‘High Dosage’ Opioid Management
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- WHO should continue to evaluate whether national essential drug lists and formularies contain the narcotic drugs that are needed for cancer pain relief.
- 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.” The simple logic of the WHO guidelines supports the use of pain medications beginning with 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, Cox-II inhibitors and/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.
Scarcity of Opioid Treatment
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, only approximately 4,000 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 (i.e. OxyContin, Palladone, MSContin, and Duragesic). Further, fentanyl is now available as an instant release “lollipop” for breakthrough pain, permitting near instantaneous absorption into the bloodstream through the buccal mucosa and 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.