A Clinical Ethics Approach to Opioid Treatment of Chronic Noncancer Pain, AMA Journal of Ethics. June 2015,
A critique of Ballantyne JC, Fleisher LA. Ethical issues in opioid prescribing for chronic pain. Pain. 2010;148(3):365-367. by Mitchell J. Cohen, MD, and William C. Jangro, DO
We are writing both to respond to Ballantyne and Fleisher’s 2010 article on the ethics of opioid prescribing  and to join the authors in calling for continued progress in rational, ethical, and practical decision making surrounding the use of opioids in the treatment of patients with noncancer chronic pain.
Given the current state of knowledge regarding long-term opioid treatment, we suggest that dilemmas associated with this treatment are best approached using patient-centered clinical ethics.
We believe principle-based, deontological, and classical Hippocratic ethical approaches have less relevance in sorting out current controversies surrounding opioid treatment.
Even though there is widespread consensus about the majority of uses for opioids for chronic malignant pain, approximately 50 percent of cancer patients still face barriers to pain care.
If this is the status of pain care in cancer, an area about which there is reasonable ethical consensus, it is not surprising that noncancer chronic pain is even less adequately addressed
Ballantyne and Fleisher trace the most recent wave of arbitrary limitations on opioid prescribing to the early twentieth century, when physician influence on treatments offered to patients began a steady decline
This decreasing influence has been ascribed to a combination of factors, including
- increased regulation of the manufacture, trade, and prescription of opioids;
- stigmatization of opioids through special prescribing requirements and criminalization of addiction ;
- expanded tracking and limitation of physician practice through “managed” care;
- attention to control of medical “utilization”; and
- physicians’ fear of review by state licensing boards
Progress in managing these potentially restrictive forces has required advocacy from patient groups, professional pain treatment organizations, and coalitions of these and other stakeholders
Need for Pain Treatment and Status of Data on Opioid Treatment
Across the United States and Europe, up to 55 percent of patients suffer some degree of chronic pain, and up to 19 percent report chronic pain of moderate or higher intensity; an additional group, as large as 10 percent of the population, have disabling pain that undermines daily function and freedom to pursue goals and interests
Since the early twentieth century, we have also learned a great deal more about opioids in chronic pain treatment. Opioids work on nociceptive and neuropathic pain states, compare favorably with gold-standard antineuralgics like tricyclics and anticonvulsants in certain disorders, have a reasonable safety profile, if properly titrated and taken as prescribed, do not necessarily impair psychomotor speed or prohibit driving or working, and can reduce pain and improve quality of life in conditions studied.
Data from animal studies raise concerns that chronic use of these drugs at high dosages may lead to hyperalgesia and opioid insensitivity, but it remains unclear whether such phenomena occur in humans
During the recent quarter century of more liberal use of opioids for noncancer pain, no well-designed studies of treatment longer than 16 weeks have been published. This lack of published efficacy data for the past 25 years is a scientific stumble, if not an ethical oversight, that demands correction
Ethical Approaches to Opioid Treatment of Noncancer Pain
We believe that the lack of data makes deontological and principle-based ethics difficult to apply.
These are deductive forms of ethical reasoning to the extent that they rely on applying overarching concepts to data to resolve particular patient dilemmas.
If we don’t have long-term outcome data, deontological imperatives like “minimize suffering” and principles like “justice” become vague.
Lack of data leaves us uncertain about whether painful suffering addressed in the short term might be replaced in the long term by different suffering (e.g., side effects), and it is hard to determine whether equal access is a moral fairness imperative in the case of an as-yet-unproven long-term therapy.
This would be true if opioids were only one of several options for pain relief, but since they are the very last resort for so many of us, there really are no alternatives.
A twice weekly $120 massage, a weekly $140 acupuncture treatment, and a monthly $100 chiropractic treatment would probably be helpful, but they only provide temporary relief. Most of these alternative treatments require regular “doses” to maintain the pain relief, just like with medications, but at 100 times the price.
Of course, insurance companies know better than to cover these scientifically unproven practices, which may work, or may not, especially since their cost quickly accrues to astronomical amounts.
And, paying only for 13 sessions per year does NOT cover the amount of treatment needed, just like 13 doses of opioids aren’t enough.
For most patients, even out-of-pocket costs for generic opioids are affordable, while all other treatments are prohibitively expensive.
Certainly, foundational Hippocratic ethical values apply—for example, primacy of the patient-doctor relationship, confidentiality, and acting in patients’ best interest.
The last Hippocratic value is relevant to opioid treatment decisions since it requires physicians to deny inappropriate treatments requested by patients, no matter how much patients or their advocates want that treatment. Opioids for pain requested by a patient who is actively abusing alcohol would therefore be prohibited. Beyond this emphasis on the clinical obligation to “say no” when opioids are not appropriate, Hippocratic values have no particular ability to clarify decisions about opioid treatment.
Since we don’t know the ultimate clinical value of chronic pain treatments, addressing the broader ethical and social questions like equal access and cost involves significant assumptions and speculation. In our view, therefore, clinical ethics can be most usefully applied to pain treatment at this time.
Six-Step Ethical Decision Making for Opioid Treatment
1. The first step is developing a patient’s pain narrative,
which includes noting the contextual and psychosocial factors affecting the patient. “Pain” is never an adequate chief complaint. Eliciting the narrative pain history is time-consuming and extends beyond inquiring about pain quality, intensity, and location(s) to learning about the person’s experience of living with chronic pain.
- How do particular pains limit function;
- how much fear and anticipation of pain are involved;
- to what degree are sleep and circadian rhythm disrupted;
- do psychiatric comorbidities like depression, anxiety, and substance use disorders (which often complicate pain-related suffering) play a role;
- do seasonal changes affect the pain; and
- what patient behaviors are relevant, helpful, or problematic?
2. The second step is attempting to identify pain pathophysiology and the pain generator(s) to the degree possible in the current state of our knowledge.
This step addresses the ethical duty to offer only those treatments that will be appropriate and effective.
Combined with the earlier statement about the impossibility of knowing beforehand how a treatment will affect a patient, this should mean a doctor has the ethical duty to offer any treatments that could possibly work.
Using opioids for poorly characterized or understood pain makes assessment of their efficacy difficult. Put simply, you must have reasonable clarity about what you’re treating to choose rational interventions and assess benefit.
If the pain is focused enough to be tracked and the physician has a reasonable sense of pain generator(s), opioid treatment may be appropriate to prevent or treat central nervous system changes—like reorganization of pain pathways, changes in dopamine levels and other neurochemicals, and lost density in cortical and precortical brain regions—that have been demonstrated in at least some patients with chronic pain.
If further clinical evidence demonstrates that such changes occur in large numbers of patients with chronic pain, if imaging of these changes becomes practical outside of research settings, and if these changes prove to be controllable with treatment, chronic pain itself, in the absence of clear pain generator(s), may become an adequate clinical indication for ethical treatment with opioids.
3. The third step, goal-setting, is the most critical. True to patient-specific practice, the goal-setting process is highly individualized and collaborative. Goals must be broader than pain reduction. Assessing only pain level—a single-variable outcome—is incongruent with the quality-of-life focus so central to clinical ethics
Specific behavioral goals to be met through opioid therapy must be accompanied by a clear description of realistic expectations for pain reduction (not elimination); discussion of side effects; and disclosure of the limitations of current knowledge, especially regarding long-term benefit. Realistic expectations of opioid therapy and possible complications have been shown to correlate with improved outcomes and increased patient satisfaction
4. Fourth, we periodically reassess patient progress and consider modifications to the treatment plan. Interventions that were unhelpful in this particular case (e.g., epidural injections or deep tissue massage) will be discontinued; others that helped (e.g., acupuncture, antineuralgic analgesics like gabapentin) will be continued. If opioids have been added, the same evaluation of whether to continue or discontinue treatment occurs.
5. In step five, goals accomplished are replaced by the next goals on the list from step three, and goals not yet completed are broken into smaller subgoals
6. In step six, fundamental treatment decisions are revisited in light of accrued clinical data. As pain diagnoses and treatment indications become clarified over time, as the benefits and side effects of treatments become real and not theoretical for a given patient, as shaping contextual and psychosocial factors become more evident, and as the patient’s own treatment preferences change with experience, these factors inform the ongoing decision making regarding continuation of opioid therapy.
Untreated chronic pain, both cancer-related and not, remains unacceptably prevalent and costly, even in medically sophisticated settings across the United States and Europe.
Available treatments for chronic nonmalignant pain have not been shown efficacious by robust data, whether the treatment in question is cognitive behavioral therapy, biofeedback, interventional anesthesia, or ongoing opioid medication.
Combining these treatments in the setting of multidisciplinary treatment programs, on the other hand, has been demonstrated efficacious in more than 60 studies, so the negative results may be partly due to studying available treatments in isolation.
Although we need better long-term data showing opioids’ efficacy, the same can be said for all available treatments for chronic pain.
In the meantime…
data to date suggest that opioids are at least partly efficacious for reducing pain and improving quality of life, with acceptable safety, for those with various chronically painful conditions.
Given the status of our current knowledge, we have suggested a six-step decision-making process for opioid treatment that is based in clinical ethics and relies on comprehensive evaluation and data accrued through longitudinal care.
Related in the AMA Journal of Ethics:
- Long-Term Opioid Treatment, May 2013
- Opioids for Nonmalignant Chronic Pain, March 2015
- Objectifying Chronic Pain: From the Patient to Diagnostic Metrics, May 2013
- Chronic Pain Patients and the Biomedical Model of Pain, May 2013
- Physicians’ Responsibility to Understand Patients’ Pain, May 2013
- Pain and Ethnicity, May 2013
- Why Must Pain Patients Be Found Deserving of Treatment? January 2008
- Gender Stereotypes in Pain Diagnosis, July 2008
- Education to Identify and Combat Racial Bias in Pain Treatment, March 2015