NCHR Comments on the Proposed 2022 Center for Disease Control (CDC) Clinical Practice Guideline for Prescribing Opioids

April 11, 2022


Public Comment of the National Center for Health Research on the Proposed 2022 Center for Disease Control (CDC) Clinical Practice Guideline for Prescribing Opioids

The National Center for Health Research (NCHR) appreciates the opportunity to provide public comments on the Proposed 2022 Center for Disease Control (CDC) Clinical Practice Guideline for Prescribing Opioids.

As a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, we focus on which prevention strategies and treatments are most effective for which patients and consumers. Our aim is to ensure that health professionals, patients, and consumers are equipped with information that can help them choose treatments that are proven safe and effective. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

We commend the CDC for their continued efforts to reduce opioid use by including evidence from many additional studies, filling the knowledge gaps that existed in 2016. We appreciate the new evidence provided on alternatives to opioids for the treatment of acute, subacute, and chronic pain, which support the recommendation that long-term use of opioids should be avoided whenever possible. However, we are very concerned that the Box 1 Guideline Recommendations are likely to be the only part of the guideline that will be widely disseminated and read, and that the impact of the Box 1 Guideline as currently written will be very harmful to patients.

It is well known that the FDA approval of oxycodone opioids for non-cancer chronic painand FDA allowing the initial misleading promotion of these products as non-addictive have fueled the opioid epidemic, resulting in overprescribing.1,2,3 Due to the FDA’s regulatory shortcomings and the overprescribing by U.S. physicians, opioid prescriptions rose by 300% during the past two decades.3 In 2015 alone, 240 million opioid prescriptions were dispensed, almost enough for every adult in the general population.4 In a study of 4,493 treatment-seeking opioid abusers, nearly half of the patients attributed their first exposure to prescriptions for pain management.5

As noted above, the current labels do not adequately warn against initiating use for chronic pain or explain the risks for long-term use. Fortunately, the CDC took action by issuing the 2016 Guideline for Prescribing Opioids for Chronic Pain, which was an effective, evidence-based tool to decrease dangerous opioid prescribing.6

Our proposed changes in this public comment would not alter the intended guidance, but would improve the Box Recommendations, making them far more useful by more clearly translating evidence and guidance contained elsewhere in the draft. NCHR recognizes the challenges faced by patients dealing with chronic pain. We agree that some physicians have inappropriately tapered the use of opioids or abruptly refused to continue to prescribe them. However, the solution is not to assume that the guideline needs to be dramatically revised as has been recommended by the opioid industry and the patients who depend on opioids. A cohort study by Goldstick et al. published in JAMA in 2021 highlighted the flaws in these criticisms, investigating the impact of the 2016 opioid guideline on initial opioid prescribing rates. They found that the evidence-based guideline was associated with positive changes in prescribing practices.7 Rather than having a negative impact on chronic pain management, as the opioid industry suggested, when care was concordant with the guideline, it led to pain management improvements, and fewer opioid related harms.7

The proposed 2022 guideline would weaken the 2016 guideline by 1) removing the recommendation that prescribers should avoid increasing doses to greater than 90 morphine milligram equivalents per day (MME/d) and 2) removing the recommendation that initial opioid prescriptions should be sufficient between three to seven days.8 These revisions will threaten the progress that has been made to keep fewer patients from starting and continuing opioid use.  Replacing these specific recommendations with general advice to physicians to use their judgment is likely to reverse the progress that was made since 2016. Physicians will benefit from specific recommendations that will improve their knowledge and prescribing behavior.

NCHR recommends the following as the CDC finalizes their guideline:

  1. The CDC must not remove the recommendation that initial opioid prescriptions from three to seven days will often be sufficient; and more than seven days will rarely be needed. This information should be added to Box Recommendation 6.

Research has clearly shown the longer the initial supply of opioids, the higher the probability of continued opioid use 1-3 years later.9 Specifically, the likelihood of chronic opioid use increases with each additional day of medication, starting with the third day.9 After only one day of taking opioids, and consistent with the next two days, the probability of continued opioid use after one year is already 6% and the probability after three years is 2.9%.9 This duration information should be included in Box Recommendation 6, to offer practical guidance on the duration of opioids that is typically needed for acute pain. Removal of this recommendation would deprive clinicians and patients of essential knowledge that should inform their prescribing choices.

  1. The CDC must not remove the recommendation that prescribers avoid increasing doses to greater than 90 morphine milligram equivalents per day (MME/d). This information should be added to Box Recommendation 4.

NCHR recognizes the challenges facing patients who have been negatively affected by rapid tapering based on misconstrued interpretations of the 2016 guidance. Reducing patient harm is vital; however, removing this guidance due to the misinterpretation or misapplication of the guideline is unwarranted. The guideline should ensure that prescribers are aware of the risks associated with doses exceeding 90 MME/d. Research has shown opioid dosages approaching 100 MME pose serious risk of adverse side effects. When compared to individuals taking 1-20 MME/d, those taking 100 MME/d or more had an 8.9 times increased risk of overdose, as well as increased risk of complications such as bowel pain, respiratory depression, bradycardia, and hypotension.10 Studies looking at postoperative pain management and long-term opioid therapy have shown that reductions in the amount of opioids prescribed does not lead to higher pain intensity, when guidelines are followed properly.11,12

Following the 2016 guideline release, the proportion of patients with initial doses of 50 MME/d or greater was lower compared to the preexisting trend.13 This demonstrates the important impact the guidance has had on reducing higher dosage opioid dependence. There is also new evidence in the proposed guideline that demonstrates significant risks of high dose opioids (>50 MME/day) and shows that alternatives to opioids often provide equal or superior benefit with a markedly better safety profile. Based on the evidence, we strongly oppose removing the recommendation to avoid increasing doses to greater than 90 MME/d, in fact, doses should be recommended to be under 50 MME/d. Including this information in Box Recommendation 4, would clarify what is meant by “dosage above levels likely to yield diminishing returns.”

  1. The CDC must express the importance of avoiding abrupt tapering in Box Recommendation 5.

To reduce incorrect adherence to the guideline, we support the guideline’s efforts to educate prescribers on the harms associated with abrupt and rapid tapering of opioids and provide new evidence on tapering for patients in whom harm is judged to exceed benefit. These steps will minimize the risk that opioids will be abruptly discontinued in patients who are physiologically dependent. The importance of avoiding abrupt opioid discontinuation should he highlighted in Box Recommendation 5.

Given that the CDC guideline is not mandatory, removing important, specific guidance on how to reduce the risks associated with certain dosages and initial prescriptions is unwise and will reverse the progress that has been made. Moreover, if the CDC is perceived as going back and forth on these essential issues, that will undermine the credibility of the CDC guidelines, adding to skepticism and cynicism in ways that are harmful to the agency and to all Americans.

The CDC needs to ensure that the new Guideline clearly relies on scientific evidence regarding how to reduce the chances of overprescribing and addiction while also recognizing the need for patient-centered care, especially for patients who became dependent or addicted to opioids due to no fault of their own.

Thank you for your careful consideration of our recommendations aimed at protecting the public health.

 

1. Kolodny, A. (2020) How FDA Failures Contributed to the Opioid Crisis. AMA J Ethics ;22(8):E743-750. doi: 10.1001/amajethics.2020.743

2. Mann, B. (2020) Doctors and Dentists still Flooding the U.S. with Opioid Prescriptions. NPR. https://www.npr.org/2020/07/17/887590699/doctors-and-dentists-still-flooding-u-s-with-opioid-prescriptions

3. Makary, M.A., Overton, H.N., Wang, P. (2017) Overprescribing is major contributor to opioid crisis. BMJ; 359:j4792 doi:10.1136/bmj.j4792

4. Madras, B.K. (2017) The Surge of Opioid Use, Addiction, and Overdoses: Responsibility and Response of the US Health Care System. JAMA Psychiatry.74(5):441–442. doi:10.1001/jamapsychiatry.2017.0163

5. Cicero, T. J., Ellis, M. S., & Kasper, Z. A. (2017). Psychoactive substance use prior to the development of iatrogenic opioid abuse: A descriptive analysis of treatment-seeking opioid abusers. Addictive behaviors65, 242–244. https://doi.org/10.1016/j.addbeh.2016.08.024

6. CDC Guideline for Prescribing opioids for Chronic Pain—United States, 2016. (2016) Centers for Disease Control and Prevention, https://www.cdc.gov/mmwr/volumes/65/rr/rr6501e1.htm

7. Goldstick, J.E., Guy, G.P., Losby, J.L., Baldwin, G., Myers, M., Bohnert, A.S.B. (2021) Changes in Initial Opioid Prescribing Practices After the 2016 Release of the CDC Guideline for Prescribing Opioids for Chronic Pain. JAMA Netw Open. 4(7):e2116860. doi:10.1001/jamanetworkopen.2021.16860

8. Proposed 2022 CDC Clinical Practice Guideline for Prescribing Opioids. (2022). Federal Register. https://www.federalregister.gov/documents/2022/02/10/2022-02802/proposed-2022-cdc-clinical-practice-guideline-for-prescribing-opioids

9. Shah, A., Hayes, C.J., Martin, B.C. (2017) Characteristics of Initial Prescription Episodes and Likelihood of Long-Term Opioid Use -United States, 2006-2015. MMWR Morb Mortal Wkly Rep 2017;66:265-269. DOI: http://dx.doi.org/10.15585/mmwr.mm6610a1

10. Lembke, A., Humphreys, K., Newmark, J. (2016) Weighing the Risks and Benefits of Chronic Opioid Therapy. Am Fam Physician. 93(12):982-990.

11. Vu, J.V., Howard, R.A., Gunaseelan V., Brummett, C.M., Waljee J.F., Englesbe M.J. (2019) Statewide implementation of postoperative opioid prescribing guidelines. N Engl J Med, 381(7):680-682. doi:10.1056/NEJMc1905045

12. Darnall, B.D., Ziadni, M.S., Stieg, R.L., Mackey, I.G., Kao, M.C., Flood, P. (2018) Patient-centered prescription opioid tapering in community outpatients with chronic pain.  JAMA Intern Med. 178(5):707-708. doi:10.1001/jamainternmed.2017.8709

13. Goldstick, J.E., Guy, G.P., Losby, J.L., Baldwin, G., Myers, M., Bohnert, A.S.B. (2021) Changes in Initial Opioid Prescribing Practices After the 2016 Release of the CDC Guideline for Prescribing Opioids for Chronic Pain. JAMA Netw Open. 4(7):e2116860. doi:10.1001/jamanetworkopen.2021.16860