UK recommendations on opioid stewardshipBMJ 2021; 372 doi: https://doi.org/10.1136/bmj.m4901 (Published 05 January 2021) Cite this as: BMJ 2021;372:m4901
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Letter from Physicians for Responsible Opioid Prescribing (PROP) to the American Medical Association (AMA) -- RE: AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing
February 16, 2021
Susan R. Bailey, MD
President, American Medical Association
330 N. Wabash Ave., Suite 39300
Chicago, IL 60611-5885
RE: AMA’s Opposition to Dose & Duration Guidance for Opioid Prescribing
Dear Dr. Bailey:
On behalf of Physicians for Responsible Opioid Prescribing (PROP), we are writing to share our concern about the AMA’s recent public statements on opioid prescribing. It is disappointing that the AMA chose to fight key elements of the CDC’s effort to address the scourge of overprescribing of opioids in its letter to Dr. Deborah Dowell. While appropriately advocating for measures to help individuals struggling with opioid use disorder (OUD), the AMA concurrently repudiates the CDC’s pain treatment recommendations on opioid dose and duration, guidance that is needed to reduce the incidence of OUD and opioid-related overdoses. In December, in both an issue brief specifically related to the opioid crisis during the COVID pandemic, and in a policy roadmap addressing opioid use disorder more broadly, industry friendly messaging on opioid use for pain can be found buried amid the effort to repair the problems created in the first place, and in no insignificant part, by erroneous messaging. 
Particularly concerning are erroneous statements such as “the nation no longer has a prescription opioid-driven epidemic” and regressive policy recommendations including “the AMA urges governors and state legislators to take action [to] remove …. arbitrary dose, quantity and refill restrictions on controlled substances.” Together, these statements send a strong message that opioid prescribing for pain is no longer problematic, and that the CDC’s recommended guardrails are no longer needed. Nothing could be further from the truth. There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths. We also now know that the population of people most likely to progress to prolonged high dose prescription opioid usage, or turn to illicit opioids, are the most distressed amongst us. This is a population that has grown with the COVID-19 pandemic and is likely to continue to grow during pandemic recovery.
While it has been reported that some of the CDC’s recommendations were misapplied as strict limits, this does not lessen the need for evidence-based opioid prescribing guidance on dose and duration. Revisions to the CDC guideline, developed in response to an urgent public health problem, are of course helpful when based on accumulating evidence and experiences. But that does not mean that sound principles contained in the guideline should be abandoned. Rather, misapplications of the guideline should be addressed specifically, while continuing to recognize that harmful past messages that promoted opioid use as safe and effective for an indefinite duration and dose contributed to rising rates of opioid use disorder and overdose deaths. Suggested dose and duration restrictions are not “arbitrary”, they are based on considerable evidence of when harm far exceeds benefit. They only become “arbitrary” when applied too rigidly, or if they are used as license to abruptly cut prescribing to individuals that have become dependent on opioids for stability.
The evidence shows that opioids are helpful when prescribed appropriately for short-term pain (including end-of-life), and less helpful, and markedly more harmful, when prescribed for a long duration. This contention is supported by abundant clinical, epidemiological and biological data. All moral, ethical, regulatory, legal and political arguments that opioids are needed so that people do not suffer needlessly should apply specifically to short-term pain management where there is proven benefit, and not to long-term pain management where evidence of benefit is largely anecdotal, and there is compelling evidence of harm. It does not make sense to apply the moral argument to a treatment known to result in harm for the majority of those treated. Being unclear about this important distinction led to a soaring increase in opioid prescribing along with parallel increases in OUD and overdose deaths. Why then is the AMA applying the moral argument to the false premise that people will suffer needlessly if they do not have unrestricted access to opioids? By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer. This is simply a repeat of the pharmaceutical industry’s playbook that led to an epidemic of opioid use disorder. Why is the AMA echoing messages from that playbook now that prescribing of opioids for chronic pain is trending in a more cautious direction? Why impede this trend when prescription opioid use remains far higher in the U.S. than in any other country on earth? Physicians were relieved to have the standards provided by the CDC guidelines. Removing these evidence-based norms for opioid prescribing will not help either physicians or patients.
Jane C. Ballantyne, MD, FRCA
Professor, Anesthesiology and Pain Medicine
University of Washington
Judy Butler, MS
Research Fellow, PROP
Paul Coelho, MD
Salem Health Pain Clinic
Gary M. Franklin, MD, MPH
Vice President, State Affairs, PROP;
Research Professor, Dept of Environmental Health, Neurology, & Health Services, University of WA; Medical Director, WA State Dept. Labor and Industries
Adriane Fugh-Berman, MD
Professor, Department of Pharmacology & Physiology
Georgetown University Medical Center
Stephen G. Gelfand, MD, FACP
Chris Johnson, MD
Diplomate, American Board of Emergency Medicine
Member & Former Chair, Minn. Dept. of Human Services Opioid Prescribing Work Group
David Juurlink, MD, PhD, FACMT, FAACT
Professor and Head,
Division of Clinical Pharmacology and Toxicology,
University of Toronto
Andrew Kolodny, MD
Vice President, Federal Affairs, PROP;
Medical Director, Opioid Policy Research Collaborative,
Heller School for Social Policy & Management
Anna Lembke, MD
Associate Professor &Medical Director
Addiction Medicine, Department of Psychiatry,
Stanford University School of Medicine
Danesh Mazloomdoost, MD
Wellward Regenerative Medicine
Rosemary Orr, MD
Department of Anesthesiology and Pain Medicine,
University of Washington
Jon Streltzer, MD
Professor Emeritus, Department of Psychiatry, Associate Director, Addiction Psychiatry Residency
John A. Burns School of Medicine, University of Hawaii
Mark D. Sullivan, MD, PhD
Professor, Psychiatry and Behavioral Sciences
Adjunct Professor, Anesthesiology and Pain Medicine, Bioethics and Humanities
University of Washington
David J. Tauben, MD, FACP
Clinical Professor Emeritus
Depts of Medicine and Anesthesia & Pain Medicine
University of Washington
Michael Von Korff, ScD
Vice President, Scientific Affairs, PROP; Investigator Emeritus, Kaiser Permanente Washington Health Research Institute
1 Letter from James Madara, M.D., CEO of the American Medical Association, to Deborah Dowell, M.D. Chief Medical Officer, National Center for Injury Prevention and Control, U.S. Centers for Disease Control and Prevention. Accessed on February 4, 2020. https://searchlf.ama-assn.org/undefined/documentDownload?uri=%2Funstruct...
2 National Roadmap on State-Level Efforts to End the Nation’s Drug Overdose Epidemic. December 2020. https://end-overdose-epidemic.org/wp-content/uploads/2020/12/AMA-Manatt-... ; AMA Issue brief: Reports of increases in opioid- and other drug-related overdose and other concerns during COVID pandemic. Updated December 9, 2020. https://www.ama-assn.org/system/files/2020-12/issue-brief-increases-in-o...
Competing interests: [Competing interest statement updated on 15 March 2021 by BMJ Editorial] All authors are on the Board of Physicians for Responsible Opioid Prescribing, an organization that advocates for more cautious opioid prescribing and improved regulation of opioid manufacturers. The following authors have nothing else to disclose: Judy Butler, Paul Coelho, Stephan Gelfand, Chris Johnson, Rosemary Orr, Jon Streltzer, David Tauben, Betts Tully, Michael Von Korff. Jane Ballantyne, Andrew Kolodny, Anna Lembke and Danesh Mazloomdoost receive fees for serving as expert witnesses on behalf of government plaintiffs in litigation against the opioid industry; Adriane Fugh-Berman is a paid expert witness at the request of plaintiffs in litigation regarding pharmaceutical and medical device marketing practices, including in cases regarding opioids and she directs PharmedOut, a research and education project that fosters rational prescribing at Georgetown University Medical Center; Gary Franklin receives federal funding for opioid related research and serves as an unpaid witness for the State of Washington against the opioid industry; David Juurlink has received payment for expert testimony for medicolegal actions related to opioids. In the past 36 months, Mark Sullivan has provided expert testimony for the States of Maryland and Missouri. He has received a research grant from Purdue Pharma not related to the current work. He has no ongoing conflicts and plans none in the next 12 months.
Re: UK recommendations on opioid stewardship and Impact of COVID-19 on pain relieving operations and the need for expansion of non-pharmacological interventions
We thank Shania Liu and colleagues  for their interest in our editorial  on the need for better opioid stewardship programmes to prevent harm from opioid use and misuse. Whilst we discuss the need for opioid stewardship across all areas of opioid prescribing , they quite rightly reiterate that the surgical patient on opioids is at particular risk of persistent postoperative opioid use . Recent evidence suggests that the risk of persistent postoperative opioid use in opioid naïve patients is 2-6%, whilst the incidence is more than 30% in those taking opioids prior to surgery . Worryingly, preoperative opioid use has become increasingly common for surgical procedures aimed at relieving chronic non-cancer pain, with up to 84% of patients taking opioids in the year preceding surgery .
Liu and colleagues argue that the preoperative period is potentially an ideal time to wean opioids to improve surgical outcomes . As healthcare professionals interested in utilising the whole of the perioperative period to improve surgical outcomes, we concur with these sentiments. It should be noted that the perioperative period extends from the moment of contemplation of surgery to complete recovery .
As well as there being evidence that the preoperative period is an ideal time to wean opioids to improve surgical outcomes, there is also increasing evidence that non-pharmacological interventions such as supervised and personalised exercise programmes are, at the very least, comparable to pharmacological interventions at relieving chronic non-cancer pain , and have additional health benefits, including increasing life expectancy . The mechanism of exercise-induced analgesia is beginning to be understood .
Reliance on non-opioid interventions to manage chronic pain conditions are even more relevant in the COVID-19 era. In May 2020 it was estimated that at least 28 million surgical procedures have been cancelled worldwide due to COVID-19, and that it would take at least 45 weeks to clear this backlog if there was an 20% increase in baseline surgical activity . Thus, it can be anticipated that with delayed treatment for pain relieving operations such as lower limb arthroplasties and surgery for chronic pancreatitis, the actual number of patients being commenced on opioids to manage their chronic pain will increase. These patients may not be able to obtain the full benefit of the surgical interventions, as they may become needlessly dependant on opioids. Thus, there is an urgent need to comply with national and international recommendations on the use of non-pharmacological strategies such as exercise and weight loss to manage painful conditions whilst waiting for the pain-relieving surgery [10-12].
In addition, there is a necessity to expand physiotherapy and weight reduction services to manage the influx of patients that require this service. Supervised prehabilitation programmes involving hospitals and communities may also help optimise patients physically, nutritionally and psychologically for surgery, resulting in better outcomes and, perhaps, easier weaning from opioids .
Moreover, opioids should only be considered as a last resort for chronic non-cancer pain, after appropriate shared decision making, and with a deprescribing plan agreed at the initial prescription as per the guidance of the Medicines and Health products Regulatory Agency [2,14].
1. Liu S, Blake E, Naylor J, et al. Rapid Response: Re: UK recommendations on opioid stewardship, 2021. https://www.bmj.com/content/372/bmj.m4901/rr (accessed 01/02/2021).
2. Levy N, Lord LJ, Lobo DN. UK recommendations on opioid stewardship. BMJ 2021; 372: m4901. doi: 10.1136/bmj.m4901 pmid: 33402365
3. Kent ML, Hurley RW, Oderda GM, et al. American Society for Enhanced Recovery and Perioperative Quality Initiative-4 joint consensus statement on persistent postoperative opioid use: definition, incidence, risk factors, and health care system initiatives. Anesth Analg 2019; 129: 543-52. doi: 10.1213/ANE.0000000000003941 pmid: 30897590
4. Lawal OD, Gold J, Murthy A, et al. Rate and risk factors associated with prolonged opioid use after surgery: a systematic review and meta-analysis. JAMA Netw Open 2020; 3: e207367. doi: 10.1001/jamanetworkopen.2020.7367 pmid: 32584407
5. Bougeard AM, Moore J. Delivering perioperative care in integrated care systems. Clin Med (Lond) 2019; 19: 450-3. doi: 10.7861/clinmed.2019.0241 pmid: 31732583
6. Henriksen M, Hansen JB, Klokker L, Bliddal H, Christensen R. Comparable effects of exercise and analgesics for pain secondary to knee osteoarthritis: a meta-analysis of trials included in Cochrane systematic reviews. J Comp Eff Res 2016; 5: 417-31. doi: 10.2217/cer-2016-0007 pmid: 27346368
7. Lee IM, Shiroma EJ, Lobelo F, et al. Effect of physical inactivity on major non-communicable diseases worldwide: an analysis of burden of disease and life expectancy. Lancet 2012; 380: 219-29. doi: 10.1016/S0140-6736(12)61031-9 pmid: 22818936
8. Lesnak JB, Sluka KA. Mechanism of exercise-induced analgesia: what we can learn from physically active animals. Pain Rep 2020; 5: e850. doi: 10.1097/PR9.0000000000000850 pmid: 33490844
9. COVIDSurg Collaborative. Elective surgery cancellations due to the COVID-19 pandemic: global predictive modelling to inform surgical recovery plans. Br J Surg 2020; 107: 1440-9. doi: 10.1002/bjs.11746 pmid 32395848
10. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain--United States, 2016. JAMA 2016; 315: 1624-45. doi: 10.1001/jama.2016.1464 pmid: 26977696
11. Centres for Disease Control and Prevention. Joint Pain and Arthritis, 2020. https://www.cdc.gov/arthritis/pain/index.htm (accessed 01/02/2021).
12. National Institute for Health and Care Excellence. Osteoarthritis: care and management, 2014. https://www.nice.org.uk/guidance/cg177/resources/osteoarthritis-care-and... (accessed 01/02/2021).
13. Levy N, Selwyn DA, Lobo DN. Turning 'waiting lists' for elective surgery into 'preparation lists'. Br J Anaesth 2021; 126: 1-5. doi: 10.1016/j.bja.2020.08.021 pmid: 32900503
14. Medicines and Healthcare products Regulatory Agency. Drug Safety Update 2020; 14 (2): 1-14. https://assets.publishing.service.gov.uk/government/uploads/system/uploa... (accessed 01/02/2021).
Competing interests: No competing interests
We thank Nicholas Levy and colleagues for their timely and insightful Editorial entitled “UK recommendations on opioid stewardship”.(1) The authors outline the harms associated with opioid misuse and subsequent recommendations made by the UK Medicines and Healthcare Products Regulatory Agency to encourage appropriate opioid use. In particular, the Editorial highlights the limited role of opioids for chronic non-cancer pain and that opioids used for this indication should be prescribed with an end date planned. We wish to elaborate on this point by asserting that a key opportunity for such deprescribing exists among surgical patients. Opioid use during surgery has been a long-standing issue with large variations in practice and many patients remaining on opioids 12 months after surgery.(2) Furthermore, pre-operative opioid use has become increasingly common for surgeries aimed at relieving chronic non-cancer pain, with up to 84% of patients taking opioids in the year preceding surgery.(3)
Similar patterns are observed among patients undergoing hip or knee arthroplasty,(4,5) despite opioids limited benefit in osteoarthritis and risks of adverse events.(6-9) A literature review of opioid use before arthroplasty reported an association between preoperative opioid use and worse postoperative pain and surgical outcomes.(9) Importantly, evidence from retrospective administrative healthcare data demonstrated that these effects may be reversible if opioids were weaned (by at least 50%) prior to arthroplasty.(10) However, due to the retrospective nature of this study, how and why opioids were weaned could not be determined. Given patients awaiting elective surgery have a theorised ‘end point’ determined by their surgery date and increased engagement with the health system before and after surgery, we propose that opioid tapering prior to elective surgeries such as arthroplasty is currently a missed opportunity which may be leveraged for significant public health benefit.
Despite the apparent sound arguments for weaning, a 2017 Cochrane review highlighted the paucity of literature on the efficacy of interventions to reduce opioid use for chronic non-cancer pain.(11) Furthermore, our group conducted a systematic review in 2020 of prospective studies to examine the effectiveness of interventions to reduce opioids for non-cancer pain prior to elective surgery (PROSPERO ID: CRD42020202221). We searched seven electronic databases; Medline, Scopus, Embase, Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts, PsycINFO and Cumulative Index of Nursing and Allied Health Literature (CINAHL), retrieving 4,088 articles. Surprisingly, no relevant studies were found. Not surprisingly, informative policies are lacking regarding preoperative opioid tapering for any elective surgery.
There appears to be more research conducted in reducing opioid use after surgery instead of preventing the issue altogether by weaning patients off opioids before the surgery. One randomised controlled trial on postoperative opioid tapering after orthopaedic surgery aimed to reduce opioid use to baseline preoperative use has been published but none exist for preoperative opioid tapering.(12) We propose interventions to preoperatively taper patients’ baseline opioid use would be even more resource-efficient and achieve greater clinical benefit. Taking the recommendations of Levy et al. regarding slow opioid tapering after prolonged treatment one step further, we assert that the preoperative period offers a longer timespan to taper opioids than the typically shorter postoperative period prior to hospital discharge or review, thus reducing the risk of acute opioid withdrawal following extended opioid. High-level studies to examine the efficacy of interventions on preoperative reduction of opioid use before elective hip or knee arthroplasty, or any elective surgery, are warranted. If shown to be cost-effective for the individual and healthcare provider, societal benefits are likely to follow.
1. Levy N, Lord LJ, Lobo DN. UK recommendations on opioid stewardship.
2. Neuman MD, Bateman BT, Wunsch H. Inappropriate opioid prescription after surgery. The Lancet. 2019 Apr 13;393(10180):1547-57.
3. Lawal, O. D., Gold, J., Murthy, A., Ruchi, R., Bavry, E., Hume, A. L., Wen, X. (2020). Rate and Risk Factors Associated With Prolonged Opioid Use After Surgery: A Systematic Review and Meta-analysis. JAMA Network Open, 3(6), e207367-e207367. doi:10.1001/jamanetworkopen.2020.7367
4. Stevens J. Inadvertent post-operative opioid use. Australian Orthopaedic Association. 2018.
5. Penm J et al. Harms and costs of opioid related adverse events in hip and knee replacements (under review). 2019.
6. Avouac J, Gossec L, Dougados M. Efficacy and safety of opioids for osteoarthritis: a meta-analysis of randomized controlled trials. Osteoarthritis and Cartilage 2007;15:957-65.
7. Naylor, J.M., Pavlovic, N., Farrugia, M, Ogul S, Hackett D, Wan A, Adie S, Brady B, Gray L, Wright R, Nazar M, Xuan W. Associations between pre-surgical daily opioid use and short-term outcomes following knee or hip arthroplasty: a prospective, exploratory cohort study. BMC Musculoskelet Disord 21, 398 (2020). https://doi.org/10.1186/s12891-020-03413-z
8. Smith SR, Deshpande BR, Collins JE, Katz JN, Losina E. Comparative pain reduction of oral non-steroidal anti-inflammatory drugs and opioids for knee osteoarthritis: systematic analytic review. Osteoarthritis and cartilage 2016;24:962-72.
9. Goplen CM, Verbeek W, Kang SH, Jones CA, Voaklander DC, Churchill TA, et al. Preoperative opioid use is associated with worse patient outcomes after total joint arthroplasty: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2019;20:234.
10. Nguyen L-CL, Sing DC, Bozic KJ. Preoperative reduction of opioid use before total joint arthroplasty. The Journal of arthroplasty 2016;31:282-7.
11. Eccleston C, Fisher E, Thomas KH, Hearn L, Derry S, Stannard C, Knaggs R, Moore RA. Interventions for the reduction of prescribed opioid use in chronic non-cancer pain. Cochrane Database of Systematic Reviews 2017, Issue 11. Art. No.: CD010323. DOI: 10.1002/14651858.CD010323.pub3.
12. Hah JM, Trafton JA, Narasimhan B, Krishnamurthy P, Hilmoe H, Sharifzadeh Y, Huddleston JI, Amanatullah D, Maloney WJ, Goodman S, Carroll I. Efficacy of motivational-interviewing and guided opioid tapering support for patients undergoing orthopedic surgery (MI-Opioid Taper): A prospective, assessor-blind, randomized controlled pilot trial. EClinicalMedicine. 2020 Nov 1;28:100596.
Competing interests: No competing interests