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Chris Stern Hyman, "Pain Management and Disciplinary Action: How Medical Boards
Can Remove Barriers to Effective Treatment"
Journal of Law, Medicine & Ethics, 24, no. 4 (1996): 338-43. (c) 1996 by the American Society of Law, Medicine & Ethics. All rights reserved. The current debate about physician-assisted suicide and the question of whether patients would ask for such help if their pain were adequately controlled place in sharp focus the issue of undertreated pain. Studies have repeatedly documented the scope of the problem. A 1993 study of 897 physicians caring for cancer patients found that 86 percent of the physicians reported that most patients with cancer are undermedicated for their pain. A 1994 study found that noncancer patients receive even less adequate pain treatment than patients with cancer-related pain, and that minority patients, the elderly, and women were more likely than others to receive inadequate pain treatment. Although the problem of undertreatment of pain is multifaceted, I only address how state medical boards contribute to the problem and suggest possible remedies. The literature on palliative care describes the numerous barriers that impede effective pain management and that result in the inadequate prescribing of pain-relieving drugs for terminally and chronically ill patients. One of the significant impediments is physicians' fear that prescribing an adequate quantity of opioids will result in an investigation by the state medical board, the Drug Enforcement Administration (DEA), or the state agency responsible for regulating controlled substances. Another is the woeful lack of knowledge of some physicians about how to treat intractable pain and their inaccurate perception about what is and is not legal. Even members of state medical boards do not have a clear understanding of what is legally and medically acceptable in using opioids to treat pain. The most effective antidote to the physicians' fear is ensuring that state medical boards are not investigating and disciplining physicians who treat pain appropriately and that state medical boards and physicians are well informed about effective pain management. Is this best accomplished by statute, regulations, or guidelines, or by using experts and education? Statutes and regulations can give physicians some reassurance, but the key to appropriate enforcement is the level of knowledge about pain management of state medical boards' members and staffs. In attempting to remove barriers to effective pain management, state medical boards should take the following steps.
(1) Objectively assess the medical board's level of knowledge of effective pain
management and the extent of the undertreatment of pain in their state. Assess the board's knowledge of pain management and the extent of undertreatment of pain Each state board needs to assess objectively whether its members are sufficiently knowledgeable about pain management. To do so, the Federation of State Medical Boards of the United States (FSMB) could assist the state medical boards by creating a self-assessment questionnaire for all boards. If, on the basis of evaluations, the level of knowledge is found to be inadequate, then training by qualified experts is essential. Experts should be hired as consultants and used to train board members as well as licensees throughout the state. Members of state medical boards have an obligation to be knowledgeable about all aspects of medical practice. Each physician obtains a medical license from the state medical board to practice in that particular state. In the United States, we have sixty-eight state medical boards (some states have more than one board--one for allopathic physicians, one for osteopathic physicians, or one for licensure and one for discipline). In return for granting a license, the state medical board gains jurisdiction over that physician's professional conduct and has the authority to investigate and bring a disciplinary action against a physician who fails to meet the acceptable level of conduct--in other words, that physician commits misconduct. In every state, statutes and regulations define physician misconduct and the process by which physicians are disciplined. Enlist pain management experts to review cases under investigation and to serve as witnesses State medical boards must enlist the expertise of physicians who are knowledgeable about pain management and must use their expertise to train investigators and attorneys, so that accurate decisions will be made about whether misconduct has occurred in a particular case. Without this expertise, the perception and, in some instances, the reality that appropriate treatment of pain exposes one to risks of disciplinary action will continue. Each state medical board should develop a list of pain management experts who will, as consultants, review cases under investigation and who will testify in a disciplinary hearing when necessary. The absence of this expertise has resulted in disciplinary actions being overturned by state courts and perpetuates the perception that physicians who appropriately prescribe controlled substances, particularly Schedule II drugs, for relief of intractable pain will face disciplinary action. For example, in Arkansas and Tennessee, appellate courts have reversed disciplinary actions taken by the state medical boards for excessive prescribing of controlled substances for relief of pain. In each case, the state board failed to produce an expert physician to testify at the disciplinary hearing about the appropriate standard of care and the extent to which the accused physician deviated from that standard. In Florida, the district court of appeals reversed the decision of the state medical board which had found that a physician had excessively prescribed Schedule II controlled substances for intractable pain. The hearing officer, after the disciplinary hearing, found that the state board had failed to meet its burden of proof on all charges and that the physician's prescribing practices were appropriate. In this instance, the hearing officer found that the state experts had never examined the medical records of the patients who were the subject of the misconduct allegations. The experts had only examined the computer printouts obtained from the pharmacies. The state medical board rejected the findings of the hearing officer and disciplined the physician. The appellate court held that the board is not free to reject the hearing officer's findings and to substitute its own when the findings are based on competent and substantial evidence. The court was also disturbed that this disciplinary decision was based on such a "paucity of evidence" after reversals in two prior cases for the state board's failure to prove that the physician had prescribed excessive amounts of controlled substances. Reversals such as these clarify why statutory protection from unwarranted disciplinary action is considered essential by its proponents, but it is questionable whether statutory protection from discipline is the best way to ensure that state medical boards function as they should. If a state court overturns a disciplinary action for lack of substantial evidence in the record to support a medical board's conclusion that the treatment of pain by a physician was inappropriate, then that state medical board and its attorneys would have to assess carefully their own level of expertise in pain management. Are experts in pain management available to the state medical board to serve as expert witnesses? Are its investigators and attorneys sufficiently knowledgeable about pain management to discern which cases to pursue and which to close? Are the correct cases being prosecuted? A statute, like those discussed below, should not be required to ensure appropriate enforcement by regulatory authority and it will not correct the paucity in knowledge about pain management and procedural rules. Consider how the regulatory process can improve pain management Each state must evaluate what will be most efficacious in improving pain management. In some states, amendments to the statutes regulating controlled substances are needed. In prescribing controlled substances, two overlapping regulatory processes govern a physician's conduct. One is the federal system for regulating the prescribing, administering, dispensing, and distribution of controlled substances, which is defined in federal statutes and regulations and enforced by DEA. The other is each state's statutes and regulations, which also govern the use of controlled substances. Some of these statutes contain barriers to effective pain treatment. Several experts have pointed out that the terms addict and addiction are defined inadequately in many state controlled-substances statutes. If addict is defined as a person who habitually uses a narcotic drug and becomes dependent on it, then the definition should be changed because it is equally applicable to a patient with nonmalignant pain who is being appropriately treated with opioids. New York has such a definition and the New York State Department of Health has tried unsuccessfully for the last several years to amend the statute to restrict the definition to a person who habitually uses a controlled substance for a nonmedical or unlawful purpose. These inaccurate definitions contribute to the misunderstandings of health care professionals and their fears about addiction. Many do not understand the distinction between drug abusers who are psychologically dependent on and compulsive users of a drug and pain patients who are physically, but not psychologically, dependent on a drug. The federal Controlled Substances Act contains a positive statement recognizing the useful and legitimate medical purpose of many controlled substances. Amendments to state statutes modeled on this federal language would balance the necessary restrictions with recognition of the therapeutic importance of these drugs. Some states have opted for statutes on intractable pain, others for regulations and/or guidelines. As of September 1996, eleven states have statutes (see Table 1). Ten states have enacted statutes that affirmatively permit prescribing of controlled substances for intractable pain, and six of them give additional reassurance by offering protection from disciplinary action with language, such as California's, that No physician and surgeon shall be subject to disciplinary action by the board
for prescribing or administering controlled substances in the course of
treatment of a person for intractable pain. The Project on Legal Constraints on Access to Effective Pain Relief, conducted by the American Society of Law, Medicine & Ethics, proposes a Pain Relief Act for adoption by state legislatures. It provides in Section 3.1 that Neither disciplinary action nor state criminal prosecution shall be brought against a health care provider for the prescription, dispensing, or administration of medical treatment for the therapeutic purpose of relieving intractable pain [when that provider] can demonstrate by reference to an accepted guideline that his or her practice substantially complied with that guideline.... This statute seeks to protect health care providers from unwarranted disciplinary actions and state criminal prosecutions if appropriate pain management occurred. The model statute defines accepted guidelines as including practice or care guidelines for pain management developed by nationally recognized organizations, specialty societies, and government-sponsored agencies, policies, guidelines, or regulations adopted by state boards. Given the persistence of the problem of undertreatment of pain, a statute that affirmatively endorses the treatment of intractable pain is appealing. However, regulatory statutes that encourage specific conduct and protect those who engage in it present problems when grafted onto an existing statutory framework. Why should legislators extend immunity from prosecution for pain management and not for any other treatment? Usually, medical practice statutes put physicians on notice of what conduct is not permitted. In New York, the state with which I am most familiar, and in most other states, state medical practice acts define the conduct that is not permitted, thus the terminology, misconduct. The Model State Medical Practice Act developed by FSMB conforms to this format. It sets forth thirty-five definitions of misconduct, all of which are prohibited actions. The statutes on intractable pain deviate from this format in that they affirmatively permit specific conduct. State legislators and medical board executives and members will ask why pain management should be singled out for different statutory treatment. Proponents of these statutes will need persuasive data to convince skeptical state legislators and regulators that the problem can best be solved by enactment of a statute. In addition to the statutes, a number of states have adopted guidelines or regulations for pain management. Nine states have guidelines and three have regulations (see Table 2) that give varying degrees of guidance to physicians. The guidelines and regulations seek to raise the consciousness of the medical profession and to reassure licensees that they should treat pain, malignant and nonmalignant, with the appropriate medications. Regulations and guidelines can contribute to effective pain management by giving guidance in how to treat patients, but they raise two issues. One is how to give practitioners sufficient specificity so that the guidance is useful and, at the same time, sufficiently flexible to allow altering the specifics as additional information is made available by experts. For the twelve states that have adopted regulations or guidelines on intractable pain, the regulations and guidelines typically address assessment of symptoms, treatment, record keeping, informed consent, and the problems of under- and overprescribing. Some are more complete than others, and this variability raises the question of whether a sufficiently high level of specificity can be achieved through the process of individual states adopting guidelines or regulations. The other issue is what amount of regulatory authority should be invested in this standard of care. The Pain Relief Act proposes "accepted guidelines," which include those developed by nationally recognized organizations, specialty societies, and so forth; but some states may not cede to an organization the authority to create guidelines. A distinct legal difference also exists between the regulatory authority of guidelines and regulations. Guidelines have no force of law. Guidelines are merely suggestions for conduct. Black's Law Dictionary defines regulation as a "rule or order having force of law issued by executive authority of government." In evaluating the relative utility of guidelines versus regulations, regulations have the advantage of being legally enforceable. They give patients reassurance that physicians must treat pain according to a standard of care or face consequences from the state medical board. Regulations can give the state medical board the authority to discipline a physician who fails to treat pain as well as provide guidance on how to treat. Guidelines cannot be enforced. On the other hand, regulations are more cumbersome to change than guidelines. Each state has a legally mandated process for amending regulations, which does not apply to guidelines. Nevertheless, given the novelty of state medical boards requiring a course of conduct for a given therapeutic treatment and the work required to create such a document, if a medical board is weighing the relative merits of a regulation versus a guideline, a regulation is preferable because it is enforceable. Evaluate how best to inform and educate licensees about pain management Michigan has opted for a statute that requires continuing education in pain management for health care professionals as part of the license renewal process. The state has created an interdisciplinary advisory committee to review the effectiveness of these requirements for the legislature. The Massachusetts legislature established a commission in May 1993 to study how pain is managed in that state. The commission's report was issued in January 1997; it contained a series of recommendations, including statutory amendments. Some states, for example, Minnesota, have held training sessions with panels of experts to discuss current practices in prescribing controlled substances. Many state medical boards have published articles in their newsletters about pain management and about prescribing opioids to treat intractable pain. However, systemic educational efforts are needed to ensure that physicians become knowledgeable and willing to treat pain patients. The fear of unwarranted prosecution, which is at the heart of physicians' concerns, can be counteracted only if the actions of state medical boards are appropriate and if these boards educate physicians about pain management. Educational efforts by the boards will have the effect of both increasing the physicians' knowledge and reassuring physicians that the boards understand what the appropriate treatment of pain is. Conclusion No patient should suffer in pain because of unnecessary barriers to treatment. The responsibility and initiative to educate health care professionals about effective pain management must be shared by all institutions and organizations that deliver health care, regulate health care delivery, train health care professionals, and represent health care professionals and consumers. Attention should also be paid to ensuring that medical students understand the importance of pain management and are knowledgeable about effective treatments as well as regulatory procedures. Research should be conducted or existing research examined, so that each state has documentation about the undertreatment of pain in its health care systems and about the difficulty patients have in obtaining effective pain management. State controlled-substances statutes that inaccurately define addict and addiction should be amended. State medical boards can do their part by educating their members and their licensees, by taking the steps necessary in their states to eradicate barriers to more effective pain management, and by ensuring that they are not contributing to the barriers. Statutes that affirmatively endorse the treatment of intractable pain are problematic. Regulations and guidelines may focus attention on the undertreatment of pain, but they are unlikely to correct serious deficiencies of knowledge among state medical board members and their staffs. The use of pain management experts to train board members and their staffs and to serve as expert witnesses in disciplinary hearings would immediately improve the quality of the decisions made in cases involving the prescribing of controlled substances, particularly opioids, for the treatment of pain. Acknowledgments The author is grateful to Beatrice S. Frank, Kenneth D. Hurwitz, and the journal's peer reviewers for their comments on earlier drafts of this article. |
Copyright 2001. ASLME. All Rights Reserved.
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