Publications
APS Bulletin • Volume 7, Number 2, March/April 1997
Pain and Public Policy
David E. Joranson, MSSW, Department Editor
State Intractable Pain Policy: Current Status
David E. Joranson, MSSW; Aaron M. Gilson, MS MSSW
EDITOR'S NOTE: Previous issues of the Bulletin have addressed intractable pain treatment laws and medical board guidelines (Joranson, 1995a, 1995b). This article reviews recent educational initiatives for state medical boards and the status of state pain policy initiatives, including medical board guidelines and intractable pain treatment laws.
Medical Board Workshops and Guidelines
Physicians' concern about regulatory scrutiny acting as a barrier to the ability to prescribe appropriately for pain management has attracted substantial study and discussion (Hill, 1993; Max, 1990; McIntosh, 1991; Nowak, 1992; Portenoy, 1990; Turk & Brody, 1992; Turk, Brody, & Okifuji, 1994; Weissman, Joranson, & Hopwood, 1991). A 1991 Pain Research Group survey of state medical board members demonstrated a need to provide updated information about opioids and pain management to medical board members (Joranson, Cleeland, Weissman, & Gilson, 1992). Indeed, a national survey revealed a need to provide more education about pain management to oncology physicians (Von Roenn, Cleeland, Gonin, & Pandya, 1991).
Discussions of the survey findings with the Federation of State Medical Boards led to cooperative efforts to sponsor a series of educational workshops entitled "Pain Management in a Regulated Environment." The workshops gave state medical boards the opportunity to review and discuss advances in knowledge and practice and the development of board guidelines concerning the use of opioids in pain management. The workshop faculty included June L. Dahl, PhD, Albert Brady, MD, J. David Haddox, DDS MD, David Joranson, MSSW, and Seddon Savage, MD. Six workshops were presented from 1993 to 1996: one for the Alabama State Board of Medical Examiners in 1993 (Angarola & Joranson, 1994), one for the North Carolina Medical Board in 1996, and four regional workshops for board members from a variety of state medical boards, during 1994 and 1995. A total of 125 board members attended (approximately 20% of the 630 state medical board members nationwide), representing 32 state medical boards.
Following these workshops, a number of boards, including those in Alabama and North Carolina, developed and disseminated guidelines for the prescribing of controlled substances for pain (Alabama State Board of Medical Examiners, 1995; North Carolina Medical Board, 1996). In most cases, the purpose of these guidelines has been to clarify that the board accepts that opioids may be used to manage chronic noncancer pain and to outline the board's basic expectations of prescribers. Table 1 lists the states having laws and/or medical board guidelines.
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Some state medical boards have taken advantage of the work in states such as Texas and California. The Medical Board of California (MBC) guidelines (California Medical Board, 1994, May, October; American Pain Society, 1995) have served as a model for medical boards. The MBC guidelines addressed the California doctors' reluctance to prescribe opioids for chronic pain for fear of investigation and possibly disciplinary action. The MBC guidelines afford California a framework within which a physician may prescribe without concern about interference from regulatory agencies (California Medical Board, 1994, July). Built on principles of good medical practice, the California guidelines do not establish specific prescribing or pain management parameters. The guidelines were reviewed by pain and legal experts, adopted unanimously, and disseminated to all California physicians. The California guidelines received endorsement from APS (1995). The California boards of nursing and pharmacy (California Board of Registered Nursing, 1994; California State Board of Pharmacy, 1996) have adopted complementary guidelines. Medical boards in Florida (Florida Board of Medicine, 1996), North Carolina (North Carolina Medical Board, 1996), and Washington (Washington Medical Quality Assurance Commission, 1996) have adopted similar guidelines.
Further guidance for state policy appears in the American Academy of Pain Medicine (AAPM) and APS consensus statement, The Use of Opioids for the Treatment of Chronic Pain (1996). This statement is the product of a joint task force of the two organizations chaired by J. David Haddox, DDS MD.
Intractable Pain Treatment Laws
While the use of opioid analgesics to manage chronic noncancer pain is being reassessed clinically and scientifically (Portenoy, 1996; Portenoy & Payne, in press), it is clear that medical boards are issuing guidelines to recognize this use.
State legislatures are also deciding the legal parameters for prescribing opioids. The states that have enacted intractable pain treatment acts (IPTAs) are listed in Table 1. Legislative consideration of IPTAs is usually stimulated by chronic pain patients who are concerned about access to opioids or by physicians who are concerned about the attitude of their state medical board. However, some of these laws may further restrict rather than expand access to opioids for chronic pain management.
Most IPTAs are based on the Texas law adopted in 1989 (Medical Practice Act of Texas, 1989). The Texas IPTA defines intractable pain and grants immunity from disciplinary action by the medical board to physicians when they prescribe opioids for intractable pain. After adoption of the IPTA, the Texas Board of Medical Examiners issued a positive statement that recognized the value of controlled substances in the treatment of pain and specified that the appropriateness of treatment will not be defined solely on the basis of quantity or duration of prescribing, but rather on the basis of diagnosis and treatment objectives (Stasney & Hill, 1993). More recently, the board issued another positive policy on intractable pain, in this case a regulation (not a guideline) (Texas State Board of Medical Examiners, 1995).
In 1990, California adopted an IPTA that followed closely the Texas provisions but in addition required that all patients have a consultation so that the physician can qualify for immunity (California Business and Professions Code, 1990).
Benefits of IPTAs
One possible benefit of an IPTA is to recognize in the law that there is a legitimate place for opioids in the treatment of chronic pain. Another perceived benefit is that an immunity provision may protect physicians from discipline, although perhaps not from investigation and its attendant legal costs. Another benefit of legislative consideration of IPTAs may be the enhancement of public attention to the inadequate treatment of pain. Such consideration could lead to creation of a state pain commission, which would have access to all of state government and which could conduct a careful study of the problem and guide the development of a variety of needed responses (Joranson, 1996).
Risks of IPTAs
IPTAs are state pain policies created by elected officials, not by organizations representing medicine and science. Opening the door to legislative action on medical issues requires careful consideration. This process is political and complex, and its outcomes are difficult to foresee.
Although IPTAs are not always alike, the following lists potentially restrictive aspects that are now official policy in some states:
- IPTAs generally define medical use of opioids for intractable pain as a therapy of last resort.
- IPTAs apply to all intractable pain patients, even if they have cancer.
- IPTAs imply that opioids may be used for pain only in cases where the cause of pain cannot be removed.
- IPTAs exclude pain patients who use drugs "for nontherapeutic purposes."
- IPTAs require an evaluation of every pain patient by a specialist in the organ system believed to be the cause of pain.
- Some IPTAs require a signed informed consent form in every case.
It is not difficult to imagine how each of these limitations, if actually enforced, could interfere with medical practice and patient care. It is also difficult to see how IPTAs would actually increase patient access to pain management.
Alternative Models
Some state legislatures, instead of adopting IPTAs, have adopted simpler model intractable pain language, which neither affords immunity nor establishes restrictions but does clarify that it is a legitimate medical practice to use opioids for intractable pain (Joranson, 1990; National Conference of Commissioners on Uniform State Laws, 1994). Washington, Colorado, and Wisconsin have adopted such language as a part of their uniform controlled substances law.
The American Society for Law, Medicine, & Ethics (ASLME) has developed a model act aimed at affording legal protection from boards for physicians who prescribe opioids for chronic pain (Dubler, Levine, & Johnson, 1996). ASLME considered a model immunity statute similar to the Texas law but settled instead on language that would allow physicians and their lawyers to claim a rebuttable presumption that their prescribing practice was legal, if they could show that they were substantially in compliance with accepted professional guidelines.
The American Medical Association House of Delegates approved in 1996 a model IPTA based on the Texas model (American Medical Association, 1996). It is therefore possible that state medical societies may become interested in legislative consideration of intractable pain treatment policy.
Conclusion
State legislatures are likely to continue considering intractable pain policy. (See Figure 1. for the cumulative number of state intractable pain policies enacted since 1980.) With the national focus on assisted suicide likely to shift to the states following the Supreme Court decision, state legislators may become even more interested in legislative action to improve pain management. Professional pain organizations should closely monitor the development of state pain policy and provide information and assistance to their elected representatives.
We should recall that state medical boards have a duty to protect the public from improper prescribing, but that they are also interested in promoting public health. A number of boards have recognized the need to clarify their policy regarding prescribing for pain. Increased collaboration between the pain community and state professional licensing boards should be encouraged and should aim to harmonize clinical practice and regulatory policy.
In all of these deliberations, we should strive to achieve a balance so that the management of pain, including the use of opioids when needed, is not impeded by state laws, regulations, or other policies that are based on outdated information.
References
Alabama State Board of Medical Examiners. (1995, March). Controlled Substances Certificate 540-X-4-.08, 4-30, 4-32.
American Academy of Pain Medicine and American Pain Society. (1996). The Use of Opioids for the Treatment of Chronic Pain. A consensus statement from the American Academy of Pain Medicine and the American Pain Society. Glenview, IL: Author.
American Medical Association. (1996, October). An act concerning the administration of controlled substances to persons experiencing intractable pain. Chicago: Author, Division of State Legislation.
American Pain Society. (1995). APS OKs California pain treatment guidelines. APS Bulletin, 5(2), 20-21.
Angarola, R.T., & Joranson, D.E. (1994). Recent developments in pain management and regulation. APS Bulletin, 4(1), 9-11.
California Board of Registered Nursing. (1994). Pain management policy. In Summit on effective pain management: Removing impediments to appropriate prescribing (p.42). Sacramento, CA: Department of Consumer Affairs.
California Business and Professions Code. (1990). Chapter 1588, §2241.5(b).
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California Medical Board. (1994, July). Text of "Guideline for Prescribing Controlled Substances for Intractable Pain." Medical Board of California Action Report, 51, 1, 8.
California State Board of Pharmacy. (1996). Dispensing controlled substances for pain: A statement of the California State Board of Pharmacy. Health Notes, 4-5.
Dubler, N., Levine, R., & Johnson, S.H. (1996). Project on legal constraints on access to effective pain relief. A Project of the American Society of Law, Medicine, & Ethics.
Florida Agency for Health Care Administration. (1996, October). Practice and regulatory guidelines. Management of Pain Using Dangerous Drugs and Controlled Substances. Tallahassee, FL: Author.
Hill, C.S. (1993). The negative influence of licensing and disciplinary boards and drug enforcement agencies on pain treatment with opioid analgesics. Journal of Pharmaceutical Care in Pain and Symptom Control, 1(1), 43-62.
Joranson, D.E. (1990). A new drug law for the states: An opportunity to affirm the role of opioids in cancer pain relief. Journal of Pain and Symptom Management, 5, 333-336.
Joranson, D.E. (1995a). Intractable pain treatment laws and regulations. APS Bulletin, 5(2), 1-3, 15-17.
Joranson, D.E. (1995b). State medical board guidelines for treatment of intractable pain. APS Bulletin, 5(3), 1-5.
Joranson, D.E. (1996). State pain commissions: New vehicles for progress? APS Bulletin, 6(1), 7-9.
Joranson, D.E., Cleeland, C.S., Weissman, D.E., & Gilson, A.M. (1992). Opioids for chronic cancer and non-cancer pain: A survey of state medical board members Federation Bulletin: The Journal of Medical Licensure and Discipline, 79(4), 15-49.
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McIntosh, H. (1991). How physicians handle drug investigations. Journal of the National Cancer Institute, 83, 1282-1284.
Medical Practice Act of Texas. (1989). §V, Article 4495c.
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North Carolina Medical Board. (1996, September). Management of chronic non-malignant pain. Raleigh, NC: Author.
Nowak, R. (1992). Cops and doctors: Drug busts hamper pain therapy. Journal of NIH Research, 4(5), 27-28.
Portenoy, R.K. (1990). Chronic opioid therapy in nonmalignant pain. Journal of Pain and Symptom Management, 5(1), Suppl. S46-S62.
Portenoy, R.K. (1996). Opioids for chronic nonmalignant pain: A review of the critical issues. Journal of Pain and Symptom Management, 5, 203-217.
Portenoy, R.K., & Payne, R. (in press). Acute and chronic pain. In J.H. Lowinson, P. Ruiz, & R.B. Millman (Eds.), Comprehensive textbook of substance abuse (3rd ed.). Baltimore: Williams and Wilkins.
Stasney, C.R., & Hill, C.S. (1993). Pain control and the Texas State Board of Medical Examiners. Texas State Board of Medical Examiners Newsletters, 15(1), 1.
Texas State Board of Medical Examiners. (1995, February). Title 22, §§170.1-170.3.
Turk, D.C., & Brody, M.C. (1992). What position do APS's physician members take on chronic pain opioid therapy? APS Bulletin, 2(2), 1-5.
Turk, D.C., Brody, M.C., & Okifuji, E.A. (1994). Physicians' attitudes and practices regarding the long-term prescribing of opioids for non-cancer pain. Pain, 59, 201-208.
Von Roenn, J.H., Cleeland, C.S., Gonin, R., & Pandya, K.J. (1991). Results of physicians' attitudes toward cancer pain management survey. Proceedings of American Society of Clinical Oncology, 10, 326.
Washington Medical Quality Assurance Commission. (1996). Management of chronic non-malignant pain. Seattle: Department of Health.
Weissman, D.E., Joranson, D.E., & Hopwood, M.B. (1991, December). Wisconsin physicians' knowledge and attitudes about opioid analgesic regulations. Wisconsin Medical Journal, 671-675.
David E. Joranson is director of the Pain and Policy Studies Group Comprehensive Cancer Center and the WHO Collaborating Center at the University of Wisconsin in Madison, WI. Aaron M. Gilson is researcher for policy studies at the Pain and Policy Studies Group Comprehensive Cancer Center and the WHO Collaborating Center at the University of Wisconsin in Madison, WI.