National Institutes of Health Pathways to Prevention Workshop: The Role of Opioids in the Treatment of Chronic Pain | February 2015 | Position Papers
This thorough and inclusive process and resulting report seems to have been buried under all the noise about the secret CDC guidelines in the works.
This National Institutes of Health (NIH) Pathways to Prevention Workshop was cosponsored by the NIH Office of Disease Prevention (ODP), the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.
During the 1.5-day workshop, invited experts discussed the body of evidence
The process described here is in complete contrast to the CDC actions:
Concerns About the CDC Guideline Process
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. Approximately 25 million have moderate to severe chronic pain that limits activities and diminishes quality of life. Pain is the primary reason that Americans receive disability insurance, and societal costs are estimated at between $560 billion and $630 billion per year due to missed workdays and medical expenses.
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
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?
The Evidence-based Practice Center (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.
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. It 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.
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.
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. 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.
Finally, fragmentation of care across multiple providers and sites often leads to patients receiving prescriptions from multiple providers
This may lead to inappropriate prescribing of not only opioids but also unsafe drug combinations
Final Panel Recommendations and Summary
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.