3. Pain management
23. Ethical considerations in interventional pain management
Mr. Summers presents to the pain clinic with a several-year history of chronic low back and posterior right leg pain. He describes his pain as 9/10, increased with activity. MRI shows a bulging disc on the right at L45. He has been told that he is not a surgical candidate. He is currently taking six oxycodone tablets per day, noting only temporary relief. He requests larger doses of opioids, but his primary care physician (PCP) has referred him to the clinic with only enough medicines to last until this appointment. The PCP has also indicated that any further pain management, including opioid prescriptions, will have to come from the clinic.
Mr. Summers is agitated and hostile, displaying exaggerated pain behaviors. He has difficulty sitting still during the interview, getting up several times to walk around. Physical examination is difficult to perform because he complains of tenderness with every area palpated, but there appears to be increased right paravertebral tone at the level of the top of the iliac crest. There is pain with extension of the right leg at approximately 70 degrees. Reflexes, strength, and sensory findings are normal other than “break away” weakness. EMG in the past was not completed because he could not tolerate the needle portion of the examination. Careful review of the MRI films shows a high intensity zone on the right at L45, and a mild central bulge at that level.
Evaluation of Mr. Summers suggests a lumbar radiculopathy from a leaking disk or referred pain from internal disc disruption. However, there is also concern that he is a drug-seeker. Management options include injection therapy (lumbar epidural, transforaminal epidural, discogram and possible intradiscal therapy) or more opioids (with or without adjuvant medications). He refuses injections, stating that a friend had injections, and “they didn’t help.” Furthermore, he states “the pills make the pain go away.”
Mr. Summers’ insurance will not cover discogram or intradiscal therapies, and requires preauthorization for even office injections. Insurance also covers only short-acting opioids or generic morphine ER, and Mr. Summers states that he has an “allergy” to morphine, which caused nausea. Should the pain specialist give Mr. Summers more opioids, discharge him, or insist on a trial of injections?
… the profession (of pain medicine) must be informed by scientific knowledge that is contemporary and progressive, but it must also be sensitive to the subjectivity of suffering, … to apply knowledge and skill … that ideally meets each patient’s individual medical needs…this is the basis of medicine as tekne … that combines … skill and … art and which is integrative … in the ideal1
In 1847, the code of ethics published by the American Medical Association stated “… from the age of Hippocrates to the present time, the annals of every civilized people contain abundant evidences of the devotedness of medical men to the relief of their fellow-creatures from pain and disease …”2 Despite the intrusion of insurance forms and changing reimbursements, medicine in general and pain medicine specifically continues to be a humanitarian pursuit with goals of relieving suffering and restoring function. Patients rely on physicians to be ethically responsible when recommending care or providing treatment. Pain patients are particularly vulnerable to exploitation, because of a desperation related to unrelieved pain, and the perception that a pill or an injection or a surgery will “fix” the problem. Therefore, each decision in pain medicine needs to be viewed from both a therapeutic and ethical perspective. Pain physicians must define the nature of pain, recognize the variability and subjectivity of its expression in the pain patient, acknowledge the vulnerabilities rendered by pain, describe the inherent characteristics and asymmetry of the patient-clinician relationship, and define the desired pain care end-point.3
With multidisciplinary or hospital-based pain clinics, a professional ethicist may be readily available to answer questions, offer advice, or arbitrate difficult decisions, such as whether the physician can ethically demand that a patient be subjected to interventional procedures in order to obtain opioid prescriptions. However, with the proliferation of independent pain physicians and clinics, the availability of multidisciplinary advice, include advice regarding ethics, is diminished. It then becomes incumbent upon the pain provider to resolve the ethical questions that are an inherent part of the care of pain patients.
According to James Giordano, ethicist for the American Society of Interventional Pain Physicians (ASIPP), the ethical crisis in pain care necessitates a three step process: identification of the problems, critical evaluation of various ethical systems, and “a description of how the structure and function of the practice –as a social good – might be enacted within a paradigm of (somewhat) non-hegemonious, integrative pain care.”4 Books such as this one attempt to provide the practical wisdom that is critical to understanding the ethical process. “Because if therapeutic and moral agency are conjoined in the sound practice of pain medicine, then the ethical character of each pain physician becomes instrumental in contributing to and maintaining the overall moral integrity of the profession.”5
Ethical principles of beneficence and nonmaleficence
An obvious precept of medical care is appropriate diagnosis of problems so that the most effective, and hopefully least harmful, treatment can be offered. One of the greatest limitations of pain management is therefore a lack of objective diagnostic tests. Internal medicine has blood sugar values and blood pressure readings, cardiology has ST depression, and dermatology has pathology results. In pain management, diagnostic testing is of limited utility, because positive findings only indicate the presence of potential causes. No test measures pain itself, which is the subjective experience that the patient reports. In the distant past, for example, a myelogram was the standard test to evaluate back pain. Virtually anyone undergoing a myelogram had reported having back pain, and when the test revealed an abnormality, it was assumed to be the cause of the pain, and not merely an incidental finding. MRI studies in asymptomatic patients, however, have now shown “surgically significant” radiologic findings in as many as 60% of asymptomatic patients.5 Even more concerning is that up to 40% of completely asymptomatic patients with positive MRIs are offered surgery, one harmful effect of poorly directed MRI over-testing. False positives are not just found in radiologic studies; 15% of asymptomatic patients will have nerve conduction studies that are compatible with the presence of carpal tunnel syndrome.6Radiologic and neurodiagnostic studies do not directly demonstrate “pain,” so how can the clinician tell if a patient is even really experiencing pain, or is falsely reporting pain for other motives – for example, to obtain narcotics?
The evaluation of pain involves a combination of clues in the history (“pattern recognition”), and a targeted physical exam. It may also require the use of diagnostic injections or other interventional procedures. “The cause of a disorder is hidden in the patient’s history and the site of the lesion is detected by physical exam.”7 In this model, diagnostic injections become integral to the evaluation process, much like an Xray to an orthopedic surgeon.
Ethical concerns regarding interventional diagnostic and therapeutic procedures include physician concerns for nonmaleficence, as well as conflicts of interest presented by third-party payers. By their nature, interventional procedures carry risks, both that there can be complications from the procedure and that the results will lead the physician to the wrong diagnostic conclusions and therefore an inappropriate therapeutic path. The subjective nature of pain reporting further complicates evaluation of procedural results. Complications may be mitigated by performing procedures in the safest environment possible, with the most up-to-date equipment, and by an experienced, highly-trained pain specialist. However, multiple factors not under the direct control of the physician or patient, such as third-party reimbursements, may have influence on such important safety factors as where and by whom pain procedures are performed.
Pain procedures can be provided in a variety of physical locations – the office, the hospital outpatient department, or a freestanding ambulatory surgery center. Although “minimally invasive,” many of the procedural injections are “maximally dangerous” with the risk of seizures, hypotension, and cardiac arrest. Specialized equipment, such as fluoroscopy and resuscitation equipment, which might mitigate this risk can be quite expensive. In addition, procedures done in the office incur a cost of supplies that, until recently, was not reimbursed. The same procedure done in the hospital or ambulatory surgery center (ASC), in contrast, may be much more expensive for the patient and the insurer. Some insurance programs, including Medicare, in an effort to move procedures out of the more expensive settings, have started to reimburse a “site of service differential” to help cover of the physician cost of providing these services in an office.
Ethical conflicts can arise when deciding where to schedule procedures, particularly if the pain physician involved has a financial interest in an ASC where he or she performs procedures – a situation which is increasingly common. Should the provider perform the procedure in the office (where the cost is low to the patient but the risks of inadequate facilities may be high) or at the ASC (where there would be equipment and personnel to handle emergency issues, but at a higher cost to the patient, and a potential financial conflict of interest for the physician)? Is the procedure being done in the best interest of the patient, or primarily for the financial gain of the provider? The current system of reimbursement in the Unites States, for example, favors serial, potentially ineffective or less effective injections (which keeps the patient coming back) rather than potentially more expensive, but curative treatment.
Insurance companies, in an effort to curb the escalating costs of health care, have at times simply denied a variety of “high tech” procedures because of their cost as a “supply side prudence.” But what happens once such technical tools are deemed reasonable and effective? If accessibility to new, more expensive treatments remains restricted, development of new treatments will be of little value.8Furthermore, assessment of the clinical effectiveness of the treatment should be as much if not more important than the cost when determining reimbursements and promoting effective pain practice. As new treatments are developed, when the efficacy of interventional procedures is unproven, insurance companies have sometimes cloaked denial of coverage not as “noncovered” service, but rather as “experimental treatment.” “Non-covered” is subject to appeal; “experimental” has less recourse. Payers then do not have to claim that the therapy is inappropriate, but merely that it is investigational because its efficacy is unproven.
Assessing efficacy of pain treatment can be difficult. Although there are journals filled with pain studies, studies of pain treatments have been remarkably difficult to do. Unlike blood pressure or HgbA1C, there are
no objective tests for pain, which is by definition a subjective experience. Pain scores, often on a scale of 0 to 10, are useful compare the improvement or lack thereof after an interventional procedure. Although many studies add, subtract and average pain scores, this does not necessarily express the patients’ pain experiences, since these numbers do not reflect discrete integers. Pain scores are not strictly linear, and can differ dramatically from patient to patient (Fig. 23.1).
Evidence-based medicine (EBM) is a concept designed to assist the clinician in the decision making process, and can be helpful in determining in general what clinical course to recommend. Studies can be enormously helpful in aiding medical decisions involving choices among competing alternative treatments. Clinical research, especially over the last few decades, as well as a spectacular increase in technological advances, has lead to a huge volume of relevant data and an increase in the complexity of trade-offs among various pain treatments. However, denying a treatment to an individual complex pain patient because it has not been shown to be the most effective for a population of patients may not be the best approach to an affliction that is highly individual in nature. In the words of Michael Gorback, “We seem to have lost the thread of EBM, which is to use the best evidence available, not deny anything without a positive RCT.”9
The pain patient is extremely vulnerable in the doctor – patient relationship. He or she is utterly reliant on the provider for continuing treatment of pain. If the patient requires opioid treatment, he or she has few other legal means by which to obtain it. Coercion by the physician is an ever-present possibility. In our case example, the physician may be tempted to threaten to withhold opioid prescriptions if the patient does not agree to undergo interventional pain procedures. Even if the physician does not intend to coerce the patient, the patient may nevertheless believe he or she had limited autonomy in deciding what therapeutic options to pursue, and which ones they may refuse.
Not only is the positive outcome of the procedure reliant on the skills and wisdom of the physician, but the negative outcome is as well. The physician has ethical obligations to be extremely vigilant, to confirm that the procedure is within the skill set of the provider, that the technique is the appropriate for this patient at this time, and that the diagnosis and proposed outcomes are as clearly defined as possible.
Professional treatment guidelines – do they help or harm?
Commonly prescribed medical treatments, such as exogenous estrogen to prevent heart disease in postmenopausal women and the efficacy of knee arthroscopies, have, in rigorous testing, not shown to be effective. Professional groups often review relevant clinical studies and physician experience in order to provide general advice about useful and non-useful treatments. It is widely held that adherence to guidelines should improve outcomes overall. However, guidelines do not encourage clinicians to consider and treat each patient as an individual, and do not necessarily stimulate original research. Guidelines are created by a laborious and artificial process, and at times may even be obsolete by the time they are published. They are often published with industry support, and can have a major impact on sales of industry products.10 Therefore, although well-constructed guidelines generally have positive effects on general patient outcomes, they nevertheless must be interpreted with their shortcomings and conflicts of interest in mind, and in the context of each individual patient’s situation.
Prescribing opioids: legal and ethical concerns
The prescribing of opioids is fraught with dangers for physician and patient alike. For patients, the risk of inappropriate use of opioids includes the risks of adverse side effects, ineffective (or less than optimally effective) pain management, problems of opioid tolerance, and in some cases even opioid addiction.
Legal implications in opioid prescribing
Pain management providers must deal with competing problems in pain management: under treatment of pain and opioid abuse. The consequences of over-prescribing as well as under-prescribing opioids can have profound legal implications. Providers who under-prescribe can be accused of abuse, while those who over-prescribe may be subject to charges of drug trafficking.
A number of systems guide and sustain the practice of caring for those who are in pain.11 The Drug Administration Agency (DEA) has strict penalties for providers prescribing without “a legitimate medical process,” who are therefore in violation of the law, and subject to civil and/or criminal penalties.12 Responsible health-care professionals must expect that they will be held accountable for their actions. Gone are the days when public trust was so complete that healthcare professionals were subject only to a limited sphere of oversight, accompanied by informal and very private sanctions when things had not gone well.13 In US vs. Shaygan,14 a Mayo Clinic trained internist was charged with 20 counts of prescribing without a legitimate medical purpose. He faced 20 years in prison for writing opioids for pain patients without aggressive treatment or monitoring. In Oregon and California, there have been two cases of physicians sued for under-treating patients. The California case resulted in an initial $1.5 million verdict against the physician (which was subsequently reduced). Another legacy of cases such as this are increasing state regulations of medical practice, such as a new California Law (AB 487) that requires every doctor in California to obtain 12 hours of CME credit in pain management and end-of-life care.15
In the US, the Federation of State Medical Boards policies16 include the following.
• Pain management is important and integral to the practice of medicine.
• Use of opioids may be necessary for pain relief.
• Use of opioids for something other than a legitimate medical purpose poses a threat to the individual and society.
• Physicians have a responsibility to minimize the potential for abuse and diversion.
• A complete patient evaluation should be performed.
• A written treatment plan should be given to the patient.
• Informed patient consent and agreement for treatment should be obtained.
• Periodic review of the course of treatment should take place.
• Physicians should show willingness to refer.
• Physicians should maintain complete and current medical records.
• Physicians may deviate from the recommended treatment steps if there is good cause.
The ethical issues of coercion (“I won’t write for pain medications unless you get an injection”), financial gain (injection treatment are much higher reimbursed compared to evaluation and management), opioidophobia (physician concern regarding opioid prescribing), as well as lack of education (“If a patient goes through withdrawal, that means the patient is addicted”), has led to a state of fear as well as greed among some physicians. The patient is caught in the middle, between inappropriate opioid use (both over-prescribing, which leads to iatrogenic addiction, and under-prescribing due to refusal to prescribe) and inappropriate injection therapy (which exposes the patient to multiple expensive but often ineffective treatments, with the concomitant risks of steroid side effects, nerve injuries, potentially increased pain, and possible death). A careful review of the agenda of both the patient and physician should help to clarify the issues of self-interest versus appropriate care.
An approach to the clinical problem
(1) Obtain an appropriate history of prior response to pain interventions.
Getting an accurate history of the initial response to prior injection therapy is critical to interpretating a subsequent negative response. For example, if there was no temporary response the another injection, it may indicate that the local anesthetic wasn’t in the right place (failure of accurate diagnosis or failure of accurate placement), or that the patient doesn’t respond to that local anesthetic, rather than that injection therapy has failed. A cohort of 1198 consecutive pain patients undergoing interventional procedures were interviewed regarding previous failure of temporary relief from injections or, if no prior injections, a history of difficulty getting numb at the dentist.17 Of 250 patients with this history were skin tested with lidocaine, bupivicaine, and mepivicaine, 36% (7.5% of the total number of patients) were noted to only be numb to mepivicaine, while another 17% (3.8% of the total) were numb only to lidocaine. Many, if not most, pain procedures are done with bupivicaine, which did not work on 10% of the total population and almost 50% of the patients with a prior failed procedure. In those patients in whom bupivicaine did not work, repeating the same procedure with the appropriate local anesthetic resulted in sustained relief in more than 60% of the patients.
(2) Perform a meticulous physical examination.
A meticulous physical exam, with attention to the most common pain generators, coupled with a recognition of common patterns of pain will help guide to the diagnosis, and from that the appropriate treatment. For example, pain radiating into the groin and the testicles (less commonly described into the vaginal region in women), coupled with the description from the male patient that his testicles “are in a vise” should lead to a directed physical exam of either the ilioinguinal nerve or the iliolumbar ligament.
(3) Use diagnostic procedures appropriately.
Based on the tenderness found on exam, a directed injection (with a peripheral nerve stimulator for the ilioinguinal nerve, or under fluoroscopy for the iliolumbar ligament), using the local anesthetic that works most effectively for this patient and a small dose of deposteroid if appropriate, may establish an accurate diagnosis. Based on the response of those injections, further therapy (cryoneuroablation for the ilioinguinal nerve, radiofrequency lesioning or regenerative injection therapy for the iliolumbar ligament) provides a rational, stepwise approach to the diagnosis and treatment of the presenting pain problem.
The provider discussed with Mr. Summers the inadvisability of long-term opioid therapy in the face of treatable disease, using an analogy of appendicitis (“It would be inappropriate to just give opioids to a patient with appendicitis, though you would be willing to support the patient while you wait for his medical condition to improve or the OR staff to arrive, and you would give opioids postoperatively as the surgical site heals”). After a discussion of the proposed etiology of the pain, and the need for an accurate diagnosis (“you can’t treat what you can’t diagnose”), and skin testing to identify the most appropriate local anesthetic, the patient agreed to undergo a diagnostic and potentially therapeutic transforaminal epidural. Because of the apparent neuropathic nature of the pain, an anticonvulsant was added to the short acting opioid. Although the desired effect would be improved pain relief and therefore decreased opioid use, the patient and physician also agreed to consider a long-acting opioid such as methadone as an alternative if there was not sustained improvement in the patient’s pain with the above interventions. After a detailed informed consent regarding the risks and potential complications of opioid use, and a screening urine drug test, patient was given a prescription for 1 month of opioids and an appointment for the diagnostic injection.
• A primary goal of medical care is the relief of suffering and restoration of function.
• Pain is a subjective patient experience, and one of the greatest limitations of pain management is a lack of objective diagnostic tests that identify and quantify pain.
• The use of interventional procedures to diagnose and treat pain involves ethical concerns of beneficence and nonmaleficence as well as potential financial conflicts of interest for the physician.
• Third party payers exert additional influence on reimbursements, and the locations where pain procedures can be performed. This in turn can have affects on patient safety, as well as access to new procedures that might be deemed “investigational.”
• In pain management, patient vulnerability is a prominent feature of the doctor-patient relationship. Coercion, intentional or otherwise, is an ever-present possibility.
• Opioid prescribing is guided by both legal regulations and professional guidelines. In the US, the Federation of State Medical Boards has express policies on pain management and the obligations of physicians involved in opioid prescribing.
1* Giordano, J. and Jonas, W.J. (2007). Asclepius and Hygieia in dialectic: philosophical, ethical and pragmatic bases of an integrative medicine. Integrative Med Insights, 2, 89–101.
2* American Medical Association. (1847) Code of Medical Ethics of the American Medical Association. Chicago: American Medical Association Press.
3 Giordano, J. and Schatman, M.E. (2008). An ethical analysis of crisis in chronic pain care: facts, issues, and problems in pain medicine; Part 2. Pain Physician, 11, 589–595.
4* Giordano, J. (2008). Ethics of, and in, pain medicine: constructs, content, and contexts of application. Pain Physician, 11, 391–392
5 Jensen, M.C., Brant-Zawadzki, M.N., Obuchowski, N., et al. (1994). Magnetic resonance imaging in the lumbar spine in people without back pain. NEJM, 331, 69–73.
6 Artoshi, I., Gummesson, C., Johnsson, R., et al. (1999). Prevalence of carpal tunnel yndrome in a general population. JAMA, 282(2), 152–8.
7 A. Staal, Department of Neurology, Leyden University, Holland.
8 Giordano, J. and Schatman, M.E. (2008). An ethical analysis of crisis in chronic pain care: facts, issues, and problems in pain medicine; Part 3. Pain Physician, 11, 775–84.
9 Michael Gorback, MD, Center for Pain Relief, Houston, TX.
10 Amerlinga, R., Winchester, J.F., and Ronco, C. (2008). Guidelines have done more harm than good. Blood Purif, 26, 73–6.
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13 Brushwood, D.B. (2001). From confrontation to collaboration: collegial collaboration and the expanding role of pharmacists in the management of chronic pain. J Law Med Ethics, 29, 69–83.
14 United States v. Shaygan, Case No. 08–20112-CR, 2009.
15 Wilner, A. (2008) Medical-legal aspects of managing chronic pain. AAPM 19th annual meeting. Nashville, TN.
16 Federation of State Medical Boards. www.fsmb.org.
17 Trescot, A. (2003). Local anesthetic “resistance.” Pain Physician, 6, 291–3.