NIH Position Paper: Opioids in Tx of Chronic Pain – repost

National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain | Position Papers | February 2015

Not once is the effectiveness of opioids for pain management discussed.

By delving only into the dangers of use, not of the benefits, this gives an unrealistic picture of how opioids are used in medicine. 

During the 1.5-day workshop, invited experts discussed the body of evidence.

After weighing evidence from the evidence report, expert presentations, and public comments, an unbiased, independent panel prepared a draft report that identified research gaps and future research priorities. The report was posted on the ODP Web site for 2 weeks for public comment.  

This article is an abridged version of the panel’s full report, which is available at https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/opioids-chronic-pain/workshop-resources#final report.

Chronic pain affects an estimated 100 million Americans, or one third of the U.S. population.

Although there are many treatments for chronic pain, an estimated 5 to 8 million Americans use opioids for long-term management.

Yet, evidence also indicates that 40% to 70% of persons with chronic pain do not receive proper medical treatment, with concerns for both overtreatment and undertreatment.

Together, the prevalence of chronic pain and the increasing use of opioids have created a “silent epidemic” of distress, disability, and danger to a large percentage of Americans

This is a much more realistic assessment of the cause of the “crisis”, which is that we do not have an effective treatment for pain except opioids. They are unfortunately addictive for those with the propensity to develop this disorder, less than 5% of the population.

The overriding question is:

Are we, as a nation, approaching management of chronic pain in the best possible manner that maximizes effectiveness and minimizes harm?

Evidence-based Practice Center (EPC)

The EPC review addressed evidence about the long-term effectiveness of opioids, the safety and harms of opioids, the effects of different opioid management strategies, and the effectiveness of risk mitigation strategies for opioid treatment.

Context

The expert panel considered in detail many contextual issues that affect understanding about the dilemma of opioid use and chronic pain

The burden of dealing with unremitting pain

  • can be devastating to a patient’s psychological well-being and
  • can negatively affect their ability to maintain gainful employment or achieve meaningful professional advancement.
  • can affect relationships with spouses and significant others;
  • may limit engagement with friends and other social activities; and
  • may induce fear, demoralization, anxiety, and depression.

Considering the wide scope and social significant damage to an individual suffering from chronic pain, it seems criminal that the most effective relief is being curtailed without providing other realistic options.

Health care providers, who are often poorly trained in the management of chronic pain, are sometimes quick to label patients as “drug-seeking” or as “addicts” who overestimate their pain.

Some physicians “fire” patients for increasing their dose or for merely voicing concerns about their pain management.

These experiences may make patients feel stigmatized or feel as if others view them as criminals and may heighten fears that their pain-relieving medications will be taken away, leaving them in chronic, disabling pain.

Some patients who adhere to their prescriptions may believe that their pain is managed adequately, but others using opioids in the long term may continue to have moderate to severe pain and diminished quality of life.

Although many physicians believe that opioid treatment can be valuable for patients, many also believe that patient expectations for pain relief may be unrealistic and that long-term opioid prescribing can complicate and impair their therapeutic alliance with the patient.

Although some patients gain substantial pain relief from opioids and do not have adverse effects, these benefits must be weighed against the problems caused by the vast number of opioids now prescribed and the fact that opioids are finding their way illicitly into the public arena.

Many historical factors have influenced opioid use. All currently available extended-release opioids have been approved for treatment of chronic pain on the basis of 12-week efficacy studies, although there are safety data for extended-release opioids from studies lasting a year (mostly open-label studies)

Many immediate-release opioids came on the market without approval from the U.S. Food and Drug Administration (FDA) for treatment of acute pain, but all received approval in recent years.

New opioids that were introduced on the market over the past decade, particularly those with extended-release formulations, were attractive to patients and clinicians, who perceived them as safe and effective despite limited evidence

Physicians have little training in how to manage patients with chronic pain and appropriately prescribe medications for them. Physicians are often unable to distinguish among persons who would use opioids for pain management and not develop problems with misuse, those who would use them for pain management and then become addicted, and those who request a prescription because of a primary substance use disorder.

Given these complexities, the panel struggled to strike a balance between the ethical principles of beneficence and doing no harm—specifically, between the clinically indicated prescribing of opioids on one hand and the desire to prevent inappropriate prescription abuse and harmful outcomes on the other

These goals should not be mutually exclusive, and in fact, approaches that attempt to achieve both simultaneously are essential to advance the field of chronic pain management.

The panel also grappled with making recommendations in the face of little empirical evidence and eventually formulated advice based on its synthesis of the EPC report (1), workshop presentations that focused on clinical experience, and smaller trials and cohort studies

Clinical Issues

Patient Assessment and Triage

Chronic pain is a complex clinical issue requiring an individualized, multifaceted approach. It spans a multitude of conditions, with varied causes and presentations. Persons living with chronic pain are often lumped into a single category, and treatment approaches are sometimes generalized without supporting evidence.

First, they must recognize that patients’ manifestation of and response to pain will vary, with genetic, cultural, and psychosocial factors all contributing to this variation.

Clinicians’ response to patients with pain may differ because of preconceived notions and biases based on racial, ethnic, and other sociodemographic stereotypes.

Treating pain and reducing suffering do not always equate, and patients and clinicians sometimes have disparate ideas about successful outcomes. A more holistic approach to the management of chronic pain that is inclusive of the patients’ perspectives and desired outcomes should be the goal.

Patients, providers, and advocates all agree that opioids are an effective treatment for chronic pain for a subset of patients and that limiting, disrupting, or denying access to opioids for these patients can be harmful.

These patients can be safely monitored by using a structured approach that includes optimization of opioid therapy, management of adverse effects, and follow-up visits at regular intervals.

The fact that some patients benefit while others do not, or may in fact be harmed, highlights the challenge of appropriate patient selection. Data are lacking on the accuracy and effectiveness of risk prediction instruments for identifying patients at highest risk for adverse outcomes (such as overdose or development of an opioid use disorder).

Yet, the panel heard from a workshop speaker that longitudinal studies have demonstrated risk factors (for example, substance use disorders and comorbid psychiatric illnesses) that are associated with these harmful outcomes, and some studies show that patients who are at high risk are most likely to be prescribed opioids and higher doses of them.

This makes no sense at all. It claims that being at high risk of addiction increases the likelihood of being prescribed opioids, almost as if high risk itself were a reason to prescribe them.

this is the problem with studies showing correlation: there is no way to tell whether there is a causative relationship and in which direction it applies and it’s possible that both are caused by an unknown third factor.

As usual, no mention is made of the pain the opioids were prescribed for.

Although evidence supporting specific risk assessment tools is insufficient, our consensus was that management of chronic pain should be individualized and should be based on a comprehensive clinical assessment that is conducted with dignity and respect and without value judgments or stigmatization of the patient.

The initial evaluation should include an appraisal of pain intensity, functional status, and quality of life, as well as an assessment of known risk factors for potential harm, including history of substance use disorders and current substance use; presence of mood, stress, or anxiety disorders; medical comorbidity; and concurrent use of medications with potential drug–drug interactions.

A redesign of the electronic health record may facilitate such an assessment, including integration of meaningful use criteria to increase its adoption. 

Finally, the incorporation of other clinical tools (such as prescription drug monitoring programs) into this assessment, although not well-studied, seems reasonable.

Patient characteristics can be used to tailor the clinical approach, with those screening at highest risk for harm being triaged to more structured and higher-intensity monitoring approaches.

Treatment Options

Data to support the long-term use of opioids for chronic pain management are scant.

Workshop speakers stressed the need to use treatment options that include a range of progressive approaches that might initially include nonpharmacologic options, such as physical therapy, behavioral therapy, and complementary and alternative medicine approaches with demonstrated efficacy, followed by pharmacologic options, including nonopioid pharmacotherapies.

The use of and progression through these treatment methods would be guided by the patient’s underlying disease state, pain, and risk profile as well as their clinical and functional status and progress

However, according to a workshop speaker, lack of knowledge or limited availability of these nonpharmacologic methods and the ready availability of pharmacologic options and the associated reimbursement structure seem to steer clinicians toward pharmacologic treatment, specifically opioids.

Yet I hear of no attacks on the insurance industry’s lack of coverage, even though it is here identified as a cause of too much opioid prescribing.

Why are patients and doctors blamed when insurance companies control the availability of non-opioid options?

The type of pain could influence its management.

Data were presented on 3 distinct pain mechanisms:

  1. peripheral nociceptive (caused by tissue damage or inflammation),
  2. peripheral neuropathic (caused by damage or dysfunction of peripheral nerves), and
  3. centralized (characterized by a disturbance in the processing of pain by the brain and spinal cord)

Speakers presented evidence that nearly all chronic pain may have a centralized component and suggested that opioids may promote progression from acute nociceptive pain to chronic centralized pain. However, several speakers and audience members cautioned against making blanket statements about who is or is not likely to benefit from opioids.

Yet that’s exactly what they went ahead and did, making blanket statements about pain, pain patients, and proper pain treatment, even though it was acknowledged that such statemens are inappropriate

Clinical Management

Clinicians have little evidence to guide them once they make the decision to prescribe opioids for chronic pain therapy.

In this, as in the rest of medicine, we should let experience guide doctors in their treatment decisions. That’s what we pay them for. 

Determination and Assessment of Outcomes

Patient assessments should be ongoing and should include both positive and negative outcomes.

The range of items on such assessments might include

  • pain intensity and pain frequency, using both a short time reference as well as a longer time frame for comparative purposes;
  • functional status, including effect on functions of daily living; quality of life;
  • depression; anxiety;
  • potential misuse or abuse of opioid medications;
  • potential adverse medical effects of opioids; and
  • other measures that mimic items obtained during the initial clinical risk profiling.

These frequent reassessments should guide maintenance or modification of the current treatment regimen, and patients who do not meet the mutually agreed-on clinical outcomes should be considered for discontinuation of opioid therapy.

This is no different than managing other complex medical issues, and is especially similar to the difficulties of treating depression. 

Adverse Events and Side Effects

Potential harms include

  • the risk for an opioid-use disorder,
  • increased risk for falls and fractures,
  • hypogonadism with resultant sexual dysfunction, and
  • myocardial infarction

The use of a more effective chronic disease care model based on a comprehensive biopsychosocial model of care may have implications for reducing the potential for a new generation of long-term opioid users.

But only if insurance companies start paying for them, which they do not.

Challenges Within the Health Care System

A major influence on opioid prescribing is the evolution of the larger health care system and the current state of primary care.

Pain is a multidimensional problem ranging from discomfort to agony and affecting physical, emotional, and cognitive function as well as interpersonal relationships and social roles.

Therefore, best practice models for chronic pain management require a multidisciplinary approach similar to that recommended for other chronic complex illnesses, such as depression, dementia, eating disorders, or diabetes

Unfortunately, team-based approaches to care for pain have largely been abandoned.

Instead, management of chronic pain has primarily been relegated to primary care providers working in health systems not designed or equipped for chronic pain management.

Primary care providers often face competing clinical priorities in patients with chronic pain because these patients often have multimorbidity and polypharmacy.

Time-consuming but important clinical tasks, such as conducting multidimensional assessments, developing personalized care plans, and counseling, have given way to care processes that can be accomplished more quickly and with fewer resources, such as prescription writing and referrals

In the case of pain management, which often requires substantial face-to-face time, quicker alternatives have become the default option. As a result, providers often prescribe opioids for pain even when other methods might be safer and more effective. Moreover, most practices do not have access to experts in pain management, including specialty pain clinics, or alternative approaches to pain management.

Payment structures and incentives are also important system-level facilitators for excessive opioid use.

Current reimbursement for evaluation and management may be inadequate to reflect the time and team-based approaches needed for integrative treatment.

The problem with pain care is fundamentally caused by insurance companies that don’t reimburse for multidisciplinary treatments, but only quick visits and generic prescriptions.

In some instances, payment structures place barriers to nonopioid therapy, such as formulary restrictions that require evidence of failure of multiple therapies before nonopioid alternatives (such as pregabalin) are covered.

Other payment structures, such as tiered coverage systems, keep nonopioid alternatives as second- or third-line options rather than placing them more appropriately as first-line therapy. Other incentives encourage prescribing opioids for several months at a time rather than prescribing them for a shorter period or using lower-volume prescriptions.

I do not understand why insurance companies have escaped blame for opioid overprescribing when they have clearly played a huge part in the situation.

Even worse, while everyone else is being blamed, these opioid-promoting insurance policies are not being blamed, attacked, and forced to change.

Finally, fragmentation of care across multiple providers and sites often leads to patients receiving prescriptions from multiple providers

Final Panel Recommendations and Summary

This may lead to inappropriate prescribing of not only opioids but also unsafe drug combinations,

The panel’s major recommendations are presented in the Table. Comments about specific research issues that merit further exploration are in the full report (https://prevention.nih.gov/programs-events/pathways-to-prevention/workshops/opioids-chronic-pain/workshop-resources#finalreport).

The increase in the number of Americans with chronic pain and the concurrent increase in the use of opioids to treat this pain have created a situation in which large numbers of Americans are receiving suboptimal care.

At the root of the problem is the inadequate knowledge about the best approaches to treating various types of pain, which balance effectiveness with the potential for harm, as well as a dysfunctional health care delivery system that promotes prescription of the easiest rather than the best approach to addressing pain

Particularly striking to the panel was the realization that evidence is insufficient for every clinical decision that a provider needs to make about the use of opioids for chronic pain, leaving the provider to rely on his or her own clinical experience.

Because of the inherent difficulties of studying pain and the large number of patients already receiving opioids, new research designs and analytic methods are needed to adequately answer the important clinical and research questions.

Until the needed research is conducted, health care delivery systems and clinicians must rely on the existing evidence as well as guidelines issued by professional societies.

Opioids are clearly the best treatment for some patients with chronic pain, but there are probably more effective approaches for many others

The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system. For the more than 100 million Americans living with chronic pain, meeting this challenge cannot wait.

 

Workshop Panelists

  1. David B. Reuben, MD, Chief, Geriatric Division, Director, Multicampus Program in Geriatric Medicine and Gerontology, Professor of Medicine, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California
  2. Anika A.H. Alvanzo, MD, MS, Assistant Professor, Medicine, Medical Director, Substance Use Disorders Consultation Service, Johns Hopkins University School of Medicine, Baltimore, Maryland
  3. Takamaru Ashikaga, PhD, Director, Biometry Facility, College of Medicine, University of Vermont, Burlington, Vermont
  4. Anne Bogat, PhD, Professor, Department of Psychology, Michigan State University, East Lansing, Michigan
  5. Christopher M. Callahan, MD, Professor of Medicine, Cornelius and Yvonne Pettinga Professor, Indiana University Center for Aging Research, Regenstrief Institute, Health Information and Translational Sciences, Indianapolis, Indiana
  6. Victoria Ruffing, RN, CCRC, Director of Patient Education, Director of Nursing, Johns Hopkins Arthritis Center, Johns Hopkins School of Medicine, Adjunct Faculty, Johns Hopkins School of Nursing, Baltimore, Maryland
  7. David C. Steffens, MD, MHS, Professor and Chair, Department of Psychiatry, University of Connecticut Health Center, Farmington, Connecticut.

Working Group

Chairpersons:

  1. David A. Thomas, PhD, Deputy Director, Division of Clinical Neurosciences and Behavioral Research, National Institute on Drug Abuse, National Institutes of Health, Rockville, Maryland, and
  2. Richard A. Denisco, MD, PhD, Services Research Branch, National Institute on Drug Abuse, National Institutes of Health, Rockville, Maryland.

Other members:

  1. Caroline Acker, PhD, Associate Professor and Head, Department of History, Carnegie Mellon University, Pittsburgh, Pennsylvania
  2. Jane C. Ballantyne, MD, Professor (retired), Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, Washington
  3. Wen G. Chen, PhD, Program Director, Sensory and Motor Disorders of Aging, Behavioral and Systems Neuroscience Branch, Division of Neuroscience, National Institute on Aging, National Institutes of Health, Bethesda, Maryland
  4. Edward C. Covington, MD, Director, Neurological Center for Pain, Cleveland Clinic, Cleveland, Ohio
  5. Jody Engel, MA, RD, Director of Communications, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland
  6. Roger B. Fillingim, PhD, Professor, University of Florida College of Dentistry, Director, University of Florida Pain Research and Intervention Center of Excellence, Gainesville, Florida
  7. Joseph T. Hanlon, PharmD, MS, Professor of Medicine and Health Scientist, Division of Geriatric Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania
  8. Christopher M. Jones, PharmD, MPH, Lieutenant Commander, U.S. Public Health Service, Team Lead, Prescription Drug Overdose Team, Division of Unintentional Injury Prevention, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, Atlanta, Georgia
  9. Margaret Kotz, DO, Director, Addiction Recovery Services, Department of Psychiatry-Adult, University Hospitals Case Medical Center, Professor, Psychiatry, Professor, Anesthesiology, Case Western Reserve University School of Medicine, Cleveland, Ohio
  10. Deborah Langer, MPH, Senior Communications Advisor, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland
  11. Elinore F. McCance-Katz, MD, PhD, Chief Medical Officer, Substance Abuse and Mental Health Services Administration, Rockville, Maryland
  12. David M. Murray, PhD, Associate Director for Prevention, Director, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland
  13. Elizabeth Neilson, MS, RN, Senior Communications Advisor, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland
  14. Ann O’Mara, PhD, RN, Head, Palliative Care Research, Community Oncology and Prevention Trials Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, Maryland
  15. Wilma Peterman Cross, MS, Deputy Director, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland
  16. Bob A. Rappaport, MD, Director, Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland
  17. David B. Reuben, MD, Chief, Geriatric Division, Director, Multicampus Program in Geriatric Medicine and Gerontology, Professor of Medicine, Division of Geriatrics, David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles, California
  18. Wendy B. Smith, PhD, MA, BCB, Director for Research Development and Outreach, Office of Behavioral and Social Sciences Research, Office of the Director, National Institutes of Health, Bethesda, Maryland
  19. Michael Von Korff, ScD, Senior Investigator, Group Health Research Institute, Group Health Cooperative, Seattle, Washington
  20. Paris A. Watson, Senior Advisor, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland
  21. Jessica Wu, PhD, Health Scientist, Office of Disease Prevention, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health, Bethesda, Maryland.

References

  1. Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, et al. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention workshop. Ann Intern Med. 2015; 162:276-86.
  2. Substance Abuse and Mental Health Services Administration. Results from the 2013 National Survey on Drug Use and Health: Summary of National Findings. NSDUH series H-48. HHS publication no. (SMA) 14-4863. Rockville, MD: Substance Abuse and Mental Health Services Administration; 2014.
  3. Warner M, Hedegaard H, Chen LH.  NCHS Health E-Stat: Trends in Drug-poisoning Deaths Involving Opioid Analgesics and Heroin: United States, 1999–2012. Atlanta, GA: Centers for Disease Control and Prevention; 2014. Accessed at http://www.cdc.gov/nchs/data/hestat/drug_poisoning/drug_poisoning.htm on 22 December 2014.
  4. Gomes T, Mamdani MM, Dhalla IA, Cornish S, Paterson JM, Juurlink DN. The burden of premature opioid-related mortality. Addiction. 2014; 109:1482-8.

Having only 4 references for this whole document shows how incredibly little evidence was used. Plus, 75% of them are studies about the harms of opioid use, not any benefits.

Sponsors

  1. NIH Office of Disease Prevention (David M. Murray, PhD, director),
  2. NIH Pain Consortium (Story Landis, PhD, chair),
  3. National Institute on Drug Abuse (Nora D. Volkow, MD, director), and
  4. National Institute of Neurological Disorders and Stroke (Story Landis, PhD, director).

See Also: The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.

See my blog post on this:
The Effectiveness and Risks of Long-Term Opioid Therapy for Chronic Pain

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