Management of Cancer Pain. Clinical Practice Guideline No. 9. AHCPR Publication No. 94-0592. Rockville, Md. Agency for Health Care Policy and Research, U.S. Department of Health and Human Resources, Public Health Service. March 1994. This is available at their website at http://text.nlm.nih.gov/. (Search clue: Search their HSTAT collection with the following words: barriers, effective, pain, management.)
Pain management is often needlessly suboptimal (Table 2). Health care professionals are seldom trained in pain management , may not realize the importance of pain management or recognize that a patient is in pain , and may fear prescribing opioid medications.
Like some clinicians, patients and families may shun the use of opioids and, because of their fears of addiction and worries about tolerance, may not complain about pain or about poor pain relief. Therefore, the panel recommends that clinicians include patient and family education about pain and its management in the treatment plan.
Another barrier is that pain management has not traditionally been a priority of the health care system. Pain treatment may not be reimbursed or readily accessible, and institutions may be more concerned about a patient's possible opioid addiction or the diversion of controlled substances than about optimizing pain relief. Clinicians should reassure patients who are reluctant to report pain and who fear addiction and unmanageable side effects that there are many ways to relieve pain safely and effectively. Talking with clinicians knowledgeable about pain management and reading the consumer versions of this guideline (Jacox, Carr, Payne, et al., in press) should help patients and their families to overcome fears and concerns that hinder effective pain relief.
Problems related to the health care system and suggestions for resolving these are addressed extensively elsewhere (Angarola and Wray, 1989; Cain and Hammes, in press; Cleeland, Cleeland, Dar et al., 1986; Cleeland, 1987; Ferrell and Griffith, in press; Hammes and Cain, in press; Hill, 1993; Joranson, in press; Kolassa, in press; Shapiro, in press, a, Shapiro, in press, b). Two of the problems restrictive regulation of controlled substances and reimbursement policies are discussed briefly here.
The Federal government attempts to ensure the availability of opioid analgesics for legitimate medical and scientific purposes while controlling the abuse and illegal diversion of such substances (Shapiro, in press, a). The Controlled Substances Act (CSA) is one of the principal Federal laws that affects the use and availability of controlled substances, including opioid analgesics. The CSA provides for the registration of all handlers of controlled substances, as well as for the labeling, order forms, recordkeeping, and reporting of substances or their use. These activities enable enforcement agencies to identify manufacturers, distributors, clinicians, and pharmacists who divert controlled substances for illicit uses. The CSA also includes provisions that explicitly aim to avoid interference with the availability of U.S. Food and Drug Administration (FDA)-approved drugs for legitimate purposes. The CSA does not restrict a clinician's medical decision about which drug to prescribe, in what amounts, or for what duration, although it does prohibit physicians from prescribing opioids to maintain narcotic addiction unless the physician is separately registered to treat addiction. "Addict" is defined in the CSA as one who habitually uses an opioid drug so as to endanger public health or safety or one who has lost control over opioid use (Controlled Substances Act, 21 U.S.C., sec. 802). This definition rarely applies to a patient being treated with opioids for cancer pain (Kanner and Foley, 1981). Furthermore, Federal controlled substances regulations clarify that the Federal law is not intended to impose limitations on a physician's ability to prescribe opioid analgesics to persons with intractable pain in situations where no relief or cure is possible or none has been found after reasonable efforts (21 CFR 1306.07(c)).
State laws vary greatly, and many restrict or regulate the prescribing of opioids in the treatment of pain in ways that Federal law does not. For example, many State drug diversion laws contain ill-defined terms that in effect restrict opioid prescribing (Joranson, 1990). Other State laws also regulate pain treatment by restricting medication prescriptions to a specific number of dosage units or to a 1-month supply, or by monitoring the prescription of controlled substances through multiple-copy prescription programs. WHO has observed that although multiple-copy prescription programs are intended to reduce careless prescribing, "Health care workers may be reluctant to prescribe, stock or dispense opioids as they feel that there is a possibility of their professional licenses being suspended or revoked by the governing authority in cases where large quantities of opioids are provided to an individual, even though the medical need for such drugs can be proved" (World Health Organization, 1990). In States with formal cancer pain initiatives, health professionals have worked with State agencies to identify and remove legal impediments to the use of controlled substances for cancer pain (Dahl, Joranson, Engber, et al., 1988).
A 1990 revision of the Uniform Controlled Substances Act addresses the legitimate use of controlled substances by recognizing that the prescribing, administering, and dispensing of opioid analgesics for intractable pain is part of professional medical treatment. It states that if terms such as addict, habitual user, and drug-dependent person are used in States' statutes, definitions of these terms should clearly indicate that they do not apply to patients receiving controlled substances pursuant to a practitioner's order (Uniform Controlled Substances Act, 1990). Each State legislature has received the revision from the Uniform Law Commissioners.
The panel recommends that laws and regulatory policies aimed at diversion control not hamper the appropriate use of opioid analgesics for cancer pain . Clinicians are responsible for knowing how controlled substances are regulated in their States. Such information can be obtained from State medical, nursing, and pharmacy licensing boards (see Angarola, 1990; Joranson, 1990; Shapiro, in press, a, for additional information on the regulation of analgesic drugs).
Determining the overall cost of pain management is difficult because it generally is not separated from other treatment costs, but rather is included as part of the patient's stay in the hospital or an outpatient visit. Components of pain management costs and a comparison of analgesic drug costs are discussed by Ferrell and Griffith (in press) and Kolassa (in press).
Access to professional services, prescription drugs, and medical equipment is usually necessary for effective pain care (Joranson, in press). Reimbursement or lack of it influences the way in which pain is treated, where it is treated, and the supportive care that is available (Yasco and Verfurth, 1992). Reimbursement policies of third-party payers for pain management differ substantially, and many people with cancer are uninsured or underinsured. According to one report (American Cancer Society, 1989), low-income people experience greater pain and suffering from cancer than do other Americans, and a disproportionate share of people with little or no insurance are minorities. For those who are insured, reimbursement policies may favor the use of more expensive pain management modalities over less expensive ones. Medicare, for example, does not reimburse for outpatient oral analgesics but will reimburse for pain management in an inpatient facility. Thus, "a person may well have reimbursement for the $4,000.00 cost of patient controlled analgesia (PCA) morphine but will have no coverage for $100.00 of oral morphine solution" (Ferrell and Griffith, in press). Joranson (in press) has reported on the variation in the policies of private payers and health maintenance organizations, in which policies are often unclear about or offer minimal coverage for pain management. Reimbursement policies on pain management should be studied to enable further understanding of those that promote the most cost effective pain management .
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