• Public Affairs

    landing-header-public-affairs_37748_17213
  • 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.

    Sincerely,

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

    Enclosures

    References

    1. Ballantyne JC. Opioid therapy in chronic pain. Phys Med Rehabil Clin N Am. 2015;26(2):201-18.
    2. Painter JT, Crofford LJ. Chronic opioid use in fibromyalgia syndrome: a clinical review. J Clin Rheumatol. 2013;19(2):72-7.
    3. Franklin GM, American Academy of Neurology. Opioids for chronic noncancer pain: a position paper of the American Academy of Neurology. Neurology. 2014;83(14):1277-84.
    4. Solomon DH, Rassen JA, Glynn RJ, Lee J, Levin R, Schneeweiss S. The comparative safety of analgesics in older adults with arthritis. Arch Intern Med. 2010;170(22):1968-76.
    5. Martell BA, O'Connor PG, Kerns RD, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007;146(2):116-27.
    6. Chou R, Fanciullo GJ, Fine PG, et al. Clinical guidelines for the use of chronic opioid therapy in chronic noncancer pain. J Pain. 2009;10(2):113-30.
    7. Federation of State Medical Boards. Model Policy on the Use of Opioid Analgesics in the Treatment of Chronic Pain. 2013.
    8. Michna E, Jamison R, Pham L, et al. Urine toxicology screening among chronic pain patients on opioid therapy: frequency and predictability of abnormal findings. Clin J Pain. 2007;23(2):173-9.
    9. Wiedemer N, Harden P, Arndt I, Gallagher R. The opioid renewal clinic: a primary care, managed approach to opioid therapy in chronic pain patients at risk for substance abuse. Pain Med. 2007;8(7):573-84.
    10. Braden JB, Sullivan MD, Ray GT, et al. Trends in long-term opioid therapy for noncancer pain among persons with a history of depression. Gen Hosp Psychiatry. 2009;31(6):564-70.
    11. Colasanti A, Rabiner EA, Lingford-Hughes A, Nutt DJ. Opioids and anxiety. J Psychopharmacol. 2011;25(11):1415-33.
    12. Grattan A, Sullivan MD, Saunders KW, Campbell CI, Von Korff MR. Depression and prescription opioid misuse among chronic opioid therapy recipients with no history of substance abuse. Ann Fam Med. 2012;10(4):304-11.
    13. Martins SS, Fenton MC, Keyes KM, Blanco C, Zhu H, Storr CL. Mood and anxiety disorders and their association with non-medical prescription opioid use and prescription opioid-use disorder: longitudinal evidence from the National Epidemiologic Study on Alcohol and Related Conditions. Psychol Med. 2012;42(6):1261-72.
    14. Sullivan MD, Edlund MJ, Steffick D, Unutzer J. Regular use of prescribed opioids: association with common psychiatric disorders. Pain. 2005;119(1-3):95-103.
    15. Howe CQ, Sullivan MD. The missing 'P' in pain management: how the current opioid epidemic highlights the need for psychiatric services in chronic pain care. Gen Hosp Psychiatry. 2014;36(1):99-104.
    16. Allen MJ, Asbridge MM, Macdougall PC, Furlan AD, Tugalev O. Self-reported practices in opioid management of chronic noncancer pain: a survey of Canadian family physicians. Pain Res Manag. 2013;18(4):177-84.
    17. Barry DT, Irwin KS, Jones ES, et al. Opioids, chronic pain, and addiction in primary care. J Pain. 2010;11(12):1442-50.
    18. Bhamb B, Brown D, Hariharan J, Anderson J, Balousek S, Fleming MF. Survey of select practice behaviors by primary care physicians on the use of opioids for chronic pain. Curr Med Res Opin. 2006;22(9):1859-65.
    19. Blake H, Leighton P, van der Walt G, Ravenscroft A. Prescribing opioid analgesics for chronic non-malignant pain in general practice: a survey of attitudes and practice. Br J Pain. 2015;9(4):225-32.
    20. Chen L, Houghton M, Seefeld L, Malarick C, Mao J. Opioid therapy for chronic pain: physicians' attitude and current practice patterns. J Opioid Manag. 2011;7(4):267-76.
    21. Dobscha SK, Corson K, Flores JA, Tansill EC, Gerrity MS. Veterans affairs primary care clinicians' attitudes toward chronic pain and correlates of opioid prescribing rates. Pain Med. 2008;9(5):564-71.
    22. Elder NC, Simmons T, Regan S, Gerrety E. Care for patients with chronic nonmalignant pain with and without chronic opioid prescriptions: a report from the Cincinnati Area Research Group (CARinG) network. J Am Board Fam Med. 2012;25(5):652-60.
    23. Esquibel AY, Borkan J. Doctors and patients in pain: conflict and collaboration in opioid prescription in primary care. Pain. 2014;155(12):2575-82.
    24. Gooberman-Hill R, Heathcote C, Reid CM, et al. Professional experience guides opioid prescribing for chronic joint pain in primary care. Fam Pract. 2011;28(1):102-9.
    25. Green CR, Wheeler JR, LaPorte F, Marchant B, Guerrero E. How well is chronic pain managed? Who does it well? Pain Med. 2002;3(1):56-65.
    26. Hutchinson K, Moreland AM, de C Williams AC, Weinman J, Horne R. Exploring beliefs and practice of opioid prescribing for persistent non-cancer pain by general practitioners. Eur J Pain. 2007;11(1):93-8.
    27. Jamison RN, Sheehan KA, Scanlan E, Matthews M, Ross EL. Beliefs and attitudes about opioid prescribing and chronic pain management: survey of primary care providers. J Opioid Manag. 2014;10(6):375-82.
    28. Johnson M, Collett B, Castro-Lopes JM. The challenges of pain management in primary care: a pan-European survey. J Pain Res. 2013;6393-401.
    29. Lalonde L, Leroux-Lapointe V, Choiniere M, et al. Knowledge, attitudes and beliefs about chronic noncancer pain in primary care: a Canadian survey of physicians and pharmacists. Pain Res Manag. 2014;19(5):241-50.
    30. Lembke A. Why doctors prescribe opioids to known opioid abusers. N Engl J Med. 2012;367(17):1580-1.
    31. Leverance R, Williams R, Potter M, et al. Chronic non-cancer pain: a siren for primary care -- a report from the PRImary are MultiEthnic Network (PRIME Net). J Am Fam Med. 2011;57:551-61.
    32. Lin JJ, Alfandre D, Moore C. Physician attitudes toward opioid prescribing for patients with persistent noncancer pain. Clin J Pain. 2007;23(9):799-803.
    33. Macerollo AA, Mack DO, Oza R, Bennett IM, Wallace LS. Academic family medicine physicians' confidence and comfort with opioid analgesic prescribing for patients with chronic nonmalignant pain. J Opioid Manag. 2014;10(4):255-61.
    34. McCracken L, Vellerman S, Eccleston C. Patterns of prescription and concern about opioid analgesics for chronic nonmalignant pain in general practice. Primary Healthcare Res Develop. 2008;9:146.
    35. Mezei L, Murinson BB, Johns Hopkins Pain Curriculum Development T. Pain education in North American medical schools. J Pain. 2011;12(12):1199-208.
    36. Michinson A, Kerr E, Krein S. Management of chronic noncancer pain by VA primary care providers: when is pain control a priority? Am J Man Care. 2008;14(2):77-84.
    37. Morley-Foster P, Clark A, Sppechley Moulin D. Attitudes toward opioid use for chronic pain: a Canadian physician survey. Pain Res Manag. 2003;8:189-94.
    38. Nishimori M, Kulich RJ, Carwood CM, Okoye V, Kalso E, Ballantyne JC. Successful and unsuccessful outcomes with long-term opioid therapy: a survey of physicians' opinions. J Palliat Med. 2006;9(1):50-6.
    39. Nwokeji ED, Rascati KL, Brown CM, Eisenberg A. Influences of attitudes on family physicians' willingness to prescribe long-acting opioid analgesics for patients with chronic nonmalignant pain. Clin Ther. 2007;29 Suppl 2589-602.
    40. O'Rorke JE, Chen I, Genao I, Panda M, Cykert S. Physicians' comfort in caring for patients with chronic nonmalignant pain. Am J Med Sci. 2007;333(2):93-100.
    41. Phelan SM, van Ryn M, Wall M, Burgess D. Understanding primary care physicians' treatment of chronic low back pain: the role of physician and practice factors. Pain Med. 2009;10(7):1270-9.
    42. Ponte CD, Johnson-Tribino J. Attitudes and knowledge about pain: an assessment of West Virginia family physicians. Fam Med. 2005;37(7):477-80.
    43. Potter M, Schafer S, Gonzalez-Mendez E, et al. Opioids for chronic nonmalignant pain. Attitudes and practices of primary care physicians in the UCSF/Stanford Collaborative Research Network. University of California, San Francisco. J Fam Pract. 2001;50(2):145-51.
    44. Roth CS, Burgess DJ, Mahowald ML. Medical residents' beliefs and concerns about using opioids to treat chronic cancer and noncancer pain: a pilot study. J Rehabil Res Dev. 2007;44(2):263-70.
    45. Scanlon MN, Chugh U. Exploring physicians' comfort level with opioids for chronic noncancer pain. Pain Res Manag. 2004;9(4):195-201.
    46. Seamark D, Seamark C, Greaves C, Blake S. GPs prescribing of strong opioid drugs for patients with chronic non-cancer pain: a qualitative study. Br J Gen Pract. 2013;63(617):e821-8.
    47. Spitz A, Moore AA, Papaleontiou M, Granieri E, Turner BJ, Reid MC. Primary care providers' perspective on prescribing opioids to older adults with chronic non-cancer pain: a qualitative study. BMC Geriatr. 2011;1135.
    48. Stannard C, Johnson M. Chronic pain management--can we do better? An interview-based survey in primary care. Curr Med Res Opin. 2003;19(8):703-6.
    49. Turk DC. Clinicians' attitudes about prolonged use of opioids and the issue of patient heterogeneity. J Pain Symptom Manage. 1996;11(4):218-30.
    50. Turk DC, Brody MC, Okifuji EA. Physicians' attitudes and practices regarding the long-term prescribing of opioids for non-cancer pain. Pain. 1994;59(2):201-8.
    51. Turk DC, Okifuji A. What factors affect physicians' decisions to prescribe opioids for chronic noncancer pain patients? Clin J Pain. 1997;13(4):330-6.
    52. Upshur CC, Luckmann RS, Savageau JA. Primary care provider concerns about management of chronic pain in community clinic populations. J Gen Intern Med. 2006;21(6):652-5.
    53. Vijayaraghavan M, Penko J, Guzman D, Miaskowski C, Kushel MB. Primary care providers' views on chronic pain management among high-risk patients in safety net settings. Pain Med. 2012;13(9):1141-8.
    54. Wenghofer EF, Wilson L, Kahan M, et al. Survey of Ontario primary care physicians' experiences with opioid prescribing. Can Fam Physician. 2011;57(3):324-32.
    55. Wilson HD, Dansie EJ, Kim MS, Moskovitz BL, Chow W, Turk DC. Clinicians' attitudes and beliefs about opioids survey (CAOS): instrument development and results of a national physician survey. J Pain. 2013;14(6):613-27.
    56. Wolfert MZ, Gilson AM, Dahl JL, Cleary JF. Opioid analgesics for pain control: wisconsin physicians' knowledge, beliefs, attitudes, and prescribing practices. Pain Med. 2010;11(3):425-34.
    57. Yanni LM, McKinney-Ketchum JL, Harrington SB, et al. Preparation, confidence, and attitudes about chronic noncancer pain in graduate medical education. J Grad Med Educ. 2010;2(2):260-8.
    58. Hegmann KT, Weiss MS, Bowden K, et al. ACOEM Practice Guidelines: opioids and safety-sensitive work. J Occup Environ Med. 2014;56(7):e46-53.
    59. Hegmann KT, Weiss MS, Bowden K, et al. ACOEM Practice Guidelines: opioids for treatment of acute, subacute, chronic, and postoperative pain. J Occup Environ Med. 2014;56(12):e143-59.