Alexander DeLuca, M.D.
1. In using opioids, standard pharmacological principles shall be followed.
2. Standard pharmacological resources (such as the Physicians Desk Reference) should be utilized in the choice of initial doses and schedules. But substantial variations occur in patient responses to various drugs and in patient metabolism of these drugs. These standard resources do not reflect these variations and are not the final word on dosing. But they are useful references and should be utilized in the choice of initial doses and schedules – particularly when the physician lacks substantial experience in adjusting treatment to patient response.
a.As no maximum dose or schedule exists for any opioid medication, the maximum dose or schedule utilized shall be determined only by clinical outcome.
b. Respiratory depression is the principal clinical event that shall be used to determine maximum dose and/or schedule. Patients shall be carefully instructed in observing for this adverse event and in the appropriate actions that should be taken in the event of respiratory depression. Other adverse effects, such as sedation, nausea, itching, and constipation should be managed symptomatically and noted in the record. If adverse effects continue to be severe, and cannot be symptomatically relieved, alternative opioids should be substituted.
c. Physiological dependency shall be carefully explained to patients and distinguished, in writing, from Addictive Disorders. Physiological dependency, in which a syndrome of physiological symptoms occur when the drug is reduced in dose or withdrawn, shall be clearly distinguished from an addiction, in which the compulsive use of a substance, often in escalating doses unauthorized by the physician, continues despite the clearly destructive consequences to the user - physically, legally, functionally and socially. Patients shall be carefully instructed in this distinction, with clear emphasis that when the use of a drug results in improved functionality and reduced symptoms, it shall not be misidentified as an addiction.
d. Pseudoaddiction, in which the patient seeks additional medication because they have not been prescribed sufficient medication to contain their pain, shall not be misidentified as addiction, and patients suffering this situation shall not be pejoratively labeled as "drug-seeking".
e. Patients will NOT be misinformed that the use of opioid substances will lead to addiction, as there is no scientifically defensible evidence that this occurs.
f. Patients will not be misinformed that opioids cause organ toxicity or brain damage.
3. Opioids shall be employed only to relieve pain and suffering in which:
a.A diagnosis has been reliably established, if possible. This can be achieved by the summation of prior medical treatment and medical records; through the consensus of medical specialists; or by the findings of appropriate diagnostics. However, when pain is present and the diagnosis remains elusive or undeterminable because of the limits of current medical knowledge, the physician must believe their patient - unless there is a scientifically defensible basis for concluding that the patient is malingering or reliable evidence emerges that reveals the pain is factitious. Physicians operating in good faith, utilizing these principles, shall not be held legally or professionally responsible for patient duplicity.
b. The pain must be treated by all available modalities - pharmacological, physiatric, psychiatric, psychological, interventional, surgical, adjunctive and alternative, with the choice of priorities and emphasis determined by the physician and patient in collaboration. As new knowledge emerges about the neurophysiology of pain, it will be clinically incorporated as fast as it becomes available. The first priority shall always be to achieve the quickest, most efficient and effective, lasting and helpful, relief possible. Suffering, functional impairment, deterioration and compromise in activities of daily living, all resulting in an unacceptably compromised Quality of Life, are incompatible with the standard of care when treatment alternatives to prevent this are available. An acceptable Quality of Life shall be defined as a Life that any ordinary person would find acceptable.
4. Pain levels will be assessed, based upon a consistent set of written criteria (see below), on a regular basis in evaluating the effectiveness of opioid treatment and the goal of treatment will be to contain the pain to a level no higher than 3 or 4, if clinically possible. If pain levels exceed 7 - 8 on a regular basis, despite an adequate trial as to dose, schedule and combination of agents, interventional treatment with injections, an opioid pump, or spinal cord stimulator, should be considered and appropriate consultation sought from a qualified specialist. Under no circumstances will recurrent pain levels of 10 be permitted to occur.
5. Progress in treatment will be assessed on a regular basis, but no less than every three months. A written record of progress in range of motion, activities of daily living, and pain levels will be consistently recorded in the patient’s records. This can be done both by physician notations or patient reporting. Pain control sufficient to permit progress in vocational activities and financial self-sufficiency will be accepted as prima facie evidence of the legitimacy and necessity of medical management of pain with opioids. In some patients illness is so severe that "progress" is not possible. As with the dying, for these patients palliative pain care is completely appropriate and acceptable.
6. These regulations confirm that legitimate pain patients have an absolute right to treatment adequate to contain their pain at levels acceptable to an ordinary person.
7. Opiophobia is herewith stated to be the categorical opposition to the use
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