Advocacy

April 5, 2022
 
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention
4770 Buford Highway NE
Mailstop S106–9
Atlanta, GA 30341
 
Attn: Docket No. CDC–2022–0024
 
To Whom It May Concern:
 
The American College of Occupational and Environmental Medicine (ACOEM) is the nation’s largest medical society dedicated to promoting the health of workers through preventive medicine, clinical care, research, and education. Our membership is comprised of 3,500 physicians, nurses, physician associates, nurse practitioners, and other health care professionals who specialize in occupational and environmental medicine (OEM).
 
The specialty of OEM focuses on the diagnosis and treatment of work‐related injuries and illnesses and ensuring that workplace environments are safe for workers. It is the medical field that concentrates on the impact of work on health and the impact of health on the ability to work. The College is in a unique position to reach American workers in a variety of settings given that our members are employed at hospitals and clinics, colleges and universities, large corporations, factories and industrial sites, law and safety departments, government agencies, the military, etc.
 
Chronic pain and opioid abuse and misuse are of importance. OEM physicians are among the many providers who treat or manage patients with chronic pain related to workplace injury and illness. Though opioids may be used in some circumstances, one of the systematic reviews performed by Guyatt et al., at McMasters University for the Canadian Opioids Guidelines showed that only 11.1% of patients who are prescribed opioids will achieve the minimally important difference of a 2-point reduction in pain (11-point scale) and only 10% will achieve an improvement in function.¹ The other systematic review showed that the average change in reduction of pain with opioids is only 0.7 on an 11-point scale.² Thus, the ability of opioids to address chronic pain is fairly limited, especially when weighed against the considerable problems of addiction and overdoses. Therefore, we recognize the importance of clinicians and health care systems in taking measures to assure both cautious, narrow use among those who benefit[1] while decreasing the inappropriate and harmful use of opioids for non‐cancer‐related chronic pain.
 
Addressing both the treatment of non‐cancer‐related chronic pain and the potential abuse and misuse of opioids in the United States requires a combination of steps that includes improved education for clinicians and patients on potential issues related to treatment, expanded research on the impact of opioids on patients, better utilization of tools aimed at reducing abuse such as prescription drug monitoring programs, and the use of evidence‐based, best‐practice guidelines regarding chronic pain treatment. While ACOEM continues to advocate for national policies to help address opioid abuse and chronic pain treatment, it is imperative that individual clinicians also take steps within their own practices that can help. ACOEM’s two Practice Guidelines on Opioids and on Chronic Pain provide a framework of clinical practices that can help decrease the inappropriate and harmful use of opioids  while recognizing the need to treat patients with non‐cancer chronic pain. These guidelines are published by the Reed Group, Ltd (www.mdguidelines.com). Summaries of our Opioids Guideline are also published in ACOEM’s Journal of Occupational and Environmental Medicine as open-access articles to help with this epidemic of opioids fatalities.^3,4
 
ACOEM is appreciative of the opportunity to provide feedback to the Centers for Disease Control and Prevention (CDC) regarding its Clinical Practice Guideline for Prescribing Opioids – United States, 2022 and is supportive of many of the changes made to CDC’s original Opioids Guideline (2016) and the overall review process. Given the marked increase in drug overdoses during the COVID-19 pandemic, it is essential that clear evidence-based guidelines be available to clinicians. We have three significant comments that we believe should be addressed:

1. There are no recommendations made for the clinician to assess the use of opioids and the work and non-work activities of the patient. These must be addressed for opioids and any other medications which may affect a patient’s cognition or balance in order to protect the safety of the patient, coworkers, and others around the patient.
2. Mental health assessments and treatment must be addressed for anyone experiencing chronic pain, and especially when chronic opioid use is being considered.
3. Regarding the methodology used for the guideline development, the document states that it follows the GRADE framework and that the recommendations are made “based on a systematic review of the available scientific evidence….” Much of the document is in alignment with the evidence and many evidence-based guidelines. However, we would recommend that any secondary sources be removed, and only primary sources be used as references. We suggest that a review of some of the gray literature currently available in pain management, may reveal areas for clarifications and improvements.

 
Below are suggested specific recommendations to address the issues raised above.
 
ACOEM Recommendation A. We advise a new recommendation to be included regarding safety critical work or activities be placed in the areas discussing clinician expected actions.
 
A safety critical work position involves work task(s) or an occupational environment where physical and/or mental (mis)performance involves danger(s) to self, coworkers, public and/or the environment. Evidence consistently shows increased risks of motor vehicle crashes associated with opioids.^4,5 A provider should assess the abilities to perform safety critical work regardless of the diagnosis and any instituted treatment. Therefore, regarding the patient on opioids or other medications that can negatively affect sleep, cognition, balance, and coordination, etc. (unless cleared to do so by a physician) should not return to activities (including at work) involving driving, use of heavy equipment or where the patient engages in potentially dangerous activities such as climbing ladders, working at heights or around moving machinery, or working with high voltage equipment without such careful decision-making. For occupations with higher risks (especially public transportation), a prescription of an opioid may be incompatible with continued employment in a safety-critical job.^4,6,7,8
 
ACOEM Recommendation B. We advise the guideline include algorithms and/or sequential approaches to treatment. This is particularly needed to mitigate this epidemic by providing the details of what the other treatment options to opioids are that should be considered prior to consideration of opioids for chronic pain. For example, for low back pain, treatment considerations should include progressive aerobic exercises, strengthening exercises and cognitive behavioral therapy (CBT). Other options may include adjunctive acupuncture.
 
ACOEM Recommendation C. Mental health disorders are major confounding and accompanying conditions for many patients. Patients with chronic pain who also may have associated mental health issues should be evaluated for those condition(s) and advised that their mental health issues need to be addressed prior to considering a trial of chronic opioid therapy.
 
Below are specific comments to the recommendations included in the current draft CDC guideline.
 
CDC Recommendation #1. This recommendation should specifically state that there is evidence from multiple RCTs of equivalent outcomes using non-opioid treatments. See our recommendations for #2.
 
This recommendation is good except it does not specifically state that there is evidence from multiple RCTs of equivalency for non-opioid treatments.³ It should state this, otherwise the impression left by those (widely) mistaught the evidence is that opioids are the best (e.g., see the first drafted bullet which so erroneously suggests). Though the draft guideline hints at it later (e.g., dental pain), it is not sufficiently direct on this major teaching point. For example, it could be considerably more robust to note specific types of exercise for low back pain which is the most common diagnosis for prescribing opioids (see ACOEM’s Low Back Disorders Guideline⁹ which is specified later in the draft).
 
In contrast, the second bullet is very good! This problem with this CDC recommendation is at least partially fixable by putting the second bullet first, though it is also suggested to tweak the recommendation statement to incorporate the above issues.
 
This recommendation would also be improved for acute pain management by including the 50mg dose limit early in the text, although it is noted later in the draft.
 
CDC Recommendation #2. A significant weakness is the summary does not note the need to first use other treatments for subacute/chronic pain. This is not in accord with GRADE/AGREE framework especially as there is quality evidence of 10-fold risks of fatality at higher doses (90+ MME).^10,11 Many treatments should be trialed first for subacute/chronic pain, as we noted under our comments for Recommendation #1. This CDC bullet provides excellent suggestions for low back pain and fibromyalgia. Another issue is that selective serotonin reuptake inhibitors (SSRIs) should be mentioned as effective for fibromyalgia.^12,13 We would recommend that you also clarify the use of specific exercise(s) for many diagnoses rather than appearing to only address specific diagnosis alternative treatments.
 
We commend the discussion of exit strategy(ies) from opioids.
 
CDC Recommendation #3. We agree. However, the 50/90 MME dose limit issues should be mentioned in this section. The adverse effects of opioids to the cardiovascular, gastrointestinal, genitourinary, endocrine, immune, neurological/psychiatric, reproductive, respiratory, and vestibular are numerous especially at the higher dosing levels.³
 
CDC Recommendation #4. We agree. While it is included in a bullet, the level of risks far surpasses the limited mention it receives in these guidelines. Dose limits deserve a clearly stated recommendation(s) regarding 50/90 MME maxima.^3,14 We agree with the initiating dose suggested as 20-30 MME/day.
 
CDC Recommendation #10. Baseline drug testing is essential. We recommend subsequent random toxicology testing rather than the current language which appears to allow the clinician to not perform any further testing.
 
Thank you for your consideration of these comments.
 
Sincerely,

Robert M. Bourgeois, MD, MPH, FACOEM
President, ACOEM
 
References

1. Busse JW, Craigie S, Juurlink DN, et al. Guideline for opioid therapy and chronic noncancer pain. CMAJ. 2017;189:E659-66. doi: 10.1503/cmaj.170363.
2. Busse JW, Wang L, Kamaleldin M, et al. Opioids for chronic noncancer pain: a systematic review and meta-analysis. JAMA. 2018;320(23):2448-2460.
3. 3.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):e143-159.
4. 4.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.
5. Sinclair 2^nd DC, Hegmann KT, Holland JP. Acceptable risk of sudden incapacitation among safety critical transportation workers: a comprehensive synthesis. J Occup Environ Med. 2021;63(4):329-342.
6. Union Pacific. Restricted Prescriptions. Available at: https://www.up.com/employee/hr/return-to-work-and-fitness-for-duty/restricted-prescription-drugs/index.htm.
7. Federal Aviation Administration. Opioid Epidemic and Aviation. Available at: https://www.faa.gov/pilots/safety/pilotsafetybrochures/media/OpioidEpidemicAndAviation.pdf.
8. BNSF Railway. Restricted Medications for Safety-Sensitive Duties. October 17, 2017. Available at: https://www.blet104.org/wp-content/uploads/Restricted-Medication-Cover-Letter.pdf.
9. Hegmann KT, Travis R, Andersson GBJ, et al. Non-invasive and minimally invasive management of low back disorders. J Occup Environ Med. 2020;62(3):e111-138.
10. Dunn KM, Saunders KW, Rutter CM, et al. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med. 2010;152(2):85-92.
11. Bohnert AS, Valenstein M, Bair MJ, Ganoczy D, McCarthy JF, Ilgen MA, Blow FC. Association between opioid prescribing patterns and opioid overdose-related deaths. JAMA. 2011;305(13):1315-21.
12. Arnold LM, Hess EV, Hudson JI, Welge JA, Berno SE, Keck Jr PE. A randomized, placebo-controlled, double-blind, flexible-dose study of fluoxetine in the treatment of women with fibromyalgia. Am J Med. 2002;112(3):191-7.
13. American College of Occupational and Environmental Medicine. ACOEM Practice Guidelines: Chronic Pain. MDGuidelines website. https://app.mdguidelines.com/acoem/disorders/chronic-pain. May 15, 2017. Accessed March 30, 2022.
14. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep. 2016;65(No. RR-1):1–49. DOI: https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm.