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  • Public Affairs

  • ACOEM Supports CDC’s Recommendations on Opioid Use to Treat Chronic Non-cancer Pain

    January 13, 2016

    National Center for Injury Prevention and Control
    Centers for Disease Control and Prevention
    4770 Buford Highway, N.E., Mailstop F-63
    Atlanta, GA 30341

    Attn: Docket CDC — 2015–0112

    To Whom It May Concern:

    The American College of Occupational and Environmental Medicine (ACOEM) supports the CDC’s 12 proposed recommendations for the safer and more effective use of opioids for chronic non-cancer pain (CNCP) and the rationales supporting them. They are reasoned and designed to improve management of CNCP and to protect patients and the American public from the adverse effects of these prescription medications.

    This guidance is especially important in light of the continued absence of quality evidence of effectiveness of opioids for CNCP and the rapid increase in adverse effects among patients and the public. As CDC has shown on its web site, there is wide variation in the rates of prescription of opioids and in overdoses and deaths among states and communities. Such variance is a sign of poor quality care. Reducing variance is a primary goal of the type of medical quality improvement programs that have reduced mortality from coronary artery disease, stroke and diabetes. Unfortunately, in the absence of valid indications and evidence of effectiveness, reliance on “clinical judgment” results in such variation. Clinical judgment must be guided by the best available evidence. To this point, physicians have been told that opioids are safe and effective for CNCP, with no upper limit (“titrate to effect”) without supporting quality evidence. In fact, harms are dose related. And, it is unlikely that opioids can be effective for CNCP due to glial up-modulation increasing rather than decreasing pain. Clearly, better guidance is needed.

    ACOEM does have a few observations and suggestions:

    Recommendation 1: In the absence of objective findings and accurate risk assessment tools, “expected benefit…anticipated to outweigh risks to the patient” is impossible to determine. This is another case of “clinical judgment” that is intuitive rather than fact based, and has often proved incorrect.

    In this regard, it would be useful to examine and recommend use of opioids by specific diagnosis.(1) A number of specialty groups and experts have recommended against opioids for specific disorders such as fibromyalgia,(2) and headaches.(3) Others have examined evidence of effectiveness for common diagnoses such as osteoarthritis(4) and low back pain,(5) and have not found quality studies. Recommendation by diagnosis fits the medical model of treating a specific problem, rather than a symptom that is present after 3 months.

    Recommendation 2: Given the relatively large population of patients already on chronic opioid therapy, and particularly for those on doses exceeding 50mg morphine equivalent dose per day and those on multiple medications, we suggest that treatment goals and informed consent be established for these patients as well.(6-9) In addition, while we acknowledge that there may be confidentiality issues, it is prudent to involve significant others in these discussions when possible, as patients on opioids may not perceive function or adverse effects accurately.

    Recommendation 7: Periodic re-evaluation of benefits and harms is clearly important. We suggest a focused review of systems covering known opioid effects, both positive and negative, at each reassessment. Some programs such as Kaiser Permanente have also found periodic administration of questionnaires about anxiety and depression such as the PHQ-9 and the AOQ valuable to monitor depression and anxiety, which can be caused by opioids or masked by opioids.(10-14) These issues can then be co-managed by psychiatrists with training in CNCP.(15) According to surveys, primary care physicians do not generally have this expertise and have asked for specialty support.(16-57)

    Recommendation 11: We would add sleeping medications, some psychiatric medications and H1 antihistamines to the list of medications that should not be co-prescribed with opioids. The ACOEM evidence review revealed increased risk for these medications when prescribed with opioids.

    Following are additional comments for your consideration:

    We would also note additional higher risk groups. Women in general appear to metabolize opioids differently, accounting for the more rapid increase in overdoses among women (reference attached). Younger patients are at risk of long term exposure and effects on the central nervous system, given that once chronic opioid treatment is started, it rarely is discontinued unless the patient stops the medication due to unacceptable side effects. Patients with prior suicide attempts by whatever means appear to be at higher risk.

    The proposed CDC recommendations are consistent with ACOEM’s most recent guidelines for the use of opioids for acute, sub-acute, post-operative and chronic pain. ACOEM updated its guidelines in 2014 using an extensive systematic review meeting Institute of Medicine (IOM) and Cochrane Collaboration criteria. A trained multi-disciplinary expert panel developed recommendations as specified by the IOM and the Guidelines International Network. The systematic review identified 263 studies for the treatment of pain with opioids, of which 157 met inclusion criteria. We attach the guidelines and other references to augment your contextual review.

    We too were unable to identify quality evidence of effectiveness of opioids for CNCP. Yet, opioids are among the most widely prescribed medications in the U.S. Without evidence, this amounts to a return to eminence-based medicine, and a “roll of the dice,” as Dr. Don Berwick called it.

    We agree that opioids pose a risk for motor vehicle crashes, as well as in other safety-sensitive and cognitively demanding jobs. The contextual review cited one recent review. ACOEM’s Expert Panel also published a review with additional studies and similar conclusions. We attach this review to augment CDC’s contextual review.(58)

    We would also stress the importance of functional improvement as probably the most important outcome of any treatment for CNCP. Presently there are no quality studies demonstrating functional improvement with chronic opioid use, although physicians believe opioids improve function. In fact, studies demonstrate worse functional outcomes with early or chronic opioid use. We attach references to add to the contextual review on function.

    Our review noted additional adverse effects and areas of concern, including changes in CNS structure and function, alterations in REM sleep that might increase pain perception, hyperalgesia that often leads to dose escalation, osteoporosis, suppression of adrenal hormones resulting in muscle mass loss, feminization in males, effects on balance, and other effects. Central nervous system changes are of particular concern as they appear to be irreversible and affect judgment and function. Please see Table 2 in the attached JOEM article summarizing the most recent ACOEM guidelines,(59) and other attached references.

    The proposed CDC guidelines should also help protect the public by fostering more appropriate prescribing practices. The rising rate of prescription drug overdoses, other adverse effects, injuries and deaths has occurred in parallel with the increase in prescribing of opioids, primarily for CNCP. This is a classic public health problem — increasing levels of potentially hazardous substances in a community is associated with increases in adverse effects. This is the result of the unprecedented widespread use of medication without evidence of effectiveness or careful consideration of hazards, resulting in what has been termed a “public health disaster.” At the least it is an uncontrolled experiment on the public. It should be noted that many overdoses and deaths occur in people using other people’s opioids, not those prescribed for them. There are two groups of people suffering adverse effects — patients for whom opioids are prescribed, and others suffering “collateral damage.”

    Especially in this situation, wide spread public education, as well as physician education, is needed due to generally poor health knowledge about the risks and benefits of opioids, particularly in the longer term. We have noted in some local coalition efforts and in patient surveys that many people believe opioids are safe if prescribed by a physician. People often view opioids as the first choice for chronic pain rather than more effective and less dangerous alternatives such as exercise, cognitive behavioral therapy, and other modalities. Physicians have stated that they want and use guidelines to create boundaries for patients demanding opioids. Caregivers are often uncomfortable saying no to patients, even if there are very good reasons for doing so.

    The redefinition of pain as “purely physical,” as was done in the 2001 VA Pain Toolkit and Pain as a 5th Vital Sign materials altered the approach to chronic pain and messaging to patients. In fact, the International Association for the Study of Pain has long defined pain as having a significant emotional component. This likely explains the significant association of CNCP with a variety of psychiatric conditions including depression, anxiety, PTSD, OCD, ADHD and personality disorders.

    If the prevalence estimates of chronic pain in the 2011 IOM report Pain in America and subsequent publications are accurate, it is conceivable that 40% of the U.S. adult population could be considered candidates for opioids. The U.S. already accounts for over 80% of the world’s prescription opioid use, and the vast majority of hydrocodone and oxycodone. Combined with lack of efficacy, this makes no sense from a public health or medical standpoint.

    It is important to note that CNCP poses a challenge for physicians and researchers. It does not fit the pathophysiologic model that is the basis for most modern medicine. In most cases, the specific pathophysiology for CNCP is not known. There are no objective tests for CNCP. Taking the traditional biomedical approach to address CNCP, i.e., looking for a disorder that medications will specifically benefit by countering inflammation (for example, RA or psoriasis), killing or stopping the reproduction of an infectious agent, correcting a physiologic abnormality (CHF or diabetes), or controlling a risk factor (hypertension, hyperlipidemia), therefore does not make sense. There is no specific identifiable molecular target or abnormality for chronic pain in most cases. Defining something by time is not a usable case definition for research or treatment. In this context, “therapy” is likely a misnomer, as there is no known lesion or pathologic process and no specific target to be controlled or cured.

    This is clearly an area for which physicians are seeking accurate, unbiased guidance. In a recent review of more than 39 surveys of U.S., U.K., and Canadian physicians’ attitudes, beliefs and knowledge about opioids and CNCP,(16-57) respondents noted minimal education in pain management at the undergraduate medical or post-graduate levels. Many felt uncomfortable prescribing opioids for CNCP because there were no objective findings or tests, and because they perceived confounding by untreated or inadequately treated psychiatric or emotional comorbidity. Most respondents expressed concerns about addiction, dependence, diversion, and side effects (the latter not well explored in almost all surveys). These surveys revealed an interesting tautology. The more opioids physicians prescribed, the more comfortable they felt prescribing them, and the more they believed that opioids were effective for CNCP. Considering the dose-response relationships between adverse effects and fatalities in combination with the lack of demonstrated efficacy, there is concern that those prescribing high doses may not be doing so appropriately.

    Again, we appreciate the CDC’s leadership in this area to protect patients and the public.


    Mark A. Roberts, MD, PhD, MPH, FACOEM



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