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
Patient vulnerability
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.
Informed consent and the pediatric patient
The use of ethics consultation regarding consent and refusal
Revising the Uniform Anatomical Gift Act – the role of physicians in shaping legislation
Conflicts of interest in research funding
Physician conscientious objection in anesthesiology practice
Opioid therapy in addicted patients: background and perspective from the US
• 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.
Related posts:
Informed consent and the pediatric patient
The use of ethics consultation regarding consent and refusal
Revising the Uniform Anatomical Gift Act – the role of physicians in shaping legislation
Conflicts of interest in research funding
Physician conscientious objection in anesthesiology practice
Opioid therapy in addicted patients: background and perspective from the US
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