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.