Saturday, February 24, 2018

Academy’s Response: CDC’s Guideline for Prescribing Opioids for Chronic Pain

Bob Twillman, Ph.D., is the Executive Director for the American Academy of Pain Management.

Bob Twillman, Ph.D., is the Executive Director for the American Academy of Pain Management.

On March 15, 2016, the US Centers for Disease Control and Prevention (CDC) released its Guideline for Prescribing Opioids for Chronic Pain in primary care settings. The guideline specifically excludes people with cancer-related pain and those receiving palliative and hospice care. CDC justified the development and issuance of this guideline by pointing to sharp increases over the past decade in fatal overdoses involving prescription opioid analgesics.

The American Academy of Pain Management (the Academy) was privileged to serve as a member of the stakeholder review group that was convened to evaluate the initial draft guideline (see our initial comments), and similarly provided extensive comments during a subsequent public open comment period, along with more than 4,000 other commenters. While we are grateful to have been afforded these review opportunities, we are saddened by the apparent lack of response by CDC to comments submitted by the Academy and numerous other pain management organizations and advocates.

Our review of the twelve recommendations included in each of the three drafts reveals that few meaningful changes took place despite more than 5,000 comments across all the comment periods. In at least one case (recommendation #7, related to acute pain), recommendations actually may have improved and then reverted to a less desirable version (see #2 below).

We remain concerned about a number of issues in this guideline, most notably, the following:

1. The guideline states that people treated with opioid analgesics should show improvement in BOTH pain AND function, in order to continue opioid therapy. Pain management clinicians recognize the fallacy in this recommendation, namely, that some people with chronic pain may improve in one of these two (modestly correlated) measures, but not in the other; while for others, stabilizing their levels of pain and function may be the best that can be expected. Our preference was to tie continuation of opioid therapy to documented progress toward goals of care that were mutually pre-determined by the clinician and the person with pain.

2. The final guideline recommends that, for acute pain of all types, three days of opioid therapy should be sufficient, and more than seven days will rarely be necessary. From the Academy’s point of view, this final recommendation is inferior to the version contained in CDC’s second draft, which specified that this refers to “nontraumatic pain not related to major surgery.” Absent this qualification, CDC’s final recommendation suggests that 3-7 days of opioid therapy should be sufficient for all acute pain, regardless of its nature. A minor back muscle spasm that resolves on its own in a day or two, a broken femur, a severe burn, and all manner of postoperative pain thus are lumped together in the final recommendation. Pain management clinicians know there is wide variability in the severity and duration of acute pain, and that the duration of therapy needs to be tied to each patient’s individual experience.

3. Throughout the guideline process, CDC has suggested that prescribers exercise additional caution when opioid doses rise above 50 mg per day in morphine-equivalent dosing, and that prescribers should rarely prescribe more than 90 mg in morphine equivalent doses per day. The Academy commented extensively on these arbitrary threshold numbers, out of concern that they may prevent some people with pain from receiving adequate doses of opioids when those doses may be beneficial. While the numbers themselves are not especially draconian, the Academy’s concern has been that many primary care clinicians may interpret these thresholds as ceiling doses, an issue about which we have written before.

We also note the emphasis in the first recommendation on maximizing the use of non-opioid medications and non-pharmacological treatments before turning to opioid therapy. Since it was founded in 1988, the Academy has always espoused this kind of integrative approach to pain care, and we are heartened to see recognition of the importance of the integrative model in this guideline. However, our concern is that this recommendation is, at present, a bit unrealistic. Many people with pain have significant insurance coverage restrictions on non-opioid medications, as their insurers either impose step therapy protocols or require exorbitant co-pays for medications with FDA approval for treatment of their painful conditions. The concern with access to non-pharmacological treatments is even more acute: in many parts of the country, access to clinicians providing this kind of care is limited, and even when those clinicians are available, insurance coverage is so poor that many cannot afford to receive this kind of care.

We call upon the CDC to join with the Academy and patient advocacy groups, as we work to increase access to integrative pain care, and specifically, to support full implementation of the National Pain Strategy upon its release. (See National Pain Strategy draft, pending final release.) It is essential that we work together. Members of Congress, the Centers for Medicare and Medicaid Services, federal medicine programs (e.g., Department of Defense, Veterans Health Administration, Indian Health Service, Federal Bureau of Prisons, etc.), state Medicaid agencies, and private third party payers all need to focus significant effort on expanding access to integrative pain care while gathering data to build the evidence base supporting the widespread use of these therapies.

Simply put, the one statement that best summarizes the goal of the CDC guideline is, “Take all steps possible to minimize exposure to opioids when treating chronic pain.” While CDC undoubtedly is well-intentioned, achieving this goal must be done in a way that does not harm the vast majority of people using opioids to manage their chronic pain–who have a positive risk/benefit ratio and who do not misuse or abuse their vital medications. The Academy stands ready to work with anyone, including CDC, to implement education and policy advocacy efforts designed to bring about this appropriately balanced result.

8 responses

  1. vicki l galvin
    March 16, 2016 at 5:32 pm

    I’ve lived with CRPS for 12 years now. It took about 13 doctors before I was properly diagnosed, and several pain specialists to find the pain medications that give me some pain relief. This terrifies me to think that someone other than my doctor is going to control my pain medications. This is wrong. Taking away my pain meds isn’t going to keep an addict from overdosing. My daughter is a recovering heroin addict, and as she says, an addict will find their next high, no matter what they have to do. This is truly insanity.

  2. Nancy Bolduan
    March 16, 2016 at 7:48 pm

    I am especially disappointed with the CDC’s new treatment guidelines for opioids. Since there are many special circumstances, and no governmental guidelines can anticipate the requirements of every individual, I fear that these recommendations will hobble the ability (or at least the perception of what is appropriate treatment) of many doctors to properly treat pain patients–especially chronic pain patients.

    Some people take longer to heal. Some might have genetic distortions that require different dosages than normal (P450s). Others may fail on the other drugs like TCA’s, NSAIDs or off label use of drugs for seizures. Experimental pain treatments like Ketamine are unsupported by much research. Marijuana is still considered a federally banned substance. What’s a suffering patient to do?

    Most people in chronic pain don’t have the will, the energy, to protest too much. It is already so difficult to have to jump through so many hoops to get their daily dose of opioid pain medication; registries, paper scripts, pharmacy suspicion and harassment, urine testing, doctors wary of getting duped by addicts, the publics belief that all opioid users must be addicted… and so on.

    I go through all of this and more, because the chronic pain I suffer from is from a genetic connective tissue disorder; Ehlers-Danlos Syndrome. Not only is my pain widespread, but it is continuous, and is both chronic and acute in nature–and it will be with me for life–and it is expected that it will increase as I age. No mention of people like me in those recommendations. I have the double whammy as few doctors know much about EDS because they think it is too rare. It is “rare” I believe, because of ignorance, it is rarely diagnosed. A conservative estimate is that at the very least 12% of people with a diagnosis of fibromyalgia actually have EDS. Many researchers think it is much higher–20% or more.

    I wish those doctors who helped shape these guidelines knew what it was like to live with a continuous, body wide pain level of a “7.” It’s difficult to sleep, to think, to function, and working at a job went by the wayside decades ago. I’m lucky I’m not in a wheelchair yet. I’ll bet those doctors don’t know much about EDS, and probably never even considered it when they were drafting their recommendations, even though it is thought to manifest in approximately 1 per 5,000 people. Researchers are now thinking this is an overly conservative number and that it is much more common as it presents on a continuum, and advances over time–and is notoriously under diagnosed.

    I think about my own problem, which is immensely helped by opioids. I have tried every single drug on the hospital’s clinical pain pathway, and also did all the subordinate therapies from Chronic Pain Classes, such as TENS, heat and ice, CBT, exercises and more. Opioids work the best by far. They have given me my life back. But what of all the other unconsidered people? What about their pain? I pray that the medication that helps so much won’t be snatched away because of the misuse and manipulation of statistics by others.

    That is what I want to tell anybody who will listen. Please don’t slam the door on people like us.
    Kindly show this to somebody who has more influence than I, a lowly patient…

  3. Paula
    March 17, 2016 at 7:12 am

    As a person who suffered with pain for three years, the CDC guidelines Made me recall how desperate I would have been, had I not been able to take hydrocodone when the pain was at its height.

    Many who truly need opioids for pain won’t get them and their lives will be further restricted by increased pain.

    Is it not predictable that some will find street drug alternatives? Consider suicide? Become clinically depressed?

    The comment about Insurance formularies restricting alternatives is a further constraint or barrier for people in pain.

    I am opioids free now by 1. Reducing stress, 2. Limiting my professional career (I was a dean and now I teach part- time online, 3. Meditating and 4. Moving to the sun. Financially, we took a hit but I feel better.

  4. George Leger III
    March 17, 2016 at 9:33 am

    As a long term Post Herpetic Neuralgia and peripheral neuropathy patient, I would have no life at all if I had no pain medications. And I take more than the 90mg a day limit.

    So, this means I get to be in pain for the rest of my life due to having not enough medicine to take away the pain completely. Because some addicts are misusing it.

    OK, so why don’t we limit access to things like guns (they kill lots of innocent people), fat (which kills way more people and causes way more problems for society at large than opioid addiction does), smoking, sugar, heck, lets limit everything that could possibly harm anyone!!!!!

    Like that makes any more sense that this CDC recommendation: it is ridiculous!!!!!

  5. Michael McNett
    March 17, 2016 at 11:19 am

    I take issue with the idea that higher doses of opioids have value. There is NO published evidence to support it, with overwhelming evidence of increasing mortality with dose. Higher dose patients have higher levels of depression, pain, dissatisfaction with care, and disability. And at 100 ME/d, the annualized mortality rate is increased 800%; 2400% at 200 ME/d. And these numbers are tripled if the patient is also on a benzo. Vioxx was taken off the market for a 70% increase! These numbers are staggering, and any treatment subjecting patients to that risk should be curative, or at least put them in total remission. Opioids do not. Though the studies suffer from selection bias, they do clearly show that high-dose opioids are not providing the results intended. Mark my words, any doctor using high-dose opioids sued by a family for creating a fatal drug addiction with have absolutely no evidence on which to base their decision. The AAPM needs to base its policies/attitudes on the medical evidence, not make recommendations based on hearsay and often highly invalid patient claims based in large part on dopamine-induced reward.

  6. Jay Bayer DO
    March 17, 2016 at 2:51 pm

    Unfortunately I disagree with the Academy. I have been member for May years . I use so many alternative treatments to restore patients to function without opioids . It can be done. But we aren’t paid for dedication in time that it necessary to do these alternate therapies. To date I have had one patient return to function on opioids. Rest never go back to work or normal life. What happens when pain is centralized. Also there is a mind body relationship and opioids interfere with this. I am disgraced by all pseudo addicts the current system has produced. Every patient in ER or walk in clinics come in on opioids- why? The profiteers who controll hospitals tell docs to give patient what they want . There are alternatives but why do it. Until generic price soared I had great success with Naproxen DS with Tylenol . Patients with Bronchitis going to these walk in clinics return with opioids- why? Cough should not be controlled with narcotics unless certain circumstances. Minor sprains strains return from ER with opioids. We should feel shame

    • Tammy Nicholas
      October 20, 2016 at 2:45 pm

      I was my orothopedic doctor’s lab rat beginning at age 21 until age 29. This was back in 1990 thru 1998 and, at one point, I was put on about every type of NSAID (including what you’re talking about) and then toradol for such a long period of continual use that I cannot even tolerate baby aspirin, let alone over the counter NSAIDs – not even steroids. My stomach is trashed because of the prolonged use of the drug you’re promoting.

      I agree, there are many other therapies that can assist with a patient’s improvement – but they aren’t medications. Opioids DO have the “tolerance” issue that makes them tricky. But, unless taken in an enormous amount for either suicide attempt or for the “high,” they are both more effective at pain relief and do not have fatal side affects with long term use. By the way, a patient (like me) who has been on opioids most of their life would be very hard pressed to use them for the sake of recreational highs (such as an addict does) or to end her life. My tolerance is so high that I am unable to achieve pain relief with the restrictions that are being placed upon the medical providers treating me couple with the added disgrace of providers having a mindset that every patient needing high doses of opioids is seeking euphoria rather than pain relief.

      There should be better advances in pharmacological treatments (if that is to be the only available treatment due to insurance, financial and/or lack of medical advancements for cures) so that opioids are not the ONLY viable option. I agree. But what you’re promoting with your drug recommendation should never be considered a viable replacement (or, even, an option) for long term use.

  7. July 17, 2016 at 11:43 pm

    If and when contextual variables are eliminated in medicine we are providing less than optimal care, as judged by outcomes. I do not believe better medical care is the result of more regulations and guidelines. I think well educated and trained physicians who are encouraged to keep the focus on patient outcomes and not regulations or reimbursements will result in the most cost-effective outcomes. I have the proof of history and experience supporting my contention. I am open to all objective evidence, and rational conclusions derived from same which question this hypothesis. For example there are good studies which demonstrate if we severely limit access to opiates by whatever means that complications from same will be less. While it impossible to argue this evidence it is the conclusion that I am concerned about. Using similar logic we should close all hospitals in order to minimize the risks associated with being hospitalized.

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About Bob Twillman, PhD, Executive Director of The American Academy of Pain Management