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PAINSCAN LITERATURE REVIEW
Issue 1, Volume 4
Addiction Medicine and Relapse Prevention
5 Articles in this Series
Introduction
The Krebs SPACE Trial
Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations
The Addiction Patient
The influence of anxiety sensitivity on opioid use disorder treatment outcomes.
Inside the NCASA Report: Ending the Opioid Crisis

Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations

2018; (Dec); Available at: www.hhs.gov/ash/:advisory-committees/pain/reports/index.html

The Comprehensive Addiction and Recovery Act (CARA) of 2016 led to the creation of the Pain Management Best Practices Inter-Agency Task Force (Task Force), whose mission is to determine whether gaps in or inconsistencies between best practices for acute and chronic pain management exist and to propose updates and recommendations to those best practices. The Task Force consists of 29 experts who have significant experience across the disciplines of pain management, patient advocacy, substance use disorders, mental health, and minority health. This draft report describes preliminary recommendations of the Task Force that will be finalized and submitted to Congress in 2019, following a 90-day public comment period [which ends April 1, 2019].

The full task force recommendations, published December 28, 2018, may be found on the HHS website as noted herein.  

Commentary

The following review comments were submitted in response to the draft report, Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations, published by the HHS Pain Management Best Practices Inter-Agency Task Force.* Authors of this commentary are: Richard A Lawhern, PhD and  Stephen E Nadeau, MD

To Be Praised

There is much to praise in the Task Force’s draft recommendations,1 including their: recognition of the vast scale of the chronic pain problem; emphasis on patient quality of life rather than just optimization of function; highlighting of the negative effects of patient stigmatization; and recognition that there is no one-size-fits-all patient or therapy plan. The emphasis on appropriate compensation for integrative medicine in multidisciplinary treatment teams that include patients and families as active collaborators – if appropriately qualified and supported by further research – may also improve clinical practice.

The emphasis on increasing the number of well-qualified pain practitioners recognizes the severe inadequacy of our current pain treatment infrastructure. The recommendation that urine testing must never be used as a basis for firing patients is most welcome. The recommendation of a partnership between physicians and pharmacists in management of patients prescribed opioids could enormously improve outcomes and substantially reduce what is currently a major source of friction and wasted effort in medical practice. The repeated and extended emphasis on resident and practitioner training is particularly welcome, as is the repeated emphasis on the need for further research.

To Be Challenged

However, there are also significant areas where corrections and redirection are particularly needed. Failure to take action at this time may leave in place processes likely to both perpetuate harmful effects on patients in pain and inhibit a shift in public policy focus to the heart of the opioid crisis: users of illicit drugs.

Most critically, the Task Force recommendations fail to advocate for full withdrawal of the 2016 CDC guideline on prescribing opioids for chronic pain.2 Even as we recognize that inter-agency political concerns are likely to operate within the Task Force, we believe this step to be absolutely imperative. The CDC guideline is fatally flawed in process and content, and it is actively dangerous to patient health and physician practice on multiple grounds.3 For instance, the guideline reflects:

  • an overestimation of the role of medically managed opioids in addiction and opioid mortality4,5
  • a broad and unacknowledged anti-opioid bias that is unsupported by science and current practice
  • a naïve declaration that opioids are ineffective for long-term treatment6 (clinical trial evidence has successfully circumvented the challenges of conducting opioid trials and demonstrates major benefit)
  • an equally naïve declaration that non-opioid therapies are available and “preferable” for treatment of chronic pain, despite the complete absence of comparative effectiveness studies, thereby opening the door to mandated substitution for analgesic therapy7
  • a failure to recognize and embrace the inherent genetic variability of opioid metabolism between individuals, which provides the basis for a 15-fold variability in effective dosage.8

 

These combined weaknesses, in the authors' opinion, disqualify the guideline, and until withdrawn, it will continue to create a perceived liability for healthcare providers, motivating them to sharply constrain physician practice under penalty of loss of clinical privileges. The guideline, and in particular, the sanctification of the 90 MMED limit, will continue to inhibit clinically indicated dosing by physicians and provide strong motivation for pharmacies and health insurance companies to limit quantities of opioids prescribed. The guideline will continue to provide a basis for the DEA and states to take legal action against physicians, based solely on the quantity of drugs prescribed to individual patients.

This deadly combination will drive even more physicians out of the field of pain management even as it distracts from efforts to treat the very real and still burgeoning illicit opioid crisis in the streets.

Data Mishaps

The draft recommendations appropriately cite the Dasgupta, et al, study,9 but fail to reference two important papers that also demonstrate the low case fatality rates associated with opioids in the treatment of chronic nonmalignant pain, even when prescribed in substantial dose (0.25% - 0.5% per year). These are Gomes, et al,10 and Bohnert, et al,11 which demonstrate that intended risks of opioid-related mortality are comparable to those experienced by patients treated with rivaroxaban or warfarin, respectively, for prophylaxis of stroke due to atrial fibrillation. Such risks seem almost certain to be acceptable to most patients with moderate to severe chronic pain. Moreover, Dasgupta, et al. is mentioned only in passing in the draft report, even as the low risks demonstrated are foundational to the accurate balancing of risks and benefits in the clinical setting. Until these low risks are widely recognized, opioid prescribing and opioid policy will continue to be driven by the notion that the use of these substances in a medical setting is associated with extreme risk and should be sharply delimited.

Large studies of post-surgical patients treated with opioids for pain reveal that medical exposure to opioids incurs a less than 0.6% risk of alleged opioid use disorder (OUD) in opioid-naïve patients.12 The incidence of sustained prescribed opioid therapy after common surgical procedures is less than 6%, plausibly reflecting not medication misuse, but rather, the emergence of chronic post-procedural pain.13

The American Medical Association has publicly rejected the CDC guideline as a basis for either mandated prescribing limits or sanctions against healthcare providers for “over-prescribing.”14 Until it is widely recognized that there is an extremely low risk that short-term use of opioids will lead to long-term use (much less OUD), the treatment of acute pain, including post-surgical pain, will be sharply constrained and patients may experience the adverse medical effects and suffering associated with inadequate pain control. Furthermore, needed research on opioid management of post-operative pain will be inhibited.

The OUD Factor

Repeated emphasis on OUD in the Task Force’s draft recommendations fosters the idea that there is high risk of this disorder in patients with chronic pain treated chronically with opioids. The scientific evidence shows that the risk of OUD is very low, certainly less than 3% in the authors’ judgment, and probably much lower. Perpetuation of this myth of high risk may inhibit prescribers from initiating opioid therapy and titrating properly. Implicitly linking prescription opioids to OUD will further incentivize efforts to deal with the opioid crisis by limiting prescriptions rather than effectively managing the complex problems of illicit drug use.

Co-Prescribing

Also problematic is an unproven assumption presented in the draft report that the combination of opioids with benzodiazepines is inherently dangerous. This assumption is likely based, in part, on large studies that have demonstrated a doubling of the risk of physician diagnosis of opioid overdose in patients on this combination. These studies, however, are not based upon response to naloxone (an objective outcome measure) and all are likely to be biased by the widespread perception by clinicians, cultivated for decades, that the combination confers additional risk. In the meantime, the pain management community lack good alternatives for treatment of comorbid anxiety, insomnia, and pain due to muscle tension and spasm, even as such treatment may be instrumental to achieving control of pain and reducing opioid dosage.

Comparative Studies

There is a major emphasis in Task Force’s draft recommendations on the use of anti-inflammatory medications, tricyclic antidepressants, anticonvulsants, various alternative therapies, “restorative” therapies, and behavioral health approaches to managing chronic pain, despite the absence of comparative effectiveness studies supporting these approaches. Further, there are even fewer studies demonstrating the effectiveness of these therapies in enabling reduction of opioid dosage. To date, no alternative therapy has been vetted by a Phase III trial.7 Very little attention is directed to the role of depression in magnifying suffering from pain, the potential value of optimal treatment of depression in improving pain control and reducing opioid dosage, the prevalence of failure to diagnose and adequately treat depression, and the critical need for research in these areas.

Several scientifically questionable references warrant removal. These include the Brummet15 study (which addressed the likelihood of a patient getting a single opioid prescription months after surgery, not their chronic use or the development of OUD) and the Krebs, et al, study.16 The paper by Krebs, et al., in the authors’ opinion was flawed by a failure to include participants representative of the population of patients with moderate to severe chronic pain and a failure to adequately titrate opioid dosage. However, its repeated reference in the draft recommendations perpetuates the myth that opioids are not effective in treating chronic pain. There is strong countervailing scientific evidence.

Total Understanding

Overall, a correction is needed in the Task Force’s current emphasis on the management of presumed but un-demonstrated risks of opioid therapy. In many acute and chronic disorders, and for the great majority of patients, opioids are safe and almost uniquely effective in pain management. To argue for mandated withdrawal of such therapy in the absence of proven alternatives is fundamentally irresponsible.

Detailed analysis of data published by the CDC itself demonstrates that rates of opioid-related mortality from all sources (ie, legal, diverted, and illegal) are unrelated to rates of prescription by doctors. It also demonstrates that patient demographics on chronic pain and addiction are largely disjoint, with the highest rates of overdose mortality occurring in youthful populations that receive the fewest prescriptions.5 While active patient oversight and support are certainly warranted in the use of opioids, it may reasonably be argued that the “physician over-prescribing” model for opioid abuse in the US is largely an urban myth.

*Edited for style and clarity. The views reflected in this paper do not reflect the views of the authors’ affiliations, including the Department of Veterans Affairs, the United States government, or the University of Florida.

Sources

1. AHS. Pain Management Best Practices Inter-Agency Task Force. Draft Report on Pain Management Best Practices: Updates, Gaps, Inconsistencies, and Recommendations. Available at: www.hhs.gov/ash/advisory-committees/pain/reports/2018-12-draft-report-on-updates-gaps-inconsistencies-recommendations/index.html. Accessed February 25, 2019.

2. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49.

3. Martin SA, Potee RA, Lazris A. Neat, plausible, and generally wrong: a response to the CDC recommendations for chronic opioid use. Medium Corporation. 2016.

4. Volkow ND, McLellan TA. Opioid abuse in chronic pain -- misconceptions and mitigation strategies.  N Engl J Med. 2016;374(13):1253-1263.

5. Lawhern RA, Tucker JA. Analysis of US opioid mortality and ER visit data. Alliance for the Treatment of Intractable Pain. 2018.

6. Tayeb BO, Barreiro AE, Bradshaw YS, et al. Durations of opioid, nonopioid drug, and behavioral clinical trials for chronic pain: adequate or inadequate? Pain Med. 2016;17(11):2036–2046.

7.Lawhern RA, Nadeau SE. Behind the AHRQ report – understanding the limitations of ‘non-pharmacological, non-invasive therapies for chronic pain. Practical Pain Management. 2018.

8. Lynch T, Price A. The effects of cytochrome P450 metabolism on drug response, interactions, and adverse events. Am Fam Physician. 2007;76(3):391-396.

9. Dasgupta N, Funk MJ, Proescholdbell S, et al. Cohort study of the impact of high-dose opioid analgesics on overdose mortality. Pain Med. 2016;17(1):85-98.

10. Bohnert AS, Valenstein M, Bair MJ, et al. Association between opioid prescribing patterns and opioid overdose-related deaths.JAMA. 2011;305(13):1315-1321.

11. Gomes T, Juurlink DN, Dhalla IA, et al. Trends in opioid use and dosing among socio-economically disadvantaged patients. Open Med. 2011;5(1):e13-22.

12.  Sun EC, Darnall BD, Baker LC, Mackey S. Incidence of and risk factors for chronic opioid use among opioid-naive patients in the postoperative period. JAMA Intern Med. 2016;176(9):1286-1293.

13. Brat GA, Agniel D, Beam A, et al. Postsurgical prescriptions for opioid naive patients and association with overdose and misuse: retrospective cohort study. BMJ. 2018;360: j5790.

14.  McMilllan FP. American Medical Association House of Delegates (I-18)”, Resolution 235 As Amended, January 2018.

15.  Brummet CM, Waljee JF, Goesling J, et al. New persistent opioid use after minor and major surgical procedures in US adults. JAMA Surg. 2017;152(6): e170504.

16.  Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018;319(9):872-882.

 

 

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