“High Dosage”
Opioid Management Considerations
in Treating Intractable Pain



By J.S. Hochman, MD,
Executive Director NFTP
Practical Pain Management; 5(2); page 39;
March 2005



INTRODUCTION


One out of every three people in the United States experiences some form of chronic pain that requires medical attention during their lifetime[1] The treatment of intractable pain is protected by Intractable Pain Acts in 11 of the 50 states, by policies and guidelines in all 50 states, by the Model Intractable Pain Act adopted by the National Federation of State Medical Boards, by the World Health Organization, by the Joint Commission on Accreditation of Healthcare Organizations, and by the professional statements and policy guidelines of the U.S. Drug Enforcement Agency, the American Academy of Pain Management, the American Pain Society, the American Society of Addictive Medicine, the American Pain Foundation, and the National Foundation for the Treatment of Pain.

In 1995, the World Health Organization published the following recommendations:

(a) WHO should expand its efforts to provide Governments with information about its analgesic method for the relief of cancer pain and to educate the public, health professionals and policy makers about the rational medical use of narcotic drugs, including the analgesic method for the relief of cancer pain;

(b) WHO should continue to inform the public, health professionals, competent authorities and policy makers about the correct definition of terms regarding dependence, as well as their significance or lack of significance when narcotic analgesics are used to treat cancer pain under medical supervision;

(c) WHO should, in cooperation with the Board, assist Governments in developing adequately controlled drug distribution systems that are capable of providing narcotic drugs to patients in hospitals and in the community;

(d) WHO should encourage health-care organizations to communicate with national narcotic control authorities about the rational use of narcotic drugs, legal requirements, unmet medical needs and impediments to availability;

(e) WHO should expand its efforts to develop methods that can be used by governmental and nongovernmental organizations to identify impediments to the appropriate medical availability of narcotic drugs;

(f) WHO should continue to evaluate whether national essential drug lists and formularies contain the narcotic drugs that are needed for cancer pain relief;

(g) WHO should inquire into the extent to which and the reasons why non-narcotic drugs are used in lieu of narcotic drugs for the treatment of severe pain, including the medical and regulatory factors behind that approach.


The American Medical Association has reported that 25 million Americans suffer from intractable pain. It is now widely accepted that virtually all chronic medical conditions result in intractable pain. There is no longer any substantive opinion that denies the existence of intractable pain or the legitimacy of its treatment.

OPIOID MANAGEMENT OF CHRONIC PAIN

The use of opioids to manage pain is recommended by the World Health Organization as one step in a “ladder of treatment” of pain. The simple logic of the WHO guidelines supports the use of pain medications beginning at the least potent, and progressing up the pharmacological ladder of potency (and potential for physiological harm). The use of opioids is guided by the universally accepted principles of pharmacology, as with all medications. These principles call for:

  • Choice of the category of medication appropriate to the medical symptoms being addressed;

  • Choice of the medication with the highest benefit to risk ratio;

  • Titration of the medication to maximal effectiveness;

  • Monitoring for adverse effects and complications;

  • Dose adjustment to minimize adverse effects;

  • Continued use of the medication concordant with the chronicity of the symptoms addressed.

Review of the pharmacology of opioids reveals that they are remarkably non-toxic. Unlike acetaminophen, NSAIDs, or steroids, the opioids have no specific organ toxicity. Their pharmacological dangers are strictly related to suppression of respiration and the development of addiction. Concerning the latter, review of the medical literature does not support the traditional view that use of pain medications in chronic pain patients leads to any significant incidence of addiction.

An objective and informed view of the use of opioids inevitably leads to the conclusion that the largest contemporary problem concerning opioids is the unavailability and inadequacy of pain treatment with opioids. Studies have shown that 75% of cancer patients continue to receive inadequate pain relief. The Joint Commission on Accreditation of Healthcare Organizations concluded that poor in-patient pain management mandated the establishment of accreditation standards for pain care, including the charting of pain as the “fifth vital sign”.

Management of pain, despite the establishment of the in-patient standards in 2000, remains grossly inadequate. Today, fewer physicians are willing to provide medical management of intractable pain than only three years ago. According to testimony before the Food and Drug Administration (DEA), only approximately 4000 doctors in the United States currently provide long term opioid pain treatment. Ironically, while the controversy within medicine about the use of opioids in long-term and intractable pain has abated greatly in recent years, the political and law enforcement climate has deteriorated, so that fear of prosecution or sanction by the federal drug enforcement administration has significantly decreased the medical practice of opioid prescription for intractable pain.

This recent trend is counter-intuitive, as the technology of opioid pain medications has advanced rapidly in the last decade. Sustained release and long acting preparations of oxycodone, hydromorphone, morphine sulfate and fentanyl are now available, using contemporary drug-delivery technology[2]. Further, fentanyl is now available as an instant release “lolliop” for breakthrough pain, permitting near instantaneous absorption into the bloodstream through the buccal mucosa, circumventing the digestive tract.

These technologies permit the clinician to establish highly consistent opioid blood levels for periods of time extending from 8 to 72 hours. This completely eliminates the problems of the “opioid roller-coaster”, in which patients are exposed to widely varying blood levels over short periods of time. As with short-acting benzodiazepines, exposure to large boluses and rapidly changing blood levels appear to be associated with problematic episodes of physiological withdrawal and cognitive impairment. These are eliminated by the maintenance of consistent opioid blood levels.

Despite these new technologies, pain management remains largely unavailable in the United States. It is not uncommon for intractable pain patients to have to travel hundreds, and even thousands, of miles to find physicians willing to undertake the long-term management of their pain. Paradoxically, locating physicians willing to expose the patients to very expensive, even risky, invasive procedures is not a problem. The professional risks of opioid prescription are thought to explain this counterintuitive situation.



HIGH DOSAGE THERAPY

As there are no reliable guidelines for opioid dosing, the term “high dosage” is probably a misnomer. Unlike all other areas of pharmacology, a range of doses for pain medications has never been established. The clinically practical dosage spectrum extends from the minimal dose required to accomplish clinically adequate pain control, to the maximum dose required to accomplish the same goal, without inducing respiratory depression.

In chronic, severe and complex pain management cases, establishing an effective dose, schedule and regimen, can be quite challenging. Many intractable pain patients are opioid resistant, most often from exposure to very high doses of short-acting medications. In such cases, the insufficiency of the opioid doses prescribed induces the patients to request higher doses - in such instances the cases are further complicated by the misperception of these patients as “drug-seeking”. The concept of “pseudoaddiction” has clarified this phenomenon.

Further, if clinicians will adhere closely to the diagnostic criteria for true addiction, this confusion and mislabeling can easily be avoided. There is a dramatic difference between the patient seeking a regimen that effectively contains their pain, and addicted patients seeking escalating doses of medications to induce euphoria. As has been observed previously[3] addicts are easily distinguished from legitimate pain patients.

Having qualified the term “high dosage”, the discussion of dosage can now be focused on the issue of efficacy. In the view of this author, the term “high dosage” is not useful. More helpful is the recognition that the only issue is effective relief of the patient’s pain. Dosage, schedule and regimen should be evaluated only by success in maximizing the patient’s functionality without inducing cognitive impairment or compromising respiration. When the patient’s function can be improved to the extent that they are able to achieve a reasonable quality of life, perform activities of daily living, and contain their pain below a “5” level,[4] the amount and variety of opioid medication required is irrelevant.

In my own practice, admittedly skewed by the severity and complexity of the cases most often referred to my practice, doses of OxyContin in the range of 160 to 240 mg q 8 hours are not unusual. Similarly, MSContin doses of 240 to 360 mg Q8 hours, methadone 60 to 100 mg twice or three times daily, fentanyl in the transdermal patch of 150 to 250 micrograms/hour, Q48 to72 hours, are commonplace. When titrated carefully to effectiveness, patients achieve dramatic improvement in pain levels and function, with no evidence of adverse effects, medical complications or addiction. Physiological dependency is routine, but entirely manageable. Addiction is non-existent in our most recent series of 204 patients followed for four years[5].

In summary, the term “high-dosage” opioid therapy should probably be avoided, as it is misleading and indefinable. The most clinically useful term would be “effective pain containment” dosage. It is definable as the dosage, schedule and regimen necessary to successful contain the patient’s pain between the 3 – 4 level with maximal functionality and no cognitive impairment or respiratory depression.



[1] Markenson, J.A. Mechanisms of chronic pain. AmJ.Med. 1996:101(1A):6S-186.
[2] See OxyContin, Palladone, MSContin, Duragesic
[3] Distinguishing Intractable Pain Patients from Addicts, J.S.Hochman MD, Practical Pain Management, June-July 2004.
[4] See Pain Scale, J.S.Hochman MD, on Pain_Chem_Dependency_LIST, 2004, [email protected] and below.
[5] In manuscript.




scale



Many patients have complained that the 0 to 10 pain scale is too vague. The following is a scale with definitions that will henceforth be used by the National Foundation for the Treatment of Pain.

Comments and suggestions are welcome.

J.S.Hochman MD



0 No pain

  1. Occasional pain effectively managed by Aspirin, Tylenol, Ibuprofen, one tablet, three times a day or less - or by opioids with no limitations on activities of daily living.
  2. Frequent pain, managed only by 1 or more tablets of ASA, acetamenophen, ibuprofen, every four hours - or by opioids with slight impairments of actitivities of daily living.

  3. Frequent pain, not effectively managed by NSAIDs, requiring an opioid medication, but not restricting daily activities of living

  4. Frequent pain, moderately affecting activities of daily living, but still controlled by opioids medications

  5. Frequent or almost constant pain. Contained by opioids, but still causing significant limitations on activities of daily living and occasionally causing the patient to be house or bed confined

  6. Constant pain, moderately contained by opioids, but with frequent limitations of activities of daily living. Frequently causes confinement to bed or the house.

  7. Constant pain, only partially contained by opioids at the doses prescribed, with continuous limitation of activities of daily living

  8. Constant pain, frequently disabling, making most activities of daily living difficult if at all possible

  9. Constant pain, uncontained by prescribed medications and doses, completely disabling of activities of daily living, requiring interventions or assistance by others, preventing any form of employment and fully qualifying the patient for Social Security Disability

  10. Intolerable pain requiring emergency room treatment, generally with opioids injections.







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