly in the interest of allowing for questions at the end. But just know that they’re there and they have links on them for you to find out more. So I’m not going to be going into details of pharmacology, just basic information about the different forms of medication-assisted treatment, the considerations you might want to make in selecting what you offer, and some general strategies around implementation.
So let me start with medication-assisted treatment - in this case I’m talking about for opioid use disorder. There are three pharmaceuticals that are approved by the FDA for use. Methadone and buprenorphine are both opioid agonists and they are, therefore, controlled substances and subject to some regulations, each of them.
They are approved to treat opioid use disorder. Now, extended release injectable naltrexone is also approved by the FDA, but for the prevention of relapse to opioid use after detoxification. So a little bit different, but obviously for the person with opioid use disorder, the goal is the same. Now, extended release injectable naltrexone is an antagonist. So it has no abuse potential, has no risk for diversion since it’s an injectable, and is not subject to any kind of regulation. So it has a number of advantages from a perspective of implementation.
Now, medication-assisted treatment regardless of the form that’s provided is one component of a successful treatment strategy. Treatment in general needs to be comprehensive, and by that I mean it needs to include behavioral therapies but also keeps management of services that address social corollaries of the illness. Now, the good news is that not all services have to be delivered by the same provider, and not every patient needs all services continuously or at the same time.
So when you’re looking at your unmet need for medication-assisted treatment in your community and you’re trying to figure out what you should be offering, you need to keep in mind that it’s important to be able to individualize care. You don’t necessarily have to offer all forms of therapy, but you should have a range of options available; and if not directly provide them yourself, then be able to coordinate the services with other providers in your community.
Some things to think about are your staffing, whether or not you have pharmacy services on site, the types of licensed prescribers you have -- whether they’re physicians, nurse practitioners, or physician assistants -- and your population. How much pregnancy will you be seeing with opioid use disorder? How much comorbidity with HIV or other substance use disorders will you be seeing? And many of you, of course, will be treating pain and addiction simultaneously. So these are the things to have in mind as you look at the different pharmacotherapies that might work for your patient population.
So I’m going to start with some details about extended release injectable naltrexone. One thing to know is that this has an indication also for alcohol use disorder. So it’s an advantage if you have someone with both of those conditions provided they want to address those events. It also means that you do have to be attentive to their alcohol use if you’re going to give this for opioids so as not to encounter problems.
Now, this is not necessarily a successful choice for people who will require opioids for pain. It’s not that - you can’t say that its contraindicated, per se, but it’s basically the risk that someone will need opioids for pain legitimately that this may not be the option to take for them because you may interfere with their ability to manage their other medical problems by doing so. Now, because a person needs to be medically detoxed first from their opioid and there’s often a period of at least a couple days before they can have the naltrexone administered, optimally you want to connect this medication to a detox or detox and rehab stay. Ideally, with the administration of the first dose before they leave the controlled treatment setting. Thereafter its’ a monthly injection.
Now the pharmaceutical itself is expensive, but it is widely covered by most state Medicaid plans. As I mentioned, it’s not a controlled substance. It is not subject to any form of regulation and can be prescribed by advanced practice nurses and physician assistants, which can help a great deal with meeting your workforce and staffing needs in providing this form of M A T.
Now here’s a couple of resources. I’m not going to spend a lot of time on here, but I do want to point out the publication clinical use of extended release injectable naltrexone for which you have a link here has a great table in it that lays out buprenorphine, methadone, and naltrexone. And gives you the side-by-side comparisons.
That may be helpful to you in starting dialogues in your clinical setting around what approach to take with the patient population.
So moving onto buprenorphine, buprenorphine is, as many of you know, Suboxone. It’s actually formulated either with or without the naloxone. The buprenorphine product when it’s by itself is primarily used for pregnancy. Combined with naloxone it has a lower abuse potentially because you get the naloxone effect if you inject it. So it has sort of a public health advantage if you prescribe the combination product, and that is the recommendation outside of pregnancy.
Now, buprenorphine and naloxone have few interactions with HIV or hepatitis C meds, or most any other pharmaceuticals for that matter. So if you have medicine for patients who require a lot of pharmacotherapies for their other conditions, this might be a good choice. This one can also be used in pregnancy, as I mentioned. So if you have a large female reproductive age population, this might be the one that you want to offer. You do not have to be detoxed from opiates to being medication, and here are generics available making it a little bit more affordable in most cases, although as with naltrexone it is covered by most state Medicaid’s. You may encounter some little barriers to overcome around prior authorizations and so on, but an efficiently run office can usually not let those - keep those from interfering with patient care.
Now, buprenorphine at this point in time - the current limit still appl. During your first year of experience as a waivered physician, you can treat only thirty patients at a time. After one year of experience, you can notify us that you’d like to treat more and you can go up to 100. This is being subject to active consideration for revision. I don’t know what the numbers might end up being, but that can be expected to change. Also at the present time you have to be a physician to prescribe buprenorphine, which means that your advanced practitioners or physician assistants can assist with patient management but cannot be the prescriber. If this limit means you’re unable to meet the need for treatment in your community, consideration should be given to becoming a certified opiate treatment program, as this removes the patient limit.
Now, you obtain what’s called a waiver to prescribe buprenorphine by filing a form with SAMHSA. And the next slide has the link for everything you need to know. The requirements that you have to meet in order to file this notice of intent is be a licensed physician and have your own DEA registration. And then you have to meet one of the following: be board certified in addiction medicine and addiction psychiatry; have completed an eight-hour training -- I’ll tell you where to get those; have been an investigator in trials to approve buprenorphine; or have training or experience approved by your state medical licensing board. Most people go the eight-hour training route, and this is - the first one is where you can go to find out how to get a waiver. And the second one is where the training and additional information about the management of opioid use disorder with medication.
Now, a quick word about methadone. In order to provide methadone treatment for opioid use disorder, you must be a certified opioid treatment program. This requires a program DEA registration. And the Dpt.samhsa.gov Web site has all the information in the application to become a certified opioid treatment program. And I threw in our phone number here because our Web site is being updated and changed into a new thing. So if you have trouble getting to the page or you happen to get it on a day when it’s being updated, you can call us. The key difference in terms of clinical services is that methadone or buprenorphine, for that matter, if it’s provided through an opioid treatment program can only be administered or dispensed by the program. It cannot be prescribed.
Now, moving on here, a word about naloxone. I mentioned that although it’s not a form of medication-assisted treatment, per se, it is an important part of our effective response to the crisis of opioid overdose in our communities. SAMHSA’s recommendation is that if you prescribe the persons who are at risk are likely to witness overdose. Now, we include in that any pain patient. So some areas of the country, North Carolina being one in particular has implemented an almost universal prescribing of naloxone to - along with opioid analgesic prescriptions. This has had a very favorable impact on overdose in North Carolina and other communities.
It’s important to also educate on risk reduction, appropriate use of medication, not using drugs alone, not mixing substances. And use the opportunity of prescribing naloxone to motivate people to seek medication-assisted treatment. And you have a link here where you can find this kit. It has information for your patient and community as well. Now, one important piece to including medication-assisted treatment and clinical practice is identifying those patients who need it. SAMHSA and a couple of other agencies here have curricula, implementation resources, and so on for how to do screening, risk intervention, referrals to treatment in your clinical setting. It’s important to remember that in a nonspecialist setting, most people are going to screen negative. Those who screen positive will most often be people with at-risk or risky behaviors and they can be addressed with a group intervention. And then you will have a small portion of people who will require referrals to treatment or delivery of services by your own program.
Now, the last thing is around resources specifically targeting integrating medication-assisted treatment into a non-substance abuse treatment specialty facility, whether it’s behavioral health or other forms of medical care. And I’ve got a SAMHSA-HRSA collaborative site here that you can use to find resources that are most specific to your setting.
And then last of all, if any of you happen to be form a federally qualified health center, there is a grant opportunity that is open for only a few more days to get financial support and technical assistance in adding medication-assisted treatment to your federally qualified health center.
Now, that is the conclusion of my slides. I will hand it back over to the staff at this point and have them handle the question and answers. Thank you.
Loretta Jackson Brown:
Thank you so much, 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 managing patients with pain conditions and want to learn steps that can be taken to improve opioid analgesic prescription for the treatment of pain. For those who have media questions, please contact CDC’s 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 as well.
Thank you. If you would like to ask a question please press star, one on your touchtone phone. You will be prompted to record your name prior to asking your question. Again, if you have a question, please press star, one. One moment please for the first question.
Loretta Jackson Brown:
And while the coordinator is working to get us our first question on the phone, I do have a question that came through the webinar system. The question - what do you think about the recent approval of oxycodone for the use in children? Perhaps Dr. Jones or Dr. Franklin can take that question.
Dr. Gary Franklin:
I’ll go first. I think it’s a terrible idea to have another potent opioid, especially on - when there’s plenty of other effective opioids around. We need to be looking at the kinds of things I spoke to in terms of limiting opioid use when it is not indicated for chronic pain, and especially in vulnerable populations like children.
Loretta Jackson Brown:
Thank you. Operator, do we have any questions coming from the phone?
Yes. One - our first question comes from Dr. Joel Hyatt from Kaiser Permanente.
Dr. Joel Hyatt:
Thank you. Can someone - one of you please comment on what we’ve been reading recently about buprenorphine, Suboxone becoming now a drug of abuse and a street drug? And maybe contributing to diversion and abuse by itself? Thank you.
Dr. Melinda Campopiano:
Sure, I can speak to that. This is Melinda Campopiano. Number one, the recommendation is to only use the buprenorphine mono product in pregnancy. We do feel that it is being overprescribed, potentially, by - in some communities. The naloxone is an important component of use deterrent for this pharmaceutical. Now, what happens when you have the combination product of buprenorphine and naloxone is that it can be diverted mostly to people who are seeking to access treatment that cannot access it either due to logistical barriers or the absence of it in their community. I’m not saying that this is okay by any means, but as far as - buprenorphine/naloxone is for an opiate-tolerant person is rarely euphoragenic. So in terms of rewarding the addictive behavior, the potential for that is low. And its safety profile is such that you don’t tend to see people overdosing with it, at least by itself. Now, that puts the risk in a little bit of a relative to other opioids used. Now, that’s not to say that mixing it with alcohol or benzodiazepines on purpose or by accident wouldn’t be hazardous; nor is it to say that allowing a child to be exposed to it would be dangerous
The question - the strategies that SAMHSA recommends is that prescribing be of the combination product, not exceed the FDA recommended dosing range, which is up to twenty-four milligrams a day and not more, and to not provide refills without supervision. It’s also important to know that while a prescriber can get a waiver to provide the medication, that person is not necessarily going to be directly responsible for the rest of their care.
And so what’s happening is that many people are not getting the benefit of behavioral health services and case management for the social component of the disease. And this is causing people to abandon treatment, and then their prescription ends up on the streets. So it’s very much a community responsibility for how you use these medications to respond to your problem. And its’ a big prescriber responsibility as well.
Loretta Jackson Brown:
Thank you. Coordinator, do we have another question from the phone?
Yes. Our next question comes from Melissa from Families and Transition.
Hi. I was actually calling - I had a question and then I was also seeing if I could get a little bit of feedback. My first question would be - I noticed on one of the slides how we talked about the dosing rates for methadone and levels they’re dosing that would reach a therapeutic level. And one of my questions is is if there’s programs in New Hampshire that are prescribing, maybe, more than what the recommended dose would be, who would you contact for that? Or how do you make changes on doses that you see coming back over in the 200 milligrams?
Dr. Melinda Campopiano:
So if it’s okay, I’ll try to respond to that one as well.
Okay. And I just had one other question.
Dr. Melinda Campopiano:
Okay. Let me go ahead and then that way we can take the team approach.
Okay. And then I guess my other question would be if there’s any feedback or recommendations that you may have for potential clients that abuse their buprenorphine prescriptions.
Dr. Melinda Campopiano:
These are both good questions. These are very thoughtful questions. So I’m assuming your first question is around methadone for the treatment of opioid use disorder, and it’s - the evidence indicates that a minimum of sixty milligrams a day is what’s most often associated with retention of treatment at one year. And retention in treatment is the main marker for benefit from the treatment.
So the typical effective dose is sixty to 120. You will have people who require more than that, if they, especially if they are being treated for pain at the same time. Now, a prescriber or a physician in an opioid treatment program has the option of dividing the dose so that they take one dose while they’re at the program and they send the remainder home to be taken in the afternoon. That tends to be a more effective strategy for if it’s pain management that you’re trying to get by increasing the dose. Not all patients can handle the responsibility of self-administering that second dose. So what happens is some providers end up having to go up on the dose so that it can be provided directly at the program rather than dividing it
So without a little more information about the circumstances of those persons that are requiring the higher doses of 200 or more, I can’t really tell you - there’s no one specific strategy. But I would still expect that a relatively small number of clinics’ population would be at those higher doses. And if you’re seeing a disproportionate number, then there may be some misunderstanding of how to apply the dosing principles with methadone.
And if that’s the case, every state has a state opioid treatment authority that’s responsible for overseeing the opioid treatment programs in the state. That person could be a resource to you if you have a concern about how your patients are being managed. Or you can contact us at SAMHSA. My email is on my title slide and our Web site also has an email address you can click on.
And then with regard to people misusing their buprenorphine, you are more likely to see that in people who are not receiving the behavioral and psychological supports that are necessary for them to change their behaviors. Medication will control their withdrawal and their cravings, but it will not teach them how to behave differently. So people are not receiving behavioral interventions or having their acute need for housing, adequate food, personal safety addressed. Then you will see some people abuse their medication in those circumstances. So looking at whether or not the appropriate services are available for these patients to maximally benefit from their medication would be the first strategy.
Second would be to look at whether the prescriber is doing the appropriate diversion control strategies such as testing the person for their medication when they come in for prescriptions, seeing them regularly enough, occasionally having them come back and check that they have the correct refills remaining on their prescription, and other preventive engagement strategies like that. And if you go to either of the resources that I provided along with buprenorphine on the slides, they can give you some additional strategies and recommendations on how to reduce abuse and diversion of buprenorphine.
Loretta Jackson Brown:
Thank you so much, presenter, for that response. We have another question through the webinar system. Could you comment on the efficacy of medical marijuana on pain management? What are recommendations on how best to deal with opioid addicted patients who also obtain medical marijuana from other providers for pain control? Perhaps Dr. Franklin?
Dr. Gary Franklin:
There was a recent systematic review of medical marijuana for various conditions including pain and chronic pain. And I think the jury’s still out on that. What I can say is that in our deliberations here in Washington State, when our doctors developed our guidelines, especially this last comprehensive guideline, they were pretty wise because a lot of people walk into their office that do some marijuana recreationally. And honestly, they don’t’ really want to be dealing with recreational marijuana use. And where we came down, which I think is a very reasonable thing, is to not use opioids in patients that have cannabis use disorder by DSM-V. In other words, differentiate those that have become more or less dependent and/or disabled in relationship to chronic cannabis use, and not really pay that much attention to the recreational cannabis use.
The only other thing is, of course, how cannabis - even prescribed cannabis might be affecting performance in dangerous jobs, et cetera. I don’t think we know that much about that at this point. So that’s really mostly what I know.
In our state, it is still not legal to use it in worker’s compensation because we only pay for drugs that are approved by the FDA. If the FDA ends up changing the schedule of marijuana from Schedule I to Schedule II, then we would have to strongly reconsider that.
Loretta Jackson Brown:
Thank you. Operator, we have time for one more question. Is there another question from the phone?
Yes. Our next question is from Tessa [ Patricia] Gray of Kaiser Permanente.
Hi, yes. This is Patricia Gray of Kaiser Permanente Southern California. Thank you for this wonderful talk. My question is regarding Suboxone use. We’re seeing it - can you comment, maybe, from Washington State’s perspective or the physician’s perspective on use of Suboxone drifting into use in chronic pain and being used long term to treat chronic pain? And then if it is and it‘s not recommended, how to take patients off safely and how to taper it off.
Dr. Gary Franklin:
I’ll start by saying - this is Gary Franklin. We’re not supporting that at all. We don’t think the evidence is there and I would maybe turn it over to our SAMHSA colleague to speak to the other part of the question. But we - I know there’s some acolytes on that, but we’re not supporting that officially in state policy.
Dr. Melinda Campopiano:
And I can add to that that Suboxone is approved by the FDA for treatment of opioid use disorder. It does not carry an indication for pain management. If buprenorphine is going to be used for pain management, there are formulations. There’s a transdermal patch and an injectable form. And we recommend that those be used for pain as indicated. Strategies for getting someone off of Suboxone who may have been inappropriately prescribed it - it should be approached like any other opioid taper. IF there’s no abuse, then it can be tapered outside of a specialty treatment program with a 10% per week kind of approach that was suggested earlier. Or a person can be provided with medical detox if they have become dependent or are misusing the Suboxone.
Loretta Jackson Brown:
On behalf of COCA, I would like to thank everyone for joining us today with a special thank you to our presenters. Dr. Jones, Dr. Franklin, and Dr. Campopiano. We invite you to communicate to our presenters after the webinar. If you have additional questions for today’s presenters, please email us at email@example.com . Put “September 24 COCA call” in the subject line of your email and we will ensure that your question is forwarded to the presenter for a response. Again, that email address is firstname.lastname@example.org .
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