DRUG TREATMENT

General

Opioid analgesics are the mainstay of pain treatment for cancer patients for whom tumor treatment has failed. Highly successful treatment of nociceptive or somatic pain is possible with the opioid analgesic drugs currently available. These drugs are less successful in treating neuropathic pain. This distinction is important because in the former situation, when opioids are used, no ceiling effect will limit the dose required to provide relief, whereas in the latter situation, escalating the dose after some relief has been obtained may cause undesirable side-effects rather than additional pain relief.

Attitudes

Attitudes of health care providers are perhaps the most influential force in determining whether a cancer patient in pain is adequately relieved of his or her pain. Cultural forces almost universally influence the physician to perceive a patient as a substance abuser who makes atypical claims about their pain experience or about his or her response to treatment. The patientıs report of pain must be believed!

Physicians are also influenced by the prescribing practices of their peers to the extent that pharmacological knowledge is subordinated to the practice customary in the community; i.e., if customary prescribing results in under treatment, but is the community standard, it is likely physicians will adopt the community standard making under treatment of pain the norm. If adequate pain treatment is to be the norm, this vicious cycle must be broken. Proper pharmacological prescribing must replace customary prescribing. In customary prescribing outcome is ignored.


Knowledge Deficits

Information about dosing for opioid drugs contained in standard pharmacological textbooks was obtained primarily from studies of single doses of opioids given to patients who had post-operative pain. No long-term studies of the use of opioids were done. Consequently, information about dosing is limited to this population of patients. The pharmacodynamic (what the drugs do to the body) effects where studied in addict volunteers at federal penal institutions. None of the subjects had pain. Such studies would be analogist to studying insulin requirements and metabolism in subjects who did not have diabetes. New studies on pain patients, such as cancer patients, taking opioids long-term for pain reveal that significant differences between knowledge gained in the old studies and knowledge gain in the new studies. This difference shows up in critical areas: 1 ) pain is a natural antagonist to the analagesic effect of opioids making it necessary to provide a dose of analgesic that will overcome this antagonism. This is the rationale for, the proper dose is whatever it takes to relieve the pain, as the dictum for guiding prescribing analgesic drugs. 2) pain is also a natural antagonist to respiratory depression. Therefore, respiratory depression in pain patients is extremely rare, no matter what the dose of opioid required for the relief of pain. This is especially true in patients who have been taking opioids over a significant time period and are tolerant to opioids, and 3) psychological dependence (addiction) in cancer patients in pain who have no previous history of drug abuse rarely become psychologically dependent on opioids given for pain.

The facts about biotransformation of drugs (pharmacokinetics - what the body does to the drug before it gets to the site of action of the drug) are often not known, misunderstood, or ignored in prescribing opioids. Therefore, equianalgesic doses between oral and parenteral opioids are not prescribed. Oral medication is subject to the "first pass effect" as the absorbed dose is reduced by its first pass through the liver, whereas parenteral medication is delivered to the central nervous system without this reduction. Oral doses must be adjusted upward to compensate for this reduction in the quantity delivered to the opioid binding sites. The perception that oral doses are larger than parenteral doses is merely an illusion.


Regulations Regarding Prescribing Controlled Drugs in Texas

Certain drugs used to treat pain and side-effects of these drugs are scheduled under both the federal and State of Texas Controlled Substance Acts. This means their use is monitored and scrutinized by government agencies responsible for monitoring these drugs, more closely than non-scheduled drugs to prevent diversion to illegal use. Unfortunately, there is no common understanding between these agencies and physicians about what the standard of practice is for their use. This confusion makes physicians reluctant to prescribe them and accounts for one of the major reasons patients get inadequate treatment of their pain.

Texas has made significant strides since 1989 to clarify the confusion about using opioids, and other controlled substances, for pain treatment and encouraging their use. In 1989 the legislature passed the Intractable Pain Treatment Act (IPTA) (Article 4495c V.T.C.A.). The major features of the Act are: 1) defines intractable pain, 2) permits the physician to prescribe controlled substances after he/she makes a diagnosis of intractable pain without regard to the etiology of the pain (malignant or benign), 3) prohibits a hospital or other health care facility from interfering with a physicianıs prescribing these drugs for an appropriately diagnosed intractable pain condition, and 4) prohibits the Texas State Board of Medical Examiners from imposing sanctions on physicians who prescribe these drugs to treat intractable pain. In 1997 this Act was amended to permit the prescribing of opioids to current substance abusers (addicts) or individuals who have a history of drug abuse who develop acute or chronic painful medical conditions. Two major categories of diseases where this situation may occur are cancer and AIDS patients. (See Appendix D, The Intractable Pain Treatment Act and its amendment, page --)

To further clarify the standards of practice for the use of Schedule II drugs for pain treatment, the Texas State Board of Medical Examiners (board) adopted rules in 1995 regarding their use. The significance of the board adopting rules is that rules have the same force as law. . An oversimplification of them is that any use of them is permissible so long as they are prescribed for a legitimate medical purpose during the usual course of medical practice and there is adequate documentation of the rationale for their use. (See Appendix E, Chapter 170. Authority of Physician to Prescribe for the Treatment of Pain, page --)


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