Intractable Pain Treatment Laws and Regulations

"Notice: this article appears on the PPSG website with the express permission of the copyright holder, who should be consulted for further permission to reproduce."

1995 Joranson DE, Intractable pain treatment laws and regulations. APS Bulletin 1995 5(2):1-3, 15-17.

Intractable Pain Treatment Laws and Regulations

David E Joranson, MSSW

Department editors' note: This first of two articles discusses current federal policy and new state laws regarding the use of opioids to treat people with intractable pain. The second article in the series will discuss state medical boards' recent progress in developing intractable pain treatment guidelines.

California
Colorado
Florida
New Jersey
Texas
Virginia
Washington

As demand for better pain management grows in the United States, the public is taking an interest in policies that govern the medical use of opioid analgesics for people with chronic pain. Although the use of opioids in acute and cancer pain is well accepted, their use in chronic noncancer pain has been considered widely to be inappropriate due to concerns about efficacy, toxicity, and addiction (Portenoy, 1990; Turk & Brody, 1991). Indeed, some state medical boards have used their disciplinary authority to reject or discourage the prescribing of opioids for chronic noncancer pain (Oregon Board of Medical Examiners, 1991; Washington State Medical Disciplinary Board, 1987).

However, the assumptions behind the belief that opioids should not be used for patients with chronic pain are undergoing a critical reappraisal in an effort to clarify patient selection and appropriate management strategies (Portenoy, 1994). At the same time, state governments have begun to adopt laws that specifically allow the use of opioids for the treatment of intractable pain.

Definitions

Intractable pain is a term that is used and defined in the federal controlled substances regulations and now in some state laws. The term generally refers to a pain state in which the cause cannot be removed or otherwise treated, and no relief or cure has been found after reasonable efforts (Code of Federal Regulations, 1988). It includes pain due to cancer as well as to other chronic diseases.

Intractable pain treatment policy refers to laws, regulations, or other government-issued policies and guidelines that address the legitimacy of the medical use of opioid analgesics to treat patients with intractable pain. These policies vary in the degree to which opioid treatment for intractable pain is accepted or rejected, and they may include specific restrictions and conditions. The focus of this article is federal and state laws and regulations, including the Federal Intractable Pain Regulation (1974); the state laws of Virginia (1988), Texas (1989), California (1990), Colorado (1992), Washington (1993), and Florida (1994); and the state regulation of New Jersey (1984).

Federal intractable pain policy

Federal regulations established in the early 1970s govern the prescribing of controlled substances (Code of Federal Regulations, 1988, Part 1300). As a general principle, the federal government does not regulate medical practice as this is a function of the states (Joranson, 1990). In 1974, however, Congress adopted a law to prohibit physicians from prescribing opioids to detoxify or maintain opioid addiction (unless they are operating as part of a separately registered narcotic treatment program). Subsequently, to clarify the critical distinctions between the treatment of opioid addiction and the use of opioids to treat pain, the Drug Enforcement Administration (DEA) issued a regulation in 1974 stating that the law was not intended to interfere with physicians who used opioids to treat intractable pain:

This section is not intended to impose any limitation on a physician or authorized hospital staff...to administer or dispense [including prescribe] narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts. (Code of Federal Regulations, 1988, p. 72)

The DEA has reiterated and communicated this policy to U.S. physicians through its Physician's Manual (Drug Enforcement Administration, 1990) and its Pharmacist's Manual (Drug Enforcement Administration, 1986).

State intractable pain treatment policies

In addition to federal regulations, physicians' prescribing is subject to the law and regulations of each state, which sometimes are more restrictive than federal law (Joranson & Gilson, 1994). A physician's prescribing of controlled substances may be reviewed by a number of agencies, including state justice departments, triplicate prescription programs, professional licensing boards, and local law enforcement agencies. Typically, these agencies want to identify physicians who are prescribing outside of legitimate medical practice. Legitimate and illegitimate medical practices are usually defined in state medical practice law and by the regulations and enforcement policies of state medical boards. There are no state laws or regulations that consider the use of opioids for intractable pain to be an illegitimate practice.

Indeed, the model for state medical practice laws recommends that state legislatures define the practice of medicine to include the use of drugs to treat pain (Federation of State Medical Boards of the United States, 1988). Further, the model for state controlled substances laws specifically recommends that prescribing opioids for intractable pain be considered legal under state law (National Conference of Commissioners on Uniform State Laws, 1990).

Physicians, however, have been investigated and prosecuted for prescribing opioids for chronic pain (Angarola & Joranson, 1993; Joranson & Gilson, 1994). According to a 1991 survey, most of the members of state medical boards of the United States said they would discourage a physician from prescribing opioids for chronic noncancer pain, and approximately one-third of state medical board members said they would investigate the practice as a potential violation of law (Joranson, Cleeland, Weissman, & Gilson, 1992).

Although most state laws and regulations still do not specifically recognize the legality of opioids for intractable pain, this is changing. In the last several years, some legislatures have begun to adopt laws to affirm the use of controlled substances for intractable pain. Typically, legislators have been responding to (a) the undertreatment of patients with pain, (b) inappropriate medical board discipline of some physicians, and (c) proposed legalization of physician-assisted suicide. Media coverage of physician-assisted suicide and inadequate pain management as well as the efforts of patients and physicians who are advocating for legislative action to improve pain management are fueling state legislative interest in intractable pain treatment policy.

Washington

In the state of Washington, the use of opioids for intractable pain became an issue in 1987 when the Washington State Medical Disciplinary Board opposed prescribing opioids for chronic pain:

Many cases reviewed by the Washington State Medical Disciplinary Board involve inappropriate prescribing of controlled substances. A significant number of these are related to the use of narcotics as a method to manage chronic pain. During fiscal year 1987 the Board experienced nearly a 100% increase in disciplinary actions related to prescribing of controlled drugs for chronic pain. The Board does not recognize repeated prescribing of controlled drugs as appropriate therapy for chronic pain [italics added]. (p. 1)

The subsequent outcry from physicians resulted in additional policy statements in 1989 and 1992 explaining that the board had not wanted "to interfere with a physician's exercise of appropriate clinical judgment" (State of Washington Department of Health, 1989, p. 1), and that chronic pain is "best not treated with opiates" (State of Washington Department of Health, 1992, p. 1). Concern about the board's position continued, and in 1993, the state legislature enacted a statute that borrowed a provision from a recently developed model for state drug laws developed by medical and legal experts (National Conference of Commissioners on Uniform State Laws, 1990):

A practitioner may dispense or deliver a controlled substance to or for an individual or animal only for medical treatment or authorized research in the ordinary course of that practitioner's profession. Medical treatment includes dispensing or administering a narcotic drug for pain, including intractable pain. (Washington Uniform Controlled Substances Act, 1993)

Colorado

In 1992, the Colorado legislature adopted an intractable pain treatment policy as part of revisions to its controlled substances act. Colorado's approach is similar to that used in Washington state.

Virginia

In 1988, Virginia enacted a law allowing physicians to prescribe heroin for treatment of terminally ill cancer patients ("Virginia Enacts Law," 1988). (Note: This occurred despite the fact that legislation at the federal level was necessary to make heroin actually available and that Congress had already soundly defeated such a bill.) The Virginia legislature adopted an additional measure to allow prescription of pain medications "in excess of recommended dosage" for patients with intractable pain ("Relieving Intractable Pain," 1988, p. C5; Commonwealth of Virginia, 1988). Both laws exemplify how drug laws can reflect common misconceptions, that is, that heroin has significant analgesic advantages over currently available opioids, and that a physician's prescription cannot legally exceed the dosage recommended in FDA-approved product labeling (Angarola & Joranson, 1995).

Texas: The first intractable pain treatment act

The first intractable pain treatment act (IPTA) was approved by the Texas legislature in 1989 and has received considerable publicity (Hill, 1992). Physicians in Texas were concerned about board investigations of physicians and ambiguous language regarding opioid prescribing in the state's Medical Practice Act and went to the legislature for relief (Hill, 1992). The purposes of the new act were to clarify legal ambiguities, bring Texas law into conformity with the federal intractable pain regulation, and

assure that no Texan requiring narcotics for pain relief, for whatever reason, was denied them because of a physician's real or perceived fear that the state regulatory agency would take disciplinary measures against the physician for prescribing narcotics to relieve pain. (Hill, 1992, p. 70)

The Texas IPTA (a) provides a definition of intractable pain that is similar to that of the federal regulation, (b) autliorizes physicians to use controlled substances (not only opioids) for treatment of intractable pain, (c) prohibits healthcare facilities from restricting the use of such drugs for intractable pain, and (d) prohibits the Texas State Board of Medical Examiners from disciplining a physician for using such drugs in the legitimate treatment of intractable pain (Medical Practice Act of Texas, 1989).

The Texas IPTA also contains important exclusions. For example, the act does not protect a physician if the pain patient is also being treated for chemical dependency or when the physician should have known that the patient was using drugs in a nontherapeutic manner.

Several years after adoption of the IPTA, the Texas State Board of Medical Examiners issued a policy statement in its official newsletter that was drafted by a board member, C. Richard Stasney, MD, and by C. Stratton Hill, MD (1993). The statement endorsed the federal intractable pain regulation and the IPTA and stated that the board would use treatment outcome and not quantity or duration of prescribing as a standard for evaluating cases against doctors. In 1995, Hill, David Rallston, and colleagues are seeking further clarification of Texas policy and have submitted to the Board of Medical Examiners a proposed regulation for the treatment of intractable pain in Texas (C.S. Hill, personal communication).

New Jersey

The only state of which we are aware that currently has a regulation on intractable pain treatment is New Jersey. The regulation mirrors the federal intractable pain regulation in part. The New Jersey regulation, however, has several conditions that delimit the boundaries of intractable pain treatment:

When protracted prescribing [of narcotic drugs] is utilized for the alleviation of intractable pain, practitioners shall remain alert to the availability of new or alternative types of treatment. The practitioner should attempt periodically to either cease the medication or taper down the dosage, or try other medication or treatment modalities in a regular and vigilant effort to reduce the addiction propensity for the patient. (New Jersey Board of Medical Examiners, 1993, p. 64)

Regulations have the force of law, and compliance with specified conditions becomes the responsibility of the practicing physician. Indeed, failure to comply with such conditions might constitute a violation. Thus, a New Jersey physician who prescribes opioids for intractable pain should document compliance with the additional conditions in the patient's chart.

California

In 1990, California became the second state to adopt an IPTA due to the efforts of State Sen. Leroy Greene and Harvey Rose, MD. This legislation was the consequence of professional and public concerns about inadequate pain management, the harsh effects on patients, and physicians' concern about investigations by the state medical board. California's law is essentially identical to the Texas IPTA, although it requires evaluation of the patient by a specialist in addition to the attending physician (California Business and Professions Code, 1990).

The adoption of the California IPTA has also served as a catalyst for a number of governmental and professional actions to identify and remove barriers to pain management. For example, other new legislation required examination of alternatives to the triplicate prescription program, distribution of information on pain management and the California intractable pain treatment policy to all physicians by the medical board, and a medical board survey of state medical schools' curricula on pain management. In March 1994, the governor sponsored the Summit on Effective Pain Management: Removing Impediments to Appropriate Prescribing to prepare a strategy for a statewide effort to improve pain management (Angarola & Joranson, 1994; State of California Department of Consumer Affairs, 1994). The licensing and disciplinary boards for medicine, pharmacy, and nursing developed positive guidelines for the appropriate use of opioids in intractable pain. The American Pain Society Board of Directors endorsed the medical board's guidelines (correspondence of APS President J. Campbell to D. Arnett, Executive Director, California Medical Board, January 11, 1995; see page 20 of this newsletter for details). The State of California's actions to make pain management a priority are exemplary.

Florida

In 1994, following an intense debate on euthanasia and physician-assisted suicide, the Florida legislature instead approved an intractable pain treatment provision. Intractable pain is defined as "pain for which, in the generally accepted course of medical practice, the cause cannot be removed and otherwise treated" (Florida Statutes, 1994, p. 2). A licensed and qualified physician must diagnose intractable pain. The new provision permits use of any controlled substance in Schedules II-V, not only opioids, to treat a person with intractable pain, provided the physician conforms to a standard of care that would be recognized by reasonably prudent physicians under similar circumstances [italics added] (Florida Statutes). (One might ask what this means, given the prevalence of inadequate pain management and the history of discouragement of extended use of strong opioids for chronic noncancer pain.) Florida's intractable pain provision also recognizes that the state does not condone euthanasia and bans the use of intractable pain treatment for such a purpose.

Discussion

The development of intractable pain treatment laws gives much-needed recognition to the necessity for better treatment of intractable pain and can help to correct past policy, which discouraged any use of opioids. However, the opportunity to develop new legislation merits our careful consideration of both benefits and risks.

For example, could there be unintended consequences from making opioid therapy for intractable pain a "treatment of last resort"? Is it medically appropriate to require physicians to demonstrate that every chronic pain problem - whether due to terminal illness or any other chronic condition-is refractory to other therapies before prescribing opioid analgesics? How much time must elapse? How many therapies must be tried, and at what expense to the patient and the healthcare system? Although these questions should be answered by the physician and patient, they may also become legal questions once intractable pain treatment laws and regulations are enacted.

Are state intractable pain treatment laws really needed? Although the states have the power to regulate medical practice, the results can be unpredictable when state legislators and other interest groups start writing new laws, especially when the subject is drugs and medical practice - witness, for example, Virginia's approval of heroin in an effort to treat cancer pain. Moreover, after a new law is passed, a state agency may adopt regulations to codify, and perhaps restrict, the treatment of intractable pain, potentially leading to new issues. For example, if intractable pain regulations include conditions and restrictions, as in New Jersey, these may expand recordkeeping requirements and, thus, increase instead of decrease the potential for violations when controlled substances are prescribed for pain.

States do not now directly prohibit by law or regulation the use of opioids for intractable pain. If a state medical, pharmacy, or nursing board discourages the use of opioids for intractable pain, this is informal policy and it should be changed. Such a change can occur without legislation-for example, through a cooperative effort of regulatory boards and pain experts to develop and communicate new guidelines (Commonwealth of Massachusetts Board of Registration in Medicine, 1989; Medical Board of California, 1994).

If the voluntary development of positive guidelines by a board proves unsuccessful, political action, including lobbying for intractable pain treatment legislation, merits consideration. In Idaho, an intractable pain treatment act was introduced to protect physicians who prescribed opioids for intractable pain from the medical board. Although the bill was not adopted, the medical board has undertaken a review of its policy on prescribing for intractable pain (Idaho State Board of Medicine, 1994).

Which language should be used? The Texas and California IPTAs might be useful if the primary goal is to protect physicians from a medical board when, in fact, that threat exists or when the board is reluctant to clarify and communicate its policy. The Texas and California IPTAS, however, also appear to restrict prescribing of opioids to substance abusers, even if they have pain. The laws in Washington and Colorado do not exclude substance abusers and are consistent with the nationally approved model for drug control laws in the United States. On the other hand, they do not establish a legal protection for physicians from their medical boards.

Can legislation be an opportunity to initiate action? A new intractable pain law, by itself, probably will do little directly to change practice patterns or improve the management of patients' pain. In California, however, the legislative sponsor and key supporters of the new IPTA have served as powerful catalysts for other positive actions to improve pain management in the state.

In addition, either a legislature or a governor can establish a pain commission to study the problem and make recommendations for action. Study commissions can, however, also waste time and energy and actually delay real progress unless there is (a) strong support for implementation of the recommendations; (b) a clear mission focused on better and more cost-effective pain management; (c) willingness to identify and address common myths and barriers; (d) competent and adequate staff resources; and (e) a membership that is balanced, knowledgeable, and committed to the mission.

Conclusions

Long-held medical beliefs and regulatory traditions have rejected the use of opioids for chronic noncancer pain but are now undergoing reassessment in light of new knowledge, recent clinical experience, and the public attention being given to better pain management. The ultimate goal of a balanced public policy should be to harmonize medical and drug regulation with clinical practice so that physicians are free to use this treatment according to good medical judgment. This harmony can sometimes be promoted through laws and certainly through the development of medical, pharmacy, and nursing guidelines. Such guidelines should encourage pain management and help clinicians select and manage patients and avoid investigation. Guidelines should also continue sanctions against sloppy and unprofessional practices that can contribute to drug abuse. Such guidelines as those issued in Texas and California give medical boards unique opportunity to encourage quality care while at the same time allowing them to focus limited resources on cases in which there is harm to public health. (Note: The second article in this series will discuss state medical boards' development of intractable pain guidelines.)

As the development of intractable pain policy proceeds in the United States, we should take care not to oversimplify the complexity of chronic pain and its treatment. We should avoid creating the impression that all prescribing of opioids is appropriate or that any person with chronic pain has a right to opioids. We should also avoid creating the impression that new policies will correct deficits in practitioners' knowledge and attitudes.

The appropriate use of a range of therapeutic options, including nonpharmacologic treatments, opioids, and other drugs, depends on careful evaluation and monitoring of results by knowledgeable professionals supported by regulatory policy and practice. Opioids and other individual therapeutic modalities should neither be prescribed nor proscribed by laws, regulations, or policies.

Do the differences in today's state intractable pain laws and regulations suggest we are moving toward a balkanized approach to the use of opioids for chronic pain? How can we uniformly raise the quality of pain care if policies differ from state to state? The quality of intractable pain treatment policy at the state level would benefit from a dialogue aimed at acheiving consensus among healthcare professional, regulatory, and patient interests in the United States. One aim of such a dialogue should be to achieve reasonable uniformity of policy among the states; another would be to address the needs of individual patients who have fallen through the cracks. The author would appreciate having readers' perspectives and any additional information about state policies.

Acknowledgments

The author gratefully acknowledges comments on the manuscript from Albert M. Brady, June L. Dahl, Kathleen M. Foley, Aaron M. Gilson, John D. Loeser, William L. Marcus, Russell K. Portenoy, Harvey L. Rose, and Joel R. Saper.

David Joranson is associate director for policy studies with the Pain Research Group at the University of Wisconsin Medical School in Madison, WI.

References

Angarola, R.T., & Joranson, D.E. (1993). More federal drug control initiatives: Are they warranted? Will they consider the patient? APS Bulletin, 3(2), 1-9.

Angarola, R.T., & Joranson, D.E. (1994). California sponsors pain summit; Maryland fends off new regulations. APS Bulletin, 4(3), 11-12.

Angarola, R.T., & Joranson, D.E. (1995). Off-label uses of prescription drugs in pain management. APS Bulletin, 5(l), 14-15.

California Business and Professions Code. (1990). Chapter 1588, � 2241.5(b).

Code of Federal Regulations. (1988). Title 21, � 1306.07(c).

Commonwealth of Massachusetts Board of Registration in Medicine. (1989, August). Prescribing practices policy and guidelines. Boston: Massachusetts Secretary of State.

Commonwealth of Virginia. (1988). Virginia Drug Control Act. Chapter 34, Article 1, � 54.1-3408.1

Drug Enforcement Administration. (1986). Pharmacist's manual: An informational outline of the Controlled Substances Act of 1970. Washington, DC: U.S. Department of Justice.

Drug Enforcement Administration. (1990). Physician's manual: An informational outline of the Controlled Substances Act of 1970. Washington, DC: U.S. Department of Justice.

Federation of State Medical Boards of the United States. (1988). A guide to the essential of a modern medical practice act (5th ed.). Fort Worth, TX: Federation of State Medical Boards.

Florida Statutes. (1994). Chapter 94-96, � 458.326(l), 458.326(3).

Hill, C.S. (1992). The intractable pain treatment act of Texas. Texas Medicine, 88(3), 70-72.

Idaho State Board of Medicine. (1994, December). Draft guidelines: Prescribing opioids for chronic pain. Boise, ID: Author.

Joranson, D.E. (1990). Federal and state regulation of opioids. Journal of Pain and Symptom Management, 5, S12-S23.

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.

Joranson, D.E., & Gilson, A.M. (1994). Controlled substances, medical practice, and the law. In H.I. Schwartz (Ed.), Psychiatric practice under fire: The influence of governments, the media, and special interests on somatic therapy (pp. 172-194). Washington, DC: American Psychiatric Association Press.

Medical Board of California. (1994, October). New, easy guidelines on prescribing. Action Report, 51, 1, 8. Medical Practice Act of Texas. (1989). � V, Article 4495c.

National Conference of Commissioners on Uniform State Laws. (1990, July). Uniform Controlled Substances Act. Milwaukee: Author.

New Jersey Board of Medical Examiners. (1993). � 13:35-6.6(g), Division of Consumer Affairs, New Jersey Department of Law and Public Safety. Trenton, NJ: Author

Oregon Board of Medical Examiners. (1991, May). Statement of philosophy: Appropriate prescribing of controlled substances. Salem, OR: Author.

Portenoy, R.K. (1990). Chronic opioid therapy in nonmalignant pain. Journal of Pain and Symptom Management, 5(l), S46-S62.

Portenoy, R.K. (1994). Opioid therapy for chronic nonmalignant pain: Current Status. In H.L. Fields & J.C. Liebeskind (Eds.), Progress in pain research and management. Vol. 1. Pharmacological approaches to the treatment of chronic pain: New concepts and critical issues (pp. 247-287). Seattle: IASP Publications.

Relieving intractable pain. (1988, April 4). The Washington Post, p. C5.

Stasney, C.R., & Hill, C.S. (1993). Pain control and the Texas State Board of Medical Examiners. Texas State Board of Medical Examiners Newsletter, 15(l), 1.

State of California Department of Consumer Affairs. (1994, March). Summit on effective pain management: Removing impediments to appropriate prescribing. Sacramento, CA: Author.

State of Washington Department of Health. (1989, August). Policy statement. Seattle: Author.

State of Washington Department of Health. (1992, April). Policy statement. Seattle: Author.

Turk, D.C., & Brody, M.C. (1991). Chronic opioid therapy for persistent noncancer pain: Panacea or oxymoron? APS Bulletin, 1(1), 1-7.

Virginia enacts law approving palliative heroin use. (1988, April 25). Hospice Forum, p. 1.

Washington State Medical Disciplinary Board. (1987, September). Bulletin to physicians. Seattle: Department of Health.

Washington Uniform Controlled Substances Act. (1993). Revised Code of Washington. Article III, � 69.50.308(g).